4th HIV Research For Prevention Conference (HIVR4P Virtual), 27 & 28 January 3 & 4 February 2021

Abstract Supplement
4th HIV Research for Prevention

conference (HIVR4P // Virtual)
27 & 28 January | 3 & 4 February 2021
Volume 24, Supplement 1, February 2021

Abstract Supplement
4th HIV Research for Prevention
conference (HIVR4P // Virtual)
Contents
Oral Abstracts 1
Poster Abstracts
Behavioural and social science research 55
Broadly neutralizing an bodies 81
Cellular immunity 87
Clinical trial results 89
Community engagement in preven on research 91
Contracep on, pregnancy and HIV preven on (incl. PMTCT) 97
COVID research: Applying lessons from HIV preven on to SARS CoV-2 102
Delivery technologies: Novel approaches, formula on and mul -purpose 110
Demand crea on, market research, human-centred design 114
Epidemiology of HIV 115
Ethics in HIV preven on research 124
High-throughput datasets in preven on science 125
HIV sequencing insights including viral diversity and an retroviral resistance 125
Humoral immunity 126
Implementa on science, including structural interven ons, PrEP & VMMC 130
Innate and trained immunity 150
Mathema cal modelling: Impact and effec veness 151
Microbiome & STI: Impact on preven on 152
Mucosal immunity 156
Novel vaccine and other preven on approaches 159
Pharmacology/PK and PD studies 161
Policy and advocacy 164
Preclinical studies for HIV preven on 167
Product acceptability and adherence 169
Tes ng: Technology, coverage, viral load, point of care, CD4 count 174
Therapeu c vaccines, viral reservoirs and eradica on/remission 175
Transmission of HIV 176
Treatment as preven on 181
Publication only Abstracts

Behavioural and social science research 184
Broadly neutralizing an bodies 194
Cellular immunity 195
Community engagement in preven on research 196
Volume 24, Supplement 1

February 2021
Contracep on, pregnancy and HIV preven on (incl. PMTCT) 197
COVID research: Applying lessons from HIV preven on to SARS CoV-2 197
Delivery technologies: Novel approaches, formula on and mul -purpose 199
Demand crea on, market research, human-centred design 201
Epidemiology of HIV 202
HIV sequencing insights including viral diversity and an retroviral resistance 203
Humoral immunity 204
Implementa on science, including structural interven ons, PrEP & VMMC 205
Mathema cal modelling: Impact and effec veness 211
Microbiome & STI: Impact on preven on 211
Mucosal immunity 212
Novel vaccine and other preven on approaches 213
Policy and advocacy 216
Preclinical studies for HIV preven on 218
Product acceptability and adherence 218
Tes ng: Technology, coverage, viral load, point of care, CD4 count 220
Transmission of HIV 221
Treatment as preven on 223
Author Index 224

Journal of the International AIDS Society 2021, 24(S1):e25659
http://onlinelibrary.wiley.com/doi/10.1002/jia2.25659/full | https://doi.org/10.1002/jia2.25659
ORAL ABSTRACTS
OA01.01 OA01.02
Evaluation of the kinetics of systemic distribution of IV Monoclonal antibodies with ultra-long CDRH3 derived from
injected monoclonal antibodies modified to alter host vaccinated cows show exceptional neutralisation potency
mediated Fc interaction in the rhesus macaque model and breadth that is retained after Fc engineering
A.M. Carias1; J. Schneider2; M. McRaven1; S. Xiao1; K. Rogers3; B. Heydarchi1; D. Fong1; A. Sethi2; J. Edwards1; N. Salazar Quiroz1;
M. Araınga3; R. Veazey4; F. Villinger3 and T.J Hope1 T. Aktepe1; C. Gonelli1; S. Grimley1; C. Mackenzie1; B. Wales3;
1
Northwestern University, Cell and Developmental Biology, Evanston, M. van Gils4; R. Sanders4; P. Gooley2; I. Rouiller2 and D. Purcell1
1
United States, 2Rush University, United States, 3New Iberia Research University of Melbourne, Doherty Institute, Melbourne, Australia,
2
Center, United States, 4Tulane National Primate Research Center, Uni- University of Melbourne, Bio21 Molecular Science and Biotechnology
ted States Institute, Melbourne, Australia, 3Dairy Production Sciences, Victorian
Department of Economic Development, Jobs, Transport and
Resources, Australia, 4Academic Medical Center, University of Amster-
Background: Antibody-mediated protection against HIV/SHIV trans- dam, Department of Medical Microbiology, Amsterdam, Netherlands
mission has been illustrated in non-human primates (NHP) with IV
injection of broadly neutralizing monoclonal antibodies (bNAbs). To
gain insights into the kinetics and dynamics of BNAb distribution and Background: A vaccine against HIV would ideally elicit broadly neu-
localization, we utilized passively transferred fluorophore-labeled tralising antibodies (BrNAbs). In HIV+ patients these immunoglobulins
VRC01, developing a platform in the living NHP model, without affect- (Ig) are rare and often display long third heavy complementarity
ing antibody function. After injection, we followed antibody distribu- determining regions (CDRH3) with high levels of somatic hypermuta-
tion over time, providing a unique perspective to observe how bNAbs tion. The average length of bovine Ig-CDRH3 is notably longer than
reach different anatomical sites. Using this platform, with anti-FcRn other species and has potential for raising novel BrNAbs. We previ-
and mutated Fc-function bNAbs, we are now unraveling the mecha- ously showed that cows vaccinated with HIV envelope (Env) produced
nisms of how FcR specificity affects antibody distribution. BrNAbs that target the CD4 binding site (CD4bs). Here we used a
Methods: Macaques were IV-administered fluorescently tagged, anti- stabilized trimer gp140 SOSIPv4.1 from the neutralisation resistant
FcRn, or a combination of VRC07-523-LS and/or Fc-mutated VRC07- ADA subtype-B strain to select a lineage of chimeric human mono-
523-LS-LALA (LALA) (mutated to disrupt FcR binding and comple- clonal BrNAbs containing bovine V-regions with ultra-long CDRH3.
ment) and/or VRC07-523-LS-DEL (DEL) (mutated to enhance FcgRIII Methods: To produce monoclonal BrNAbs (mAbs), bovine memory B-
antibody binding and ADCC activity). Animals were necropsied cells were isolated from cows vaccinated with AD8 gp140 (clade B),
between 6 hours and 1 week, tissues collected and imaged with AD8 SOSIP gp140v4.1 or KNH1 SOSIP gp140 and BG505 SOSIP.664
deconvolution microscopy. gp140. The IgG+, SOSIP gp140 v4.1 AD8+ cells were FACS-sorted
Results: By analyzing those animals that received fluorescently and variable heavy (VH) and light (VL) genes were amplified and
tagged anti-FcRn, we are now able to discern the cellular locations of cloned into human constant region expression vectors. The mAbs were
FcRn: on endothelial cells and select monocytes. Additionally, in colum- expressed and characterised for Env binding and neutralisation
nar and brain tissues, we are able to visualize antibody distribution activity.
through the vascular system, with antibody-FcRn interactions. Lastly, Results: Among many Env binding mAbs, fourteen showed heterolo-
although studies are still ongoing, we visualize differences in VRC07- gous neutralisation with CDRH3 length of 12 to 61 residues. Six
523-LS, VRC07-523-LS-LALA and VRC07-523-LS-DEL distribution mAbs with shorter-length CDRH3 showed modest neutralisation
amongst different tissues, across multiple time points. against tier 1 clade B viruses. Another six mAbs with ultra-long
Conclusions: These data build on our previous data looking at the CDRH3 could neutralise tier 1 and tier 2 of clade B and clade C as
distribution and localization of fluorescently labeled anti-HIV bNAbs. well as tier 2 of clade A HIV virus. But three common-lineage mAbs
However, and importantly, these studies provide novel insights into Fc isolated from a KNH1/BG505 SOSIP vaccinated cow were highly
receptor-associated mechanisms of antibody delivery to different potent (IC50 ~0.001 μg/ml) in neutralising the global panel of twelve
organs and tissues after IV injection into multiple animals. These HIV pseuodoviruses in the TZM-bl assay. Binding and neutralisation of
experiments will provide critical insights into the mechanism(s) of dis- Env mutant pseudoviruses confirmed these three potent bovine mAbs
tribution and localization of systemic antibodies by following the time bound the CD4 binding site and required contact residues in C3, C4
course of distribution of passively transferred antibodies in a gain or and C5 of gp120. These potent mAbs strongly out-competed VRC01
loss of function experimental fashion. and other elite human BrNAbs for binding the CD4bs, yet were not
polyreactive with human antigens. Antigen binding activity of these
bovine V-region chimeric mAbs was fully retained after re-engineering
cellular-immune functionality into the human IgG Fc region.
Conclusions: BrNAbs with novel structured ultra-long CDRH3 from
Env vaccinated cows give new insights into conserved gp120-CD4bs
epitopes.
1
Conclusions: HIV-negative serum IgA, and to a lesser extent HIV-

OA01.03 positive IgA, reduced the functional capacity of HIVIG and BnAbs, sug-
FcɣRIIa rs10800309 polymorphism is an HLA-B57 and gesting IgA may inhibit through two mechanisms: epitope competition
HLA-B27 independent predictor of HIV control and IgA-FcaR mediated inhibitory mechanisms. Understanding the
C. Moog1; R. Carapito2; L. Mayr2; A. Molitor2; M. Verniquet2; mechanisms behind why IgA inhibits Fc responses could lead to
O. Tahar2; P. Marialuisa3; D. Rey3; O. Lambotte4; S. Schmidt2 and improved future HIV vaccine design and educate passive transfer
S. Bahram2 monoclonal antibody therapies.
1
U1109, Institute of Virology, France, 2U1109, France, 3NHC Stras-
bourg, France, 4U1018, France OA01.05LB
Opening the HIV-1 envelope for neutralization and
Background: Fcɣ receptors (FcɣRs) are key immune regulatory recep- antibody-dependent cellular cytotoxicity
tors that connect antibody mediated immune responses to cellular D.N. Nguyen1; J. Richard2; W.D. Tolbert1; R. Gasser2; S. Ding2;
effector functions. They are involved in the control of various immune D. Vezina2; S.Y. Gong2; G. Gendron-Lepage2; H. Medjahed2;
functions including responses to infections. Genetic polymorphisms of S. Gottumukkala2; J. Pre vost2; A. Finzi2 and M. Pazgier1
1
FcɣRs coding genes (FCGR) have been associated with the regulation Uniformed Services University of the Health Sciences, Medicine,
of HIV infection and progression. Bethesda, United States, 2Centre de Recherche du Centre Hospitalier
Methods: In this study we analyzed the potential impact of five can- de l’Universite de Montreal (CRCHUM), Montre al, Canada
didate FcɣR SNPs on viral control by genotyping 251 HIV controllers
and 250 progressors.
Results: The rs10800309 AA genotype of the FcɣRIIa coding gene Background: The apparent successes of cancer cure strategies that
FCGR2A was found to be significantly associated with HIV control are based on therapeutic antibodies have caused a re-evaluation of
and this association was independent of HLA-B57 and HLA-B27 (OR, the potential for similar strategies to achieve a functional HIV cure.
2.84; 95% CI, 1.20 to 6.89; Pcor = 0.033). We further confirmed the However, most of the currently explored antibody-based therapies
functional role of this polymorphism by showing an association of this and eradication strategies are based on broadly neutralizing antibod-
same AA genotype with an increased in vitro FcɣRII expression on ies. By contrast, strategies for a functional cure using non-neutralizing
myeloid cells including dendritic cells (p = 0.0032). Abs (nnAbs) known to eliminate HIV-infected cells through Fc recep-
Conclusions: Together, these results suggest that the AA genotype of tor (FcR) effector functions including antibody-dependent cell medi-
rs10800309 confers an improved immune response through FcɣRII ated cytotoxicity (ADCC) remain a significant yet largely unexploited
upregulation in favor of a role of Fc mediated inhibition in HIV control. avenue of research.
Moreover, this polymorphism may serve as an additional predictive Highly conserved CD4 inducible (CD4i) epitopes within the constant
marker of HIV control. region 1 and 2 (C1C2 or Cluster A) and the co-receptor binding site
(CoRBS) have been shown to be suitable targets for Abs capable of
inducing ADCC against infected cells expressing Env in an “open” con-
OA01.04 formation. As strictly CD4 dependent, these potent ADCC targets
Serum IgA inhibits HIV-specific broadly neutralising become available for Ab recognition upon triggering of Env trimer
antibody Fc functions with cell surface CD4 therefore are occluded and not accessible for
S. Davis; A. Chung and S. Kent Ab targeting on infected cells where expression of CD4 is downregu-
The Peter Doherty Institute for Infection and Immunity, Department lated.
of Microbiology and Immunology, Australia Methods: Here we present a structure-based design of new CD4-
antibody fusion molecules and evaluate their abilities to sensitize HIV-
1-infected cells to ADCC-mediated killing. We developed two classes
Background: The importance of antibody Fc functions were high- of Ab fusion proteins in which domains 1 and 2 of soluble human
lighted in the human HIV RV144 vaccine trial, however, serum IgA CD4 are linked with either a C1C2 (class 1) or a CoRBS (class 2)
reduced vaccine efficacy and Fc functions. Elucidating how serum IgA specific monoclonal antibody through a flexible (G4S)6(G4T)2-linker. We
modulates Fc responses is essential. Furthermore, macaque HIV- found optimal conjugation sites and linker lengths that allows each of
broadly neutralizing antibodies (BnAbs) passive transfer studies sug- these novel bispecific fusion molecules to recognize the native “closed”
gest a vital role of Fc functions in protection. Here we endeavour to Env trimers and to initiate the structural rearrangements required for
determine if serum IgA influences the Fc capacity of IgG from HIV exposure of these conserved Env epitopes.
individuals or BnAbs. Results: Our in vitro functional testing shows that these fusion pro-
Methods: Pooled purified IgG from HIV individuals (HIVIG) along teins efficiently target and eliminate HIV infected cells through ADCC
with a panel of BnAbs including PGT121 and VRC01, currently in activity. Surprisingly, attaching sCD4 to these otherwise non-neutraliz-
human clinical trials, were assessed for their Fc functional capacity. ing parent cluster A and CoRBS specific Abs has rendered them
The influence of IgA upon IgG was assessed by adding pooled HIV- potent neutralizing activity against tier 1 and 2 viruses. Competition
specific IgA (n = 10), pooled HIV-negative IgA (n = 10), IgA1 or IgA2 experiments reveal that these biological activities rely on both Ab and
and colostrum IgA. CD4 moieties interaction with Env.
Results: HIV-specific IgA showed minor inhibition of phagocytosis Conclusions: Altogether, our results raise the exciting possibility of
(median = 10.38%, IQR = 8.09%, p > 0.05). Intriguingly, significant using these fusion proteins in the ongoing efforts to achieve a func-
inhibition was observed when HIV-negative IgA was added (me- tional cure.
dian = 21.24%, IQR = 14.28%, p < 0.001). Similarly, significant inhibi-
tion was observed with IgA1 (median = 23.11%, IQR = 18.18%,
p < 0.001), IgA2 (median = 19.88%, IQR = 4.60%, p < 0.001) and
colostrum IgA (median = 23.31%, IQR = 5.76%, p < 0.001) when
added to HIVIG and BnAbs. Addition of FcaR block to these assays
was capable of reconstituting Fc functions, suggesting that IgA inhibi-
tion is mediated through IgA-FcaR binding.
2
infection, 241 (47%) were chronically infected, and 72 (14%) had inde-
OA02.01 terminate recency at time of diagnosis. We detected a greater per-
Profiling the HIV epidemic with recency of infection centage of recent infections in 2019 than 2018 (44% vs. 35%,
instead of recency of diagnosis: 2 years of experience in p = 0.06). By comparing the characteristics of recent versus chronic
North Carolina, USA infection at diagnosis, we found that young people were more likely to
S. Zhou1; S. Sizemore2; M. Moesers1; S. Zimmerman3; E. Samoff3; be diagnosed in the recent infection stage (p < 0.01), and individuals
V. Mobley3; S. Frost4; A. Cressman5; J. Eron2; M. Clark1; C. Jones2; diagnosed with recent infection were more likely to be in active trans-
M. Cohen2; J. Nelson1; R. Swanstrom1 and A. Dennis6 mission clusters than those with chronic infection (p < 0.01). K103N
1
University of North Carolina, Lineberger Comprehensive Cancer was the most commonly seen DRM (approximately 10%) while other
Center, Chapel Hill, United States, 2University of North Carolina, Cha- clinically significant DRMs were rarely seen.
pel Hill, United States, 3North Carolina Department of Health and Conclusions: We demonstrate an all-in-one platform to monitor HIV-
Human Services, United States, 4Microsoft Research, United States, 1 recency, DRMs, and phylogenetically linked transmission clusters in
5
University of North Carolina, Globl Health and Infect Disease, Chapel near real-time. We believe this approach has the potential to be a use-
Hill, United States, 6University of North Carolina, Infectious Diseases, ful tool as part of public health efforts to reduce new infections by
Chapel Hill, United States monitoring the percentage of recency among new HIV diagnoses and
providing opportunity to interrupt transmission within clusters.
Background: The identification of recent (incident) HIV infections OA02.02

among people who are initially diagnosed for the first time is critical
Correlates of high HIV transmission areas in a generalized
to HIV prevention. We developed a Multiplexed Primer ID-Next Gen
Sequencing (MPID-NGS) approach to identify recent infection by mea-
hyperendemic setting: findings from a national survey in
suring the intra-host viral diversity over multiple regions of the HIV Eswatini
genome. We examined the field implementations of MPID-NGS to N.M. Philip1; G.S. Lovasi2; R. Nkambule3; Q. Abdool Karim4;
identify recent infection and drug resistance mutations (DRMs) among J. Justman1 and B. Mathema5
1
persons with new HIV diagnoses reported by the North Carolina ICAP at Columbia University, Mailman School of Public Health, New
State Laboratory of Public Health in 2018 and 2019. York, United States, 2Drexel University, Dornsife School of Public
Methods: The MPID-NGS libraries were constructed for protease Health, United States, 3Ministry of Health, Department of Health Ser-
(PR), partial reverse transcriptase (RT), integrase (IN), and the V1 to vices - Public Health, Eswatini, 4Centre for AIDS Programme of
V3 region of the env gene using remnant serological diagnostic tests. Research in South Africa (CAPRISA), Durban, South Africa, 5Columbia
New diagnoses were restricted to sera collected within 30 days of University, Mailman School of Public Health, New York, United States
HIV diagnosis dates. The MiSeq platform was used for sequencing.
The TCS-DR pipeline was used for bioinformatics analysis and to iden-
tify DRMs. Recent infection was defined as infection <9 months old, Background: Small areas with high uncontrolled HIV infection pro-
and the RT and V1/V3 regions were used to assess recency. We mote ongoing transmission and micro-epidemics. Whether they result
examined factors associated with recency using surveillance data. from geographic clustering of multiple HIV risk factors is unknown but
Results: A total of 515 persons with new diagnoses from 2018 to key to designing place-based, combination interventions for epidemic
2019 were successfully sequenced. Overall, 202 (39%) had recent control.
Abstract OA02.02-Figure 1.
3
Methods: A nationally representative, household-based sample of Conclusions: We observed limited progress on TasP in Africa and lit-
adults, ages 18 to 49 years, was enrolled from December 2010 to tle prospect of reaching global targets for HIV/AIDS elimination. Vary-
June 2011 from 575 enumeration areas in Eswatini. Consenting adults ing outcomes in countries at the same development level suggest
completed an interview and rapid HIV testing. Viral load was inadequate resource allocation and low effectiveness of HIV/AIDS
quantified using the COBAS AmpliPrep/Taqman HIV-1 Test, v 2.0. programs. Although some funding agencies are considering withdrawal
Multi-level latent class modeling identified statistically significant com- from supporting Africa, more fattention to funding and expanding test-
binations of biomedical and behavioral risk factors and classified the ing and treatment are needed in this region.
combinations into small (enumeration) area risk profiles, categorized
by HIV risk types. Linear regression assessed the correlation between OA02.04
area profiles and area prevalence of detectable viremia (≥20 copies/
HIV prevalence and incidence among FSWs participating in
milliliter) among all adults regardless of HIV status.
Results: 18,172 surveyed adults were categorized into one of six HIV
a HIV vaccine preparedness study in Dar es Salaam,
risk types, each showing a unique pattern of five risk factors that con- Tanzania
veyed HIV transmission and/or acquisition risk propensity. The three D. Faini1; F. Msafiri2; P. Munseri3; M. Bakari4; A. Joachim2; T. Nagu3;
most frequent composite prevalences of HIV risk types were catego- E. Tarimo5; E. Lyamuya2; E. Sandstro €m6; G. Biberfeld6; C. Nilsson6;
6 6
rized into area profiles: low-moderate acquisition (low), moderate C. Hanson and S. Aboud
1
acquisition/transmission (moderate), and high acquisition/transmission Muhimbili University of Health and Allied Sciences, Epidemiology and
(high). Detectable viremia prevalence increased from low [17.7%], Biostatistics, Tanzania, United Republic of, 2Muhimbili University of
moderate [25.4%], and high [35.1%] profiles and was 7.4% [p < .001] Health and Allied Sciences, Microbiology and Immunology, Tanzania,
and 17.1% [p < .001] higher in moderate and high profile areas, United Republic of, 3Muhimbili University of Health and Allied
respectively, when compared with low profile areas. High profile areas Sciences, Internal Medicine, Tanzania, United Republic of, 4Ministry of
comprised the largest proportions of the highest transmission/acquisi- Health, Community Development, Gender, Elderly, and Children, Tan-
tion risk types. The two highest risk types, high acquisition and very zania, United Republic of, 5Muhimbili University of Health and Allied
high transmission risk adults, were seronegative and undiagnosed Sciences, Tanzania, United Republic of, 6Karolinska Institute, Stock-
seropositive, respectively, with the greatest likelihood of no prior HIV holm, Sweden
testing, multiple partnerships, and partners with unknown status.
Conclusions: Area HIV risk profiles can explain variation in area HIV
viral measures. Co-location of higher transmission and acquisition risk Background: PrEPVacc is a phase IIb multicenter HIV vaccine trial
types in small areas may enable uncontrolled HIV viremia and geo- planned to be conducted at five sites in four sub-Saharan African
located sources of transmission. countries that aims to evaluate safety and efficacy of two combina-
tions of HIV vaccine regimens; HIV DNA + gp120/alum and HIV
DNA, MVA + gp140/MPLA. A PrEPVacc HIV-negative registration
OA02.03 cohort study was established to determine HIV prevalence and inci-
Progress toward HIV elimination goals: trends in and dence among female sex workers (FSW) in Dar es Salaam, Tanzania.
projections of treatment as prevention strategy in 38 Methods: Between October and December 2018, a total of 773
African countries FSW aged 18–45 years were screened for eligibility and 700 were
P. Nguyen1; S. Gilmour1; P. Le1; K. Onishi1; K. Kato2 and H. Nguyen1 enrolled. At screening and at 3-monthly follow-up visits, demographics
1
St. Luke’s International University, Graduate School of Public Health, and risky behavioural assessment and collection of blood samples
Japan, 2Kanto Rosai Hospital, Department of Obstetrics and were done. HIV testing was performed using two sequential rapid
Gynaecology, Japan diagnostic tests; SD Bioline HIV1/2 and Uni-Gold HIV-1/2. HIV reac-
tive samples were confirmed using Siemens Enzygnost HIV Integral 4
ELISA. Logistic regression was used to estimate odds Ratios for fac-
Background: We aimed to estimate the trends and projections of tors associated with HIV prevalence. Time-to-event analysis was per-
indicators of Treatment-as-Prevention (TasP), the key global strategy formed using Poisson regression to estimate HIV incidence. Women
for HIV elimination in Africa, and to calculate the probability of reach- were censored at 12 months of follow-up or earliest date of HIV
ing key UNAIDS targets. seroconversion. Date of seroconversion was assumed to be midway
Methods: We included 1,456,224 sexually active adults age 15 to 49 between last negative and first positive HIV test results.
in 38 African countries from 112 nationally representative population- Results: HIV prevalence at screening was 8% (59/773), associated
based surveys 2003 to 2018. Bayesian mixed-effect models were with older age (p < 0.001), lower education levels (p < 0.001) and
applied to estimate the prevalence of annual HIV testing and condom being single (either never married or separated/divorced/widowed)
use for every country and year to 2030, and the probability of reach- (p < 0.001). FSWs who reported being raped or having used drugs,
ing UNAIDS targets in 2020 and 2030. were more likely be HIV-infected than their counterparts (p = 0.01
Results: Most countries have upward trends in TasP outcomes, but and p = 0.002, respectively). Attendance at 12 months was 80%
seven saw downward trends in annual HIV testing and five saw (560/700) with women in the cohort contributing a total of 609 per-
decreases in condom use (Figure 1). The highest coverage of annual son-years-at risk (PYR). Twenty-one FSWs seroconverted with the HIV
HIV testing in 2030 is predicted in Swaziland with 92.6% (95% CrI: incidence rate in the cohort of 3.45 per 100 PYRS (95% CI; 2.25 to
74.5%-98.1%), Uganda with 90.5% (72.2%-97.2%) and Lesotho with 5.28/100 PYRS).
90.5% (69.4%-97.6%). Meanwhile, Swaziland, Lesotho, and Namibia Conclusions: HIV prevalence and incidence were high among FSW in
will have the highest proportion of condom use in 2030 at 85.0% Dar es Salaam. These findings demonstrate feasibility of recruiting
(57.8%-96.1%), 75.6% (42.3%-93.6%), and 75.5% (42.4%-93.2%). The FSW for HIV vaccine prevention trials.
probabilities of reaching targets range from 0% to 28.5% for HIV test-
ing and 0% to 12.1% for condom use and no country showed a high
probability (>50%) of meeting either target (Table 1).
4
Abstract OA02.03-Table 1. Estimated coverage and annual rate of change (ARC) of annual HIV testing and condom use in 38 African countries, 2003–2030
Annually tested for HIV (95% Credible Interval) Condom used at last sex (95% Credible Interval)
% reaching % reaching
Country 2003 2010 2020 2030 ARC (%) targets* 2003 2010 2020 2030 ARC (%) targets*
Angola 49.0 (31.2, 67.8) 61.1 (42.2, 77.1) 76.0 (53.3, 89.5) 86.5 (61.9, 96.2) 4.3 (0.4, 9.6) 6.0% 9.6 (4.1, 20.8) 11.6 (5.7, 22.4) 14.9 (6.8, 29.6) 18.9 (6.8, 42.3) 0.0 (4.6, 4.9) 0.0%
Benin 44.1 (27.6, 61.6) 43.2 (27.5, 60.6) 42.2 (24.2, 62.7) 41.1 (19.2, 67.0) 3.2 (6.8, 0.4) 0.0% 7.4 (3.7, 14.1) 8.2 (4.4, 14.7) 9.5 (4.8, 18.1) 11.0 (4.5, 24.7) 1.3 (5.3, 2.6) 0.0%
Burkina Faso 45.2 (28.4, 62.7) 48.3 (28.9, 68.1) 52.8 (24.6, 79.1) 57.1 (18.5, 88.9) 1.0 (6.9, 5.2) 0.3% 11.6 (5.9, 21.2) 13.7 (6.9, 25.2) 17.4 (6.9, 36.9) 21.7 (5.8, 54.2) 0.1 (5.5, 4.9) 0.0%
Burundi 46.2 (29.4, 63.9) 49.8 (32.3, 67.6) 55.0 (33.4, 75.1) 60.4 (31.6, 83.3) 0.7 (4.7, 3.4) 0.0% 5.1 (2.2, 10.9) 5.1 (2.5, 9.8) 5.1 (2.3, 10.7) 5.1 (1.7, 14.2) 2.8 (7.7, 1.7) 0.0%
Cameroon 45.5 (28.8, 63.3) 46.5 (29.6, 64.2) 47.8 (25.8, 70.8) 49.3 (20.3, 78.1) 2.2 (6.7, 2.3) 0.0% 17.5 (9.4, 30.5) 22.5 (12.8, 36.3) 31.1 (16.4, 51.4) 41.3 (18.0, 70.1) 1.6 (3.0, 6.5) 0.0%
Central Africa 45.4 (28.0, 63.6) 48.7 (29.3, 68.7) 53.3 (24.3, 80.3) 57.9 (18.0, 89.9) 0.9 (6.9, 5.5) 0.3% 8.2 (3.8, 16.8) 9.5 (4.4, 19.0) 11.6 (4.3, 27.4) 14.0 (3.5, 41.5) 0.6 (6.0, 5.0) 0.0%
Chad 47.4 (30.4, 65.1) 54.0 (35.6, 70.9) 63.6 (40.3, 81.9) 71.9 (40.7, 90.6) 1.1 (3.3, 5.7) 0.2% 4.2 (2.0, 8.2) 3.8 (2.0, 7.3) 3.4 (1.4, 7.8) 3.0 (0.9, 9.6) 4.1 (9.0, 0.3) 0.0%
Comoros 44.7 (27.8, 63.0) 45.9 (28.0, 64.9) 47.9 (22.5, 74.3) 49.8 (16.3, 83.0) 2.0 (7.5, 3.5) 0.0% 9.4 (4.2, 19.4) 11.0 (5.2, 21.7) 14.0 (5.6, 30.8) 17.7 (5.0, 46.6) 0.2 (5.4, 5.2) 0.0%
Congo 42.8 (26.3, 60.6) 41.6 (25.3, 59.5) 40.1 (21.1, 63.0) 38.3 (15.1, 68.5) 3.4 (7.7, 1.0) 0.0% 14.4 (7.6, 25.8) 18.4 (10.3, 30.6) 25.2 (12.8, 43.1) 33.6 (14.1, 60.9) 1.2 (3.1, 5.9) 0.0%
Cote dÌvoire 43.9 (27.6, 61.9) 45.2 (28.5, 63.2) 47.3 (26.5, 69.0) 49.1 (22.4, 76.1) 2.0 (5.9, 2.2) 0.0% 14.1 (7.3, 25.4) 16.6 (9.1, 27.8) 20.8 (10.6, 36.7) 25.6 (10.3, 50.2) 0.1 (4.7, 4.1) 0.0%
DR Congo 44.7 (28.1, 62.6) 46.7 (29.6, 64.5) 49.3 (27.0, 72.1) 52.2 (21.9, 80.6) 1.7 (6.2, 2.9) 0.0% 6.7 (3.3, 13.0) 7.4 (3.9, 13.7) 8.4 (3.8, 17.3) 9.5 (2.9, 25.8) 1.5 (6.4, 3.3) 0.0%
Ethiopia 46.8 (30.1, 64.3) 54.9 (37.0, 71.4) 65.9 (43.7, 82.8) 75.6 (46.8, 91.4) 1.9 (2.3, 6.3) 0.2% 5.2 (2.6, 10.2) 5.5 (2.9, 10.3) 5.9 (2.7, 12.3) 6.3 (2.1, 16.7) 2.1 (6.4, 2.1) 0.0%
Gabon 47.1 (29.7, 65.4) 54.2 (34.6, 72.3) 63.8 (36.5, 84.4) 72.8 (35.0, 93.2) 1.3 (4.0, 7.1) 0.8% 20.9 (9.9, 39.2) 28.8 (15.4, 47.3) 42.7 (21.3, 67.6) 58.0 (25.1, 86.1) 3.3 (2.3, 9.9) 0.4%
Gambia 42.5 (25.5, 60.9) 39.2 (23.9, 57.0) 34.3 (18.2, 55.5) 30.0 (12.2, 57.1) 4.7 (8.5, 0.6) 0.0% 5.4 (2.5, 11.2) 5.9 (3.0, 11.4) 6.8 (2.9, 15.2) 7.7 (2.2, 23.2) 1.5 (6.5, 4.1) 0.0%
Ghana 41.2 (25.2, 59.4) 39.5 (24.4, 57.3) 36.7 (18.9, 59.6) 34.3 (12.9, 65.2) 3.8 (8.1, 1.0) 0.0% 11.4 (6.1, 20.6) 12.7 (7.2, 21.5) 14.8 (7.1, 28.3) 17.2 (6.1, 38.1) 1.1 (5.8, 2.8) 0.0%
Guinea 44.8 (28.6, 62.6) 43.4 (27.5, 60.8) 40.9 (22.7, 62.2) 38.6 (16.7, 65.6) 3.7 (7.6, 0.0) 0.0% 8.9 (4.5, 16.8) 10.2 (5.6, 17.8) 12.4 (6.3, 23.0) 15.0 (6.3, 32.1) 0.7 (4.8, 3.3) 0.0%
Kenya 49.0 (31.9, 66.3) 60.9 (42.4, 76.5) 75.7 (52.9, 89.5) 86.1 (60.4, 96.2) 4.2 (0.5, 9.7) 6.2% 10.9 (5.7, 19.9) 14.6 (8.0, 25.1) 21.4 (10.3, 39.4) 30.5 (11.9, 60.4) 1.9 (2.2, 6.9) 0.0%
Lesotho 50.6 (32.6, 68.6) 64.6 (45.9, 79.2) 80.6 (60.1, 92.0) 90.5 (69.4, 97.6) 5.6 (0.4, 11.4) 17.5% 22.5 (12.0, 38.3) 34.9 (21.3, 51.3) 56.4 (33.1, 77.8) 75.6 (42.3, 93.6) 6.0 (0.3, 13.2) 3.8%
Liberia 46.1 (29.6, 64.0) 51.2 (32.9, 69.1) 58.5 (32.5, 80.6) 65.3 (28.8, 89.4) 0.1 (4.9, 5.6) 0.2% 8.8 (4.3, 17.1) 10.4 (5.3, 19.1) 12.8 (5.6, 26.9) 15.7 (4.9, 39.9) 0.5 (5.4, 4.6) 0.0%
Madagascar 43.3 (27.1, 61.1) 38.1 (22.4, 57.8) 31.2 (12.9, 57.9) 25.0 (5.9, 61.6) 5.7 (11.2, 0.4) 0.0% 3.6 (1.7, 7.2) 2.9 (1.5, 5.6) 2.2 (0.8, 5.9) 1.6 (0.3, 6.9) 5.7 (12.0, 0.2) 0.0%
Malawi 47.5 (30.8, 65.0) 55.4 (38.0, 71.8) 66.0 (45.2, 82.1) 75.3 (49.9, 90.4) 1.7 (2.1, 5.7) 0.1% 9.2 (4.6, 17.1) 12.5 (6.8, 21.6) 18.9 (9.8, 33.6) 27.4 (11.9, 52.3) 2.0 (1.7, 6.9) 0.0%
Mali 45.1 (28.8, 62.8) 45.1 (28.4, 62.3) 45.5 (25.8, 66.8) 45.8 (20.1, 73.0) 2.6 (6.7, 1.4) 0.0% 3.7 (1.8, 7.4) 4.1 (2.2, 7.7) 4.7 (2.2, 9.6) 5.3 (1.8, 15.5) 1.5 (5.8, 3.6) 0.0%
Mozambique 50.6 (32.8, 68.6) 58.3 (40.2, 74.2) 68.8 (46.5, 84.5) 77.3 (48.0, 92.4) 1.7 (3.3, 6.2) 0.4% 11.4 (6.0, 20.5) 15.3 (8.6, 25.6) 22.8 (11.6, 40.4) 32.4 (14.0, 60.5) 2.0 (1.9, 6.9) 0.0%
Namibia 49.2 (31.7, 67.3) 61.6 (42.5, 77.5) 76.4 (52.0, 90.7) 86.8 (58.5, 97.0) 4.4 (1.0, 10.4) 9.1% 32.0 (17.6, 51.2) 43.4 (27.1, 61.3) 60.7 (37.0, 80.3) 75.5 (42.4, 93.2) 4.2 (1.8, 10.8) 2.7%
Niger 44.3 (27.5, 62.0) 44.8 (27.5, 63.5) 45.8 (21.4, 71.7) 46.9 (14.3, 80.7) 2.4 (7.8, 3.0) 0.0% 2.2 (1.0, 4.6) 1.8 (0.9, 3.6) 1.4 (0.5, 3.8) 1.0 (0.2, 4.7) 5.5 (12.0, 0.3) 0.0%
Nigeria 41.0 (24.6, 59.5) 42.2 (26.6, 60.0) 44.2 (25.4, 65.2) 46.1 (21.3, 73.6) 2.0 (5.9, 2.7) 0.0% 8.3 (4.4, 15.1) 9.8 (5.4, 17.0) 12.2 (6.2, 22.6) 15.0 (6.2, 31.7) 0.4 (4.2, 3.3) 0.0%
Rwanda 47.7 (30.6, 65.1) 53.8 (35.7, 71.1) 62.5 (39.0, 81.1) 70.3 (38.5, 89.6) 0.8 (3.7, 5.3) 0.1% 7.1 (3.5, 13.7) 9.7 (5.2, 17.6) 14.9 (7.0, 29.9) 22.3 (8.1, 52.3) 2.0 (2.2, 8.2) 0.0%
Sao Tome 47.0 (29.9, 64.9) 52.5 (34.1, 70.4) 60.4 (35.9, 80.6) 67.7 (35.1, 89.3) 0.4 (4.2, 5.3) 0.1% 15.3 (7.5, 28.7) 20.6 (11.3, 34.3) 30.1 (15.3, 51.5) 41.8 (17.7, 72.6) 2.3 (2.5, 8.0) 0.0%
Principe
Senegal 44.9 (28.3, 62.7) 45.7 (29.7, 62.9) 46.5 (28.7, 65.4) 47.3 (25.4, 70.2) 2.4 (5.6, 0.9) 0.0% 6.5 (3.3, 12.5) 6.9 (3.9, 12.2) 7.4 (3.9, 13.8) 7.9 (3.3, 17.9) 2.1 (6.0, 1.6) 0.0%
Sierra Leone 43.2 (26.4, 61.6) 38.5 (23.2, 56.2) 31.9 (16.4, 52.8) 26.2 (10.0, 54.0) 5.4 (9.5, 1.4) 0.0% 5.2 (2.6, 10.4) 5.4 (2.9, 10.2) 5.7 (2.4, 12.4) 6.0 (1.7, 18.3) 2.3 (7.5, 2.6) 0.0%
South Africa 49.4 (31.6, 68.0) 62.4 (43.6, 78.0) 78.1 (56.6, 90.6) 88.4 (65.5, 96.8) 4.9 (0.0, 10.2) 9.6% 24.2 (10.6, 46.8) 34.2 (18.7, 53.9) 51.5 (30.4, 71.9) 68.4 (38.5, 88.5) 4.3 (0.9, 10.8) 0.5%
South Sudan 45.0 (27.8, 63.3) 47.5 (27.9, 67.4) 50.7 (22.4, 78.4) 54.4 (15.9, 87.8) 1.4 (7.5, 4.8) 0.2% 3.2 (1.4, 7.2) 3.0 (1.4, 6.6) 2.7 (0.9, 7.8) 2.4 (0.4, 10.7) 3.9 (10.3, 2.1) 0.0%
Swaziland 51.1 (33.1, 69.3) 66.4 (48.5, 80.5) 83.2 (64.0, 93.2) 92.6 (74.5, 98.1) 6.6 (1.2, 12.5) 28.5% 37.5 (21.5, 56.7) 51.7 (35.0, 67.5) 71.1 (48.9, 86.4) 85.0 (57.8, 96.1) 5.6 (0.3, 12.4) 12.1%
Tanzania 49.1 (32.0, 66.5) 57.9 (39.6, 74.2) 69.6 (45.0, 86.5) 79.4 (48.3, 94.1) 2.4 (2.7, 7.4) 1.3% 12.0 (6.5, 20.8) 13.7 (7.7, 23.0) 16.3 (8.3, 29.7) 19.5 (7.6, 40.3) 0.7 (5.0, 3.0) 0.0%
Togo 44.1 (27.3, 62.5) 44.8 (27.8, 63.6) 45.4 (23.9, 68.8) 46.3 (18.6, 77.2) 2.5 (7.0, 2.1) 0.0% 11.8 (5.7, 22.9) 14.4 (7.7, 25.2) 19.1 (9.3, 35.3) 24.8 (8.9, 52.2) 0.5 (4.5, 5.6) 0.0%
Uganda 49.8 (32.0, 67.9) 64.0 (45.8, 78.5) 80.5 (61.4, 91.2) 90.5 (72.2, 97.2) 5.8 (1.1, 10.8) 15.2% 9.9 (5.0, 18.5) 11.8 (6.4, 20.9) 15.3 (7.5, 28.8) 19.4 (7.5, 42.1) 0.0 (4.1, 4.4) 0.0%
Zambia 48.9 (31.6, 67.1) 60.7 (42.2, 76.5) 75.4 (52.4, 89.8) 85.9 (59.5, 96.4) 4.2 (0.9, 9.9) 6.5% 15.3 (7.7, 28.4) 19.4 (10.7, 32.8) 26.8 (13.0, 47.0) 35.9 (13.6, 66.3) 1.3 (3.6, 6.4) 0.0%
Zimbabwe 47.9 (30.6, 65.5) 59.9 (42.2, 75.1) 75.0 (55.1, 88.0) 85.6 (64.7, 95.1) 4.2 (0.1, 8.9) 3.0% 15.4 (8.0, 27.6) 20.4 (11.7, 32.9) 29.4 (16.3, 47.6) 40.3 (18.9, 66.4) 2.0 (2.2, 6.8) 0.0%
5
Abstract OA02.03-Figure 1. Trends of coverage in reporting annual HIV testing and condom use from 2003 to 2030 in 38 African countries
6
Abstract OA02.04-Table 1.
OA02.05LB was 1.32% annually (95% CI: 0.99 to 1.74) and higher in MSM and
TGW (8.84%, 95% CI: 5.40 to 13.65) or those with an STI (2.99%,
Risk factors for HIV transmission in heterosexual men, men
95% CI: 1.63 to 5.01). Based on multiplicity-adjusted univariate analy-
who have sex with men, and transgender women
ses, anal sex (HR 6.34, 95% CI: 3.45 to 11.66), transactional sex (HR
participating in the HVTN 702 “Uhambo” and HVTN 503/ 3.42, 95% CI: 1.80 to 6.51), and MSM or homosexual identity (HR
503-S “Phambili” HIV vaccine trials 15.62, 95% CI: 7.82 to 31.81) were significantly associated with HIV
M. Malahleha1; H. Janes2; F. Laher3; L.-G. Bekker4; B. S. Prigmore5; acquisition. In a multivariate model of published HIV risk factors, only
D. Grove5; J.J. Kee5; M. Allen6; M. Andrasik2; M. Atujuna4; N. Singh7; MSM and homosexual identity (HR 12.90, 95% CI: 4.03 to 41.29;
D. Kalonji8; G. Meintjes9; P. Kotze10; N. Grunenberg2; Y. Huang2; p < 0.001) was significantly associated with HIV acquisition.
Z. Moodie2; J. A. Odhiambo11; P. Smith4 and G. Gray11
1
Setshaba Research Centre, Clinical Research, Pretoria, South Africa, Abstract OA02.05LB-Table 1. Multivariate Cox proportional hazards
2
Fred Hutchinson Cancer Research Center, Vaccine and Infectious Dis- regression model characterizing the association between published
ease Division, Seattle, United States, 3Perinatal HIV Research Unit baseline HIV risk factors for African cisgender men and TGW, strat-
(PHRU), Vaccine Research, Soweto, South Africa, 4The Desmond Tutu ified by study and treatment arm. aMultiple imputation used to
HIV Centre, University of Cape Town, Institute for Infectious Disease impute missing data. HR = hazard ratio.
and Molecular Medicine, Cape Town, South Africa, 5Fred Hutchinson
Cancer Research Center, Statistical Center for HIV/AIDS Research & p-
Prevention, Seattle, United States, 6National Institute of Allergy and Category HR (95% CI) value
Infectious Diseases (NIAID), National Institutes of Health (NIH), Divi-
Age years: 22 to 25 versus 18 to 21 0.84 (0.38 to 1.86) 0.653
sion of Acquired Immunodeficiency Syndrome (DAIDS), Rockville, South
Age years: 26 to 35 versus 18 to 21 1.46 (0.70 to 3.05) 0.306
Africa, 7South African Medical Research Council (SAMRC), HIV Preven-
Number of sex partners: ≥2 1.96 (0.91 to 4.19) 0.083
tion Research Unit (HPRU), Verulam Clinical Research Site, Durban,
versus ≤ 1
South Africa, 8South African Medical Research Council (SAMRC), HIV
Exchange of sex for money/gifts: Yes 1.71 (0.81 to 3.61) 0.151
Prevention Research Unit (HPRU), Isipingo Clinical Research Site, Dur-
versus No
ban, South Africa, 9University of Cape Town, Faculty of Health Sciences,
Anal sex: Yes versus No 0.91 (0.30 to 2.77) 0.867
Clinical Platform of the Wellcome Centre for Infectious Diseases
Sex with alcohol/drug use: Yes 0.86 (0.46 to 1.58) 0.612
Research in Africa (CIDRI-Africa), Cape Town, South Africa, 10Qhakaza
versus No
Mbokodo Research Clinic, Clinical Research, Ladysmith, South Africa,
11 Circumcision at baseline: No versus 1.29 (0.66 to 2.51) 0.445
South African Medical Research Council, Parow Valley, South Africa
Yes
Heterosexual: No versus Yes 12.90 (4.03 to 41.29) <0.001
Background: South Africa has the highest HIV incidence globally. HIV Any STI: Yes versus No 2.11 (0.86 to 5.15) 0.097
risk has been extensively studied in South African cisgender women; how- a
Uhambo: median 1.8 years follow-up; Phambili: median 6 years
ever, less is known about risk drivers in cisgender men and transgender
follow-up.
women (TGW). We characterised HIV incidence, and sexual behaviours
and clinical characteristics associated with HIV acquisition, amongst cis-
gender men and TGW in two South African HIV vaccine efficacy trials. Conclusions: Identifying as MSM or homosexual is a strong predictor of
Methods: We included data from heterosexual cisgender men HIV acquisition in South African men and TGW. While overall incidence in
(HCM), men who have sex with men (MSM) and TGW who partici- cisgender men and TGW is low relative to women, subpopulations of cis-
pated in Uhambo (N = 1611 randomised to vaccine/placebo, 2016 to gender men and TGW experience exceptionally high incidence.
2020) and Phambili (N = 219 randomised to placebo, 2007 to 2011;
vaccinees excluded due to potential vaccine-increased risk). Cox pro- HY01.01LB
portional hazards models were used to associate baseline variables— VRC01 antibody prevention of HIV
self-reported last thirty-days (Uhambo) or six-months (Phambili) sexual L. Corey; P.B. Gilbert; N.M. Mgodi; S. Edupuganti and M.S. Cohen
behaviours and laboratory-confirmed STIs—with HIV acquisition.
Fred Hutchinson Cancer Research Center, Seattle, United States
Results: Median age was 25 (IQR: 22 to 30). Most identified as
heterosexual or reported no male partner (1636/1830 [89.40%]).
More MSM and TGW versus HCM reported anal sex (90.21% vs. Background: We designed proof-of-concept trials to determine if a
5.01%), transactional sex (41.75% vs. 11.37%), ≥2 partners (82.99% broadly neutralizing HIV antibody (bnAb) directed at the CD4 binding
vs. 65.28%), sex with alcohol/drugs (67.53% vs. 55.50%) or sex with site of HIV-1 (VRC01) was capable of preventing HIV acquisition.
an HIV-positive partner (71.65% vs. 44.74%). Overall HIV incidence
7
Methods: We enrolled men and transgender persons who have sex HIV prevention in cisgender women. The blinded trial was stopped at
with men (MSM/TG) in the Americas (HVTN 704/HPTN 085) and a planned interim DSMB review in November 2020.
women in sub-Saharan Africa (703/081) into two parallel trials. Enrol- Methods: HIV-uninfected PrEP eligible cisgender women were ran-
lees received 10 intravenous infusions at eight-week intervals of domized 1:1 to either active CAB plus TDF/FTC placebo or active
VRC01 10 mg/kg, VRC01 30 mg/kg, or placebo. Participants were TDF/FTC plus CAB placebo. Participants received 5 weeks of daily
assessed for HIV acquisition at four-week intervals. In vitro neutraliza- oral product followed by intramuscular injections every eight weeks
tion sensitivity of VRC01 for each acquired isolate (IC80) was mea- after an initial four-week interval load, alongside daily oral pills. Partici-
sured by the TZM-bl assay. pants who discontinued injections were offered open-label daily TDF/
Results: VRC01 reduced acquisition of HIV isolates with in vitro sen- FTC for 48 weeks after last injection. The primary endpoints were
sitivity to the antibody of IC80 <1 μg/mL. Against this group of highly incident HIV infection and ≥grade 2 clinical and laboratory events.
sensitive viruses, receipt of VRC01 achieved 75% protection over the Results: Overall, 3224 participants were enrolled at sites in South
20-month study period in both women at risk of HIV infection in sub- Africa (n = 7), Zimbabwe (5), Uganda (3), Malawi (2), Botswana (1),
Saharan Africa exposed to subtype C variants and MSM/TG persons Eswatini (1) and Kenya (1). Median age was 25 years (range 18, 45),
in South America, Switzerland and the US exposed to subtype B vari- 54% (n = 1754/3210) had 2+ partners in past month, 32%
ants. Susceptibility to the antibody was the important determinant of (n = 1019/3210) had partner with HIV or unknown status, 19%
antiviral activity. The incidence of HIV among isolates sensitive to (n = 601/3190) had chlamydia and 7% (n = 211/3190) had gonor-
VRC01 (IC80 <1 μg/mL) was 0.2/100 person-years in VRC01 recipi- rhoea at enrolment. Participant visit completion at months 6, 12, 18,
ents versus 0.86 in control recipients (p < 0.001) (estimated efficacy and 24 was 94%, 90%, 87% and 86%. Thirty eight incident infections
75.4%, 95% CI: 45.5, 88.9). VRC01 did not prevent acquisition of iso- were observed over 3808 person-years (HIV incidence 1.0%, 95%
lates with IC80 >1.0 μg/mL. The AMP trials were designed conjectur- confidence interval [CI] 0.71, 1.37); 4 in the CAB arm (incidence 0.21,
ing that strains with an IC80 <10 mg/mL would be effectively inhibited 95% CI 0.06, 0.54) and 34 in the TDF/FTC arm (incidence 1.79%,
by VRC01, an in vitro cutoff met for 65% to 81% of strains in con- 95% CI 1.24, 2.51) (hazard ratio 0.11 [95% CI 0.04, 0.32]). Injection
temporaneous subtype B and C panels. Because only 30% of control coverage was 93% of person-years. In a random subset of 375 TDF/
arm-acquired isolates had IC80 <1 μg/mL, overall prevention efficacy FTC participants, 62% of plasma samples had detectable TDF/FTC;
was 26.6% (95% CI: 11.7, 51.8) for 704/085 and 8.8% (45.1, 42.6) 46% had concentrations consistent with daily dosing. Adverse events
for 703/081 (p > 0.10). were mild-moderate and balanced by arm. Among CAB participants,
Conclusions: These studies provide proof-of-concept for bnAbs to injection site reactions were more common (32% vs. 9%), but most
prevent HIV acquisition. The breadth and levels of a bnAb required were mild. Nausea was more common in the TDF/FTC (9%) compared
for effective prevention are predicted by the in vitro neutralization to the CAB participants (5%). Pregnancy incidence was 1.3 per 100
sensitivity of the viruses circulating in the community as measured in person-years (95% CI 1.0, 1.7); no congenital anomalies were
the TZM-bl assay. These findings provide the guideposts for clinical reported.
development of combination bnAbs for the prevention of sexually Conclusions: While both products demonstrated high prevention effi-
acquired HIV. cacy and were safe and well tolerated; CAB was superior to TDF/FTC
in preventing HIV infection in cisgender women.
HY01.02LB
Long acting injectable cabotegravir is safe and effective in OA03.01
preventing HIV infection in cisgender women: interim Safety and single-dose pharmacokinetics of VRC07-523LS
results from HPTN 084 administered via different routes and doses
S. Delany-Moretlwe1; J. Hughes2; P. Bock3; S. Gurrion4; S. Walsh1; C. Gay2; S. Karuna3; O. Hyrien3; T. Skalland3; K.H. Mayer4;
P. Hunidzarira5; D. Kalonji6; N. Kayange7; J. Makhema8; P. Mandima5; M. Sobieszczyk5; P. Andrew6; C. Karg3; J. Baumblatt7; L. Polakowski7;
C. Mathew1; M. Mokgoro6; J. Mpendo9; P. Mukwekwerere5; W. Chege7; S. Hasan3; X. Han3 and A. McDermott7
N. Mgodi5; P. Nahirya Ntege10; G. Nair11; C. Nakabiito12; 1
Brigham & Women’s Hospital, Infectious Diseases, Boston, United
H. Nuwagaba-Biribonwoha13; R. Panchia14 and N. Singh6 States, 2University of North Carolina, Chapel Hill, United States, 3Fred
1
Wits RHI, University of the Witwatersrand, Johannesburg, South Hutchinson Cancer Research Center, Seattle, United States, 4Fenway
Africa, 2Statistical Centre for HIV/AIDS Research Prevention Fred Institute, Boston, United States, 5Columbia University, New York, Uni-
Hutchinson Cancer Research Institute, Seattle, United States, 3Des- ted States, 6FHI 360, Durham, United States, 7National Institute of
mond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Allergy and Infectious Diseases, Rockville, United States
Africa, 4Kisumu CRS, KEMRI, Kisumu, Kenya, 5University of Zimbabwe
College of Health Sciences Clinical Trials Research Centre, Harare,
Zimbabwe, 6HIV Prevention Research Unit, South African Medical Background: Broadly neutralizing antibodies (bnAbs) are a promising
Research Unit, Durban, South Africa, 7Blantyre CRS, College of Medi- approach for HIV-1 prevention. VRC07-523LS targets the CD4-binding
cine, Blantyre, Malawi, 8Botswana Harvard AIDS Institute Partnership site of Env and was engineered for increased breadth and half-life. In
(BHP), Gaborone, Botswana, 9UVRI-IAVI, Entebbe, Uganda, 10Baylor the only bnAb HIV prevention efficacy studies, the AMP studies,
College of Medicine Children’s Foundation Uganda, Kampala, Uganda, another CD4-binding site targeting bnAb, VRC01, was administered
11
Desmond Tutu Health Foundation, University of Cape Town, Cape intravenously (IV). However, subcutaneous (SC) or intramuscular (IM)
Town, South Africa, 12Makerere University - Johns Hopkins University administration may be preferred. We present the first interim data
Research Collaboration, Kampala, Uganda, 13Eswatini Prevention Cen- comparing these routes of bnAb administration from the ongoing
ter, Columbia University Mailman School of Public Health, New York, HVTN127/HPTN087 study.
United States, 14Perinatal HIV Research Unit, University of the Wit- Methods: 124 healthy, HIV-uninfected participants were randomized
watersrand, Johannesburg, South Africa to receive VRC07-523LS via the IV (2.5 mg/kg, 5 mg/kg, 20 mg/kg),
SC (2.5 mg/kg, 5 mg/kg) or IM (2.5 mg/kg, placebo) routes. Safety
data were collected for 112 weeks following the first administration.
Background: HPTN 084 is a Phase 3 randomized, double-blind, dou- VRC07-523LS serum concentrations were measured by ELISA at Day
ble-dummy superiority trial evaluating safety and efficacy of long-act- 0, 3, 6, 28, 56, 84, and 112. The log-linear portion of the time-
ing injectable cabotegravir (CAB) compared to daily oral TDF/FTC for concentration curve was used to estimate the elimination half-life.
8
Results: Injections were well-tolerated, with mild pain or tenderness 20 mg/kg SC at week 2, 4, and 8. Ongoing growth contributed to the
reported commonly in the SC and IM groups and mild to moderate fall in VRC07-523LS concentration but levels remain over the target
erythema or induration reported commonly in the SC groups. Infu- of 10 mcg/mL at week 12.
sions were generally well-tolerated, with infusion reactions reported in Conclusions: We identified no safety or tolerability findings when
3 participants in the 20 mg/kg IV group. VRC07-523LS has an esti- VRC07-523LS is administered to neonates. Week 12 is an appropriate
mated median half-life of ~40 days. Median peak concentrations (with time for a second dose in infants with ongoing breastmilk exposure.
interquartile range) were 42.2 (35.1, 52.7) lg/mL, 80.3 (72.3, 106.1) VRC07-523LS, with its enhanced potency and extended half-life, could
lg/mL, and 353.6 (278.0, 461.97) lg/mL for the IV groups; 11.4 (8.4, achieve target levels for the duration of breastfeeding with dosing
15.2) lg/mL and 24.5 (18.8, 27.0) lg/mL for the SC groups; and 17.8 every 3 months.
(15.5, 19.1) lg/mL for the IM group. Geometric mean trough concen-
trations were 3.4 (2.5, 4.6) lg/mL, 6.5 (5.6, 7.5) lg/mL, and 27.2 OA03.05
(23.9, 31.0) lg/mL for the IV groups; 0.9 (0.6, 1.4) lg/mL and 3.1 (2.2,
Neutralization profiles of HIV-1 subtype C breakthrough
4.3) lg/mL for the SC groups; and 2.6 (2.1, 3.3) lg/mL for the IM
group. The peak VRC07-523LS serum concentrations increased lin-
viruses from the Southern African VRC01 AMP trial (HVTN
early with the administered dose. At a given dose, peak and trough 703/HPTN 081)
concentrations were highest in the IV groups and lowest in the SC N.N. Mkhize1; R.E. Mapengo1; V. Bekker1; T. Modise1; P. Kgagudi1;
groups. B.E. Lambson1; H. Kaldine1; R.T. van Dorsten1; N. Mgodi2; S. Karuna3;
Conclusions: VRC07-523LS appears to be safe and well-tolerated S. Edupuganti4; L. Corey3; M.S. Cohen5; J. Hural3 and J. McElrath3
1
across a range of doses and routes and is a promising bnAb for inclu- National Institute for Communicable Diseases, HIV Virology, Johan-
sion in HIV-1 prevention regimens. nesburg, South Africa, 2University of Zimbabwe, College of Health
Sciences Clinical Trials Research Centre, Harare, Zimbabwe, 3Fred
Hutchinson Cancer Research Center, Vaccine and Infectious Disease
OA03.02 Division, Seattle, United States, 4Emory University, Department of
Safety and PK of potent anti-HIV monoclonal AB
Medicine, Atlanta, United States, 5University of North Carolina at
VRC07-523LS in HIV-exposed infants Chapel Hill, Department of Medicine, Chapel Hill, United States
C. Cunningham1; E. Capparelli2; E. McFarland3; P. Muresan4;
C. Perlowski5; E. Smith6; R. Hazra7; L. Purdue8; P. Harding3;
A. McDermott9; J. Mascola9 and B. Graham9 Background: HIV-1 Env reference panels are used to guide the clini-
1
Duke University School of Medicine, Pediatrics, Durham, United cal development of broadly neutralizing antibodies (bNAbs) but need
States, 2University of California, San Diego, United States, 3University to be updated periodically as genetic drift may impact neutralization
of Colorado Anschutz Medical Campus, United States, 4Harvard T.H. phenotypes. We assessed the neutralization sensitivity of break-
Chan School of Public Health, Boston, United States, 5FHI 360, Dur- through viruses from the southern African VRC01 AMP trial (HVTN
ham, United States, 6NIH, Bethesda, United States, 7National Institute 703/HPTN 081) as geographically relevant, current subtype C trans-
of Child Health and Human Development, United States, 8DAIDS, mitted/founder viruses.
NIAID, Bethesda, United States, 9Vaccine Research Center, NIAID, Methods: Envelope sequences of breakthrough infections from 30
Bethesda, United States women in the AMP trial (prior to unblinding) were used to produce
transmitted/founder (T/F) pseudotyped viruses. These were tested
against 14 bNAbs targeting the CD4bs (n = 4), V3-glycan (n = 3), V2-
Background: Despite the effectiveness of antiretroviral therapy, verti- apex (n = 3), gp120-gp41 interface (n = 2) and the MPER (n = 2) in
cal HIV transmission continues. A potent, broadly neutralizing, mono- the TZM-bl neutralization assay. Single bNAb neutralization data was
clonal antibody (bNAb) administered to HIV-exposed infants might used in the Loewe additive model (CombiNAber) to model the efficacy
reduce transmission. VRC07-523LS is 5-fold more potent and has a of bNAb combinations. Weakly neutralizing antibodies targeting nor-
prolonged half-life compared to VRC01. VRC07-523LS may provide mally occluded epitopes on HIV Env (V3, CD4i, V2 and gp41) were
therapeutic levels over the duration of breastfeeding with infrequent included to assess the tier phenotype of the viruses.
doses. Results: All breakthrough viruses were of the tier 2 phenotype, typi-
Methods: This is an open-label study of VRC07-523LS administered cal of T/F viruses. At a concentration of 1 μg/ml at IC50, 91% of
to HIV-exposed infants. Non-breastfed infants receive 80 mg subcuta- viruses were neutralized by VRC07-523LS (GMT IC50=0.16) repre-
neous (SC) within 72 hrs of birth. Infants and mothers receive ART to senting the best coverage by a single bNAb. Combinations of two to
prevent transmission. Infants have safety assessments and VRC07- four bNAbs increased the number of viruses neutralized with the 4
523LS levels at 24 hrs, week 2, 4, 8, 12 and every 12 weeks through bNAb combination (CAP256-VRC26.25/PGT121/VRC07-523LS/
week 96. The target week 12 plasma level is 10 mcg/mL: the level 35022) neutralizing 100% of viruses (GMT IC50=0.01). The best-
needed to neutralize > 90% of tier II viruses in a multiclade panel. in-class 3 bNAb combination (CAP256-VRC26.25/PGT121/35022)
Plasma VRC07-523LS levels are determined through week 12 and provided 97% coverage (GMT IC50=0.01). Clinically advanced triple
compared to previously reported levels of VRC01. combinations such as CAP256-VRC26.25.25/PGT121/VRC07-523LS
Results: The non-breastfed cohort fully accrued (N = 11) from US and/PGDM1400/PGT121/VRC07-523LS both resulted in a coverage
sites Jan-Sep, 2019. All infants received 80 mg VRC07-523LS SC of 97% (GMT IC50 = 0.02) against this panel of 30 subtype C break-
within 72 hours of birth (mean 1.5 days), resulting in an average dose through viruses.
of 28 mg/kg (range 23 to 32 mg/kg). Enrollees were 45% male, 73% Conclusions: Our data confirm the need to use combination bNAbs
Black, 18% Hispanic. One infant withdrew after 4 weeks. VRC07- in passive immunization trials to improve coverage of subtype C
523LS was well tolerated. Local reactions were rare and mild: 1 infant viruses. The exposure of a subset of these breakthrough viruses to
had injection site erythema of 0.5 cm and 1 had tenderness. Five VRC01 may have affected their phenotype, and this will be investi-
infants developed Grade 3/4 events within 28 days of receipt of gated when the AMP trial data is unblinded. Overall, these break-
VRC07-523LS (vomiting [N = 2], neutropenia, hyperkalemia, and through viruses represent a unique resource for defining the
parainfluenza sepsis), none considered related to study treatment. sensitivity of contemporaneous circulating viral isolates to bNAbs.
Pharmacokinetic measures through week 12 show average levels of
68.7, 31.1, 16.3mcg/mL at weeks 4, 8, and 12, respectively. Mean
VRC07-523LS levels exceeded those previously reported for VRC01
9
phenotypes, and in some cases, low frequency resistance mutations

OA03.04LB that were likely to be due VRC01 pressure. The study is not yet
Analysis of genetic diversity and VRC01 pressure on HIV-1 unblinded.
breakthrough viruses from the AMP trial (HVTN 703/HPTN
081 and HVTN 704/085) OA03.03LB
C. Williamson1; D. Westfall2; W. Deng2; A. Pankow2; D. Matten1; HIV-1 bnAb M4008_N1 targets a novel site of vulnerability
B. Murrell3; T. York1; A. Gwashu-Nyangiwe1; M. Rolland4,5;
at the V3 crown
P. Edlefsen6; E. Giorgi7; C. Magaret6; D. Montefiori8; L. Morris9; M.
K.-W. Chan1; C. Luo1; H. Lu2; X. Wu2 and X.-P. Kong1
S. Cohen10; L. Corey11; J. Hural11; J. McElrath11; M. Juraska6;
1
P.B. Gilbert6; J. I. Mullins2 and HVTN703/HPTN081 and HVTN704/ NYU School of Medicine, Department of Biochemistry and Molecular
HPTN083 protocol team, sequencing working group, community and Pharmacology, New York City, United States, 2Columbia University
participants Vagelos College of Physicians and Surgeons, Aaron Diamond AIDS
1 Research Center, New York City, United States
University of Cape Town, Institute for Infectious Diseases and
Molecular Medicine, Cape Town, South Africa, 2University of Washing-
ton, Department of Microbiology, Seattle, United States, 3Karolinska Background: Most of the human monoclonal antibodies (mAbs) tar-
Institutet, Department of Microbiology, Tumor and Cell Biology, Stock- geting the V3 crown of HIV-1 gp120 can only neutralize tier 1 easy-
holm, Sweden, 4Henry M. Jackson Foundation for the Advancement of to-neutralize viruses. We have isolated a broadly neutralizing mAb
Military Medicine, Bethesda, United States, 5Walter Reed Army Insti- (bnAb) M4008_N1 encoded by IGHV1-69 and IGKV1-5 genes that
tute of Research, U.S. Military HIV Research Program, Bethesda, Uni- neutralized about 40% of tier 2 circulating viruses. M4008_N1 binds
ted States, 6Fred Hutchinson Cancer Research Center, Statistical to JR-FL gp120 independent of glycans, and it effectively competes
Center for HIV/AIDS Research and Prevention, Seattle, United States, with known anti-V3 crown mAbs, such as 447-52D, 2219, and 2424,
7
Los Alamos National Laboratory, Los Alamos, United States, 8Duke as well as bnAb PGT128 targeting the V3 base glycan region.
University Medical Center, Duke Human Vaccine Institute, Durham, Methods: We determined a cryo-EM structure of Fab M4008_N1 in
United States, 9National Institute for Communicable Diseases, complex with BG505 DS-SOSIP at a 3.2A resolution.
National Health Laboratory Service, Johannesburg, South Africa, Results: Our structure revealed that M4008_N1 contacts a large
10
University of North Carolina at Chapel Hill, Department of Medi- envelope surface area surrounded by several glycans and centered at
cine, Chapel Hill, United States, 11Fred Hutchinson Cancer Research the V3 crown of gp120. M4008_N1 interacts with gp120 using both
Center, Vaccine and Infectious Disease Division, Seattle, United States heavy and light chains, but primarily through its CDR H3 to form a
beta sheet-like interaction with the N-terminal strand of V3 crown
hairpin. It interacts as well the V1V2 stem and the C4 region. These
Background: The Antibody Mediated Prevention (AMP) trial evalu-
contacts likely force V3 to remain sequestered underneath the V1V2
ated if VRC01, a CD4 binding site broadly neutralizing antibody, could
domain, compatible with the native closed conformation of the prefu-
prevent HIV-1 acquisition. To inform our understanding of how pre-
sion envelope trimer, and thus distinctive from other known anti-V3
vention efficacy depended on viral env gene charateristics, viral quasis-
crown mAbs. In addition, its binding on SOSIP trimer spatially blocks
pecies and neutralization sensitivity of HIV-1 breakthrough infections
the access to the CD4-binding site on the neighboring gp120 pro-
were analyzed.
tomer.
Methods: The trial evaluated VRC01 in women from sub-Saharan
Conclusions: Our results revealed a new mode of bnAb approaching
Africa (703/081); and men and transgender persons who have sex
the N-terminal strand of the sequestered V3 loop in the HIV-1 native
with men (704/085), from the Americas. Control samples from Thai-
closed envelope trimer, thus a novel neutralization mechanism target-
land, Kenya and South Africa are being used for calibrating infection
ing a site of vulnerability at the HIV-1 V3 crown. This new mode of
timing using sequence data. Rev-env-nef (REN) sequences were gener-
bnAb recognition is relevant for the design of immunogens targeting
ated using Sanger and PacBio Single Molecule Real-Time (SMRT)
this site of vulnerability.
sequencing platforms. To improve PacBio accuracy and enable quanti-
tation, each viral RNA molecule was labelled with a unique molecular
identifier (SMRT-UMI). Rev-env genes from imputed founder viruses OA04.01
were synthesized for pseudovirus production and in vitro sensitivity User assessment of a microarray patch for HIV PrEP and as a
to VRC01 determined using the TZM-bl assay. multipurpose prevention technology for HIV and pregnancy
Results: Approximately 84 000 unique REN sequences were gener- prevention: perspectives from Uganda and South Africa
ated from the first HIV-1 positive visit from 218 infected individuals M. Kilbourne-Brook1; A. Ismail2; S. Magni2; T. Fellows2;
in both trials, and two to four weeks later from a subset of individuals, A. Ruhweza Katahoire3; F. Ayebare3; G. Siu3; F. Semitala4;
providing a median of 174 unique env sequences per participant per P. Kyambadde5; D. Katuntu6; A. Rein-Weston1 and C. Jarrahian1
time point. In approximately 2/3 of individuals, viral diversity was low, 1
PATH, Medical Devices and Health Technologies, Seattle, United
consistent with infection with a single founder virus. Of the 1/3 of
States, 2Genesis Analytics, South Africa, 3Makerere University, Child
individuals with higher viral diversity, consistent with infection with
Health and Development Centre, Kampala, Uganda, 4Makerere
multiple founders, a third had low frequency variants (<5% of
University, College of Health Sciences, Department of Internal Medi-
sequences). We synthesized 1 to 4 Env-pseudoviruses per person, and
cine, Kampala, Uganda, 5Ministry of Health, MARPI, STD/AIDS Control
identified some individuals infected with variants with different neu-
Program, Kampala, Uganda, 6PATH, Uganda, Kampala, Uganda
tralization phenotype, including infection with both sensitive
(IC80<1 μg/mL) and resistant (IC80>3 μg/mL) viruses. In some individ-
uals, the unique VRC01 resistance mutations were associated with Background: Innovative HIV and pregnancy prevention products that
distinct viral lineages, suggestive of infection with resistant viruses. are easy to use and acceptable are needed to expand prevention
However, we also found evidence of low frequency resistant muta- options, especially for adolescent girls and young women (AGYW). A
tions, that were likely derived from resistance acquired after infection. microarray patch (MAP)—a novel drug delivery system—is being
Conclusions: SMRT-UMI sequencing allowed a very detailed evalua- developed to administer HIV PrEP and as a multipurpose prevention
tion of viral populations following infection, including identification of technology (MPT) to protect from HIV and unintended pregnancy.
minor founders not detected using conventional approaches. We Feedback from user/stakeholder assessments early in product
found evidence of infection with viruses of mixed neutralization
10
development can help refine product features to meet the needs of with the use of 2 TAF implants per animal. All macaques receiving
intended users. TAF implants were SHIV RNA negative following 12 virus exposures
Methods: Employing focus group discussions (FGD), key informant and remained negative for 16 weeks after implant removal. In con-
interviews, and mock-use exercises with prototypes, we explored user/ trast, 7/8 controls were infected after median of 4 SHIV exposures
stakeholder perceptions of the MAP technology and needs/prefer- (Wilcoxon p-value = 0.0037). Despite slight to no skin reactions, H&E
ences regarding product features that could influence usability, accept- revealed marked deep dermal necrosis and inflammation by 7 weeks
ability, and programmatic integration. This study was conducted among post-implantation. Recovered implants maintained a high degree of
6 target audiences in 8 rural and urban sites in South Africa and drug purity (>96%) and showed a strong correlation with in vitro
Uganda. Overall, we conducted 14 FGDs with AGYW (18–24 years), release-rates (median per animal = 0.77 mg/d).
2 with female sex workers (FSW), 8 with heterosexual men, and 2 Conclusions: TAF implants releasing 0.7 mg/d resulted in high TFV-
with men who have sex with men. We also interviewed 20 HIV and DP levels in PBMCs that provided complete protection against vaginal
family planning health care providers, 4 FSWs, and 6 policymaker/pro- SHIV infection. Findings define benchmarks needed for full protection
gram managers. Seventy additional participants representing all user against vaginal infection with single agent TAF. Improved TAF implants
groups evaluated the usability of MAP prototypes. Findings were that maintain high efficacy while reducing local toxicity have the poten-
coded/analyzed using Atlas.Ti software. tial to provide long-lasting protection against vaginal HIV infection.
Results: All groups expressed interest in the MAP technology, report-
ing potential advantages over methods such as pills and injectables. OA04.03
Most participants preferred a smaller MAP and long-term protection
Distribution of long-acting (LA) cabotegravir (CAB) in
(1–3 + months) with some differences noted across groups. Self-
administration and discreet use were valued by all. Preferred applica-
plasma, mucosal tissues, and associated fluids after a single
tion site and duration of application varied by MAP size. An MPT ultrasound-guided intramuscular (IM) injection in healthy
MAP was preferred over an HIV prevention-only MAP by most adult participants
AGYWs and FSWs. Participants wanted more confidence from the E. Weld1; J. Sadik Shaik2; S. Edick3; E. Fuchs4; S. Riddler3;
feedback indicator regarding correct MAP application and drug deliv- M. Marzinke1; R. D’Amico5; K. Bakshi2; Y. Lou6; C.W. Hendrix4;
ery. Participants wanted more information about how the MAP works K. Han2; S.L. Ford2; D. Margolis5; W. Spreen5 and P. Patel5
1
and voiced concerns about potential drug-related side effects and John Hopkins University School of Medicine, Department of Medi-
effectiveness. cine - Clinical Pharmacology, Baltimore, United States, 2GlaxoSmithK-
Conclusions: This early-stage user assessment of MAPs for HIV PrEP line, Research Triangle Park, United States, 3University of Pittsburgh,
and MPT found high potential acceptability among users/stakeholders. Pittsburgh, United States, 4John Hopkins University School of Medi-
MAP size and duration of protection are key attributes that will influ- cine, Baltimore, United States, 5ViiV Healthcare, Research Triangle
ence acceptability and uptake. Ongoing user assessments are essential Park, United States, 6Precision Biosciences, Durham, United States
to refine MAP prototypes to better meet users’ needs.
Background: CAB LA dosed at 2-month intervals demonstrated viro-

OA04.02 logic efficacy in maintaining HIV-1 suppression as part of a dual regi-
High protection against vaginal SHIV infection in macaques men with rilpivirine LA and is undergoing Phase 3 evaluation as a
single agent for HIV-1 pre-exposure prophylaxis (PrEP). CAB pharma-
by a biodegradable implant releasing tenofovir alafenamide
cokinetics (PK) in plasma and mucosal tissues associated with sexual
I. Massud
HIV-1 transmission were evaluated following single CAB LA IM injec-
Centers for Disease Control and Prevention, Laboratory Branch, Divi- tion.
sion of HIV/AIDS Prevention, Atlanta, United States Methods: Participants received 4 weeks of daily oral CAB 30 mg, fol-
lowed by 14 to 42 day washout and a single ultrasound-guided gluteal
IM injection of CAB LA 600 mg (3 mL). PK samples were collected
Background: To realize the promise of ending the global epidemic,
after oral dosing and through 12 weeks post-injection in plasma, rectal
long-lasting HIV protection is needed through sustained release of
tissue (RT), cervical tissue (CT), vaginal tissue (VT), cervicovaginal fluid
antiretroviral drugs for months to years. Leveraging promising explora-
(CF), and rectal fluid (RF). CAB concentrations were determined by
tory pharmacokinetics (PK) showing high TFV-diphosphate (TFV-DP)
HPLC-MS/MS. PK parameters were estimated using noncompartmen-
levels in PBMCs and dose escalation in rhesus macaques, we investi-
tal analysis. Pearson correlations of time-matched tissue and plasma
gated the PK and efficacy of a polycaprolactone implant releasing
concentration pairs were determined.
tenofovir alafenamide (TAF) in pigtail macaques for preventing vaginal
Results: Nineteen participants (10F, 9M) enrolled with mean age
SHIV infection.
33 years, weight 79.4 kg, and BMI 27.2 kg/m2. Two participants with-
Methods: Implants were administered subcutaneously in the arm
drew before injections, one did not undergo tissue sampling, and one
using a contraceptive trocar. The PK profile of implants releasing
was hospitalized for unrelated serotonin syndrome. Median CAB con-
0.35 mg/day of TAF was evaluated in 3 pigtailed macaques. Efficacy
centration-time profiles are presented by matrix (Figure 1). Median
was evaluated in 6 macaques that received two TAF implants (one
CAB tissue:plasma ratio was 9% to 10% in RT (r = 0.96), 14% to 18%
per arm; total release-rate = 0.7 mg/day). Macaques were exposed
in CT (r = 0.94), 14% to 16% in VT (r = 0.92), 8% to 13% in CF
vaginally to SHIV162p3 twice-weekly for 6 weeks. Infection outcome
(r = 0.65), 32% to 45% in RF (r = 0.19). Geometric mean (CVb%)
was compared to 8 untreated controls. SHIV RNA was monitored in
plasma half-life was 19.1 (81.4%) days.
plasma by RT-PCR. TFV-DP in PBMCs and vaginal lymphocytes was
Conclusions: Plasma CAB PK was consistent with prior studies, and
measured by LC-MS/MS. Skin biopsies near implantation were
CAB concentrations in tissue and fluid were proportional to plasma
assessed by H&E staining.
over time. Correlations with plasma concentrations were stronger for
Results: Median TFV-DP levels in PBMCs over 84 days with a single
tissue (RT, CT, VT) than for luminal fluid (CF and RF). Tissue concen-
TAF implant were 954 [range 398 to 2080] fmols/106 cells. TFV-DP
trations were 1/6th (CT, VT) to 1/10th (RT) of plasma concentrations.
was consistently detected in vaginal lymphocytes 24 h post implant
With sufficient distribution into mucosal tissues associated with sexual
removal (50.7 [range 29.3 to 67.9] fmol/106 cells). Median TFV-DP
HIV-1 transmission, CAB tissue:plasma ratios may serve as important
levels in PBMCs during the challenge phase were 1.6-fold higher
measurements in evaluating CAB LA as an effective PrEP agent.
(1,519 [range 1068 to 1897] fmols/106 cells), which was consistent
11
hydrophilic polyether urethane membrane. The membrane was

OA04.04 selected so that it can conduct the drug into the subcutaneous space.
Design and testing of a cabotegravir reservoir implant for The implants were manufactured with dimensions of 47 mm lumen
HIV prevention length, 3.6 mm outer diameter, and 200 μm wall thickness. Four
T.J. Hope1; D. Karunakaran2; S.M. Simpson2; J.T. Su3; cabotegravir pellets were loaded in the core, with a total drug loading
E. Bryndza-Tfaily4; R. Vezy5; G. Dobek6; J. Qiu2; D. Watrous2; S. Sung2 of 274 3 mg.
and J.E. Chacon2 Results: After implantation, the implant swelled and released an aver-
1
Feinberg School of Medicine, Northwestern University, McCormick age of 0.35 mg/day of cabotegravir in rhesus macaques. Five implants
School of Engineering and Obstetrics and Gynecology, Evanston, Uni- achieved an average cabotegravir plasma concentration of 373 ng/ml
ted States, 2Northwestern University, McCormick School of Engineer- in macaques. Adjacent implants demonstrated a PK less than antici-
ing, Evanston, United States, 3Elon University, College of Art and pated, revealing that implant placement is important because of
Science, Elon, United States, 4Feinberg School of Medicine, North- potential implant interference. The nonhuman primates tolerated the
western University, Cell and Developmental Biology, Evanston, United implant without gross or microscopic signs of toxicity compared to
States, 5Tulane University, Division of Comparative Pathology, New placebo after 1 month and 3 months. Cabotegravir plasma levels in
Orleans, United States, 6Tulane University, New Orleans, United macaques dropped below detectable levels within two weeks after the
States removal of the implants. Extended PK studies in Rats revealed stable
release of cabotegravir for 6 months.
Conclusions: Long-acting formulations of antiretroviral compounds
Background: Long-acting antiretroviral implants may be an essential have the potential to increase the efficacy of PrEP by eliminating
means of protecting high-risk individuals from HIV infection. Long act- issues of compliance that can be associated with daily pill taking in
ing formulations can overcome issue of compliance associated with high risk populations. We describe a cabotegravir reservoir implant
current pill forms of PrEP. Here we describe the design and testing of designed to last 1 year before removal and replacement (as needed).
a reservoir subcutaneous implant capable of releasing cabotegravir for The removal of the implant avoids the drug PK tail associated with
a year. long-acting injectable formulations. The release is stable for at least
Methods: We compressed cabotegravir along with solubilizing excipi- 6 months and shows no evidence of adverse host reactions to the
ents into cylindrical pellets and inserted them into a heat-sealed
12
implant after histological analysis. Although the function of this reser- PK model were used to assess the interim observed plasma and
voir implant in humans and the plasma cabotegravir concentrations PBMC PK data. Safety was assessed by adverse event (AE) reporting.
required for protection in humans remains to be conclusively deter- Results: As of 17 September 2020, 171 of a planned 250 (68.4%)
mined, this reservoir implant has the potential to provide an additional participants have been randomized and dosed (68.4% Female, median
option for individuals seeking efficient PrEP for HIV prevention. age 33 years, 70.8% white); 126 participants received all 6 planned
doses, 38 completed the trial (through final follow-up visit) and 8 dis-
OA04.05LB continued the trial early. Blinded safety monitoring suggests that
study drugs were well tolerated. Interim PK analysis shows ISL-tripho-
Trial design, enrollment status, demographics, and
sphate trough concentrations following either 60 mg or 120 mg
pharmacokinetics (PK) data from a blinded interim analysis monthly doses were all above the pre-specified PK threshold for HIV-
from a phase 2a trial of Islatravir once monthly (QM) for 1 prophylaxis of 0.05 pmol/106 PBMCs. Preliminary PK analysis of
HIV pre-exposure prophylaxis (PrEP) biopsied tissues suggest rapid, sustained and adequate distribution of
S. Hillier1; L.G. Bekker2; S. Badal-Faesen3; C. W. Hendrix4; S. ISL to sampled tissues. ISL PK exhibited linear dose proportionality
A. Riddler5; S. Rasmussen6; H. Schwartz7; G. Nair2; J. H. Lombaard8; (Figure 1).
Y. Caraco9; A. Peer10; M. Patel11; B. Evans11; B. Homony11; V. Teal11; Conclusions: This interim analysis suggests that monthly doses of ISL
P. Hwang11; M. Robertson11 and R. Plank11 60 mg and 120 mg achieved the pre-specified efficacious PrEP PK
1
Magee-Womens Research Institute & Foundation, Pittsburgh, United threshold.
States, 2Desmond Tutu HIV Centre, Cape Town, South Africa,
3
University of the Witwatersrand, Johannesburg, South Africa, 4John OA05.01
Hopkins Hospital, Baltimore, United States, 5University of Pittsburgh,
Role of HLA-E antigen presentation on NK control of HIV
Pittsburgh, United States, 6Celerion, Lincoln, United States, 7Research
infection
Centers of America, Hollywood, United States, 8Josha Research,
Bloemfontein, South Africa, 9Hadassah Medical Center, Jerusalem, L. Romero-Martin1; C. Duran-Castells1; M. Olivella2;
Israel, 10Rambam Health Care Campus, Haifa, Israel, 11Merck & Co., M. Rosas-Umbert1; M. Ruiz-Riol1; A. Olvera1 and C. Brander1
1
Inc., Kenilworth, United States Institut de Recerca de la Sida (IrsiCaixa), Hospital Universitari Ger-
man Trias I Pujol, T Cell Immunity and Vaccinology, Barcelona, Spain,
2
University of Pompeu Fabra, Spain
Background: Islatravir (ISL, MK-8591) is the first nucleoside reverse
transcriptase translocation inhibitor (NRTTI) in development for the
treatment and prevention of HIV-1. ISL is being evaluated as a once Background: MHC-E restricted T-cell responses have been observed
monthly tablet as PrEP. Trial design, enrollment demographics and stain SIV-vaccine strategies using CMV-based vectors but their contribu-
tus, and PK data from an ongoing phase 2a study are presented. tion to virus control is unclear. HLA-E was originally identified as a
Methods: This randomized, double-blind, placebo controlled, parallel- ligand of some NKG2 family receptors expressed by NK cells. Two
group, multi-center study is assessing the safety, tolerability and PK of highly frequent, functional, HLA-E alleles (*01:01 and *01:03) have
oral ISL in adults aged 18 to 65 who have low-risk for HIV-1 acquisi- been defined and T-cell responses to bacterial and viral pathogens
tion. Participants were randomized in a 2:2:1 ratio into one of 3 restricted by these molecules have been described.
groups receiving six doses of ISL 60 mg, ISL 120 mg, or placebo Methods: In order to evaluate the interaction of HLA-E-presented
administered orally once monthly. ISL plasma levels were measured in viral epitopes with NK- and T-cell receptors, we modeled the struc-
all participants and ISL PK in peripheral blood mononuclear cells tural interaction of HLA-E presenting canonical (VL9) and non-canoni-
(PBMCs) and mucosal tissue (rectal, cervical and/or vaginal) was mea- cal (HIV-derived RL9 and PM9) epitopes with NKG2A/2C or TCR. We
sured in a subset. Simulations using a previously developed population determined the ability of 14 peptides (including VL9, 1 CMV-, 1 EBV-
Abstract OA04.05LB-Figure 1.
13
and 11 HIV-derived) to stabilize HLA-E *01:01 and *01:03 and how ablation of the fully functional HES4 isoform while simultaneously
this modified NK degranulation and cytotoxic activity. In vitro inhibition favoring expression of a HES4 isoform lacking one of its DNA binding
of viral replication by NK cells was assessed in autologous HIV domains.
infected CD4+ T-cells from HIV-seronegative individuals (N = 12). Conclusions: Our work provides the first insights into how retroviral
HLA-E expression on these target cells was assessed by RT-PCR and infection indirectly influences alternative splicing in NK cells in any
flow cytometry. The relationship of HLA-E expression with in-vivo HIV species. Further, we have identified several genes, including BHLH
control was tested by measuring HLA-E expression in HIV-controllers transcription factors that may play a role in the formation of adaptive
(N = 31) and non-controllers (N = 16) by RT-PCR. NK cell responses. This may provide several opportunities for better
Results: Our structural models evidenced that TCR have less affinity directing NK cell responses during HIV infection.
for HLA-E than NKG2 receptors. Interestingly, HIV peptides RL9 or
PM9 presented by HLA-E*01:01 or HLA-E*01:03 showed a predicted OA05.03
increase in affinity to NKG2A and NKG2C, respectively. In vitro exper-
Compartment specific changes of innate lymphoid cells
iments indicated that HLA-E*01:01 was generally less stable on the
cell surface, but none of HIV-derived peptides stabilized HLA-E. HIV
within the intestinal mucosa of HIV-1 infected individuals
KG9-HLA-E*01*03 and RL9/TP9/VI9/YG9-HLA-E*01*01 decreased O.E. Asowata1; R. Fardoos2; A. Singh1; Y. Zungu1; A. Ngoepe1;
NK cytokine secretion. RL9/MD9-HLA-E*01:01 resulted in increased F. Nene1; A. Ntuli1; F. Karim1; A. Shalek3; F. Anderson4; A. Leslie1 and
lysis of peptide pulsed target cells. NK-mediated inhibition of viral H.N. Kløverpris1
1
replication correlated positively with HLA-E expression. Conversely, in Africa Health Research Institute, K-RITH Tower Building, Durban, South
HIV-infected individuals, HLA-E expression on total PBMC was signifi- Africa, 2University of Copenhagen, Department of Immunology and Micro-
cantly higher in non-controller individuals. biology, Denmark, 3Massachusetts Institute of Technology, Institute for
Conclusions: The elevated expression of HLA-E in uncontrolled HIV Medical Engineering & Science and Department of Chemistry, Cambridge,
infection and its potential differential interaction with NKG2 mole- Massachusetts, United States, 4University of KwaZulu-Natal, Discipline
cules depending on peptide binding indicates a pivotal role in NK dur- General Surgery, Inkosi Albert Luthuli Central Hospital, South Africa
ing HIV infection. As such, HLA-E presenting HIV-derived epitopes
may sensitize target cells for NK lysis in early infection whereas pro-
longed, elevated expression of HLA-E may lead to NK reduced viral Background: HIV infection occurs predominantly in the mucosal sur-
faces of the gastrointestinal tract and is associated with compromised
control.
intestinal barrier integrity and dysbiosis that is not reversed by current
antiretroviral therapy (ART). Innate lymphoid cells (ILCs) orchestrate
OA05.02 mucosal barrier defences and are involved in the regulation of tissue
Acute SIV Induces BHLH gene variants prior to adaptive homeostasis. However, the impact of HIV-1 infection on ILCs in the
natural killer cell formation human intestinal mucosa and gut draining lymphoid tissue is unknown.
D. Ram; K. Kroll; M. Aid and R.K. Reeves Methods: Here, we present a large cohort of patients from a gas-
Beth Israel Lahey Health, Center for Virology and Vaccine Research, trointestinal clinic in KwaZulu-Natal, South Africa recruited within
Boston, United States extremely high HIV endemic areas. Human gut draining lymph nodes
and intestinal biopsies were collected during surgical procedures.
Phenotypic characterization of ILCs was done using flow cytometry
Background: Adaptive natural killer (NK) cells have been demon- and immunohistochemistry. Moreover, we employed single-cell tran-
strated against a wide range of viral infections including CMV, influen- scriptomics of pre-sorted ILCs to examine the gene expression profile
za, SIV, and HIV, but are generally not detectable until late in and ex vivo response to HIV infection.
infection due to their low magnitude. In this study we analyzed puri- Results: Total ILC levels in the gut of HIV uninfected individuals were
fied NK cells in acute SIV infection to evaluate potential molecular comparable. However, we found ILC subtype-specific and regional
mechanisms of early adaptive NK cell formation. changes between the small and large intestine. Intraepithelial ILC1
Methods: Peripheral NK cells from a longitudinal acute SIV infection (p < 0.0001) and NK cells (p < 0.0001) were significantly enriched in
study in rhesus macaques (n = 6) were sorted and RNA-Seq per- the duodenum compared to the colon, whereas ILC3s were signifi-
formed using an Illumina platform. RNA-Seq data was aligned using cantly expanded in the colon compared to the duodenum (p < 0.0001)
STAR aligner and Tophat suite was used for quantification of reads. in HIV uninfected individuals. In HIV infected participants, we
To determine alternatively spliced transcripts the data was aligned observed expansion of duodenal ILC3s (p = 0.03) that was not found
with salmon and alternative transcripts were quantified and annotated within the colon compared to HIV uninfected participants. The gut
using the IsoformSwitchAnalyzeR package. Custom probesets target- compartment-specific difference in ILC3 levels was independent of
ing various exon regions were designed to identify the desired isoform CD4 T-cell depletion observed in both compartments (p < 0.0001).
using RNA-probe flow cytometry to complement up to 30-parameter We found modest changes in ILC3 levels within gut lymph nodes in
traditional flow cytometry. HIV infected and uninfected individuals. Single-cell RNAseq of pre-
Results: Rhesus NK cells were identified and sorted using a standard sorted ILCs from lymph nodes reveals tissue-specific transcriptional
gating strategy: CD3-CD14-CD20-NKG2A/C + . Using traditional profiles between NK, ILC1 and ILC3 subsets with pending analysis of
RNA-Seq data analysis we identified several groups of genes associ- their response to HIV infection ex vivo.
ated with normal NK cell antiviral responses, including IFN, cell cycle Conclusions: Compartment-specific differences in ILC subsets suggest
and mTOR-associated genes. Interestingly, multiple BHLH transcrip- distinct roles for these cells throughout the small and large intestine. Strik-
tion factor family members were significantly induced, including ingly, ILC subset change in response to HIV infection within the small
BHLHB42 (HES4) and BHLHE40 (DEC1) which clustered with multi- intestine with enriched ILC3s in HIV infected duodenal biopsies, irrespec-
ple antigen processing and downstream memory cell signaling modules tive of CD4 T cell depletion, suggests that ILC3s may play important roles
paralleling CD8 T cell memory formation. Using the IsoformSwitchAn- in intestinal epithelial homeostasis that should be explored further for
alyzeR package revealed an even more restricted gene-set of alterna- therapeutic potentials during chronic HIV-1 infection.
tively spliced genes including several TNFR and zinc finger
transcription factor family members. RNA-flow was then used to vali-
date some of the identified genes, revealing several alternatively
spliced transcript variants. For example, acute infection induced total
14
the context of effective ART and immune reconstitution. It will be crit-

OA05.04 ical to further understand the disruption of the RM immune environ-
Disruption of immune cell homeostasis within rectal ment in young HIV+ individuals, who are potentially facing a lifetime
mucosal tissue of HIV+ young men who have sex with men of chronic gut inflammation. To that end, additional transcriptomic and
S.A. Smith1; P.K. Amancha1; P.M. Murray1; I.R. Pollack1; C.G. Ackerley1; microbiome analyses are ongoing.
R.R. Amara2 and C.F. Kelley1
1
The Hope Clinic of the Emory Vaccine Center, Infectious Disease, OA06.01
United States, 2Yerkes National Primate Research Center, Atlanta, Pharmacokinetics, safety, and vaginal bleeding associated
United States
with continuous versus cyclic 90-day use of dapivirine and
levonorgestrel vaginal rings for multipurpose prevention of
Background: Ongoing inflammation within rectal mucosal tissue (RM) HIV and pregnancy
is a hallmark of HIV infection. While HIV infection is known to cause S. Achilles1; C.W. Kelly2; D.L. Blithe3; J. Long3; B.A. Richardson2;
profound alterations in RM T cell populations in older adults, the B. Devlin4; C.W. Hendrix5; S.M. Poloyac6; M.A. Marzinke5; D. Singh7;
effects of HIV infection on the immune cell ecosystem within RM tis- J.M. Piper8; J. Steytler4 and B.A. Chen9
sue of young adults is not well understood. 1
University of Pittsburgh, Department of Obstetrics, Gynecology and
Methods: We analyzed immune cell subsets in RM biopsies from 71 Reproductive Sciences/School of Medicine, Pittsburgh, United States,
HIV- and 28 HIV+ young men who have sex with men (YMSM) aged 2
Statistical Center for HIV/AIDS Research & Prevention/Fred
18 to 24 years who were taking antiretroviral therapy with sup- Hutchinson Cancer Research Center, Seattle, United States, 3NIH/
pressed viremia (VL < 400 copies/mL), and relatively preserved Eunice Kennedy Shriver National Institute of Child Health and Human
peripheral CD4+ T cells counts (median 633, range 232 to 1706), by Development, Division of Intramural Population Heath Research, Con-
multicolor flow cytometry. Median proportions of innate and adaptive traceptive Development Program, Bethesda, United States, 4Interna-
immune cell subsets were compared between groups with Mann- tional Partnership for Microbicides, Silver Spring, United States,
Whitney tests (threshold of discovery: p < 0.01), and associated with 5
Johns Hopkins University, Department of Medicine, Division of Clini-
peripheral CD4 counts via Spearman correlation coefficients. cal Pharmacology, Baltimore, United States, 6University of Pittsburgh,
Results: Despite generally healthy peripheral CD4 counts, we observed Department of Pharmaceutical Sciences, School of Pharmacy, Pitts-
a significant decrease in CD4+ T cells within the RM of HIV+ YMSM burgh, United States, 7Magee-Womens Research Institute, Pittsburgh,
(p = 0.0007). This included reduced memory CD4+, CCR5+ CD4+, and United States, 8NIH/National Institute of Allergy and Infectious Dis-
IFNc+ or TNFa+CD4+ (all p < 0.009), but not Treg (p = 0.34) or IL- eases, Division of AIDS, Bethesda, United States, 9University of Pitts-
17A+ (p = 0.60). Conversely, we observed an increase in Ki67+ CD4+ in burgh, Department of Obstetrics, Gynecology and Reproductive
the RM of HIV+ YMSM (as a percentage of CD4+ T cells, p = 0.0002), Sciences, School of Medicine, Pittsburgh, United States
as well as an increase in CD8+ T cells, including memory CD8+, non-tis-
sue resident CD69-CD103-CD8+, Ki67+ CD8+, and IFNc+CD8+ (all
p < 0.002). We also observed increases in mucosal-associated invariant Background: We compared pharmacokinetics, safety, and vaginal
T cells (MAIT) (p = 0.010), accompanied by a decrease in CD16-CD56+ bleeding associated with continuous versus cyclic use of a 90-day mul-
NK cells (p = 0.002). No differences were observed in RM cd T cells, tipurpose prevention technology (MPT) vaginal ring for sustained
macrophages, B cells, neutrophils, CD1c+ myeloid dendritic cells, or delivery of dapivirine (DPV) for HIV pre-exposure prophylaxis and
plasmacytoid dendritic cells. Peripheral CD4 counts did not correlate levonorgestrel (LNG) for contraception.
with immune cell population proportions within the RM. Methods: In this Phase-1 trial, healthy HIV-uninfected women were
Conclusions: In addition to perturbations in the CD4+ and CD8+ T randomized (1:1) to continuous or cyclic (28-days in/2-days out) use
cell compartments, HIV infection among YMSM is associated with pattern of an MPT ring containing 200 mg DPV/320 mg LNG over
alterations in MAIT and NK cells populations within the RM, even in 90-days. We quantified plasma DPV and LNG via liquid
15
chromatography-mass spectrometry. We assessed vaginal bleeding and cervical mucus quality markers and serum progesterone measurement
adverse events (AE) by daily text messaging. for ovulation inhibition.
Results: Twenty-five evaluable participants had median age Results: Among 312 women screened, 27 were randomized to use
36.0 years (range 21 to 43) and BMI 27 (range 20 to 39), and 20 IVRs: TFV/LNG (n = 11); TFV alone (n = 11); and placebo (n = 5).
(80%) self-identified as white. There were 84 AEs: 59 Grade-1, 24 Most screen fails were due to vaginal infections. Median (IQR) days of
Grade-2, and one Grade-4 (anemia related to cyclic product use). The ring use was 68 (36 to 90). Women reported more intermittent bleed-
number of women with = Grade-2 genitourinary AEs did not differ by ing events with TFV/LNG IVR use than in the other two arms, but
continuous (3/12, 25%) or cyclic (5/13, 38%) use. With continuous otherwise adverse events (AE) were distributed similarly among arms.
use, median Cmax for DPV and LNG were 750 pg/mL (IQR 475 to There were two non-product related AEs graded >2. No visible genital
1401) and 1675 pg/mL (IQR 645 to 2575), respectively (Figure 1). lesions were observed. Steady state geometric mean concentration
Two days after ring removal (cyclic group), plasma DPV (ssGMC) vaginal TFV amount was comparable in the TFV/LNG arm
remained = concentration associated with previously demonstrated (44.0 lg/swab (95% CI (31.2, 62.0)) and the TFV alone arm (30.3 lg/
efficacy. Number of days with no bleeding, spotting/light, moderate, swab (95% CI (18.1, 50.7)), p = 0.25. Plasma TFV ssGMC was
and heavy bleeding did not differ by use pattern (Table 1). <10 ng/mL for both TFV rings. In vitro, CVF anti-HIV activity showed
increased HIV inhibition over baseline following IVR use, from a med-
Abstract OA06.01-Table 1. Days of bleeding ian of 7% to 84% in TFV/LNG, 15% to 89% in TFV alone, and –27%
(increased ex vivo infection) to –20% in placebo participants. LNG
Continuous (n = 12) Cyclic (n = 13) ssGMC was 240 pg/mL (95% CI 170, 340) with rapid decline after
removal to 90 pg/mL (95% CI 60, 120) within 24 hours. Following
Total days 967 days on study 1156 days on study
15 days of IVR use, progesterone levels in luteal phase indicated
No bleeding 557 (58%) 671 (58%)
anovulation (<3 ng/mL) more frequently using TFV/LNG (63.6%) com-
Spotting/light bleeding 303 (31%) 353 (31%)
pared to TFV (18.2%) and placebo (0.0%).
Moderate bleeding 101 (10%) 112 (10%)
Conclusions: TFV/LNG and TFV alone IVRs were shown to be safe
Heavy bleeding 6 (1%) 20 (2%)
when used by African women. Pharmacokinetic characteristics and
markers of protection against HIV-1 and pregnancy suggest the
potential for clinical efficacy of these IVRs.
Conclusions: Serum DPV and LNG concentrations previously associ-
ated with efficacy for HIV and pregnancy prevention respectively are OA06.03
achieved or exceeded with cyclic and continuous use of this MPT ring Randomized, placebo controlled phase I trial of safety,
without toxicity. Vaginal bleeding profiles did not differ. pharmacokinetics, pharmacodynamics and acceptability of a
multipurpose prevention vaginal ring containing tenofovir
and levonorgestrel
OA06.02 A. Thurman1; V. Brache2; A.L. Ouattara1; N. Chandra1; T. Jacot1;
Randomized, placebo-controlled trial of safety,
S. Jackson1; M. Clark1; M.M. Peet1; H. Hanif1; T. McCormick1; S. Ju1;
pharmacokinetics, and pharmacodynamics of 90-day J.L. Schwartz1; M. Marzinke3; D.W. Erikson4 and U. Parikh5
intravaginal rings (IVRs) releasing tenofovir (TFV) with and 1
CONRAD, Eastern Virginia Medical School, Norfolk, United States,
without levonorgestrel (LNG) among women in Western 2
PROFAMILIA, Biomedical Research Department, Santo Domingo,
Kenya Dominican Republic, 3Johns Hopkins University, School of Medicine,
N. Mugo1; V. Mudhune2; R. Heffron3; K. Thomas3; E. McLellan-Lemal4; General Chemistry, Baltimore, United States, 4Oregon National Pri-
S. Peacock1; S. O’Connor4; B. Njoroge5; B. Nyagol2; E. Ouma2; mate Research Center, Endocrine Technologies Core, Beaverton, Uni-
R. Ridzon4; N. Isoherranen6; D. Erikson7; R. Haaland4 and S. Morrison3 ted States, 5University of Pittsburgh, Infectious Diseases, Magee
1
University of Washington, Kenya Medical Research Institute, Centre Womens Research Institute, Pittsburgh, United States
For Clinical Research, Kenya, 2Kenya Medical Research Institute, Cen-
tre for Global Health Research, Nairobi, Kenya, 3University of Wash-
ington, Global Health, International Clinical Research Center, Seattle, Background: Multipurpose prevention technologies that provide pro-
United States, 4Centers for Disease Control and Prevention, Office of tection against HIV acquisition and unintended pregnancy, are safe
Infectious Diseases, National Center for HIV/AIDS, Viral Hepatitis, and acceptable, and support flexible use, are critically needed. We
STD, and TB Prevention, Atlanta, United States, 5Kenya Medical report results from a Phase I study evaluating the safety, pharmacoki-
Research Institute, Centre For Clinical Research, Nairobi, Kenya, netics (PK), pharmacodynamics (PD), and acceptability of CONRAD’s
6
University of Washington, Department of Pharmaceutics, Seattle, tenofovir/levonorgestrel (TFV/LNG) intravaginal ring (IVR) following
United States, 7Oregon Health & Science University, Endocrine Tech- 3 months of continuous or interrupted use in women.
nologies Core, Oregon National Primate Research Center, Portland, Methods: CONRAD A15-138 was an outpatient, randomized, par-
United States tially blinded, placebo-controlled, parallel study conducted in Norfolk,
VA and the Dominican Republic. Participants were healthy, 18 to
50 years old, had a body mass index <30 kg/m2 and reported no use
Background: Globally, young women face parallel epidemics of HIV of exogenous hormones and regular menses. Participants were ran-
infection and unintended pregnancy. Protection from both requires domized to 1 of 4 study arms: TFV/LNG or placebo IVR worn contin-
safe and effective prevention tools. uously for ~90 days or cyclically for 3 cycles of 28 days of use with
Methods: Healthy women ages 18 to 34 years, not pregnant, HIV- 3 days removal then re-insertion.
seronegative, HBsAg-negative, not using hormonal contraception, of Results: We screened 68 women; 47 were randomized onto study
reproductive potential, and at low risk for HIV were randomized 2:2:1 and 40 completed all visits. IVRs were safe with no significant changes
to continuous use of a TFV/LNG, TFV or placebo IVR. We assessed in cervicovaginal epithelium, immune cell populations or soluble
genital and systemic safety, TFV concentrations in both plasma and immune and inflammatory markers from baseline. Most TFV/LNG IVR
cervicovaginal fluid (CVF) and LNG levels in serum using mass spec- users reported no change in their menstrual cycle or fewer/lighter
trometry. We further evaluated TFV pharmacodynamics (PD) through bleeding days. Median vaginal fluid TFV concentrations were 546 to
anti-HIV and anti-HSV activity in CVF ex vivo, and LNG PD using 3077 ng/mg throughout 90 days of use. Median TFV-DP tissue
16
concentrations exceeded 1000 fmol/mg within 72 hours of IVR inser- their ideal product as vaginally delivered (IRR: 0.48, 95% CI: 0.26,
tion. At 1 and 3 months of use, vaginal fluid of women using TFV/ 0.90, p = 0.02).
LNG IVRs had significantly greater inhibitory activity against HIV Conclusions: Couples, both individually and jointly, indicated high
growth in vitro compared to baseline and to placebo (p < 0.01). TFV/ interest in DPP products that combine HIV and pregnancy prevention.
LNG IVR users had mean serum LNG concentrations exceeding Ideal product characteristics, particularly delivery form, signaled a role
200 pg/mL within 2 hours of IVR insertion. All placebo users ovulated for partner engagement and disclosure to support use of vaginally
each month, while only 39% to 71% of TFV/LNG users ovulated dur- delivered products.
ing months 1, 2 or 3, consistent with previously tested, effective con-
traceptive LNG IVRs. TFV/LNG IVR users had significantly lower OA06.05
cervical mucus (CM) Insler scores and a higher proportion of poor or
A phase I study to assess safety, pharmacokinetics and
abnormal in vitro CM sperm penetration (p < 0.05).
Conclusions: The TFV/LNG IVR was safe, acceptable and delivered
pharmacodynamics of a topical multipurpose prevention
high TFV concentrations locally correlating with local PD. The micro- insert containing tenofovir alafenamide fumarate and
dose of LNG caused changes in CM, sperm penetration and ovulation elvitegravir dosed vaginally
compatible with contraceptive efficacy, while inducing acceptable A. Thurman1; A.L. Ouattara1; N. Yousefieh1; T. Jacot1; H. Hanif1;
changes in menstrual bleeding patterns. P. Anderson2; L. Bushman2; X. Fang1; M.M. Peet1; N. Vann1;
T. McCormick1; V. Agrahari1; O. Singh1; M. Clark1 and G.F. Doncel1
1
OA06.04 2
CONRAD, Eastern Virginia Medical School, Norfolk, United States,
University of Colorado, Skaggs School of Pharmacy and Pharmaceuti-
Heterosexual couples’ preferences for dual-purpose
cal Sciences, Aurora, United States
prevention products for HIV and pregnancy prevention: the
CUPID Study (MTN-045) in Uganda and Zimbabwe
A. Minnis1; J. Etima2; M.K. Shapley-Quinn3; P. Musara4; D. Kemigisha2; Background: A discreet, on-demand, vaginal or rectal, pre- or post-
E. Browne3; M. Stoner3; N. Mgodi4; C. Nakabiito2; M. Hartmann3; exposure prophylaxis product is unique and fills an important gap in
N. Macagna5; J. Piper6 and A. van der Straten1 human immunodeficiency virus (HIV) and herpes simplex virus type 2
1
RTI International, Women’s Global Health Imperative, Research Trian- (HSV-2) multipurpose prevention. We describe the safety, acceptability
gle Park, United States, 2Makerere University-Johns Hopkins Univer- and multi-compartmental pharmacokinetics (PK) and pharmacodynam-
sity (MU-JHU) Research Collaboration, Kampala, Uganda, 3RTI ics (PD) after healthy women used a single vaginal insert containing
International, Research Triangle Park, United States, 4University of tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG).
Zimbabwe College of Health Sciences, Harare, Zimbabwe, 5FHI 360, Methods: This was a Phase I, open-label, study. Women (n = 16) self-
Durham, United States, 6National Institute of Allergy and Infectious administered one TAF (20 mg)/EVG (16 mg) insert vaginally in the
Diseases, National Institutes of Health, Bethesda, United States clinic and were randomized (1:1) into one of two sample collection
time groups (4 and 48 vs. 24 and 72 hours). All women were sampled
7 days post dosing. We assessed safety by treatment emergent
Background: Most research with end-users of future HIV prevention adverse events. We measured EVG, TAF and tenofovir (TFV) concen-
products has focused on women despite male partners’ important role trations in plasma, vaginal fluid and tissue and TFV-diphosphate (TFV-
in product use decision-making. The CUPID Study assesses prefer- DP) in vaginal tissue. PD was modeled ex vivo by quantifying the
ences for future dual-purpose prevention (DPP) products for preg- change in inhibitory activity of vaginal fluid and vaginal tissue against
nancy and HIV prevention and examines relationship-based influences HIV and HSV-2 after treatment, compared to baseline.
pertinent to the development and use of DPP products. Results: The TAF/EVG insert was safe, well tolerated and acceptable
Methods: CUPID is a multi-methods cross-sectional study targeting following a single vaginal dose. We measured high cervicovaginal fluid
400 heterosexual couples in Uganda and Zimbabwe (female partners TFV, with mean and median concentrations exceeding 200 000 ng/mL
aged 18 to 40 and HIV negative by self-report) imitated in January for up to 24 hours post dosing (median 340 854 IQR (232 508,
2020. Couples complete interviewer-administered surveys individually, 474 736 ng/mL) and exceeding 1000 ng/mL for up to 7 days post
followed by a joint interview that includes an interactive Ideal Product dosing. All participants had vaginal tissue EVG concentrations
Activity (IPA), self-directed by the couple and observed by a trained of > 1000 ng/g at 4 and 24 hours post dosing. TFV-DP tissue concen-
researcher. The IPA asks couples to select the most preferred charac- trations exceeded 1000 fmol/mg by 24 and 72 hours post dosing in
teristics of a DPP product (e.g., delivery form, effect on menses, 75% of participants. Vaginal fluid inhibition of HIV and HSV-2 ex vivo
effects on return to fertility, timing of use and duration of effective- was significantly (p < 0.05) increased from baseline and was similarly
ness). We examined overall attitudes toward DPP products, preferred high at 4 and 24 hours post dosing. Consistent with high tissue TFV-
characteristics elicited in the IPA, and relationship decision-making DP concentrations, p24 antigen production from ectocervical tissues
characteristics associated with these preferences using Poisson infected ex vivo with HIV was significantly (p < 0.05) decreased from
regression models with robust standard errors. baseline at 4 hours post dosing.
Results: Among 117 couples (mean age, females: 27, males: 32) Conclusions: A single vaginal dose of TAF/EVG topical insert was
enrolled through March 2020, nearly all (92%) indicated a preference safe, acceptable and effective in preventing HIV-1 and HSV-2 infection
for a dual vs. single purpose product. Primary advantages cited include ex vivo in this first-in-woman clinical study. PK data support an
ease of using a “2 in 1” product and, among females, ability to present extended window of high mucosal exposure.
the product as only a contraceptive; disadvantages included concerns
regarding side effects in a combined product and the need to switch
methods when pregnancy is desired. The majority (61%) of couples
selected oral tablets as their ideal formulation, while 39% preferred a
vaginally delivered product (ring, insert or film). Though longer-dura-
tion products were favored (two to three months), one-third indicated
their ideal product would be monthly and 10% preferred on-demand.
Women who reported they usually made their health care decisions
individually (vs. jointly with their partner) were less likely to indicate
17
results from a randomized controlled trial of SMS reminders to sup-

OA07.01 port PrEP adherence among young women in Kenya.
SMS reminders did not improve PrEP adherence in a Methods: The MPYA (Monitoring PrEP among Young Adult women)
randomized controlled trial among young Kenyan women study involved 18 to 24-year-old women with high HIV risk. PrEP
J. Haberer1; N. Mugo2; E. Bukusi2; M. Pyra3; K. Oware2; adherence was measured over 2 years with a real-time electronic
C. Kiptinness2; K. Thomas4; L. Garrison5; N. Musinguzi6; S. Morrison4; monitor (Wisepill) and pharmacy refill; tenofovir-diphosphate (TFV-
P. Anderson7; K. Ngure8 and J. Baeten4 DP) levels were determined from dried blood spots for 15% of partici-
1
Massachusetts General Hospital, Global Health, Boston, United pants. Participants were randomized 1:1 to SMS reminders versus no
States, 2KEMRI, Nairobi, Kenya, 3University of Chicago, United States, reminders. Reminders were initially sent daily, although participants
4
University of Washington, Seattle, United States, 5Massachusetts could opt for “as needed” reminders (if they missed doses). The effect
General Hospital, United States, 6Mbarara University of Science and of SMS reminders on adherence was assessed by Poisson models
Technology, Global Health Collaborative, Uganda, 7University of Color- adjusted for study site.
ado, United States, 8Jomo Kenyatta University, Kenya Results: Of 348 women in the study, 173 were assigned daily SMS
reminders; 9% opted for “as needed” reminders. Participants were a
median of 21 years old and two-thirds reported condomless sex in
Background: Pre-exposure prophylaxis (PrEP) is highly effective in the month prior to enrollment. As shown in the figure, adherence
preventing HIV acquisition. However, adherence among young women decreased over time by both electronic monitoring and pharmacy
has been challenging. SMS reminders have been shown to improve refill. Correlation between electronically monitored adherence and
adherence to antiretroviral therapy in some contexts. We present TFV-DP levels was high (R2 = 0.73). Among participants picking up
18
PrEP, electronically monitored adherence was 26.9% over 24 months

and did not differ by arm (27.0% with SMS; 26.7% without SMS; OA07.03
adjusted incidence rate ratio 1.07 [95% CI 0.86, 1.33], p = 0.55). No Limited knowledge of, interest in, and eligibility for
differences were seen between arms when assessing adherence for all event-driven PrEP among MSM in two samples in the
participants regardless of PrEP refills, by pharmacy refill data, with United States
only 12 months of follow-up, or by site. M. Newcomb; D. Ryan; C. Xavier Hall; K. Macapagal and B. Mustanski
Conclusions: SMS reminders did not overcome adherence challenges Northwestern University, Institute for Sexual and Gender Minority
among young Kenyan women taking PrEP over two years. Given the Health and Wellbeing, Evanston, United States
overall low adherence in the trial, additional interventions are needed
to support PrEP use in this population.
Background: Uptake of daily oral pre-exposure prophylaxis (PrEP)
OA07.02 among men who have sex with men (MSM) in the United States is
increasing rapidly. Non-daily event-driven PrEP (ED-PrEP, or “2-1-1”)
“I just decided to stop:” understanding PrEP discontinuation
also substantially reduces HIV risk and is recommended by the World
among individuals initiating PrEP in HIV care centers in Health Organization (WHO) for MSM with more infrequent sexual
Kenya and its implications for a public health approach to behavior. In the absence of national guidelines for ED-PrEP use in the
prevention United States, it is unclear how many MSM in the U.S. are aware of,
A. Dollah1; F. Ongolly2; K. Ngure3; J. Odoyo1; E. Irungu2; interested in, and eligible for this dosing strategy.
K. Mugwanya4; J. Morton4; E. Bukusi1; N. Mugo2; J. Beaten4 and Methods: We analyzed data from 2 independent samples of HIV-nega-
G. O’Malley4 tive MSM in the U.S. First, an analytic sample of 424 MSM were drawn
1
KEMRI/RCTP, Research, Nairobi, Kenya, 2KEMRI/PHRD, Nairobi, from RADAR, a longitudinal cohort study of >1200 young MSM in the
Kenya, 3Jomo Kenyatta University of Agriculture and Technology, Chicago area (current data collected October 2019 to March 2020).
Research, Kenya, 4University of Washington, Gloabal Health, Seattle, Second, 267 MSM were drawn from a larger U.S. national cross-sec-
United States tional survey recruited via social media focused on biomedical HIV pre-
vention (collected November 2019 to March 2020). We conducted
descriptive statistics using SPSS to examine use, knowledge, and inter-
Background: Although PrEP discontinuation rates in clinical trials and est in ED-PrEP. We calculated eligibility for ED-PrEP based on WHO
demonstration projects have been well characterized, little is known guidelines (i.e., 2 or fewer sexual encounters/week, ability to anticipate/
about it in routine public health settings. Understanding discontinua- delay sex within 2 to 24 hours of first dose).
tion decisions in non-study settings is important for calibrating expec- Results: Across both samples, 2.3% of MSM reported using ED-PrEP.
tations of PrEP persistence in national programs and strengthening In the U.S. national sample, 38.9% had heard of ED-PrEP, but only
public health approaches to HIV prevention. 18.5% knew all details of the 2-1-1 dosing method. Among current
Methods: In-depth interviews were conducted with 47 individuals PrEP users, a substantial minority of MSM were eligible for ED-PrEP
who initiated PrEP at 25 different HIV comprehensive care centers (46.7% Chicago, 30.5% U.S. national), but most preferred daily dosing
(CCCs) in Central and Western Kenya, whose clinic record indicated (preference for ED-PrEP was 21.2% Chicago, 17.7% U.S. national). A
had not returned for scheduled refills. We explored decisions around marginally higher number of MSM who were eligible for ED-PrEP
initiation, discontinuation, and restarting PrEP. An inductive, thematic, expressed preference for this method, compared to those who were
content-analytic approach was used to analyze the data. ineligible.
Results: Clients initiated PrEP because they had one or more sexual Conclusions: Although many MSM in the U.S. would be eligible for
partners who were either HIV positive or of unknown status. Many ED-PrEP based on WHO guidelines, knowledge of this strategy
discontinued PrEP when their perceived risk decreased (i.e. because remains limited and most MSM report preferring daily dosing. As
those relationships ended, because they were living apart from a pri- knowledge of ED-PrEP increases, interest will likely also grow among
mary partner, or when a known HIV positive partner became virally MSM. Thus, it is critical that national U.S. health organizations develop
suppressed). These participants expressed willingness to re-start PrEP guidelines for ED-PrEP use and that MSM are given accurate informa-
if their partnership situation changed. Others reported discontinuation tion about how to effectively use this dosing strategy.
due to side effects (dizziness, nausea, weight gain) or found daily pill-
taking too burdensome, and preferred condoms for prevention pur-
poses. Some participants (mostly women) discontinued PrEP due to OA07.04
their partner’s insistence and wished for additional PrEP education I’m taking PrEP for myself and not for people: PrEP
and counselling to foster partner support. Though relatively few par- disclosures influence adherence journeys for adolescent
ticipants identified facility level factors as primary reasons for discon- girls and young women in South Africa
tinuing PrEP, many described stigma-related discomfort with accessing J. Daniels1; D. Bresenham2; L. de Vos2; R. Mawarire2; M. Atujuna3;
PrEP at CCCs, inconvenient clinic location and/or operating hours, S. Hosek4; C. Celum5; L.-G. Bekker3 and A. Medina-Marino2
long wait times, and short refill dates as barriers. Most individuals 1
Charles R. Drew University of Medicine and Science, Psychiatry and
reported multiple reasons for deciding to discontinue PrEP and did Human Behaviors, Willowbrook, United States, 2Foundation for Pro-
not inform health facilities of their decision to stop. fessional Development, South Africa, 3Desmond Tutu HIV Foundation,
Conclusions: Clients make intentional decisions to discontinue PrEP Cape Town, South Africa, 4Cook County Health, Chicago, United
as they weigh different prevention options and navigate fluid and States, 5University of Washington, Seattle, United States
sometimes challenging relationships. Many clients will decide to dis-
continue PrEP when perceiving themselves to be at reduced risk and
PrEP counseling approaches must include provisions for addressing Background: Prevention effectiveness of oral PrEP is directly associ-
‘seasonal risk.’ PrEP will not be the right prevention method for every- ated with levels of adherence. To improve the prevention-effective-
one. However, expanding PrEP access points and increasing sex-positive use of PrEP, we explored behavioral, social and community factors
messaging may facilitate PrEP being a better option for many. associated with PrEP disclosure and use among adolescent girls and
young women (AGYW).
Methods: Individual in-depth interviews (IDI) were conducted with
40 AGYW (aged 16 to 25 years) participating in the Community PrEP
19
study in Eastern Cape Province, South Africa. IDI guides were devel- Women who were married had lowest odds of taking PrEP compared to
oped using Social Practice Theory (SPT). IDI domains included: PrEP unmarried women (aOR = 0.11; 95% CI = 0.02 to 0.73), though over
knowledge and use, study site experiences, PrEP actions plans and one-fourth didn’t know her partner’s serostatus (27%). Thirty-five per-
influences, and PrEP discussions in social spaces. AGYW cent of women were diagnosed with a STI. Those with a STI had a non-
with ≥ 12 months of study participation were interviewed, with equal significant greater odds of initiating PrEP (aOR = 1.60; 95% CI = 0.89
representation of AGYW with high and low PrEP adherence measured to 2.89). Pregnant women who reported high internalized PrEP stigma
via tenofovir-diphosphate (TFV-DP) blood concentrations. IDIs were had lower odds of initiating PrEP (aOR = 0.06; 95% CI = 0.03 to 0.12).
conducted in isiXhosa, audio-recorded, transcribed and translated for At 1 m, 72% women returned for a repeat prescription; at 3 m, 60%
analysis using an iterative process guided by SPT to assess factors returned. Among those returning at 3 m, 87% reported adhering to
influencing PrEP disclosure and adherence. PrEP in past seven-days. Being postpartum was associated with lower
Results: Most participants (78.4%) were enrolled in high school, lived odds of PrEP persistence and adherence (aOR = 0.31; 95% CI = 0.16
with family (97.3%), had a current partner (51.4%), and were sexually to 0.61) adjusting for follow-up study, maternal and gestational age.
active (64.9%) within the last year. All participants considered their Retention was lower in women who reported side-effects (22% of
high HIV risk and future goals as primary PrEP motivators. Partici- women reported nausea, dizziness and vomiting).
pants described PrEP disclosure events to family members, friends Conclusions: PrEP uptake was high especially in high-risk women.
and boyfriend/partners, with 91.7% of those with high TFV-DP blood PrEP persistence and adherence were higher than other SA popula-
concentrations disclosing to all three categories, while only 57.9% of tions. Anticipated stigma, side effects and the postpartum period pre-
those with low TFV-DP blood concentrations disclosed to all three. sented challenges to optimal PrEP use, pointing to potential targets
Receiving PrEP support from multiple individuals helped in navigating for interventions to improve PrEP adherence in pregnant/postpartum
PrEP disinterest from others, lack of PrEP education within the com- women.
munity, and mistrust in relationships. After disclosure, gossip and PrEP
myths were not influential for those with multiple disclosures and OA08.01
sources of support. All participants described taking PrEP as an inde-
Antibody isotype switching as a mechanism to counter HIV
pendent journey, but with support from different people in their lives.
Conclusions: PrEP initiation was strongly influenced by one’s future
neutralization escape
goals, while PrEP adherence was seen as an independent journey C. Scheepers1; V. Bekker1; C. Anthony2; S. Richardson1;
influenced by disclosures to key individuals in different social spaces. B. Oosthuysen1; T. Moyo1; P. Kgagudi1; D. Kitchin1; M. Nonyane1;
AGYW with high TFV-DP blood concentrations described larger cir- B. Mabvakure1; Z. Sheng3; B. Lambson1; A. Ismail1; N. Garrett4 and
cles of assembled support. Prevention-effective-use of oral PrEP S. Abdool Karim4
1
among AGYW may be dependent on building disclosure skills to National Institute for Communicable Diseases, HIV and STIs, San-
develop a PrEP support system. dringham, South Africa, 2Institute of Infectious Disease and Molecular
Medicine, South Africa, 3Columbia University, New York, United
States, 4Centre for the AIDS Programme of Research in South Africa
OA07.05LB (CAPRISA), Durban, South Africa
High initiation and persistence on pre-exposure prophylaxis
(PrEP) in HIV-uninfected pregnant women in Cape Town,
South Africa Background: Neutralizing antibodies (nAbs) to highly variable viral
D. Joseph Davey1; R. Mvududu2; N. Mashele2; M. Lesosky2; L.- pathogens show remarkable diversification during infection, resulting
G. Bekker3; P. Gorbach1; T. Coates4; L. Myer2 and PrEP-PP study in an “arms race” between virus and host. Somatic hypermutation
1
University of California Los Angeles, Epidemiology, Los Angeles, Uni- (SHM) in immunoglobulin variable regions enables maturing antibodies
ted States, 2University of Cape Town School of Public Health and to neutralize emerging viral escape variants. However, antibody diver-
Family Medicine, Division of Epidemiology and Biostatistics, Cape sification also occurs through class-switch recombination (CSR) result-
Town, South Africa, 3Desmond Tutu Health Foundation, Cape Town, ing in intra-lineage isotype variation. The immunoglobulin constant
South Africa, 4UCLA, Medicine, Los Angeles, United States region can influence epitope recognition and viral escape, but whether
CSR also contributes to the maturation of natural antibody lineages
during the course of HIV infection has not been explored.
Background: Oral PrEP is a safe and effective prevention strategy to Methods: Longitudinal deep sequencing of an HIV-directed nAb lin-
reduce women’s risk of HIV in pregnancy and postpartum. Successful eage, CAP88-CH06, identified several co-circulating isotypes (IgG3,
PrEP outcomes require PrEP adherence at the time of potential HIV IgG1, IgA1, IgG2 and IgA2), some of which shared identical variable
exposure, especially in pregnancy when tenofovir plasma concentra- regions. CAP88-CH06 lineage members were expressed as multiple
tions are lower than postpartum. naturally occurring isotypes and tested for neutralization and binding
Methods: The PrEP in pregnancy and postpartum (PrEP-PP) study is against longitudinal single-genome derived autologous envelope clones
an ongoing prospective cohort which enrolls consenting pregnant, and epitope mutants.
HIV-uninfected women (>15-years) at first antenatal care visit, fol- Results: We show that higher levels of SHM were associated with
lowed through 12-months postpartum. Interviewers collect data on improved neutralization potency against the T/F virus, and an
participant socio-demographics, relationships, HIV risk factors includ- increased ability to neutralize viruses from later time points. However,
ing: partner’s serostatus, intimate partner violence, substance use and we also show differences in neutralization and binding of autologous
depression. At baseline we provided point-of-care STI testing/treat- viruses and epitope mutants, based on the isotype of the antibody. In
ment of chlamydia, gonorrhea and trichomonas (GeneXpert). We eval- all instances, IgG3 and IgA1 isotypes were better able to neutralize
uate factors associated with: PrEP initiation, PrEP persistence longitudinal autologous viruses and epitope mutants than IgG1 ver-
(returning for PrEP repeat prescription) and PrEP adherence (report- sions of the same antibody, in some cases by >70 fold. We further
ing taking PrEP ≥ 5 of last seven-days) at three-months after PrEP show that CSR directly impacts nAb lineage maturation, with some
start using multivariable logistic regression controlling for baseline age switches such as IgG3 to IgG1 resulting in reduced neutralization of
and gestational age. circulating viruses, creating “dead-end” antibody sub-lineages. How-
Results: Between Aug’19 and Oct’20 we enrolled 712 pregnant women ever, these detrimental switches could be rescued by a further CSR
(median gestation = 21w; median age = 26y). Following counseling, event, from IgG1 to IgA1, which restored neutralization capacity of
91% of women initiated PrEP at their first antenatal visit (n = 649). these antibodies, and enabled further lineage maturation.
20
Conclusions: Our data suggest as with SHM, CSR may have beneficial Single chain variable fragments (scFv) of bNAbs have advantages over
or deleterious outcomes for antibody maturation. In the CAP88-CH06 full antibodies as their smaller size may permit improved diffusion into
lineage, a beneficial CSR event following a detrimental switch, a process mucosal tissues and facilitate vector-driven gene expression. We have
we term “switch redemption”, enabled the continued maturation of that previously shown that scFv of bNAbs individually retain significant
sub-lineage. Thus, CSR represents an additional immunological mecha- breadth and potency. Here we tested combinations of five scFv derived
nism to counter viral escape from HIV-specific antibody responses. Fur- from bNAbs CAP256-VRC26.25 (V2-apex), PGT121 (N332-supersite),
thermore, vaccine design strategies aimed at promoting class-switch 3BNC117 (CD4bs), 8ANC195 (gp120-gp41 interface) and 10E8v4
recombination could enhance antibody responses and vaccine efficacy. (MPER) for their efficacy against multiple HIV subtypes.
Methods: We combined two or three scFv in equimolar amounts in a
OA08.02 neutralization assay and tested them against a multiclade panel of 15
viruses. Experimental IC50 and IC80 data were compared to neutraliza-
Vaccination induces maturation of diverse unmutated
tion titres predicted using the Loewe additive model. This model was
VRC01-class precursors to HIV-1 broadly neutralizing extrapolated to a 45-virus panel and optimal combinations were calcu-
antibodies in an Ig-humanized mouse model lated.
X. Chen1; T. Zhou1; S. Schmidt1; H. Duan1; C. Cheng1; G.-Y. Chuang1; Results: Like full-sized antibodies, combinations of two and three scFv
Y. Gu1; M. Louder1; B. Lin1; C.-H. Shen1; Z. Sheng2; M.G. Joyce3; showed significantly improved potency and breadth compared to single
N. Doria-Rose1; L. Shapiro2 and M. Tian4 scFv. Two scFv combinations generally followed the additive model for
1
NIAID, VRC, Bethesda, United States, 2Columbia University, New York, breadth and potency, except for CAP256.25 + 10E8v4 scFv, which
United States, 3Walter Reed Army Institute of Research, Silver Spring, showed higher experimental potency compared to predicted titres. Low-
United States, 4Boston Children’s Hospital, Boston, United States levels of synergy were also observed in 6/10 triple combinations, most
of which contained CAP256.25 and/or 10E8v4. No significant antago-
nism was observed for any of the double or triple combinations. Extrap-
Background: The vaccine elicitation of broadly neutralizing antibodies olation to a 45-virus panel revealed that at 1 lg/mL (IC50 titres) there
(bnAbs) is a key HIV-research goal. The VRC01-class of bnAbs targets was 100% coverage for one dual combination (CAP256.25 + 10E8v4)
the CD4-binding site on the HIV-envelope trimer and requires exten- and three of the triple combinations containing these two scFv. The
sive somatic hypermutation to neutralize effectively. Despite substan- geometric mean potency of the best triple combination (CAP256.25 +
tial progress in developing germline-engaging immunogens to activate 10E8v4 + 3BNC117) was significantly more potent than any of the
VRC01-class bnAb precursors and using transgenic mouse models for single scFv (0.047 lg/mL at IC50 and 0.18 lg/mL at IC80).
eliciting VRC01-class antibodies, vaccine-induced VRC01-class antibod- Conclusions: Combinations of scFv show significantly improved
ies starting from unmutated precursors have exhibited limited neutral- breadth and potency over individual scFv, as previously observed for
ization breadth, particularly against viruses bearing glycan at residue full-sized antibodies. The V2-specific bNAb CAP256.25 and the MPER
N276 (glycan276), which is present on most circulating strains. bNAb 10E8v4, were the most common scFv in the best double and tri-
Methods: Here, using an immunoglobulin (Ig)-humanized mouse model in ple combinations and were also more likely to show synergy. Given their
which the VRC01-class germline VH gene recombines with diverse mouse size advantage, combinations of scFv show potential for passive immu-
D and JH gene segments and pairs with an unmutated rearranged light nization.
chain to create a diverse repertoire of unmutated VRC01-class precur-
sors, we compared a “multi-strain, heterologous boost” sequential immu-
nization strategy, which presents the conserved CD4bs in different gp120 OA08.04
cores or trimers for better immune focusing on the CD4bs, with previ- Active tuberculosis co-infection enhances HIV-1 specific
ously tested strategies based on germline-binding 426c cores with differ- humoral immunity
ent levels of glycan shielding of the CD4bs (Tian et al., 2016) or repeated B. Adeoye1; A.J. Olson2; L. Nakiyingi3; Y.C. Manabe4; K.R. Jacobson5;
eOD-GT8 60mer priming followed by diverse Env boosts. J. Ellner6 and M. Sagar7
Results: With both the new strategy and the 426c-core strategy, we 1
Boston University School of Medicine, Microbiology, Boston, United
elicited cross-clade neutralizing serum titers against a sentinel panel States, 2Boston Medical Center, Infectious Disease, Boston, United
of eight HIV-1 strains, including five bearing glycan276. We further States, 3Makerere University College of Health Sciences, Kampala,
identified multiple lineages of VRC01-class bnAbs from the immunized Uganda, 4Johns Hopkins University, Baltimore, United States, 5Boston
animals, including two neutralizing >50% of a 208-strain panel, and University School of Medicine, Infectious Disease, Boston, United
carried out mutagenesis and crystal structure analyses, revealing key States, 6Rutgers Robert Wood Johnson Medical School, Medicine, Pis-
sites of SHM and mechanisms for surmounting glycan276 to achieve cataway, United States, 7Boston Medical Center, Medicine, Boston, Uni-
neutralization breadth. ted States
Conclusions: Overall, our study provides proof-of-concept for the
induction of VRC01-class bnAbs of greater than 50%-neutralization
breadth by sequential immunization, succeeds in eliciting antibodies Background: Mycobacterium tuberculosis has been shown to
capable of recognizing glycan276-bearing strains, and uses longitudinal enhance antibody responses against diverse viruses, potentially via the
analysis to pinpoint the development of specific SHM in response to impact of lipid antigens or trained immunity. We hypothesized that
specific immunogens. active tuberculosis (TB) enhances the development of HIV-1 neutraliz-
ing antibodies in HIV-1 co-infection.
Methods: We compared anti-HIV-1 antibody responses among treat-
OA08.03 ment-naive plasma samples from 15 HIV-1 participants with TB (HIV-
Combinations of scFv of HIV bNAbs demonstrate high 1/TB) and 16 HIV-1 participants without TB. Ability to inhibit 12 dif-
breadth and potency against a multiclade panel of viruses ferent tier 1 and 2 HIV-1 variants of diverse subtypes in the TZM-bl
R.T van Dorsten; P. Moore and L. Morris neutralization assay was used to estimate a neutralization breadth and
NICD, Center for HIV and STIs, Johannesburg, South Africa potency (BP) score. ELISA was used to compare antibody titers
against other latent infections.
Results: HIV-1/TB and HIV-1 infected participants had similar base-
Background: Broadly neutralizing antibodies (bNAbs) are currently line plasma virus levels (p = 0.33) and CD4 counts (p = 0.40). HIV-1/
being assessed in clinical trials for their ability to prevent HIV infection. TB individuals had a significantly higher BP score (0.57 0.05, range
21
0.32 to 0.97) than HIV-1 group (0.41 0.05, range 0.24 to 0.57, Conclusions: Our results are relevant not only to the development of
p = 0.02). The plasma activity of 6 HIV-1/TB individuals with high an HIV-1 vaccine aimed at eliciting VRC01-class antibodies, but to
baseline BP scores clustered with CD4 binding site and membrane- general effort to activate specific B cell lineages that produce protec-
proximal external region targeting broadly neutralizing antibodies tive antibodies, and further suggest that ai-mAbs-derived immunogens
(bnAbs). After completing TB treatment and/or starting HIV-1 therapy may have general utility as germline targeting immunogens against
for 6 months, HIV-1/TB (0.64 0.09, n = 6, range 0.22 to 0.99) as diverse B cell targets.
compared to HIV-1 participants (0.48 0.09, n = 8, range 0.26 to
0.78) still had higher neutralizing capacity, but the difference was not OA09.01
statistically significant (p = 0.11). Neutralization BP score did not cor-
BCG.HTI2auxo.int priming vaccination enhances the HIV-1
relate with the total plasma IgG, baseline viral load, CD4 count, IL-6,
sCD163, and MCP-1 concentrations. HIV-1/TB (0.02 0.01) as com-
specific T cell immune responses elicited by MVA.HTI
Olvera2; T. Hanke3;
N. Saubi1; A. Kilpel€ainen1; Y. Eto1; C.-W. Chen1; A.
pared to HIV-1 (0.03 0.01; p = 0.68) group had similar level of
HIV-1 envelope diversity. The HIV-1/TB and HIV-1 only participants C. Brander2 and J. Joseph4
1
had similar anti-tetanus (p = 0.44) and anti-HSV (p = 0.25) antibody Vall d’Hebron Institut de Recerca, Microbiology, Barcelona, Spain,
2
titers. Irsicaixa, AIDS Research Institute, Badalona, Spain, 3The Jenner Insti-
Conclusions: Our results suggest that active TB enhances the neu- tute, Nuffield Department of Medicine, Oxford, United Kingdom,
4
tralizing capacity of anti-HIV-1 antibodies, possibly leading to the Hospital Universitari de la Vall d’Hebron, Microbiology, Barcelona,
emergence of bnAbs that target conserved envelope domains. TB nei- Spain
ther potentiates pre-existing antibody responses against latent infec-
tions nor correlates with other factors previously shown to be
Background: As part of our contribution to the EAVI2020 consortium
important for bnAb emergence. Mechanisms that account for the
enhanced HIV-1 neutralization in HIV-1 individuals with active TB research project to get a preventive HIV vaccine, we’ve constructed
recombinant Mycobacterium bovis BCG expressing the EAVI2020 T-
could be leveraged in the generation of a more effective humoral
cell immunogens.
response in HIV-1 vaccination and treatment.
Methods: In this study, we constructed an integrative E. coli-
mycobacterial shuttle plasmid, p2auxo.HTI.int, expressing the HIVA-
OA08.05LB CAT T-cell immunogen (HTI). The plasmid was transformed into a
Development of a novel VRC01-class germline targeting lysine auxotrophic BCG strain (BCGDLys) to generate BCG.HTI2auxo.int.
immunogen derived from anti-idiotypic antibodies The DNA sequence coding for the HTI immunogen and HTI protein
E. Seydoux1; Y.-H. Wan1; J. Feng1; A. Wall1; S. Aljedani1; L.J. Homad1; expression were confirmed and vaccine stocks were genetically and
A.J. MacCamy1; C. Weidle1; M.D. Gray1; L. Brumage1; J.J. Taylor1,2,3; phenotypically characterized. We demonstrated that the vaccine was
M. Pancera1; L. Stamatatos1,2 and A.T. McGuire1,2 stable in vitro for. BALB/c mice were immunized with BCG. HTI2auxo.int
1
Fred Hutch, VIDD, Seattle, United States, 2University of Washington, prime and MVA.HTI boost was safe and induced HIV-1-specific T-cell
Department of Global Health, Seattle, United States, 3University of responses. T-cell responses were assessed by IFN-c ELISpot upon
Washington, Department of Immunology, Seattle, United States stimulation with 17 peptide pools spanning the HTI proteome.
Results: The highest total magnitude of IFN-c spot forming cells
(SFC)/106 splenocytes was observed in BCG.HTI2auxo.int primed mice
Background: Numerous broadly neutralizing antibodies (bNAbs), compared to mice receiving MVA.HTI alone or mice primed with
which exhibit remarkable breadth and potency in their ability to neu- BCGwt, although the differences between the vaccination regimens
tralize HIV-1, have been isolated from HIV-1-infected individuals. only reached trends. In order to evaluate the differences in the
VRC01-class antibodies are among the most broad and potent bNAbs breadth of the immune response between mice primed with
known and they were isolated from at least 10 different donors. They BCG.HTI2auxo.int and BCGwt, we examined the number of reactive
bind the CD4-binding site on Env and use a unique combination of peptide pools per mouse. Interestingly, both BCG.HTI2auxo.int and
VH1-2*02 VH gene paired with light chains expressing rare 5 amino BCGwt primed mice recognized an average of 4 peptide pools per
acid long CDRL3 domains. Precursor VRC01-class bNAbs display no mouse. However, the variation was higher in BCG.HTI2auxo.int primed
reactivity to recombinant Env, which lead to the development of germ- mice with one mouse recognizing 12 peptide pools and three mice
line-targeting immunogens to engage and stimulate na€ıve VRC01-class recognizing few or no peptide pools. On the other hand when compar-
precursor B cells. However, these immunogens also present off-target ing the percentage of responding mice per peptide pool, all BCGwt
epitopes that could hinder the maturation of VRC01-class bNAbs. primed mice respond to the more dominant peptides IKProt and
Methods: As an alternative to Env-derived germline-targeting 2BRT, whereas the recognition profile appeared to be more spread
immunogens, we developed and characterized a panel of monoclonal out for BCG.HTI2auxo.int primed mice and mice only receiving
anti-idiotypic antibodies (ai-mAbs) that can target and potentially acti- MVA.HTI, with these groups having a few mice responding to less rec-
vate putative VRC01-class precursors with high affinity. ognized pools such as 1Dp17, IEp24, 1JProt. Mice were monitored
Results: In B cell sorting experiments, none of the ai-mAbs were able weekly for signs of malaise. No vaccine-related deaths, no local
to reliably engage VRC01-class precursor B cells. By integrating ai- adverse events, and no associated systemic reactions were observed.
mAb binding, structural and B cell sorting analyses, we engineered a Conclusions: This vaccine candidate may be a useful tool in the
bispecific molecule (iv4/iv9) derived from two ai-mAbs (iv4 and iv9), development of an effective vaccine platform for priming protective
from which the iv9 arm is specific for VRC01-class heavy chains and responses against HIV-1/TB and other prevalent paediatric pathogens.
the iv4 arm for VRC01-class light chains. Compared to the parental
ai-mAbs, iv4/iv9 could bind ex vivo B cell receptors comprised of a
germline VRC01-class heavy or light chain, but it preferentially cross-
linked and activated B cells expressing both VRC01-class heavy and
light chains. Using a murine adoptive transfer model, we observed that
when used as an immunogen, the bispecific ai-mAb was more efficient
at engaging and expanding putative VRC01-class precursor B cells
in vivo than either iv4 or iv9 Fabs.
22
responses than the corresponding non-adapted epitopes (NAE). A sig-

OA09.02 nificant proportion (30% to 40%) of these HLA-II associated viral poly-
Anti-Env antibody-independent protection of repeated morphisms are encoded in HIV-1 vaccine immunogens. However, the
intrarectal low-dose SIVmac239 challenges in rhesus impact of these HLA-II associated adaptations on vaccine immuno-
macaques by vaccination inducing Gag/Vif-specific CD8+ T genicity has not been previously studied.
but not CD4+ T cells Methods: Vaccine recipient and placebo PBMC samples were
H. Ishii1; K. Terahara2; T. Nomura1; T. Tokusumi3; T. Shu3; obtained from three different HIV-1 vaccine trials. These included
H. Sakawaki4; T. Miura4 and T. Matano1 MRKAd5 or HVTN 502 (n = 24), DNA/rAd5 or HVTN 505 (n = 24),
1
National Institute of Infectious Diseases, AIDS Research Center, and DNA/MVA or HVTN 106 (n = 40). Vaccine-matched epitopes
Tokio, Japan, 2National Institute of Infectious Diseases, Department of were then grouped together into adapted epitope and non-adapted
Immunology, Tokio, Japan, 3ID Pharma Co., Ltd., Japan, 4Institute for epitope pools. Immunogenicity was then tested utilizing a CD8-
Frontier Life and Medical Sciences, Kyoto University, Japan depleted IFNg ELISpot assay (n = 88) and a more sensitive flow-based
activation induced marker (AIM) assay (n = 58) to identify antigen-
specific CD4+ T cells.
Background: Virus-specific CD4+ T cells are important for induction Results: In the 88 samples, we identified 10 positive IFNg ELISpot
of effective CD8+ T cells but can be preferential targets for HIV/SIV responses to non-adapted epitopes, while we only identified 1 positive
infection. Recent studies have indicated the detrimental effect of vac- response to adapted epitopes (p = 0.013, Fisher’s Exact). Out of the
cine-induced CD4+ T cells on HIV vaccine efficacy (J Virol 88:14,232, 58 samples tested by the AIM assay, we identified a trend towards
2014; Sci Transl Med 11:eaav1800, 2019), suggesting supporting a more non-adapted epitope responses, with 28 responses to non-
rationale for vaccine design inducing HIV-specific CD8+ T-cell adapted epitopes and 18 responses to adapted epitopes (p = 0.087,
responses without HIV-specific CD4+ T-cell induction. Recently, we Fisher’s Exact). Overall, there was an increased magnitude of AIM
have developed an novel immunogen, CaV11, consisting of tandemly marker expression in response to non-adapted epitopes (p < 0.0001,
connected overlapping 11-mer peptides spanning viral Gag capsid Wilcoxon). This shows that CD4+ T cells from vaccine recipients pro-
(CA) and Vif. Immunization with DNAs and Sendai virus (SeV) vectors duce more IFNg and are more activated in response to vaccine-
expressing CaV11 efficiently effectively induced CD8+ T cells but not matched non-adapted epitopes. Finally, we also report a positive cor-
CD4+ T cells targeting Gag and Vif with SeV-specific CD4+ T-cell help relation between non-adapted epitope-specific CD4 response magni-
in rhesus macaques (J Virol 94:e01876-19, 2020). In the present tude and Env-specific IgG antibody generation in DNA/rAd5
study, we investigated efficacy of the CaV11-expressing vaccine (p = 0.014, Spearman’s), suggesting that these CD4 responses may
against repeated intrarectal low-dose SIVmac239 challenges in rhesus play a role in eliciting HIV-specific antibodies. Ongoing studies are
macaques. being performed to determine the phenotype and function of these
Methods: Twelve rhesus macaques received four times of intramus- CD4+ T-cell responses at the single-cell level.
cular vaccination with CaV11-expressing DNAs at weeks 0, 1, 3 and 4 Conclusions: Our data demonstrate that non-adapted epitopes
and four times of intranasal and intramuscular vaccination with encoded within human HIV-1 vaccine immunogens are immunogenic.
CaV11-expressing SeV vectors (SeV-CaV11) at weeks 6, 7, 12 and 18. This suggests that modified vaccine inserts should be considered to
These twelve vaccinated and seven unvaccinated macaques were enhance CD4 responses and that such optimization strategies may
intrarectally challenged with low-dose (200 TCID50) SIVmac239 have implications for future HIV-1 vaccine design.
biweekly starting from 6 weeks after the last vaccination.
Results: All the vaccinated animals efficiently induced Gag/Vif-specific OA09.04
CD8+ T-cell responses with inefficient Gag/Vif-specific CD4+ T-cell Applying insights from HIV to guide the development of a
induction after the SeV-CaV11 vaccination as observed in our previ-
T-cell vaccine for SARS-CoV-2
ous study. After eight times of SIV challenge, six of the seven unvacci-
A. Nathan1; G. Gaiha1; E. Rossin2; C. Kaseke1; R. Tano-Menka1 and
nated macaques were infected, whereas eight of the twelve
B. Walker1
vaccinated were protected from SIV infection. Kaplan-Meier analysis
1
indicated a significant difference in the number of challenges for HIV Ragon Institute of MGH, MIT, and Harvard, Ragon Institute of MGH,
acquisition between the unvaccinated and the vaccinated (p = 0.0341 MIT, and Harvard, Boston, United States, 2Massachusetts Eye and
by Log-rank test). Furthermore, even the SIV-infected vaccinees Ear, United States
showed significantly lower acute viral loads compared to the unvacci-
nated macaques.
Background: There is urgent need for a safe and effective vaccine
Conclusions: The present study for the first time indicates that
for SARS-CoV-2. While most current vaccine candidates aim to induce
canonical CD8+ T cells induced by Env-independent vaccination can
broadly neutralizing antibodies, recent studies have highlighted the
protect the establishment of HIV infection after intrarectal virus expo-
critical importance of CD8+ T-cells in reducing COVID-19 severity.
sure. Our results suggest that selective induction of virus-specific
We apply structure-based network analysis to the SARS-CoV-2 pro-
CD8+ T cells by using this immunogen design is a promising HIV vac-
teome and a novel HLA class I-peptide stability assay to define muta-
cine strategy.
tionally constrained CD8+ T-cell epitopes across 18 globally relevant
HLA alleles in order to the guide the rational design of an effective
OA09.03 SARS-CoV-2 T-cell vaccine.
Impact of HLA-II associated HIV-1 adaptations on vaccine- Methods: Structurally constrained, mutation-resistant regions within
induced CD4 T-cell immune responses 15 SARS-CoV-2 proteins were identified using a structure-based net-
J. Files; S. Sterrett; T. Fram; N. Erdmann; A. Bansal and P. Goepfert work analysis algorithm initially developed and validated on HIV. Epi-
University of Alabama at Birmingham, Medicine, United States tope network scores were calculated on all 16,649 possible 8 to 11-
mers. Only 312 of the 2235 highly networked epitopes were strong
HLA class I binders for 18 HLA alleles as predicted by NetMHC-
Background: Our group has previously used HLA-II associated HIV Pan4.1. To experimentally confirm binding, we employed a novel HLA-
viral polymorphisms to predict CD4+ T-cell escape in HIV infected peptide stability assay using CRISPR/Cas9-edited TAP-deficient
individuals. In both acute and chronic HIV infection, adapted epitopes monoallelic HLA class I-expressing cell lines. Experimentally validated
(AE) encompassing these polymorphisms elicited weaker CD4 immune binders were incubated with PBMCs from 23 healthy donors and 25
23
mild, convalescent COVID-19 patients prior to assessment of CD137

expression in the CD8+ T-cell pool as an indicator of epitope-specific
OA09.05LB
Spontaneous in vivo control of HIV replication is
reactivity.
Results: Highly networked regions in SARS-CoV-2 demonstrated low underpinned by the cross-clade antiviral potency of HIV-
sequence entropy across the SARS-CoV-2 proteome, SARS-CoV-1, specific CD8 T cells
MERS, and bat betacoronaviruses. HLA-peptide stability assays identi- J. Makinde1; N. Fernandez1; P. Hayes1; C. Ochsenbauer2; J. Dalel1;
fied 104 of these highly networked epitopes that have >50% relative J. Hare1; S. Joseph1; D. King1; I.P.C Investigators1; E. Sanders3;
stability to an immunodominant HIV epitope and provide broad HLA M. Price4,5; E. Hunter6 and J. Gilmour1
1
population coverage. Incubation of these peptides with PBMCs from IAVI Human Immunology Laboratory, Imperial College London, Lon-
convalescent patients showed significantly higher CD137+ CD8+ T - don, United Kingdom, 2University of Alabama, Birmingham, Alabama,
cell reactivity to the structural protein epitopes than did healthy United States, 3Kenya Medical Research Institute-Wellcome Trust
donors, with 72% of patients responding. Research Programme, Kilifi, Kenya, 4IAVI, New York, United States,
5
Conclusions: Application of structure-based network analysis and University of California at San Francisco, Department of Epidemiol-
HLA class I-peptide stability assays identified a set of highly conserved ogy and Biostatistics, San Francisco, California, United States, 6Emory
and stabilizing epitopes across 18 globally relevant HLA alleles, setting Vaccine Center, Atlanta, Georgia, United States
the stage for rational T-cell vaccine design for SARS-CoV2, with broad
betacoronavirus coverage.
Background: CD8 T cells are critical in the resolution of acute HIV
viraemia and long term spontaneous persistent virus control. Obtain-
ing a better understanding of the specificity and potency of the CD8
T cells response during the resolution of acute infection and how if
differs between individuals who show exceptional long term in vivo
control of viraemia compared to individuals who fail to control, may
direct the rational design of T cell based immunogens and better tools
to assess clinical vaccine candidates.
Methods: Three groups of individuals were selected from a multisite
early infection HIV cohort of 613 volunteers drawn from nine clinical
research centres in five African countries. Ten HIV+ volunteers, who
24
rapidly and persistently controlled HIV in vivo were selected, and the technical Working Groups (WG), facilitate discussion, and synthesize
breath and anti-viral potency of their CD8 T cell responses assessed the output of the WG. Participants included key global stakeholders
against a broad panel of replication competent transmitted founder representing policymakers, Ministries of Health, normative agencies,
HIVs (TFVs). These samples were matched and compared with 2 fur- funders, procurers, implementers, researchers, and advocates. The
ther groups of 10 volunteers who either failed to control their virus, WG used CAB LA as a case study to identify critical components of
or had intermediated control. Polyclonally expanded CD8 T cells from product introduction (pre- and post-licensure) across four areas:
PBMC were assessed at three timepoints (2 acute and 1 chronic) Guidelines & Policy; Resource Needs & Procurement; Service Deliv-
post-infection for CD8 T cell-mediated viral inhibition of a cross-clade ery; and Additional Research Planning.
panel of TFV isolates tagged with Renilla reniformis luciferase. The Results: From October 2018 the four WG met to identify and priori-
cross-clade panel of 10 TFVs selected represents approximately tize needs/concerns based on previous experience with PrEP introduc-
53.2% of conserved predicted CD8 T cell epitopes within the cohort tion. A summary of critical needs was sorted into activities that could
from which the subjects were drawn. be initiated during trials for planning and priority setting, after regula-
Results: At all three timepoints, polyclonally expanded CD8 T cells tory approval, and during product scale-up. The AB endorsed this
from the controllers showed significantly higher levels of inhibition of framework and requested dissemination of the strategy and plans to
viral replication compared to the non-controllers. Furthermore 50% of track and monitor execution against the framework. The CAB LA strat-
controllers at all three timepoints were capable of inhibiting all 10 egy further informed BioPIC’s product-adaptable framework, which is
TFVs in the cross-clade panel, compared to just 30% of intermediates a foundational roadmap for next-generation products.
and 20% of the non-controllers. Conclusions: Over 100 global HIV prevention experts contributed to
Conclusions: Our results suggest that intrinsic qualities of the CD8 T a comprehensive introduction framework for a novel HIV prevention
cell responses that allow for the recognition of more HIV-1 variants product. This CAB LA strategy informed BioPIC’s product-adaptable
might underpin the spontaneous control of infection in the absence of framework for pipeline products. Validity and success of the BioPIC
treatment. Understanding these qualities is the focus of ongoing inves- model with continued refinement will ultimately be judged by reduced
tigations in the pursuit of the rational design of better immunogens time to public health impact of CAB LA and any next-generation
aimed at prevention and cure. biomedical prevention product.
OA10.01 OA10.02
Planning for success: generating an early roadmap with Pathways to global access for novel HIV prevention
global stakeholders for increasing access and uptake of new technologies
biomedical prevention products in resource-limited settings: S. Malhotra1; N. Sender1; M. Keane1; M. Price2 and A. Kurzman1
The Biomedical Prevention Implementation Collaborative 1
IAVI, Global Access, New York, United States, 2IAVI, Epidemiology,
(BioPIC) New York, United States
A.R. Rinehart1; C.D. Amole2; M. Warren3; M. Czarnogorski4;
M. Gross5; L. Van Damme6; I. Mukui7; B. Grinsztejn8; C. Celum9;
A. Gomez10; N. Madidi11; S.Y. Jenkins12; C. Sozi13; J. Reid12 and Background: Early planning to identify and address potential barriers
R. Baggaley14 to access are critical in ensuring that once forthcoming technologies
1 are available, they are widely accessible and deliver impact. This
ViiV Healthcare, Research Triangle Park, United States, 2Clinton
research aims were to identify key considerations and potential strate-
Health Access Initiative, Global HIV Access, Washington, United
gies for supporting broad availability and uptake of forthcoming long-
States, 3AVAC, New York, United States, 4ViiV Healthcare, Innovation
acting HIV prevention products by. The goal of this research was to
and Implementation Science, Research Triangle Park, United States,
5 inform efforts to accelerate future access to new HIV biomedical pre-
Bill and Melinda Gates Foundation, HIV and Integrated Delivery,
vention innovations in LICs and LMICs.
Washington, United States, 6Bill and Melinda Gates Foundation, Global
Methods: In-depth interviews were conducted between Q2 Q4 2019
Health, HIV, Washington, United States, 7DNDi, HIV Access and Medi-
with 45 representatives from 19 leading global health organizations
cal Affairs, Kenya, 8Instituto Nacional de Infectologia Evandro Chagas,
and programs involved in supporting access to global health preven-
FIOCRUZ, Rio de Janeiro, Brazil, 9University of Washington, Depart-
tion products. Interviews were used to gather lessons learned from
ment of Global Health, Seattle, United States, 10Independent Consul-
past experiences that could be transferable to new HIV prevention
tant, United Kingdom, 11Population Services International, Centurion,
products and identify key challenges and opportunities for global
Zimbabwe, 12Clinton Health Access Initiative, Washington, United
access. Data from qualitative interviews was supplemented by an in-
States, 13United Nations, Resident Coordinator, Ethiopia, 14World
depth review of the literature on HIV prevention technologies.
Health Organization, Department of HIV and Global Hepatitis Pro-
Results: Several enabling strategies to accelerate access to promising
gramme, Geneva, Switzerland
HIV prevention technologies were identified along different stages of
the research, development, and product introduction continuum,
Background: Decreasing the time from Phase 3 efficacy results to Establishing platforms to support early information-sharing and
product introduction and public health impact requires advanced plan- coordination across global health stakeholders
ning in parallel with trials. A global collaborative approach, with Improved harmonization of regulatory procedures. Bridge funding
insights from prior product introductions from stakeholders engaged and de-linking pooled procurement from donor funding to ensure
early to develop a comprehensive and coordinated strategy, should countries do not lose the benefits of large volume purchasing as
help to ensure that activities are well-designed, well-timed, and appro- they transition to financial independence.
priately funded. BioPIC tested this model in planning for the investiga- Mobilizing innovative collaborations and novel financing mecha-
tional long-acting injectable cabotegravir (CAB LA) for HIV PrEP and nisms to catalyze R&D, drive co-investment, and support afford-
developed a product-adaptable framework to support the introduction ability.
of next-generation biomedical HIV prevention products. Ensuring a robust package of evidence that addresses cost-effec-
Methods: BioPIC convened a diverse group of 104 global health and tiveness, programmatic suitability, and epidemiological impact to
HIV prevention experts across more than 80+ organizations and 20 support timely and widespread adoption.
countries (Jul 2018 to present). An Implementation Strategy Commit-
tee (ISC) was formed to convene an Advisory Board (AB) and four
25
Understanding potential acceptability and implementation barriers Conclusions: Advocates’ input informed the D4P protocol and
early in development to ensure they are factored in product Gilead’s ongoing negotiations with regulatory agencies. Engagement
design and roll-out strategies. should be sustained to ensure stakeholder support and ownership of
the trial, results, and product introduction.
Conclusions: While the availability of forthcoming LA-HIV prevention The process provides a model for robust engagement of advocates
products is eagerly anticipated, research findings suggest that these
with product developers around complex, next-generation prevention
products could confront challenges resulting in access delays and inef- trials.
ficiencies, unless addressed. Beginning early in development, coordi-
nated efforts are needed to support early engagement, drive broad
availability, ensure affordability, facilitate adoption and support uptake. OA10.04
Concerted and coordinated action will be needed to deliver upon key Amplifying youth voices in HIV prevention: lessons learned
recommendations articulated in this research. from a community-based adolescent health project in
Durham, NC
OA10.03 A.C. Maragh-Bass1; J.T. Mitchell2; N.L. Bhushan3; M. Stoner4;
Advocates’ perspectives on an efficacy trial of F/TAF as L. Riggins5; K. LeMasters5; M. Walker5; S.L. Debnam5; A.F. Lightfoot5;
PrEP for women C. Golin5 and A.E. Pettifor5
1
S. Hannah1; M. Warren2; N. Luthuli3; D. Ouya4; Y. Raphael5; N. Yola5; FHI 360, Division of Behavioral, Epidemiological, and Clinical
B. Kanyemba5; M. Chatani2 and L. Mworeko6 Sciences, Durham, United States, 2Duke University Medical Center,
1 Durham, United States, 3University of North Carolina, Institute for
AVAC, Research Engagement, New York, United States, 2AVAC, New
Global Health and Infectious Diseases, Chapel Hill, United States, 4RTI
York, United States, 3AVAC, Durban, South Africa, 4AVAC, Nairobi,
International, Women’s Global Health Imperative, Berkeley, United
Kenya, 5APHA, Durban, South Africa, 6ICW-EA, Uganda
States, 5University of North Carolina, Chapel Hill, United States
Background: The October 2019 FDA approval of F/TAF (Descovy) as

Background: African American (AA) youth have the highest national
daily oral PrEP excluded individuals at risk of HIV infection from
rates of HIV. We established a 20-person working group to develop
receptive vaginal sex, and required Gilead, the product’s developer,
an agenda for multilevel HIV prevention research in the southeastern
conduct an efficacy trial in cisgender women. Gilead plans to conduct
United States where HIV incidence is particularly elevated.
the Descovy for PrEP (D4P) trial in women in sub-Saharan Africa,
Methods: Adolescent Health Working Group (AHWG) stakeholders
using background HIV incidence from previous trials, including ECHO,
included local housing authority members and residents, city council,
to estimate efficacy.
health department, faith-based groups, and youth from Durham, North
Given scrutiny around the clinical development of F/TAF, AVAC, Advo-
Carolina. Meetings solicited perspectives on critical issues related to
cacy for Prevention of HIV/AIDS (APHA) and International Community
HIV risk and pre-exposure prophylaxis (PrEP) access and awareness.
of Women living with HIV Eastern Africa (ICW-EA) convened indepen-
The research team processed meeting notes, debriefed challenges,
dent civil society consultations to engage with Gilead and inform the
recorded ‘a running list of topics,’ and identified informational needs.
design of the D4P protocol.
Results: Six meetings were held. Youth (ages 17 to 24 years old) felt
Methods: APHA and ICW-EA, in collaboration with AVAC, led
that the AHWG was “dominated by adult voices,” thus we recruited
engagement with civil society stakeholders in South Africa and
additional youth, established a suggestions box for anonymous feed-
Uganda, respectively, through the following activities:
back, and youth team members co-facilitated subsequent meetings.
• Series of six consultations with approximately 100 advocates, to Adults expressed parental concern for PrEP safety and children con-
build research literacy and discuss advocacy concerns; senting to PrEP without parental knowledge. Therefore, we provided
• Online survey to gather perspectives and consolidate positions and educational materials about state minor consent laws and HIV/PrEP.
priorities; In contrast, youth were interested in challenges including daily PrEP
• Direct consultation with Gilead. adherence. The AHWG recommended that HIV/PrEP needs are part
of a larger issue of ‘sexual health education because it doesn’t happen
All activities were conducted virtually in light of COVID-19.
in schools.’ Some youth mentioned that the arts may be a form of
communication they would appreciate and that ‘they would listen to
Results: The quantitative survey revealed diverse perspectives, espe-
someone their age who had HIV, not old people.’
cially those related to inclusion of pregnant and breastfeeding women,
Conclusions: Youth-specific PrEP messages should be youth-led,
providing important nuance in discussions with Gilead.
avoid terms such as “high risk” or stigmatizing terminology, and
Feedback centered around:
encompass larger conversations about stigma, sex, and specific needs
• Safety profile of F/TAF among adolescents and pregnant and of Black youth and LGBT-identified youth. Our work highlights that:
breastfeeding women and possibilities of including these population
a) youth investment in research requires using trusted media and
in the trial;
information sources;
• Size, color and packaging of the pill;
b) the importance of our additional work to create a protected space
• Standard of prevention, reproductive health package, adherence
led by youth voices in addition to a combined youth/adult group;
counselling and social-behavioural support during the trial;
c) PrEP awareness must be increased via larger conversations and
• Post-trial access to PrEP;
tailoring messages to youth and their trusted adults.
• Efficacy calculations based on ECHO incidence, given the unknown
impacts of COVID-19 on HIV rates, and that Uganda was not an Future community partnerships should consider a greater number of
ECHO country; AHWG meetings to further facilitate genuine relationships and youth
• Sustained and diverse stakeholder and community engagement leadership building as a part of youth-focused HIV prevention
throughout the trial life-cycle, ensuring local relevance and accep- research.
tance;
• Framing F/TAF as an additional, rather than a “better”, PrEP option
to TDF/FTC.
26
numbers, geography, and other indicators. This analysis examined data

OA10.05 from Quarter 3 (Q3) 2016 to Q2 2020 to highlight global and regio-
Associations of climate shocks, HIV, and HIV-related nal PrEP initiation trends.
behaviors amongst women in Mozambique based on the Results: Global PrEP uptake has increased six-fold in approximately
2015 Demographic Health Survey and Climate Hazards four years, from 102,446 initiations in 2016 to 651,586 in 2020.
Group InfraRed Precipitation with Station Data Annual growth has slowed over time, from 104% from 2017 to 2018,
T. Carpino1 and A. Low2 to 55% from 2018 to 2019, to 18% from 2019 to 2020. At the regio-
1
Columbia University, ICAP at Columbia University, New York, United nal level, Oceania has the highest rate of change, with total PrEP
States, 2Columbia University, New York, United States initiations increasing from 318 to 29,093, driven largely by Australia.
Sub-Saharan Africa has substantially expanded PrEP access, from
4154 initiations in 2016 to 290,981 by mid-2020, comprising 44% of
Background: The past three decades, Mozambique had climate the global total. South Africa and Kenya have led this growth, counting
shocks including drought, cyclones, and flooding. Low et al (2019) 69,876 and 63,000 cumulative initiations, respectively. Brazil is leading
found that severe drought (SD) is associated with higher HIV preva- PrEP uptake in Latin America and the Caribbean, accounting for two-
lence in some communities of young women in Africa. Potential theo- thirds of initiations, and Thailand comprises 51% of initiations in Asia.
ries attribute these associations to alterations of sexual behavior i.e. The United States has the most cumulative initiations at 203,837,
transactional sex due to a loss of income. This study analyzes the asso- about one-third of the global total, but has comparatively modest
ciations of climate shocks, HIV and preventive behaviors in Mozambi- growth rates. Shared traits in many of these settings are early
can women. adoption, national commitment to scale-up, and programs tailored to
Methods: We used the 2015 Mozambique Demographic Health Sur- populations at high risk offering rights-based services and linkages to
vey to select a nationally representative sample of women who com- social support.
pleted an interview and HIV testing. Deviations in rainfall for May Conclusions: While PrEP initiations have grown exponentially in sev-
2014 June 2016 were measured using precipitation data from Cli- eral countries, global uptake falls far short of UNAIDS’ target of 3 mil-
mate Hazards Group InfraRed Precipitation with Station Data lion users, indicating a need for sustained demand creation where
(CHIRPS), with severe drought (SD) set at < 15% of the empirical PrEP programs exist, and scale-up where PrEP is provided via demon-
proportion of rainfall from 1981 to 2016. The associations between stration projects with limited reach. Countries should replicate suc-
climate and HIV-related outcomes were analyzed using logistic regres- cessful approaches, including service delivery models that meet end
sion, incorporating stratification by age, urbanicity, region, wealth users’ needs, to achieve notable reductions in new HIV infections.
index, and education.
Results: Flooding was strongly associated with HIV status in women OA11.02
under 20 (OR = 2.77, 95% CI: 1.34 to 5.69). There was no significant A multi-country investigation of pre-exposure prophylaxis
association between flooding and condom use, although there was a
preferences among young people at risk of HIV in sub-
significantly greater average partner number for women in areas of
flooding. Drought was associated with lower odds of HIV infection in
Saharan Africa
women aged 20 and older. Drought was associated with lower odds J. Dietrich1; N. Ahmed2; S. Nash3; G. Tshabalala1; T. Nematadzira4;
of condom use in women under 20 (OR = 0.59, 95% CI: 0.38 to 0.90) S. Hornschuh1; M. Atujuna2; M. Mulaudzi1; R. Muhumuza5;
and greater odds of condom use in women 20 and older (OR = 1.79, A. Ssemata5; A. Kakande5; L. Stranix-Chibanda6; N. Martinson1; L.-
95% CI: 1.37 to 2.35). Significant associations were found between G. Bekker2 and H.A. Weiss3
1
drought, partner alcohol consumption, and violence. Perinatal HIV Research Unit, Faculty of Health Sciences, University
Conclusions: The findings of this study do not fully align with the of the Witwatersrand, Wits Health Consortium, Johannesburg, South
existing literature. Sexual behaviors and prevention methods are dif- Africa, 2Desmond Tutu HIV Foundation, University of Cape Town,
ferentially associated with the exposures based on age. Further review Desmond Tutu HIV Foundation, Cape Town, South Africa, 3MRC Trop-
is needed into the drivers of these disparities and considerations of ical Epidemiology Group, Department of Infectious Disease Epidemiol-
VLS, recent HIV infection, transactional sex, and an exploration of tem- ogy, London School of Hygiene & Tropical Medicine, Infectious
porality or reverse causality concerns. We recognize that the environ- Disease Epidemiology, London, United Kingdom, 4University of Zim-
ment can affect individual behaviors and health, and with the babwe, College of Health Sciences, Clinical Trials Research Centre,
expected rise of climate disasters globally, we must further investigate Clinical Trials Research Centre, Harare, Zimbabwe, 5Medical Research
these findings to determine how to best intervene. Council/ Uganda Virus Research Institute and London School of
Hygiene & Tropical Medicine Uganda Research Unit, London School of
Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda,
OA11.01 6
University of Zimbabwe, College of Health Sciences, Department of
The evolution of oral PrEP access: tracking trends in global Paediatrics, Harare, Zimbabwe
oral PrEP use over time
K. Segal1; L. Fitch2; F. Riaz2; J. Rodrigues2 and M. Warren2
1
AVAC, Product Introduction and Access, Washington, DC, United Background: Daily Pre-Exposure Prophylaxis (PrEP) is highly effective
States, 2AVAC, New York, United States when adhered to, but its personal and public health benefits it limited
by cost, user-acceptability and uptake. The Combined HIV Adolescent
PrEP and Prevention Study (CHAPS) is a three-country study to inves-
Background: Since oral pre-exposure prophylaxis (PrEP) was tigate the acceptability of different PrEP regimens amongst young
approved for HIV prevention in 2012, 78 countries have begun offer- people in sub-Saharan Africa. We describe preferences for daily and
ing PrEP in some form. Measuring progress against global targets and on-demand PrEP in Cape Town and Johannesburg (South Africa),
sharing strategies across countries are critical to driving impact. Since Entebbe (Uganda) and Harare (Zimbabwe).
2014, AVAC has collected data from PrEP programs to track and gen- Methods: Trained interviewers conducted cross-sectional, structured
erate insights on PrEP implementation. online surveys capturing socio-demographics, HIV risk behaviours,
Methods: The Global PrEP Tracker is a comprehensive database of preferences for daily and on-demand PrEP (three dosing options; (1)
PrEP projects and national programs. Data are collected through a two pills before and after sex, (2) two pills a few hours before sex, (3)
quarterly survey to 253 programs, and include PrEP initiation
27
two pills a few hours after sex). Data were analysed by site and gen- progressively increased from 25% in 2017 to 36% in 2018, to 44% in
der using STATA. 2019 unlike in public facilities. Overall, receiving a month-three refill,
Results: Of 1339 participants aged 13 to 24 years enrolled, 49.7% upon receiving a month-one refill, increased from 26% in 2017 to
were female, with most (70.7%) aged 18 to 24 years. The majority 52% in 2018 and 69% in 2019.
(78.9%) had sex, 83.3% a current partner, and 38.3% knew to have Conclusions: Overall, 72%, 34%, and 62% of HIV-negative clients in
sex two hours in advance. Overall, 22.2% reported first sex aged primary care settings did not receive risk screening, first prescription,
14 years or younger and 50.8% weekly sexual activity. About half or one-month refill respectively, culminating in 322,981 individuals
(51.4%) reported using a condom at last sex (55.6% females; 47.6% who might have benefited from PrEP that didn’t receive it. Missed
males). Twenty-five percent had ever heard of PrEP before the study opportunities underscore the need for continuous surveillance to iden-
(11.8% in Entebbe) and willingness to use PrEP was 95.8%. Overall, tify and respond to implementation challenges and opportunities to
on-demand PrEP was the preferred option (59.5%) except for Cape enhance PrEP’s impact.
Town, where 68.2% preferred daily PrEP. Males (65.2% vs 53.8%)
preferred on-demand while females (46.3% vs 34.8%) preferred daily OA11.04
use. Despite an overall preference (59.5%) across sites for on-demand
Integrating STI screening into PrEP services for adolescent
PrEP versus daily PrEP, more participants (36.8%) reported that tak-
ing daily PrEP would be the easiest compared to the on-demand regi-
girls and young women (AGYW) in two primary health care
men options (26.2% (1), 27.5% (2) and 9.5% (3)). (PHC) facilities in Johannesburg: lessons from Prevention
Conclusions: Awareness of PrEP was low, despite high willingness to Options for Women Evaluation Research (POWER)
use PrEP. PrEP demand creation needs to be reviewed, optimised and D. Travill1; M. Ndlovu2; L. Kidoguchi3; T. Tlou2; L. Lunika2; J. Morton3;
tailored to socio-demographic differences and designed in conjunction R. Johnson3; J. Baeten3; C. Celum3 and S. Delany-Moretlwe2
1
with young people. Additionally, although overall more participants in Wits RHI, Research, Johannesburg, South Africa, 2Wits RHI, Johan-
our sample preferred on-demand options, their sexual behaviour pat- nesburg, South Africa, 3University of Washington, Seattle, United
terns may not support its use (e.g. sex events are unplanned for States
many). Strategies in sexual health education and promotion particularly
around assessing and understanding sexual risk behaviour needs fur-
ther exploration. Background: High rates of STIs have been demonstrated in AGYW
initiating PrEP. Most infections are asymptomatic and missed by stan-
dard-of-care STI syndromic management. We assessed the prevalence
OA11.03 and factors associated with return for STI treatment following urine
Surveillance data from public and private primary care STI screening during the POWER study in Johannesburg, South Africa.
facilities uncover implementation successes and gaps during
pre-exposure prophylaxis (PrEP) scale-up: Results from the Methods: POWER aimed to demonstrate models of PrEP delivery to
Jilinde project in Kenya AGYW. We enrolled a cohort of HIV negative AGYW aged 18 to 25
A. Musau1; D. Were1; J. Mutegi1; P. Ongwen1; B. Wakhutu1 and at a dedicated adolescent PHC clinic or a conventional PHC clinic.
J. Reed2 Urine from participants was tested for chlamydia (CT) and gonorrhoea
1
Jhpiego, Jilinde Project, Nairobi, Kenya, 2Jhpiego, Baltimore, United (GC) by GeneXpert at enrolment. Participants with positive results
States were contacted by phone or WhatsApp (at least 3 attempts) and
offered treatment. We assessed associations between baseline charac-
teristics and treatment return using logistic regression.
Background: Government and private sector facilities constitute the Results: Of 776 screened, 763 (98%) were enrolled and 737 (96%)
majority of health facilities in Kenya. Primary care units in these facili- initiated PrEP. Median age was 21, 11% reported >1 partner in past
ties have supported a vibrant HIV program and yield enormous poten- 3 months, 18% reported consistent condom use, and 3% reported
tial to accelerate PrEP scale-up reaching diverse populations. PrEP is genital symptoms at enrollment. 622/763 (82%) were screened for
nascent in Kenya and lessons garnered through various implementa- STI, and 211 (34%) had any curable STI, 27% CT, 3% GC, and 3%
tion platforms are germane. This study employs a cascade approach to both CT/GC at enrollment. Of those with any STI, 136 (65%) were
elucidate successes and gaps in PrEP delivery through primary care successfully contacted and treated.
units in Kenya. Participants were more likely to return for treatment if they had
Methods: The Jilinde project supports PrEP scale-up in ten Kenyan reported consistent condom usage (OR 4.9, 95% CI 1.5 to 16.1) com-
counties through 50 public and 12 private facilities. Routinely inte- pared to those that never used condoms, or reported using any form
grated PrEP is offered by trained providers who collect and aggregate of contraception at enrolment compared to those that did not (OR
service data using nationally approved tools, which is routinely ana- 2.04; 95% 1.33 to 3.66). Despite apparent lower STI prevalence at
lyzed to inform programmatic changes. We analyzed these data using the dedicated adolescent clinic (29% vs 37%), participants were more
a prevention cascade approach to unearth implementation gaps com- than three times likely to return for STI treatment as compared to
paring trends in proportions of clients receiving services across the the conventional PHC (OR 3.08, 95% 1.66 to 5.73).
PrEP continuum: behavioral risk screening; clinical eligibility assess- Conclusions: Prevalence of asymptomatic curable STIs is high in this
ment; receipt of first PrEP prescription; and, receipt of refill prescrip- PrEP initiating population. A third of participants did not return for
tions. treatment highlighting the need for point of care diagnostics and novel
Results: Between May 2017 and October 2019, 334,068 individuals STI control interventions especially for those at highest risk for STIs
tested HIV-negative, of which (93,429) 28% received behavioral risk and HIV, to interrupt transmission and prevent complications. More
screening. Among these, 16,673 (18%) were clinically assessed and research is needed to determine reasons for low uptake of STI treat-
deemed eligible. From the pool of eligible individuals, 11,087 (66%) ment. Quality, integrated, adolescent-responsive health services are an
initiated, consisting of 55% HIV-negative individuals in serodiscordant essential component of AGYW STI/HIV prevention.
relationships, 25% high-risk general population individuals, 14% female
sex workers, and 2% men who have sex with men. After a month,
3610 (34%) clients returned for a PrEP refill. Rates of attrition did
not vary by population group or public vs. private facilities. The pro-
portion of clients receiving month-one refills in private facilities
28
profound immediately after 15 March 2020, and returned to pre-

OA11.05LB restriction levels mid-May 2020. The proportion of days with PrEP-
Transient changes in daily sexual behavior and pre- use decreased from 74% before to 58% after 15 March 2020
exposure prophylaxis use after the implementation of (p < 0.001). After 15 March 2020, PrEP coverage of sex acts
COVID-19 restrictions among men who have sex with men decreased with UCP (b=0.36; 95% CI=0.72 to 0.00), but not with
V. W. Jongen1; H. M. L. Zimmermann1; A. Boyd1,2; E. Hoornenborg1; SP and KCP; condom use during sex acts decreased with KCP
M.A.M. van den Elshout1; U. Davidovich1,3; Y.T.H.P. van Duijnhoven1; (b=0.36; 95% CI=0.67 to 0.04) and UCP (b=0.24; 95% CI=0.46
H.J.C. de Vries1,4; M. Prins1,5; M.F. Schimvan der Loeff1,5; L. Coyer1 to 0.03), but not with SP; and use of PrEP and condoms during sex
and o.b.o.t. Amsterdam PrEP Project team in the HIV Transmission acts decreased with KCP (p = 0.026) and UCP (p = 0.011), but not
Elimination Amsterdam Initiative6 with SP.
1
Public Health Service of Amsterdam, Department of Infectious Dis- Conclusions: MSM decreased sex acts with casual partners and
eases, Amsterdam, Netherlands, 2HIV Monitoring Foundation, Amster- increased sex acts with SP, but changes were transient. Decreases in
dam, Netherlands, 3University of Amsterdam, Department of Social sex with casual partners paralleled decreases in PrEP-use. However,
Psychology, Amsterdam, Netherlands, 4Amsterdam UMC, University of condom-use during sex with casual partners decreased, indicating the
Amsterdam, Department of Dermatology, Amsterdam Infection and importance of continued sexual health services, including STI screen-
Immunity (AII), Amsterdam, Netherlands, 5Amsterdam UMC, Univer- ing and PrEP care, during COVID-19 restrictions.
sity of Amsterdam, Department of Infectious Diseases, Amsterdam
Infection and Immunity (AII), Amsterdam, Netherlands, 6H-TEAM, OA12.01
Amsterdam, Netherlands Fine-tuning of in vitro transcribed mRNA for optimising a
vaccine platform against HIV-1
Background: We assessed how the Dutch restrictions of 15 March S. Linares Fernandez; J. Moreno; B. Verrier and J.-Y. Exposito
2020 affected sexual behavior, pre-exposure prophylaxis (PrEP)- and CNRS and University Claude Bernard Lyon 1, Laboratoire de Biologie
condom-use among PrEP-users from the Amsterdam PrEP demonstra- nierie The
Tissulaire et Inge rapeutique, Lyon, France
tion project.
Methods: We collected daily data on
Background: The main hypothesis of this study is that changes in
(1) PrEP-use,
mRNA sequences, coupled to production and purification shortcuts
(2) anal sex acts and
can drastically impact the mRNA translation.
(3) condom-use, per partner type (steady [SP], known casual [KCP],
Methods: Endpoint: Measurement of mRNA expression (eGFP) in
unknown casual [UCP]), from a mobile application used between
DC2.4 and HeLa by FACS.
1 December 2019 and 30 June 2020. We compared the period
Reference mRNA Sequence:50 UTR of Human b-Globin, eGFP, two
before versus after 15 March 2020 with respect to average
copies in tandem of 30 UTR human of b-Globin and 148 Poly-A. Poly-
proportion of days per week at which each endpoint was
A: Three poly-A sizes were tested (76A, 112A and 148A) and evalu-
reported (multilevel logistic regression) and average proportion
ated overtime (4, 24, 48, 72 and 144 hours). 50 UTR: 6 different syn-
of anal sex acts covered by PrEP and/or condom (bivariate pro-
thetic 50 UTR were tested and evaluated overtime (4, 24, 48 and
bit regression). We evaluated whether the difference in sex acts
96 hours).
could also be observed before versus after the same date in
Results: Poly-A: Our data suggest the 148 poly-A tail was better than
the previous year.
the poly-A 76 and the poly-A 112.
Results: We included data from 136 MSM. After 15 March 2020, the
50 UTRs: The synthetic 50 UTR-(4) had an increase of 37% compared to
proportion of days with anal sex increased with SP (OR = 1.25; 95%
the human b-Globin mRNA Production: Vaccinia capping showed an
CI = 1.09 to 1.44) and decreased with KCP (OR = 0.73; 95%
increase >75%, compared to ARCA. mRNA purification: The depletion
CI = 0.64 to 0.82) and UCP (OR = 0.54; 95% CI = 0.48 to 0.61),
of dsRNA increased the translation (Arca 15%, Vaccinia 35%). Double
while these changes were not (SP/KCP) or less apparent (UCP) during
purification had the greatest impact on (approximately +80% in ARCA
the previous year (Figure 1). Shifts in partner types were most
and Vaccinia). Global Results.
29
Abstract OA12.01-Figure 1. mRNA Production: Two capping production methods were tested (Anti-Reverse Cap analogs-ARCA, and Vacci-
nia enzymatic Capping) and evaluated 24h after transfection.
mRNA purification: dsRNA was elimited with cellulose and 5'PPP was eliminated with Antarctic Phosphatase. Double purification was also
performed. eGFP expresion was evaluated 24h post-transfection.
Abstract OA12.01-Figure 2. On going experiments for expression of HIV antigens (expected results for the conference).
Our optimisation results showed an increase of up to 280% with non- Institute, CCR, Rockville, United States, 6University of Pennsylvania,
optimized mRNAs. Philadelphia, United States
Conclusions: We demonstrated that variations in untranslated
sequence, production and purification methods had an impact in
mRNA translation efficiency. Background: We hypothesized that simultaneous recognition of
immunogens delivered as DNA and protein by the draining lymph
node may impact the quality of the vaccine-induced immune
OA12.02 responses. To address this hypothesis, we compared the protective
Comparison of co-immunization of DNA and protein in the efficacy of an HIV vaccine comprised of DNA (env and gag) and Env
same anatomical sites and in contralateral sites to identify proteins by co-administration of both components in the same muscle
mechanisms of protective immune response or by delivering the two vaccine components (DNA and Protein) sepa-
B. Felber1; Z. Lu1; X. Hu1; A. Valentin1; M. Rosati1; J.A. Weiner2; rated in contralateral sites.
X. Shen3; G.D. Tomaras3; C. LaBranche3; D.C. Montefiori3; Methods: Female rhesus macaques (20 animals/group) were immu-
W.B. Williams3; K.O. Saunders3; S.G. Reed4; D.J. Venzon5 and nized with a 6-valent vaccine including DNA plasmids expressing
G.M. Shaw6 membrane-anchored gp145 Env sequentially isolated from a HIV-1
1
National Cancer Institute at Frederick, Center for Cancer Research, infected individual (CH505). The DNA was delivered by IM injection
Frederick, United States, 2Thayer School of Engineering, Dartmouth followed by in vivo electroporation. The vaccine also included a gp120
College, Hanover, United States, 3Duke University Medical Center, Env protein component adjuvanted in GLA-SE matching the sequences
Durham, United States, 4IDRI, Seattle, United States, 5National Cancer encoded by the plasmid DNA. The DNA and protein vaccine
30
components were administered in the same anatomical sites (‘Co- responses. There was an overall trend of a direct correlation between
administration group’) or in contralateral sites (‘Separate Administra- the magnitude of vaccine responses and valency of the vaccine cock-
tion group’). After vaccination, the macaques were challenged by tail both for individual epitopes and the overall ‘global’ response.
weekly intravaginal exposures with low dose T/F tier-2 SHIV CH505 Conclusions: Our data show a great potency of this vaccine platform
stock. Detailed flow and proteomics/transcriptomics analysis was per- for induction of T-cell responses and support evaluation of the HIV-
formed. consvM mRNA LNPs in humans, the species in which HIV-1 evolved
Results: Only the co-administration vaccine group was protected and for which further vaccine optimizations and response analyses will
against SHIV CH505 acquisition, with a 67% risk reduction per expo- be the most relevant.
sure after 15 weekly intravaginal challenges. Macaques in the
co-administration group developed higher Env-specific humoral and OA12.04LB
cellular immune responses. Non-neutralizing anti-Env antibodies,
A VSV-based HIV-1 vaccine provides protection in
ADCC and anti-Env antibodies with strong binding affinity to Fc-
gamma Receptor IIIa were associated with decreased transmission
macaques against low dose cross-clade SHIVenv_SF162_P3
risk. Analysis of vaccine-induced and innate immune responses and challenge
their association with mechanisms contributing to protection will be E. Arts1; A. Berger2; J. Pedersen2; M.-A. Lafrance2; J. Knapp1;
discussed. Follow-up boosting of the protected animals showed that H. Azizi2; Y. Li1; F. Scholte2; J. Mann1; A. Kamen3; K. Fowke4; X. Yao4;
the immune response can be further enhanced and the antibody C.-Y. Kang1; E. Cohen5 and G. Kobinger2
1
specificity can be broadened. Western University, London, Canada, 2Universite Laval, Quebec,
Conclusions: Co-immunization of DNA+Protein in the same muscle Canada, 3McGill University, Montreal, Canada, 4University of Mani-
induces rapid and effective immunity able to protect from tier-2 SHIV toba, Winnipeg, Canada, 5IRCM, Montreal, Canada
challenge. These data suggest that simultaneous recognition, process-
ing and presentation of DNA+ Env protein in the same draining lymph
node plays a critical role in the development of protective immunity. Background: We developed a series of 30+ VSV-based constructs
This vaccine regimen, using simultaneously DNA and protein adminis- containing HIV-1 Env chimeras with or without SIV gag in absence of
tration, could also be beneficial in protecting against other pathogens. VSV-G and with or without the Ebola glycoprotein. After pre-clinical
analyses of production/expression and small animal testing, a subset
of 4 were used to immunize macaques that were later challenge with
OA12.03 low dose SHIV.
Tetravalent immunogen assembled from conserved regions Methods: VSVdelG-based vectors were produced to express codon
of HIV-1 and delivered as mRNA demonstrates potent optimized HIV-1 ecto Env of NL4-3 or subtype A, strain 74 Env with
preclinical T cell immunogenicity and breadth N425K Env with different transmembrane and intracellular tails
N.A. Moyo1; E. Wee1; B. Korber2; K. Bahl3; S. Falcone3; S. Himansu3; (TMIC) of the VSV G, Ebola GP, mutated HIV-1 and SIVmac239 Env.
A.L. Wong4; A.K. Dey4; M. Feinberg4 and T. Hanke1 VSVdelG replication was driven either by the functional Env chimera
1
University of Oxford, The Jenner Vaccine Research Institute, Oxford, or by cis addition of Ebola or Marburg GP. Expression and Env func-
United Kingdom, 2Los Alamos National Laboratory, Theoretical Biology tion for entry was tested and VSV vectors were produced for mouse
and Biophysics, United States, 3Moderna Inc, Cambridge, United immunizations to measure humoral (binding and neutralizing Abs) and
States, 4International AIDS Vaccine Initiative, United States CTL responses. The best candidates were then tested in rabbits and
macaque challenge studies.
Results: Details of the three year preclinical screening and subse-
Background: A vaccine will likely be one of the key tools for ending quent correlates of protection for the best vaccine candidates will be
the HIV-1/AIDS epidemic by preventing HIV-1 spread within unin- provided in the presentation. The best candidate, VSVdelG_A74-
fected populations and achieving a cure for people living with HIV-1. gp140/SIV-TMIC_Ebola-GP was used as the prime followed by a boost
The currently prevailing view of the vaccine field is to introduce pro- with VSVdelG_SIV-Gag + A74-gp140/SIV-TMIC_Ebola-GP and then a
tective antibodies, nevertheless, an effective vaccine may need to har- boost with VSVdelG_A74-gp140/SIV-TMIC_Ebola_GP (Grp1). Eight of
ness protective T cells. We postulated that focusing a T-cell response ten of the control macaques (Grp2) and 10 of 10 in an alternative
on the most vulnerable regions of the HIV-1 proteome while maximiz- vaccine regimen (Grp2) were infected with SHIV_SF162-p3 by the
ing a perfect match between the vaccine and circulating viruses will final low dose 7 challenges. Four of ten animals of the best performing
control HIV-1 replication. Here, we exploit the mRNA lipid nanoparti- vaccinated group were infected by challenge 7th.
cle (LNP) platform by designing tetravalent immunogens to assess Conclusions: Building on the VSV-Ebola vaccine technology, we engi-
induction of T-cell responses in a pre-clinical model. neered/tested an improved VSV-based HIV vaccine and observed one
Methods: Two Gag and four Pol protein regions of the HIV-1 proof the best protections against low dose heterologous challenges in
teome were selected for their high conservation among the HIV-1 macaques to date. Findings also suggest that use of VSV-HIV_Env con-
Group M isolates and inclusion of beneficial regions. These were com- struct with Gag may be important for protection, especially in boost-
puted into two complementing mosaics, which together achieved over ing CTL response, but its inclusion in the final boost (groups 2 and 4)
80% match of potential 9-mer T-cell epitopes over most of the six may promote an activated CD4+ T cell population capable of increas-
HIVconsvX regions. Here, using a novel epigraph algorithm, two ver- ing SHIV infection. These findings suggest an important balance of
sions of the same six regions were sequentially designed to cover cell-based versus humoral immunity in prime/boost vaccine strategies
additional common variants of potential 9-mer epitopes and make fur- for optimal protection. The current study is one of the first reports of
ther improvements over the previous vaccine in matching the global meaningful cross-clade heterologous protection.
HIV-1 isolates. These two mosaics and 2 epigraphs were converted
into mRNA and the fully synthetic tetravalent mRNAs, collectively
called HIVconsvM, were encapsulated into LNPs.
Results: In a mouse model, intramuscular injection of the LNP-
encapsulated mRNA induced high frequencies of T cells, which
recognized seven out of seven examined H-2d class I-restricted
epitopes in most animals. This combination of mRNA and tetravalent
immunogens induced potent, broad and polyfunctional T-cell
31
8
University of Washington, Department of Medicine, Seattle, United
OA12.05 States, 9National Institute of Allergy and Infectious Diseases, Depart-
Improved in vitro expression and in vivo immunogenicity of ment of AIDS, United States, 10Women’s Global Health Imperative,
a candidate MVA-vectored HIV-1 vaccine compared to RTI, Research Triangle Park, United States
SAAVI MVA-C
N. Douglass1; M. Van Diepen2; R. Chapman2; S. Galant2; E. Margolin2;
P. Ximba2; T. Hermanus3; P. Moore3 and A.-L. Williamson2 Background: The MTN-034/REACH trial, evaluating safety and pref-
1 erences of oral pre-exposure prophylaxis (PrEP) and the dapivirine
University of Cape Town, Pathology, South Africa, 2University of
vaginal ring among adolescent girls and young women (AGYW) in
Cape Town, South Africa, 3University of Witwatersrand, Johannes-
sub-Saharan Africa, was in full implementation when the COVID-19
burg, South Africa
pandemic erupted. Associated socio-economic upheaval and mobility
disruptions impacted the 247 enrolled AGYW, and staff, potentially
Background: SAAVI MVA-C was previously developed in South Africa jeopardizing study quality and development of HIV prevention meth-
and tested in Phase 1 clinical trials. Following more recent advances ods. In response, accrual was paused and rapid modifications to
in antigen design, modifications were made to the HIV-1 genes follow-up procedures were implemented to distribute study product,
expressed by modified vaccinia Ankara (MVA) and a head-to-head monitor safety, handle biological samples and testing, and support
comparison was performed using the SAAVI MVA-C and newly con- product adherence.
structed MVAGD5 vaccines. Methods: As sites prepared for impending lockdowns, guidance was
Methods: MVAGD5 was constructed with an HIV-1 subtype C issued regarding safety and confidentiality precautions, mitigating
mosaic gag inserted in the A11R-A12L locus and a modified form of social harms (e.g. counseling/referrals, reimbursements for food secu-
the Du151 env gene inserted between I8R and G1L of MVA, both rity) and COVID-19 education for participants and staff. A contingency
under vaccinia virus mH5 promoter control. The env gene was modi- plan for study conduct, tiered by operational status, was developed
fied as follows: replacement of the native leader sequence with that and implemented according to site capacity. All modifications, including
of the human tissue plasminogen activator, replacement of the furin telephonic visits in lieu of clinic visits, providing extra study product,
cleavage site with a flexible linker (2x GGGGS), inclusion of an I559P and prioritizing in-person procedures, were monitored in real-time for
mutation and truncation of gp160 to gp150. operational and analysis considerations. Community engagement
The two vaccines were compared for HIV-1 gene expression in included study updates to local stakeholders and delivery of COVID-
HEK293T cells, by western blot analysis and immunofluorescence. 19 key messages for community sensitization.
Immunogenicity was tested in rabbits inoculated intramuscularly with Results: Implementation modifications during country lockdowns
108pfu recombinant MVA at weeks 0 and 4; and 40 μg soluble tri- resulted in nearly uninterrupted study product and contraceptive
meric Du151 protein at week 12. Rabbits were bled at weeks 0, 4, 8, access for participants. Clinic access remained critical for participants
12, 14 and 16 and serum was tested for binding antibodies by ELISA without options for secure telephonic visits or with onsite needs,
and neutralising antibodies using the TZM-bl pseudovirus assay. therefore sites operated in reduced capacity, with staff rotations and
Results: Compared to SAAVI MVA-C the modified MVA vaccine, transport for staff and participants. Counselors expanded adherence
MVAGD5, showed increased expression of both Gag and Env in support with remote reminders and check-ins, using alternative docu-
HEK293T cells. These two proteins were detected in the clarified mentation and confidentiality practices. Completion rates for expected
medium from MVAGD5-infected cells, but not SAAVI MVA-C-infected study visits and procedures were high. Sites maintained contact with
cells. Co-localisation of Gag/Grttn and Env was observed by fluores- most participants despite lockdowns (Table 1).
cence microscopy in infected HEK293T cells for both MVAGD5/
SAAVI MVA-C vaccines. MVAGD5 elicited binding antibodies after the Abstract OA13.01-Table 1.
first inoculation, whereas SAAVI MVA-C only elicited binding antibod-
Expected visits and procedures
ies after the protein boost. MVAGD5 elicited neutralising antibodies
completed during operational Completed/expected (%) from
to Tier 1A and Tier 1B pseudovirions whereas SAAVI MVA-C gener-
disruptions 26 MAR to 29 APR 2020
ated no significant neutralising response. Neither vaccine elicited
autologous Tier 2 neutralising antibodies. Expected Visits Completeda 172/200 (86)
Conclusions: Modifications made to both gag and env genes in the Expected in-clinic visits completed 111/200 (55)
construction of SHIP MVAGD5, compared to the historic SAAVI MVA- as telephonicb
C vaccine, resulted in superior in vitro expression of both HIV-1 genes Expected clinic/testing procedures completedc
and improved immunogenicity in rabbits. Physical Exam 141/144 (97.9)
Pelvic Exams completed 44/45 (97.8)
OA13.01 Pregnancy test 138/144 (97.2)
Implementing a rapid response to the COVID-19 global HIV-1 testing 138/14 (97.2)
pandemic in MTN-034/REACH: an HIV prevention trial a
Visits completed within protocol-defined window, including telephonic
among adolescent girls and young women in Africa contacts with modified procedures in lieu of in-clinic visits.
1 2 2 3 3
T. McClure ; J. Davis ; M. Garcia ; K.R. Eddy ; T. Palanee-Phillips ; b
Includes visits partially done telephonically.
B. Bam4; G. Nair4; S. Kassim4; C. Agwau Akello5; P. Ndadziyira6; c
Expected key clinical/testing procedures completed for visits con-
K. Ngure7; C. Celum8; L. Soto-Torres9 and A. van der Straten10 ducted. Missed procedures due to modified visits (e.g. telephonic,
1
FHI 360, Science Facilitation, Durham, United States, 2FHI 360, Dur- shortened in-clinic visit).
ham, United States, 3Wits Reproductive Health and HIV Institute,
University of the Witwatersrand, Johannesburg, South Africa, 4Ema- Conclusions: Well-orchestrated modifications to study implementa-
vundleni Research Centre, Desmond Tutu HIV Foundation, University tion ensured participant and staff safety, and maintained study integ-
of Cape Town, Cape Town, South Africa, 5Makerere University-John rity and community engagement during COVID-related disruptions.
Hopkins University Research Collaboration, Kampala, Uganda, The MTN-034/REACH strategy serves as a template for optimal
6
University of Zimbabwe College of Health Sciences Clinical Trials study operations during times of upheaval, especially when supporting
Research Centre, Harare, Zimbabwe, 7Jomo Kenyatta University of AGYW.
Agriculture and Technology, College of Health Sciences, Kenya,
32
OA13.02 (TGW) aged ≥ 18 years receiving PrEP through a Public Health Ser-
vice or the ImPrEP demonstration study were analyzed. The impact of
Social, economic, mental health and medical care impacts of
social distance in their lives, acceptability of telemedicine and HIVST
COVID-19 in a US cohort of sex and gender diverse
procedures were assessed.
adolescents and young adults at-risk for HIV Results: Of 3536 who completed the questionnaire, 2677 MSM/
~oz1; S. Hosek2 and A. French2
P. Serrano1; J. Diaz1; A. Mun TGW self-reported HIV negative/unknown status, 705 were PrEP
1
Ruth M. Rothstein CORE Center, Research, Chicago, United States, users and 654 reported receiving PrEP from a Public Health Service
2
John H. Stroger, Jr., Hospital of Cook County, Infectious Disease, Chi- (50.9%; 333/654) or the ImPrEP demonstration study (49.1%; 321/
cago, United States 654) were included in this analysis. The median age was 35.1 years
(IQR:25 to 35), most were cisgender men (641;98.0%). For 66.5%
(n = 435) social distance had a high impact in their lives, mainly in the
Background: The United States’ national response to the COVID-19 economics (252;38.5%) and affective/sexual (217;33.2%) aspects.
pandemic disrupted schools, work places, and healthcare. As the shut- Despite recommendations for social distancing, 44.5% (n = 291)
down continued, the American Public Health Association warned of reported sex with casual partners; 54.3% (158/291) had condomless
developing mental health crises across the US. In this study we aim to receptive anal sex with them. During this period, 72.6% (n = 475)
understand the scope of the pandemic on the emotional and financial maintained daily PrEP use due to fear of getting HIV (284;59.8%), sex
well-being as well as access to routine HIV/STI and pre-exposure pro- with casual partners (84;17.7%), HIV-positive partner (64;13.5%) and
phylaxis (PrEP) among sexual and gender minority youth and young belief that PrEP protected against COVID-19 (43;9.1%). PrEP telecon-
adults. sultation was experienced by 20.9% (n = 137) and 89.1% (n = 122)
Methods: Participants in the Keeping it LITE virtual cohort study felt satisfied with this procedure. For those who did not experience a
were surveyed in May of 2020, and were administered an online sur- teleconsultation, 69.6% (n = 360) reported being very comfortable to
vey asking them to reflect on their COVID-19 related experiences try it. Awareness about HIVST was high (488; 74,6%) but only 26.6%
since March of 2020. The survey collected demographic data and (n = 174) had ever used it. Among those who never used, willingness
questions on the impacts of COVID-19. Those enrolled in the parent to use was 78.3% (n = 376). For 87.2% (n = 570) home delivery of
study were ages 13 to 34, cisgender men or transgender/gender non- PrEP refills would be acceptable.
conforming individuals, who have behavioral risk factors that make Conclusions: Telemedicine procedures for PrEP delivery including
them vulnerable to HIV. Descriptive statistics were collected and HIVST showed to be highly acceptable among PrEP users as well as
reported via Qualtrics. home delivery PrEP refills. These results point out that such technolo-
Results: 2116 participants, or over half of the cohort responded gies could be an option to be implemented by Public Health Services
(61.5%). Mean age was 26.21 (SD = 4.84), a majority were male in Brazil to avoid PrEP access shortage during the COVID-19 pan-
(81%), White (55%), and gay (69%). Many participants reported demic.
decreased wages (33.33%) or losing their jobs (27.41%). A majority of
participants reported negative impacts on mental health (80.61%),
including increased anxiety (58.3%) and depression (42.93%). A signifi- OA13.04
cant minority of PrEP users (42.3%) reported changing or stopping The COVID-19 pandemic and transition to telehealth:
PrEP during the pandemic, due to disrupted PrEP follow-up care appointment attendance and patient perspectives at an
(43.8%), while 20% reported difficulty accessing HIV/STI testing dur- adult HIV clinic
ing the pandemic. I. Auchus; K. Jaradeh; A. Tang; B. Boslett and J. Marzan
Conclusions: Most of the study participants experienced disruptions University of California, 360 Wellness Center, San Francisco, United
to their daily lives in the areas of employment and healthcare. During States
this relatively short time period, these vulnerable youth reported an
alarming rise in mental health problems, financial distress, and difficul-
ties in accessing HIV preventive and STI care. Longitudinal data are Background: In the United States, up to 35% of HIV primary care
needed to quantify the full impact of the pandemic on the mental patients struggle to routinely attend follow-up appointments. The
health and prevention behaviors of sexual and gender minority youth COVID-19 pandemic forced many institutions to transition to a tele-
and young adults. health-focused model of care to maintain patient and provider safety.
However, it was unknown how telehealth would impact patient atten-
OA13.03 dance and perceptions about their care, particularly in populations at
high risk of appointment non-adherence. To understand the impact of
Acceptability of telemedicine and HIV self-test among PrEP
telehealth on retention in care for a vulnerable HIV-infected popula-
users during the COVID-19 pandemic in Brazil
tion, we assessed patient perspectives of telehealth and its effect on
B. Hoagland1; T.S. Torres1; D.R.B. Bezerra1; A. Garner2; K. Geraldo1; appointment attendance.
L. Freitas1; C. Jalil1; E. Carvalheira1; A. Nabor1; E. Bastos1; D. Waite1; Methods: We studied patients at the UCSF 360 Wellness Center, an
J.R. Grangeiro1; T. Santos1; L. Monteiro1 and J. Freitas1 HIV Primary Care Clinic at the University of California, San Francisco,
1
Instituto Nacional de Infectologia Evandro Chagas INI/Fiocruz, Lap- during the 2019 to 2020 fiscal year. To assess the effect of the city-
clin-AIDS, Rio de Janeiro, Brazil, 2Hornet INC, United States wide shelter-in-place orders and subsequent transition to telehealth,
we compared appointment attendance before and after the order.
Patient perceptions were collected via anonymous survey through a
Background: In March 2020 telemedicine and HIV self-testing
secure online portal. The survey included multiple-choice questions
(HIVST) were adopted by some Brazilian Public Health services to
and free-text responses. Patients who did not have portal access were
minimize disruptions in pre-exposure prophylaxis (PrEP) access and
reached by telephone. Responses were analyzed and coded for
delivery during social distancing and community containment recom-
themes.
mendations related to the COVID-19 pandemic.
Results: Before March 16, telehealth comprised 5.2% of all clinic vis-
Methods: During April-May/2020, Brazilian cisgender men who have
its; after, telehealth comprised 86.9% of visits. No-show rates across
sex with men (MSM) and transgender/non-binary people were
all in-person visits before March 16th averaged 16.5% during the
recruited to complete a web-based survey advertised on Hornet,
prior 6 months. Telehealth visits after March 16th had a no-show rate
Facebook and WhatsApp. Data from MSM and transgender women
of 13.7%. Of the 134 survey responses, 19.6% of patients reported
33
preference for in-person visits, 9.8% reported preference for tele- Conclusions: The strong CE infrastructure developed by the HVTN
health visits, and 70.7% had no preference. Perceived strengths of allowed for a seamless pivot to engaging communities and addressing
telehealth included: challenges in COVID-19 vaccine trials during the SARS-CoV-2 pan-
demic.
1) improved convenience;
2) safety in avoiding other patients; and
3) increased privacy. OA14.01
Improved killing of HIV-infected cells by a combination of
Several disadvantages included:
three neutralizing and non-neutralizing antibodies
1) technical barriers; M. Tuyishime1; C. Garrido2; S. Jha1; M. Moeser2; D. Mielke1;
2) lack of familiarity with video visit platform; and C. LaBranche1; D. Montefiori1; B.F. Haynes3; S. Joseph4; D. Margolis5
3) lack of human connection as compared to in-person visits. and G. Ferrari6
1
Conclusions: The majority of our respondents (80.5%) said they are Duke University, Surgery, Durham, United States, 2UNC HIV Cure
equally or more likely to attend telehealth visits as compared to in- Center, United States, 3Duke Human Vaccine Institute, Duke Univer-
person visits, and our data demonstrated improvement in appointment sity, Medicine, Immunology, Durham, United States, 4UNC HIV Cure
attendance. We plan to continue telehealth visits as a permanent and Center, Lineberger Comprehensive Cancer Center, UNC, Microbiology
prevalent visit option to support HIV care for our patients. To further and Immunology, United States, 5UNC HIV Cure Center, UNC, Medi-
improve the telehealth experience, patients would benefit from more cine, Microbiology and Immunology, and Epidemiology, United States,
6
robust technical support. Duke University, Surgery 9 Department of Molecular, Durham, Uni-
ted States
OA13.05LB
Utilizing a robust HIV prevention community engagement Background: Pre-clinical and clinical antibody-dependent cellular cyto-
framework to engage communities in COVID-19 prevention toxic (ADCC) responses correlating with protection from HIV-1 infec-
efforts tion provide the rationale to leverage them for treatment purposes.
M. Andrasik; F. Rentas; L. Oseso; S. Wallace and G. Broder We evaluated ADCC mediated by 62 monoclonal antibodies (mAbs)
Fred Hutchinson Cancer Research Center, Vaccine and Infectious Dis- combinations to identify those effective against latent reservoir
ease Division, Seattle, United States viruses (LRVs) isolated from ART-suppressed HIV+ donors using
Latency Reversing Agents (LRA)-exposed resting latently infected
CD4+ T cells.
Background: The HIV Vaccine Trials Network (HVTN) has built a Methods: HIV-1 envelope-specific CD4-binding site CH557, C1/C2
solid foundation of community engagement (CE) rooted in Good Par- A32, V1/V2 PG9, V3 PGT121, gp120-gp41 interface PGT151 and
ticipatory Practice, driven by the belief that engaging communities at MPER DH511.2K3 mAbs were tested at a concentration ≤ 1 μg/mL
each phase of research from pre-study implementation through for their ability to mediate ADCC individually and in combinations.
results dissemination fosters trust and mutual understanding. CE Target cells were either primary CD4+ T cells infected in vitro with a
efforts utilize Community-Based Participatory Research approaches panel of 10 clade B LRVs or ART-suppressed HIV+ donor cells
and are informed by models of health behavior change. With the onset exposed to LRAs. We used an Infected Cell Elimination assay and a
of the SARS-CoV-2 pandemic, the HVTN joined a large group of part- novel ex vivo modified viral outgrowth assay (Latent Clearance Assay)
ners to form the COVID-19 Prevention Network (CoVPN). The CE in presence of autologous primary NK cells, respectively.
infrastructure existing within the HVTN was tapped to lead the Results: We observed that within 2 hours of incubation at ≤ 1 μg/
CoVPN’s vaccine study efforts. mL, 3 mAbs combinations mediated significantly higher killing
Methods: The CoVPN developed a seven-part strategic plan which (p < 0.005) compared to single or paired mAbs. Addition of more than
has facilitated robust CE. The plan includes: (1) development, produc- 3 mAbs did not further increase specific killing. A32+ DH511.2K3+
tion and dissemination of materials for participants/potential partici- PGT121 was the best combination with a mean of 33.1% ADCC activ-
pants; (2) development, production and dissemination of materials for ity. Three LRVs were resistance to neutralization by PGT121, one of
clinical research sites; (3) utilization of Priority Population Scientific which (P800) was also resistant to PG9 and DH511.2K3. The resis-
Expert Panels for protocol review and guidance; (4) convening a Com- tance was caused by the escape mutations within HIV-1 Env of these
munity Working Group; (5) stakeholder engagement activities to build LRVs. These results were confirmed by the loss of the binding of
and enhance trust; (6) developing a Marketing and Community Influ- PGT121 and/or DH511.2K3 to cells infected with these LRVs. After
encers plan; (7) developing a CoVPN website with a centralized reg- 24 hours of incubation, we observed remarkably increased ADCC
istry; and (8) convening CE advisory committees for sponsor activity against 4 LRVs tested with the A32+ DH511.2K3+ PGT121
organizations. The plan identifies priority populations most impacted combination, and demonstrated elimination of cells infected with 3-
by COVID-19: Native/Indigenous, African American/Black, Latina/o/x/ bNAbs-resistant P800 LRV. Further, the A32+ DH511.2K3+ PGT121
Hispanic, Older Adults (aged 65+)/Veteran populations, and essential combination efficiently cleared ex vivo latently infected LRA-treated
workforce. All activities are tailored for each priority population and resting CD4+ T cells from P800 donor by autologous NK cells during
the overall focus is on building and maintaining relationships. The plan a 25-day culture.
supported early identification of recruitment and retention barriers Conclusions: MAbs combinations targeted the diverse HIV-1 Env epi-
and built on existing infrastructure, allowing for expeditious identifica- topes on the surface of infected cells, upon reactivation of the latent
tion of strategies to mitigate CE challenges. infection, more efficiently than individual mAbs. The results strongly
Results: Long standing relationships with partners helped disseminate indicate the importance of mAb combinations to achieve the broadest
materials, open additional channels for dissemination, and identify and activity against HIV-1 infected cells in future cure strategies.
nurture new relationships to build trust. Support at the federal level
facilitated new partnerships among the research network, Dept. of
Defense, Veterans groups, and other NIH teams. Implementation of
the CoVPN CE strategies resulted in a surge of interest in the Pre-
ventCOVID.org website and increases in racial and ethnic minority
enrollment in the CoVPN registry.
34
at a 1:1 (p = 0.0041; 0.005) or 1:5 (p < 0.0001) target: effector ratio.

OA14.02 CD45RA-CD27+ CCR7+ CD8+ T cells displayed the highest suppres-
Unprimed CD8+ lymphocytes promote the maintenance of sion activity in our assays.
HIV latency in CD4+ T cells Conclusions: Our studies demonstrated a CD8+ lymphocyte medi-
L. Franchitti; Z. Zhang; M. Statzu; H. Wang; M. Paiardini; G. Silvestri ated suppression of HIV expression in CD4+ T cells capable of main-
and D. Kulpa taining latency in the presence of activation signaling. Understanding
Emory University, Department of Pathology and Experimental Medi- the mechanisms by which CD8+ lymphocytes suppress virus transcrip-
cine, Atlanta, United States tion and ultimately promote HIV latency in ART-treated HIV-infected
individuals may provide critical insight to the design of HIV eradication
approaches.
Background: Therapeutic strategies to reactivate the latent reservoir
to facilitate clearance of HIV-infected cells have had limited success
in vivo. Recent studies have demonstrated that the presence of CD8+
OA14.03
T cells may inhibit virus replication during treated HIV/SIV infection;
Analysis of the early responses to HIV-1 in matched
however, the mechanisms responsible for this antiviral effect remain treatment na€ıve individuals reveals early soluble proteins
poorly understood. that are associated with in vivo virus control
Methods: We used our primary cell based in vitro model of HIV J. Makinde1; E.W. Nduati2; A. Freni Sterrantino3; C. Streatfield1;
latency to study the CD8+ T cell mediated suppression of HIV expres- C. Kibirige1; J. Dalel1; S.L. Black1; P. Hayes1; G. Macharia1; J. Hare1;
sion. To examine the impact of CD8+ T cells on the activity of latency D. King1; S. Joseph1; E. McGowan1; B. Abel1 and E. Hunter4
1
reversing agents (LRA), CD4+ T cells generated in our in vitro latency Imperial College London, IAVI Human Immunology Laboratory,
model were treated with IL-15, the IL-15 superagonist N-803, or TCR Department of Infectious Diseases, London, United Kingdom, 2Kenya
stimulated in the presence or absence of activated autologous CD8+ Medical Research Institute-Wellcome Trust Research Programme, Kil-
T lymphocytes (1:1 or 1:5 target: effector ratios). To identify the phe- ifi, Kenya, 3Imperial College London, MRC-PHE Centre for Environ-
notype of CD8+ T lymphocytes with pro-latency activity, we sorted ment and Health, Department of Epidemiology and Biostatistics,
memory and na€ıve subsets based upon CD45RA, CD27 and CCR7 London, United Kingdom, 4Emory University, Emory Vaccine Centre,
surface expression, followed by co-culture with HIV-infected CD4+ T Yerkes National Primate Research Centre, Atlanta, United States
cells. All assays were monitored for intracellular Gag expression on
CD4+ T cells, and the frequency of integrated HIV DNA was deter-
mined by qPCR. Background: In attempting to define the correlates associated with
Results: Treatment with LRA in the presence of activated CD8+ T natural protection against HIV, extreme heterogeneity in the datasets
lymphocytes resulted in a significant suppression of HIV latency rever- generated from systems methodologies can be further complicated by
sal. TCR activation induced a high frequency of Gag+ cells in the the inherent variability encountered at the population, individual, cellu-
monoculture (~27%, n = 8), that was reduced 3-fold at 1:1 lar and molecular levels. Furthermore, such studies have been limited
(p = 0.0002) and 17-fold at 1:5 ratio (p < 0.0001). Treatment with IL- by the paucity of well-characterised samples and linked epidemiologi-
15 or N-803 induced a lower frequency of Gag expression in the cal data, including the duration of infection and clinical outcomes.
monocultures (~4% and 3% respectively), but also showed a significant Methods: We identified newly HIV-infected individuals from a multi-
decrease in latency reversing activity in the presence of CD8+ T cells site HIV incidence cohort drawn from nine clinical research centres in
35
five African countries. Selected volunteers were further characterized virions and events prior to reverse transcription. Targeting S1P
with regards to early and persistent in vivo control of HIV-1 replica- appears to modulate SAMHD1 phosphorylation as well as modify the
tion, in the absence of antiretroviral treatment. We utilised a propen- cell cycle to promote a less infection-permissive state. Our research
sity score matching approach to control for the influence of five suggests that therapeutic targeting of this pathway early in infection
factors (age, risk group, virus subtype, gender, and country) known to may aid in the development of strategies to prevent establishment of
influence disease progression on causal observations. The concentra- initial infection and the latent reservoir.
tions of fifty-two soluble plasma proteins were assessed. This
approach is unique because it focuses on the specific period of OA14.05LB
dynamic immunological control of viral replication for all volunteers in
Impact of HIV kick-and-kill therapy on host epigenetic and
the absence of treatment.
Results: Among 603 volunteers, we identified three distinct groups of
transcriptional programs in PBMC, and viral rebound after
individuals (Low, Intermediate and High viral load volunteers) matched cART interruption
on all five factors and for whom samples were available at two time- B. Oriol-Tordera1,2; A. Esteve-Codina3; M. Berdasco4,5; E. Goncalves6;
points within the dynamic phase of immunological control of in vivo 10; B. Clotet1,10,11; M.L. Calle11;
M. Esteller4,5,7; T. Hanke8,9; J. Molto
replication following peak viraemia (i.e., within 0 to 365 days post- B. Combadiere6; A. Sanchez-Pla12,13; B. Mothe1,10,11; M. Ruiz-Riol1 and
infection). We were able to confirm some of the factors related to, or C. Brander1,11,14
1
already known to influence disease progression such as the possession IrsiCaixa AIDS Research Institute, Institute for Health Science
of B*57 HLA Class I allele, and the infecting virus subtype. Our Research Germans Trias i Pujol (IGTP), Badalona, Spain, 2Autonomous
results also indicate possible roles for IL-17C and MIP-1a in the early University of Barcelona, Cerdanyola, Spain, 3Centro Nacional de Anali-
and sustained control of infection. sis Geno mico (CNAG), Parc Cientıfic de Barcelona, Barcelona, Spain,
4
Conclusions: Our results highlight the need to consider factors that Cancer Epigenetics and Biology Program (PEBC), Bellvitge Biomedical
could potentially introduce heterogeneity in datasets and mask valid Research Institute, L’Hospitalet de Llobregat, Spain, 5Josep Carreras
differences when designing studies to define immune correlates. Leukaemia Research Institute (IJC), Badalona, Spain, 6Sorbonne
Universite, Centre d’Immunologie et des Maladies Infectieuses – Paris
(Cimi-Paris), INSERM U1135, Paris, France, 7Department of Physiolog-
OA14.04 ical Sciences II, School of Medicine, University of Barcelona, Barcelona,
Targeting sphingosine-1-phosphate signaling prevents
Spain, 8The Jenner Institute, University of Oxford, Oxford, United
cell-to-cell transmission of HIV-1 Kingdom, 9Joint Research Center for Human Retrovirus Infection,
R. Resop1; R. Fromentin2; D. Newman1; H. Rigsby2; L. Dubrovsky1; Kumamoto University, Kumamoto, Japan, 10Fundacio Lluita contra la
M. Bukrinsky1; N. Chomont2 and A. Bosque1 Sida, Infectious Diseases Department, Hospital Universitari Germans
1
George Washington University, Microbiology, Immunology and Tropi- Trias i Pujol, Badalona, Spain, 11Universitat de Vic-Central de Catalu-
cal Medicine, Washington, D.C., United States, 2CRCHUM and Univer- nya (UVic-UCC), Vic, Spain, 12Statistics Department, Biology Faculty,
sit
e de Montre al, Microbiology, Infectious Diseases and Immunology, University of Barcelona, Barcelona, Spain, 13Statistics and Bioinformat-
Mongtre al, Canada ics Unit Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain,
14
Catalana de Recerca i Estudis Avancats (ICREA), Barce-
Institucio
lona, Spain
Background: Sphingosine-1-phosphate (S1P) is a modulator of a myr-
iad of cellular processes and therapeutic targeting of S1P signaling is
under clinical investigation. We sought to determine the role of S1P in Background: BCN02 was a pilot kick-and-kill clinical trial that com-
cell-to-cell transmission of HIV. bined therapeutic vaccination (MVA.HIVconsv) with the latency
Methods: Using a primary cell model, we examined whether targeting reversing agent romidepsin (RMD) followed by a monitored antiretro-
S1P receptors altered HIV transmission in memory CD4+ T cells. We viral pause (MAP) in 15 early-treated HIV+ individuals
activated and expanded na€ıve human CD4+ T cells and infected them (NCT02616874). Out of 12 evaluable participants for an omics sub-
with HIV, in the presence of the S1PR functional antagonist FTY720 analysis, 8 participants showed early (pVL > 2000 copies/
before or after infection. In addition, we examined transmission of HIV mL < 4 weeks) and 4 a more delayed viral rebound (pVL > 2000
from infected macrophages to autologous CD4+ T cells in a coculture copies/mL > 4 weeks) in MAP. Systems biology analyses identified epi-
system in the presence of FTY720. We quantified productive infection genetic and molecular mechanisms associated with response to vacci-
by p24-Gag flow cytometry, measured frequency of cells harboring nation and RMD and viral rebound kinetics.
total and integrated HIV DNA by qPCR, and examined reactivation of Methods: Genome-wide gene expression (Ilumina HiSeq2500) and
latent virus following T cell receptor stimulation. Mechanistically, we DNA Methylation (Infinium HumanMethylation450 BeadChip) were
investigated internalization of virions, cell cycle signaling, and innate assessed in frozen PBMC-pellets at baseline, 1 week after vaccination
HIV-1 restriction factor activity following FTY720 treatment. and 1 week after the 3rd RMD infusion (post-RMD). After pre-pro-
Results: FTY720 treatment reduced HIV transmission between CD4+ cessing and normalization steps we applied principal component analy-
T cells as well as between macrophages and CD4+ T cells in co-cul- ses (PCA) and differential expression/methylation analyses (limma-R/
ture assays. Mechanistically, treatment with FTY720 targeted early Biocondcutor). GSEA was used for functional analysis, and sPLS-DA
stages of the HIV-1 life cycle, as evidenced by 1) Reduced internaliza- (MixOmics-R/Bioconductor), to identify pathways explicative of differ-
tion of virions by viral entry assay; 2) Relative increase in the active ential viral rebound kinetics.
form of SAMHD1, an innate restriction factor; 3) Reduction in total Results: The largest impact on host transcriptional and DNA methyla-
and integrated HIV-1 DNA; and 4) Reduced frequency of productively tion (DNAm) profiles was observed after the combined effect of vacci-
infected cells. Moreover, FTY720 reduced susceptibility to infection nation and RMD, with 733 differentially expressed genes and 5695
by decreasing the percentage of transcriptionally active, cycling cells, differentially methylated positions being detected between baseline
and downregulated Cyclin D3. These alterations were consistent with and post-RMD (adjusted p < 0.1). Modulated pathways at gene
reduction in cell-to-cell transmission, which directly corresponded to expression and/or DNAm level, were mainly associated with processes
reduced latent virus in CD4+ T cells. including cell cycle, DNA repair or metabolism and HIV, innate and
Conclusions: Our results demonstrate that targeting S1P signaling adaptive immunity (GSEA q-value < 0.15). Of note, PCA revealed that
with FTY720 inhibits cell-to-cell transmission in multiple cell types. only DNAm levels after the combined intervention segregated partici-
FTY720 targets early stages of the HIV-1 life cycle, including entry of pants by their early or late viral rebound kinetics in MAP. We
36
summarized the therapy-modulated pathways with eigenvectors of

DNAm at post-RMD, and identified HIV, innate immunity and T-cell OA15.02
pathways among the most relevant to discriminate the two viral In vitro and in vivo analyses of HIV-1 clade C Envelope
rebound profiles in MAP. Interestingly, 3 CpG positions in the HIV cat- trimers highlight optimal antigenic profiles of novel HIV-1
egory, 37 in the innate immunity group and 10 in the T cell category Env-based vaccine candidates
were differentially methylated between individuals with different viral A. Hauser1; D. Peterhoff1; T. Hartinger1; M. Schachtner1;
rebound profile (adjusted p < 0.1). N. Friedrich2; A. Trkola2; C. Moog3; W. Weissenhorn4; Q. Sattentau5;
Conclusions: Host transcription and epigenetic programs provide a R. Sanders6 and R. Wagner1
deeper understanding of the molecular mechanisms induced during 1
University of Regensburg, Institute of Medical Microbiology and
HIV cure therapies. While DNAm after a kick-and-kill strategy could Hygiene, Regensburg, Germany, 2University of Zurich, Zurich, Switzer-
be used to predict viral rebound kinetics after ART interruption, fur- land, 3Universite de Strasbourg, France, 4Institut de Biologie Struc-
ther study is warranted in future controlled studies. turale, France, 5University of Oxford, United Kingdom, 6Academic
Medical Center, Amsterdam, Netherlands
OA15.01 Abstract not available.
Heterologous vaccination with DNA and two different
poxvirus vectors, expressing HIV-1 envelope on the surface
of Gag virus-like particles, elicit autologous Tier 2
OA15.03
Novel trimer-only (TO) producing HIV-1 envelope
neutralising antibodies
1 1 1 1 1 glycoprotein constructs for inducing broadly neutralizing
R. Chapman ; M. van Diepen ; N. Douglass ; S. Galant ; E. Margolin ;
P. Ximba1; T. Hermanus2; P. Moore2; E. Rybicki3 and A.-L. Williamson1 antibody responses by genetic vaccination
1 I. del Moral Sanchez1; E.G. Wee2; S.M. Koekkoek1; E.E. Schermer1;
University of Cape Town, Pathology, South Africa, 2National Institute
W.H. Lee3; S. Kumar4; R. Zwolsman1; J.D. Allen5; A. Torrents de la
for Communicable Diseases of the National Health Laboratory Service,
Pen ~a3; M.M. van Haaren1; E. Reiss1; M. van Gils1; M. Crispin5;
Johannesburg, South Africa, 3University of Cape Town, Moelcular &
G. Ozorowski3 and A.B. Ward3
Cell Biology, South Africa 1
Amsterdam UMC, Medical Microbiology, Amsterdam, Netherlands,
2
The Jenner Institute, University of Oxford, Nuffield Department of
Background: The only HIV vaccine trial (RV144) to show any efficacy Medicine, United Kingdom, 3The Scripps Research Institute, Depart-
used a canary poxvirus vector and recombinant protein for immunisa- ment of Integrative Structural and Computational Biology, United
tion; leading to the further exploration of poxviruses as HIV vaccine States, 4All India Institute of Medical Sciences, New Delhi, India,
5
vectors. Our group has shown that heterologous prime boost immuni- University of Southampton, School of Biological Sciences, Highfield
sations of mice and macaques with a novel capripoxvirus vector, lumpy Campus, Southampton, United Kingdom
skin disease virus (LSDV) and modified vaccinia Ankara (MVA) induced
high magnitude, broad cellular immune responses. Here, we present
data on further modifications to the vaccines, which were tested in Background: Soluble immunogens that properly mimic the HIV-1
different regimens, for immunogenicity in rabbits. envelope glycoprotein (Env), such as SOSIP and native flexibly linked
Methods: DNA (D), MVA (M) and LSDV (L) vaccines expressing HIV- (NFL) trimers, are used as constituents for a number of HIV-1 vaccine
1 CAP256SU gp150 and subtype C mosaic Gag (GagM) were con- approaches. However, most NFL and SOSIP constructs are not only
structed. The expression of Env and Gag by all three vaccine was expressed as trimers, but also produce undesired monomers and
characterised in vitro. Groups of five rabbits were inoculated with four dimers that expose non-neutralizing epitopes. Usually, chromatography
different vaccine regimens: DDMMLL; DDMLML; DDLMLM and procedures are used to isolate the desired trimers for vaccination.
DDLLMM at 0, 4, 8, 12, 16 and 20 weeks. The titres of binding and However, this also implies that conventional SOSIP and NFL con-
neutralising antibodies in the rabbit sera were determined. structs might be less suitable for genetic vaccination. Here, we
Results: The expression and secretion of HIV-1 CAP256SU gp150 describe a novel HIV-1 Env construct that was designed to express as
and GagM by all three vaccine vectors was verified in vitro. In addition, trimers only (TO).
the formation of Gag virus-like particles containing gp150 was con- Methods: First, we combined the TO design with BG505 env to gen-
firmed using negative stain electron microscopy and western blotting erate a BG505 TO-SOSIP construct as a proof-of-concept. Next, we
following density gradient centrifugation. The quaternary structures of used TO-SOSIP as a design template to generate a number of differ-
gp150 on the cell surface was assessed by immunostaining with ent HIV-1 Env immunogens: 1) TO-SOSIP in which immunodominant
human monoclonal binding antibodies (MAbs) to HIV-1 Env, and fluo- strain-specific glycan holes were hidden by glycan masking (GM) (TO-
rescent microscopy or FACS analysis. Binding of MAbs, PG16, SOSIP.GM). 2) TO-SOSIP containing germline-targeting (GT) mutations
PGT145 and CAP256 VRC26_08, confirmed that all three vaccines that enable binding by na€ıve precursors of CD4bs broadly neutralizing
expressed some native, trimeric Env. All four vaccination regimens eli- antibodies (bNAbs) (TO-SOSIP.GT).
cited high titres of neutralising antibodies (NAbs) to Tier 1A pseu- Results: Transient transfection followed by lectin affinity chromatog-
dovirus MW965.26 two weeks after the final immunisation. However, raphy showed that the BG505 TO-SOSIP construct expressed only as
5/5 rabbits in the DDLMLM, 3/5 in the DDLLMM, 2/5 in the trimers, of which >85% displayed a native-like conformation, while
DDMLML and none in the DDMMLL group developed NAbs to Tier BG505 SOSIP and NFL-SOSIP preparations contained significant
1B pseudovirus 6644. Two of the rabbits from the DDLMLM group amounts of dimers and monomers. Furthermore, TO-SOSIP interacted
also developed low levels of autologous Tier 2 NAbs. efficiently with quaternary dependent bNAbs, such as PGT145 and
Conclusions: Low levels of autologous Tier 2 NAbs were induced in PGT151, while showing weak binding to most non-NAbs. Both glycan
2/5 rabbits inoculated with the DDLMLM vaccination regimen. Fur- masked and germline targeting variants also expressed only trimers.
ther studies are planned to determine if these vaccines elicit good cel- TO-SOSIP.GM showed negligible reactivity to glycan hole-targeting
lular immune responses. antibodies, while several TO-SOSIP.GT variants showed efficient bind-
ing to inferred germline versions of several CD4bs bNAbs. Remark-
ably, the TO design approach also allowed us to generate influenza
hemagglutinin (HA) immunogens that express only as trimers without
heterologous trimerization domains.
37
Conclusions: The TO design is a useful platform for generating Env

and HA immunogens and is especially suitable for genetic vaccination OA15.05LB
purposes. In the context of DNA prime and protein boost vaccination Cross-reactivity between HIV-1 bnAbs and parasite glycans
strategies, the glycan masked and germline targeting TO-SOSIP con- I. Huettner1; S. Krumm1,2; E. Landais3; K. Brzezicka4; S. Serna4; A.van
structs could prove essential for the early activation of potentially Diepen5; J. Angulo6; F. Allan7; A. Emery7; N. Reichardt4; R. Hokke5;
cross-neutralizing epitopes. P. Poignard3,8,9 and K. Doores1
1
King’s College London, School of Immunology and Microbial Sciences,
OA15.04 London, United Kingdom, 2BioNTech, Mainz, Germany, 3International
AIDS Vaccine Initiative, Neutralizing Antibody Center, La Jolla, United
Structural basis of neutralizing antibodies targeting the
States, 4CICbiomaGUNE, Biofunctional Nanomaterials Unit, San
CD4-binding site and fusion peptide elicited by
Sebastian, Spain, 5Leiden University Medical Center, Parasite Glycobi-
immunization with heterologous HIV-1 Env in NHP ology Group, Leiden, Netherlands, 6University of East Anglia, School
T. Zhou1; A. Nazzari2; X. Chen1; J. Gorman1; M. Sastry1; A.S. Olia1; of Pharmacy, Norwich, United Kingdom, 7Natural History Museum,
K. Xu1; B. Zhang1; C.S. Cheung1; C. Cheng1; A.R. Corrigan1; Life Sciences Department, London, United Kingdom, 8The Scripps
E.K. Sarfo1; K. McKee1; R. Casner3 and G. Cerutti3 Research Institute, Department of Immunology and Microbiology, La
1
National Institute of Health, Vaccine Research Center, Bethesda, Uni- Grenoble Alpes, Institut de Biologie
Jolla, United States, 9Universite
ted States, 2National Institute of Health, Bethesda, United States, Structurale, Grenoble, France
3
Columbia University, New York, United States
Background: Many HIV-1 broadly neutralizing antibodies (bnAbs) iso-

Background: Elicitation of broadly neutralizing antibodies remains a lated from HIV-1 infected donors directly engage, or are dependent
challenge to the development of an effective HIV-1 vaccine. While upon, N-linked glycans on the HIV-1 envelope-trimer for neutraliza-
most neutralizing epitopes identified are present on the prefusion tion. It can take many years for bnAbs to develop following HIV-1
closed form of HIV-1 envelope trimer (Env), only limited neutralization infection making it a challenge to identify immunization strategies that
breadth has been achieved with previous HIV-1 Env immunizations. will re-elicit these bnAbs through vaccination. Since other glycosylated
Methods: Here we characterize the antibody response in non-human pathogens, such as bacteria and parasites, can raise a strong anti-gly-
primates (NHP) following sequential immunization with HIV-1 Env can antibody response, the question arises whether the development
variants, priming by Env with glycans removed around the CD4-bind- of glycan-dependent HIV-1 bnAbs could be guided by Abs targeting
ing site (CD4BS), boosting with Envs with gradually restored glycans glycans on other pathogens. We therefore set out to study cross-reac-
and eventually with natively glycosylated Envs. Sera were evaluated tivity of glycan-binding bnAbs with parasite glycans and prevalence of
with a sentinel panel of viruses. PBMCs of a selected group of NHPs seroreactivity to parasite Schistosoma mansoni in the IAVI Protocol C
with broad sera neutralization activity were analyzed using probe- cohort.
based B cell sorting and monoclonal antibody cloning. Antibodies were Methods: To measure cross-reactivity of known glycan-binding bnAbs
selected by binding affinity to gp120 core and Env trimer. Large panel with non-self parasite-derived glycans, we used a synthetic parasite
neutralization and structural studies were conducted to map major glycan microarray and a ‘shotgun’ parasite glycan microarray. The
sites of antibody targeting. mode of glycan binding was assessed using STD NMR. We further
Results: The sequential Env-only immunization scheme elicited sub- confirmed cross-reactivity with S. mansoni using confocal microscopy
stantial sera neutralization activity in a subgroup of NHP and NHPs and immunohistochemical analysis. To understand the seroprevalence
primed/boosted with deglycosylated 4501dG5 trimers elicited higher of this parasitic infection in HIV-1 infected individuals in S. mansoni
titers against the fusion peptide (FP). Isolated antibodies with gp120- endemic regions we screened plasma from the well-studied IAVI Pro-
binding activity had limited breadth, only neutralizing HIV-1 strains tocol C cohort for seroreactivity to S. mansoni antigens by ELISA.
lacking glycan on Asn276. Structural studies revealed that these anti- Results: We observed cross-reactivity of glycan-specific bnAbs to self
bodies target the CD4BS, however, in an orientation that fails to and non-self S. mansoni glycans and were able to further confirm
accommodate glycan 276. In contrast, one of the Env-interactive anti- cross-binding of bnAbs to S. mansoni glycoproteins by confocal micro-
bodies, VRC7324, showed 34% breadth on a 208-virus panel and a scopy and immunohistochemical analysis. STD NMR analysis demon-
median IC50 of 0.98 μg/ml. VRC7324 bound to diverse FP and com- strated that bnAb PGT121 contacts both self and non-self
peted with FP-directed antibodies. Cryo-electron microscopy was car- components of a representative parasite glycan. We detected an over-
ried out to determine the structure of VRC7324-Env complex and all 41% seroprevalence against S. mansoni in a subset of IAVI protocol
elucidate how a single antibody can recognize different FPs to achieve C donors, with a higher occurrence in donors with medium and top
broad neutralization. plasma neutralization (88% vs. 63%). We further observed cross-reac-
Conclusions: Immunization with glycan-removed Env increases tivity of N332/V3 specific PCDN76 bnAb lineage, including the unmu-
immune responses. However, optimal glycan shield around the CD4BS tated common ancestor, with S. mansoni.
may be essential to train developing antibodies to accommodate gly- Conclusions: These findings suggest antibody responses against para-
cans on Env. In contrast, Env-only immunizations can elicit broadly site glycoproteins are readily found in HIV-1 positive donors. The
neutralizing FP-targeting antibodies and we identified that the cross-reactivity with parasite glycoproteins, particularly of the unmu-
4501dG5 Env can be a promising priming immunogen for eliciting the tated common ancestor of a bnAb suggest a non-self-glycan response
FP-targeting antibodies. could direct the development of glycan reactive HIV-1 bnAbs. These
observations will inform and aid HIV-1 immunogen design.
38
chlamydia (p = 0.116) and urogenital gonorrhoea (p = 0.973) were

OA16.01 stable, and syphilis incidence increased (6.8/100 py to 11.8/100 py;
Trends in incidence of bacterial sexually transmitted p < 0.001). For both cohorts, gonorrhoea and chlamydia incidence
infections among gay and bisexual men using PrEP in were greater among GBM < 35 years, with declines most prominent
Australia among those ≥ 35 years. Syphilis rates and trends did not differ by
M. Traeger1; J. Asselin1; C. El-Hayek1; J. Dittmer1; E. Wright2; age.
A. Carter3; T. Vickers3; P. Patel3; C. Fairley4; B. Donovan3; R. Guy3; Conclusions: Representing the largest cohort analysis of STI inci-
M. Hellard1 and M. Stoove 1 dence among PrEP-users reported internationally, these data suggest
1
Burnet Institute, Disease Elimination, Melbourne, Australia, 2Alfred that initial increases in incidence of some STIs following PrEP initiation
Health and Monash University, Department of Infectious Diseases, may be attenuated over time. Frequent testing or changes in the risk
Melbourne, Australia, 3UNSW Sydney, Kirby Institute, Sydney, Aus- profile of PrEP initiates over time may explain some reductions. Risk-
tralia, 4Melbourne Sexual Health Centre, Australia mitigation strategies may be needed for younger GBM and to curtail
syphilis incidence.
Background: Multiple PrEP studies suggest incidence of bacterial OA16.02

STIs among gay and bisexual men (GBM) increases following PrEP ini-
For MSM attending sexual health clinics in England, rates of
tiation, possibly due to changes in behaviour, sexual networks or test-
ing. Regular, asymptomatic STI testing of PrEP users (Australian
new HIV infections decreased and rates of new rectal GC
guidelines recommend three-monthly) may also help suppress inci- diagnosis increased between 2010 and 2018
dence longer-term. Using national sentinel surveillance data, we report D. Donnell1; K. Zewdie2; N. Ratna3; V. Miller4; J. Saunders3;
trends in STI incidence among GBM PrEP-users. V. Delpech3; N. Gill5 and H. Mohammed3
1
Methods: Retrospective patient data were extracted from 35 clinics, Fred Hutchinson Cancer Research Center, VIDD, Seattle, United
with individuals’ records linked between clinics. HIV-negative GBM States, 2University of Washington, Department of Epidemiology, Seat-
with evidence of TDF/FTC prescription (excluding PEP) contributed tle, United States, 3National Infection Service - Public Health England,
person-time from their first subsequent STI test and were censored Blood Safety, Hepatitis, Sexually Transmitted Infections (STI) and HIV
at their last test or six months after their last PrEP script. Censored Science, United Kingdom, 4University of California, Forum for Collabo-
participants could re-enter at PrEP re-initiation. Infection date was rative Research, School of Public Health, Berkeley, United States,
5
imputed as a random date between diagnosis and previous negative National Infection Service - Public Health England, STI and HIV
test. Using Poisson regression, we estimated half-yearly incidence and Department, United Kingdom
assessed trends (July 2016-December 2019) for syphilis, chlamydia
and gonorrhoea, overall and stratified by anatomical site and age
(</>35 years). To account for selection bias associated with Background: Incidence of rectal gonorrhea (GC) has been hypothe-
differences in characteristics of GBM initiating PrEP over time, a sized as a correlate of HIV exposure risk in HIV prevention trial
closed-cohort analysis was conducted among GBM continuously using cohorts, because both infections occur after condomless anal sex. High
PrEP across the study period. rectal GC rates might be a useful measure for selecting sites for HIV
Results: Among 17,250 PrEP-users contributing 24,823 person-years prevention or vaccine trials, and high rectal GC incidence in trial par-
(median time between tests = 84 days) chlamydia (51.3/100 py to ticipants of new biomedical prevention drugs may provide supportive
39.1/100 py; p < 0.001) and gonorrhoea (43.1/100 py to 32.8/ evidence for ongoing HIV risk.
100 py; p < 0.001) incidence declined, whereas syphilis incidence Methods: Rectal gonorrhea and HIV are routinely tested in sexual
increased (6.4/100 py to 9.9/100 py; p > 0.001). Among 3498 contin- health clinics (SHCs) throughout England and pseudonymised, patient-
uous-PrEP-users (10,538 person-years), declines were observed for level data are reported to Public Health England. Through evaluation
overall chlamydia (54.0/100 py to 42.3/100 py; p < 0.001) and gonor- of repeated visits to SHCs by individual clients, we assessed HIV inci-
rhoea (43.8/100 py to 34.9/100 py; p < 0.001) incidence; pharyngeal dence and new rectal GC diagnoses in HIV-negative MSM from 2010
39
to 2018, predating widespread roll-out of PrEP. We used meta-analy- (SD 23.8) pg/mg respectively. DPV was detected in only 1/31 rectal
sis regression to assess the population-level association between (log) biopsies collected at 1 and 4 hr post dose.
HIV and rectal GC incidence over the 9 years, both overall and Conclusions: Evidence of local delivery and systemic absorption of
adjusted for geographic region. DPV when dosed as an anal lubricant indicates potentially feasible
Results: Between 2010 to 2018, 625,273 MSM attended SHCs in development of lubricant delivered rectal microbicides. However,
England, 322,857 person years were included in the assessment of roughly 3-fold lower DPV exposure in plasma and lack of detectable
HIV incidence, 205,946 in assessment of rectal GC. HIV incidence DPV in tissue biopsies indicate formulation changes are necessary to
assessed each calendar year among MSM attending SHCs fell from achieve protective tissue concentrations informed by vaginal microbi-
1.45/100 PY in 2010 to 0.46/100 PY in 2018. Rectal GC rates cide experience. Our data suggests that DPV gel was safe and easy to
increased from 20/100 PY to 34/100 PY over the same period. Fig- use. Further development of a lubricant microbicide strategy is war-
ures 1a and b show a negative correlation between rectal GC and ranted.
HIV both overall (slope = 0.139, p = <0.001), and when adjusted for
different regions (slope = 0.100, p < 0.001). OA16.04
Conclusions: Among MSM attending SHCs in England, rectal GC inci-
Phase 1 safety and pharmacokinetic study of candidate
dence substantially increased while HIV incidence substantially
decreased from 2010 to 2018. HIV incidence likely decreased through
rectal microbicide PC-1005 rectal gel (MIV-150/zinc
expanded HIV testing, prompt ART initiation and increased viral sup- acetate/carrageenan) in HIV-1 seronegative adults (MTN-
pression in HIV-positive (U=U), interventions that did not decrease 037)
rectal GC. Interpretation of rectal gonorrhea as a correlate of HIV K. Ho1; C. Hoesley2; P. Anderson3; C. Kelly4; Y. Jiao4; S. Edick5;
exposure risk is complex and context-dependent, given effective HIV N. Reddy2; R. Brand5; R.K. Ayudhya6; J. Piper7; R. Scheckter8;
prevention interventions in both HIV-positive and uninfected MSM. B.A. Friedland9; G.W. Creasy9; I. McGowan10 and C.W. Hendrix11
1
University of Pittsburgh, Medicine, Pittsburgh, United States,
2
OA16.03 University of Alabama at Birmingham, United States, 3University of
Colorado, United States, 4Fred Hutchinson Cancer Research Center,
Comparing applicator vs. “as lubricant” delivery of rectal
Seattle, United States, 5University of Pittsburgh, Pittsburgh, United
dapivirine gel (MTN-033)
States, 6Magee Womens Research Institute, United States, 7National
K. Ho1; C. Dominguez-Islas2; D. Szydlo3; N. Macagna4; R. Brand1; Institute of Allergy and Infectious Disease/DAIDS, United States, 8FHI
J. Piper5; J. Bauermeister6; M. Marzinke7; S. Riddler1; S. Edick1; 360, Durham, United States, 9Population Council, New York, United
S.L. Hillier8; J. Steytler9; J. Nuttall9 and C.W. Hendrix10 States, 10Orion Biotechnology, Spain, 11Johns Hopkins University,
1
University of Pittsburgh, Medicine, Pittsburgh, United States, 2Fred Department of Medicine, Baltimore, United States
Hutchinson Cancer Research Center, Vaccine Research, Seattle, Uni-
ted States, 3Fred Hutchinson Cancer Research Center, Seattle, United
States, 4FHI 360, Durham, United States, 5National Institutes of Background: On demand topical PrEP may meet the needs of those
Health, Bethesda, United States, 6University of Pennsylvania, School who prefer episodic, non-systemic PrEP or struggle with or reject
of Nursing, Philadelphia, United States, 7Johns Hopkins University daily oral PrEP. PC-1005 gel, which contains MIV-150, is active against
School of Medicine, Pathology, Baltimore, United States, 8University of HIV-1, HPV, and HSV-2 - an attractive multipurpose prevention tech-
Pittsburgh, Obstetrics and Gynecology, Pittsburgh, United States, nology candidate. We evaluated rectal safety and pharmacokinetics
9
International Partnership for Microbicides, Silver Spring, United (PK) of PC-1005 gel applied rectally.
States, 10Johns Hopkins University School of Medicine, Medicine, Bal- Methods: HIV-uninfected persons >18 years of age each received a
timore, United States series of 3 rectal gel doses at increasing volumes of 4, 16, and 32 mL
with a washout period between doses. Following each dose, plasma,
rectal tissue and fluid, and vaginal fluid were collected up to 7 times
Background: Rectal microbicides are promising strategies for local, over 48 hours.
non-systemic delivery of HIV pre-exposure prophylaxis, especially in Results: We enrolled 13 participants, 7 men and 6 women (birth sex),
men who have sex with men. Tenofovir gel administered intrarectally median 34 years of age, including 6 white, 5 black, and 2 mixed race/
with an applicator had lower acceptability as compared to a daily oral ethnicity. 12 participants completed all 3 doses.
PrEP regimen and traditional lubricant use in prior phase II studies. Thirteen adverse events were reported, all Grade 1 or 2, of which 5
Data to enhance the behaviorally congruent delivery of rectal microbi- were judged related to study drug without relationship to dose vol-
cides as lubricants are scant. ume. Median (interquartile range) plasma MIV-150 concentration
Methods: MTN-033, a single site, open label, sequence randomized, peaked 1 or 2 hours after dosing at 0.074 ng/mL (0.052, 0.086),
crossover study, enrolled HIV negative men to receive 0.05% dapivir- 0.184 (0.162, 0.211), and 0.171 (0.098, 0.316), after 4, 16, and 32 mL
ine (DPV) gel by intrarectal dosing using an applicator (2.5 g) and self- doses, respectively; median concentrations were below assay quantita-
administered on an artificial phallus as lubricant (up to 10 g). Plasma, tion limits (BLQ) 24 hours after dosing. Median half-life was 1.4 to
rectal fluid, and rectal biopsies were collected over 24 hr post dose. 1.9 hours across dose volumes. Rectal Tissue MIV-150 peaked 0.5 to
Participants completed behavioral acceptability surveys after each dos- 1 hours after dosing at 1.4 ng/g (ng/mL) (0.8, 1.9), 46.0 (30.7, 831.0),
ing regimen. We compared delivery methods using Wilcoxon tests for and 79.7 (11.9, 116.0), respectively, after each dose volume. Median
PK parameters. tissue concentrations were BLQ (0.7 ng/g) at 1.5 to 3, 24, and 3.5 to
Results: 16 participants used DPV gel by applicator and 15/16 partic- 5 hours after each escalating dose volume, respectively. Median rectal
ipants used gel as lubricant (mean 1.8 g, SD 0.8). No related adverse fluid concentrations were >14 ng/mL (ng/g) through 5 hours in all
events were reported. Participants all felt the gel was easy to use. arms; vaginal fluid samples were all BLQ (0.2 ng/mL). Across dose vol-
Peak DPV concentration in plasma (pg/mL) was higher using an appli- umes, 83%-92% of participants rated the gel as comfortable or very
cator, median 319 (interquartile range [IQR] 247, 603), than use as comfortable.
lubricant, 85 (IQR 54, 218; p < 0.01). Plasma DPV 24 hour area Conclusions: PC-1005 gel was well-tolerated with low systemic expo-
under the curve (ng-hr/mL) after applicator (median 3.5; IQR 3.1, 6.2) sure. MIV-150 rectal tissue concentrations were transient and below
was higher than after use as lubricant (median 1.3, IQR 0.7 to 2.4; the 100 ng/g target; no MIV-150 was detectable in vaginal fluids.
p < 0.01) Mean DPV concentrations in rectal fluid 1 hr post dose Based on concentration data, a longer-acting reformulation delivering
were similar with applicator and as lubricant, 20.9 (SD 33.6) and 25.6
40
more MIV-150 to rectal tissues is likely needed to support further

development of PC-1005 as an on demand HIV rectal microbicide. OA17.01
Eliciting participant feedback in focus group discussions to
strengthen the implementation of a HIV prevention study
OA16.05 I. Hawley1; S. Roberts1; M.K. Shapley-Quinn1; A. Young1; M. Garcia2;
A randomized, double blind, placebo-controlled, phase 1
K. Ngure3; L. Soto-Torres4; D. Kemigisha5; M. Chitukuta6;
safety and pharmacokinetic study of dapivirine gel (0.05%) F. Mathebula7 and N. Mangxilana8
administered rectally to HIV-1 seronegative adults (MTN- 1
RTI International, Women’s Global Health Imperative, Research Trian-
026) gle Park, United States, 2Family Planning International, United States,
C. Hoesley1; K. Ho2; E. Dunne3; C. Dominguez Islas4; M. Marzinke5; 3
Jomo Kenyatta University of Agriculture and Technology, Kenya,
R.P. Kunjara Na Ayudhya6; J. Piper7; J. Bauermeister8; S. Johnson9; 4
NIAID, DAIDS, Bethesda, United States, 5Makerere University -
H. Gundacker4; B. Devlin10; J. Nuttall10; C.W. Hendrix5; I. McGowan6 Johns Hopkins University (MU-JHU) CRS, Kampala, Uganda, 6Spilhaus
and R. Cranston2 Clinical Research Site, Zimbabwe, 7Wits Reproductive Health and HIV
1
University of Alabama at Birmingham, Medicine, United States, Institute CRS, Johannesburg, South Africa, 8Emavundaleni CRS, South
2
University of Pittsburgh, Pittsburgh, United States, 3Silom Commu- Africa
nity Clinic CRS Thailand MOPH-U.S. CDC Collaboration, Thailand,
4
SCHARP/Fred Hutchinson Cancer Research Center, Seattle, United
States, 5Johns Hopkins University, Medicine (Clinical Pharmacology), Background: Adolescent girls and young women (AGYW) in sub-
Baltimore, United States, 6Microbicide Trials Network, United States, Saharan Africa are disproportionately affected by HIV, yet there is lim-
7
National Institute of Allergy and Infectious Diseases, Division of ited guidance on their engagement in biomedical HIV prevention
AIDS, United States, 8University of Pennsylvania, Philadelphia, United research. Engaging AGYW through focus group discussions (FGDs) on
States, 9FHI 360, Durham, United States, 10International Partnership study implementation may help inform and improve study procedures,
for Microbicides (IPM), Silver Spring, United States address concerns and challenges, and ensure their needs are met in a
timely manner.
Methods: Implementation-focused FGDs were conducted in MTN-
Background: HIV prevention needs persist, in part, because of daily 034/REACH, an ongoing trial evaluating the safety of and adherence
oral PrEP challenges, hence, interest in on demand topical options. to the monthly dapivirine vaginal ring and daily oral PrEP among
The dapivirine vaginal ring demonstrated 30% risk reduction in HIV-1 AGYW (16 to 21) in three African countries (South Africa, Uganda,
infections, but has not been evaluated for rectal use. We evaluated Zimbabwe). Trained social scientists facilitated 8 FGDs using a semi-
rectal safety, pharmacokinetics (PK) and pharmacodynamics (PD) of a structured guide with topics related to motivation to join the study,
dapivirine gel formulation. interactions with staff, challenges to product adherence, disclosure of
Methods: We enrolled HIV-uninfected men and women, 18 to product use, and community perceptions of the products and trial.
45 years of age, at Thailand and United States sites. We randomized Each FGD was conducted with participants who have completed two
eligible participants 2:1 to receive blinded dapivirine (0.05%) or pla- to six months of the 18-month study. Summary reports of each FGD
cebo gel via rectal applicator. A single dose phase was followed by were disseminated to behavioral researchers, clinical researchers, and
observed daily dosing for seven days. Plasma, and fluid and tissue staff within and across sites.
from both rectum and cervix were collected at baseline and 5 times Results: These procedures offer an innovative bottom-up approach to
over 72 hours after each dose for PK, ex vivo HIV-1 biopsy challenge improve study implementation in real-time using participant feedback.
(PD), tissue histology, and flow cytometry. Creating positive environments for receiving feedback and systemati-
Results: We randomized 28 participants; two terminated early. Nine cally distributing feedback across the study team facilitated the cre-
participants were female and 19 male (sex at birth); 12 were white, ation of actionable plans to address participants’ concerns and
11 Asian, 4 black, 1 other race/ethnicity. Mean years of age were 28.5 challenges. Feedback communication channels included.
and 34.2 in the dapivirine and placebo arms, respectively.
Thirty adverse events occurred (Grade 1 or 2, except one unrelated (1) FGD facilitators presenting findings to clinic staff at internal
Grade 3) without study arm differences or any drug related discontin- meetings,
uation. Dapivirine rectal tissue concentrations (median [interquartile (2) site investigators consulting staff mentioned in FGDs, and
range]) 0.5 to 1 and 2, hours after a single dose were 256 ng/gm (be- (3) study management sharing findings with adherence counselors.
low limit of quantitation [BLQ], 666) and BLQ (BLQ, 600), respectively,
Reviewing the objectives of these FGDs in advance improved staff’s
then BLQ (BLQ, BLQ) from 24 to 72 hours; multiple dose concentra-
receptivity to feedback and criticisms. These FGDs resulted in actions
tions were similar. Peak dapivirine plasma concentrations were
such as organizing laboratory tours for community members to dispel
0.33 ng/mL (0.15, 0.48) after one dose and 0.40 (0.33, 0.49) after
rumors related to the trial, limiting the number of staff present during
seven doses. Cervical tissue and fluid concentrations were all BLQ.
clinical procedures to increase privacy, and improving the efficiency of
Flow cytometry indicated no changes or study arm differences. Ex vivo
clinic flow during participants’ visits.
biopsy challenge showed ~10-fold reduction in viral replication, but
Conclusions: For clinic staff and behavioral scientists involved in the
only through 2 hours after dosing.
design and implementation of HIV prevention trials for AGYW, early-
Conclusions: Dapivirine gel was well-tolerated with dapivirine plasma
stage implementation-focused discussion groups can help identify chal-
concentrations similar to those of the dapivirine vaginal ring observed
lenges participants face, open communication channels among
in clinical trials. However, the rectal ex vivo antiviral effect and tissue
research staff, and address the needs of young participants.
concentrations were only transient and well below vaginal tissue
results with the dapivirine vaginal ring. A long-acting reformulation or
higher dose is likely needed to provide protection from anal sex.
41
early in the research process and served as a main form of commu-

OA17.02 nication. In Zambia, CAB engagement included quarterly meetings,
A synergistic model of engagement: the ECHO Global protocol review, and participation in national HIV events. At commu-
Community Advisory Group and HC-HIV Advocacy nity level, however, the CAB had limited spaces to provide feedback
Working Group to community health structures, civil society organizations (CSOs)
J.W. Mwangi1; Y. Raphael2; L. Mworeko3; M. Happy4; E. Bass5; and the general population. To help address this gap, seven CSOs
T. Njoki6 and A. Forbes7 formed the Community Partnership Platform (CPP). This “outside-in”
1
AFROCAB Treatment Access Partnerships, Programs, Nairobi, Kenya, or CSO led model of engagement built broader support for the
2
APHA, ED, Durban, South Africa, 3ICWEA, Programs, Uganda, 4Advo- study intervention.
cacy for Quality Health Uganda (AQH-Uganda), Entebbe, Uganda, Methods: The CPP partnered with the PopART trial team to build
5
AVAC, New York, United States, 6Athena, United States, 7Indepen- capacity of stakeholders on the Good Participatory Practice guidelines
dent Consultant, United States (GPP). The CPP used a mixed method approach to identify the impact
of the trial sites’ stakeholder engagement programs. Score cards were
created to anonymously evaluate perceived stakeholder engagement
Background: In 2019, the Evidence for Contraceptive Options in HIV quality by the community in line with GPP. Focus groups were con-
Outcomes (ECHO) study found no substantial difference in risk of ducted with a range of stakeholders to provide a robust picture of
HIV infection among women using one of three safe and effective community involvement throughout the research process. Findings
contraceptive methods (DMPA-IM, LNG implant, copper IUD). The were reported back to the trial in real-time.
trial used a range of advisory mechanisms that aligned to global stan- Results: Through community trainings, the CPP identified treatment
dards in stakeholder engagement, including an ECHO-specific Global literacy needs and supported development of effective training tools
Community Advisory Group (GCAG). and evaluation measures. Through networking, the CPP held meetings
Methods: The HC-HIV Advocacy Working Group includes highly visi- with at-risk populations to create demand, increase awareness, and
ble women leaders from diverse geographies who advocate on the ensure meaningful engagement with the study team. At the national
global, national and local stage; their advocacy paved the way for the level, the CPP represented community groups and CSOs in the
formation of the ECHO GCAG. The GCAG included a subset of advo- National Steering Committee of the PopART study. This helped amplify
cates from the Working Group that advised and communicated regu- the community voice during Pop ART study forums.
larly with the ECHO Consortium around key trial issues-particularly Conclusions: The use of CSOs as a community engagement mecha-
community engagement. nism is critical to optimizing the research process. The CPP initiative
Results: The strength of the GCAG/HC-HIV Advocacy Working provided a parallel opportunity for engaging broader stakeholders in
Group model was the high degree of synergy between the two research and ensures the wider viewpoints of a community are
groups. The GCAG workshopped issues with the Group, and together included. This approach has the potential to improve transparency and
ensured the voices of women were well-represented in the study. Fol- accountability at a range of stakeholder levels from trial staff to policy
lowing the trial, the Group provided a space for GCAG members to makers.
continue advocacy efforts - including communicating the implications
of the trial results to their communities, pushing for integrated sexual OA17.04
and reproductive health services in national Task Forces, and monitor-
Examining systemic racism in “empowerment-based” HIV
ing WHO and Ministry commitments. This demonstrates how the
model can advance advocacy from research to policy and implementa-
prevention research: reflections of a US-France research
tion. partnership
Conclusions: The model is now driving discussions around engage- T. Albritton1; K.B. Coulibaly2; I. Zoumenou3; M. Paige1; C. Davis4;
ment for future HIV prevention clinical trials. A study looking at a S. Carillon5; D. Matthews1; P. Saintonge Austin6; L. Miles1; V. Frye1
new daily oral PrEP using F/TAF, planned in communities similar to and A. Gosselin7
1
the ECHO study, highlighted the model as part of their stakeholder CUNY School of Medicine, Community Health and Social Medicine,
consultations. Advocates engaged in the study include members of the New York, United States, 2Universite de Paris, Centre Population et
GCAG, and study sponsors are utilizing existing advocacy networks to Development, France, 3Afrique Avenir - Me diatrice en Sante
, Afrique
inform the engagement strategy. Similar to the ECHO study, the F/ Avenir, Paris, France, 4Compassioniton, New York, United States,
TAF trial has global implications for women. It remains to be seen if 5
Universite Paris Descartes, CEPED, UMR IRD-Equipe SAGESUD,
the study will replicate or adapt facets of the model; however, it is ERL INSERM U 1244, Paris, France, 6Children’s Aid NYC, New York,
clear that there is much that can be learned from the relationship United States, 7Institut Pierre Louis d’Epidemiologie et de Sante
Publi-
between the Working Group and GCAG and how it can support que (IPLESP/INSERM_S1136), Social Epidemiology Department (ERES)
engagement and implementation. Faculte de Me decine de St Antoine, Paris, France
OA17.03 Background: HIV prevention research projects often apply “empow-

The value of outside engagement-civil society led erment” approaches to achieve scientific goals and redress power
engagement in PopART imbalances between the study team and marginalized communities,
C. Chilende1; C. Kasanda1; J. Salzwedel2; N. Jain2 and F. Mwanza3 particularly communities of color. Simultaneously, there have been
1
Treatment Advocacy & Literacy Campaign, Lusaka, Zambia, 2AVAC, calls for both scientific leadership and study methods that recognize
New York, United States, 3Treatment Advocacy & Literacy Campaign, the role of systemic racism within study team and the power differen-
Luanda, United States tials between study leadership and the communities.
Methods: ETOILE, Experiences of Tensions in Organizations and
Interventions Leveraged for Empowerment and Prevention, is a
Background: Between 2013 and 2018 the PopART study, a ran- French-American cooperative project to explore and characterize how
domized study evaluating community level impact of a package of researchers in France and the US have addressed tensions related to
HIV prevention interventions on HIV incidence, was conducted in race/racism-related power imbalances within two empowerment-based
South Africa and Zambia. Community Advisory Boards (CABs), a HIV prevention projects and how these tensions influence study
common mechanism of community engagement, were established implementation. Each project involved has predominately white
42
leadership and predominately Black (US) or Black African/Black vaccines and cure research, comorbidities. We developed a research
French (France) staff and community representatives. ETOILE applies agenda and advisory committees to help address these gaps.
reflexive, comparative, qualitative process evaluation methods to iden- Conclusions: Incorporation of FSWs’ and their research priorities in
tify how tensions related to race/racism-related power imbalances all stages of research is key for building trust, ownership and success-
manifest in various aspects of the study. Originally planned as a face- ful implementation. Therefore, researchers need to invest in research
to-face intervisitation between French and US teams, we have con- literacy for biomedical research activities for a better understanding.
ducted with three semi-structured, web-based group interviews, Utilize FSW advisory mechanisms as a model to empower FSW to be
where study scientific leadership, staff, and community representa- involved in defining and informing research especially structural priori-
tives, discussed within-project power relations, representation in study ties and results shared with all stakeholders.
leadership and the role of race/racism, privilege and voice, related to
community location, education and status. Interviews were conducted OA18.01
via Zoom and Skype and transcribed. Analysis is ongoing.
Early Vaccine-Induced V1V2 Antibody Responses in Four
Results: Preliminary analyses have identified several overarching
themes, including racialized organization of labor within each team;
Pox-Protein Public Private Partnership (P5) HIV Vaccine
resistance to sharing power; need for strategies and opportunities for Trials
Black scholars in HIV prevention research; the role of country-specific F. Laher1; C. DiazGranados2; C. Innes3; E. Andersen-Nissen4;
history and contexts; and need for white researchers to systematically G.E. Gray5; H. Lu6; J. Hutter7; K. Mngadi3; K. Marshall6;
undo marginalization of black researchers. L. Polakowski7; L.-G. Bekker8; M. Koutsoukos9; M. Allen7;
Conclusions: Failing to reflexively consider the role of within study M. Hosseinipour10 and N. Grunenburg6
1
team-based, race/racism-related power imbalances in empowerment- University of the Witwatersrand, Perinatal HIV Research Unit, Johan-
based HIV prevention research may threaten the integrity and impact nesburg, South Africa, 2Sanofi Pasteur, United States, 3The Aurum
of the research and potentially reinforce the social conditions the Institute, South Africa, 4Cape Town HVTN Immunology Lab, Cape
research may be attempting to mitigate. Our hope is that by identify- Town, South Africa, 5University of the Witwatersrand, Johannesburg,
ing how these tensions emerge in our own research and engaging in a South Africa, 6HIV Vaccine Trials Network, United States, 7National
structured analysis of the similarities and differences across contexts, Institute of Allergy and Infectious Diseases, National Institutes of
we will identify best practices that reduce race/racism-related power Health, Bethesda, United States, 8Desmond Tutu HIV Centre, Cape
imbalances and advance both in US and French HIV prevention Town, South Africa, 9GSK, Belgium, 10UNC Project Lilongwe, Malawi
research.
Background: RV144 demonstrated modest HIV preventive vaccine

OA17.05 efficacy in Thailand. Amongst multiple identified correlates, IgG V1V2
Redefining ownership: the mismatch between female sex antibodies were associated with 43% HIV risk reduction. The P5
workers’ research priorities and the field in Kenya aimed to further this by investigating subtype C vaccine regimens
G.V. Owino1; R. Kasiba2; J. Oluoch3 and S. Kabura4 with different vectors (canarypox, DNA plasmid), adjuvants (alum,
1
IAVI, Global Affairs, Nairobi, Kenya, 2Sex Worker Research Commit- MF59, AS01B, or none), gp120 protein doses (40mcg, 200mcg,
tee, Kenya, 3Community-Led Research Advisory Committee, Kenya, 600mcg), dosing strategies (prime-boost, co-administration) and
4
Coast Research Advisory Committee, Kenya administration methods (needle-syringe, Biojector). We compare IgG
V1V2 responses across P5 trials with available data.
Methods: In the HVTN100, HVTN107, HVTN108, and HVTN111 tri-
Background: Participation of Female Sex Workers (FSWs) in research als, serum specimens were obtained two weeks after the fourth vaccina-
remains challenged due to significant stigma, discrimination and in tion. We measured the frequency and, amongst positive responders, the
some cases violence from the society and law enforcement. This magnitude (MFI*: background-subtracted mean fluorescence intensity
demeans their priorities in health and research programs that eventu- minus blank responses) of HIV-1-specific IgG (1:50 dilution) responses
ally affect ownership and implementation of research. This warrants a against V1V2 antigens for subtype C, gp70-TV1.GSKvacV1V2/293F
different approach of engagement that emphasizes involvement and (matched to subtype C protein vaccine), or subtype CRF01_AE,
inclusion of FSWs’ priorities and ownership. We aimed at identifying AE.A244 V1V2 Tags/293F (matched to subtype B/E protein vaccine),
the challenges faced by FSW in research, develop their own research depending on protein administered. Responses were measured on Bio-
agenda and a mechanism to take it forward. Rad using a standardized custom Luminex HIV-1 binding antibody multi-
Methods: A total of 65 participants (58 FSWs and 7 researchers) plex assay.
convened, from three participatory forums in three regions: Kisumu, Results: Amongst these subtype C regimens, the lowest response rate
Nairobi and Coastal Kenya. The forums were held over 2 days per was induced by a regimen of two subtype C ALVAC primes followed by
region to identify challenges and gaps in FSW engagement, develop three boosts of subtype C ALVAC +200 mcg unadjuvanted gp120 (4/
research questions and mechanisms to take this forward. 17 = 23.5%, CI 9.6%-47.3%); median magnitude 727.1MFI* (IQR 430.1
Results: Gaps were identified in research literacy, engagement and to 1152.1). The highest response rates were in co-administration
ownership of past and ongoing research, some FSW had knowledge of groups of adjuvanted protein plus DNA or ALVAC at all timepoints).
some past research studies, were involved in some stages, most did Rates, median magnitudes were 93.8%, 12124.8MFI* (DNA +40 mcg
not know about past or ongoing research, nor involved in the research gp120 + AS01B at 3 timepoints); 91.4%, 21756.9MFI* (DNA + 200
life cycle. A disconnect between FSWs’ and researchers’ priorities was mcg gp120 + AS01B at 3 timepoints); 89.1%, 7147.25MFI* (DNA +
identified. FSW research priorities were heavily around structural 200 mcg gp120 + MF59 by needle-syringe at 3 timepoints); 88.5%,
issues, and to understand complex processes in biomedical research 7745MFI* (DNA by Biojector + 200 mcg gp120 + MF59 by needle-
initiatives. FSW top structural priorities included: forms, causes and syringe at 3 timepoints); 86.7%, 6205.1MFI* (subtype C ALVAC +
effects of sexual violence, mental health, existing mechanisms to 200 mcg gp120 + MF59 at 4 timepoints). For subtype C regimens,
engage FSW in research, decriminalization of sex work, impact of pooled response rates were higher for: (i) co-administration regimens
stigma and discrimination on accessing services, involvement in health versus regimens omitting protein in the first two doses (152/169 =
policies and decision making, and impact of police and local authorities’ 89.9% versus 233/374 = 62.3%, p < 0.00,001) and (ii) groups with
sensitization in dealing with violations. Common biomedical questions DNA vaccines versus those with ALVAC (202/253 = 79.8% versus 187/
were: factors that facilitate FSW to participation, NPTs, PrEP, HIV 299 = 62.5%, p < 0.00,001).
43
Conclusions: Strategies which optimized IgG V1V2 responses in P5 the V1V2 panel antigens were low to moderate across treatment
subtype C vaccine trials included adjuvanted protein, and co-adminis- groups, ranging from 0% to 25.0%.
tration of adjuvanted protein + DNA or ALVAC vaccination. Responses Conclusions: Env-specific antibody response rates between Alum and
to DNA administration by needle and syringe or Biojector were equiv- MF59-adjuvanted vaccine regimens were similar, including V1V2 IgG
alent. response rates that correlated with decreased HIV risk in RV144. On
the other hand, co-administration of ALVAC-HIV with gp120 in MF59
OA18.02 induced the highest antibody response rates and magnitudes. Addi-
tional studies of vaccine-elicited antibody specificity and function will
Similar antibody responses to subtype C ALVAC-HIV/gp120
inform adjuvant-specific induction of potentially protective humoral
vaccine regimens using different adjuvants (MF59 vs. alum) immune responses.
but enhanced response rates and magnitude when ALVAC-
HIV and gp120 were co-administered
P. Goepfert1; K. Mngadi2; Z. Moodie3; N. Grunenberg3; J.J. Kee3;
OA18.03
K. Seaton4; G. Tomaras4; E. Andersen-Nissen5; O. Dintwe5; F. Laher6; Alum-adjuvanted protein administered in combination with
L. Stranix-Chibanda7; N. Naicker8; L. Polakowski9 and ALVAC-HIV downregulates early serum cytokine responses
M. Koutsoukos10 to the vaccine whereas MF59 enhances the early cytokine
1
University of Alabama at Birmingham, Medicine, Birmingham, United burst
States, 2The Aurum Institute, Clinical Research, South Africa, 3Fred E. Andersen-Nissen1; V. Voillet2; A. Naidoo2; J. Kee1;
Hutch, Vaccine and Infectious Diseases, United States, 4Duke Univer- A. Fiore-Gartland1; O. Dintwe2; N. Grunenberg1; L. Polakowski3;
sity, Surgery, Durham, United States, 5Cape Town HVTN Immunology L. Fleurs4; I. Jani5; M Sebe6; F. Laher7; L. Stranix-Chibanda8;
Laboratory, Cape Town, South Africa, 6PHRU Vaccines Research, N. Naicker9 and K. Mngadi10
Soweto, South Africa, 7University of Zimbabwe College of Health 1
Fred Hutchinson Cancer Research Center, Vaccine and Infectious
Sciences, Harare, Zimbabwe, 8Centre for the AIDS Programme of Diseases Division, Seattle, United States, 2Hutchinson Centre
Research in South Africa, Durban, South Africa, 9National Institute of Research Institute of South Africa, South Africa, 3NIAID, Division of
Health, NIAID, Bethesda, United States, 10GlaxoSmithKline, Belgium AIDS, Bethesda, United States, 4Desmond Tutu HIV Foundation, Cape
Town, South Africa, 5CISPOC, Maputo, Mozambique, 6Aurum Tembisa
Clinical Research Site, Tembisa, South Africa, 7University of Witwater-
Background: The partially efficacious RV144 HIV-1 vaccine trial uti- srand, Perinatal HIV Research Unit, Johannesburg, South Africa,
lized a gp120 protein boost adjuvanted with alum, whereas the non- 8
University of Zimbabwe College of Health Sciences, Harare, Zim-
efficacious HVTN 702 preventive HIV vaccine utilized a gp120 protein babwe, 9Centre for the AIDS Programme of Research in South Africa,
boost adjuvanted with MF59. We compared Env-specific IgG and IgA Durban, South Africa, 10The Aurum Institute, Clinical Research
responses in HVTN 107, a phase 1/2a partially double-blinded clinical Department, South Africa
trial, utilizing a Clade C ALVAC-HIV prime and 100 mcg gp120 pro-
tein boost adjuvanted with alum or MF59 vs. a protein-only boost.
Methods: We randomized 132 participants into 4 groups and ana- Background: Vaccine adjuvants are detected by the innate immune
lyzed Env-specific IgG and IgA binding antibodies at Months 6.5 and system and influence adaptive immune responses. The modestly effica-
12 (NCT03284710). cious RV144 Thai trial used alum to adjuvant the gp120 protein
Results: Robust IgG (96.3% to 100%) and IgA (92% to 93%) boost, whereas the non-efficacious HVTN 702 South African trial used
responses were seen for all trial arms at the month 6.5 timepoint to MF59. Volunteers enrolled in HVTN 107 (NCT03284710) were
gp120 Env proteins contained in the vaccine regimen (ZM96, TV1.C administered these adjuvants with a subtype C pox-protein vaccine,
and 1086.C). Compared to all other trial arms, T3 (MF59-adjuvanted affording a unique opportunity to contrast systemic innate immune
co-administration) exhibited significantly greater response rates and responses and potentially inform the results of HVTN 702.
magnitudes to vaccine-matched Env proteins at the month 12 time- Methods: Eighteen volunteers were enrolled per group. T1, T2 and
point. Comparable IgG response rates and magnitudes to vaccine- T4 received 2 doses of ALVAC-HIV followed by 3 doses of ALVAC-
matched Env proteins were observed between the alum and MF59 HIV plus subtype C gp120 administered with MF59 (T1), alum (T2),
prime-boost trial arms. Compared to other groups, T3 exhibited signif- or un-adjuvanted (T4). T3 received 4 doses of ALVAC-HIV with MF59-
icantly higher IgG response rates to V1V2 panel antigens gp70_B.Ca- adjuvanted gp120. Innate immune responses were measured pre-
seA_V1V2 (83% vs. 18%-48%, p <=0.010) and TV1_V1V2 (87% vs. T2: vaccination and at days 1, 3 and 7 after the first (T3) or third (T1,T2,
56% p = 0.017; vs. T4: 24% p < 0.001) at the 6.5 month timepoint. T4) vaccinations. Alterations in circulating leukocytes were assessed
Median response magnitude among positive responders was higher in by CBC. Thirty-one serum immunomodulatory mediators were quanti-
T3 vs. T1 for TV1_V1V2 (p = 0.006). At month 12, response rates to tated.
44
Results: Neutrophil concentrations increased on day 1 in all groups infected. An unvaccinated control group was also challenged weekly
(FDR-p’s < 0.02) and monocyte concentrations increased in T2,T3 until they became infected.
and T4 (FDR-p’s < 0.12); lymphocyte concentrations significantly Results: The expression and secretion of HIV-1 Env and SIV Gag by
decreased at day 1 only in T1 (FDR-p = 0.03). Serum cytokines were all three vaccine vectors was verified in vitro. Following vaccination, all
also significantly altered post-vaccination in all groups (FDR-p’s < 0.2). the animals developed IFN-c ELISPOT responses after the DNA vacci-
On Day 1, nine cytokines were induced in T1, including pro-inflamma- nations (median: 255 sfu/million) which were boosted by the MVA
tory IFN-g, CXCL10, TNF-a, IL-6, as well as CCL4 and IL-2, with many inoculations (median: 1031 sfu/million). After protein boost, all animals
factors remaining elevated at Day 3 and returning to baseline on Day 7. had NAbs to MW965.26 (median titre: 426.5) and ZM109.B4 (median
In contrast, only IL-2 and IL-6 were induced in T2 on Day 1 and twelve titre: 29.5) pseudovirions and 3 of 6 to 6644.v2.c33 pseudovirions.
factors were repressed on Day 7 relative to pre-vaccination, including The animals in the vaccine group became infected following challenge
IFN-g and monocyte-chemotactic factors CCL8, CCL13, and CCL22. at a similar rate to the controls, however, median peak viraemia in the
Responses in the MF59 groups differed when co-administered at the vaccine group (1.8x103 copies/ml) was lower than the controls
first vaccination (T3) relative to the third vaccination (T1) with 12 (1.6x104/ml). Viral replication kinetics were similar in all animals with
cytokines repressed on Day 1 in T3. rapid decline to undetectable levels by 12 weeks post infection.
Conclusions: Alum-adjuvanted protein administered in a prime/boost Conclusions: These data provide proof of concept regarding the util-
regimen including ALVAC-HIV reduced early systemic serum cytokine ity of our ChRM virus challenge model and support further testing of
and chemokine responses to the vaccine, in stark contrast to MF59, our novel vaccines using this model.
where induction of a diverse immunomodulatory cytokine profile was
observed in Southern African volunteers. Work on elucidating the dif- OA18.05LB
ferential effect of these two adjuvants on the types of innate immune
Multivalent antigen presentation increases the antibody
cell responses in humans continues.
binding breadth and neutralizing potency upon the
immunization with a self-assembling HIV env vaccine
OA18.04 J.-L. Chen1; C. Fries2; M. Dennis3; J. Eudailey3; A. Moody3; S. Permar3;
Heterologous prime boost immunisations with improved J. Collier2 and G. Fouda3
DNA, MVA and protein HIV-1 subtype C vaccines elicit Tier 1
Duke University, Molecular Genetics and Microbiology, Durham, Uni-
2 neutralising antibodies in a Chinese rhesus monkey model ted States, 2Duke University, Biomedical Engineering, Durham, United
R. Chapman1; C. Adams1; A. Keyser1; M. van Diepen1; N. Douglass1; States, 3Duke University, Duke Human Vaccine Institute, Durham, Uni-
L. Morris2; P. Moore2; A.-L. Williamson1 and G. Chege3 ted States
1
University of Cape Town, Pathology, Cape Town, South Africa,
2
National Institute for Communicable Diseases, Centre for HIV and
STIs, Johannesburg, South Africa, 3South African Medical Research Background: Although previous studies have demonstrated that anti-
Council, Primate Unit and Delft Animal Centre, Cape Town, South gen valency is important to diversify the B cell repertoire, the ability
Africa of multivalent HIV vaccines to increase the breadth of vaccine-elicited
antibodies and to promote neutralization remain unclear. Herein, we
utilized a novel nanomaterial platform (Q11) to evaluate the influence
Background: We previously reported establishment of a simian-human of antigen valency on the HIV vaccine-elicited antibody responses.
immunodeficiency virus (SHIV) challenge model using Chinese-origin Methods: Self-assembly of the fiber-like nanoscale structure of Q11
rhesus macaques (ChRM) for testing the efficacy of HIV vaccines was triggered by increasing the solvent ionic strength, followed by
in South Africa. In the current study, we sought to establish proof of conjugation of HIV Envelope gycoprotein120 of clade C strains. We
concept using a vaccine regimen that had elicited autologous Tier 2 constructed vaccines with distinct valency by changing the concentra-
neutralising antibodies (NAbs) in rabbits. tion of antigen in the conjugation. Mice and rabbits were immunized
Methods: The Env glycoprotein consensus sequence of the ChRM- with 15 lg of gp120 or Q11-conjugated gp120 vaccine (gp120-Q11)
adapted SHIV was determined and utilised in the vaccines designed in along with a TLR7/8 and 9 agonist adjuvant STR8SC. A bead-based
this study. DNA and MVA vaccines expressing SIV Gag and HIV Env multiplex assay was used to measure antibody binding to heterologous
antigens were constructed and in vitro expression confirmed. A soluble Envs of subtypes B, C, and CRF_AE, and the TZM-bl cell assay was
gp140 protein was expressed from a stable HEK293 cell line and used to measure neutralization.
purified using lectin affinity chromatography and gel filtration. Six Results: Mice immunized with gp120-Q11 demonstrated higher anti-
ChRM were inoculated with two DNA, followed by two MVA and body titers against the autologous Env (p =0.027) after three immu-
finally two protein vaccinations on weeks 0, 4, 8, 12, 20 and 28. Vac- nizations; and higher binding to the 4 heterologous Env after each
cine-induced T cell immunity was measured by IFN-c ELISPOT using immunization than mice immunized with gp120 (Figure 1). The
peptide pools derived from SIV Gag and subtype C consensus Env increased magnitude and breadth were only observed in mice immu-
while the NAbs were evaluated against Tier 1A (MW965.26), Tier 1B nized gp120-Q11 with 3 to 4 antigens on each fiber but not with
(6644.v2.c33) and Tier 2 (ZM109.B4) pseudovirions. The macaques gp120-Q11 with lower valency, suggesting that multivalent antigen
were then challenged weekly from week 32 until they became presentation on Q11 contributed to the enhanced response.
45
Immunization of rabbits indicated that Q11-gp120 also induced higher

neutralization titer against the autologous tier 1 virus than gp120 (p OA19.02
=0.0285). Construction of a comprehensive bacterial genome
Conclusions: We demonstrated that increasing the antigen valency catalogue for the female genital tract identifies hundreds of
by Q11 conjugation enhanced the humoral response in two distinct new species
animal models, showing the potential of such nanomaterial in vaccine M. Hayward1; S. Bloom1; M. France2; N. Mafunda1; J. Xu1; J. Rice1;
delivery. As a more clinically relevant model is required to further M. Ghebermichael3; J. Marrazzo4; C. Mitchell5; J. Ravel2;
assess this platform, we plan to conjugate SOSIP trimer to Q11 and C. Huttenhower6 and D. Kwon1
assess its immunogenicity in non-human primates. 1
Ragon Institute of MGH, MIT and Harvard, Kwon Lab, Boston, Uni-
ted States, 2Institute for Genome Science, University of Maryland
OA19.01 School of Medicine, United States, 3Ragon Institute of MGH, MIT and
Impact of LACTIN-V (Lactobacillus crispatus CTV-05) on Harvard, Boston, United States, 4University of Alabama at Birming-
genital immunology following standard bacterial vaginosis ham, Division of Infectious Diseases, United States, 5Massachusetts
General Hospital, Obstetrics and Gynecology, United States, 6Harvard
treatment: Results from a randomized placebo-controlled
TH Chan School of Public Health, Boston, United States
trial
E. Armstrong1; A. Hemmerling2; S. Miller3; K. Burke4; S. Newmann2;
S. Morris5; H. Reno6; S. Huibner7; C.R. Cohen2 and R. Kaul1,7,8 Background: Specific cervicovaginal bacteria are associated with ele-
1
University of Toronto, Institute of Medical Science, Toronto, Canada, vated inflammation in the female genital tract (FGT) and a number of
2
University of California San Francisco, Department of Obstetrics, poor reproductive outcomes, including HIV acquisition. These associa-
Gynecology, & Reproductive Sciences, San Francisco, United States, tions have been identified using bacterial 16S rRNA gene sequencing,
3
University of California, San Francisco, Department of Laboratory which has limited resolution and often fails to achieve species-level
Medicine, United States, 4Ruth M. Rothstein CORE Centre and Stro- taxonomic assignment. Genome sequencing of bacteria affords strain-
ger Hospital of Cook County Health, Chicago, United States, 5Univer- level resolution, revealing that many species contain enough genes to
sity of California San Diego, Department of Family Medicine and make multiple independent genomes, reflecting a tremendous amount
Public Health, San Diego, United States, 6Washington University, Divi- of diversity in potential phenotypes (virulence factors, antibiotic resis-
sion of Infectious Diseases, St. Louis, United States, 7University of tance, metabolic function, etc.). Few studies have used these methods
Toronto, Department of Medicine, Toronto, Canada, 8University to characterize the FGT microbiome, leaving much of the microbial
Health Network, Toronto General Hospital, Immunodeficiency Clinic, diversity unexplored.
Toronto, Canada Methods: We isolated 1400 bacteria using selective media and per-
formed whole genome sequencing, applying cutting-edge methods for
combining these data with assembled microbial genomes from over
Background: Bacterial vaginosis (BV) is associated with genital inflam- 1200 newly shotgun sequenced metagenomes from multiple geo-
mation and enhanced HIV risk. In contrast, a vaginal microbiome pre- graphic locations, to produce a comprehensive genome catalogue.
dominated by Lactobacillus crispatus is associated with lower Imposing species-level phylogenetic clustering on the resulting gen-
proinflammatory cytokine levels and reduced HIV risk. We investi- omes allowed us to identify both known and previously unknown spe-
gated the genital immune impact of a L. crispatus-based live biothera- cies. Mapping of shotgun metagenomic reads to these genomes
peutic (LACTIN-V), which was recently demonstrated to reduce BV allowed us to determine prevalence and amount of genetic diversity
recurrence following standard BV treatment (NCT02766023). accounted for by these new species across multiple demographic fac-
Methods: In this pilot immune study, genital cytokine levels were tors (race, ethnicity, geography, pregnancy and menopause).
assayed for 48 participants who reported near-perfect adherence to Results: We identified 605 species in the female genital tract, 130 of
assigned treatment during the phase 2b randomized double-blind pla- which have not been previously described. Of these, 46 were only
cebo-controlled trial of LACTIN-V to prevent BV recurrence. All par- found in samples from African American and African women. Many of
ticipants received topical metronidazole for 5-days and were then these new species were highly prevalent and co-occurred with known
randomized 2:1 to LACTIN-V or matched placebo for 11 weeks. Vagi- and previously unknown species in community assemblages. Further-
nal swabs were collected before and after metronidazole therapy, and more, we significantly increased observable genetic diversity for
then at 4-, 8-, 12-, and 24-weeks. Cytokines were assayed using the known species associated with poor reproductive outcomes. One
MSD multiplex platform. The primary comparison was the impact of notable example is Prevotella bivia, a bacterium associated with
LACTIN-V use on vaginal levels of IL-1a, the prototypic inflammatory increased HIV acquisition risk, was found to be different in both meta-
cytokine elevated during BV. bolic and antibiotic resistance gene content in South African isolates
Results: Vaginal IL-1a levels fell promptly in all participants immedi- when compared to those from North America.
ately following metronidazole treatment (3.319 vs. 2.832; p = 0.0055). Conclusions: We have massively expanded the observable genetic
While this reduction was sustained for at least 24 weeks among par- diversity in the FGT microbiome and identified both new species and
ticipants subsequently receiving LACTIN-V (n = 32), vaginal IL-1a previously unrecognized sub-species structures. This catalogue will
levels rebounded to baseline levels by 24 weeks in the placebo arm contribute to developing novel approaches to modulate the vaginal
(n = 16; t = 2.638, p = 0.012). At 24 weeks, L. crispatus CTV-05 microbiome and reduce poor reproductive outcomes, including HIV
was detected by PCR in 16 participants (50%) in the LACTIN-V arm acquisition risk.
and 0 participants (0%) in the placebo arm (p = 0.001).
Conclusions: Treatment with LACTIN-V following standard antibiotic
treatment of BV not only reduced BV recurrence and increased L.
crispatus CTV-05 colonization, but also resulted in more sustained
reductions in vaginal IL-1alevels. Given the link between genital proin-
flammatory cytokines and female HIV acquisition, LACTIN-V may rep-
resent a novel strategy to reduce HIV risk among women.
46
Background: While there are methods to prevent HIV infection,

OA19.03 there is still a need for a prevention device that is effective, user-con-
Transcriptional analysis of cervical cell populations reveals trolled, easily transported without refrigeration, inexpensive and dis-
inflammatory signatures and differential epithelial creet. Importantly, such a device should be attractive to the user to
keratinization associated with Depo-Provera use avoid the problem of low adherence, particularly among at-risk youth.
E.H. Byrne1; M. Farcasanu2; S. Bloom3; N. Xulu4; J. Xu2; S. Handley5; We have developed the silk fibroin (SF) platform to encapsulate and
J. Bramante2; C. Mitchell6; A.-C. Villani7 and D.S. Kwon2 release a single or combination of HIV inhibitors, including the lectin
1
Ragon Institute, Harvard Medical School, United States, 2Ragon Insti- Griffithsin (Grft), that does not need refrigeration. These small silk
tute, United States, 3Massachusetts General Hospital, Infectious Dis- devices can be inserted vaginally and rectally, and be formulated
ease, United States, 4Ragon Institute, South Africa, 5Washington either for quick-dissolve or sustained release.
University School of Medicine, Pathology and Immunology, United Methods: We have used silk-Grft inserts in female rhesus macaques
States, 6Massachusetts General Hospital, Obstetrics and Gynecology, (n=11), placing them vaginally and rectally. These compartments were
United States, 7Massachusetts General Hospital, Center for Immunol- swabbed to test for amount of Grft released and changes in local
ogy and Inflammatory Diseases, United States microbiome. Tissue biopsies were obtained and tested for protection
against SHIV infection.
To determine the user acceptability of silk inserts, we held four focus
Background: Injectable progestin-only contraceptives (IPCs), including groups in California during summer 2020. These groups were com-
Depo-Provera (DMPA), have been associated with HIV acquisition risk in posed of sexually active women and men, both straight and gay, who
some epidemiological studies and in animal models. This risk has not been were shown a variety of silk fibroin inserts. Participants discussed HIV
consistently observed and the risk of IPCs must be weighed against the prevention knowledge and practices in the context of varying relation-
known benefits of effective contraception. Regardless, understanding how ship statuses, impacts of COVID-19 on their sexual activity, and their
IPCs shape the mucosal environment of the female genital tract can help perceptions of the silk inserts.
elucidate biological mechanisms underlying their potential impact on HIV Results: The Silk-Grft inserts readily dissolved in the vaginal and rec-
acquisition risk and may lead to new HIV prevention strategies. tal compartments in macaques, where Grft levels were substantially
Methods: Cervical cytobrushes were collected from HIV-uninfected above 100-fold IC50, indicating effective release of Grft inhibitor. Tis-
women aged 18 to 23 years through the FRESH (Females Rising sue biopsies from both compartments were fully protected against
through Education, Support, and Health) study in Umlazi, South Africa, ex vivo SHIV infection, with neither inflammation nor change in micro-
and cervical epithelial and CD4+ T cells were FACS-sorted. RNAseq biome.
was performed on the sorted cells and data was analyzed using STAR, In focus groups, young, sexually active adults uniformly expressed posi-
HTSeq, DESeq2, and GSEA. tive sentiments and high interest when presented with silk inserts in
Results: Cervical epithelial cells were compared between women who an array of shapes and colors. These opinions included repeated pref-
reported using DMPA (n = 6) and women in the follicular phase of erence for silk inserts over oral PrEP, due to the utility of silk inserts
the menstrual cycle by reported last menstrual period (n = 6). tSNE as spontaneous protection that did not require daily dosing.
clustering showed clear segregation between groups, and 369 genes Conclusions: Together, these recently obtained results show that silk
were significantly differentially expressed. Of these genes, two of the fibroin is an excellent candidate for formulating HIV inhibitors, being
most highly expressed in DMPA users were CCL3 and CCL3L3, medi- both highly effective in preventing infection and also attractive to
ators of T cell homing. GSEA analysis demonstrated that the epithelial young, sexually active adults, which may lead to higher adherence and
gene sets most significantly over-expressed in DMPA-using women protection.
were keratinization, cellular response to IFNg, and keratinocyte differ-
entiation (FDR q < 0.05). Parallel analysis of cervical CD4+ T cells OA19.05LB
identified 5 significantly differentially expressed genes (fold change
Pharmacokinetic and pharmacodynamic study of tenofovir
>90) and a significantly enriched gene set in DMPA users, “positive
regulation of T cell mediated immunity” (FDR q-val 0.087).
and tenofovir alafenamide for PrEP in foreskin tissue
Conclusions: In DMPA users, cervical epithelial cells express higher levels C. Herrera1; L. Else2; S.D. Penchala3; A.-D.A. Pillay4; T.B. Seiphetlo4;
of the T cell homing cytokines CCL3 and CCL3L3, while cervical CD4+ T L. Lebina5; C. Callebaut6; N. Martinson5; J. Fox7 and S. Khoo2
1
cells exhibit inflammatory gene set enrichment. At the same time, kera- Imperial College London, Department of Infectious Disease, London,
tinization pathways may be altered in DMPA users, as suggested in previ- United Kingdom, 2The University of Liverpool, Department of Molecu-
ous literature. Together, these results suggest possible mechanisms by lar and Clinical Pharmacology, Liverpool, United Kingdom, 3The
which progestins may contribute to genital inflammation and/or differential University of Liverpool, Liverpool, United Kingdom, 4University of
barrier function in the genital mucosa. These findings may point towards Cape Town, Division of Immunology, Cape Town, South Africa,
5
potential biological approaches to reduce HIV acquisition risk in women. University of the Witwatersrand, Perinatal HIV Research Unit, Johan-
nesburg, South Africa, 6Gilead Sciences, Foster City, United States,
7
Guys and St. Thomas’ NHS Foundation Trust and King’s College Lon-
OA19.04LB don, London, United Kingdom
Silk fibroin as a mucosal delivery vehicle for Griffithsin and
antiviral compounds: effective protection of macaques and
high acceptance among user groups Background: Pre-exposure prophylaxis (PrEP) studies have focussed
P. LiWang1; K. Crakes2; C. Herrera3; J. Morgan1; A. Lopez4; M. Palupi predominantly on the efficacy in female reproductive and colorectal
Rasajan4; S. Dandekar2 and N. Burke4 tracts, with limited research on the efficacy of PrEP candidates in the
1
University of California Merced, Molecular Cell Biology, Merced, Uni- male genital tract. We assessed the ex vivo pharmacological profile of
ted States, 2University of California Davis, Department of Medical Tenofovir (TFV) and Tenofovir alafenamide (TAF) in foreskin tissue to
Microbiology & Immunology, Davis, United States, 3Imperial College, inform the design of the CHAPS oral PrEP trial (NCT03986970).
Department of Medicine, London, United Kingdom, 4University of Cal- Methods: Foreskin specimens were obtained with signed informed
ifornia Merced, Public Health, Merced, United States consent from HIV-negative males who voluntary requested medical
circumcision. Inner mucosal and outer skin were cut in explants and
exposed to serial dilutions of TFV or TAF for one hours prior to addi-
tion of HIV-1BaL at a high (HVT) or a low viral titre (LVT) for two
47
hours. Infection was assessed at different time points during 15 days Conclusions: We have identified a subpopulation of CD8+ T-cells
of culture by measurement of p24 in culture supernatants. TFV, TAF with Tfc-like cytokine profile targeting HIV Pol and Env that corre-
and TFV-diphosphate (TFV-DP) concentrations were measured in tis- lated with pVL and antibody class switching. Further characterization
sue, culture supernatants and dosing and washing solutions using LC- of those Tfc-like cells is needed to confirm their role in natural HIV
MS methods. control.
Results: Dose-response curves were obtained for both drugs against
the two viral titres tested with greater inhibitory potency observed OA20.02
against LVT. Inhibitory equivalency mimicking oral dosing was defined
HIV-resistant dual CD28/4-1BB costimulated CAR T cells
between 1 mg/mL of TFV and 15 lg/mL of TAF against HVT for the
dosing post-ex vivo challenge included in the design of CHAPS trial.
mitigate HIV pathogenesis in humanized mice
Concentrations of TFV-DP in foreskin explants were at least 5 times D. Claiborne1; C. Maldini2; K. Okawa3; T. Chen1; D. Dopkin2; X. Shan2;
higher after ex vivo dosing with TAF vs. TFV. Statistically significant K. Power1; R. Trifonova1; K. Krupp1; M. Phelps1; V. Vrbanac1;
negative linear correlations were observed between explant TFV-DP S. Tanno1; T. Bateson1; G. Leslie2 and J. Hoxie2
1
levels and p24 concentrations following HVT (r2=0.6867, p =0.0001 Ragon Institute of MGH, MIT and Harvard, Massachusetts General
for TFV and r2=0.6696, p =0.0002 for TAF). Hospital, Boston, United States, 2University of Pennsylvania, Philadel-
Conclusions: Pre-clinical evaluation of TAF reveals greater potency phia, United States, 3Ragon Institute of MGH, MIT and Harvard, Bos-
than TFV against penile HIV transmission. Ex vivo dose-challenge stud- ton, United States
ies in human foreskin explants can be used as surrogate for in vivo
studies to compare doses and preventive agents to be included in clin-
Background: A potent and sustained T cell response will likely be a
ical trials.
requisite component of an effective HIV cure. Chimeric antigen recep-
tor (CAR) T cells, whereby autologous T cells are engineered with
OA20.01 specific antigen-targeting and functional attributes, have been effec-
Alternative T cell effector functions are linked to humoral tively employed against a number of chemotherapy-refractive cancers.
responses to HIV infection However, a highly effective CAR T cell against HIV has yet to be
L. Romero-Martin1; M.L. Rodriguez de la Concepcio n2; J. Carrillo2; developed, which could represent a powerful approach to target the
J. Blanco ; B. Mothe ; M. Ruiz-Riol ; C. Brander and A. Olvera2
2 3 2 2 HIV reservoir.
1
Institut de Recerca de la Sida (IrsiCaixa), Hospital Universitari German Methods: Bone marrow, liver, thymus (BLT) humanized mice were
Trias I Pujol, T Cell Immunity and Vaccinology, Barcelona, Spain, 2Institut used to iteratively test CAR T cell efficacy against both acute and dis-
de Recerca de la Sida (IrsiCaixa), Hospital Universitari German Trias I seminated HIV infection. A CD4 ectodomain-expressing CAR was used
Pujol, Barcelona, Spain, 3Fundacio Lluita contra la Sida, Infectous Dis- to target HIV Env-expressing cells. We compared CAR T cells express-
eases Department, Hospital Universitari Germans Trias i Pujol, Spain ing the 4-1BB and CD28 co-stimulatory domains either individually, in
a tandem “3rd generation” construct, or as a novel Dual CAR T cell
simultaneously expressing independent 4-1BB and CD28 co-stimulated
Background: T cell populations showing a particular cytokine polar- CARs. A CXCR4-C34 fusion inhibitor was co-expressed to protect
ization may have a key role in inducing and maintaining effective cellu- CAR T cells from HIV infection.
lar and humoral immunity to HIV. In addition to the commonly Results: HIV-specific CAR T cells expressing 4-1BB or CD28 costimu-
assessed Th1 and CTL responses, other T cell profiles involved in the latory domains exhibited either enhanced proliferation and survival or
immune response to HIV infection are not well characterized and enhanced effector function respectively, and the 3rd generation tan-
their contribution to virus control remains unknown. dem construct took on the phenotype of the CD28 membrane proxi-
Methods: Cryopreserved PBMCs from HIV-1 controllers (n = 15, mal domain; all constructs had negligible impact on HIV pathogenesis
median plasma HIV-1 RNA, pVL: 210 copies/mL, median CD4+ T-cell in vivo. In contrast, Dual CAR T cells simultaneously expressing inde-
count: 786 cells/mm3) and non-controllers (n = 15, median pVL: pendent 4-1BB and CD28 costimulated CARs exhibited the prolifera-
52,435 copies/mL, median CD4+ T-cell count: 406 cells/mm3) were tion and survival of 4-1BB and the effector function of CD28 and
stimulated with 17 peptide pools covering the entire HIV proteome. prevented HIV-induced CD4+ T cell loss despite persistent viremia.
Effector function profiles of virus-specific T-cells were evaluated by Importantly, protection of the Dual CAR T cells from HIV infection
“boosted flow cytometry”; a novel methodology based on labeling through expression of the C34-CXCR4 fusion inhibitor significantly
cytokines that characterize specific T cell profiles with the same fluo- increased their efficacy resulting in reductions in acute phase viremia,
rochrome (Th1/Tc1: INFg, IL-2, TNFa; Th2/Tc2: IL-4, IL-5, IL-13; accelerated viral suppression in combination with ART, and reduced
Th17/Tc17: IL-17A, IL-22; Treg: IL-10, TGFb and Tfh/Tfc: IL-4, IL-21). viral burden in lymphoid tissues.
We also evaluated the humoral response to HIV (IgM, IgA and IgG) to Conclusions: These data describe a novel CD4-based Dual CAR
identify T-cell profile associated with humoral response. Finally, cellu- approach, harnessing the favorable attributes of both 4-1BB and
lar and humoral responses correlated with respective clinical parame- CD28 costimulation. When protected from HIV infection, these Dual
ters (pVL, CD4 count). CAR T cells were capable of mitigating HIV pathogenesis in the con-
Results: The total magnitudes of HIV-specific CD4+ Tfh and CD8+ text of a robust and fully disseminated HIV infection in vivo, while
responses with a Tc2 or Tfc profiles were significantly higher in HIV reducing tissue viral burden, a goal of HIV cure strategies.
controllers. Total Tfh/Tfc (CD4+ and CD8+) responses correlated nega-
tively with pVL. Different polarization profiles were observed for
responses targeting different HIV proteins, and overall a broader range
of alternative effector functions were seen in cells from HIV controllers
(Rev/Vpr/Env-specific Tc2, Pol/Env-specific Tfc and Pol-specific Tfh
responses). HIV controllers also showed higher IgG responses to HIV-
gp120 while their virus-specific IgM antibodies titers were lower than
in HIV non-controllers. IgM titers correlated positively with pVL and
negatively with HIV Tfc-specific responses. The frequency of Tfc cells
correlated with the gp120-IgG/IgM ratio, supporting a possibly pivotal
role of those in HIV control and antibody isotype switching.
48
transmission being CD4+ T cells. HIV target cells can be divided into
OA20.03 subsets based on several criteria including their memory status. Little
Immune perturbation is more profound in newborn than in attention has been paid to a relatively new subset of tissue-resident
infant macaques during acute SHIV infection memory cells (TRM) in the FGT, including their relative frequency and
N. Haigwood1; M. Shapiro2; T. Cheever1; S. Pandey1; E. Mahyari3; ability to regulate the genital tract milieu and HIV infection risk.
K. Onwuzu3; J. Reed4; H. Sidener5; J. Smedley1; L. Colgin5; A. Lewis5; Methods: We enrolled reproductive-aged women from gynecological
A. Johnson5; B. Bimber3; J. Sacha1 and A. Hessell1 clinics in Winnipeg, Canada. Specimen collection included vaginal swabs,
1
Oregon Health & Science University, Pathobiology & Immunology, SoftCupTM samples, endocervical cytobrushes, and ectocervical biop-
ONPRC, Beaverton, United States, 2Oregon Health & Science Univer- sies. Immune cells collected from the latter two specimen types were
sity, Molecular Microbiology & Immunology, Beaverton, United States, analyzed by flow cytometry and sorted for single-cell RNA sequencing
3
Oregon Health & Science University, Genetics, ONPRC, Beaverton, using the 10x genomics chromium system. Sociodemographic, behav-
United States, 4Oregon Health & Science University, VGTI, Beaverton, ioral and clinical data were collected using a standard questionnaire.
United States, 5Oregon Health & Science University, Comparative This abstract includes pilot results from an ongoing analysis.
Medicine, ONPRC, Portland, United States Results: We analyzed samples from 5 women by flow cytometry
included a subset that was sorted (CD45+) for single-cell analyses.
TRM (defined as live CD3+ CD4+ CD69+ CD103+ cells) were ~4
Background: Progress in preventing vertical HIV-1 transmission has times more frequent [Mean (SD)] in ectocervical biopsies [12.14
stalled, with 160,000 infants infected annually. Newborns and infants (7.78)] compared to endocervical cytobrushes [3.67 (3.41)], p = 0.098.
exhibit higher viral loads and more rapid disease progression than adults Phenotypically, Treg (CD25+ CD127low FoxP3+) were enriched by
and older children, with the lowest survival rates in those infected as ~3fold in the CD103-CD69+ T cell subset compared to CD103+
newborns. While immunologic immaturity likely promotes pathogenesis CD69+ TRM, while Th17 (CCR6+ CD161+) frequencies were similar
and poor viral control, little is known about immune damage in infants. between subsets. To date, all biopsies contained sufficient cells for
Neonatal immunity is distinct from that of adults in ways that are pre- capturing ~6000 CD45+ cells for single-cell RNA sequencing.
sumed to hinder newborns’ ability to control viral infection. Conclusions: CD4+ TRM were more commonly isolated in the ecto-
Methods: Here we examined virologic and immunologic outcomes in cervical tissue compared to from endocervical cytobrush samples, pos-
rhesus macaques exposed to SHIVSF162P3 at one to two weeks or four sibly because the latter sample type is from columnar vs stratified
months of age. To answer this question, we compared virologic out- squamous epithelium, and/or because it represents a superficial collec-
comes, adaptive immune responses, frequencies and phenotypes of tion method. In depth characterization of the phenotype and function
key leukocyte subsets, and transcriptome profiles during pathogenic of CD4+ TRM from cervicovaginal tissue could have important impli-
SHIV infection in Newborn (one to two weeks old) and Infant (15 to cations for understanding microbiota interactions, genital inflammation,
16 weeks old) rhesus macaques that were lacking the two major and HIV risk in women.
MHC-I alleles for post-acute viral control.
Results: Although differences in plasma viremia and seeded reser-
voirs during acute infection were minimal, we observed age-dependent
OA20.05
alterations in leukocyte subsets and gene expression. Compared with
HIV-1 infection and the control of viral replication are
infants, newborns had stronger skewing of monocytes and CD8+ T associated with greater expression of interleukin-21
cells toward differentiated subsets and little evidence of type I inter- receptor on CD8+ T cells
feron responses by transcriptomic analysis. Infants had evidence of a J. Dalel; U.S. Kuong; P. Hayes; L. Black; S. Joseph; D. F. King;
robust antiviral program mediated by type I IFN responses. In con- J. Makinde and J. Gilmour
trast, newborns had a transcriptional signature dominated by the Imperial College London, Human Immunology Laboratory, London,
downregulation of genes involved in mitotic, cell cycle, and activation United Kingdom
processes; the near-absence of a viral infection response; and upregu-
lation of CXCL10, a biomarker of greater disease severity.
Conclusions: Taken together, our findings suggest a role for defective Background: Interleukin-21 plays an important role in the develop-
innate defenses and elevated immune activation in age-dependent differ- ment of the immune response where it has been linked with the gen-
ences in pathogenesis. We conclude that SHIV, like HIV-1, wreaks greater eration of virus-specific memory CD8+ T-cells, limiting exhaustion and
havoc in newborns than in infants infected at older ages, reinforcing the promoting effector function during viral infection. However, little is
validity of this model for understanding mechanisms of pathogenesis in known about the expression of interleukin-21R (IL-21R) during HIV-1
vertically acquired HIV infection. Ultimately, therapeutic intervention as infection or its role in HIV-1 specific CD8+ T cell maintenance and
early as possible after birth is more likely to have a durable effect on dis- subsequent viral control.
ease progression by limiting damage to the immune system. Methods: We compared IL-21R expression on total and memory sub-
sets of CD8+ T-cells from HIV-1 positive and HIV negative donors.
We also measured IL-21R on antigen specific CD8+ T cells in volun-
OA20.04 teers who were positive for HIV-1 and had CMV responding T cells.
Tissue-resident memory CD4+ T cells in ectocervical versus Results: IL-21R expression was significantly higher on CD8+ T cells (p
endocervical specimens = 0.0050), and on naive (p =0.0003), central memory (p =0.0008) and
A. Ssemaganda1; K. Nyambura2; F. Mulhall3; F. Nuhu1; N. Jahan1; effector memory (p =0.0105) CD8+ T cell subsets from HIV-1+ve indi-
K. Downing3; B. Sandberg3; H. Elands3; R. Groff3; A. Altman3; viduals relative to HIV-1-ve individuals. For those infected with HIV-1,
C. Robinson3; V. Poliquin3; J. Arsenio2 and L.R. McKinnon1 the levels of IL-21R expression on HIV-1-specific CD8+ T cells corre-
1
University of Manitoba, Department of Medical Microbiology and lated significantly with visit viral load (r= 0.8571, p = 0.0238, n=7).
Infectious Diseases, Winnipeg, Canada, 2University of Manitoba, Lastly, CD8+ T cells from individuals with lower set point viral loads and
Departments of Internal Medicine and Immunology, Winnipeg, Canada, demonstrated viral control had the lowest levels of IL-21R expression.
3
Health Sciences Winnipeg, Winnipeg, Canada Conclusions: Our data demonstrates significant associations between
IL-21R expression on peripheral CD8+ T cells and viral load and dis-
ease trajectory. This suggests that the IL-21 receptor could be a novel
Background: HIV susceptibility is likely determined in women at the marker of CD8+ T cell dysfunction during HIV-1 infection.
female genital tract (FGT), with initial targets of the virus during
49
OA21.01 Background: In Peru, considerable gaps remain in achieving the goal

of the HIV cascade, undetectable viral load. Services provided by navi-
Effect of navigation services to achieve viral suppression
gators to facilitate linkage and retention in HIV-care have proven suc-
among men who have sex with men (MSM) and
cessful; however, their utility has rarely been studied in Latin America,
transwomen living with HIV who attend public HIV care nor specifically among MSM/Transwomen (TW). We studied if naviga-
services in Lima, Peru tion services delivered by peer navigators can facilitate MSM/TW
G. Calvo1; K.A. Konda1; C.F. Caceres1; X. Salazar Lostanau1; HIV-care engagement in Lima.
A. Silva-Santisteban1; A. Maiorana2 and S.M. Kegeles2 Methods: As part of the Orgullo+ intervention, four peer counselors
1
Universidad Peruana Cayetano Heredia, Center for Interdisciplinary living with HIV already working in the intervention area were trained
Research in Sexuality, AIDS and Society, Peru, 2University of California as navigators to use strengths-based counseling. MSM/TW living with
San Francisco, Center for AIDS Prevention Studies, United States HIV attending public health services in this area were assigned to a
navigator. Navigators worked with the MSM/TW to help them link or
reengage in HIV-care, while the comparison area’s cohort at other
50
health facilities received standard services. We collected health care men although this difference was not statistically significant
data from these cohorts of MSM/TW to estimate the effect of naviga- (aOR = 0.72, p = 0.08).
tors on achieving undetectable viral load using multivariable Cox Conclusions: Methadone use was strongly associated with reported
regression. ART use amongst PWID in Kenya. Women were significantly less likely
Results: We enrolled, 364 MSM/TW, 192 were assigned a navigator. than men to take methadone and were also less likely to be taking
Individuals with a navigator included more TW, more reporting diffi- ART. These findings can guide policies and practices for targeted
culties in linkage-to-care and in attending their appointments, all methadone support programs in Kenya.
(p < 0.001). At the endline, 79% of MSM/TW with a navigator had an
undetectable viral load compared to 67% of MSM/TW without a navi- OA21.03
gator (p = 0.008). In multivariable model, MSM/TW with a navigator
Using an HIV risk assessment tool to increase frequency of
achieved viral suppression 79% faster than MSM/TW without
(p < 0.001) and those reporting difficulties in attending their appoint-
HIV testing in men who have sex with men in Beijing,
ments achieved undetectable viral load 35% later than those without China: an app-based randomized, controlled trial
difficulties. No significant differences in achieving undetectable viral Q. Luo1; Z. Wu2 and G. Mi2
1
load were found by population group, age, linkage-to-care difficulties Binzhou Medical University, School of Nursing, Yantai, China, 2China
or time to linkage-to-care (all p > 0.05). Center for Disease Control and Prevention, Beijing, China
Conclusions: Working with a navigator helped MSM/TW achieve an
undetectable viral load in a shorter time compared to those who
received standard services. Our study suggests that receiving naviga- Background: Low risk perception hinders human immunodeficiency
tion services can help to successfully engage and retain MSM/TW in virus (HIV) testing among men who have sex with men (MSM). We
HIV-care. aimed to promote HIV testing uptake and reduce sexual risk behaviors
through a social networking application-based intervention.
Methods: This was a randomized control trial conducted from Octo-
OA21.02 ber 2017- September 2018 among MSM in Beijing, China. Partici-
Methadone program participation and current ART use pants were randomly assigned into three groups: Group 1, Group 2,
among people who inject drugs in Kenya and Control received routine, comprehensive HIV education. In addi-
L. Mbogo1; A. Monroe-Wise2; B. Sambai1; B. Guthrie2; D. Bukusi3; tion, Group 1 took an HIV risk assessment tool and received tailored
W. Sinkele4; P. Macharia5; N. Ludwig6; J. Herbeck6; M. Dunbar6; feedback based on their risk assessment score, while Group 2 took
E. Gitau4; C. Farquhar2; H. Musyoki5 and S. Masyuko5 the HIV risk assessment only. The number of HIV tests over twelve-
1
University of Washington/KNH, HIV Testing and Counselling, Kenya, month study period was assessed using an intention to treat analysis,
2
University of Washington, Global Health, Seattle, United States, and the proportion of self-reported unprotected anal intercourse
3
Kenyatta National Hospital, HIV Testing and Counselling, Kenya, (UAI) over the six-month period after randomization was assessed by
4
SAPTA, Kenya, 5NASCOP, Nairobi, Kenya, 6University of Washington, modified intention-to-treat analysis.
Seattle, United States Results: 9280 MSM were recruited and randomly assigned into
Group 1 (n = 3028), Group 2 (n = 3065), or the Control group
(n = 3187). Over the twelve-month study period, Group 1 took 391
Background: In Kenya HIV prevalence among people who inject tests (mean 2.51 tests/person), Group 2 took 352 tests (mean 2.01
drugs (PWID) is estimated at 18% versus 5.6% in general population. tests/person), and the Control group took 295 tests (mean 1.72 tests/
To reduce opioid addiction and HIV risk, methadone was introduced person). Participants in Group 1 had an increased mean number of
in Nairobi and Kenya’s coastal region in 2013. Studies in high-income HIV tests within twelve months compared to the Control group (IRR:
countries have shown that methadone is associated with antiretroviral 1.32, [95% CI: 1.09–4.58, p = 0.01]). The proportion of UAI was not
therapy (ART) uptake, however, it is not known whether participation statistically different among the three groups.
in a methadone program is associated with increased ART use among Conclusions: Implementing repeated HIV risk assessments coupled
PWID in Kenya. with tailored prevention messaging, particularly using an app-based
Methods: Participants were recruited from an ongoing study of tool, could be incorporated into routine HIV prevention to promote
Assisted Partner Services (APS) to identify, test and link to care the HIV testing among MSM in China.
sexual and injecting partners of HIV-positive PWID in Kenya. Recruit-
ment for index participants was done from NSP programs and metha-
done clinics in Nairobi, Kilifi and Mombasa countie where they were
OA21.04
receiving HIV care. In this study we interviewed all HIV-positive index
Peer-distributed HIV self-test kits to increase demand for
participants who had injected drugs in the last one year about linkage HIV prevention and care services in rural KwaZulu-Natal,
to care, ART uptake, methadone use and current injecting practices. South Africa: a three-armed cluster-randomised trial
We used logistic regression to evaluate associations between metha- comparing social-networks versus direct delivery
done program participation and current ART use, adjusting for demo- M. Shahmanesh1; N. Mthiyane2; C. Herbst2; O. Adeagbo2;
graphic and behavioral characteristics. M. Neuman3; P. Mee3; J. Dreyer2; N. Chimbindi2; T. Smit2;
Results: A total of 668 HIV-positive index participants were enrolled. N. Okesola2; T. Zuma2; G. Harling1; N. McGrath4; J. Seeley3 and
Of these, 138 (21%) were on methadone and 527 (79%) reported F.M. Cowan5
they were taking ART. The majority of participants were male (52%) 1
University College London, Institute for Global Health, United King-
and median age was 36 years (IQR 31 to 42). Of 138 currently dom, 2Africa Health Research Institute, Durban, South Africa, 3London
enrolled in methadone programs, 128 (93%) were on ART compared School of Hygiene and Tropical Medicine, London, United Kingdom,
to 399 (75%) of the remaining 530 not taking methadone. After 4
University of Southampton, Southampton, United Kingdom, 5Liver-
adjusting for age, sex, marital status, and living conditions, those on pool School of Tropical Medicine, Zimbabwe
ART were over 4 times more likely to take methadone (adjusted Odds
Ratio [aOR] = 4.21, p < 0.001). Of 346 men 89 (26%) were on
methadone compared with 49 (15%) of 322 women (aOR = 0.45, Background: HIV elimination in South Africa calls for innovative
p < 0.001). Women were also less likely to be on ART compared to approaches. We investigated HIV self-testing (HIVST) for increasing
demand for HIV care and prevention services, comparing two peer-
51
distribution approaches (direct distribution and an incentivized social- coding (reviewed to ensure intercoder reliability) and analysis using
network approach) against peer-navigators providing information and NVivo 12.
referrals only. Results: We interviewed 25 postpartum women with high PrEP
Methods: Restricted randomisation (1:1:1) allocated 24 peer-navigator adherence who were on PrEP for a median of nine-months, median
pairs in rural Kwa-Zulu Natal into: (1) incentivized-peer-networks age 26-years, and median baseline gestational age 24-weeks. Themes
(IPN): peer-navigators recruited “seeds” to distribute 5 packs to 18 to identified as key drivers of optimal PrEP use were HIV risk perception
30 year olds within their social networks. Packs contained 2 HIVST – primarily due to partner’s perceived risky sexual behaviors and
kits (OraQuick) and standard of care (SOC) materials. “Seeds” received unknown serosatus and a strong desire to have a baby free of HIV.
20 Rand (US$1.5) for each recipient who went on to distribute packs Reported disclosure of PrEP use to family, partners and friends facili-
themselves; (2) peer-navigator-distribution (PND): peer-navigators tated PrEP adherence. Women continued PrEP postpartum because
distributed HIVST packs and SOC materials directly; (3) SOC: peer- they felt empowered by PrEP and did not want to “go backwards” and
navigators distributed barcoded clinic referral slips and sexual health increase their HIV risk as before PrEP. Women who reported high
information promoting HIV testing, pre-exposure prophylaxis (PrEP) adherence all discussed having community support and reminders to
and antiretroviral therapy (ART). PrEP/ART linkage rates were defined take PrEP on time. The primary barriers were anticipated or experi-
as numbers screened for PrEP eligibility or starting ART within enced stigma, which most overcame through education of partners/
90 days of referral slip distribution per peer-navigator outreach family about PrEP. Pregnant women experienced transient side effects,
month (pnm). The primary outcome compared PrEP/ART linkage rates but found ways to continue, including taking PrEP at night. Women
between arms for women aged 18 to 24 years. Secondary outcomes believed PrEP education and counselling were accessible when inte-
included linkage rates for youth (18 to 30 years). Intention to treat grated into antenatal care which contributed to high PrEP adherence.
analysis was used. Investigators and statisticans were blinded to allo- Conclusions: Facilitators of optimal PrEP use through pregnancy and
cation. postpartum included fear of HIV acquisition for self and infant, mostly
Results: Between March and December 2019, 7563 (2055 IPN, due to partner sexual behaviors and unknown serostatus, along with
2069 PND, 2539 SOC) packs were distributed during 144 peer-navi- PrEP disclosure, and encouragement from partners and family. PrEP
gator outreach months, with 272 young adults linked to PrEP/ART programs for pregnant and postpartum women should integrate
(1.9/pnm). Linkage rates for women aged 18 to 24 years were lower strategies to assist women with realistic appraisals of risk and teach
for IPN (n = 26, 0.54/pnm) than PND (n = 45, 0.80/pnm) and SOC skills for securing support for significant others.
n = 49, 0.85/pnm), although not significantly so (rate ratios [RR] 0.68,
95% CI 0.28 to 1.66 and 0.64, 95% CI 0.38 to 2.36, respectively). OA22.01
Adding HIVST kits to peer-navigator distribution (PND vs SOC) did
R5 tropic HIV-1 is preferentially translocated of across
not change linkage rates (RR 0.95, 95% CI 0.38 to 2.36). Youth (18 to
30 years), results were similar but with stronger evidence of lower
genital mucosa while X4 tropic HIV-1 is selectively
linkage rates (0.88/pnm) for IPN than PND (2.11/pnm, RR 0.42, 95% sequestered in genital epithelial cells and activates type I
CI 0.18 to 0.98) and SOC (2.07/pnm, RR 0.42 95% CI 0.18 to 1.02). IFN signaling
Conclusions: Peer-based HIVST distribution reached large numbers A. Nazli1; M.A. Zahoor2 and C. Kaushic1
1
of young men and women, but did not increase demand for PrEP/ART, McMaster University, Department of Pathology and Molecular Medi-
unless combined with peer-navigator PrEP/ART promotion. Incen- cine, Hamilton, Canada, 2University Health Network (UHN), 3Toronto
tivized peer network models resulted in fewer linkages compared to Center for Liver Disease (TCLD), Toronto, Canada
direct peer-navigator mobilization with or without HIVSTs.
Registration: NCT03751826.
Background: Women constitute more than 50% of the population
currently living with human immunodeficiency virus (HIV-1) worldwide.
OA21.05LB Majority of HIV-1 transmission occurs in women through heterosexual
Partners support, disclosure and side effects: facilitators of intercourse. Although both CCR5-tropic (R5) and CXCR4-tropic (X4)
high maternal PrEP adherence in Cape Town, South Africa HIV-1 strains are present in semen, transmission occurs predomi-
D. Joseph Davey1; L. Knight2; K. Dovel3; N. Tsawe4; N. Mashele4; nantly through R5 HIV-1. The mechanism underlying this preferential
J. Markt-Maloney1; Y. Gomba4; P. Gorbach1; L.-G. Bekker5; T. Coates3; selection of R5 HIV-1 is incompletely understood. In the female geni-
L. Myer4 and PrEP-PP study tal tract, HIV-1 has to first cross the epithelial barrier lining before it
1
University of California Los Angeles, Epidemiology, Los Angeles, Uni- can infect target cells. We hypothesized that interactions between X4
ted States, 2University of Cape Town School of Public Health and and R5 strains of HIV-1 and genital epithelial cells (GECs) may be
Family Medicine, Cape Town, South Africa, 3UCLA, Medicine, Los responsible for preferential selection of R5 strains for mucosal trans-
Angeles, United States, 4University of Cape Town School of Public mission.
Health and Family Medicine, Division of Epidemiology and Biostatis- Methods: Viral translocation was studied by adding HIV-1 strains on
tics, Cape Town, South Africa, 5Desmond Tutu Health Foundation, apical side of confluent polarized GEC monolayers and translocated
Cape Town, South Africa virus was detected in basolateral supernatant by P24 ELISA and
TZMbl indicator cell line. Presence of coreceptors and interferon stim-
ulated gene expression (ISGs) were detected by qPCR. Type I IFN pro-
Background: HIV incidence is high during pregnancy and postpartum duction was measured by ELISA.
in many settings. PrEP is safe and effective but requires adherence Results: When X4 and R5 HIV-1 were added to GEC monolayers, X4
during potential HIV exposure, yet the facilitators of high maternal HIV-1 was selectively sequestered in endosomal compartment in
adherence are not well understood in high HIV burden settings. GECs, while majority of R5 virus was translocated through the cells to
Methods: We conducted semi-structured interviews with women the basolateral side. To determine if the uptake of HIV was differen-
who reported high adherence (PrEP use ≥25 days in last 30-days) tially mediated through co-receptors expression, CXCR4 and CCR5
within a PrEP service for pregnant and postpartum women located in expression was determined before and after HIV-1 exposure. Both co-
a large primary care facility in a high-HIV burden township. Topics for receptors were expressed on GECs but while both HIV-1 strains
interviews included: individual and interpersonal risk, disclosure, antici- upregulated expression of CXCR4 co-receptor, CCR5 co-receptor
pated PrEP stigma, safety, side-effects, and facility-level factors effect- expression was downregulated by both X4 and R5 HIV-1. Our previ-
ing adherence. A thematic approach guided an iterative process of ous studies have demonstrated that Type I IFN is induced in GECs
52
through a TLR-2 dependent mechanism following HIV-1 exposure. studies is warranted given that systemic vaccination induces differing
When we examined the involvement of IFN pathway in differential patterns of immune response between compartments.
selection of HIV-1, we found that X4 HIV-1 induced significantly
higher levels of TLR2, ISGs gene expression and IFN-b production in OA22.03
GECs compared to R5-tropic HIV-1.
Temporal and spatial characterization of SIV infection
Conclusions: Altogether, we found that GECs show a differential
response to X4 vs R5 HIV-1 both in the uptake and transcytosis of
dynamics in rhesus macaque mucosal tissues
the virus and innate immune responses, which could explain the pref- D. Maric; T.J. Hope; M. McRaven; G. Cianci and L. Corbin
erential transmission of R5 over X4 HIV-1 across female genital Northwestern University, Cell and Developmental Biology, Chicago,
mucosa. Better understanding of transmission mechanisms could pro- United States
vide information about prevention strategies.
Background: The objective of this study is to characterize the early
OA22.02 infection events using the wild-type virus at the mucosal sytes. We
Dynamics of mucosal immune responses elicited by hypothesized that as infection progresses the infected cells will be
systemic prime/boost vaccination more heterogeneous due to the recruitment of different immune cell
A. Schuetz1; Y. Phuangngern2; M.A. Eller3; S. Akapirat2; J. Dhitavat4; types to the site of infection. Also we hypothesized to see differences
P. Pitisutthithum4; S. Nitayaphan5; S. Chariyalertsak6; N. Phanuphak7; in infected cell profiles between stratified squamous tissues of anus
C.A. DiazGranados8; J.H. Kim9; M.L. Robb3; N.L. Michael10; and simple columnar epithelia of the rectum.
R.J. O’Connell10 and S. Vasan3 Methods: Twelve female rhesus macaques were challenged rectally
1
MHRP Thailand, Retrovirology, Thailand, 2AFRIMS, Retrovirology, with a mixture of a single round luciferase reporter virus and wild-
Bangkok, Thailand, 3MHRP, Retrovirology, United States, 4Mahidol type SIVmac239. Animals were sacrificed either 48-, 72- or 96 h later.
University, Thailand, 5AFRIMS, Bangkok, Thailand, 6Research Institute Luciferase signal was used to quickly scan large areas of the tissue
for Health Sciences, Thailand, 7SEARCH, Thailand, 8Sanofi Pasteur, and hone in on small regions that likely contain infected cells. Infected
United States, 9International Vaccine Institute, Korea, Republic of, cells were identified microscopically by staining for SIV viral proteins
10
Walter Reed Army Institute of Research, Silver Spring, United and were validated by spectral imaging and nested PCR.
States Results: Comprehensive phenotyping of nearly 2000 SIV infected
cells revealed that the Th17 T cells infection rate does not vary much
over the first 96 h. However, from 48 h to 96 h, there is a pro-
Background: Mucosal surfaces play a critical role in HIV-1 transmis- nounced decrease in immature dendritic cells infection rate and an
sion and disease pathogenesis, hence new vaccine strategies should increase in infection of other T cell subtypes, suggesting immune cell
induce protective mucosal immune responses. Previous studies recruitment to the site of infection. Since anorectal tissues are com-
demonstrated that additional boosting of the 6 months (mo) RV144 posed of two structurally different tissues- squamous epithelia in the
regimen with longer boosting intervals improved/maintained immune anus and columnar epithelia in the rectum, we compared the infected
responses. Here we assessed cellular mucosal responses elicited after cell phenotypes in these tissues. Much like in FRT the infected cells in
the RV144 ALVAC-HIV/AIDSVAX B/E prime/boost intramuscular vac- the anus are mostly T cells (75%) while those in the rectum are
cine regimen followed by additional late boosts (RV306). mostly non-T cells (69%). We are currently in the process of studying
Methods: Sigmoid biopsies were collected two weeks post the 6mo if these two cell types are targeted preferentially or if targeting were
priming regimen and the 15mo and 18mo late boosts with ALVAC- solely a function of relative abundance.
HIV/AIDSVAX B/E. Dynamics of mucosal cell populations and vaccine- Conclusions: We demonstrated that early infection events at the
specific cellular immune responses were assessed by flowcytometry. mucosal sites are very dynamic. While certain cell types are infected
Results: After the late boost at 15/18mo we observed an increase in at the constant rates others increase or decrease as the infection pro-
the frequency of mucosal ß7highCD4+ T cells (21.5%) compared to the gresses. In our future work we hope to paint the full picture of the
6mo boost (11%, p = 0.01). This was accompanied by a decrease of HIV/SIV sexual transmission in time and in space by developing three
ß7highCD4+ T cells in the periphery after the 15/18mo boost to dimensional imaging techniques to visualize the infected cell foci and
3.85% compared to 4.65% post 6mo (p = 0.04). After the 15/18mo immune cell responses.
boost, 100% of vaccine recipients developed mucosal TH023-specific
CD4+ T cell TNFa responses compared to just 30% after 6mo. Corre- OA22.04
spondingly, the magnitude of those responses after 15/18mo
Immune oscillatory nature through menstrual cycle
increased to 0.92% from 0.04% post 6mo (p = 0.009). A similar trend
was observed for mucosal TH023-specific Th17 cells that increased to
regulation drives SHIV susceptibility from vaginal challenge
0.11% after the 15/18mo boost while not being detectable post six A. Kohlmeier1; J. Brody2; A. Sheth3; F. Hardnett4; S. Sharma4;
months (p = 0.04). This is in strong contrast to univariate peripheral I. Ofotokun5; I. Massud4 and G. Garcia-Lerma4
1
CD4+ T cell TNFa responses that peaked post 6mo and were not aug- CDC, DHAP, Atlanta, United States, 2Emory University, Department
mented by late boosting, with no peripheral TH023-specific Th17 of Physics, Atlanta, United States, 3Emory University, Department of
responses detected at any timepoint. We also observed an increase in Medicine, Atlanta, United States, 4CDC, Atlanta, United States,
5
mucosal IgA-producing plasmablasts upon 15/18mo boost to 17.2% Emory University, Atlanta, United States
compared to 8.6% after 6mo (p = 0.04), however no vaccine-specific
IgA was detected in rectal secretions. The frequency of peripheral
plasmablasts and vaccine-specific plasma IgA did not increase after Background: AIDS-related illness is a leading cause of death globally
in women aged 15 to 49. Increased susceptibility to HIV or SHIV
the late boosts.
infection has been proposed to occur during the luteal phase of the
Conclusions: Late boosts with ALVAC-HIV/AIDSVAX B/E induced
menstrual cycle when levels of the immunosuppressive sex-hormone
mucosal CD4+ T cell homing and improved vaccine-specific mucosal
CD4+ T cell responses including the induction of mucosal Th17 cells progesterone are fluctuating. We sought to better define the contribu-
tion of the menstrual cycle to HIV susceptibility through studying lon-
and increase in the frequency of IgA-producing plasmablasts. Detailed
gitudinal immune properties.
characterization of mucosal immune responses in future vaccine
53
Methods: Immune properties were defined throughout the menstrual OA22.05

cycle in 9 pigtail macaques with standard cycles (average length:
The impact of penile-vaginal sex on penile immune
32.8 days). Plasma progesterone and cytokines levels were measured
correlates of HIV susceptibility
by enzyme or bead-based immunoassay. CD38, CCR5, CXCR3, PD-1,
FoxP3, IFNg and TNFa from CD4 T cells in PBMC were measured A. Mohammadi1; S. Bagherichimeh1; Y. Choi2; A. Fazel1; E. Tevlin3;
using fluorochrome-conjugated antibody recognition. Power spectral S. Huibner2; W. Tharao3 and R. Kaul2
1
analysis by Lomb-Scargle algorithms was used to detect molecular University of Toronto, Medicine, Canada, 2University of Toronto,
oscillations in progesterone and CCR5 expression over reproductive Canada, 3Women’s Health In Women’s Hands Community Centre,
cycles. Relationships between SHIV susceptibility and phase of the Toronto, Canada
menstrual cycle were defined in macaques infected during repeated
exposures to low (50TCID50) doses of SHIV162p3. PBMCs from 10
Background: The penis is the primary site of HIV acquisition in
healthy women were used to define inflammatory behaviors during
heterosexual men. The per-act probability of HIV acquisition is
the cycle. Statistical modeling to evaluate pairwise comparisons of
enhanced by the presence of a foreskin, sexually transmitted infec-
means were fit using generalized estimating equations.
tions (STIs) and/or microbiome dysbiosis, with elevated penile inflam-
Results: Menstrual cycle phase was associated with variations in cir-
matory cytokines acting as a common central pathway. However, the
culating adaptive cellular characteristics, including CD4 T cell expres-
impact of sex itself on the penile immune milieu is unknown. We
sion of CCR5, activation-associated molecules PD-1, CD38, and
hypothesized that condomless penile-vaginal sex would transiently
CXCR3, and functional responses defined by IFNg and TNFa. Compre-
increase penile cytokines, with increases being more profound and
hensive innate immune characterizations corroborated T cell variations
sustained in uncircumcised men.
and identified elevated type-1 inflammatory properties predominantly
Methods: To address this hypothesis we recruited 37 STI-free
occurring in the late luteal phase. Using power spectral analysis, we
heterosexual couples to the Sex, Couples and Science Study (SECS),
identified sinusoidal expression patterns of CCR5 that synchronized
an observational prospective study ran from July to November 2018
with reproductive cycles. SHIV163P3 infection in macaques was linked
through the Women’s Health in Women’s Hands Clinic (Toronto,
to challenges during periods of increasing inflammatory properties,
Canada). Approximately half of the male partners were circumcised.
while expression abundance or cycle phase alone was not strongly
Baseline penile swabs, semen samples, cervical secretions and blood
correlated. Analogous fluctuations in T cell inflammatory properties
were collected after a period of abstinence, and 48 hours later cou-
were found in healthy menstruating women.
ples engaged in either condomless (n=30) or condom-protected (n=8)
Conclusions: We demonstrate that periodic shifts in the immune
penile-vaginal sex. One couple participated twice, once in each group.
landscape under menstrual cycle regulation drives type-1 inflamma-
Repeat penile swabs and blood were collected after one to two hours,
tory properties and dictates infection opportunities. We posit that
seven to eight hours and fourty-eight to seventy-two hours. Soluble
novel prevention strategies that reduce local inflammation events in
immune factors were quantified by multiplex immunoassay, and blood
the FRT, such as occurs under menstrual cycle regulation, may help
immune cell subsets were determined by flow cytometry; the study
prevent HIV transmission events in women.
co-primary immune endpoints were the penile levels of IL-8 and MIG,
cytokines previously linked to HIV acquisition. Statistical comparisons
were performed using the Wilcoxon Signed Ranked test.
Results: One hour after sex there was a dramatic increase in coronal
sulcus levels of IL-8 and MIG, regardless of condom use, with a return
to baseline by 72 hours; similar patterns were observed for other
chemoattractant chemokines. The extent and duration of these
increases were similar in circumcised and uncircumcised men, and cor-
related closely with cytokine levels in the female partner’s genital
tract (after condomless sex) or in the participant’s semen (after con-
dom-protected sex).
Conclusions: Relatively sustained increases in penile inflammatory
cytokines after penile-vaginal sex appear to reflect penile coating with
cervico-vaginal secretions and/or semen. Since external application of
cytokines enhanced HIV acquisition in a foreskin explant model, these
novel findings have important implications for the biology of penile
HIV acquisition.
54
POSTER ABSTRACTS
targeting this population. Many young Nigerians are ardent social-

media (SM) users but few studies are available on the role of this
Behavioural and social science research technology in HIV prevention. This study therefore, investigated the
effects of SM-delivered intervention on HIV risk perception (HRP),
intention for testing (IfTe), and risky sexual behaviours (RSB) among
students of selected tertiary institutions in South-western Nigeria.
PE01.01 Methods: The quasi-experimental study was conducted in two
Screening for common mental disorders among anti- selected public polytechnics in Oyo and Lagos States which were ran-
retroviral therapy (ART) users: Implications of case-finding domly allocated into Experimental Group (EG) and Control Group
for treatment of mental disorders, ART adherence and viral (CG) respectively. A total of 101 (EG) and 99 (CG) participants were
suppression selected through a four-stage simple random sampling technique.
Baseline data collected using a pre-tested self-administered question-
A. Kagee1; J. Bantjes2; W. Saal2 and L. Andersen3
1
naire included; types and frequency SM used, 12-point HRP scales,
Stellenbosch University, Psychology, South Africa, 2Stellenbosch IfTe among HIV yet to be tested participants, and 10-point RSB
University, South Africa, 3University of Cape Town, South Africa scales. Scores ≤ 6, 7 to 12, >12 were respectively categorised as low,
average, and high HRP. Baseline findings were used to design and
Background: In South Africa (SA), the prevalence of common mental implement a four-month intervention using WhatsApp; the most com-
disorders (CMDs) is high among PLWH. CMDs interfere with adher- monly used SM among the participants. A post-intervention survey
ence to HIV care, contributing to greater morbidity and mortality and was conducted after a one-month follow-up using the instrument ear-
greater likelihood of ongoing HIV transmission. Limited data exist on lier used at baseline. Data were analysed using descriptive statistics,
whether screening instruments are useful in detecting caseness for Chi-square, and t-test at a0.005.
CMD’s. Results: Respondents’ mean age was 21.4 2.7 years, while males
Methods: We administered the major depression, posttraumatic consisted of 61.4% and 70.7% in EG and CG, respectively. High HRP
stress, and alcohol use disorder modules of the SCID, the Centre for was 42.6% (EG) and 42.5% (CG) at the baseline, at the post-interven-
Epidemiological Studies Depression Scale Revised (CESD-R), the PTSD tion, high HRP significantly increased in EG (75.3%) compared with
Checklist for DSM-5 (PCL-5), and the Alcohol Use Disorder Identifica- 43.6% in CG. At the baseline, 67.3% (EG) and 64.6% (CG) have never
tion Test (AUDIT) to 688 patients receiving ART services at HIV clin- been tested for HIV while IfTe among them was 82.6% (EG) and
ics near Cape Town. 87.5% (CG). At the post-intervention, significantly all yet to be tested
Results: 43.17% had any CMD as determined by the SCID; 24.8% participants (100%) in EG were willing to undergo HIV test while only
met the criteria for major depressive disorder; 14.7% had posttrau- 67.5% were willing in CG. Mean score on RSB significantly decreased
matic stress disorder; and 22.1% had alcohol use disorder. In the from 4.2 2.6 to 2.4 1.4 in EG while CG increased from
receiver operating characteristic curve analyses, the area under the 3.7 2.3 to 4.2 2.8, comparing baseline with post-intervention.
curve for each of the measures ranged from 0.89 to 0.95. Sensitivity, Conclusions: Social-media intervention increased HRP and IfTe and
specificity, and positive and negative predictive values for the three reduced RSB among the participants. SM interventions are therefore
screening instruments were as follows: CESD: 81.28, 82.33, 60.26 recommended to reach young persons on HIV preventive related mat-
and 92.98; PCL-5: 88.12, 88.18, 56.33, and 97.72; AUDIT: 88.03, ters.
88.62, 89.93, and 86.51.
Conclusions: All three measures, the CESD, PCL-5, and AUDIT were PE01.05
excellent in predicting non-cases, i.e. true negatives for major depres- Race, minority stress and HIV prevention: the impact of
sion, posttraumatic stress, and alcohol use disorder, respectively. Their intersectional stigma on PrEP engagement among black
utility in predicting caseness, i.e. true positives for these conditions was men who have sex with men
somewhat lower. Yet, the accurate detection of cases of CMD’s may play
P. Burns1 and A. Omondi2
an important role in ensuring that those in need of treatment may be 1
accurately referred. Referral of large numbers of non-cases will over- University of Mississippi Medical Center, Population Health Science,
load the health care system. Non-referral of cases, i.e. persons meeting Jackson, United States, 2Jackson State University, Jackson, United
the diagnostic criteria for CMD’s will mean non-treatment of people States
who may benefit from it. CMD’s, especially mood disturbance and harm-
ful alcohol use, are implicated in poor ART adherence, sexual risk beha- Background: Sexual and racial minorities are disproportionately
viour, and viral transmission. Effective screening, referral and treatment impacted by HIV. Globally, studies in HIV pre-exposure prophylaxis
may help in efforts to prevent new cases of HIV. continue to reveal persistently alarming low rates of uptake among
key populations, particularly among Black gay and bisexual men. There
PE01.03 is an urgent need to reduce stigma and discrimination and promote
Social-media intervention: effects on HIV risk perception, racial/ethnic equity in PrEP access.
intention for testing and risky sexual behaviours among Methods: Utilizing data from ACCELERATE! Initiative, an HIV pre-
tertiary institutions students in south-western Nigeria vention program targeting Black MSM, we examined 322 African-
American/Black who were surveyed at clinical and community-settings
O. Olaleye and A. Ajuwon
in a medium-sized city in the Southern region of the United States,
University of Ibadan, Health Promotion and Education, Nigeria the epicenter of the HIV epidemic. Between January 2016 and
September 2017, participants were invited to take a computer-
Background: In Nigeria, HIV disproportionately affects young per- assisted self-interviewing (CASI) survey which assessed intersectional
sons, underscoring the need for enhanced prevention intervention stigma and engagement in PrEP.
55
Results: Of the 322 participants, 170 were HIV-negative and poten- PE01.07
tially eligible for PrEP; 42% (n = 72) had taken PrEP in the past
Dynamics and complexities of sexual and reproductive
12 months; 46.5% (n = 79) reported they had never taken PrEP. Next,
health for young people living with HIV in Gauteng, South
we assessed the prevalence of minority stress among our sample of
African-American/Black MSM. Thirteen percent reported the following Africa
about their sexual orientation: Nearly 1 in 5 (19%) felt like an outcast; B. Ndlazi and T. Masango
18% felt like an unusual person, 13% resented being gay or bisexual; UNISA, Health Studies, Pretoria, South Africa
11% were embarrassed and 9% were depressed. Respondents who
were not taking PrEP were 10% more likely to feel like an outcast.
Conclusions: Findings point to high rates of minority stress ramong Background: Young people between 10 and 24-years-old continue to
Black MSM who experience social marginalization. There is an urgent be vulnerable to HIV and its effects. Adolescents, particularly girls, liv-
need for combination HIV prevention interventions to address both ing in settings with a generalized HIV epidemic are in most cases
social and structural forms of stigma to increase uptake of PrEP socially and economically disadvantaged. Despite the scourge of HIV,
among key populations. the infected young population’s sexual and reproductive health (SRH)
and rights are faced by challenges.
Methods: Convergent parallel mixed methods was conducted in five
PE01.06 facilities; selected from 3 metro districts in Gauteng Province. Data
Socio-behavioral predictors of HIV serostatus among adults were collected among YPLHIV age 18 to 24. Semi-structured (106
(≥15 years) in Eswatini: evidence from the 2016 to 2017 respondents) and in-depth (11 participants) interviews were con-
Eswatini HIV Incidence Measurement Survey (SHIMS 2) ducted. STATA software stable release version 15.1 used for quanti-
M.C. Shongwe1; L.P. Dlamini2; M.S. Simelane3; S.K. Masuku4 and tave data analysis with the Statistical significance set at p < 0.05.
F.S. Shabalala4 Thematic data analysis was conducted for the qualitative data with
1
University of Eswatini, Midwifery Science, Mbabane, Eswatini, 2Taipei themes divided into catergories. The results and findings were then
Medical University, School of Nursing, College of Nursing, Taipei, Tai- merged to identify conversion and diversion.
wan, Province of China, 3University of Eswatini, Statistics and Demog- Results: A majority (66%) of respondents have never discussed sex
raphy, Faculty of Social Sciences, Matsapha, Eswatini, 4University of related matters with parents. A cultural belief that portrayed SRH dis-
Eswatini, Community Health Nursing Science, Faculty of Health cussion with parents as disrespectful was found to be a common bar-
Sciences, Mbabane, Eswatini rier to information. Majority (85.7%) indicated that they were
currently dating. About 46.3% indicated condom usage on first sexual
encounter. Intimate partner disclosure remains low at 45% accompa-
Background: In Eswatini, a country with the highest HIV prevalence nied by low condom usage. Fear of rejection was reported by 64.8%
in the world (at 27%), only 73% of those on antiretroviral therapy are of the respondents as the major cause for non-disclosure to intimate
virally suppressed; meaning, nearly a quarter can readily transmit the partners. One participant alluded to the findings by saying, “My part-
virus if having unprotected sex. For that reason, there is a need to ner was distance and kind of afraid of me after I disclosed my status
understand the social and behavioral determinants of HIV seropositiv- to him”. Being male was associated with low (28.5%) serostatus disclo-
ity in the general population. The study sought to identify the socio- sure compared to 53.6% of females.
behavioral factors (i.e. age at sexual debut, number of lifetime multiple Conclusions: Parental and family support is critical in addressing SRH
sexual partners (LMSPs), marital status, alcohol intake, condom use at needs and rights. The results from this study have proven that there’s
first sex and access to condoms) predicting HIV serostatus among the a compulsion for an improved and innovative way of implementing the
adult general population in Eswatini. SRH programme for adolescents and young people living with HIV.
Methods: This study was a secondary analysis of data for adults (15 The adjustments are required so that the programme could possess
to 80 years) who had a valid HIV test result in the 2016/17 Swazi- the power to respond to the specific needs of young people living
land HIV Incidence Measurement Survey (SHIMS 2), a nationally rep- with HIV. The study highlights the need for programme integration at
resentative household survey designed to assess the impact of HIV all level to eliminate the social and structural factors affecting the
treatment programs. We performed gender-stratified, multivariate bin- level of care provided to young people living with HIV.
ary logistic regression analyses among 7,121 participants (56.6%
women). PE01.08
Results: Adjusting for age, region, residence, educational level and
Syndemic conditions and PrEP use are independently
wealth quintile in all models, women who initiated sex at <15 years
associated with rectal inflammation in sexual minority men
(adjusted odds ratio [AOR]=1.92, 95% confidence interval [CI]: 1.32,
2.79), at 15 to 17 years (AOR = 1.23, 95% CI: 1.06, 1.42), and who G. Tapia1; T. Glynn2; C. Miller3; A. McGaugh3; J. Manuzak3;
had ≥ 3 LMSPs (AOR = 1.41, 95% CI: 1.05, 1.90), had higher odds of C. Broedlow3; R. McIntosh2; J. Bauermeister4; C. Grov5; R. Parisi6;
being HIV seropositive. However, those who had one LMSP D. Martinez6; N. Klatt3 and A. Carrico7
1
(AOR = 0.66, 95% CI: 0.49, 0.89) and those with 2 LMSPs Loyola University Chicago Stritch School of Medicine, United States,
2
(AOR = 0.71, 95% CI: 0.52, 0.99), had lower odds of being HIV University of Miami, United States, 3University of Miami Miller
seropositive. For men, those who were ever married/cohabited School of Medicine, United States, 4University of Pennsylvania School
(AOR = 1.90, 95% CI: 1.55, 2.33) and those who reported difficulties of Nursing, Philadelphia, United States, 5The City University of New
in getting condoms (AOR = 1.61, 95% CI: 1.21, 2.15) had higher odds York School of Public Health, United States, 6AIDS Healthcare Foun-
of being HIV seropositive. Neither alcohol consumption nor condom dation, Los Angeles, United States, 7University of Miami Miller School
use at first sex was significantly associated with HIV serostatus. of Medicine, Public Health Sciences, United States
Conclusions: Behavior change interventions should target married/co-
habiting men and should emphasize the risk of lifetime multiple part-
Background: Syndemic theory is a way to contextualize co-occurring
ners across the genders. Condom distribution campaigns should solicit
epidemics (e.g., substance use, mental health) that act synergistically
and incorporate the views of men, including on how the barriers
to drive HIV incidence. Indeed, a positive dose-response relationship
towards obtaining condoms can be overcome. Adolescent HIV preven-
has been shown between number of syndemic conditions with HIV
tion programs should encourage delaying sexual debut until the legal
risk behavior (condomless receptive anal intercourse; CRAI) and HIV
age of sexual consent (18 years).
56
Abstract PE01.08-Table 1.
seroconversion among sexual minority men, a group disproportionately assessment questionnaire. Thereafter, they provided feedback on the
burdened by HIV in many Western nations. However, little is known HIV risk assessment content, their opinion towards using an internet-
about the biological pathways whereby a syndemic could amplify bio- enabled HIV Risk Assessment, and recommendations to adapt the HIV
logical vulnerability to HIV. Rectal mucosal inflammation is one possi- risk assessment questionnaire into an internet-enabled HIV Risk
ble mechanism for increased risk of HIV acquisition. Assessment. Qualitative data were analyzed thematically using NVivo
Methods: This cross-sectional study examined the association qualitative data analysis software.
between number of syndemic conditions and PrEP use with biomark- Results: Discussions with participants reiterated their preference for
ers of rectal inflammation among 92 HIV-negative, sexual minority an interactive and informational online HIV Risk Assessment, allowing
men recruited at four AIDS Healthcare Foundation STI clinics in South to ask questions about their health and about nearest youth-friendly
Florida (USA), a region with disproportionately higher HIV incidence. clinics for HIV testing. Young people preferred discrete and private
All participants reported CRAI and no antibiotic use in the past three means to assess their own risk for HIV. The majority concurred that
months. Rectal inflammatory cytokines were quantified using LEGEN- the design and logo of the internet-enabled HIV Risk Assessment
Dplex. Participants completed screening measures for the following should not depict anything related to HIV. Participants wanted to
syndemic conditions: depression, PTSD, hazardous alcohol use, and receive notifications or reminders from the online HIV Risk Assess-
any stimulant use. A count variable (0 to 4) was created by summing ment to test for HIV every three months. HIV risk assessment ques-
conditions participants screened positive for. tions (such as penetrative vaginal/anal sex; receive vaginal/anal/oral
Results: After adjusting for age, race/ethnicity, and number of CRAI sex) identified as confusing and difficult were revised (vaginal/anal/oral
partners, greater number of syndemic conditions was associated with sex). During the software development phase, participants’ opinions
higher log10 levels of IFN-c, IL-8, and IL-23. PrEP use was indepen- and recommendations from FGDs and IDIs were considered in devel-
dently associated with higher log10 levels of IFN-c, IL-6, IL-8, IL-17a, oping a Chabot for HIV Risk Assessment.
and IL-23. Conclusions: A collaborative and user-driven process is crucial when
Conclusions: These findings are among the first to demonstrate that designing and developing an HIV prevention tool for targeted groups.
sexual minority men with more syndemic conditions and PrEP users Privacy and confidentiality are important features that may promote
display greater rectal inflammation. An increase in local cytokines may acceptability and willingness to use internet-enabled HIV prevention
mobilize the innate immune response, potentially amplifying biological methods.
vulnerability to HIV as well as other STIs.
PE01.10
PE01.09 Sharing objective measures of adherence to a vaginal
Developing a chatbot for HIV risk assessment among young microbicide promoted candor about actual use and
people living in Soweto, South Africa bolstered motivation to prevent HIV during MTN-025/
G. Tshabalala; M. Mulaudzi; S. Hornschuh; E.K. Okyere-Dede and HOPE
J. Dietrich B. Kutner1; R. Giguere1; C. Lentz1; C. Kajura-Manyindo2; C. Dolezal1;
Wits Health Consortium, Perinatal HIV Research Unit, Johannesburg, S. Butheliezi2; M. Gwande3; S. Nampiira4; T. Ndlovu2; P. Mvinjelwa5;
South Africa W. Mwenda6 and I. Balan1
1
HIV Center for Clinical & Behavioral Studies at NY State Psychiatric
Institute and Columbia University, Division of Gender, Sexuality and
Background: Young people in South Africa have low uptake of HIV
Health, New York, United States Minor Outlying Islands, 2South Afri-
testing and treatment initiation. Lack of confidentiality in accessing
can Medical Research Council Clinical Trials Unit, South Africa,
HIV prevention services are due to long waiting queues, and sharing 3
University of Zimbabwe College of Health Sciences Clinical Trials
HIV testing facilities with other health care services. There is a need
Research Center, Harare, Zimbabwe, 4Makerere University – Johns
for remote HIV prevention methods that tap into platforms that
Hopkins University Research Collaboration Clinical Research Site,
young people can engage with in a non-intrusive way. This study aimed
Kampala, Uganda, 5Emavundleni Clinical Research Site, South Africa,
to develop an internet-enabled HIV Risk Assessment through an itera- 6
Queen Elizabeth Central Hospital, College of Medicine Clinical
tive approach with young people.
Research Site, Malawi
Methods: Two groups of participants stratified by gender (females
and males, aged 18 to 24 years) participated in two focus group dis-
cussions each, conducted over 2 days. Additionally,18 in-depth inter- Background: Discrepancies between self-reported and actual adher-
views were conducted once-off with young key populations (i.e. Gay, ence to biomedical HIV interventions can compromise the integrity of
Bisexual, Lesbian, Transgender), aged 18 to 24 years. To enable the clinical trials. One solution is to monitor adherence more objectively
development process, participants completed a paper-based HIV risk through biological assays. However, it is not well understood how to
57
communicate these metrics in ways that foster honest reporting transcribed, coded, and analyzed for key themes. Thematic analysis
rather than defensiveness. examined convergent and divergent themes emerging from the inter-
Methods: MTN-025/HOPE was a Phase 3b open-label trial of a vagi- views.
nal ring to prevent HIV, conducted across four sub-Saharan African Results: Majority of participants noted numerous positive motivations
countries. The trial involved testing each ring to measure its residual for participating in the trial (e.g., contributing to the development of
drug level (RDL), an objective marker of adherence. During successive HIV prevention products, healthcare access), and voiced how their
adherence counseling sessions at Months 3, 6, 9, and 12, counselors interactions with clinical staff supported their trial participation (e.g.,
shared with participants each ring’s RDL, re-conceptualized as a level flexible scheduling). Participants highlighted their appreciation for staff
of protection ranging from 0 “No Protection” to 3 “High Protection.” being receptive to feedback, clearly explaining study procedures, and
After the trial, from July 2018-May 2019, we interviewed 22 coun- asking for consent before performing a procedure. While some partici-
selors and conducted a matrix analysis to characterize their perspec- pants mentioned feeling discomfort during clinical procedures (e.g.,
tives about RDL conversations. biopsies), they discussed the importance of the study and offered
Results: Counselors perceived that participants appreciated RDL feed- behavioral strategies to overcome discomfort during study procedures
back as an indication of their protection from HIV. Indeed, reactions (e.g., watching Netflix on their phone, listening to music, or looking
varied depending on the RDL. Higher drug levels (RDL = 2 or 3) stimu- away from the monitors). No thematic differences regarding study
lated elation and relief whereas lower levels (RDL = 0 or 1) resulted in procedures were observed between Thai and US participants.
disappointment and, more rarely, in anger when participants self- Conclusions: Ensuring participants’ optimal engagement with study
reported higher adherence. A nonjudgmental stance and support for protocols is a pivotal aspect of any trial. Our findings support the
autonomy to choose alternatives to the ring promoted disclosure of need for multiple strategies staff can advise participants to engage in
causes of lower adherence that otherwise might have remained forgot- to overcome discomfort during study visits. Additionally, beyond
ten (e.g., taking the ring out during menses) or concealed (e.g., prefer- acceptability of an investigational drug, our findings underscore the
ring not to use the ring). Reframing RDL monitoring as “protection” need to support planning and implementation efforts seeking to
rather than “adherence” also helped pivot from numerical results toward enhance internal (e.g. scheduling of and interactions during clinic visits)
the trial’s ultimate goal of HIV prevention. This emphasis on women’s and external (e.g. altruistic motivators) factors linked to participants’
motivations to prevent HIV, rather than on ring use, encouraged consis- trial experience and engagement.
tent users to continue and infrequent users to switch to an alternative
HIV prevention approach. Counselors noted that adherence conversa- PE01.12
tions might have been more cursory if based solely on self-report, with-
Association of social support and HIV-related stigma on
out the anchoring metric of a woman’s current protection against HIV.
Conclusions: Personalizing feedback from objective adherence ratings
detectable viral load and condomless anal sex (CAS) among
is complex and requires careful navigation to minimize defensiveness a diverse sample of HIV-positive MSM enrolled in an
but can also be implemented in ways that motivate disclosure of non- mHealth study
adherence and evoke commitment to preventing HIV acquisition. K. Horvath1; O. Shalhav2; A. Talan2; J. Rendina2 and S. Lammert3
1
San Diego State University, Psychology, San Deigo, United States,
2
PE01.11 City University of New York, Pride Research Health Consortium,
New York, United States, 3University of Minnesota, United States
Experiences participating in rectal microbicide clinical trials:
insights from MTN-026 & MTN-033
R. Tingler1; J. Bauermeister1; S. Johnson2; N. Macagna2; J. Piper3; Background: We assessed the impact of change in social support and
K. Ho4; C. Hoesley5; E. Dunne6 and R. Cranston7 HIV-related stigma on detectable viral load and condomless anal sex
1
University of Pennsylvania, School of Nursing, Philadelphia, United (CAS) among a diverse community sample of HIV-positive MSM resid-
States, 2FHI 360, Durham, United States, 3National Institute of Allergy ing in New York City and participating in an mHealth antiretroviral
and Infectious Diseases, Bethesda, United States, 4University of Pitts- (ART) adherence intervention, called Thrive with Me (TWM).
burgh, Department of Medicine, Division of Infectious Diseases, Pitts- Methods: Demographic, sexual behavior, viral load (VL), and psy-
burgh, United States, 5University of Alabama at Birmingham, chosocial factors (including internalized, anticipated, and enacted HIV
Birmingham, United States, 6Centers for Disease Control and Preven- stigma subscales and emotional, tangible, affectionate, social interac-
tion, Atlanta, United States, 7University of Pittsburgh, Medicine, Divi- tion social support subscales) were collected at baseline, and during
sion of Infectious Diseases, Pittsburgh, United States follow-up (Month-5, Month-11, and Month-17). Level of detection for
VL was defined as <20 copies. Social support and stigma change was
calculated by averaging the measures over follow-up and subtracting
Background: Successful implementation of clinical trials depends on from the baseline score. Social Support measures were dichotomized
participants’ engagement with and commitment to study protocols. as highest decreased support (decrease in support >1.5*SD) vs consis-
Increasingly, implementation scientists have noted the importance of tent/increased support. Stigma measures were dichotomized as high-
examining how internal (e.g., experiences with study procedures and est increased stigma (increase in stigma >1.5*SD) and consistent/
staff) and external (motivations for participating) factors influence par- decreased stigma. Detectable VL was defined as any report of a
ticipants’ engagement with clinical trials. As part of two Phase I rectal detectable VL during follow-up and CAS was defined as 2+ follow-up
microbicide clinical trials (MTN-026 and MTN-033), we ascertained periods with self-reported CAS. Risk Ratios and 95% confidence inter-
how internal and external factors facilitated participants’ engagement vals were calculated using generalized linear models (GLM).
throughout the clinical trial experience. Results: 401 participants were recruited for TWM. Participants, on
Methods: Forty-four participants (age range: 19 to 47; 35 male, 9 average, were 39 years old (IQR = 30–48). More than three-quarters
female) were enrolled across three sites (Bangkok, Thailand and Birm- of participants were racial or ethnic minorities, including 57% African
ingham, Alabama and Pittsburgh, Pennsylvania, USA) and completed American and 27% Hispanic/Latino. At baseline, 154 (38.5%) of partic-
semi-structured, video-facilitated in-depth interviews (IDI). During ipants had a detectable VL and more than half (58.6%) reported CAS
these interviews, we explored participants’ study experiences, includ- in the past 3 months. Among participants with follow-up, 246 (61.9%)
ing motivations to participate in the trial and comfort with clinical had at least one detectable VL while 165 (41.2%) reported at least
(e.g., anoscopy) and behavioral (e.g., surveys and IDIs) procedures. two follow-up periods with CAS. A high decrease in emotional
Interviews were conducted by trained qualitative interviewers, (RR = 1.31; p = 0.048), tangible (RR = 1.38; p = 0.003), affectionate
58
(RR = 1.43; p < 0.001), and social interaction support (RR = 1.42;
p < 0.001) were associated with an increased risk of a detectable VL. PE01.14
No associations were found between change in HIV-related stigma Community beliefs and practices during pregnancy and
and detectable VL. No associations were found between either social their potential effect on HIV prevention products use in
support or HIV-related stigma and CAS. Sub Saharan Africa
Conclusions: Future interventions may benefit from activities that P. Mutero1; J. Ryan2; K. Reddy3; D. Kemigisha4; D. Gondwe5;
buffer against substantial changes in social support to protect against T. Chitowa1 and P. Musara1
loss of viral control. HIV care practice may consider evaluating mea- 1
University of Zimbabwe College of Health Sciences, Clinical Trials
sures of social support frequently as a sudden decrease may predict Research Centre, Harare, Zimbabwe, 2Women’s Global Health Impera-
poor virologic outcomes. tive (WGHI) RTI International, RTI International, Berkeley, United
States, 3Wits Reproductive Health and HIV Institute, School of Clinical
PE01.13 Medicine, University of the Witwatersrand, School Of Clinical Medi-
PrEP stigma affects PrEP uptake: attitudes towards pre- cine, Johannesburg, South Africa, 4Makerere University – Johns Hop-
exposure prophylaxis (PrEP) amongst HIV vaccine trial kins University Research Collaboration, Kampala, Uganda, 5Johns
Hopkins Project-College of Medicine, University of Malawi, Blantyre,
participants in Soweto, South Africa
Malawi
F. Laher1; T. Salami2; S. Hornschuh1; L.M. Makhale1; M. Khunwane1;
M. Andrasik3; G.E. Gray1; H.-V. Tieu4 and J.J. Dietrich1
1
University of the Witwatersrand, Perinatal HIV Research Unit, Johan- Background: Pregnant and breastfeeding (P/BF) women are at high
nesburg, South Africa, 2University of Texas, United States, 3HIV Vac- risk of HIV acquisition due to biological and behavioural factors and
cine Trials Network, United States, 4New York Blood Center, need better prevention options. Uptake of new prevention products
Laboratory of Infectious Disease Prevention, United States may be impacted by beliefs and practices during these periods. The
MTN-041/MAMMA study explored the hypothetical acceptability of a
vaginal ring and oral pre-exposure prophylaxis (PrEP) use during preg-
Background: South Africa has the most annual new HIV infections, nancy and breastfeeding in Sub-Saharan Africa. We explored preg-
14% of the global total. Daily oral Truvada for HIV pre-exposure pro- nancy beliefs and practices and how they may impact future HIV
phylaxis (PrEP) was investigated in 3 clinical trials in South Africa, prevention product use.
showing low to modest effectiveness (-4% to 44%). In 2015, South Methods: 23 Focus Group Discussions (FGDs) and 36 In-depth inter-
Africa licensed Truvada for PrEP. In 2016, the national phased imple- views (IDIs) were conducted among 226 participants in Malawi
mentation began, prioritizing key populations, with low uptake and (N = 51), South Africa (N = 47), Uganda (N = 68) and Zimbabwe
adherence. In 2017, the SAMRC-HVTN established a programme to (N = 60). Participants included P/BF women aged 18 to 40 (median
bolster PrEP availability at HIV vaccine efficacy trial sites in southern age 26), men aged 18+ with P/BF partners (median age 30), grand-
Africa. We explored attitudes to PrEP amongst trial participants. mothers aged 18+ (median age 49) and key informants aged 18+ (me-
Methods: We conducted a qualitative study with 38 participants dian age 50). FGDs and IDIs were conducted in local languages,
enrolled in the HVTN 702 preventive HIV vaccine efficacy trial in transcribed, coded using Dedoose software (v7.0.23) and analysed
Soweto, South Africa. Stratified by age, gender and sexual orientation, using a socio-ecological framework. Data analysis was done by com-
5 focus group discussions were conducted during Sep-Oct 2018. Dis- paring and contrasting data across sites and study groups.
cussions were audio-recorded, transcribed, translated and thematically Results: Across sites, participants in all study groups described that
analyzed. pregnant women perform cultural practices to promote their health
Results: Participants’ median age was 26 (IQR = 23 to 30) years, and the health of the unborn baby, ease birthing process and for spiri-
50%(n = 19) identified as male, 47%(n = 18) female, and 3%(n = 1) tual guidance. Most participants admitted engaging in these practices.
transgender. Two major themes emerged. Additionally, women often register for antenatal care for detection of
(i) PrEP stigma. A barrier to uptake and adherence was the concern pregnancy abnormalities. Birth preparation practices for opening the
that others would see and misidentify the pills as HIV treatment, birth canal include inserting fingers, herbs, drinking herbal mixtures
resulting in PrEP users being mistaken as HIV-infected: “. . .there is a and birth canal lubricants like okra. Pregnant women consult tradi-
stigma that goes with tablets with my people when people see you tional healers and prophets because they are believed to deal with
drinking that medication. They automatically assume that it’s ARV’s bad spells that cause prolonged labour, caesarean section and abnor-
[for treatment]” (MSM/TG_18 to 35 years). PrEP side effects also car- mal babies. Participants believed that birth canal opening practices
ried stigma and the risk of inadvertent disclosure: “I am taking it could cause ring expulsion, while herbal interaction with HIV preven-
secretly. So what I don’t want is a situation where I become ill. . .and tion drugs could harm both mother and baby. Seeking care from tradi-
my partner will have those questions about what’s making me ill” tional healers and spiritual leaders could impact product use since
(F_25 to 35 yearss). PrEP could hamper socializing: “You cannot take some are against use of medications.
the pill because you are at a party” (M_25 to 35 years). Participants Conclusions: Cultural beliefs and practices during pregnancy may
stigmatized PrEP use as being connected to infidelity and sexual impact decision making around HIV prevention product use. As such,
promiscuity. community roll out of prevention methods needs to be accompanied
(ii) Disadvantages of pills. Forgetfulness was common: “. . .even if I by education that takes these beliefs and practices into account to
make alarms and put systems in place in order for me not to forget, I encourage uptake.
always do. Yeah, so like the tablets are not for me.” (MSM/TG_18 to
35 years). Further disadvantages were difficulty swallowing large
tablets and fear of side effects.
Conclusions: PrEP stigma poses uptake and adherence barriers.
Strategies to reduce PrEP stigma in South Africa need investigation.
59
Methods: Following ASPIRE, clinicians disseminated results of a 27%

PE01.15 reduction in HIV acquisition for all women and no reduction among
Choice period counselling for dapivirine vaginal ring and women under 25 through group meetings with participants. In AHA,
truvada in MTN-034 study; experiences of counsellors at single in-depth interviews (n = 98) and 12 focus group discussions
MU-JHU CRS site Kampala, Uganda (n = 89) were conducted with women at 7 sites in Malawi, South
F. Asiimwe Biira; R. Nakalega; H. Kalule Nabunya; E. Mulumba; Africa, Uganda and Zimbabwe. Eligibility included participation in the
B.G.M. Gati Mirembe; C.N. Nakabiito; E.K. Kyomukama; J. Etima and ASPIRE active arm, and ring use for >3 months. Interview guides eli-
C. Agwau Akello cited an in-depth assessment of how perceptions of ring efficacy
Makerere University-John Hopkins University Research Collaboration, impacted adherence and sexual risk behaviors during ASPIRE, and
Kampala, Uganda how perceptions and understanding of efficacy results impacted future
ring use interest. Interviews were audio-recorded, transcribed into
English, coded and thematically analyzed.
Background: Adolescents Girls and Young Women (AGYW) in Results: AHA women were on average 27 years old, mostly unmar-
Uganda are typically not empowered to make their own choices in ried (62%), and 48% had completed secondary school. Many didn’t
many matters related to sexual and reproductive health. The MTN- know their partner’s HIV status (37%) or if their partner had other
034/REACH study involves AGYW who were randomized to either sexual partners (58%). Perceptions of ring efficacy while in ASPIRE
the Dapivirine vaginal ring or oral Truvada. At the end of a one-year varied; majority described efficacy as a binary assessment: the ring
crossover period after using both products, participants are offered worked or not. Women who believed it worked described simply
an opportunity to select a product of their choice or neither product trusting it, or having confidence in the ring because they, or others in
for a final 6-month choice period. We will explore the practices and risky situations remained HIV-uninfected. Participants recounted
experiences of counselors to prepare for the choice period of this ASPIRE results through feelings of happiness and pride that the ring
study where there is no random assignment. they used, and their trial participation, were successful. Many did not
Methods: Two training sessions were held for counsellors to prepare remember exact figures because of lack of comprehension or memory
them for the choice period, during which counselling manuals and but recalled key details about differences in efficacy by age. The
peer rating tools of counselling sessions were reviewed to identify majority expressed interest in future ring use since it provided some
best practices to be adopted to prepare participants for visits during level of protection.
the choice period. Additionally, counsellors held 4 meetings at the site Conclusions: Perceptions and understanding of efficacy influenced
with other study staff and they brainstormed on strategies of how to some women’s adherence to and eventual interest in future ring use.
best deliver the information about “choice’. Notes were taken of the Numeric trial efficacy results were not well comprehended/under-
best practices and experiences were documented in the counselling stood suggesting the need for cultural/linguistic specificity and end-
reports. user involvement in message development.
Results: The team adopted pre-choice counselling in individual or
group sessions as the main strategy to prepare AGYW for the choice PE01.18
period. During these sessions, the counsellors use skills that include:
Response to a novel technology-assisted HIV self-testing
active listening, empathy, being non-judgmental as they answer ques-
tions and provide information in an unbiased manner about the ring
intervention in Kampala, Uganda by age and gender
and Truvada. Counsellors have learnt that it is hard for AGYW to K. Horvath1; J.M. Bwanika2; S. Lammert3; H. Banonya4; D. Musinguzi4;
make a choice and sometimes they request that the team makes a S. Magambo4 and A. Kiragga4
1
choice for them. The counseling team however, empowered partici- San Diego State University, Psychology, San Deigo, United States,
2
pants to make informed choices and supported their decisions. AGYW The Medical Concierge Group, Director of Research, Uganda,
3
should not be rushed to make decisions but rather be motivated as University of Minnesota, United States, 4The Medical Concierge
they tend to oscillate from option to option before making a final deci- Group, Uganda
sion. Participants were also given the option of choosing neither pro-
duct and informed about other available HIV prevention methods like
Background: There were an estimated 22,000 new HIV infections
condoms. AGYW appreciated the counselling and support provided.
among Ugandan youth (15 to 24 years of age) in 2018, of which
Conclusions: Participants felt empowered to make the best HIV pre-
women accounted for 15,000 (68%). We assess variability in response
vention choices and counsellors learnt that providing appropriate
to a novel technology-assisted HIV self-testing (HIVST) intervention
information while maintaining impartiality is key.
among adults in Kampala, Uganda by age and gender groups.
Methods: In 2019, our team conducted a single-arm trial of a tech-
PE01.17 nology-assisted intervention to promote HIVST among at-risk adults
Does the ring work? Perceptions and understandings of the living in Kampala, Uganda over a 3-month period. Participants
efficacy of a vaginal ring for HIV prevention amongst received theoretically grounded messages and had access to an exist-
women participating in the MTN-032/AHA study ing call-in center to order free HIVST kits and have them delivered to
J. Etima a location of their choice. Intervention acceptability and outcomes
Makerere University-Johns Hopkins University Research Collabora- were examined by the following age (18 to 24 vs. 25 to 49 years) and
tion, Psychosocial Support, Kampala, Uganda gender groups: younger women (YW; n = 33); younger men (YM;
n = 27); older women (OW; n = 16), and older men (OM; n = 23).
Results: At baseline, over half (53%) of YW were tested for HIV in the
Background: MTN-020/ASPIRE showed the dapivirine vaginal ring as past 6 months, compared to 56% OW, 61% OM, and 76% YM. Women
a safe and partially effective (in part due to suboptimal adherence) were less likely to have heard of (16% of women; 42% of men) or ever
HIV prevention option. ASPIRE was placebo-controlled, and a potential used (1% of women; 22% of men) HIVST at baseline. A lower percent-
influence on participants’ ring use was their perception of its efficacy. age of OW reported that HIVST was very easy to complete (58% vs.
The MTN-032/AHA study was an exploratory qualitative study with 77% YW, 80% OM, 81% YM), that the instructions were very clear
women who exited ASPIRE to understand reasons for nonuse and use (83% vs. 93% OM, 95% YM, 96% YW), and that they were very satisfied
of the ring during the trial. with HIVST (92% vs. 93% OM, 95% YM, 96% YW) compared to other
groups. Across all groups, only 1 older man would not recommend
60
HIVST. A lower percentage of OM (83%) ordered HIVST kits for them- Conclusions: Fidelity monitoring of counseling sessions in large multi-
selves compared to other groups (85% YW, 83% OM, 89% YM). Once site biomedical HIV prevention studies is acceptable and can feasibly
delivered, nearly all participants across all groups used the test and 1 guide and support counselors by providing structured feedback.
younger man tested positive for HIV and was successfully linked to care. Future international trials using behavioral interventions should
Conclusions: Gender and age group differences in HIVST awareness include fidelity monitoring to ensure adherence to effective practices.
and use at baseline (lowest among YW), intervention acceptability
(lowest among OW), and ordering of HIVST kits (lowest among OM) PE01.20
were found. These findings may be important for future HIVST inter-
Demystifying myths and misconceptions about use of the
vention trials and community roll out of HIVST programs in Uganda
and other sub-Saharan countries.
Dapivirine Vaginal Ring and Truvada among adolescent girls
and young women in the MTN-034 study; observations
from Kampala site
PE01.19 E. Mulumba1; R. Nakalega2; S. Nanyonga2; H. Kalule Nabunya2;
Counselors’ acceptability of adherence counseling session F.A.B. Asiimwe Biira2; E. Kyomukama2; J. Etima Ongom2; B. Gati
recording, fidelity monitoring, and feedback in a multi-site Mirembe2; C. Nakabiito2 and C. Agwau Akello2
HIV prevention study in four African countries 1
Makerere University-John Hopkins University Research Collabora-
R. Giguere1; C. Lentz1; C. Kajura-Manyindo1; B.A. Kutner1; tion, Psycho-social, Kampala, Uganda, 2Makerere University-John Hop-
C. Dolezal1; M. Buthelezi2; I. Lukas3; S. Nampiira4; C. Rushwaya5; kins University Research Collaboration, Kampala, Uganda
E. Sitima6; A. Katz7; A. van der Straten8 and I.C. Balan1
1
Columbia University and New York State Psychiatric Institute, HIV
Center for Clinical and Behavioral Studies, New York, United States, Background: Communities in Africa have a major influence on the
2
South African Medical Research Council, South Africa, 3Wits Repro- behaviors of adolescent girls and young women (AGYW) and their
ductive Health and HIV Institute, Johannesburg, South Africa, 4Maker- opinions are highly valued in the decision making processes of this
ere University - Johns Hopkins University Research Collaboration, young and vulnerable population at risk of HIV infection. Since myths
Kampala, Uganda, 5University of Zimbabwe College of Health and misconceptions have the potential to affect the utilization of the
Sciences, Harare, Zimbabwe, 6Johns Hopkins University - Blantyre dapivirine vaginal ring (Ring) and Truvada while also affecting
Clinical Trials Unit, Malawi, 7RTI International Women’s Global Health the research process, it is imperative that researchers understand the
Imperative, Research Triangle Park, United States, 8RTI International concerns and also find means to address them. We seek to explore
and University of California at San Francisco, Women’s Health Global the myths and misconceptions about the use of the Ring and the Tru-
Imperative and Center for AIDS Prevention Studies, Research Triangle vada tablet among AGYW in the MTN 034 study at Kampala and also
Park, United States describe the strategies adopted to mitigate them.
Methods: The MTN-034 is an ongoing, cross-over study of daily oral
PrEP and monthly dapivirine vaginal ring safety and preferences, From
Background: To retain effectiveness, evidence-based counseling inter- June 2019 to Feb 2020, 26 adherence support meetings were held
ventions must be delivered with fidelity. We report on acceptability of with about 15 to 20 participants attending each of these bi-weekly
the adherence counseling fidelity monitoring process used in MTN- sessions. Additionally, one-on-one counselling sessions, community sen-
025/HOPE Study, the largest biomedical HIV prevention trial to inte- sitization meetings, and parents/guardians meetings are held during
grate fidelity monitoring using audio recordings of counseling sessions. study implementation. Summary notes are used to record the myths
Methods: The MTN-025/HOPE Study, a Phase 3B open label exten- and misconceptions including challenges and proposed solutions that
sion trial across fourteen sub-Saharan African sites involving 1456 arise during these sessions.
women, explored safety and adherence to the dapivirine vaginal ring Results: The team addressed these myths and misconceptions by pro-
for HIV prevention between August 2016 and October 2018. Adher- viding accurate information about the study and study products to
ence counselors were trained to conduct Options Counseling, a Moti- participants and community members. Participant and community
vational Interviewing-based intervention. A sample of their audio- engagement sessions plus scheduled counselling visits were a platform
recorded sessions were monitored by a New York-based multilingual to dispel misconceptions.
team, to support intervention fidelity. The rating team evaluated ses-
sions using a fidelity monitoring tool and was itself assessed monthly Abstract PE01.20-Table 1.
for interrater reliability (IRR). To understand acceptability and feasibil-
ity of fidelity monitoring, we surveyed 42 counselors and interviewed Myths and
22 counselors, and examined spontaneous mentions of session record- Misconceptions Ring Truvada
ings by 10 study participants among 91 interviewed. Quantitative data
were analyzed using descriptive statistics. Qualitative data were coded Study Product It causes cancer of Truvada can infect one
and thematically summarized. reproductive with HIVCauses
Results: In total, 5366 Options sessions were audio-recorded, of organsCauses extensive liver
which 1238 (23%) were reviewed for fidelity. On a scale of 1 to 7, barrennessWidens damageCauses
counselors indicated that session ratings were very helpful (mean rat- the vaginaMay abdominal swellings,
ing of 6.64). Most counselors reported progressing from apprehension disappear in the body tumors and
to confidence about the fidelity monitoring process after conducting and go to lungsLoops infertilityCauses
25 or fewer sessions, with 88% reporting feeling confident in their the partner’s weight gain and body
abilities and 90% likely to use skills learned through Options in the penisSucks blood deformation – big
future. In interviews, study participants had mixed reactions to from the sexual head, thin legs etc.The
recorded sessions; some reported receiving better counseling when partner drug also piles in the
sessions were monitored, and others found them time-consuming and lungs and can cause
burdensome. For raters, assessment of IRR was essential, as drift in sudden death.
ratings occurred over time. Furthermore, internal reviews of rating
forms revealed the need for specific training to shape written feed-
(Continues)
back in a supportive, client-centered manner.
61
Table 1. (Continued) increasingly tolerable HIV-treatment and the acceptance of the Unde-
tectable=Untransmissable message, HIV may be seen more than ever
Myths and as an easily manageable condition. This might negatively affect HIV-
Misconceptions Ring Truvada prevention uptake. We investigated current perceptions on the gen-
eral severity and potential consequences of an HIV-infection and its
Study Researchers are taking blood to use it for sale and association with sexual risk behavior among HIV-negative MSM living
Participation manipulation of African genes in the Netherlands.
The examination lump burns the vagina during the Methods: In-depth interviews with recently diagnosed MSM were
pelvic exam used to develop a questionnaire measuring the severity and antici-
Vaginal specimen will be used to design products pated consequences of HIV-infection. The questionnaire was dis-
that make African infertile. tributed online using gay dating sites/apps and social media between
April-July 2019. A structural equation model was constructed to
explore which anticipated consequences contributed most to the gen-
eral perceived severity of HIV-infection and to assess the association
Conclusions: Implementation of interventions requires sensitization between perceived severity and sexual risk behavior (i.e. condomless
of communities prior to study initiation to mitigate myths and miscon- anal sex with casual partners without PrEP-use).
ceptions. Continuous education and engagement of communities, as Results: We analyzed 1072 HIV-negative MSM completing the sur-
well as participants, is key to dispelling myths and misconceptions. vey, of whom 28% reported sexual risk behavior in the preceding
6 months. 77% perceived HIV as a severe illness. Anticipated negative
PE01.21 consequences of HIV on sex/relationships were strongly related to
Perceived severity of HIV infection in the biomedical era the general perceived severity of HIV (b = 0.32, 95% CI 0.23 to 0.42,
and its association with sexual risk behavior among HIV- p < 0.001) (Figure 1). Moreover, anticipated psychological (p < 0.001),
disclosure-related (p < 0.001) and health-related negative conse-
negative men who have sex with men
quences of HIV-infection (p = 0.04) were also related to general
W.P. van Bilsen; H.M. Zimmermann; A. Boyd and U. Davidovich
severity perceptions. Finally, a higher general perceived severity of
Public Health Service of Amsterdam, Department of Infectious Dis- HIV was correlated with lower sexual risk taking (b = -0.06; 95%
eases, Amsterdam, Netherlands CI = -0.11,-0.01; p = 0.02).
Conclusions: One-quarter of HIV-negative MSM did not perceive
HIV as a serious illness, which was associated with more prevalent
Background: Health-related behaviors are closely linked to the per-
sexual risk taking. Perceptions on the severity of an HIV-infection
ceived severity and potential consequences of a disease. With
Abstract PE01.21-Figure 1.
62
mainly consisted of anticipated burdensome interpersonal aspects of without moral judgement, encourage conversations about HIV preven-
living with HIV. These data imply that prevention strategies are chal- tion at consultations, and foster trust in patient-physician relation-
lenged by the perceptions of low HIV-infection severity among some ships.
HIV-negative MSM.
PE01.23
PE01.22 Prevalence and correlates of intimate partner violence
Interpersonal and structural stigma towards HIV pre- among high-risk adolescents aged 14 to 19 years in
exposure prophylaxis among community-based physicians Kampala, Uganda
delivering sexual health services in Taiwan O. Kamacooko1; Y. Mayanja2; J.F. Lunkuse2; J. Seeley2 and P. Kaleebu2
I.Y.-H. Chu1; C. Strong2; C.-W. Li3; S.W.-W. Ku4; N.-Y. Ko5; A. Bourne6; 1
MRC/UVRI & LSHTM Uganda Research Unit, Statistics, Entebbe,
H. Burchett1 and F. Hickson1 Uganda, 2MRC/UVRI & LSHTM Uganda Research Unit, Entebbe,
1
London School of Hygiene and Tropical Medicine, Department of Uganda
Public Health, Environments and Society, Faculty of Public Health and
Policy Faculty of Public Health and Policy, London, United Kingdom,
2
National Cheng Kung University Hospital, College of Medicine, Background: Intimate partner violence (IPV) is of public health signifi-
National Cheng Kung University, Department of Public Health, Tainan, cance as it impacts adversely on wellbeing. Adolescents involved in
Taiwan, Province of China, 3National Cheng Kung University Hospital, high risk behaviours are exposed to violence but often have limited
College of Medicine, National Cheng Kung University, Department of access to prevention and treatment services. We studied the preva-
Internal Medicine, Tainan, Taiwan, Province of China, 4Taipei City lence and factors associated with IPV among 14 to 19 year old high-
Hospital Renai Branch, Division of Infectious Disease Department of risk adolescents in Kampala, Uganda.
Medicine, Taipei, Taiwan, Province of China, 5National Cheng Kung Methods: We conducted a cross-sectional study among male and
University Hospital, College of Medicine, National Cheng Kung female volunteers aged 14 to 19 years. We defined IPV as a volunteer
University, Department of Nursing, Tainan, Taiwan, Province of China, reporting prior experience of at least one form of violence (physical,
6
Australian Research Centre in Sex, Health & Society, La Trobe emotional and sexual) from sexual partners. Indicators of spousal vio-
University, Melbourne, Australia lence were combined to form two categories: never experienced the
specific violence, and experienced at least one type of the specific vio-
lence (binary outcome). Data on socio-demographics, sexual behaviour
Background: Engagement with HIV pre-exposure prophylaxis (PrEP) and substance use were collected. We analysed factors associated
by healthcare providers can be negatively impacted by both interper- with IPV using logistic regression (Stata 15.0).
sonal and structural stigma (Hatzenbuehler and Pachankis, 2016). Results: We enrolled 365 participants, mean age 17.8 (SD 1.02)
Since 2018, Taiwan has implemented government-funded and self-paid years, of whom 64% were female. Of 184 (50%) who reported ever
PrEP but few physicians provide PrEP services. We qualitatively experiencing IPV, 105 (57%) had experienced IPV 3 months prior to
explored PrEP-related stigma among physicians to understand barriers the interview. IPV was most prevalent among female participants,
to PrEP scale-up. (79%). Prevalence of IPV by type was: emotional (35%), physical
Methods: From June to October 2019, sixteen face-to-face in-depth (28%) and sexual (24%). Females commonly reported sexual violence
interviews were conducted with physicians delivering sexual health (89%) while males commonly reported emotional violence (22%).
services at community-based clinics. We applied stratified sampling to Emotional and physical violence were mainly perpetrated by regular
ensure diversity of geography, specialities and experience in PrEP pre- non-paying partners while sexual violence was mainly perpetrated by
scribing. Interviews were audio-recorded, transcribed, and thematically casual non-paying partners. After adjusted analysis participants who
analysed. were aged <18 years (aOR = 0.57; 95% CI 0.34 to 0.96) and single
Results: Interpersonal stigma included participants’ own biases (aOR = 0.46; 95% CI 0.23 to 0.93) were less likely to suffer IPV while
towards PrEP users (e.g. association with condomless sex, STIs and earning from paid sex (aOR = 3.16; 95% CI 1.68 to 5.95) and alcohol
wasting public health resources) and expected biases of other physi- dependency (aOR = 3.19; 95% CI 1.36 to 7.46) were highly associ-
cians (e.g. the exclusiveness of PrEP for gay men, reluctance in taking ated with IPV.
blood samples from PrEP clients and worries about the spread of HIV Conclusions: Many adolescents experienced IPV, highlighting a need
drug resistance). for support to reduce high-risk behaviour and situations that expose
Structural stigma was related to PrEP being an HIV prevention mea- them to IPV.
sure. Negative social norms relating to HIV which now spill over to
PrEP (“When it comes to HIV, even though PrEP is just a medication, PE01.25
many people become frightened”) and reinforced HIV stigma on PrEP
Factors associated with transactional sex in the African
service users (“The general public won’t come to my clinic as they
think many HIV patients are often here”). Sexual stigma disproportion-
Cohort Study
ately suppressed PrEP-prescribing behaviour among criticism-averse N. Dear1; A. Esber1; M. Iroezindu2; E. Bahemana3; H. Kibuuka4;
physicians. Some clinicians treated STI patients without taking sexual J. Owuoth5; J. Maswai5; T. Crowell1; J. Ake1 and C. Polyak1
1
histories nor offering information on PrEP to those eligible. (“If you Walter Reed Army Institute of Research, U.S. Military HIV Research
actively ask [about their sexual histories], patients will become Program, Silver Spring, United States, 2Henry Jackson Foundation
annoyed and doubt whether you mean they are promiscuous.”). Inter- MRI, Nigeria, 3Henry Jackson Foundation MRI, Tanzania, United
personal stigma and the health system were interrelated. The cloud- Republic of, 4Makerere University Walter Reed Project, Kampala,
based electronic health record (EHR) in Taiwan’s healthcare system Uganda, 5Henry Jackson Foundation MRI, Kenya
could amplify interpersonal PrEP stigma. Physicians worried that docu-
menting PrEP on users’ EHR might reinforce other providers’ biases
Background: Transactional sex can put vulnerable groups at increased
(“If I document [PrEP] clients as sex buyers in the [EHR] system, how
risk for HIV acquisition and transmission. Better understanding the
can that be right!”).
characteristics of those engaging in transactional sex can help preven-
Conclusions: Multifaceted PrEP stigmas perceived or operationalised
by physicians impede the impact of PrEP in Taiwan. Future PrEP tion programs identify and serve at-risk groups. We identified factors
implementation programmes could promote medical professionalism
63
associated with transactional sex in the African Cohort Study (AFRI- Table 1. (Continued)
COS).
Methods: AFRICOS prospectively enrolls adults at risk for HIV and All (n = 3466) OR PLWH (n = 2880) OR
persons living with HIV (PLWH) at 12 PEPFAR-supported clinics in (95% CI) (95% CI)
Uganda, Kenya, Tanzania, and Nigeria. At twice-yearly study visits, ques-
tionnaires are administered and clinical outcomes assessed. Multivariate Yes Ref Ref
logistic regression with generalized estimating equations were used to Disclosed HIV status to spouse/partner, parent, sibling, children,
estimate odds ratios (ORs) and 95% confidence intervals (95% CIs) for grandparents, extended family members, friend, roommate, or
associations between factors identified a priori and engaging in transac- church members
tional sex, defined as having received money, shelter, food, drugs, favors, No Ref
or gifts in exchange for sex in the past 6 months. To evaluate HIV-speci- Yes 2.09 (1.62 to 2.70)
fic factors, a subgroup analysis was performed among PLWH. Experienced HIV stigma
Results: Between January 2013 and December 2019, 3466 partici- No Ref
pants were enrolled, of whom 83.1% were PLWH. At enrollment, 365 Yes 1.64 (1.16 to 2.33)
participants (10.3%), of whom 80.5% (n = 294) were PLWH and Taking ART
71.2% (n = 260) female, reported transactional sex with a median of 1 No 1.73 (1.22 to 2.43)
transactional sex event per month (interquartile range 1 to 3). Factors Yes Ref
independently associated with increased likelihood of transactional sex HIV Viral Load
included female sex, younger age, clinical site, being unmarried, having 1000 copies/mL 1.30 (0.95 to 1.78)
less education, consuming alcohol, having experienced physical harm, <1000 copies/mL Ref
having had forced sex, and not having enough food to eat in the past
year (Table 1). Among PLWH, additional factors associated with trans-
Conclusions: Multidimensional socio-behavioral and economic factors
actional sex included status disclosure, experiencing HIV-related
were associated with transactional sex. Among PLWH, those engaging
stigma, and not taking antiretroviral therapy (ART).
in transactional sex were less likely to be taking ART, potentially
amplifying transmission risk in this subgroup. Comprehensive public
health programming that addresses these factors is essential to curb-
All (n = 3466) OR PLWH (n = 2880) OR ing the HIV epidemic.
(95% CI) (95% CI)
Site
PE01.26
Using emoji stickers to understand opinions of the
Kayunga, Uganda Ref Ref
South Rift Valley, 0.67 (0.50 to 0.90) 0.70 (0.50 to 0.97)
dapivirine vaginal ring for HIV prevention among female
Kenya end-users and their male partners
Kisumu West, 0.98 (0.74 to 1.28) 1.20 (0.88 to 1.64) A.W.K. Katz1; L.E. Mansoor2; M. Tsidya3; F. Mathebula4; D. Singh5;
Kenya S. Siva6; C. Akello7; T.H. Chitowa8; M. Garcia9; L. Soto-Torres10 and
Mbeya, Tanzania 0.52 (0.37 to 0.73) 0.35 (0.24 to 0.52) E.T. Montgomery1
1
Abuja & Lagos, 0.50 (0.31 to 0.83) 0.52 (0.30 to 0.90) RTI International, Women’s Global Health Imperative, Berkeley, Uni-
Nigeria ted States, 2Centre for the AIDS Programme of Research in South
Sex Africa (CAPRISA), Durban, South Africa, 3UNC-Lilongwe, Lilongwe,
Male Ref Ref Malawi, 4Wits RHI, Johannesburg, South Africa, 5International Clinical
Female 2.19 (1.72 to 2.78) 2.15 (1.65 to 2.80) Research Center, Department of Global Health, Seattle, United States,
6
Age at visit South Africa Medical Research Council, HIV Prevention Research
18 to 29 2.49 (1.93 to 3.20) 1.95 (1.45 to 2.63) Unit, Durban, South Africa, 7Makerere University-Johns Hopkins
3 to 39 1.50 (1.18 to 1.90) 1.41 (1.09 to 1.83) University Research Collaboration, Kampala, Uganda, 8University of
40+ Ref Ref Zimbabwe College of Health Sciences Clinical Trials Research Centre
Education (UZCHS-CTRC), Harare, Zimbabwe, 9FHI 360, Durham, United States,
10
None or some 1.40 (1.02 to 1.92) 1.54 (1.10 to 2.17) NIH, Division of AIDS, Bethesda, United States
primary
Primary or some 1.36 (1.01 to 1.83) 1.38 (0.99 to 1.92)
secondary Background: The monthly dapivirine vaginal ring (VR) is a promising
Secondary and Ref Ref female-initiated prevention method that, with high adherence, has
above shown reduced risk of HIV acquisition in clinical trials. Understanding
Marital status VR acceptability among experienced end-users and their male part-
Not married 2.61 (2.15 to 3.17) 2.42 (1.95 to 3.01) ners (MP) offers insight into factors that might impact its effective
Married Ref Ref use at a population level.
Consume alcohol Methods: To explore VR acceptability, following the Microbicide Trials
No Ref Ref Network (MTN) HIV Open-label Prevention Extension (HOPE) trial,
Yes 2.75 (2.12 to 3.57) 2.88 (2.16 to 3.85) former HOPE participants and MP were recruited from 6 of 14 sites,
Experienced physical harm by partner or acquaintance representing all trial countries (Malawi, South Africa, Uganda, Zim-
No Ref Ref babwe). During in-depth interviews (IDI) or focus-group discussions
Yes 2.49 (1.85 to 3.34) 1.63 (1.15 to 2.29) (FGD), participants selected and placed emoji stickers on an “opinion
Had forced sex tool” to stimulate discussion of attitudes towards the VR over time.
No Ref Ref Emoji use was tabulated; qualitative data were transcribed, translated,
Yes 4.54 (3.51 to 5.89) 3.67 (2.74 to 4.92) and coded using Dedoose software.
Had enough food over past 12 months Results: Fifty-eight women and one MP had an IDI; 53 men partici-
No 1.42 (1.18 to 1.71) 1.30 (1.06 to 1.61) pated in one of 11 FGDs. 12 of 22 possible emojis (55%) were
(Continues)
64
Abstract PE01.26-Table 1. PE01.27

When to put it on: decision-making regarding condom use
among MSM PrEP-users
H. Zimmermann; V. Jongen; A. Boyd; E. Hoornenborg; M. Prins;
H. de Vries; M. Schim van der Loeff and U. Davidovich
Public Health Service Amsterdam, Department of Infectious Diseases,
Amsterdam, Netherlands
Background: It is feared that pre-exposure prophylaxis (PrEP) will

result in decreased condom use and increased STI incidence. In this
multi-method study, we explored per-sex act condom-use decisions
among PrEP-users.
Methods: We analyzed data acquired with a mobile application of the
Amsterdam PrEP project (AMPrEP) (August 2015-February 2019)
among men who have sex with men who used daily (dPrEP) or event-
driven PrEP (edPrEP). The app allowed participants to register daily
selected by at least 10% of women or MP (Table 1). Although emoji their sex-acts, PrEP-use and condom-use per partner type (steady
interpretation varied widely, the activity facilitated detailed discussions (SP) and casual partners (CPs)). Additionally, we qualitatively analysed,
about VR opinions. Both groups felt primarily positive about the VR using 43 in-depth-interviews among AMPrEP-participants, motives for
because it provided HIV protection, was easy to use, lacked side four PrEP- and condom-use strategies:
effects, improved or did not change sex, and enabled involvement in
HIV prevention (MP only). Common negative opinions were shock or (1) PrEP-only;
fear due to a lack of understanding (MP only), suspected lack of HIV (2) PrEP and condoms;
protection, and fear of or actual side effects. Many women reported (3) condoms-only; and
consistently positive opinions throughout HOPE. Some women and (4) no-PrEP, no-condom.
men’s opinions improved over time with increased familiarity and Results: 352 AMPrEP-participants reported 48,949 anal sex-acts, of
receipt of more information about the VR, or counselor and staff which 11,632 were with SPs and 37,317 with CPs. PrEP-only was the
encouragement. most common prevention-strategy with any partner type (n = 39,650/
Conclusions: An emoji activity stimulated MP and women to provide 48,949, 81%) regardless of PrEP-regimen or time since PrEP-initiation
multiple VR opinions, predominantly positive. Opinions pointed to edu- (Figure 1). PrEP-only motivations were primarily based on prospects
cational messages that could enhance future understanding, accep- of more pleasurable sex. Combining PrEP and condoms was more
tance and adjustment of ring use. often chosen for sex-acts with CPs (n = 6,829/37,317; 18%) than for
65
sex-acts with SPs (n = 614/11,632; 5%) and was linked to higher STI/ optimise uptake and adherence to biomedical HIV prevention and fur-
HIV-risk-perceptions, CPs wish for condom-use, additional safety reas- ther contribute to the decline in HIV acquisition among P/BF women
surance, or to avoid PrEP-use disclosure. Condoms-only was uncom- in this community.
mon but occurred occasionally among edPrEP-users (n = 379/8,695;
4%). dPrEP-users only replaced PrEP by condoms if non-adherent to PE01.29
PrEP. The no-PrEP, no-condom strategy occurred mostly among
User recommendations to optimize a mobile phone sexual
edPrEP-users in sex-acts with SPs (n = 538/2,122; 25%) and was
motivated by low perceived HIV-risk. We observed an increasing
health risk assessment for HIV prevention clinical research
trend (p < 0.001) in practicing the no-PrEP, no-condom strategy in G. Benadé1; M. Mulaudzi1; A. Kagee2; S. Hornschuh1; M.P. Lemos3;
sex-acts with SPs among edPrEP-users since PrEP-initiation, but not E. Lazarus1; M. Andrasik3; K.J. Horvath4 and J.J. Dietrich1
1
among dPrEP-users (Figure 1). Perinatal HIV Research Unit, Faculty of Health Sciences, University
Conclusions: Our data suggest that condom use remains a viable of the Witwatersrand, Johannesburg, South Africa, 2Faculty of Arts
option among PrEP-users in certain settings. Condoms were primarily and Social Sciences, University of Stellenbosch, Department of Psy-
applied in perceived higher risk settings, to avoid PrEP-use disclosure, chology, South Africa, 3Fred Hutchinson Cancer Research Center, Vac-
or as substitute for PrEP, especially among edPrEP-users. cine and Infectious Disease Division, Seattle, United States, 4San
Diego State University, Department of Psychology, United States
PE01.28
Grandmothers as key influencers on pregnant and Background: Accurate self-report of sexual behaviour assists in iden-
breastfeeding women’s health and HIV prevention related tifying potential HIV exposure in HIV prevention trials. Brief mobile-
decision making in Johannesburg, South Africa phone assessments, completed daily or after sexual activity, can
K. Reddy1; T. Palanee-Phillips1; F. Mathebula1; S. Tenza1; J. Ryan2; improve the validity and reliability of self-reported sexual behaviour
N. Macagna3; P. Musara4 and A. van der Straten2 and allows for remote completion, outside of the clinic setting. Our
1
Wits Reproductive Health and HIV Institute, Research Centre, Hill- study describes user recommendations to adapt and optimize an exist-
brow, Johannesburg, South Africa, 2RTI International, Women’s Global ing mobile phone sexual risk assessment.
Health Imperative, San Francisco, United States, 3FHI 360, Science Methods: We conducted four age-stratified focus group discussions
Facilitation, Durham, United States, 4UZ-UCSF Research Programme, (FGDs) and analysed a brief socio-demographics and mobile phone
Harare, Zimbabwe access questionnaire. All participants completed the existing sexual
risk assessment before the FGD. Sexually active, HIV seronegative
men (n = 14) and women (n = 15) 19 to 39 years were recruited
Background: The MTN-041/MAMMA study explored attitudes of through a HIV counselling and testing clinic and community outreach
pregnant and breastfeeding (P/BF) women, male partners and grand- in Soweto. Using a framework analytic approach, data were coded
mothers (mothers/mothers-in-law of P/BF women) regarding use of with Nvivo software.
the dapivirine vaginal ring (VR) and oral pre-exposure prophylaxis Results: All participants had access to mobile phones and internet,
(PrEP) during these periods of high HIV risk. Herein, we describe the and 27 (93.1%) were able to download applications on their personal
influence of grandmothers on P/BF women’s health and HIV preven- phones. Analysis of FGDs showed that participants prefer mobile risk
tion related decision making in Johannesburg, South Africa. assessments to be offered in a choice of South African languages,
Methods: We collected behavioural data through surveys and con- using formal language (as opposed to emojis), with straight-forward
ducted focus group discussions (FGDs) with three groups of partici- wording and limited to five to ten questions. Most participants found
pants (total N = 47): HIV-uninfected, currently or recently P/BF it acceptable to complete the assessment once a week, on a weekday,
women aged 18 to 40 years (median 26; N = 15), male partners aged while a few were willing to complete it after each sexual encounter. A
≥18 years (median 33; N = 12) and grandmothers (median age 57;N message reminder to complete the assessment should be sent at least
= 20). FGDs were conducted in English and/or Zulu by trained facilita- daily until it is done. The majority agreed that a password-protected
tors using semi-structured guides and included a brief educational application with a discreet logo is ideal for privacy, ease of use and
video about VR and oral PrEP and an opportunity to handle sample flexibility for completion in any setting. A concern with this format,
products. Discussions were audio-recorded and summarized in debrief however, was the potential data requirement. Participants expressed
reports before being transcribed in English, coded using Dedoose soft- privacy concerns with using SMS, WhatsApp and other social media
ware (v7.0.23), and thematically analysed. for the risk assessment. Most agreed on an airtime incentive between
Results: In surveys, maternal grandmothers were identified by 40% ZAR5-10 (USD 0.29 to 0.58) per assessment. Participants encouraged
of P/BF women as key influencers on their decision making even researchers to provide feedback about their sexual risk with coun-
though they considered themselves primary decision makers for medi- selling to reduce their risk.
cation use during pregnancy (60%) and breastfeeding (70%); a view Conclusions: Completion of mobile phone risk assessments can be
similarly upheld by male partners (67% during pregnancy, 58% during optimized with minimal incentives by ensuring questionnaires are sim-
breastfeeding). Grandmothers’ influence was further explored during ple, brief, infrequent and have well-controlled privacy measures. Fur-
FGDs, with maternal grandmothers described by all three groups of ther investigation of methods to address risk behaviours identified in
participants as important sources of information due to their experi- the mobile phone assessment responses is required.
ence using traditional medicine and their healthy pregnancies and chil-
dren. Paternal grandmothers were also included as key influencers if
the male partner had compensated an unmarried pregnant woman’s
family for a pregnancy [“paid damages”]. For HIV prevention-related
decision making and oral PrEP/VR use specifically, P/BF women indi-
cated they would make the decision themselves as with medication
but would welcome support from their grandmothers.
Conclusions: Grandmothers appeared to make significant contribu-
tions to P/BF women’s health-related decision making with potential
to play a supportive role in HIV prevention product use. With the
right framing and approach, grandmothers’ advice and support could
66
PE01.30 PE01.31
Identifying profiles of sexual risk and PrEP initiation among Adolescent girls and young women’s (AGYW) PrEP-user
Black sexual minority men in HPTN 073 journey during an implementation science study in South
D. Dangerfield II1; I. Kuo2; M. Magnus2; G. Beauchamp3; S. Fields4; Africa and Kenya
L. Nelson5; S. Shoptaw6; L. Wilton7 and D. Wheeler8 E. Rousseau1; A.W.K. Katz2; S. O’Rourke2; L.-G. Bekker1; S. Delany-
1
Johns Hopkins School of Nursing, School of Nursing, Baltimore, Uni- Moretlwe3; E. Bukusi4; D. Travill3; V. Omollo4; J. Morton5;
ted States, 2George Washington University School of Public Health, G. O’Malley5; R. Johnson5; C. Celum5; J.M. Baeten5 and A. van der
United States, 3Fred Hutchinson Cancer Research Center, Baltimore, Straten2
United States, 4New York Institute of Technology, Baltimore, United 1
Desmond Tutu Health Foundation, University of Cape Town, Cape
States, 5Yale University School of Nursing, Baltimore, United States, Town, South Africa, 2RTI International, Research Triangle Park, United
6
University of California Los Angeles, Baltimore, United States, 7State States, 3Wits RHI, University of Witswatersand, Johannesburg, South
University of New York at Binghamton, United States, 8Iono College, Africa, 4Kenya Medical Research Institute, Nairobi, Kenya, 5University
Baltimore, United States of Washington, Seattle, United States
Background: Black gay, bisexual, and other Black sexual minority men Background: Oral pre-exposure prophylaxis (PrEP) efficacy in pre-
(BSMM) continue to bear the greatest HIV burden in the U.S. Efforts venting HIV is well established. However, adhering to a daily regimen
to successfully engage BSMM to use pre-exposure prophylaxis (PrEP) can be challenging, especially for adolescent girls and young women
are urgently needed. However, additional strategies to understand HIV (AGYW) in sub-Sahara Africa. With PrEP scale-up ongoing, it is impor-
risk profiles among BSMM are needed. Since few studies show high tant to understand AGYW’s motivations and lived experiences in the
uptake of PrEP among BSMM, the purpose of this study is to identify uptake and use of PrEP.
sexual risk profiles and PrEP use among BSMM in the vanguard study Methods: In-depth interviews were conducted with a purposive sam-
HPTN 073. ple of 91 AGYW (ages 16 to 25) in the POWER implementation pro-
Methods: A total of 226 BSMM were recruited from Los Angeles, ject offering PrEP for up to 36 months from adolescent-friendly,
CA, Chapel Hill, NC, and Washington D.C. from 2013 to 2015; 79% mobile, and family planning clinics, in Johannesburg and Cape Town,
initiated PrEP. Latent class analysis (LCA) was used to identify sexual South Africa and Kisumu, Kenya, respectively. A rapid analysis of
risk profiles using baseline data from HPTN 073 study (n = 226). coded transcripts and interview summaries was conducted to explore
Relationship status, condom use, number of sexual partners, substance AGYW’s PrEP-user journey from motivation to initiate, persistence
use, STI history, and partner HIV status were used as latent class indi- (sustained PrEP use), discontinuation, and restarting PrEP.
cators as guided by the CDC PrEP risk behavior assessment. Age and Results: Motivations to initiate PrEP included partner infidelity, a cur-
PrEP initiation were used as covariates in a multinomial regression to rent STI, history or fear of sexual violence, and having an HIV positive
identify correlates of class membership. family member or partner. AGYW who initiated PrEP early in study
Results: Three latent classes were identified: displayed high awareness of HIV vulnerability, attributed to their inti-
mate relationship dynamics or personal lifestyle, and frequently shared
1) Single with Condomless Partners (69.4%),
that starting PrEP empowered them to take control of their sexual
2) Single with Multiple Partners (19.0%), and
health. Early PrEP use challenges and delayed uptake were often due
3) Serodiscordant Partners (11.5%).
to community stigma and PrEP misconceptions and AGYW prioritizing
Single with Multiple Partners had the highest conditional probability family, peers, and/or partners social approval (despite HIV vulnerability
of having condomless sex (90.5%), having greater than three male awareness). Disclosure to family and/or partners occurred early for
partners in the previous six months (93.6%), substance use before sex AGYW who persisted with PrEP; conversely, most non-persistors dis-
(58.1%), and receiving an STI diagnosis in the previous six months. closed use later in the journey or not at all. Unplanned PrEP pauses
Serodiscordant Partners had a 100% conditional probability of both occurred due to PrEP access problems when traveling to rural areas
engaging in condomless sex with a male partner and having a male or attending school/work. Planned PrEP pauses occurred during peri-
partner who was living with HIV. Relative to BSMM who did not initi- ods of no sexual activity (e.g. when partners travel). Many AGYW who
ate PrEP, BSMM who initiated PrEP had 93% lower odds of being had PrEP interruptions restarted PrEP. PrEP discontinuation was often
classified as Single with Condomless Partners than Serodiscordant due to perceived side effects, low social support (particularly from
Partners, after adjusting for age (AOR=0.07, 95% CI=0.02, 0.66). mothers), perceived change in HIV risk or logistical PrEP access barri-
Conclusions: Findings show low odds for PrEP use among single men ers.
with condomless partners, an important subgroup of BSMM with Conclusions: AGYW in South Africa and Kenya recognize their HIV
high-transmission risk behaviors who comprise most of this sample. vulnerabilities and the benefits of PrEP, however implementing use is
Conversely, serodiscordant partners were more likely to use PrEP. To impacted by their social relationships and circumstances. Tailored flexi-
increase uptake of PrEP, culturally relevant tailored and targeted mes- ble interventions are needed to address young women’s diverse PrEP
saging strategies for BSMM with a combination of high sexual risk motivations, social contexts and understandings of prevention-effective
indicators are needed. adherence.
67
Support for equitable SRH decision-making was high in both settings:

PE01.33 89% of AGYW in Gem and 90% in Nairobi had a mean score equiva-
Association between DREAMS invitation and attitudes lent to ‘agree’ or ‘strongly agree.’ For inequitable norms around vio-
towards gender norms amongst young women in urban and lence, only 47% of AGYW in Gem had a score representing mean
rural Kenya, measured using an adapted and validated disagreement, whereas in Nairobi, 82% of AGYW disagreed. There
version of the GEM Scale was no evidence of an association between DREAMS invitation and
K. Nelson1; F. Magut2; S. Mulwa1; S. Khagayi2; A. Ziraba3; D. Kwaro2; SRH decision-making nor violence attitudes, in both Gem (SRH deci-
S. Floyd1 and I. Birdthistle1 sion-making: adjusted OR=1.13; 95% CI 0.69 to 1.87; Violence:
1
London School of Hygiene and Tropical Medicine, Faculty of Epidemiol- aOR=0.84; 95% CI 0.62 to 1.08) and Nairobi (SRH decision-making:
ogy and Population Health, London, United Kingdom, 2Kenya Medical aOR=1.28; (0.76 to 2.15); violence: aOR=1.08; 95% CI 0.72 to 1.64).
Research Institute, Centre for Global Health Research, Kisumu, Kenya, Conclusions: We found no evidence of an effect of DREAMS on indi-
3
African Population and Health Research Center, Nairobi, Kenya vidual attitudes towards gender norms amongst AGYW, after three
years of DREAMS implementation. It is possible that shifts in norms
at the community level are not immediately reflected in individual atti-
Background: Gender norms play an important role in shaping health- tudes. While support for equitable norms was generally high, our find-
related behaviours, experiences, and expectations from an early age. ings highlight a need to understand and address inequitable norms
Shifting inequitable norms therefore has the potential to improve sex- around intimate partner violence, especially in rural Kenya.
ual and reproductive health (SRH) outcomes, including HIV risk. We
evaluated the impact of DREAMS, a multi-component HIV prevention PE01.34
programme, on individual attitudes towards gender norms amongst Preferences for PrEP formulations and service delivery:
adolescent girls and young women (AGYW) in two Kenyan settings.
Results from qualitative in-depth interviews with
Methods: AGYW aged 15 to 22 in Gem (n = 888) and Nairobi (n =
1081), Kenya, were randomly selected for enrolment into survey
transgender women in three South African cities
cohorts (in 2017 and 2018, respectively) and followed-up to 2019. T. Poteat1; L.L.A. van der Merwe2; A. Cloete3; D. Adams4; M. Malik4 and
We validated and adapted the Gender Equitable Men (GEM) scale A. Wirtz4
1
using factor analysis, and used it to describe attitudes towards gender University of North Carolina Chapel Hill, Department of Social Medi-
norms stratified by age group and setting. Logistic regression was cine, Chapel Hill, United States, 2Social Health Empowerment Feminist
used to estimate the association between being a DREAMS benefi- Collective of Transgender Women of Africa, South Africa, 3Human
ciary by 2018 and GEM scores in 2019, adjusting for confounders. Sciences Research Council, South Africa, 4Johns Hopkins Bloomberg
Results: We identified four factors measured by the GEM Scale School of Public Health, Baltimore, United States
items: equitable norms around SRH decision-making (n = 5 items;
alpha=0.86), and inequitable norms around violence (n = 6 items;
Background: Transgender women (TW) in South Africa have an HIV
alpha=0.76), need for sex (n = 3 items; alpha=0.67), and initiation of
prevalence over 60% in some cities. The National Strategic Plan rec-
sex (n = 2 items; alpha=0.62). The first two factors were considered
ommends pre-exposure prophylaxis (PrEP) for transgender people.
as primary outcomes.
68
However, data on TW’s preferences for PrEP formulations and service with them. In the multi-variable model, ‘non-intenders’ were younger
delivery is absent. (<25yrs) (aOR[95% CI]= 3.68[2.14;6.33]), more likely to live in loca-
Methods: We purposively sampled 36 TW in Cape Town, East Lon- tions with few PrEP access points (1.74[1.13;2.68]), not have been
don, and Johannesburg between 06/01/2018 and 11/30/2018. Fol- spoken to about PrEP at a hospital (12.34[8.87;17.18]) or at a commu-
lowing informed consent, we conducted qualitative in-depth interviews nity service/drop-in (4.88[3.45;6.89]), not report hepatitis B vaccina-
with 12 TW in each city in English, Xhosa, or Afrikaans. We asked tion (2.20[1.45;3.35]), and have lower knowledge about on-demand
about perspectives on oral, injectable, and topical PrEP; and prefer- (11.62[7.45;18.11]) and daily PrEP (2.53[1.25;5.15]). They also
ences for PrEP service delivery. Interviews were audio-recorded, tran- reported greater self-efficacy regarding safer sex (1.62[1.10;2.38]).
scribed verbatim, translated, and coded by two coders with Conclusions: “Non-intenders” were less engaged with the healthcare
discrepancies resolved by consensus. We grouped codes by topic and system and despite lower HIV-related risk, were eligible for PrEP.
analyzed for salient recurrent themes. While PrEP may not meet the prevention needs for all “non-intenders”
Results: Table 1 lists participant characteristics and exemplar quotes (preference for/use of TasP, self-testing, etc), on-demand PrEP may be
for salient themes. Of the 36 participants, 32 had heard of PrEP, 6 a suitable HIV prevention tool for others. Therefore, health and com-
had ever taken PrEP, and 3 were currently on PrEP. Dislike of daily munity workers should increase their efforts to identify “non-inten-
dosing was a common theme and the most common reason for prefer- ders” and talk about on-demand PrEP in addition to other prevention
ring injectable or topical to oral formulations of PrEP. Many TW tools.
expressed a desire for an injectable option; however, some partici-
pants preferred a topical formulation. Overall, the need for choices in PE01.36
prevention technologies emerged as salient theme. Reports of discrim-
Transgender women’s experiences using a blood-based,
ination were ubiquitous, including mistreatment by health care provi-
ders. In fact, TW mentioned a reduction in health facility visits as an
combination HIV/syphilis at-home rapid test kit that
advantage of injectable PrEP over oral PrEP, which required monthly delivers Results in 60-seconds (INSTI Multiplex) for self-
facility visits for medication refills. Throughout all interviews, the need and partner-testing
for de-stigmatizing services was a powerful and consistent theme. C. Tagliaferri Rael; J. Lopez-Rıos; C. Lentz; C. Dolezal; B. Kutner;
Conclusions: TW are eager for alternatives to daily pill taking; and R. Giguere; A. Carballo-Die guez and I. Balan
provision of respectful transgender-competent services will be key to NYSPI/Columbia University, HIV Center for Clinical and Behavioral
PrEP engagement, regardless of PrEP formulation. This study con- Studies, New York, United States
tributes important data to inform implementation of PrEP services
that meet the needs of TW.
Background: We report on the self- and partner-testing experiences
of N = 11 transgender women (TW) in New York City who used the
PE01.35
INSTI MultiplexO, an at-home, blood-based, combination HIV/syphilis
Factors associated to the non-intention to use PrEP in men rapid test that delivers results in 60-seconds, and a corresponding
who have sex with men in France: Results from the smartphone app to scan test results.

European MSM Internet Survey (EMIS-2017) Methods: TW participants were given six INSTI MultiplexO tests to
M. Di Ciaccio1; V. Villes1; R. Delabre1; T. Alain2; D. Michels2; take home and use on themselves or with potential sexual partners.
A.J. Schmidt3; D. Rojas Castro1 and A. Velter4 Participants were also oriented to the corresponding smartphone app
1
Coalition PLUS, Community-Based Research Laboratory, Pantin, used to scan test results. After one month, 11 participants returned

France, 2AIDES, Pantin, France, 3Sigma Research, Department of Pub- for an interview on their experiences with the INSTI MultiplexO, and
lic Health, Environments and Society, London School of Hygiene and the app. Themes discussed in the interviews included, what it was like
Tropical Medicine, London, United Kingdom, 4Sante Publique France, to use the test, with whom participants used tests (including decision-
Saint-Maurice, France making around testing), partners’ reactions to the idea of testing/sub-
sequent test results. Data were independently analyzed by two
coders.
Background: PrEP (on-demand or daily) has been fully reimbursed Results: Participants (N = 11) had a median age of 40 years. Roughly
by the French national health insurance system since 2016. 50,000 half (n = 6) reported Latinx ethnicity, and nearly all (n = 10) reported
Men who have Sex with Men (MSM) were estimated to be eligible being women of color. Participants had a median of 10 sexual partners
for PrEP. However, there were an estimated 10 000 users in 2018. during the one-month intervention. They used self-test kits to test
To increase PrEP coverage, we need to better characterize MSM themselves, or a partner a median of 3.5 and 1.5 times, respectively.
who may benefit from PrEP but are not using it. The objective of Some participants reported that remembering the test sequence of

this study was to identify factors associated with non-intention to the INSTI MultiplexO could be complicated, and that not all partners
use PrEP among MSM who are (1) eligible according to French were willing to give blood through the finger prick procedure. How-
guidelines (based on sexual behaviours), and (2) aware of PrEP ever, the speed of test results (e.g., 60-seconds), and the simultaneous
(‘non-intenders’). syphilis test was motivating for participants and partners to overcome
Methods: Data comes from EMIS-2017, an anonymous, 33-language, this in some cases. Participants reported that most partners who were
cross-sectional online survey among MSM, conducted across 50 coun- offered the test were receptive, and few became angry or refused.
tries between October 2017 and January 2018. We assessed the per- Most of the time, partners who were offered the test were already
centage of PrEP users and ‘non-intenders’ amongst respondents who known to the participant.
have not been diagnosed with HIV living in France. Socio-demographic Conclusions: Overwhelmingly, participants’ experiences with the

characteristics, sexual behaviours and HIV knowledge were compared blood-based INSTI MultiplexO were positive. Most partners who were
between PrEP users and ‘non-intenders’ using logistic regression mod- presented with the test were willing to use it. Though the finger prick
els. procedure was not favorable, the fact that results appear in 60-sec-
Results: Among 8,009 participants, 734 (9.2%) were using PrEP and onds, alongside a syphilis test result may have helped to overcome
1,098 (13.7%) were ‘non-intenders’, with a median age of 38[IQR 31– this. This suggests that using a rapid, blood-based HIV/syphilis test
46], and 35[26–45], respectively. ‘Non-intenders’ were more likely to could be a viable harm reduction strategy for TW.
live in smaller towns, be a student, identify as bisexual, report fewer
non-steady intercourse partners and higher frequency of condom use
69
PE01.37 and intimate partner violence (IPV). Depressive symptoms at PrEP ini-
tiation may reduce PrEP adherence. However, the proportion of
Perspectives on use of PrEP from Black and Latinx sexual
AGYW initiating PrEP with persistent depressive symptoms, the rela-
and gender minority youth
tionship between symptoms and other psychosocial factors, and the
F. Shorrock1; A. Alvarenga2; K. Hailey-Fair2; D. Celentano3 and impact of persistent symptoms on PrEP adherence have not been
R. Arrington-Sanders2 studied.
1
Johns Hopkins School of Medicine, General Pediatrics and Adolescent Methods: HPTN 082 was an open-label PrEP study among AGYW
Medicine, Baltimore, United States, 2Johns Hopkins School of Medi- (ages 16 to 24) in Harare, Zimbabwe and Cape Town and Johannes-
cine, Pediatrics, Baltimore, United States, 3Johns Hopkins Bloomberg burg, South Africa from 2016 to 2018. Depressive symptoms were
School of Public Health, Epidemiology, Baltimore, United States measured at enrollment and months 3, 6, and 12, using the 10-item
Center for Epidemiologic Studies scale; a score >10 is correlated with
clinical depression. PrEP stigma, IPV, sexual behavior, and PrEP adher-
Background: Pre-exposure prophylaxis (PrEP) effectively protects
ence were also assessed at these visits. High PrEP adherence was
against HIV, yet uptake has been low among sexual and racial minori-
defined as tenofovir diphosphate levels >=700 fmol/DBS punch. Group-
ties. We sought to understand sex-specific PrEP use in a sample of
based trajectory modeling was used to model longitudinal patterns of
Black and Latinx sexual and gender minority youth (BLSGMY) at-risk
depressive symptoms, assigning participants to a trajectory (e.g., persis-
for or recently diagnosed with HIV.
tent, sporadic, no symptoms). We assessed psychosocial predictors of
Methods: In-depth interviews (IDIs) were conducted with 31
trajectories to understand factors associated with symptom patterns
BLSGMY (19 at risk for and 12 living with HIV and young transgender
and used generalized estimating equations to model associations
women) age 15 to 24 who were recruited into randomized control tri-
between group trajectory membership and 12-month PrEP adherence.
als aimed at increasing PrEP uptake and ART adherence. Interviews
Results: At enrollment, 179 (41.9%) of 427 participants had elevated
lasted 45 to 60 minutes and focused on barriers and facilitators of
depressive symptoms consistent with clinical depression. 33.0%,
prevention and treatment. Interviews were transcribed verbatim.
36.7%, and 36.9% had elevated symptoms at months 3, 6, and 12,
Inductive and deductive coding was used to organize excerpts. Coded
respectively. Group-based trajectory models revealed persistent ele-
transcripts were organized into individual and partner-specific cate-
vated symptoms in 49.2%, declining symptoms in 13.5%, and steady
gories and then by HIV status. Emergent themes were grouped and
low/no symptoms in 37.3%. AGYW who engaged in transactional sex,
categorized using a grounded theory approach.
reported IPV, or had traumatic stress symptoms were more likely to
Results: Nearly one-half of BLSGMY at risk for HIV reported having
be assigned to the persistent elevated symptom group compared with
been on PrEP (n = 9/19), with 5 currently taking or having recently
the steady low/no symptom group (Wald test p-value all < 0.01). Par-
taken PrEP. Most BLSGMY living with HIV (n = 11/12) reported never
ticipants assigned to the persistent depressive symptom trajectory
having heard of or taken PrEP prior to their diagnosis. For both
had significantly lower odds of high PrEP adherence than those in the
groups, a desire to engage in protected condomless anal sex was the
low/no symptom trajectory (aOR=0.73; 95% CI: 0.56 to 0.96).
major theme that emerged around sex-specific PrEP-use. Non-use
Conclusions: Depressive symptoms were common and persistent
themes included: 1) low perceived risk for HIV because of few concur-
among AGYW seeking PrEP in sub-Saharan Africa. Integration of
rent or random sex partners; 2) feeling that condoms were more
depression screening and treatment into HIV prevention programs
effective because they also protect against other STIs; and 3) feelings
may improve PrEP effectiveness among African women.
of trust, seriousness, and/or perceived monogamy in their partnership.
Both at-risk for and living with HIV respondents shared that discus-
sions of PrEP eased ‘status disclosure conversations’ by promoting PE01.39
those at risk to ask about the status of their partners and youth living Attitudes towards two biomedical HIV prevention
with HIV to disclose one’s HIV status. strategies among HIV-negative men who have sex with
Conclusions: Sex positive communication with partners (particularly men: an attitude network analysis in the Amsterdam Cohort
in serodiscordant relationships) and promotion of protective condom- Study
less sex may be a key factors in increasing BLSGMY to engage with H. Zimmermann1; U. Davidovich1 and F. van Harreveld2
PrEP. To effectively engage youth in PrEP, efforts will need to focus 1
Public Health Service Amsterdam, Department of Infectious Diseases,
around perceptions of risk, condom efficacy and partner-specific fac-
Amsterdam, Netherlands, 2University of Amsterdam, Department of
tors like trust, which may be key drivers of PrEP non-use in this popu-
Social Psychology, Amsterdam, Netherlands
lation.
PE01.38 Background: The impact of biomedical HIV-prevention strategies

Assessing longitudinal patterns of depressive symptoms and among men who have sex with men (MSM) depends on uptake. Using
the influence of symptom trajectories on PrEP persistence an attitude network analysis, we aimed to investigate which beliefs
are associated with the uptake of pre-exposure prophylaxis (PrEP) and
among adolescent girls in HPTN 082
viral load sorting (VLS, i.e. treatment as prevention), which can be tar-
J. Velloza1; S. Hosek2; D. Donnell3; P. Anderson4; M. Chirenje5;
geted in behavior change interventions.
N. Mgodi5; L.-G. Bekker6; S. Delany-Moretlwe7 and C. Celum3
1
Methods: HIV-negative MSM reporting anal sex during the previous
University of Washington, Department of Global Health, Seattle, Uni- six months were drawn from one six-monthly data wave (January-June
ted States, 2Stroger Hospital of Cook County, Department of Psychia- 2019) of the Amsterdam Cohort Study. We estimated a weighted,
try, United States, 3University of Washington, Seattle, United States, undirected, partial correlation network (Figure) where we included
4
University of Colorado, United States, 5University of Zimbabwe, Har- condom, PrEP and VLS use, HIV risk perception, 10 VLS-beliefs and
are, Zimbabwe, 6The Desmond Tutu HIV Centre, Cape Town, South 23 PrEP-beliefs. We report on (1) partial correlations to identify direct
Africa, 7University of the Witwatersrand, Johannesburg, South Africa correlates of condom, PrEP and VLS use, (2) community detection to
identify clustering beliefs, and (3) node centrality to identify the nodes
most influential in the network.
Background: African adolescent girls and young women (AGYW) who
Results: We included 532 HIV-negative MSM, of whom 246 (46%)
may benefit from HIV pre-exposure prophylaxis (PrEP) face high levels
reported condom use, 131 (25%) reported PrEP use, and 39 (7%)
of depression and related psychosocial issues, including PrEP stigma
reported VLS in the previous six months. Strongest correlates of
70
condom use were no PrEP use (r = -0.21, p < 0.001) and lower HIV Methods: In preparation for an HIV vaccine efficacy trial, adults (18
risk perception (r = -0.18, p < 0.001). Strongest correlates of PrEP to 45 years) at high risk of HIV infection were recruited from July
use were lower expected burden of PrEP procedures (r = 0.12, p < 2018 to February 2020 in Masaka, south-western Uganda. Volunteers
0.001) and PrEP’s perceived positive impact on quality of sex life (r = were provided quarterly risk-reduction counselling and those willing
-0.10, p < 0.001), the latter was also the strongest correlate of VLS to start PrEP referred to a provider. Self-reported sexual behaviour
use (r = 0.05, p =0.018). Community detection suggests that PrEP data were collected at baseline and every six months using standard-
uptake clusters with several practical considerations such as PrEP’s ised questionnaires. We assessed changes in HIV risk indicators
anticipated affordability (green in Figure). PrEP’s expected impact on between baseline and one year, using proportion differences, McNe-
quality of sex life was the most central node within the network. mar chi-square test for binary predictors and ordinary chi-square for
Conclusions: Our findings suggest that PrEP and VLS use are per- other categorical predictors.
ceived as having a positive impact on one’s quality of sex life which may Results: Four hundred and forty-one volunteers were enrolled of
be used in communication to improve uptake among non-users. whom 184 (42%) had completed their one year assessments. Of the
Addressing specific practical considerations of PrEP may also improve 184, 80 (43%) were female and 91 (49%) ≤25 years. The following dif-
PrEP uptake. ferences in the prevalence of reported high-risk sexual behaviour were
observed between baseline and one year of follow-up: unprotected sex
PE01.40 with ≥3 partners in the last 3 months (47% vs. 17%,
p < 0.001); transactional sex in the last 3 months (60% vs. 46%,
Changes in risky sexual behaviour among adult men and
p =0.004); sex when drunk (18% vs. 15%, p =0.04); ≥6 sexual partners in
women receiving regular personalised counseling in an HIV the last 3 months (23% vs. 16%, p =0.02). 38 (21%) of the participants
vaccine preparedness study in south-western Uganda had initiated PrEP at one year. Absolute differences in the prevalence of
J. Kitonsa1; S. Kansiime2; M. Onyango2; K. Safina2; D. Asio2; reported high-risk sexual behaviour between baseline and one year
A. Kabarambi2; S. Kusemererwa2; E. Ruzagira2 and P. Kaleebu2 were larger among participants who started PrEP: unprotected sex with
1
MRC/UVRI & LSHTM Uganda Research Unit, Research, Entebbe, ≥3 sexual partners in the last 3 months (32% vs. 30%); transactional sex
Uganda, 2MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda in the last 3 months (21% vs. 11%); ≥6 sexual partners in the last 3
months (16% vs. 6%). No difference was observed in the frequency of
drunken sex among participants who initiated PrEP.
Background: Changes in sexual behaviour may occur over time when Conclusions: We observed a reduction in reported high risk sexual
individuals receive regular HIV risk reduction counselling; while con- behaviour in this cohort including in participants who initiated PrEP.
cerns about risk compensation among those initiating pre-exposure Regular risk-reduction counselling should be considered for individuals
prophylaxis (PrEP) remain. We assessed changes in sexual behaviour at high-risk of HIV acquisition in addition to PrEP and other HIV pre-
among adults in an HIV vaccine preparedness cohort study. vention interventions.
71
PE01.41 PE01.42
Service providers perception of a home-based intervention MTV-SHUGA: how did MTV-Shuga improve HIV prevention
to test and start (HITS) in rural KwaZulu-Natal, South Africa and sexual health outcomes among adolescents and young
O. Adeagbo1; F. Tanser2; K. Hae-Young3; T. Mathenjwa3; people in rural KwaZulu-Natal?
T. Barnighausen3; N. McGrath4; A. Blandford5; M. Shahmanesh6 and
T. Zuma1; N. Kyegombe2; S. Hlongwane3; M. Nhlenyama3;
J. Seeley7
1
N. Chimbindi3; J. Seeley2 and M. Shahmanesh4
Africa Health Research Institute, Social Science & Research Ethics, 1
Africa Health Research Institute, Social Science and Research Ethics,
Durban, South Africa, 2University of Lincoln, United Kingdom, 3Africa
Durban, South Africa, 2London School of Hygiene and Tropical Medi-
Health Research Institute, Durban, South Africa, 4University of
cine, London, United Kingdom, 3Africa Health Research Institute, Dur-
Southampton, Faculty of Medicine, Southampton, United Kingdom,
5 ban, South Africa, 4Institute for Global Health, University College
University College London, UCL Institute of Healthcare Engineering,
London, London, United Kingdom
United Kingdom, 6University College London, Institute for Global
Health, United Kingdom, 7London School of Hygiene and Tropical
Medicine, Global Health & Development, London, United Kingdom Background: MTV-Shuga is a mass-media behaviour change interven-
tion that seeks to address social and structural drivers of HIV infection
amongst young people in South Africa. It is delivered through television
Background: Men are missing from the HIV treatment cascade in
storylines related to sexual and reproductive health, HIV/AIDS, abor-
South Africa, contributing to higher HIV cause-specific mortality in
tion, transactional sex and intimate partner violence. We explore ways in
men and onward transmission to their female partners. Home-based
which MTV-Shuga could improve HIV prevention and sexual health out-
Intervention to Test and Start (HITS), a factorial design randomised
comes among adolescents and young people in rural KwaZulu-Natal.
controlled trial (#NCT03757104) was designed to assess the effec-
Methods: Between May and November 2019, we conducted eight (n
tiveness of financial micro-incentives (R50[$3] food vouchers) and/or
= 4 in schools and n = 4 in community settings) 22-minute screenings
a male-targeted tablet-based counselling application (Empowering Peo-
of episodes of MTV-Shuga Down South in five communities in rural
ple through Informed Choice for HIV [EPIC-HIV]) to support home-
KZN. Following these, and using a semi-structured topic guide, we
based testing and linking men to care in rural South Africa. The use of
conducted 13 FGDs, 25 IDIs, and structured observations with female
a once-off voucher increased the uptake of home-based testing by
and male participants aged 15 to 30 years. IDIs and FGDs were con-
more than 50%. We report on service providers’ (fieldworkers and
ducted in isiZulu, audio recorded and transcribed verbatim. Data anal-
clinical staff) perceptions of HITS study.
ysis was thematic.
Methods: Ten in-depth interviews and one group discussion were
Results: MTV-Shuga may have had an impact through:
conducted with a purposive sample of fieldworkers who offered
home-based HIV testing [n = 10] and clinical staff [n = 4] providing 1) valuable access to information on sexual and reproductive health
HIV treatment and prevention services between August 2018 and to adolescents;
February 2019. Transcripts were coded and categorised using NVIVO 2) positive storylines, through which adolescents could model positive
while identified themes were thematically analysed. and aspirational behaviours;
Results: Service providers reported that the intervention was deliv- 3) negative storylines including about physical abuse, forced sex, par-
ered as planned and the voucher acted as a powerful ‘catalyst’ for, tying, abortion and dating sugar daddies (Blessers) may have
whilst EPIC-HIV information “nudged” men towards, HIV testing and offered young people an example of how their decisions could lead
linkage to care. However, they were concerned that some participants to adverse outcomes, although some participants believed that
with prior knowledge of their HIV status tested because of the vou- these storylines could influence young people to manifest these
cher; sustainability of voucher provision; and poor linkage to care in negative behaviours in their own lives;
men. Participants in non-financial arms resented missing out on the 4) participants identified with the characters or knew someone in
voucher and fieldworkers sometimes felt exhausted explaining why their community who identified with the characters, and thus,
certain participants and communities were ineligible for vouchers. easily understood, and examined characters’ choices. For example,
They felt the training received was adequate, but the time allocated participants critically engaged with scenes which encouraged sub-
was too short to absorb the information before implementation. mission and silence in females and control and coercion in males;
Conclusions: Home-based HIV service delivery and financial incen- 5) participants valued the space the viewings provided to discuss
tives have been advocated as tools to improve HIV outcomes and the topics including, HIV, ART, contraceptives, and other sexual and
HITS trial demonstrated that provision of a small once-off voucher reproductive health issues “alone” as young people. They juxta-
substantially increased the uptake of HIV testing. Fieldworkers and posed this with the awkwardness of discussing these topics with
clinicians interviewed in this sample felt that whilst the vouchers had parents or older adults in their households.
acted as a powerful catalyst for HIV testing, they were unsure
Conclusions: Edutainment interventions such as MTV-Shuga posi-
whether such a strategy would be sustainable in the long term.
tively impact young people’s sexual and reproductive health through
different mechanisms and could usefully complement other interven-
tions designed for this purpose.
PE01.43
PrEP persistence among Black ciswomen in Chicago, USA
M. Pyra1; L. Rusie2; C. Blum2; S. Irby2 and J. Ridgway3
1
Howard Brown Health, EEE, United States, 2Howard Brown Health,
United States, 3University of Chicago, Medicine, United States
Background: While 11% of new HIV infections in the US are in Black

ciswomen, few Black ciswomen are using PrEP and little is known
regarding how they use PrEP.
72
Methods: We used prescription data from electronic medical records during pregnancy and STI risk at 6 months postpartum, controlling for
from 2015 to 2019 at an urban federally qualified health center in covariates.
Chicago, IL, USA, to examine PrEP persistence (having ≥ 6 PrEP pills Results: 13% of adolescent mothers had at least one incident STI at
per week) and retention (having ≥ 1 quarterly HIV test) over the first end line (Table 1). The median relationship control score was 36 (IQR:
6 months of PrEP use for all Black ciswomen. We used logistic regres- 32 to 39). In multivariate analysis, there was a significant interaction
sions to examine demographic, clinical, and social factors associated between relationship control and familial support. For adolescent
with PrEP persistence and retention. mothers with high familial support (85th percentile), post-hoc analysis
Results: Among 142 women, 74% were ≤ 35 and 61% identified as indicated that relationship control was negatively associated with inci-
straight; more than half used public insurance. Most PrEP initiation visits dent STI (simple slope: b = 0.17; p = 0.01) (Figure 1). However,
(49%) specifically mentioned PrEP as the chief complaint. The average there was no association between relationship control and familial
zipcode HIV prevalence was 1.2%. Overall, 19% of ciswomen persisted support for adolescent mothers with average (50th percentile) or low
on PrEP for 6 months and 32% continued in care for HIV prevention. In (15th percentile) familial support. Interaction between relationship
the adjusted models for persistence, ciswomen with chief complaint of control and peer support was not significant.
PrEP/PEP-to-PrEP were more likely to achieve persistence (aOR 7.64 Conclusions: Our findings suggest relationship control is negatively
[95% CI 1.29, 45.1]) compared to those with non-STI/HIV chief com- associated with STI risk for adolescent mothers with high familial sup-
plaints; neighborhood of residence (North, West, South or outside Chi- port. Future research is needed to identify other social factors that miti-
cago) and earlier year of PrEP initiation were also significantly gate adolescent mothers’ HIV/STI risk. Interventions that increase
associated with higher odds of persistence. Age, insurance status, provi- familial support during the perinatal period may reduce HIV/STI risk,
der race, and provider gender were non-significant. In the adjusted particularly for those women in highly controlling relationships. Tar-
models of retention, there were no significant associations; however geted interventions aimed to reduce STIs among this particularly vul-
neighborhood residence and higher HIV prevalence among females (by nerable population can improve adolescent mother and her baby’s
zipcode) were associated with lower retention, at p = 0.07. health.
Conclusions: PrEP persistence and retention over the first six
months were low among Black ciswomen in this sample; efforts are PE01.45
needed to better understand the reasons that Black ciswomen may
“What the %*^! is PrEP?”: what social media engagement
step away from PrEP, and explore what support could be helpful for
them to sustain PrEP when desired. Persistence was significantly
with MTV Shuga reveals about knowledge and attitudes to
higher among ciswomen who sought PrEP during their medical visit, PrEP
suggesting that pre-existing knowledge of PrEP may be an important V. Baker1; I. Birdthistle1; S. Cousens2; S. Sarrassat2; C. Cawood3 and
factor. Neighborhood was significantly associated with persistence and D. Khanyile3
1
almost significantly associated with retention, suggesting the impor- London School of Hygiene and Tropical Medicine, Department of
tance of structural factors. Community-level awareness of and access Population Health, London, United Kingdom, 2London School of
to PrEP may be important avenues to improve PrEP use among Black Hygiene and Tropical Medicine, Department of Infectious Disease Epi-
ciswomen. demiology, London, United Kingdom, 3Epicentre Health Research, Dur-
ban KwaZulu-Natal, South Africa
PE01.44
Examining how support influences the association between Background: ‘MTV Shuga’ is a multi-media campaign designed to
relationship control and postpartum STI amongst South equip young people with knowledge and resources to make informed
African adolescent mothers choices about their sexual and reproductive health and avert HIV. It is
L. Gebrekristos1; A. Groves1; H.L. McNaughton Reyes2; S. Maman2 centered around a popular edutainment TV drama, with social media
and D. Moodley3 activities to boost participatory engagement. Recent series have aimed
1
Drexel University Dornsife School of Public Health, Community to increase PrEP awareness and we examine viewers’ knowledge and
Health and Prevention, United States, 2University of North Carolina attitudes about PrEP, as they engage with the show via social media.
Gillings School of Global Public Health, Health Behavior, Chapel Hill, Methods: We extracted 2,296 YouTube comments from MTV Shuga
United States, 3University of KwaZulu-Natal, Department of Obstet- (‘Down South 2) episodes featuring PrEP storylines. Posts were down-
rics and Gynaecology, South Africa loaded and transcripts analyzed using an inductive thematic approach.
Emerging themes on PrEP were discussed and refined in meetings
with the production and research teams.
Background: Adolescent girls, and particularly adolescent mothers, Results: Viewers’ comments reflected mixed levels of knowledge
are disproportionately impacted by HIV infection in sub-Saharan about PrEP. Some were learning of PrEP for the first time (“What the
Africa. Recent studies have focused on the impact of sexual relation- hell is prep? I never heard of it”) while others willingly shared knowl-
ship dynamics (i.e., control) on adolescent mothers’ HIV/STI risk. Yet, edge (“PrEP has some side effects when you first use, but once your
the protective effects of familial and peer support, has been under- body is used to it you’re fine”). People posted questions to learn more
studied. Therefore, this study examines whether familial and peer sup- about PrEP (“Does PrEP alter your body functions?”) and received
port buffers the association between adolescent mothers’ relationship advice and resources from online peers or MTV Shuga staff. One per-
control in pregnancy and STIs in the first 6 months postpartum. son was critical about the PrEP messaging in the show saying it felt
Methods: Adolescent mothers (<20 years) were recruited at a hospi- “forced and unnatural” and some shared false, negative information
tal’s maternity ward near Durban between July 2017 and April 2018. (“Dat prep sh*t is killing ppl and causing castration”) to which produc-
Participants completed biological and behavioral assessments at tion staff replied with corrections (“You are incorrect, fam”).
6 weeks (baseline) and 6 months postpartum (end line). Adolescents Conclusions: MTV Shuga raised audience members’ interest and
who were HIV-negative and had no STIs at baseline (n = 61) were awareness of PrEP on social media. PrEP was a topic that viewers
included in the analyses. Relationship control during pregnancy was were motivated and comfortable discussing online. Social media was a
measured using the Sexual Relationship Power Scale. Higher scores useful tool for correcting misinformation, reinforcing accurate mes-
indicated higher relationship control. We used a modified Poisson sages around PrEP and disseminating additional resources. It revealed
regression with robust standard errors to test whether familial and both support and resistance to PrEP, offering insights to improve PrEP
peer support weaken the association between relationship control uptake among young people.
73
PE01.47 are needed to enhance the prevention toolbox for AGYW. An

underutilized yet potentially important strategy is to capitalize on fam-
The impact of PrEP intent and use disclosure on PrEP
ily strengths to reduce sexual risk in AGYW. In particular, female care-
adherence and persistence among South African adolescent
giver-adolescent girl relationships may be critical to fostering
girls and young women supportive environments for HIV risk reduction among adolescent
D. Giovenco1; A. Pettifor1; K. Gill2; J. Morton3; A. van der Straten4; girls and young women in South Africa.
C. Celum3 and L.-G. Bekker2 Methods: The study reports the steps taken to systematically contex-
1
University of North Carolina at Chapel Hill, Epidemiology, Chapel Hill, tualize and adapt an evidence-based mother-daughter HIV/STI pre-
United States, 2Desmond Tutu HIV Centre, Cape Town, South Africa, vention program (IMARA) for 15 to 19-year-old South African AGYW
3
University of Washington, Global Health, Seattle, United States, 4RTI and their mothers/female caregivers. IMARA consists of joint and sep-
International, Global Health Imperative, Research Triangle Park, Uni- arate mother-daughter activities designed to strengthen family rela-
ted States tionships and communication, increase condom use self-efficacy,
improve maternal monitoring, and promote gender and racial/ethnic
pride. Consistent with the ADAPT-ITT model (Wingwood & Dicle-
Background: Despite knowledge of the important roles various social mente, 2008), we implemented several stakeholder activities, including
groups play in the lives of most young people, there is a lack of community advisory board (CAB) meetings (youth n = 10; adults
research exploring social influences on PrEP use. The objective of this N = 9). Next, mother-daughter dyads were recruited through street
analysis was to determine if PrEP disclosure was associated with outreach, libraries, and schools to participate in theatre testing
adherence and persistence among adolescent girls and young women (N = 76) where facilitators presented the IMARA curriculum and
(AGYW). requested feedback. We analyzed data using the framework analysis
Methods: The 3Ps for prevention study (3P) was a prospective cohort approach.
study conducted among 200 HIV-uninfected AGYW in Cape Town, Results: CAB members, AGYW, and mothers uniformly reported that
South Africa using daily oral PrEP for 12 months. Participants were the intervention was acceptable, timely, suitable, and should ideally be
asked if they disclosed their intent to use PrEP at enrollment and their offered at schools, churches, clinics, and anywhere mothers and
PrEP use during follow-up separately for partners, parents, and peers. daughters congregate, either together or separately. Participants
High PrEP adherence was defined as tenofovir-diphosphate (TFV- placed importance on balancing long-held cultural traditions with mod-
DP) ≥ 700 fmol/punch and persistence as detectable TFV-DP (≥16 ern lifestyle without disempowering and reducing mothers’ role in the
fmol/punch) in dried blood spots. Modified Poisson regression was used upbringing of their daughters. Mothers and daughters embraced the
to determine if disclosure at enrollment or during follow-up was associ- effective communication module as essential, facilitating close mother-
ated with adherence and persistence through month 3. Findings were daughter relationships and easing discussions around sensitive topics.
stratified by age and assessed for effect measure modification. Families underscored the urgent need for accurate information about
Results: Participants had a median of 19 years (range = 16 to 25). At sexual and mental health, HIV, STIs, and the different prevention tools
enrollment, most (91%) had disclosed their plans to use PrEP–52% to including PrEP.
a partner, 62% to a parent, and 79% to a friend. Similar proportions Conclusions: Family relationships are an important yet underused
disclosed their PrEP use to at least one partner (56%), parent (57%), strategy to enhance prevention efforts for AGYW. IMARA appears to
and friend (82%) during the first three months of follow-up. Almost be acceptable and promising in the South African context with adapta-
half (48%) of participants had high adherence and 83% were persis- tions and the next steps include testing effectiveness in this setting.
tent with PrEP through month 3. Among AG (≤18 years), those who
disclosed their intent to use PrEP to a parent at enrollment were
more likely to persist (aRR = 1.41, 95% CI: 1.04 to 1.92) and those PE01.50
who disclosed their PrEP use to a friend during follow-up were less Multi-level factors influencing temporary and permanent
likely to persist (aRR = 0.88, 95% CI:0.81 to 0.97) with PrEP through interruptions in PrEP use among young women in Siaya
month 3. These associations were not observed among YW County, Kenya
(>18 years). There was evidence of effect measure modification by B. Perry1; K. Agot2; D. Ochieng Ngoje2 and A. Corneli1
age (Wald p-value for interaction = .041 and .039, respectively). 1
Duke University, Population Health Sciences, Durham, United States,
Conclusions: PrEP intent disclosure to parents may facilitate 3-month 2
Impact Research and Development Organization, Kisumu, Kenya
persistence among AG. Further, PrEP disclosure to peers was fre-
quently reported but negatively associated with persistence. PrEP pro-
grams for AG that involve peer support should find ways that peers Background: Given the dynamic nature of sexual behavior, people
can motivate PrEP use. may start and stop PrEP as their perceived HIV risk fluctuates,
referred to as ‘seasons of risk’. Understanding the multi-level factors
PE01.49 influencing short- and long-term interruptions in young women’s (YW)
PrEP use is vital to inform programs supporting YW through these
Engaging female caregivers to improve South African girls’
‘seasons’.
and young women’s sexual and reproductive health
Methods: As part of a larger photovoice project on PrEP adherence
outcomes and persistence among YW in Kenya’s Siaya County, we explored tem-
M. Atujuna1; K. Merill2; S. Ndwayana1; E. Emerson2; L. Fynn1; L.- porary and permanent interruptions in YW’s PrEP use. YW taking
G. Bekker1 and G. Donenberg2 PrEP (n = 18) took photographs depicting reasons YW 1) stop taking
1
Desmond Tutu Health Centre, Department of Medicine, Health PrEP for short periods of time, such as a few days or weeks, and 2)
sciences Faculty, UCT, Cape Town, South Africa, 2Centre for Dissemi- stop taking PrEP permanently. YW discussed their photographs in a
nation and IS, University of Illinois Chicago, Chicago, United States group with other YW. All discussions were conducted in Dholuo or
Kiswahili, audio recorded, simultaneously translated and transcribed,
and analyzed using applied thematic analysis.
Background: Despite global reductions in incident HIV infections, Results: YW described that interpersonal factors often led to tempo-
South African adolescent girls and young women (AGYW) continue to rary interruptions in PrEP. Participants reported that YW stop PrEP
acquire HIV at twice the rate and much earlier than their male coun- temporarily 1) if they perceived their live-in male partner would dis-
terparts (Shisana et al 2012; UNAIDS,2015). Innovative approaches agree with their PrEP use, and 2) when temporarily living apart from
74
their partner (e.g., when he travelled for work). Permanent PrEP inter- Background: DREAMS promotes a comprehensive HIV prevention
ruption was primarily related to intrapersonal and community factors. approach, including supporting adolescent girls and young women
Intrapersonal factors included lower perceived risk for HIV due to (AGYW) to stay in school and achieve secondary education. Educating
changes in YW’s known risk factors, such as changes in their own sex- girls has a multiplier effect, with the potential to reduce HIV risk both
ual behaviors, or assumed changes in partner’s behaviors. Community directly and indirectly.
factors focused on the influence of church/religious teachings, such as Methods: In two informal settlements in Nairobi, a cohort of 1081
promotion of monogamous marital relationships, sexual exclusivity, AGYW aged 15 to 22 years was randomly selected in 2017 and fol-
rejecting Luo inheritance rituals, and relying on faith and prayer to lowed-up to 2019. AGYW who reported invitation to participate in
preserve and protect health over medication. Negative rumors about DREAMS during 2017 to 2018 were classified as “DREAMS beneficia-
PrEP’s side effects and disparaging remarks about PrEP users, could ries”. We used current schooling status and highest level of education
also influence permanent PrEP use interruption, as could relational in 2019 to create composite measures of educational attainment. Our
and structural factors, such as negative pressure to stop taking PrEP main outcome was being in school and/or having completed at least
from partners, doctors, and peers, and frequent clinic stock outs. secondary form two. Using causal inference framework, we estimated
Conclusions: Temporary and permanent PrEP interruptions is the proportions achieving this outcome if all AGYW, versus no AGYW,
impacted by intrapersonal, interpersonal, and community influences. were DREAMS beneficiaries, adjusting for the propensity to be a
PrEP counseling should focus on reasons YW chose to stop taking DREAMS beneficiary.
PrEP to ensure YW remain safe when stopping PrEP. Results: Of 852 AGYW followed-up in 2019, 63% and 45% were in
school at cohort enrolment and endline, respectively, and 5% re-
PE01.51 enrolled in 2018 or 2019 (Table 1). Proportions in each education cat-
egory were higher among DREAMS beneficiaries than non-DREAMS
Impact of the DREAMS Partnership on educational
beneficiaries (Figure 1:Panel A). DREAMS was estimated to increase
attainment among adolescent girls and young women: proportions in school or completing minimum secondary form two
Causal analysis of a prospective cohort in urban Kenya from 82% if none were DREAMS beneficiaries to 86% if all were ben-
S. Mulwa1; J. Osindo2; E.O. Wambiya2; A. Gourlay3; I. Birdthistle3; eficiaries (+4% [95% CI 2,10%], with stronger evidence of effect
A. Ziraba2 and S. Floyd3 among younger versus older AGYW (Figure 1:Panel B).
1
London School of Hygiene & Tropical Medicine, Department of Popu- Conclusions: We found some evidence that DREAMS improved edu-
lation Health, London, United Kingdom, 2Africa Population and Health cational attainment among AGYW living in the Nairobi informal settle-
Research Center, Nairobi, Kenya, 3London School of Hygiene & Tropi- ment areas, facilitating both retention and re-enrolment.
cal Medicine, London, United Kingdom
75
a promising strategy to promote positive attitudes and behaviours

PE01.52 related to mental health and HIV prevention. This study reports on
Willingness to use HIV self-tests among female sex workers the acceptability and feasibility of IMARA (Informed, Motivated, Aware
from diverse sex work contexts: A qualitative study in S~
ao and Responsible Adolescents and Adults), an evidence-based mother-
Paulo, Brazil daughter HIV prevention program for the South African context.
D. Ferraz1; L. Murray2; I. Sorrentino3; E. Miura Zucchi4 and Methods: A feasibility study was conducted at the Desmond Tutu
A. Grangeiro3 HIV Foundation Youth Center (DTHFYC) in a township on South Afri-
1
Fundac~ao Oswaldo Cruz, Escola FIOCRUZ de Governo, Brazil, ca’s Cape Peninsula. Black mothers and daughters, 15 to 19 years-old,
2
Universidade Federal do Rio de Janeiro, Brazil, 3Universidade de S~ao were recruited over one month using street outreach and clinic-based
Paulo, Faculdade de Medicina, Depto de Medicina Preventiva, Brazil, recruitment. Interested AGYW (n = 146) provided contact data to
4
Universidade Cato lica de Santos, Programa de Pos-Graduac~ao em obtain additional information, and 67% (n = 43) of mother-daughter
Saude Coletiva, Brazil dyads attended at least one of two sessions and provided feedback on
IMARA’s curriculum and its acceptability and feasibility for HIV/STIs
prevention efforts.
Background: The introduction of new HIV prevention technologies, Results: AGYW (M = 17 years-old) and mothers (M = 36 years-old)
such as HIV self-test (HIV-ST), demands understanding the possible provided recommendations to improve attendance and intervention
repercussions of their use. This is especially important in sex work implementation. Both noted that attendance by biological mothers
(SW) contexts as environmental and structural factors, like working would be difficult because they cannot miss work as the primary
conditions and stigma, have been shown to influence HIV prevention. breadwinners. Also, South African culture typically relies on maternal
We analyzed female sex workers’ (FSW) willingness to use HIV-ST aunts to provide sexual and reproductive health guidance to AGYW.
considering their perception of their work environments. Participants suggested including alternative female caregivers to
Methods: Data was collected as part of Combina, a demonstration address this concern. Participants also recommended limiting the
study on HIV combination prevention conducted in five Brazilian cities. intervention duration to fit family needs. In terms of acceptability,
From October 2018 to February 2019, we interviewed 12 FSW in mothers and daughters actively participated in the sessions and
S~ao Paulo from diverse SW contexts: street, massage parlors, night offered recommendations to engage future participants. Mothers wel-
clubs, and apartment buildings. Interviews focused on their percep- comed the opportunity to engage with daughters on sensitive health
tions of their work environments, HIV prevention practices, and will- topics and form relationships with other mothers who differ in parent-
ingness to use HIV-ST. Data were analyzed using thematic analysis. ing styles and HIV prevention strategies. Mothers and daughters
Results: Participants’ ages ranged from 21 to 38. Nine had a high expressed satisfaction and excitement about the IMARA content and
school degree or higher. All but one reported skin color as black or its potential impact on reducing HIV infections among AGYW in their
brown. Nearly all evaluated their workplaces positively, valuing auton- community.
omy, fair payment, and safety. All but one had previously been tested Conclusions: This study supports the feasibility and acceptability of a
for HIV, but only three had heard of HIV-ST. None had previously group-based mother-daughter HIV prevention intervention in South
used it. Although time was a concern for use with clients, all were Africa with careful consideration of innovative and creative recruit-
interested in using HIV-ST in their workplace and believed their col- ment and retention strategies.
leagues would also be. Forms of possible use varied from personal to
a way to earn more money from condomless sex, especially in oral PE01.54
sex. Perceived risks of use included: being coerced into testing or con-
Attitudes towards PrEP and correlates of common mental
domless sex, clients feeling offended or suspecting the FSW had HIV,
manager/pimp reprimands, and fear of not knowing how to react if
disorder symptoms and substance use among young people
faced with a positive result (for themselves or clients). T. Nematadzira1; H. Weiss2; L. Stranix-Chibanda1; T. Bere3;
Conclusions: Knowledge of HIV-ST was low among participants. FSW A. Ssemata4; R. Muhumuza4; J. Dietrich5; S. Vermaak6; G. Tshabalala6;
believed its use would be feasible across all SW contexts, which might N. Ahmed7; M. Atujuna7; J. Seeley4 and J. Fox8
1
be related to their broader positive evaluation of their workplaces. University of Zimbabwe College of Health Sciences Clinical Trial
The identified risks indicate that HIV prevention programs need to Research Centre, College of Health Sciences, Harare, Zimbabwe,
2
promote HIV-ST appropriate use, ensure strong connections to HIV MRC Tropical Epidemiology Group London School of Hygiene and
treatment and support services, and educate clients and /pimps, in Tropical Medicine, London, United Kingdom, 3University of Zimbabwe
addition to FSW, on the technology. HIV-related stigma also must be College of Health Sciences, Department of Psychiatry, Harare, Zim-
addressed as a cross-cutting issue. babwe, 4Medical Research Council/Uganda Virus Research Institute
and London School of Hygiene &Tropical Medicine Uganda Research
Unit, Entebbe, Uganda, 5University of Witswatersrand, Perinatal HIV
PE01.53 Research Unit/Health Systems Research Unit/South African Medical
South African mothers and daughters perspectives on a Research Council, South Africa, 6University of Witswatersrand, Perina-
family-based intervention to improve girls’ sexual and tal HIV Research Unit, South Africa, 7Desmond Tutu HIV Foundation,
mental health University of Cape Town, Cape Town, South Africa, 8King’s College
L. Fynn1; M. Atujuna1; K. Merrill2; S. Ndwayana1; E. Emerson2; London, London, United Kingdom
L.-G. Bekker1 and G. Donenberg2
1
Desmond Tutu Health Centre, Department of Medicine, Faculty of
Health Sciences, University of Cape Town, Cape Town, South Africa, Background: Poor mental health can increase HIV risk by influencing
2
Centre for Dissemination and IS, University of Illinois, Chicago, sexual behavior and hindering uptake of HIV prevention strategies.
United States We assessed the associations of attitudes to HIV prevention strate-
gies with common mental health symptoms and substance use, among
young people (YP) in sub-Saharan Africa.
Background: South African adolescent girls and young women (AGYW) Methods: We recruited 673 male and 657 female HIV-uninfected YP
have one of the highest HIV incidence rates globally and twice the rate aged 13 to 24 years in South Africa, Uganda and Zimbabwe as part
of their male peers. Addressing their needs is essential to achieve an of the Combined HIV Adolescent PrEP and Prevention Study (CHAPS)
AIDS-free generation. Group-based mother–daughter interventions are in 2019. Participants completed a local language, tablet-based,
76
quantitative survey evaluating PrEP attitudes/preference, HIV risk practices: A key difference was motivation prior to recruitment among
behavior and alcohol/substance use. Outcomes included depression continuers, while discontinuers were mostly offered PrEP at enrollment.
(PHQ-9 > 10), anxiety (GAD-2 > 3), self-reported binge drinking (>6 Interaction with the community: both groups perceived positive reac-
drinks on one occasion at least once a month) and self-reported drug tions from their family and friends and negative reactions from sexual
use in the past month. Multivariable logistic regression assessed fac- partners. Care seeking and provider interactions: For both groups,
tors associated with screening positive for each condition, adjusting being able to trust their providers was essential. Structural: both groups
for site, age and sex. perceived health facilities as offering little privacy; operating at inflexible
Results: 40.7% (540/1328) participants screened positive for at least hours, and exposing them to situations of discrimination based on sexual
one condition (depression:17.4%, anxiety:15.7%, binge drinking:19.2%, orientation and gender identity.
and drug use:12.6%). Poor mental health was more common in South Conclusions: Key aspects in PrEP continuation included: appropriate
Africa than in Zimbabwe and Uganda. Probable depression was associ- background awareness; prior motivation to use PrEP due to reasons
ated with female sex (aOR = 2.02; 95% CI 1.49 to 2.77) and age 18 of safety, control and personal satisfaction. Conversely, discontinuers
to 24 vs 13 to 15 years (aOR = 2.04; 95% CI 1.17 to 3.55). Only perceived themselves to be at low risk, and were less tolerant to side
25% of YP had heard about PrEP. Binge drinking was associated with effects and to the adherence and regular check-up requirements of
concern about PrEP drug side-effects (aOR = 2.09, 95% CI 1.16 to the program.
3.77), forgetting to take pills (aOR = 2.15, 95% CI 1.08 to 4.29) and
sexual risk disinhibition (aOR = 2.68, 95% CI 1.34 to 5.36). Anxiety PE01.56
disorder symptoms were associated with concerns about the cost of
‘When you are old like me, then you get circumcised, you
paying for PrEP (aOR = 2.15, 95% CI 0.99 to 4.69). There was no
effect of depression, anxiety, binge drinking and drug use with poten-
will become like a castrated bull’: Barriers to VMMC uptake
tial use of condoms, injectable PrEP as HIV prevention modalities. in Eswatini
However binge drinking and drug use were associated with less will- A. Adams
ingness to use HIV testing and counselling services (binge drinking: Center for HIV/AIDS Prevention Studies (CHAPS), Health, Mbabane,
aOR = 0.69, 95% CI 0.49 to 0.97; drug us; aOR = 0.73; 95% CI 0.49 Eswatini
to 1.09).
Conclusions: There was some variation in attitudes to HIV preven-
tion strategies by mental health and substance use behaviors integrat- Background: Compelling evidence from three randomized controlled
ing mental health and substance use screening into HIV prevention trials which showed that voluntary medical male circumcision (VMMC)
services and specific HIV prevention messaging depending on mental reduces HIV infection from women to men by up to 60% led to the
health symptoms could be an effective strategy to promote in PrEP WHO recommending that VMMC be implemented in 14 priority
use as an HIV prevention strategy among young people. countries. As one of the priority countries, Eswatini aimed to reach
80% VMMC coverage among males 10 to 49 years since program
inception in 2009. By the end of 2019, the country had reached a
PE01.55 modest 40%. With the highest HIV prevalence in the world at 27%
Challenges in the Implementation of PrEP in Peru: a among those aged 15 and above, VMMC remains a crucial HIV pre-
qualitative perspective from the experience of MSM vention strategy in the country. This study aimed to explore the rea-
continuers and discontinuers in the ImPrEP study sons why there is limited VMMC uptake among Swazi men as well as
J.P. Jiron Sosa1; K.A. Konda1; C. Sandoval Figueroa1; J.V. Guanira2; strategies improve to the program.
E.H. Vega Ramirez3; V. Veloso4 and C.F. Caceres Palacios1 Methods: Six focus group discussions were used to collect data from
1
Universidad Peruana Cayetano Heredia, Lima, Miraflores, Peru, males aged 15 to 49 years in Mbabane East in 2020 and analyzed
2
Investigaciones Me dicas en Salud (INMENSA), Lima, Lima, Peru, using thematic content analysis.
3
Instituto Nacional de Psiquiatrıa Ramon de la Fuente Mun ~iz, Ciudad Results: There are significant barriers among Swazi men which lead to
de Me xico, Mexico, 4Instituto Nacional de Infectologia Evandro Cha- the continued slow uptake of VMMC services in Eswatini. The study
gas, Fundac~ao Oswaldo Cruz, Rio de Janeiro, Brazil found that VMMC is symbolically linked, especially for uncircumcised
men, to perceptions of masculinity. VMMC is constructed as a threat to
masculinity at multiple levels, including reduced sexual performance.
Background: In 2018, when the PrEP Implementation project, Perceptions of masculinity are also intrinsically linked to material reali-
ImPrEP, started in Peru, PrEP became a reality in HIV prevention for ties around income provision for families. As many men are breadwin-
many MSM at very high risk for HIV in the country. While there were ners within their family, men were concerned about time lost while
many enrollees searching to use PrEP and succeeded to adapt, others healing from a circumcision wound and consequently being unable to
faced various challenges that prevented adherence and led them to provide for their dependents. Respondents also report that ambiguous
discontinue PrEP. This study explored the experiences, perceptions information available on VMMC is a barrier to uptake. Finally, Partici-
and challenges faced by continuers and discontinuers from ImPrEP. pants also assumed that HIV testing is essential for circumcision. The
Methods: We conducted semi-structured interviews with 27 MSM fear of taking an HIV test may stop men from getting circumcised.
(13 continuers; 14 discontinuers) from 3 regions of Peru. The inter- Conclusions: VMMC programmes need to consider the material reali-
views explored five dimensions: cognitive/affective, sexual behavior ties of the men who are targeted by the programme. These include cli-
and preventive practices, interactions with the community, care seek- ents compensated for time lost after circumcision, mobilizers should
ing and provider interactions, and Structural. The interviews were ana- target families, and sensitizing political and traditional leaders as gate
lyzed to produce recommendations to improve various aspects of the keepers.
ImPrEP Project.
Results: Cognitive/affective dimension: Continuers possess more pre-
cise information on the effectiveness, use, and indications of PrEP, and
feel trust, security, greater freedom and satisfaction in their sexual
encounters; they see PrEP as a need in terms of their wellbeing and
ability to control their sexual health; in turn, discontinuers explain their
dropping out based on a low perceived risk, side effects, and difficulty in
adhering to the daily PrEP regimen. Sexual behavior and preventive
77
future HIV status. This is an important finding for policy makers and
PE01.57 suggests the importance of targeting HIV prevention programs to
HIV, risk and time preferences: evidence from a general risk-loving individuals and therefore improving program efficiency.
population sample in Lesotho
€rkman Nyqvist1; L. Corno2; D. De walque3 and J. Svensson4
M. Bjo
1
PE01.58
Stockholm School of Economics, Sweden, 2Universita’ Cattolica del Lessons learned from rolling out the Stepping Stones
Sacro Cuore, Italy, 3The World Bank, Development Research Group,
program in informal settlements in South Africa
Washington, United States, 4Stockholm University, Institute for Inter-
C. Milford1; J. Pulerwitz2; M. Mtshali1; S. Psaki2; B. Zieman2 and
national Economic Studies, Sweden
M. Beksinska1
1
MRU (MatCH Research Unit), Obstetrics and Gynaecology, Faculty
Background: Identifying individuals most at risk of HIV infection is a of Health Sciences, University of the Witwatersrand, Durban, South
priority for policy makers. Apart from specific groups, however, little is Africa, 2Population Council, New York, United States
known about how to identify and target those at high risk in a popula-
tion at large. Research in psychology and behavioral economics suggests
that attitudes towards risk (risk preferences or risk sensitivity) and how Background: The community-based Stepping Stones program –
individuals’ trade off costs and rewards over time (time preferences or designed to promote HIV prevention through addressing HIV risk, vio-
delayed gratification) may influence risky sexual behavior, but no studies lence, relationship skills, and gender – has been implemented widely.
have so far investigated the interplay between risk attitudes, time pref- Yet, limited evidence is available about the challenges/successes of pro-
erence and HIV infection. Using data from a two-year trial, we assess gram scale-up – and program effects - when adapting to new settings.
the correlation between baseline measures of risk and time preferences, Methods: Qualitative research was used to explore the experiences
and the subsequent risk of becoming infected by HIV. and effects of implementing Stepping Stones (as a component of
Methods: We collected data on risk and time preferences using hypo- USAID/CCI’s Community Responses program) in informal settlements
thetical games (multiple price list (MPL) method) at baseline, and HIV in KwaZulu-Natal, South Africa. Six focus group discussions (n = 52)
prevalence over a two-year period (2010 to 2012), among 675 partici- and 14 in-depth interviews were held with community participants
pants, males and females 18 to 32 years old drawn from 29 rural and (34 males, 32 females), plus ten IDIs with program staff. Eight Step-
peri-urban villages in Lesotho. We report unadjusted and adjusted odds ping Stones sessions were directly observed (different session topics/
ratios between HIV prevalence at endline and the measures of attitudes facilitators). Interviews were transcribed and coded, and analyzed via
towards risk and time preference, measured at baseline. Adjusted OR NVivo v10.
are adjusted for gender, age, marital status, education and wealth. Results: Male and female participants expressed positive reactions to
Results: The positive association between HIV prevalence at endline Stepping Stones, both in terms of HIV and GBV-related knowledge
and risk-loving attitudes at baseline is statistically significant and gained, and the opportunity to discuss sensitive issues in a safe and sup-
robust, while the association with risky behavior as measured by portive environment –“they are able to help you talk [. . .] and feel com-
either alcohol or tobacco consumption or elicited measures of time fortable”. They also reported improvements in couple communication,
preferences (present-orientation and hyperbolic discounting) is posi- HIV service use, and HIV prevention behaviors – “I now test every
tive but not statistically significant. month and I use the condom”. They preferred mixed sex groups. How-
ever, there were some challenges – sourcing an appropriate venue was
Abstract PE01.57-Table 1. Risk attitude, risky behaviors, time pref- difficult – “we don’t have venues”, and competing priorities (such as work
erences and HIV prevalence commitments) made it difficult for community members to stick to ses-
sion times. In addition, some facilitators found it difficult to follow the
Dependent variable: HIV Unadjusted Adjusted session manuals, and often skipped some program content.
prevalence OR OR Conclusions: Continued implementation of Stepping Stones in informal
settlements of South Africa, for HIV and violence prevention, is feasible
Panel A: Risk preference and acceptable. The program was well received, and positive effects
Risk lover 1.74 1.51 were reported. Yet there were also challenges with implementation in
95% C.I. [1.22, 2.48] [1.02, 2.24] the informal settlement setting. Recommendations include: shorter ses-
Baseline controls No Yes sions as well as catch-up sessions, balance of sexes in groups, careful
Observations 640 640 venue selection (e.g., indoors), and ongoing mentorship of facilitators.
Panel B: Risky Behavior
Usually drink or smoke 1.36 1.61
95% C.I. [0.86, 2.17] [0.99, 2.62]
PE01.59
Baseline controls No Yes Using social maps to explore young women’s experiences
Observations 581 581 with social support of their oral PrEP use in Kenya and
Panel C: Time preference South Africa
Present-oriented 1.08 1.19 A.W.K. Katz1; E. Rousseau2; N. Khoza3; F. Mogaka4; E. Bukusi4;
95% C.I. [0.73, 1.59] [0.79, 1.79] S. Delany-Moretlwe3; L.-G. Bekker2; J. Morton5; R. Johnson5;
Baseline controls No Yes C. Celum5; J. Baeten5 and A. van der Straten1
Observations 530 530 1
RTI International, Women’s Global Health Imperative, Berkeley, Uni-
Panel D: Time preference ted States, 2Desmond Tutu Health Foundation, University of Cape
Hyperbolic discounting 1.29 1.60 Town, Cape Town, South Africa, 3Wits RHI, University of the Witwa-
95% C.I. [0.74, 2.25] [0.86, 2.98] tersrand, Faculty of Health Sciences, Johannesburg, South Africa,
4
Baseline controls No Yes Kenya Medical Research Institute, Nairobi, Kenya, 5University of
Observations 502 502 Washington, Seattle, United States
Conclusions: A measure of attitude towards risk which is relatively Background: Oral PrEP adherence is challenging for adolescent girls
easy to administer to individuals in a survey is highly predictive of and young women (AGYW) in sub-Saharan Africa, despite their desire
78
Results: Twenty interviews were conducted representing eight HIV

organizations (IPS) at eight Colombian cities. Two major themes
emerged: PrEP acceptability and PrEP Complexity. Regarding accept-
ability, PrEP was perceived as an effective intervention, having a rela-
tive advantage when compared to other prevention strategies,
amenable to pilot implementation in a setting with capacity for this.
Notable barriers were uncertainty about how the intervention would
be covered by the health care system, the misinformation in health
care providers, and issues of compatibility e.g. moral values. Regarding
complexity, managers expressed barriers related to the lack of guideli-
to stay HIV-free. We explored AGYW’s views on social influencers of nes, sociocultural diversity that may require adaptations (e.g. rural vs.
PrEP use and AGYW’s perception of those influencers’ PrEP knowl- urban; trans vs. gay men), and the need to adjust existing institutional
edge and support. resources (e.g. space allocation, training of personnel). Administrators
Methods: Focus group discussions (FGD) were conducted with a pur- worried about medication adherence and misuse, stigma, and risk
posive sample of AGYW during the POWER PrEP demonstration pro- compensation.
ject (South Africa and Kenya). Participants completed a social mapping Conclusions: Structuring this situational analysis around the CFIR
exercise by placing pre-labeled stickers of PrEP influencers (e.g. was instrumental in identifying multi-level factors that will affect the
mother, sex partner, clinic counselor) on an egocentric circle map, rep- large-scale adoption of PrEP. Future research is encouraged to identify
resenting their level of influence (from inner/most influential circle to among all the barriers the one to target and propose some implemen-
outer/least influential circle). Participants color marked the influence tation strategies.
as positive (e.g. encouragement and reminders to use PrEP; advice
and guidance), negative (e.g. discouragement/disapproval, judgement),
or both. AGYW then discussed their map with the group. PE01.61LB
Results: Six FGDs occurred with 33 AGYW. Mothers and counselors MRSI evaluation in the whole brain of HIV-1 clade C
were labeled mostly as positive influencers and placed in the inner circle infected treatment na€ıve individuals
by >50% of participants; sex partners were also placed in the inner cir- D. Aggarwal1; G. Garg1; A. Sharma1; S. Vyas1; A. Sharma1;
cle by a majority but were either labeled negative influencers or both M. Mohanty1; C. Ahuja1; D.J. Weiss2; S. Weiss2; M. Kumar2;
(Table 1). Regarding peers, best friends (41% inner circle) were mostly V. Govind2 and P. Singh1
positive influencers whereas “friend groups” (25% inner circle) were 1
Postgraduate Institute of Medical Education and Research, Radiodiag-
negative or both. For the inner circle, AGYW mentioned both direct (e.g. nosis and Imaging, Chandigarh, India, 2University of Miami, Miller
criticism or praise) and indirect influence (e.g. partner’s behavior or School of Medicine, Miami, United States
knowing a person living with HIV). Participants labeled some outer circle
influencers as uninterested or unwilling to learn about PrEP. Participants
wanted all levels and types of influencers to be better educated about Background: HIV can enter into the central nervous system in the
PrEP and ultimately to accept and support their PrEP use. initial stages and over time can cause HIV-Associated Neurocognitive
Conclusions: Through social mapping, AGYW described key support- Disorders (HAND). HIV viral density and infection status vary across
ers and detractors, with mothers, counselors, and best friends emerg- brain anatomical regions. Also, there is an ambiguity in the association
ing as important supporters of AGYW’s PrEP use. To improve PrEP of different type of HIV clades with HAND. A single centre blinded
outcomes, community- and peer-based PrEP sensitization and delivery study was conducted to evaluate the HIV-1 clade C infection in the
programs should be evaluated. whole brain of treatment na€ıve people living with HIV through MRSI.
Methods: Treatment na€ıve HIV+ (age between 18 to 45 years) were
recruited from the HIV clinic of a teaching research institute in North
PE01.60LB India (2017 to 2020). Age and sex matched healthy controls were also
What do HIV clinic administrators think about PrEP recruited. Subjects with history of cerebral vascular diseases, brain
implementation in Colombia? A qualitative CFIR guided injury, neurological or psychiatric illness, or any other CNS disease
were excluded. Demographic details and clinical characteristics were
study
recorded. CD4, viral load and clade subtype were investigated. Rou-
mez1; J.L. Martınez-Cajas2; H.F. Mue
S.A. Go ses3,4; B. Alvarado-Llano2;
tine and whole brain MRI and MRSI evaluation were performed. Aver-
X. Galindo ; P. Camargo ; E. Martınez ; J. Torres6 and
3,4 2 5,4
age metabolite values (NAA and Cho) and ratios (NAA/Cre, Cho/Cre,
M. Arrivillaga1
1
and Cho/NAA) over each lobar region were evaluated.
Pontificia Universidad Javeriana, Cali, Colombia2Queen’s University, Results: 147 subjects were enrolled (HIV+: n=79; HIV-: n=68). The
Kingston, Canada3Corporacio n de Lucha contra el Sida, Cali, Colom- median age was 30 years with 67% male in HIV+ and 61% male in
bia4Red VIH-Col, Cali, Colombia5Universidad del Valle, Cali, Colom- HIV- group. Average number of years of education was similar in the
bia6Montefiore Medical Center, New York, United States two groups (10.35 years in HIV+ vs. 11.15 years in HIV- group). Most
of the HIV+ individuals were recently diagnosed and asymptomatic.
Median CD4 count and viral load were 346 (range 14 to 938) and
Background: PrEP implementation needs to be informed by the per-
20300 copies/mL (441-6120561), respectively (Table 1). MRSI data
ceptions of health service administrators. This study uses the Consoli-
showed altered metabolite levels throughout the brain of the subjects
dated Framework for Implementation Research (CFIR) to gain insight
in the HIV+ group. There was a significant decrease of NAA and NAA/
into the perspectives of managers of health care services of HIV clin-
CR (p <0.05) and a significant increase of Cho/NAA (p <0.05), within
ics in Colombia given eventual attempts to implement PrEP nationally.
all lobes of the HIV+ as compared to HIV- individual. Also, the levels
Methods: This qualitative study conducted semi-structured interviews
of MI increased but NAA decreased significantly in HIV+ group (p
in a purposive sample of HIV clinic administrators. The CFIR was used
<0.05).
to guide data collection and analysis. Content Analysis was used to
Conclusions: The altered metabolites indicate neuronal dysfunction
determine the relevance of one of the CFIR constructs, namely char-
or loss (NAA) and inflammation (MI and Cho) in HIV+ treatment na€ıve
acteristics of the intervention on PrEP implementation in HIV clinics
individuals as compared to HIV- cohort. Since, the findings were
in Colombia.
79
consistent across different regions, the involvement of whole cere-

brum is suspected. PE01.63LB
“. . .I am here going strong”: HIV-positive adolescents’
perspectives on the influence of Operation Triple Zero
PE01.62LB initiative on HIV adherence and viral load suppression in
MyPrEP Decision Support Tool increases PrEP persistence
Kisumu, Kenya
in adolescent girls and young women attending an urban
E. Ododa1,2; G. Owino3; F. Odhiambo2,4; M. Moghadassi5; N. Okoko2,4;
primary health care clinic in South Africa
C.R. Cohen5; E.A. Bukusi2,1 and J.L. Kulzer5
D. Seidman1; D. Travill2; C. Celum3; C. Dehlendorf4; M. Mdlovu2; 1
Family AIDS Care and Education Services, (FACES), Kisumu, Kenya,
K. Zewdie3; D. Donnell3; J. Morton3; J. Baeten3 and S. Delany- 2
Center for Microbiology Research, Kenya Medical Research Institute,
Moretlwe2
1 Kisumu, Kenya, 3Family AIDS Care and Education, HIV Testing Ser-
University of California San Francisco, Obstetrics, Gynecology &
vices, Kisumu, Kenya, 4Family AIDS Care and Education Services, Clini-
Reproductive Sciences, San Francisco, United States, 2Wits Reproduc-
cal Services, (FACES), Kisumu, Kenya, 5University of California San
tive Health and HIV Institute, University of the Witwatersrand, Johan-
Francisco, Department of Obstetrics, Gynecology & Reproductive
nesburg, South Africa, 3University of Washington, Seattle, United
Sciences, San Francisco, United States
States, 4University of California San Francisco, Family & Community
Medicine, San Francisco, United States
Background: Adolescents living with HIV (ALHIV) in sub-Saharan
Africa have higher rates of virologic failure compared to adults. Opera-
Background: Meeting the HIV prevention needs for adolescent girls
tion Triple Zero (OTZ) aims to empower ALHIV to achieve: zero
and young women in Southern Africa, where the HIV incidence
missed appointments, zero missed drugs, and zero viral load with
remains high, includes efficiently delivering PrEP services using per-
emphasis on treatment literacy and psycho-social support. This study
son-centered care approaches. Decision support tools (DSTs) have
explored ALHIV perspectives on OTZ and its influence on viral sup-
been successfully used in healthcare to improve patients’ risk percep-
pression.
tion and knowledge of options, and facilitate informed decision-making.
Methods: In September 2019, eight focus group discussions (FGDs)
Patient-facing DSTs may be particularly beneficial in busy clinical envi-
were purposively sampled to recruit 80 ALHIV (10 to 21 years) in
ronments, or when new services are integrated and clinicians may be
eight government health facilities implementing OTZ in Kisumu
less consistent with counseling, such as the integration of PrEP into
County, Kenya. FGDs were conducted in the local language using
primary health clinics (PHC).
semi-structured guides, audio-recorded, transcribed, and analyzed
Methods: We developed a tablet-based, patient-facing DST, MyPrEP,
using Dedoose software.
which included youth-friendly images, young women’s narratives about
Results: Of 80 participants, 42 (53%) were female, median age was
HIV prevention decision-making, and information about PrEP. Women
13 years (range: 10 to 21 years). Themes encompassed OTZ influence
ages 18 to 25 and HIV-negative, presenting to a PHC in Johannes-
on health ownership, social support and long-term health impact.
burg South Africa in 2019 to 2020, were randomized by day to either
ALHIV exhibited self-drive to achieve the three zeros for a healthy
the DST or a general health website on a tablet (control). Participants
life. “The OTZ pledge enlightens and motivates me to commit myself to
were then seen by study clinicians blinded to DST vs. control alloca-
zero missed appointments, zero missed drugs and reminds me to take full
tion, who provided standard counseling and offered PrEP. Participants
charge of my life” and “I can say OTZ has helped me because I now have
completed a survey and laboratory-based STI testing. We assessed
a suppressed virus”. Social support garnered from OTZ helped ALHIV
PrEP initiation and PrEP persistence at 1 month by pharmacy records.
gain confidence, develop friendship bonds, and value health. ‘’Before I
Results: Of 386 women screened, 353 were randomized. Participants’
joined OTZ, I never knew other HIV positive adolescents existed. In OTZ I
median age was 21 years, 98% were unmarried, 100% were sexually
found friendship which has encouraged me to take my life seriously and
active in the prior 3 months, 85% used condoms sometimes or never,
care for my health so I can succeed in life. . .”. Participants expressed
and 37% were diagnosed with gonorrhea or chlamydia. Participants’
increased self-acceptance, ability to manage discrimination, and share
reasons for attending the PHC that day included 57% for an HIV test
and address challenges. “OTZ has helped me a lot. I was isolated by
and 29% for family planning services. All characteristics were similar
friends at school, they talked ill about me, discriminated me until I stopped
between the DST and control groups. PrEP initiation was high in both
taking my medication but due to OTZ, I am here going strong.” Sustaining
groups (97% DST vs. 94% control, p =0.2). At 1 month, PrEP persis-
viral suppression in their adult lives will be aided by OTZ: “. . .all that
tence was higher in the DST compared to the control group (20% vs.
we are taught in OTZ will help throughout one’s life”.
11%, OR 1.97, 95% CI 1.08 to 3.69, p =0.03).
Conclusions: Through OTZ, ALHIV feel motivated and capable of sus-
Conclusions: A patient-facing DST offered at a South African PHC
taining viral suppression now and in their adult lives. Sense of belong-
resulted in two-fold higher PrEP persistence at 1 month among young
ing and confidence gained through OTZ helps ALHIV manage
women. While overall PrEP persistence was low in this population not
discrimination, secure social support systems, and navigate obstacles.
specifically presenting for HIV prevention services, findings suggest a
brief, one-time intervention at PrEP initiation, such as a PrEP DST,
may support young African women’s informed decision-making about
PrEP.
80
Broadly neutralizing antibodies PE02.03

Antibody-antigen distance of broadly neutralizing HIV-1
antibodies correlates with glycan-shield coverage of HIV-1
envelope trimer
PE02.01 M. Lee1; R. Rawi1; L. Shapiro2; P. Kwong1 and G.-Y. Chuang1
1
Structure of a CD4 binding site directed antibody in a National Institutes of Health, National Institute of Allergy and Infec-
donor with broadly neutralizing antibodies tious Diseases, Bethesda, United States, 2Columbia University, New
T. Moyo1; C. Scheepers1; T. Sicard2; Z. Makhado1; F. Ayres1; York, United States
R.E. Mapengo1; J.-P. Julien2; L. Morris1 and P. Moore1
1
National Institute for Communicable Diseases, HIV Virology Section, Background: Antibody-antigen distance (AAD) – the distance between
Johannesburg, South Africa, 2The Hospital for Sick Children Research an antibody and a protein antigen – is a fundamental parameter govern-
Institute, University of Toronto, Canada ing antibody recognition. We have recently quantified AAD for over
1000 non-redundant antibody-protein antigen complexes in the Protein
Data Bank, and found AAD to have a Gaussian distribution, with 2.3 A
Background: HIV broadly neutralizing antibodies (bNAbs), required
standard deviation (SD). We observed a few antibody-antigen complexes
for an HIV vaccine, develop in only a subset of chronically HIV-
(less than 1%) to have AAD of > 5 SDs longer than average. Interest-
infected individuals. In some infected donors, a single dominant bNAb
ingly, all of the longer AAD were broadly neutralizing antibodies direc-
lineage confers breadth. In contrast, in other donors, multiple antibod-
ted against HIV-1. None of the antibodies against other viral antigens,
ies with moderate neutralizing activity contribute to breadth, a devel-
including those against influenza hemagglutinin and ebolavirus glycopro-
opmental pathway that may be easier to achieve by vaccination.
tein, had an AAD extending > 3 SDs longer than average.
Methods: Here, we studied an HIV-infected donor, CAP314, who
Methods: Here, we hypothesized that the very dense glycan shield of
developed at least three distinct antibody specificities that contributed
HIV-1 might provide an explanation for the observed extended AADs.
to breadth within 2 years of HIV infection. We isolated several monoclonal
To test this hypothesis, we developed a computational method incor-
antibodies (mAbs) from this participant at multiple weeks post-infection
porating molecular dynamics simulations to quantify the number of
(wpi) including mAb CAP314_52 from 115 wpi which exhibited 15%
glycan atoms neighboring each surface residue on the HIV-1 envelope
breadth. To define its epitope, we crystallized the antibody in complex
(Env) trimer. Epitope-glycan coverage was determined by normalizing
with a gp120 envelope protein from the CAP314 transmitted/founder
the number of glycan atoms with surface area of the epitopes on the
(TF) virus and obtained a structure at 3.3 A resolution.
protein surface and averaging over one microsecond of molecular
Results: CAP314_52 has a uniquely long CDRL3 loop insertion of 29
dynamics simulation.
amino acids, supported by a disulphide bond. This is unlike most HIV-
Results: We found antibodies with high AADs to recognize region of
1 bNAbs which have CDRL3 loops ranging from 5 to 12 amino acids.
the Env trimer with high glycan shield coverage, whereas, antibodies
Sequence analysis of the CAP314_52 lineage implicated the CDRL3 in
with average AADs to recognize regions of the Env trimer with lower
neutralization breadth. Early lineage members from 24 wpi lacked the
glycan coverage. High correlation (R2 = 0.776, p < 0.0001) was
insertion, having a CDRL3 of only 9 amino acids, whereas antibodies
observed between AAD and glycan coverage for 23 classes of HIV-1
from 90 wpi which exhibited increased neutralizing activity had the
broadly neutralizing antibodies.
extended CDRL3. Structural analysis showed that the CAP314_52
Conclusions: Glycan coverage of the Env-trimer surface thus corre-
CDRL3 loop interacts with residues in the CD4bs of the HIV envel-
lates with extended AADs for antibodies recognizing these surfaces.
ope, and is responsible for > 50% of the interactions between this
We are currently exploring AAD for antibodies recognizing glycan
antibody and its epitope. The CDRH3 also mediates epitope contacts
holes, and how an understanding of AAD and its relationship to glycan
within the CD4bs, though to a lesser extent. The angle of approach of
coverage may provide insights into the parameters governing the elici-
CAP314_52 is more similar to HJ16 (with 30% breadth) than the
tation of broadly neutralizing antibodies.
exceptionally broad CD4bs bNAb, VRC01 (91% breadth).
Conclusions: Sequencing and structural analysis of a novel CD4bs
antibody lineage suggests that a CDRL3 insertion contributes substan- PE02.04
tially to the binding and neutralization breadth of mAb CAP314_52. Variation in neutralization susceptibility of HIV-1 Indian
The characterization of novel neutralizing antibodies targeting the subtype C to potent and broadly neutralizing monoclonal
CD4bs may provide insights into the diverse pathways used by anti- antibodies (bnAbs) having distinct epitope specificities
bodies to target this site. N. Hingankar1; R. Mullick1; J. Sutar1; S. Deshpande1; M. Bansal1;
N. Kumar1; L. Morris2; D. Sok3 and J. Bhattacharya1
1
Translational Health Sciences & Technology Institute, HVTR (Infection
and Immunology), Faridabad, India, 2National Institute for Communica-
ble Diseases, Centre for HIV & STI’s, Johannesburg, South Africa,
3
International AIDS Vaccine Initiative, Scripps Research Institute,
IAVI’s Neutralizing Antibody Center, San Diego, United States
Background: Broadly neutralizing antibodies (bnAbs) have shown

promising results in phase I clinical trials as agents for HIV-1 preven-
tion and treatment. However, given the substantial geographic varia-
tion of HIV-1 subtypes, we aim to assess neutralization resistance and
sensitivity of available bnAbs against region-specific circulating HIV-1
subtypes/recombinants in India. In the present study, we report neu-
tralization susceptibility of 56 HIV-1 Indian subtype C Env-pseudo-
typed viruses against four potent bnAbs targeting three different
81
epitope specificities on HIV Env (VRC01, PGT121, PGDM1400 and elements and intergenic regions of the IGHV genes, which were
CAP256.VRC26). detected across half the sample population. CNV was present in ~33%
Methods: Complete gp160 env genes were amplified from donor of these participants with one gene being deleted and eight IGHV genes
plasma (n = 24) and cloned into pcDNA3.1TOPO mammalian expres- being duplicated; one of which (IGHV1-69) was duplicated in over 20%
sion vector. Env-Pseudotyped viruses were produced in 293T cells of participants sequenced by targeted NGS. Further, IGH capture iden-
and tested in standard neutralization assays using TZM-bl cells. Basis tified 5 large SVs (an insertion or deletion greater than 50 bp) that led
for neutralization resistance was assessed through sequence analysis to the insertion of 10 genes, demonstrating that the genetic diversity in
and CATNAP database. this population exists at both nucleotide and structural levels.
Results: At a concentration of 5 μg/mL, we identified several strains Conclusions: This study demonstrates that considerable genetic com-
(36/56, 64.28%) with resistance (IC50 > 5 μg/mL) against at least plexity remains to be uncovered in the African antibodyome. Studying this
one of these four bnAbs and some (17/56) with resistance against at genetic variation is important for understanding l immune responses to
least two bnAbs. However, only four viruses were resistant to three infection and vaccination, particularly as the continent is disproportion-
of the four bnAbs and none resistant to all four. There are varying ately burdened by infectious diseases such as HIV, TB and malaria.
degrees of resistance of Env-pseudoviruses to CAP256.VRC26 (14/
56), PGT121 (15/56), PGDM1400 (19/56) and VRC01 (9/56). PE02.06
Detailed sequence analysis reveals that characteristic substitutions at
Founder Env-specific IgM B cell responses during acute
the key epitope residues are associated with neutralization resistance.
In some cases, resistant viruses with some intact epitope residues
HIV-1 infection associate with the development of broadly
indicates not yet known env sequence features that contribute to neu- neutralizing antibodies
tralization resistance. S. Townsley1; G. Donofrio1; N. Jian1; D. Leggat1; V. Dussupt1;
Conclusions: Our study indicates that Indian subtype C strains L. Mendez-Rivera1; L.A. Eller1; B. Slike1; P. Ehrenberg1; A. Geretz1;
among those chronically infected with HIV-1 are relatively resistant to N. Doria-Rose2; V. Polonis3; J. Mascola2; M. Rolland1 and
individual bnAbs, but are less resistant or sensitive to combinations of S. Tovanabutra1
1
bnAbs targeting different epitopes. This resistance profile presents an Walter Reed Army Institute of Research, HJF/U.S. Military HIV
urgent need for assessing the efficacy of bnAbs that are under clinical Research Program, Silver Spring, United States, 2NIH, Vaccine Research
development, individually as well as in combinations, against a larger Center, Bethesda, United States, 3Walter Reed Army Institute of
panel of subtype C strains that are currently circulating in different Research, U.S. Military HIV Research Program, Silver Spring, United
geographical regions and distinct key population in India. This assess- States
ment will clarify our understanding as to whether these promising
bnAbs will be efficacious individually and/or in combination against
Indian subtype C. Background: Generating broadly neutralizing antibodies (bNAbs) that
overcome the sequence diversity of HIV-1 envelope glycoprotein
(Env) is thought to be a critical component toward the design of a
PE02.05 protective vaccine, yet no HIV-1 vaccine candidate to date has suc-
Antibody genetic diversity with large structural variation in cessfully elicited bNAbs. Understanding the humoral response to Env
a South African population during the acute stages of infection may provide insight into the
A. Marsden1; W. Gibson2; O. Rodriguez3; A. Ismail4; B. Lambson1; development of bNAbs.
P. Moore1; C. Watson2; L. Morris1 and C. Scheepers1 Methods: Longitudinal PBMCs from the RV217 cohort spanning from
1
National Institute for Communicable Diseases, Centre for HIV and acute to chronic infection were assessed for founder Env specific- B
STIs, Johannesburg, South Africa, 2University of Louisville School of cell phenotyping and binding antibodies in 13 broad and 12 non-broad
Medicine, Biochemistry and Molecular Genetics, United States, 3Icahn neutralizers. B cells that were able to bind to their respective founder
School of Medicine at Mount Sinai & Icahn Institute for Genomics and Envs were analyzed using flow cytometry and sorted for BCR
Multi-Scale Biology, New York, United States, 4National Institute for sequencing. In addition, longitudinal plasma were tested for antibody
Communicable Diseases, Sequencing Core, Johannesburg, South Africa binding to respective founder Envs using a Luminex assay.
Results: Higher frequencies of founder Env-specific B cells 1 month
post-infection were predictive of the development of neutralization
Background: The immunoglobulin heavy chain variable (IGHV) genes breadth (p = 0.035). B cell phenotyping revealed higher frequencies of
make up the largest portion of the antigen binding site of an antibody. Env-specific na€ıve B cells, harboring both IgD and IgM, starting at
These genes are highly polymorphic and demonstrate copy number vari- 14 days post-infection. Significantly higher frequencies of IgM heavy
ation (CNV) due to structural rearrangement of the immunoglobulin chains were isolated from broad neutralizers compared to non-broad
heavy chain (IGH) locus. There is increasing evidence that this genetic neutralizers at month 1, with both groups showing similar levels of
variation leads to differential immune responses in infection and vacci- somatic hypermutation, CDRH3 lengths, and heavy chain usage. Early
nation. Previous studies of South African populations have described engagement of na€ıve B cells resulted in significantly elevated IgM bind-
substantial undocumented allelic diversity within the antigen binding ing antibodies to respective autologous founder Envs starting at day 14
region of IGHV genes. However, the level of structural and regulatory in broad neutralizers compared to non-broad neutralizers. Higher levels
region diversity, including CNV, within this population, is unknown. of longitudinal autologous IgM responses in plasma significantly pre-
Methods: We used two methods to explore IGHV genetic diversity. Tar- dicted the development of neutralization breadth (p = 0.001), while autol-
geted amplicon NGS (using PacBio and MiSeq) was used to investigate sin- ogous IgG and IgA responses were similar between the two groups.
gle nucleotide variation (SNV) across the entire IGHV gene, including the Conclusions: These results demonstrate that early engagement of
regulatory regions, in 70 CAPRISA participants. Large structural variants founder Env by na€ıve B cells and subsequent secretion of IgM to
(SVs) were studied in two CAPRISA individuals using an IGH hybridization autologous founder Envs associate with the development of broad
capture assay in which IGH specific probes were used to isolate large neutralizing antibodies. Factors that have the potential to enhance ini-
DNA fragments before amplification and sequencing using PacBio. tial antigen engagement by na€ıve B cells should be considered when
Results: Of the 85 novel alleles that our group has previously reported, designing immunogens for HIV-1 vaccines.
36 were found in new individuals included in this larger cohort. In addi-
tion, another seven novel IGHV alleles were discovered in multiple indi-
viduals. Furthermore, we observed > 3000 SNVs in the regulatory
82
mechanism for this is poorly defined. We have previously isolated a

PE02.07 monoclonal antibody (mAb), CAP88-CH06, as an IgA1. We also
IgG3 HIV broadly neutralizing antibodies show improved showed that multiple co-circulating IgG1, IgG3 and IgA1 isotypes of
neutralization potency and phagocytosis compared to IgG1 the CAP88-CH06 lineage exist, some of which share identical variable
variants regions, but exhibit markedly different neutralization capacity. Here
S. Richardson; F. Ayres; N. Manamela; B. Oosthuysen; Z. Makhado; we have explored the mechanism whereby isotype impacts neutraliza-
B. Lambson; L. Morris and P. Moore tion potency.
National Institute for Communicable Diseases, Antibody Immunity Methods: The CAP88-CH06 IgA1 mAb was engineered as IgG1 and
Research Unit, Johannesburg, South Africa IgG3 isotypes, with all three mAbs sharing identical variable regions.
These were tested against a panel of autologous env-pseudotyped
viruses isolated from the first year of infection. Constant heavy chain
Background: The ability of broadly neutralizing antibodies (bNAbs) to (CH1) and hinge region swaps were constructed between the three
protect against HIV infection is enhanced through Fc receptor binding. mAbs, and these variants were assessed for neutralization potency
The isotype of the antibody can modulate this effect, with IgG3 asso- and antibody-dependent cellular phagocytosis (ADCP).
ciated with improved HIV control and vaccine efficacy. HIV bNAbs are Results: The CAP88-CH06 IgG3 (GMT 0.01 μg/mL) and IgA1 (GMT
rarely assessed in the context of isotypes other than IgG1. We 0.01 μg/mL) isotypes showed enhanced neutralization of autologous
recently showed that an IgG3 version of CAP256-VRC26.25 exhibited viruses respectively, both in terms of potency and number of viruses
more potent neutralization and phagocytosis than its IgG1 counter- neutralized, compared to the CH06 IgG1 (GMT 0.04 μg/mL). Hinge
part. Here, we expanded this analysis to 14 additional bNAbs swaps indicated that the increased neutralization potency of the IgG3
targeting all major bNAb epitopes. isotype could be attributed to its longer hinge region (62 amino acids),
Methods: The variable regions of antibodies to the V2-apex, V3- compared to that of IgG1 (15 amino acids) or IgA1 (22 amino acids).
glycan supersite, CD4 binding site, gp41-gp120 interface and MPER In contrast, in IgA1, we showed that the CH1 was responsible for the
were cloned into vectors with CH1-3 Fc regions from both IgG3 enhanced potency of this isotype compared to IgG1. ADCP assays
and IgG1. Pairs were assessed for neutralization potency against 11 revealed that the increased phagocytic activity of the IgG3 mAb, com-
viruses from the global panel. Antibody dependent cellular cytotoxic- pared to its IgG1 and IgA1 counterparts, was also attributable to the
ity (ADCC) and phagocytosis were measured using infectious hinge region, highlighting the contribution of the hinge to the poly-
viruses and global panel SOSIP Env trimers, respectively. Binding to functionality of IgG3.
the neonatal Fc receptor (FcRn) and Fcc receptors were measured Conclusions: Overall, these data show that enhanced neutralization
using ELISA. potency of CAP88-CH06 IgA1 and IgG3 compared to IgG1 is
Results: IgG3 bNAbs showed similar or higher (up to 60 fold) neu- achieved by distinct mechanisms, which differentially impact mAb
tralization potency than IgG1 versions, though the effect was virus- potency. This interplay between Fc and Fab regions may have broader
specific. This improvement was statistically significant for CAP256- applicability for the use of nAbs as therapeutics.
VRC26.25, 35,022, PGT135 and CAP255.G3. Comparison of antibody
combinations as IgG1 or IgG3 indicated that the best triple combina- PE02.09
tion consisted of IgG3 versions of CAP256-VRC26.25, 35,022 and
35O22 and VRC44 define a new highly glycan-dependent
PGT121. IgG3 bNAbs also showed significantly improved binding to
FccRIIa which correlated with enhanced phagocytosis of all trimeric
multidonor class of HIV-1 gp120:gp41 interface-directed
Env antigens. Isotype-dependent differences in ADCC were antigen bnAbs
and bNAb-specific, indicating a role for antibody specificity beyond E. Cale1; J. Gorman1; A. Bennici1; J. Driscoll1; M. Messina1;
FccRIIIa binding alone. Lastly, we explored the pH dependence of vari- N. Radakovich1; D. Xie1; A. Olia1; C.-H. Shen1; R. Rawi1; R. Verardi1;
ants for FcRn binding; a decrease in which typically impairs the half- Y. Yang1; B. Zhang1; E. Crooks2 and M. Connors3
1
life of IgG3 antibodies. We showed that reduced pH dependence is Vaccine Research Center, National Institute of Allergy and Infectious
specific to IgG3 bNAbs with j-light chains, whereas IgG3 bNAbs that Diseases, NIH, Vaccine Research Center, Bethesda, United States,
2
use k-light chains showed similar pH dependence to their IgG1 coun- San Diego Biomedical Research Institute, United States, 3Laboratory
terparts. This implicates the j-light chain, specifically, in the reduced of Immunoregulation, National Institute for Allergy and Infectious Dis-
half-life of IgG3 compared to IgG1. eases, NIH, Laboratory of Immunoregulation, Bethesda, United States
Conclusions: This study supports the manipulation of the constant
region to improve both the neutralizing and Fc effector activity of
bNAbs, and indicates that IgG3 versions may be preferable for passive Background: At least seven sites on the HIV-1 trimer are known epi-
immunity given their polyfunctionality. topes for HIV-1 broadly neutralizing antibodies (bnAbs), and two of
these epitopes have been shown to be targeted by bnAbs from multi-
ple individuals using the same germline V-genes and structural mode
PE02.08 of recognition. These are the VH1-2 “VRC01 class” that targets the
Defining the mechanism for varied neutralization potency CD4 binding site and the VH1-69 “4E10 class” that targets gp41.
of HIV neutralizing antibodies with identical variable Here, we define a new reproducible, multidonor class of antibodies,
regions but differing isotype the “35O22 class”, that targets a highly glycosylated region of the
Z. Makhado; T. Moyo; C. Scheepers; P. Kgagudi; F. Aryes; gp41:gp120 interface of the trimer.
N. Manamela; S. Richardson; P. Moore and L. Morris Methods: B cells from an HIV-1 chronic donor were stained with flu-
National Institute for Communicable Diseases (NICD), Centre for HIV orescently labeled HIV-1 SOSIP trimers and sorted individually into
and STIs, Johannesburg, South Africa PCR plates by flow cytometry. Cells were subjected to RT-PCR ampli-
fication of variable heavy and light chain genes to enable cloning and
expression of antibodies. Antibodies were evaluated for neutralization
Background: HIV-1 neutralizing antibodies (nAbs) are an important of a global panel of HIV-1 Env-pseudotyped viruses by the TZM-bl
focus of HIV-1 vaccine development due to their ability to inhibit HIV- neutralization assay. Cryo-EM of antibodies in complex with trimer
1 entry into host cells. NAbs exist as various isotypes with each hav- was performed with strain C1080 SOSIP trimer stabilized by RnS
ing unique effector functions, conferred by their respective Fc region. mutations.
However, isotype can also impact neutralization potency, though the
83
Results: Two clonally related antibodies, VRC44.01 and VRC44.02, germline targeting potential of immunogens is physiologically relevant.
demonstrated a combined neutralization breadth of 57% of 208 Env- This reveals how frequent precursors to bNAb lineages are in the NB
pseudotyped viruses that mapped to the same highly glycosylated repertoire and aids iterative immunogen design for better vaccine trial
gp41:gp120 interface site that is targeted by the previously character- outcomes.
ized bnAb 35O22. Cryo-EM indicated that VRC44.01 and 35O22
binding modes closely overlap in their angle of approach to the HIV-1 PE02.11
Env trimer and contacts with glycans N88 and N625. Strikingly, both
Low dose administration of unmodified 10E8v4, but not
lineages are able to achieve 100% neutralization breadth of 31 Env-
pseudotyped viruses produced under conditions where glycan pro-
FccR/complement dual enhanced or dual ablated 10E8v4
cessing is arrested at the oligomannose state. variants, decreases viremia in SHIV challenged macaques
Conclusions: Our results define a new multidonor “class” of gp120- D. Spencer1; B. Goldberg2; J. Dufloo3; T. Bruel3; O. Schwartz3;
gp41 interface bnAbs that use the same germline heavy chain variable M. Ackerman2 and A. Hessell1
1
genes and mode of trimer recognition. Moreover, this class exhibits Oregon Health and Science University, Pathobiology, Beaverton, Uni-
extensive glycan dependence, with approximately 70% of the binding ted States, 2Dartmouth College, United States, 3Institut Pasteur, Paris,
epitope composed of glycans. These findings highlight the potential France
interest for the 35O22 epitope as a template for vaccine design, as it
is targeted reproducibly by multiple HIV-1-infected individuals, and
that priming immunogens with oligomannose glycans may be a poten- Background: Optimizing broadly neutralizing antibodies (bNAbs) for
tial strategy for eliciting such lineages. prevention of HIV infection is critical. Numerous studies affirm an Fc-
mediated contribution to protection, particularly as neutralization
titers wane, but little is known about the specific contribution of com-
PE02.10 plement activity. We hypothesized that bNAb dually enhanced for
Precursor frequencies of na€ıve B cells targeting HIV FccR interaction and complement could mediate better therapeutic
candidate immunogens outcomes than the unmodified equivalent.
M. Prabhakaran1; A. Ruppel1; D. Leggat1; J. Plyler1; J. Brand1; Methods: A panel of 10 bNAbs with Fc mutations altering comple-
X. Chen1; H. Holdsworth1; Y.-T. Lai1; R. Derking2; R. Sanders2; ment and/or FccR interaction was generated and screened in vitro.
A. Stuart3; L. Stamatatos3; P. Kwong1 and A. McDermott1 We selected 10E8v4 bNAb, and EFTAE (dual enhanced) and LALA (d-
1
National Institutes of Health, Vaccine Research Center, Bethesda, ual knockdown) mutations, because 10E8v4 has weak neutralization
United States, 2Amsterdam UMC, Amsterdam, Netherlands, 3Fred against the challenge virus (IC50 30 mg/mL), no ADCC activity, and
Hutchinson Cancer Research Center, Seattle, United States high complement mediated viral lysis. Rhesus macaques were pre-
treated with 5 mg/kg unmodified, 10E8v4 EFTAE, 10E8v4 LALA, or
an irrelevant Ab (N = 6/group) prior to SHIVSF162P3 challenge. A sepa-
Background: Lineage-based vaccine design strategies engineer rate cohort was treated with 10 or 20 mg/kg unmodified 10E8v4 or
immunogens capable of engaging broadly neutralizing antibody 10E8v4 EFTAE (N = 2/dose/group). Viremia and 10E8v4 dynamics,
(bNab)-precursor B cells (BP) from the exceptionally diverse na€ıve B immunogenicity, and impact on subsequent SHIV-specific humoral
cell (NB) repertoire and subsequently both expanding and driving high responses were monitored.
somatic hypermutation levels to achieve neutralization breadth. Pre- Results: 10E8v4 plasma t1/2 in unmodified, LALA, and EFTAE groups
clinical assessment and validation of candidate immunigens (CI) is was 5.31, 5.27, and 2.21 days, respectively. In high dose animals, a
paramount to predicting their function in clinical trials. The selection median of 0.010 μg/mg unmodified 10E8v4 was measured in rectal
of CI for vaccine development has been guided by their ability to bind tissue 7 days after injection but not detected in EFTAE treated ani-
predicted germline-reverted or intermediate forms of bNabs. We set mals. Anti-drug antibody (ADA) responses were weak or undetectable
out to calculate the frequencies of BP in the NB compartment capable except in the EFTAE groups, where 33.3% (2/6 low dose) and 75%
of binding to HIV CI; GT1.1.v4.1_BG505 SOSIP (CD4-binding site – (3/4 high dose) displayed ADA. Compared to the control group,
and apex), 426C DM RS CORE (CD4-binding site), Mut16 (CD4-binding plasma viremia was reduced in 10E8v4 unmodified groups (p = 0.022
site), Mut49 (CD4-binding site), T117Fv3 (MPER), FP9-PEG12 (Fusion low dose, p = 0.0285 high dose) but not in LALA or EFTAE groups.
peptide), designed to engage with lineages specific to supersites on Consistently, tissue viral DNA was lower in the unmodified group
gp140. (p = 0.0049) at necropsy. Flow analysis suggested distinct effector cell
Methods: To assess the proportion of BP capable of binding to CI in differentiation between groups, while in vitro studies showed spleno-
the NB compartment, we enriched for B cells from 100 million cytes pretreated with sub-neutralizing 10E8v4-EFTAE increased infec-
PBMCs from multiple individuals and sorted na€ıve B cells using fluo- tion over controls dependent on the presence of monocyte derived
rescently labelled CI and any associated epitope-specific knock-out dendritic cells.
proteins. We amplified B cell receptor heavy and light chains from Conclusions: Non-ADCC effector functions reduce viremia with
sorted cells, sequenced them and queried the sequences for the pres- 10E8v4 in the absence of sterilizing neutralization. The EFTAE muta-
ence of known bNab signatures. tion reduced efficacy by altering pharmacokinetics and/or through
Results: The precursor frequencies of B cells capable of engaging complement-mediated infection enhancement. Thus, complement
CIs range from 16 – 65 NB per million B cells. We calculated the enhancement may reduce antibody therapeutic efficacy and warrants
percentage of B cells containing signatures associated with CD4-bind- further study.
ing site targeting bNab classes. We observed Mut49 exhibited a high
degree (14.5% of sorted cells) of selection for VRC01-class precursor
B cells, followed by Mut16 (4.3%), within the same individual. GT1.1
BG505 SOSIP was able to engage NIH45-46 lineage precursors,
while 426C DM RS CORE selected precursors of NIH45-46,
VRC16.01 and CH103 lineages. T117Fv3 did not identify signatures
associated with an MPER bNAb. No NB were observed binding to
FP9-PEG12.
Conclusions: Studying the interaction of the NB repertoire with lin-
eage-based vaccine candidates is paramount to understanding if
84
PE02.12 PE02.13
Functional convergence of clonally related but genetically Enhanced protection at the site of challenge of rhesus
distinct bNAbs that target the V3-glycan epitope macaques that receive PGT121 one week prior to
D. Kitchin1; J. Bhiman2; T. Moyo1; F. Ayres1; Z. Molaudzi1; intravaginal challenge with SHIV-SF162P3
B. Oosthuysen1; B. Lambson1; S.S. Abdool Karim3; N.J. Garrett3; J. Schneider1; F. Engelmann2; A. Carias2; D. Barouch3 and R. Veazey4
N.A. Doria-Rose4; J.R. Mascola4; L. Morris1 and P. Moore1 1
Rush University, Microbial Pathogens and Immunity, Chicago, United
1
National Institute for Communicable Diseases, Centre for HIV and States, 2Northwestern University, Evanston, United States, 3Harvard
STIs, Johannesburg, South Africa, 2National Institute for Communica- University, Boston, United States, 4Tulane University, United States
ble Diseases, Centre for Respiratory Diseases and Meningitis, Johan-
nesburg, South Africa, 3Centre for the AIDS Programme of Research
in South Africa, Durban, South Africa, 4Vaccine Research Center, Background: In a recent study, rhesus macaques (RM) that got an
National Institute of Allergy and Infectious Diseases, National Insti- intravenous (IV) infusion of the broadly neutralizing antibody (bNAb)
tutes of Health, Bethesda, United States PGT121, 24 hrs prior to intravaginal challenge with SHIV-SF162P3,
had distal site accumulation of virus one to three days after challenge.
Using Cy5-labeled VRC01 IV-injected into RMs we found that it takes
Background: Several broadly neutralizing antibody (bNAb) lineages antibodies ~1 week to achieve peak anatomical distribution in mucosal
directed at the HIV-1 envelope (Env) V3/glycan epitope have geneti- tissues. The aim of this study is to determine if giving antibodies more
cally divergent branches that are all able to mature to breadth using time to fully distribute can block distal site accumulation of virus fol-
different strategies. Delineating the ontogeny of these complex lin- lowing intravaginal challenge.
eages may provide insights into how immunogens could be designed Methods: Utilizing Cy5-labeled PGT121 and sham antibody DEN3,
to elicit V3/glycan responses. we compared 7 days (n = 5) and 1 days (n = 5) IV infusion prior
Methods: Sequencing and phylogenetic methods were used to estab- to intravaginal challenge with SHIV-SF162P3 in RM and measured
lish the ontogeny of two clonally related V3/glycan bNAbs, virus 48 hrs after challenge. Tissue and plasma levels of viral RNA and
CAP255.C5 (56% breadth) and CAP255.G3 (55% breadth), isolated at DNA were detected using gag qPCR and antibody levels were mea-
149 weeks post infection (wpi) from donor CAP255. Breadth and sured through Cy5 fluorescence using deconvolution microscopy and
potency of longitudinal intermediates were assessed in neutralization a fluorometer. Transcriptomics in these tissues was assessed through
assays against a panel of Env-pseudotyped viruses. Through mutagene- RNA-seq.
sis and by exchanging heavy and light chains, or complementary deter- Results: Whereas we detected viral RNA and DNA at the site of chal-
mining regions (CDRs), between broad and non-broad lineage lenge in all the DEN3 and 1 day PGT121 RMs, we only detected
intermediates, residues essential for the maturation of neutralization viral DNA in 1/5 RMs in the 7 day PGT121 group. In a small subset
breadth were identified. of RMs in both the 7 and 1 day PGT121 groups, we detected viral
Results: CAP255.C5 and CAP255.G3 were shown to belong to dis- DNA in the lymph nodes (LN) and viral DNA and RNA in the brain. In
tinct branches of a single lineage that diverged shortly after the emer- these tissues that were qPCR positive, PGT121 was also present.
gence of the precursor B cell. Although rapid CDRH3 maturation RMs that received DEN3 had no distal site accumulation of viral RNA
occurred in the CAP255.C5 branch, with the mature 149 wk CDRH3 or DNA. In the 7 day PGT121 group, there was an anti-viral signa-
sequence observed as early as 47 wpi, this was not responsible for ture detected via RNA-Seq in the vaginal epithelium at 48 hrs post
neutralization breadth. Rather, the light chain and mutations in heavy challenge.
chain regions outside the CDRH3, especially a Y34F mutation in the Conclusions: We have found that giving antibodies more time to dis-
CDRH1 and a 60VYG62 insertion in the CDRH2, were essential for tribute enhances protection at the site of challenge as shown both
breadth. The CAP255.G3 branch acquired breadth differently, with through a decrease in viral RNA and DNA as well as changes in anti-
neutralization largely mediated by the heavy chain, which lacked indels viral transcriptomics. However there was still distal site accumulation
but was more somatically mutated. Despite following divergent affinity of viral DNA and RNA 48 hours after challenge in a small subset of
maturation pathways, CAP255.C5 and CAP255.G3 shared an epitope animals. Since this does not occur in DEN3-injected RMs, the early
footprint and showed remarkable functional convergence. Among a distal site accumulation of viral RNA and DNA in the LN and brain
208-virus panel, 108 viruses were neutralized by both mAbs, with appears to be PGT121 dependent.
only 8 and 6 viruses exclusively neutralized by CAP255.C5 and
CAP255.G3, respectively.
Conclusions: The functional convergence of genetically distinct
PE02.14LB
CAP255 clonal relatives confirms the multiplicity of options available to
Functional barriers in the elicitation of broadly neutralizing
V3/glycan bNAb lineages. This includes a largely CDRH3-independent antibodies against the glycan-V3 site of Env by vaccination
CAP255.C5 approach, different from most reported V3/glycan lineages. O. Swanson1; B. Rhodes1; A. Wang1; A. Sanzone1; M.K. Lauder2;
This has implications for HIV vaccine design as immunogens will ideally J. Mascola2; K.O. Saunders1; M. Bonsignori1; K. Wiehe1; B.F. Haynes1
need to drive maturation of breadth in V3/glycan-directed lineages with and M.L. Azoitei1
1
multiple, diverse branches. Duke University, Duke Human Vaccine Institute, Durham, United
States, 2National Institute of Allergy and Infectious Diseases, Vaccine
Research Center, Bethesda, United States
Background: Induction of broadly neutralizing antibodies (bnAbs) as

part of an HIV vaccine will likely require “priming” the immune system
to robustly activate antibody precursors, followed by a series of
“boosts” to mature these initial responses to neutralization breadth.
BnAbs that target the glycan-V3 epitope on Env, such as DH270.6,
are of great interest for vaccine development. However, these bnAbs
contain rare sequence and structural features, like long CDR-H3 loops
and high levels of somatic mutations, that make their elicitation
85
challenging. Here we determined key functional barriers for the induc- to 2.55 A and 4.05 A resolution respectively. N49P6 similar to N49P7
tion of DH270.6-like bnAbs by vaccination and identified immunogen omits the Phe43 cavity and relies instead on the gp120 inner domain
properties required to overcome these hurdles. layer 3 in binding to the primary gp120 protomer. N49P6 also con-
Methods: High throughput library screening guided by computational tacts the inner domain layer 1 on the adjacent gp120 in the trimer
and structural analysis, together with recombinant antibody produc- mimicking the interprotomer contact of host receptor CD4. The high
tion and neutralization assays were employed: 1) to identify the ability conservation of these contact residues contributes to N49P6 neutral-
of existing germline targeting immunogens to engage potential ization breadth and potency.
DH270.6 antibody precursors with diverse CDR-H3 loops and 2) to Conclusions: N49P6 utilizes many of the same unique characteristics
determine the key acquired mutations required for antibody matura- used by N49P7 to achieve similar neutralization breadth. Further-
tion to DH270.6-like neutralization breadth. more, when binding the HIV trimer N49P6 mimics CD4 in its initial
Results: Current DH270.6 germline-targeting immunogens were quaternary contacts with the neighboring gp120 in the trimer. The
shown to be highly sensitive to the CDR-H3 sequence of potential details of these interactions pave the way to the creation of the next
precursors and to have limited recognition of such loops present in generation of HIV-1 neutralizing Abs for the use in preformed vacci-
the natural human antibody repertoire. Beyond precursor engage- nes and HIV-1 therapeutics.
ment, we determined a subset of 12 out of the 42 mutations acquired
by DH270.6 that is sufficient to provide approximately 90% of the PE02.16LB
bnAb breadth and potency. The majority of these mutations are pre-
Improved potency, breadth, and pharmacokinetics of
dicted to occur with low probability in vivo. However, using high
throughput screening, we identified alternative amino acids at these
VRC01-class antibodies for HIV-1 prevention and treatment
key sites that are more likely to emerge upon lineage activation. Y.D. Kwon1; B. Zhang1; J. Gorman1; M. Louder1; K. Mckee1; A. Pegu1;
Based on these results, optimized “priming” and “boosting” immuno- M. Asokan1; E.S. Yang1; R. Verardi1; B. Lin1; Q. Liu2; P. Lusso2;
gens to elicit DH270.6-like antibodies were developed and will be dis- N. Doria-Rose1; J. Mascola1 and P. Kwong1
1
cussed. Vaccine Research Center, National Institutes of Health, Bethesda,
Conclusions: Our studies demonstrate that for robust “priming”, United States, 2Laboratory of Immunoregulation, National Institutes of
immunogens need to engage DH270.6 precursors with discrete CDR- Health, Bethesda, United States
H3 loops through regions encoded by particular D genes. Once the
lineage has been activated, only a few acquired mutations are suffi-
Background: Passive transfer of broadly neutralizing HIV-1 antibodies
cient to mature antibody responses to DH270.6-like breadth and
has shown promise in preventing infection from HIV-1 exposure. The
potency. Multiple amino acid variants are possible at the key sites that
high dose required for this therapy in humans, however, limits the
control DH270.6 function, revealing that diverse evolution pathways
route of administration to infusion, which demands further improve-
can be pursued to develop breadth by “boosting”.
ment of the potency of antibodies to circumvent this disadvantage
and to reduce the cost of treatment.
PE02.15LB Methods: Here we sought to increase the potency and breadth of
The near-pan-neutralizing, plasma deconvoluted antibody VRC01-class antibodies by structure-based rational design. We gener-
N49P6 mimics CD4 in its quaternary interactions with the ated a matrix of antibody variants with mutations that fill interspatial
HIV-1 envelope trimer cavity, extend their contacts to the neighboring Env protomer, or
W. Tolbert1; D. Nguyen1; Z. Tehrani2; M. Sajadi2,3 and M. Pazgier1 reduce potential steric clashes, and assessed their neutralization
1
Uniformed Services University of the Health Sciences, Infectious Dis- potency, autoreactivity, pharmacokinetics, and determined the cryo-
ease Division, Department of Medicine, Bethesda, United States, EM structure of BG505 DS-SOSIP Env trimer in complex with a
2
Institute of Human Virology, University of Maryland School of Medi- VRC01 variant.
cine, Divisions of Vaccine Research and Clinical Care and Research, Results: Against a 208-virus panel, one variant, VRC01.23LS, showed
Baltimore, United States, 3Baltimore VA Medical Center, Department increased breadth and ~10-fold improvement in potency, with a geo-
of Medicine, Baltimore, United States metric mean IC80 of 0.12 mg/ml and a breadth of 96%. Moreover, its
serum half-life was maintained at a level comparable to that of
VRC01LS. Another variant, VRC07-523-F54-LS.v3, exhibited even
Background: The first step in the HIV-1 entry process is the attach- greater potency and breadth, with a geometric mean IC80 of
ment of the Envelope (Env) trimer to target cell CD4. The CD4 bind- 0.072 mg/ml and a breadth of 97%. Cryo-EM structure of BG505
ing site (CD4bs) therefore remains one of the only universally DS-SOSIP.664 Env trimer in complex with VRC01.23LS Fab deter-
accessible sites on the Env trimer. Few antibodies (Abs) are able to mined at 3.4-A resolution confirmed the structural basis for the
capitalize on this however, due the steric constraints involved in improved potency, revealing that the Trp at position 54 in the heavy
accessing the CD4bs. N49P7 is a VRC01-like CD4bs Ab isolated from chain occupied the Phe43CD4 cavity on gp120, the extended heavy
the plasma of a HIV-1 “elite neutralizer” that achieves near pan neu- chain framework region 3 contacted the neighboring Env protomer,
tralizing breadth against HIV-1. It does this in part through unique and the truncated N-terminal light chain enabled the antibody to bet-
interactions to the highly conserved gp120 inner domain layer 3. We ter accommodate diverse conformations of the V3 loop of gp120.
determined the structure of N49P6, another CD4bs Ab isolated from Conclusions: Thus, a matrix-based approach combined with autoreac-
the same donor, in complex with gp120 and BG505 SOSIP to better tivity measurements and with serum half-life assessment in human
understand the breadth and potency of this class of CD4bs Abs. neonatal Fc receptor mice enabled the engineering of VRC01-class
Methods: N49P6 IgG was expressed in HEK 293 cells and purified variants with improved potency, breadth, and pharmacokinetics.
by protein A affinity. Clade A/E 93TH057gp120coree and clade A
BG505 SOSIP.664 were expressed in GnT1- cells and purified with
antibody affinity columns, 17b and 2G12 respectively. 93TH057gp120
was deglycosylated with EndoHf and N49P6 Fab was generated from
IgG by papain digest. Complexes were made and used to grow protein
crystals for x-ray structure determination.
Results: We determined the structures of the N49P6 Fab-
93TH057gp120coree and N49P6 Fab-BG505 SOSIP.664 complexes
86
PE02.17LB Cellular immunity

A lineage of exceptionally potent and broad BnAbs with
ultralong CDRH3 from vaccinated cows focus low-mutation
rate from germline into a globular knob contacting the
CD4bs PE03.01
N. Salazar Quiroz1; B. Heydarchi1; S. Li1; M. Corcoran2; G. Karlsson Breadth of CD8 T-cell mediated inhibition of HIV-1
Hedestam2 and D. Purcell1 replication correlates with breadth of epitope recognition
1
The University of Melbourne, Microbiology and Immunology, Mel- mapped with a comprehensive Gag, Nef, Env and Pol
bourne, Australia, 2Karolinska Institutet, Microbiology, Tumor and Cell potential T-cell Epitope (PTE) peptide set
Biology, Stockholm, Sweden N. Fernandez; P. Hayes; J. Dalel; C. Streatfield; G. Macharia; J. Hare;
L. Black; D. King and J. Gilmour
Background: Despite the known challenges of producing broadly neu- IAVI Human Immunology Laboratory, Imperial College London,
tralising antibodies (BnAbs) against HIV-1 envelope (Env), bovines eli- London, United Kingdom
cit antibodies with neutralising features only weeks after vaccination
with stabilised Env trimers. Previous results in our laboratory showed
Background: Full characterisation of CD8 T-cell functional HIV-1
high neutralising titres in cows vaccinated with KNH1/BG505 SOSIP
responses, including identification of HIV-1 epitopes recognised and
gp140 and mild neutralisation in cows vaccinated with AD8 uncleaved
CD8 T-cell ability to directly inhibit HIV-1 replication, would assist
gp140. Moreover, potent BnAbs were isolated from one animal from
HIV-1 vaccine development. Identification of individual epitopes recog-
KNH1/BG505 SOSIP group (monoclonal antibodies (mAbs) 1842,
nised is hampered by immense HIV-1 diversity. A Potential T-cell Epi-
1872 and 2129). In order to understand the development of neutralis-
tope (PTE) peptide set (NIH AIDS Reagent Program) designed to
ing antibodies in these animals, analysis of IgG sequences by next-gen-
address HIV-1 sequence diversity consists of 1408 HIV-1 Gag, Nef,
eration sequencing (NGS) was performed.
Pol and Env peptides. Mapping of individual CD8 T-cell epitopes
Methods: Four Holstein Friesian cows were vaccinated in two phases,
within such large peptide sets is problematic due to limits in volunteer
receiving AD8 Unc gp140 or KNH1/BG505 SOSIP gp140 during
blood sampling. This was addressed through polyclonal expansion of
phase 1, and AD8 SOSIP gp140 or BG505 SOSIP gp140 during phase
CD8 T-cells.
2. Total RNA from PBMCs isolated after phase 1 and phase 2 of vac-
Methods: CD8 T-cells were polyclonally expanded from PBMC from
cination was purified, and Multiplex PCR was used to construct IgM
13 HIV-1 seropositive anti-retroviral na€ıve subjects using CD3/CD4
and IgG libraries from cDNA, using specific primers targeting VDJ
bi-specific antibody.
region for further Illumina paired-end sequencing. Sequence analysis
Identification of individual peptides recognised by CD8 T-cells was
was performed using programs IgDiscover and AbMining Toolbox. Addi-
achieved by 2-step IFN-c ELISpot approach utilising peptide matrices
tionally, sequences from mAbs isolated from same animals were anal-
following 7-day expansion followed by single peptide confirmation at
ysed.
expansion day 10. Responses of CD8 T-cells isolated directly from
Results: IgM library sequences allowed the design of custom data-
PBMC or following polyclonal expansion were compared. CD8 T-cell-
bases, using novel V gene alleles discovered in each animal. Using
mediated inhibition of HIV-1 replication of a diverse cross-clade panel
these animal-specific databases, IgG sequences of KNH1/BG505
of 10 HIV-1 isolates in autologous CD4 T-cells was assessed using a
SOSIP 100 and AD8 Unc 500 groups showed that KNH1/BG505
Renilla reniformis luciferase viral inhibition assay (VIA).
SOSIP gp140 induced slightly higher rates of somatic hypermutation
Results: Polyclonal expansion from 1 frozen PBMC vial provided suf-
(SHM) in germline genes compared to AD8 Unc gp140. BnAbs 1842,
ficient CD8 T-cells for 2-step IFN-c ELISpot analysis of peptide recog-
1872 and 2129 showed ultra-long CDRH3s which concentrated most
nition in 12 of 13 subjects. One subject required an additional vial for
of the mutations found in the whole variable region, with rates below
both ELISpot steps. Median 36 (5 to 65) individual PTE peptides and
7.4% in V segment, in comparison with non-neutralising antibodies
median 18 (3 to 41) epitope regions were recognised. The numbers of
which presented higher SHM rates.
peptides recognised was positively correlated with HIV-1 isolate inhi-
Conclusions: High levels of affinity maturation were not required to
bition breadth (r = 0.667, p = 0.021) as measured in the VIA. There
obtain BnAbs in bovines. Ultra-long CDRH3 antibodies, which repre-
was no significant difference in ELISpot magnitudes between
sented around 8% of total sequences found in libraries, needed less
expanded and directly PBMC-isolated CD8 T-cells (p = 0.832).
than 7.4% of SHM to achieve broad neutralisation, and in contrast
Conclusions: A 2 step IFN-c ELISpot approach allowed identification
presented a highly variable CDRH3. The study shows that bovines
of HIV-1 PTE peptides recognised by CD8 T-cells polyclonally
present genetic advantages to produce BnAbs against HIV-1 rapidly
expanded from 1 frozen PBMC vial. CD8 T-cell-mediated inhibition
compared to humans, and that KNH1/BG505 SOSIP gp140 induces
breadth was positively correlated with the number of HIV-1 PTE pep-
higher rates of SHM than uncleaved trimers.
tides recognised. This approach overcomes the problem of fully char-
acterising HIV-1 specific CD8 T-cell functional responses in the
context of immense HIV-1 diversity and can be applied to inform on
HIV-1 pathogenesis and vaccine design, with minimal sample require-
ments.
87
PE03.03 PE03.04LB
Incidence, clinical spectrum, risk factors and outcome of Infection with a highly Gag pre-adapted virus broadens the
immune reconstitution inflammatory syndrome (IRIS) among proteins targeted by CTLs during acute HIV infection
HIV patients on highly active anti-retroviral therapy D. Monaco1; P. Hayes2; D. Dilernia1; D. Wooding2; J. Gillmour2 and
(HAART) in the south west region of Cameroon E. Hunter1
1
M. Julius1; N.F. Peter2; M.C. Kebeya3; N.A. Forbinake4 and Emory Vaccine Center, Emory University, Atlanta, United States,
2
O.C. Stephane5 Human Immunology Lab, Imperial College London, London, United
1
Cameroon Baptist Convention Health Services, HIV Free Project, Kingdom
Bamenda, Cameroon, 2Faculty of Health Sciences, University of Buea,
Public Health, Cameroon, 3Cameroon Baptist Convention Health Ser-
Background: Pre-adaptation, the degree to which the polymorphisms
vices, Baptist Hospital Mutengene, Bamenda, Cameroon, 4Medecins Sans
in the T/F virus are linked to the HLA allele repertoire of the newly-
Frontiere, Cameroon, 5University of Yaounde 1, Yaounde, Cameroon
infected individual, has been shown to impair virus control and accel-
Background: Immune reconstitution inflammatory syndrome (IRIS) in erate disease progression. This impact was associated with an reduced
HIV- infected patients initiating highly active antiretroviral therapy ability to target epitopes in the highly pre-adapted protein and weaker
(HAART) results from an exhuberant restoration of pathogen-specific responses towards the adapted epitopes. In this study, we looked to
immunity. The overall incidence of IRIS is unknown and there are still identify the targets of the cellular immune response at the whole-pro-
limited data from resource-limited settings. Given the paucity of data teome level during acute infection, comparing individuals infected with
in sub-saharan Africa, our study characterises a typical Cameroonian a high or low pre-adapted virus in Gag.
cohort, useful to anticipate and prevent this syndrome in patients initi- Methods: Gag was sequenced in plasma samples (<45 days post-EDI)
ating ART. Our objective was determine the incidence, clinical spec- from recipients in epidemiologically-linked heterosexual transmission
trum, risk factors and outcome of IRIS in HIV-infected patients pairs from Zambia (Zambia Emory Research Project) to determine
initiating ART in South West Region, Cameroon. their level of pre-adaptation (N=27). PBMCs samples from early in
Methods: 120 consecutive ART-naive HIV-infected adults aged infection (<6 months post-EDI) were polyclonally expanded for 9 days
21 years and over, initiating ART at two major treatment centres in using a CD3/CD4 bispecific antibody and IL-2. IFN-g responses
the South West Region were prospectively followed for development against pools spanning each HIV protein were tested via ELISpot. Pep-
of IRIS over 16 weeks. Following their consent, patients were inter- tides used to construct the pools were 15-mers, overlapped by 11,
viewed on a face to face basis and on their subsequent visits IRIS representing the consensus of chronic sequences obtained from the
events were classified using diagnostic criteria by Haddow et al. Data same Zambian cohort. Responses higher than 50 SFU/106 cells were
were analyzed using SPSS version 21.0. considered positive.
Results: During a 16 week follow-up period from ART initiation, the Results: Individuals infected with highly pre-adapted viruses showed
cumulative incidence of IRIS was 10.8% with incidence rate of 43.0/ a significantly greater number of proteins being targeted outside of
100 person-years. 13 patients (M:F-3:10) experienced 15 IRIS clinical Gag (p =0.049) than individuals infected with low pre-adapted
events with 9/15 (60%) unmasking and the remaining paradoxical. viruses. Pol was significantly more targeted in the high pre-adapta-
Diagnoses included: miliary tuberculosis (1/15, 6.7%), psoas abscess tion group, in which all the individuals showed a positive response
(1/15, 6.7%) folliculitis (3/15, 20.0%), herpes zoster (1/15, 6.7%), her- against the Pol pool (p =0.03; 10/10 vs. 4/9). Among accessory pro-
pes simplex (1/15, 6.7%), cryptococcal meningitis (2/15, 13.3%), proteins, in the high pre-adaptation group, Nef and Vif were the most
gressive multifocal leucoencephalopathy (PML) (1/15, 6.7%), cellulitis targeted while Tat was the least. Interestingly, Tat along with Nef
(1/15, 6.7%), lymphadenitis (1/15, 6.7%), genital warts (1/15, 6.7%), were the most targeted accessory proteins in the low pre-adapta-
and Kaposi’s sarcoma (2/15, 13.3%). Median time to IRIS onset was tion group.
28 days (interquartile range, 14 to 84) from ART initiation. Low CD4 Conclusions: These results support the hypothesis that a high degree
count (<200 cells/μL) was the only risk factor (p = 0.036) on univari- of preadaptation in Gag forces the immune response to redirect
ate analysis of the pre-ART predictors. Most IRIS cases were mild. 11/ against proteins that seem to be less efficient in controlling HIV repli-
13 patients recovered, 3/11 of whom required hospitalisation. Two cation, as evidenced by the faster disease progression observed in this
deaths were attributable to IRIS (PML and psoas abscess). group. Identifying subdominant Gag epitopes, which do not select or
Conclusions: For every 100 HIV patients initiated into HAART in transmit escape, in these high Gag pre-adaptation individuals may be
South West Region, Cameroon, 10 to 11 patients may develop IRIS of an important strategy to find novel targets for future vaccines.
varied patterns primarily around 28 weeks from HAART initiation,
particularly those with advanced immunosuppression. However, severe
life-threatening IRIS is uncommon. Close follow-up of ART naive cli-
ents especially those with low initiating CD4 counts is therefore perti-
nent.
88
Abstract PE04.01-Table 1. Results from multivariable logistic regres-

Clinical trial results sion adjusted for site accepting a DVR at enrollment visit and consis-
tently accepting a ring in Multivariate Analyses. Cells marked NA
indicate the variable was not included in that multivariable regression
Accepting
PE04.01 DVR at
Correlates of dapivirine vaginal ring uptake among women enrollment
participating in an open label extension trial-MTN-025/ N = 1342 Consistently accepting DVR
(92%) N = 1153 (79.2%)
HOPE
Baseline
B. Gati Mirembe1; M.V. Cabrera2; M. Cobbing3; N. Mgodi4; characteristic OR (95% CI) p-value OR (95% CI) p-value
T.P. Palanee5; A. Mayo6; S. Dadabhai7; L.E. Mansoor8; S. Siva9;
G. Nair10; C.A. Akello1; C. Nakabiito1; L.E. Soto-Torres11; Education level less N/A N/A 0.67 (0.43, 1.04) 0.07
A. Van der Straten12 and J. Baeten13 than secondary
1
Mujhu Research Collaboration, Kampala, Uganda, 2University of school
Had Primary Partner 3.88 (1.62, <0.01 3.44 (1.77, 6.69) <0.01
Washington, Biostatistics, Seattle, United States, 3HIV Prevention
at enrollment 9.28)
Research Unit, South Africa Medical Research Council, Pharmacy, Dur- Any unprotected sex N/A N/A 0.87 (0.62, 1.21) 0.41
ban, South Africa, 4University of Zimbabwe College of Health Sciences in the past 7 days
Clinical Trials Research Centre, Harare, Zimbabwe, 5Wits Reproduc- HIV risk perception N/A N/A (ref) 0.75
tive health and HIV Institute (Wits RHI) University of the Witwater- Not worried 0.95 (0.67, 1.33) 0.05
srand, Johannesburg, South Africa, 6FHI 360, Durham, United States, Somewhat low 1.47 (1, 2.18)
7 risk
Malawi College of Medicine-Johns Hopkins University Resreach Pro-
ject, Queen Elizabeth Central Hospital Blantyre Malawi, Malawi, 8Cen- Very worried
tre for AIDS Programme of Research in South Africa, University of Perceives the ring to 1.67 (1.01, 0.05 1.08 (.075, 1.55) 0.68
offer a lot of 2.78)
Kwazulu Natal, Durban, South Africa, 9HIV Prevention Research Unit,
protection
South Africa Medical Research Council, Durban, South Africa, 10The Very likely to use 1.77 (1.11, 0.02 1.68 (1.23, 2.29) <0.01
Desmond Tutu HIV Centre, University of Cape Town, Cape Town, the ring if it 2.81)
South Africa, 11Division of AIDS, National Institute of Allergy and becomes available
Infectious Diseases, National Institutes of Health, Bethesda, United Reports use of Oral 0.5 (0.29, <0.01 0.4 (0.27, 0.58) <0.01
States, 12W omens Global Health Imperative,RTI International, Berk- HC 0.87)
erly, Research Triangle Park, United States, 13University of Washing- Has implant for N/A N/A 1.19 (0.8, 1.77) 0.39
ton, Department of Global Health Medicine, Epidemiology, Seattle, contraception
United States
Cells marked NA indicate the variable was not included in that multi-
variable regression.
Background: MTN-025/HOPE was a Phase IIIb open-label extension
trial of the dapivirine vaginal ring (DVR) for former participants of Conclusions: Uptake and sustained acceptance of the DVR was high
MTN-020/ASPIRE, one of two phase 3 studies that showed the DVR in HOPE. Factors predictive of ring acceptance included: having a pri-
was well-tolerated and reduced the risk of HIV infection by approxi- mary partner, high perception of HIV risk and use of oral contracep-
mately 30%. Use of the DVR was not required for participation in tives. Future efforts should consider these factors when targeting
HOPE and women could change their mind about ring acceptance populations for DVR rollout and in designing counseling messages.
during study follow-up. We explored factors associated with DVR
uptake in MTN-025/HOPE. PE04.02
Methods: MTN-025/HOPE was conducted at 14 sites in Malawi,
Tenofovir-only and tenofovir/levonorgestrel intravaginal
South Africa, Uganda, and Zimbabwe between July 2016 and August
2018. To be eligible for the study, women had to be HIV uninfected,
rings are unlikely to impact the genital microbiota of
not pregnant, not breastfeeding and willing to provide informed con- sub-Saharan women
sent. The DVR was offered monthly for the first 3 months, then quar- S. Dabee1; N. Mugo2; V. Mudhune3; E. McLellan-Lemal4; S. Peacock5;
terly (3 rings dispensed) thereafter at months 3, 6 and 9. Logistic S. O’Connor4; B. Njoroge3; B. Nyagol3; A.R. Thurman6; E. Ouma3;
regression analysis was used to assess correlates of DVR uptake from R. Ridzon4; J. Wiener4; H.S. Haugen5; M. Gasper1 and C. Feng1
1
entry to month 9 adjusting for region, including demographics, partici- Seattle Children’s Research Institute, Infectious Disease, Seattle, Uni-
pant/partner characteristics, sexual behavior, HIV risk perception, fam- ted States, 2Kenya Medical Research Institute, Center for Clinical
ily planning methods, and intention to use the ring in future. Research, Nairobi, Kenya, 3Kenya Medical Research Institute, Center
Covariates from univariate analyses that were significant at p < 0.10 for Global Health Research, Nairobi, Kenya, 4U.S. Centers for Disease
were included in a multivariate analysis. Control and Prevention, Division of HIV/AIDS Prevention, Atlanta,
Results: A total of 1456 women (median age 31 years) enrolled in United States, 5University of Washington, Global Health, Seattle, Uni-
HOPE and 8390 visits were included in the analysis. At baseline, ted States, 6Eastern Virginia Medical School, Obstetrics and Gynecol-
1342 (92.0%) chose to accept the DVR and 1153 (79.2%) were con- ogy, CONRAD, United States
sistent acceptors (accepted the ring at all visits). Significant correlates
of ring uptake (at p < 0.05) are included in Table 1 below:
Background: Multipurpose HIV/HSV-2 prevention intravaginal rings
(IVRs) with and without contraceptive co-formulation are under devel-
opment. We investigated the impact of 90-day tenofovir (TFV) IVRs
with/without levonorgestrel (LNG) relative to placebo on the genital
microbiota of Kenyan women.
Methods: In this phase 2a, double-blind, placebo-controlled, random-
ized trial, 27 women ages 18 to 34 years (non-pregnant, negative for
89
HIV, Treponema pallidum, Chlamydia trachomatis, Neisseria gonor- study participants would consider using the product for protection
rhoeae and Trichomonas vaginalis, Nugent score <7, and without any against HIV or pregnancy.
contraindications to LNG or TFV) were randomized 2:2:1 to continu- Conclusions: OB-002H gel was safe and well tolerated with a good
ous use of IVRs containing: TFV (n = 11); TFV/LNG (n = 11); or pla- acceptability profile and high intentionality of future use. Future stud-
cebo (n = 5). Using lateral vaginal and IVR swab samples from each ies are needed to assess the extended safety and acceptability of the
participant at the time of ring insertion and removal, the absolute product in sexually active participants.
abundance of bacteria per swab was determined by real-time PCR of
the 16S region, and 16S rRNA gene sequencing was used to deter- PE04.04LB
mine the microbial composition of the female genital tract.
Can the offer of regular HIV self-testing kits reduce time to
Results: Women used the IVR for a median of 67 days (range: 15 to
91 days). Vaginal total bacterial burden increased between insertion
HIV diagnosis in MSM? Results from the SELPHI RCT
and removal of the placebo ring (0.32 log increase) and decreased L. McCabe1; A. Rodger2; A. N. Phillips2; F. Lampe2; F. Burns2;
with both TFV and TFV/LNG IVR use (0.57 and 0.27 log decrease D. Ward1; V. Delpech3; J. Khawam3; P. Weatherburn4; T.C. Witzel4;
respectively; all p > 0.05). Compared to the genital lateral wall, the R. Pebody5; R. Trevelion6; Y. Collaco-Moraes1; S. McCormack1 and
TFV/LNG IVR tended to have a higher biomass, the placebo IVR a D. Dunn1
1
lower biomass, and no difference with the TFV IVR. Median Shannon MRC Clinical Trials Unit at UCL, London, United Kingdom, 2Institute
a-diversity decreased among women randomized to use the TFV/LNG for Global Health, University College London, London, United King-
IVR (1.79 vs. 1.29; p = 0.26), increased in women using the TFV IVR dom, 3National Infection Service, Public Health England, London, Uni-
(0.85 vs. 1.56; p = 0.07) and remained stable in women with placebo ted Kingdom, 4London School of Hygiene & Tropical Medicine,
IVR (1.80 vs. 1.88; p = 0.77). Overall, the TFV/LNG IVR had a ‘stabiliz- London, United Kingdom, 5NAM, London, United Kingdom, 6HIV i-
ing’ effect on the FGT microbiota whereby 50% of the participants’ Base, London, United Kingdom
microbiota composition did not change and 50% shifted toward more
lactobacillus-dominant states. More specifically, TFV/LNG IVR use was
Background: There remains a lack of evidence on the effectiveness
accompanied by increased abundances of L. gasseri and the genital
of free HIV self-testing (HIVST) to improve early diagnosis in men
probiotic species L. fermentum, and a decrease in Streptococcus spp
(all false discovery rate-adjusted p < 0.01). who have sex with men (MSM), particularly in men who have frequent
condomless anal intercourse (CAI) with multiple partners. We investi-
Conclusions: We found that the TFV and TFV/LNG IVRs had no sign
gated if the offer of free, regular HIVST kits led to a reduction in time
of detrimental impact on genital microbiota, with the latter being asso-
taken to receive an HIV diagnosis.
ciated with increased lactobacillus abundance. These findings warrant
Methods: SELPHI is an internet based, open-label, randomised con-
further investigation in next-phase studies of these IVR.
trolled trial that recruited men interested in HIVST with a second ran-
domisation 3 months later for those who wanted to test regularly
PE04.03LB with HIVST. Enrolment criteria for the second randomisation were
Phase 1 evaluation of the safety, acceptability, and CAI with ≥1 partner in the previous three months, and tested nega-
pharmacokinetic profile of an OB-002H gel tive using the baseline HIVST. Participants were randomised 1:1 to
I. McGowan1; B. Kosak1; M. Tomaszewska-Kiecana2; J. Engstrom3; receive free HIVST every 3 months (Regular Test [RT]) versus no
B. Korczak1 and O. Hartley3,4 Regular Test [nRT]). Surveys were delivered every 3 months post-ran-
1
Orion Biotechnology Polska, Krakow, Poland, 2BioVirtus Research Site domisation, at which participants in RT could request a new kit. Pri-
Sp. z o.o., Jozefow, Poland, 3Orion Biotechnology, Ottawa, Canada, mary outcome was time between randomisation and date of
4
University of Geneva, Geneva, Switzerland confirmed HIV diagnosis.
Results: 2308 men were randomised (1161 RT, 1147 nRT); median
age 34 years (IQR 27 to 44); 89% white; 19% born outside the UK;
Background: OB-002 is an extremely potent CCR5 antagonist that 0.7% trans men; 47% degree educated. At the time of initial randomi-
has previously been shown to completely block vaginal transmission of sation, 8% ever and 4% currently used PrEP. Survey completion ran-
a SHIV virus (SF162P3) in a non-human primate model of HIV infec- ged from 47% to 84%, decreasing over time. Median follow-up time
tion (Veazey R et al. JID 2009). The purpose of this study was to was 78 weeks (IQR 52 to 91). RT participants requested and used
characterize the safety, acceptability, and systemic absorption of a gel the HIVST kit in 78% of follow-up surveys. There was no significant
formulation of OB-002 (OB-002H). difference in confirmed HIV diagnoses between arms (8 [0.7%] in RT
Methods: The trial had two phases, an open label single dose expo- vs. 7 [0.6%] in nRT; hazard ratio 1.12 95% CI 0.41, 3.08). Men in RT
sure (vaginal and rectal) and a randomized placebo controlled multiple were much more likely to HIV test in the previous 3 months (range
dose phase during which study participants received five vaginal daily 85% to 88% across surveys) than men in nRT (34% to 42%) (p
doses of OB-002H gel or matched placebo in a 2:1 ratio. The first <0.001). There were no statistical difference in STI testing, STI diag-
three participants in the multiple dose phase of the study received noses, or reported CAI between the groups.
open label OB-002H gel. All gel administration was performed by Conclusions: New HIV diagnoses were low overall throughout follow-
medical staff. Serum OB-002 levels were quantified at multiple time up, reflecting national trends in MSM, with no significant difference
points up to 24 hours after the first dose. Participants also completed between those receiving HIVST and those not. However, men in RT
a product acceptability questionnaire after the final dose of gel. HIV tested more often with no decrease in STI testing or increases in
Results: A total of 30 participants were enrolled in the study. Twelve STI diagnoses or CAI.
participants were enrolled in the single dose phase of the study (six in
the vaginal and six in the rectal administration arms of the study),
three participants were enrolled in the open label multiple vaginal
dose phase, and fifteen participants in the randomized phase of the
study. Only two product related transient Grade 2 events (both vulval
dryness) occurred in the study, both were in the OB-002H gel ran-
domized multiple dose arm. All colposcopic and anoscopic assessments
were normal. There was no evidence of systemic absorption of OB-
002. Overall, the product had a positive acceptability profile, and most
90
Conclusions: Successful recruitment of AGYW requires a multipronged

Community engagement in prevention approach with community stakeholders, parents/guardians and the
young women themselves to achieve accrual within specified timelines.
research
PE05.02
Involvement of stakeholders in planning and implementing
PE05.01 HIV clinical research trials among pregnant and
Recruiting adolescent girls and young women into the breastfeeding women in Uganda
MTN-034 Study: lessons learnt from the Kampala and D. Kemigisha
Johannesburg sites MU-JHU Research Collaboration, Psychosocial Support, Kampala, Uganda
M.J. Nambusi1; H. Rampyapedi2; Y. Naidoo2; R. Nakalega3; J. Etima3;
S. Nanyonga3; D. Kemigisha3; S. Sibeko2; L. Gama2; K. Reddy2;
T.P. Phillips2; B.G. Mirembe3; C. Nakabiito3; C. Agwau Akello3 and Background: Phase IIb and III trials on the safety and efficacy of the
T. Nakyanzi3 dapivirine vaginal ring (DVR) involved women of reproductive age, yet
1
Makerere University-John Hopkins University Research Collaboration, pregnant and breastfeeding women were excluded from enrolling.
Psycho-social Support, Kampala, Uganda, 2Wits Reproductive Health Those who became pregnant during study participation were required
and HIV Institute, Johannesburg, South Africa, 3Makerere University- to discontinue study product immediately. As such, limited information
John Hopkins University Research Collaboration, Kampala, Uganda is known about the safety of the DVR in pregnant and breastfeeding
women, despite high vulnerability to HIV in these populations. For this
reason, the Microbicide Trials Network (MTN) designed the MTN042/
Background: The MTN 034/REACH is an 18 month cross-over study DELIVER and MTN-043/B-PROTECTED studies to better understand
of daily oral PrEP and monthly dapivirine vaginal ring safety and prefer- safety of the DVR, as well emtricitabine/tenofovir disoproxil fumarate
ences, recruiting adolescent girls and young women (AGYW) aged 16 to (Truvada) as oral PrEP, among these groups of women.
21 years across 4 African sites; Uganda, Zimbabwe, Johannesburg and Methods: MTN, AVAC, MU-JHU and civil society partners identified
Cape Town. AGYW are usually study na€ıve, undecided about their sex- a range of stakeholders from both the HIV prevention and maternal
ual and reproductive health care and fear peer and community judg- health arenas to attend a two day meeting to provide their input in
ment; hence effective recruitment strategies are critical. Recruitment preparation for and implementation of the two protocols. This was fol-
involves presenting potential participants with adequate information lowed by two smaller group engagement meetings, one for the Kam-
about the study to help establish interest and trust, willingness to partic- pala Capital City Authority (KCCA) health workers and the other for
ipate and eligibility assessment. We describe the strategies employed at community-based private health practitioners and local leaders. Agen-
the Kampala and Johannesburg sites to recruit AGYW in to the MTN- das were developed that allowed open discussion and the provision of
034 study, share challenges faced and lessons learned. key issue feedback to the research team.
Methods: Memorandums of Understanding (MoUs) were established Results: Three meetings were held and 214 (97%) of the 220 invited
with different stakeholders prior to sensitization and recruitment. stakeholders attended, including policy makers, regulators, civil society,
Contacts for mobilization were established with different partners and religious leaders, private midwives, political leaders, former participants
communities. Peer contacts in Reproductive Health centers referred in DVR studies, PrEP and Prevention to Mother To Child Transmission
potential participants to the site clinic. Sensitization about the study (PMTCT) beneficiaries, mentor mothers, KCCA health workers, commu-
was conducted in different areas and activity records kept in pre- nity based-private health practitioners, local leaders, and other commu-
screening logs. A pre-screening/recruitment checklist was used to nity stakeholders. Attendees were supportive of the studies proposed
determine presumptive eligibility in the community and for continued and made suggestions to improve implementation that included: joint
pre-screening in the clinic. Pre-enrollment sessions were conducted to protocol reviews by regulating bodies to minimize delays in obtaining
address questions and concerns before enrollment. approvals, substantial male involvement to minimize social harm, devel-
Results: A total of 129 AGYW were enrolled out of 623 prescreened opment of information and education materials to promote better
(Table 1). In Kampala – contacts were made with 74 stakeholders (re- understanding of the studies, and continuous community sensitization
ligious, local leaders and parents/guardians community partners) and about oral PrEP, pregnancy-related complications, birth defects and the
recruitment spots were established to mobilize AGYW. Similarly, In known study product side effects to help minimize the potential of com-
Johannesburg - contacts were made with 50 stakeholders, ward coun- munities apportioning blame to study products.
cils, community health facilities and with Adolescent Friendly Clinics. Conclusions: Careful selection of stakeholders and interactive agendas
enabled meaningful engagement and solicitation of input to support the
Abstract PE05.01-Table 1. Recruitment statistics and challenges planning, preparation, and implementation of the two protocols.
faced in AGYW recruitment (Jan 2019 to Feb 2020)
Clinical Research Site (CRS) Kampala Johannesburg PE05.03
Community implementation of a peer group intervention
Sensitized 755 870
Pre-screened 322 301 increases condom use at last sex in rural Malawi
Presumptively eligible 235 226 K.F. Norr1; C.K. Banda2; D.L. Jere3; L.L. McCreary1; C.G. Park1;
Minors (16 to 17) 59 51 C.L. Patil1; L.C. Kumbani2 and L. Liu4
Young women (18 to 21) 176 175
1
Presented at clinic 148 134 University of Illinois at Chicago, Nursing, Chicago, United States,
2
Minors 40 36 Kamuzu College of Nursing, University of Malawi, Blantyre, Malawi,
Young women 108 98 3
Kamuzu College of Nursing, University of Malawi, Maternal-Child,
Challenges faced at both sitesSome minors have no parents or guardianDifficulty locating and
identifying authentic parents/guardians to consentSome minors were not ready to disclose
Blantyre, Malawi, 4University of Illinois at Chicago, Epidemiology and
to their parents that they are sexually activeLack of or poorly working cell phonesLimited Biostatistics, Chicago, United States
awareness/knowledge of PrEPRumors and misconceptions about research in
communitiesMany AGYW are still in school, tertiary institutions or employedFear of the
unknown (research and study products) Background: Previous efficacy research from rural Malawi showed
that our peer group intervention for HIV prevention increased
91
condom use. To scale-up, we transferred ownership to communities. PE05.04

We assessed whether this intervention when delivered by community
Design of a care pathway for pharmacy-based PrEP
volunteers also increased condom use.
delivery in Kenya: Results from a collaborative stakeholder
Methods: Using a stepped-wedge design, three communities sequen-
tially implemented the intervention. We surveyed 1016 adults and consultation
youth (ages 13 to 19) at Time 1 (T1, baseline), at T2 after community K. Ortblad1; P. Mogere2; S. Roche3; K. Kamolloh4; J. Odoyo4;
1 completed the intervention and at T3 after community 2 completed N. Mugo4; J. Pintye3; J. Baeten1; E. Bukusi4 and K. Ngure5
1
the intervention. The response rate at T3 was 91.7%. All sexually University of Washington, Department of Global Health, Seattle, Uni-
active participants at T1 are included and the dependent variable is ted States, 2Partners in Health and Research Development, Nairobi,
condom use at last sex. Baseline predictors are gender, youth or adult, Kenya, 3University of Washington, Seattle, United States, 4Kenya Med-
education, and level of involvement in religious activities. Time-varying ical Research Institute, Nairobi, Kenya, 5Jomo Kenyatta University of
predictors are intervention vs. control and living together with a part- Agriculture and Technology, Community Health, Kenya
ner. Longitudinal logistic regression with backward model selection
tested interactions between time and group to identify the interven-
tion effect. Background: In Kenya, pre-exposure prophylaxis (PrEP) for HIV pre-
Results: At T1, the sample was 46% female, 32% youth, 43% living vention is almost exclusively delivered at healthcare facilities. Develop-
with partner, 42% had not completed primary school, and 66% were ing novel PrEP delivery models is important for increasing the reach
highly involved in religious activities. After receiving the intervention, and reducing the cost of PrEP. In Kenya, retail pharmacies are com-
the proportion using a condom at last sex was significantly higher in monly used as a first-line access point for medical care, but have not
the intervention group (T2, Intervention = 71%, Control = 53%; T3, been utilized for PrEP delivery. We conducted a collaborative consul-
Intervention = 64%, Control = 56%). In the final regression model, tative meeting of stakeholders to develop a care pathway for
the intervention group reported more condom use than the control pharmacy-based PrEP delivery for Kenya.
group at both T2 and T3 (Table 1). Those who were male, youth, not Methods: In January 2020, we conducted a one-day meeting in Nair-
living with a partner and highly involved in religion were more likely obi with 36 stakeholders with diverse professional backgrounds and
to report using a condom at last sex. roles in PrEP delivery. Attendees reviewed results from formative
qualitative research with pharmacy providers and clients and consid-
Abstract PE05.03-Table 1. Final multivariate logistic regression for ered potential core components of pharmacy-based PrEP delivery:
condom use at last sex (N = 749) counseling, HIV testing, prescribing, and dispensing. Stakeholders par-
ticipated in small and large group discussions to identify potential
Predictors OR Estimates 95% CI challenges and solutions; we synthesized the key findings.
Results: Stakeholders were enthusiastic about a model for pharmacy-
Intervention versus Control at T2 1.37 (1.04, 1.79)
Intervention versus Control at T3 1.60 (1.07, 2.39)
based PrEP delivery, particularly one that could be piloted to provide
Gender (Male vs. Female) 1.25 (1.00, 1.55) evidence for larger-scale implementation. Potential challenges identi-
Religious Involvement (very vs. less involved) 1.53 (1.22, 1.92) fied included insufficient pharmacy provider knowledge and skills, reg-
Age Group (Youth vs. Adult) 2.05 (1.60, 2.64) ulatory hurdles to providing affordable rapid blood-based HIV testing
Partner Status (No partner vs. Having a partner) 1.47 (1.17, 1.84)
at pharmacies, and undefined pathways for PrEP procurement. Poten-
tial solutions included having pharmacy providers complete the Kenya
Ministry of Health-approved PrEP training, use a PrEP prescribing
Conclusions: When implemented by community members, this evi- checklist with remote clinician oversight as needed, and conduct provi-
dence-based intervention remained effective in increasing condom der-assisted HIV self-testing, and having the government provide PrEP
use. These findings support UNAIDS’ emphasis on community-cen- and HIV self-testing kits to pharmacies during a pilot test. A care
tered initiatives. Additional research is needed to address age and pathway was collaboratively developed during the meeting, Figure 1.
gender inequality and explore the role of religious involvement for Conclusions: PrEP delivery stakeholders in Kenya were strongly sup-
HIV prevention. portive of developing and testing a model for pharmacy-based PrEP
delivery to increase PrEP access. We collaboratively developed a care
92
pathway for pilot testing that has the potential to expand PrEP deliv- PE05.06
ery options in Kenya and other similar settings.
Exploring community understanding of HIV vaccine-induced
seropositivity in Soshanguve, South Africa
PE05.05 M. Malahleha1; R. Malamatsho1; T.E. Mbatsane1; M. Keefer2 and
Devising an integrated and creative response to support J. Jean2
participant retention in a global biomedical HIV prevention 1
Setshaba Research Centre, Clinical Research, Soshanguve, South
study during the COVID-19 pandemic Africa, 2University of Rochester, Rochester, United States
J. Lucas1; C. Collins2; S. Karas3; M. Del Rosario Leon4; A. Yousef5;
D. Gondwe6; R. Gonzalez7; S. Tenza8; P. Dechasakulpan9; A. Johnson1
and S. Johnson10 Background: The high HIV prevalence and incidence in South Africa
1 warrants conducting HIV vaccine trials in this country. However, fear
FHI 360, Science Facilitation, Durham, United States, 2Microbicide
of vaccine-induced seropositivity (VISP) may be a barrier to participat-
Trials Network, Communications and External Relations, Pittsburgh,
ing in HIV vaccine trials. The community of Soshanguve, including com-
United States, 3University of Pittsburgh, Department of Medicine,
n, Community munity stakeholders and health professionals, were na€ıve to HIV
Pittsburgh, United States, 4Impacta Salud y Educacio
vaccines and HIV vaccine research in 2015, when the first phase 1
Engagement Unit, San Miguel, Peru, 5University of Alabama at Birm-
trial was undertaken at Setshaba Research Centre, Soshanguve. In
ingham, School of Medicine, Division of Infectious Diseases, Birming-
order to facilitate recruitment into HIV vaccine trials, we aimed to
ham, United States, 6Johns Hopkins Project, College of Medicine,
assess and contextualise the community’s understanding of VISP.
Blantyre, Malawi, 7Bridge HIV, San Francisco Department of Public
Methods: In-depth, semi-structured interviews were conducted to
Health, San Francisco, United States, 8University of the Witwater-
assess:
srand, WITS RHI, Johannesburg, South Africa, 9Research Institute for
Health Sciences, CMU HIV Prevention, Chiang Mai, Thailand, 10FHI (a) knowledge, attitudes, and beliefs regarding VISP,
360, Science Facilitation, Washington, United States (b) perceptions, fears and issues around VISP, and
(c) personal understanding and community knowledge/perceptions of
VISP.
Background: The COVID-19 pandemic dramatically altered clinical
research sites (CRS) approaches to participant follow-up and retention Individuals >18 years who attended community educational work-
in Microbicide Trials Network (MTN) 035 – a global open-label cross- shops/training were eligible to participate. Audio recordings of inter-
over study evaluating three placebo products (douche, suppository views were transcribed verbatim and coded based on question
and fast-dissolving insert) as potential methods for delivery of a rectal themes.
biomedical HIV prevention product. Evolving local and national guideli- Results: Results based on 17 participants (mean age 30.9 years; 12
nes restricting travel, large gatherings, and nonessential services females) are presented. Only five participants (all female) defined VISP
prompted rapid development of contingency plans to sustain partici- as testing HIV positive at clinics and negative at the research site.
pant follow-up, as well as innovative measures by CRSs to meet these They defined this as occurring due to the vaccine, the use of different
challenges while ensuring participant and staff safety. instruments and/or the HIV test falsely indicating a positive result.
Methods: MTN-035 is being conducted among transgender people The main fears about VISP were 1) not understanding how one can
and cisgender men who have sex with men (MSM) from communities test positive at one clinic/facility, test negative at the research centre
in Malawi, Peru, South Africa, Thailand and the United States. Enroll- and still be negative, 2) fears of HIV acquisition, and 3) uncertainty of
ment lasted 12 months (April 2019 to March 2020) and participants one’s HIV status after study completion. A majority of respondents
were followed for 3.5 months. MTN-035 protocol and communication believed that communities’ perceptions of VISP will negatively affect
teams developed guidance and key messages for CRSs to support HIV vaccine trial recruitment efforts.
optimal operation during the COVID-19 pandemic. MTN-035 CRSs Conclusions: While a minority of participants understood the concept
implemented culturally appropriate site-specific multipronged of VISP, the majority had an inaccurate and incomplete understanding.
approaches to decrease the risk of COVID-19 transmission to study Thus, in addition to what VISP is, a basic understanding of how vacci-
participants and staff, and to support study retention. nes work and why VISP occurs is required. By framing VISP in the
Results: CRSs adapted various engagement strategies tailored to the context of other vaccines, this added perspective may address the
local context. In-person study visits were converted to telehealth fears and misunderstanding expressed by participants of testing HIV
study visits (computer assisted self-interviews, in-depth interviews, positive at a facility other than the research site.
SMS communication, counseling). Transportation in CRS vans sanitized
daily was provided for participant study visits. COVID-19 exposure/ PE05.07
symptoms screening prior to entering the van or clinic and protective Comparison of community-led distribution of HIV self-tests
personal equipment (face masks, gloves and hand sanitizer) was pro-
kits with distribution by paid distributors: a cluster
vided. Social distancing strategies implemented included operating
randomised trial in rural Zimbabwean communities
reduced or adaptive clinic hours, limiting the number of people per-
mitted inside CRSs and offering curbside pick-up or postal delivery of E.L. Sibanda1; M. Neuman2; C. Mangenah1; M. Tumushime1;
study product. Social and traditional media were utilized to inform C. Watadzaushe1; M. Mutseta3; J. Dirawo1; K. Fielding2; C. Johnson4;
participants, key stakeholders, and the broader community of safety M. Taetgmeyer5; K. Hatzold6; E. Corbett2; F. Terris-Prestholt2 and
modifications and distribute COVID-19 prevention messages. Result- F.M. Cowan5
1
ing retention rates were ≥85% weeks 4, 9, and 14. CeSHHAR Zimbabwe, Research, Harare, Zimbabwe, 2London School
Conclusions: Development of rapid response contingency plans and of Hygiene & Tropical Medicine, London, United Kingdom, 3PSI Zim-
“out-of-the-box” strategies during a pandemic is an important first step babwe, Harare, Zimbabwe, 4World Health Organization, Geneva,
to ensuring participant and staff safety. Providing guidance on study Switzerland, 5Liverpool School of Tropical Medicine, Liverpool, United
procedures modification and key messages for participants to CRSs Kingdom, 6PSI, Washington, United States
while allowing for site-specific culturally appropriate responses can
support participant retention and strengthen participant rapport.
93
Background: Community-based HIV self-testing (HIVST) increases participation in a HIV vaccine trial to discuss and visually map the
testing uptake and ART linkage. Sustainable distribution is required. pain-points/roadblocks that might influence their decision making. The
We evaluated community-led HIVST in rural Zimbabwe. data was analyzed deductively using a theoretical thematic approach.
Methods: Forty ‘village groups’ were randomly allocated to (i) com- Results: The roadblock maps facilitated open conversations where
munity-led HIVST; (ii) paid distribution (PD). In the community-led participants shared their understanding of personal fear, social pres-
arm, communities developed and implemented HIVST models. In the sures and structural barriers influencing their involvement in HIV pre-
PD arm, distributors were paid US$50 to distribute kits door-to-door. vention and research.
Distribution was for four weeks. Four months post-distribution, we Motivational challenges at individual, interpersonal and societal levels
conducted a population representative survey, with self-reported pri- included:
mary outcomes analysed using random-effects logistic regression: (i)
proportion of new HIV diagnoses; (ii) composite outcome - linkage to a) Self-efficacy: An individual’s decision-making was highly influenced
confirmatory testing, pre-exposure prophylaxis (PrEP) or voluntary by his/her belief system and self-confidence which ranged from
medical male circumcision (VMMC). We compared provider’s distribu- fear of stigmatization and judgement if tested HIV positive to fear
of being judged for negotiating use of condom/other contracep-
tion costs of community-led intervention with costs of new (<1 year’s
implementation) and mature (>1 year’s implementation) PD programs. tives;
We conducted a time-series analysis on monthly ART initiations in all b) Relationship outcome: In all scenarios, significant anxiety about
sustainability of intimate relationship as well as fear of abuse/vio-
study district clinics six months before, during and three months after
lence from partners restrained the individual from independent
HIVST distribution.
Results: From January-December 2019, 27,812 and 36,699 HIVST decision-making;
kits were distributed in community-led and PD communities. Five c) Stigma and discrimination: Social expectations and belief often
lead to severe stigma against HIV which was essentially seen as
community-led clusters only distributed kits door-to-door; in others
kits were also available at other locations. We surveyed 11,150 partic- result of ‘inappropriate behavior’ and ‘bad character’ where
ipants; HIVST coverage was 21.6% and 27.5% in the community-led women were discriminated for defying the social stereotype.
and PD arms respectively. There were no differences in primary out- Major structural barriers, other than financial constrain, were lack
of empathy and rudimentary gender sensitization among health-
comes: new HIV diagnosis was reported by 223 (4%) community-led
arm versus 190 (3.4%) PD arm participants, AOR 1.19 (0.82 to 1.73); care providers.
315 (26.1%) community-led arm participants linked to confirmatory Conclusions: Roadblock mapping exercise provided a unique space
testing, PrEP or VMMC, versus 364 (23.8%) in PD arm, AOR 1.09 for community-researcher dialogue that may potentially advance
(0.79 to 1.51). Sub-group analysis showed no differences by age or nuanced understanding of human behavior and lived realities that
sex. shape health choices. Complexity and subjectivity of gendered experi-
We recorded 5,302 ART initiations at 133 clinics, with no difference ences revealed by this activity suggest the need for focused commu-
in initiations in clinics within and outwith HIVST clusters, RR 0.94 nity engagement for informing design and implementation of equitable
(0.83 to 1.02). In post-hoc analysis ART initiations increased during and inclusive HIV prevention programs/trials.
HIVST distribution across all facilities, AOR 1.30 (1.24 to 1.37), falling
to baseline levels post-distribution. Cost per HIVST kit distributed in PE05.09
community-led arm was US$14.52, compared with US$14.52 and US
Recruitment of participants into an HIV vaccine
$10.63 in new and mature PD programs.
Conclusions: Community-led HIVST can perform as well as paid dis-
preparedness study: experiences from Masaka, Uganda
tribution, with similar costs in first program year. As seen with PD D.J. Asio1,2; S. Nabukenya1,2; S. Kusemererwa1,2; J. Mugisha Okello1,2;
programs, these costs may reduce with program maturity/learning. E. Ruzagira1,2 and P. Kaleebu1,2
1
Community-based HIVST improves ART uptake. Medical Research Council/Uganda Virus Research Institute, HIV
Intervention, Entebbe, Uganda, 2London School of Hygiene and Tropi-
cal Medicine, London, United Kingdom
PE05.08
Using participatory action research tools to understand
gender dynamics in uptake of HIV prevention measures and Background: Successful identification and recruitment of suitable vol-
participation in research: insights through a road-block unteers is essential for HIV prevention trials. We describe the experi-
mapping exercise ence of recruiting individuals into an HIV vaccine preparedness study
P. Saha1; J. Mukherjee1; D.L. Bose2; S. ul Hadi2 and K. Goyal3 in Masaka, Uganda.
1 Methods: Adults identified through community HIV counselling and
IAVI, Research and Development, New Delhi, India, 2IAVI, Advocacy
testing (HCT) from highway towns and fishing villages in Masaka,
and Communication, New Delhi, India, 3DCT Mindlinks, India
Uganda were invited to the study clinic in Masaka for screening and
possible enrolment into an HIV vaccine preparedness study. At the
Background: Gender inequity and underrepresentation of women in screening/enrolment visit, participants were provided information about
HIV biomedical research highlight need for gender-responsive inter- the study first in group sessions followed by one-on-one discussions to
ventions towards comprehensive disease management. Strong social ensure adequate informed consent. To enroll into the study individuals
structures with rigidly defined gender roles and stereotypes often had to be aged 18 to 45 years, willing to undergo HCT, pregnancy test-
encoded in religious and cultural traditions impede women’s decision- ing if female, available for follow-up and willing to complete socio-beha-
making ability about their lives and health. Therefore, it is imperative vioral questionnaires and at risk of HIV infection. Individuals were
to engage with the community to uncover the socio-economic-cultural considered to be at risk of HIV infection if they were sexually active and
drivers influencing women’s vulnerability to HIV/AIDS. An interactive had at least one of the following in the past three months: diagnosis/
roadblock mapping activity helped deconstruct these gendered experi- treatment for a sexually transmitted infection, abnormal genital signs/
ences affecting uptake of HIV prevention measures and research par- symptoms, unprotected sex with ≥2 partners or a new partner or in
ticipation. exchange for money/goods. Individuals were excluded if they tested
Methods: 32 participants including Transwomen, MSM, PLHIV, HIV-positive, were participating in other HIV prevention studies, or had
researchers and behavioral scientists were divided in small groups and any condition that would make it difficult to participate in the opinion of
presented unique situations around HIV testing, condom use and
94
the investigator. Proportions were measured for screened and enrolled

participants and screen-out reasons. PE05.11LB
Results: Screening/enrolment was conducted between July 2018 and Online methods for recruiting transgender women at risk of
February 2020. A total of 701 (46% female) volunteers were screened HIV acquisition in the United States: findings from the LITE
of whom 441 (63%) were enrolled. Of those screened-out, 248 (97%) study
were determined to have low risk for HIV infection, 4 (1.6%) tested pos- E. Cooney1; S. Reisner2,3,4; M. Stevenson1; A. Wirtz1 and American
itive for HIV, 2 (0.8%) were not available for follow-up/unwilling to pro- Cohort To Study HIV Acquisition Among Transgender Women (LITE)
vide locator information, 1 (0.4%) was unwilling to undergo HCT, and 1 1
Johns Hopkins Bloomberg School of Public Health, Baltimore, United
(0.4%) was unwilling to undergo pregnancy testing. States, 2Brigham and Women’s Hospital, Boston, United States, 3The
Conclusions: Despite a relatively high number of screen-outs, we suc- Fenway Institute, Boston, United States, 4Harvard T.H. Chan School of
cessfully identified and recruited individuals that may be suitable for Public Health, Boston, United States
enrolling in HIV vaccine efficacy trials.
PE05.10LB Background: Online recruitment strategies have been implemented

to enroll cohorts of transgender women (TW) in HIV prevention
The role of community clinical service assistance points in
research. While technology-enhanced methods have been compared
improving case finding and linkage for key populations in to traditional methods for efficiency and cost-effectiveness, no studies
hard to reach areas of North East, Nigeria have compared sociodemographic and HIV risk profiles of TW
A. Ukaere1; J. Anyanti1; A. Salihu1; O. Idogho1; M. Katbi2 and recruited through these methods.
D. Oyedeji1 Methods: The LITE Study enrolled 1304 seronegative TW in the U.S.
1
Society for Family Health, Abuja, Nigeria, 2USAID, Abuja, Nigeria into a cohort between March 2018 August 2020 to assess engage-
ment in HIV prevention and care (following observed seroconver-
sions). Participants were recruited through traditional (clinic-based,
Background: In Nigeria, key populations (KPs) including female sex respondent-driven sampling, flyers, ads on public transportation) and
workers (FSW), men who have sex with men (MSM), transgender online (dating applications, social media, google ads) methods. Sociobe-
(TG), prison inmates, and people who inject drugs (PWIDs) make up havioral surveys, STI testing, and HIV screening to confirm HIV-nega-
only 3.4% of the population, yet account for around 32% of new HIV tive serostatus were completed. We compared characteristics by
infections. Despite being at markedly high risk of HIV infection, KPs recruitment method.
have very low access to HIV services and poor linkage rates particu- Results: Of the 1304 TW enrolled at baseline, 96% (n=1252) had
larly in hard to reach areas due to stigma/discrimination, criminaliza- recruitment data available. Over half of participants (53%) were
tion, harassments, and government legislation against their activities. recruited through traditional methods; the remaining were recruited
We deployed a community-based differentiated service delivery initia- via online methods. Participants recruited online were significantly
tive, to mitigate the effect of poor access to HIV services, improve younger; more likely to be U.S. born, identify as non-Hispanic White,
case finding and linkage for KPs in these hard to reach areas. Commu- report non-prescription hormone source, and to screen for alcohol use
nity Clinical Service Assistance Point (CCSAP) is a sustainable commu- disorder; and less likely to have been tested for HIV. Participants
nity-based service delivery model, introduced to provide KP-friendly, recruited through traditional methods were significantly more likely to
rights-based, non-discriminatory, and gender-responsive HIV services test positive for an STI at baseline, report sex work history, and be
to KPs in the hard to reach areas. These CCSAPs are KP-competent indicated for PrEP based on adapted CDC guidelines.
community-based public, private and faith-based facilities, identified by
KP peers and through engagements with the government. They are Abstract PE05.11LB-Table 1. Sociodemographic and HIV risk pro-
certified safe spaces for KPs and within walking distances from their files of transgender women (TW) enrolled in The LITE Study by
homes. method of recruitment (n=1252)
Methods: A cross-sectional analysis of the programmatic data of the
CSSAP intervention implemented under the Key Population Commu- Traditional Online
recruitment recruitment p-
nity HIV Care Services for Action and Response (KP CARE-2) in
m N=665 N=587 value
North-East Nigeria was carried out from October 2019 to September
2020. Pre-intervention period was from October 2019 to March Age, mean(SD) 35 (13) 31 (10) <0.001
2020 while post-intervention period was from April 2020 to Septem- Immigrated to the US 102 (15.5%) 33 (5.6%) <0.001
ber 2020. Variables of interest were case identification and linkage to Participant race/ethnicity
Non-Hispanic White 265 (39.9%) 394 (67.1%) <0.001
care. Summary statistics were to estimate case finding and linkage to Black, Indigenous and People of Color 392 (58.9%) 184 (31.3%)
care. (BIPOC)
Results: 1902 HIV positives KPs were identified in the pre-interven- STI (NG, CT, or syphilis) diagnosis at 69 (12.9%) 13 (7.3%) 0.043
tion phase (October 2019 to March 2020) with 93% (1780) of them enrollment
Ever tested for HIV 543 (81.7%) 406 (69.2%) <0.001
linked to ART treatment while 2168 new cases were identified in the Sex work engagement (lifetime) 288 (43.8%) 162 (28.0%) <0.001
post-intervention period (April 2020 to September 2020) representing Number of transgender women in social 146 (22) 46 (13) <0.001
a 12% increase with 100% (2160) of them linked to treatment. network, mean(SD)
Conclusions: The implementation of the CCSAP initiative improved Anticipated discrimination in healthcare 332 (37.8%) 345 (54.6%) <0.001
Non-medical source of hormones (current) 59 (8.9%) 72 (12.4%) 0.027
case finding and notably improved linkage to ART treatment of KPs in Alcohol Use Disorder (AUDIT-C) 201 (30.2%) 203 (34.6%) 0.034
hard to reach locations. This differentiated model of care should be Indicated for PrEP based on adapted 366 (55.0%) 223 (38.0%) <0.001
explored further as it presents a great opportunity for achieving epi- criteria for TW
demic control in Nigeria.
Conclusions: TW bear a disproportionate burden of HIV, with trans-
gender women of color experiencing disparities in access to HIV pre-
vention. The exclusive use of online recruitment methods for HIV
prevention research could potentially exacerbate these disparities by
excluding participants who stand to benefit the most from this
95
research. However, a combination of traditional and online methods

may reach TW with distinct HIV risk profiles. PE05.13LB
Community engagement for the Voluntary Medical Male
Circumcision (VMMC) program: an analysis of key
PE05.12LB stakeholder roles to promote a sustainable program in
HIV prevention research in trans and gender-diverse
Zambia
communities, what’s missing — as told from those who
A. Rosen1; J. Zulu2; M.P. Chavula2; M.J. Mulawa2; M. Kaimba2;
hold the answers
T.F.L. Matenga2; G. Sichone2; T. Mwamba1; M. Silondwa1;
M.N. Appenroth1; R. Kgositau-Kanza2; I.N. Mugo3; C. Feuer4;
M. Chilembo1; N. Chagoma1; T. Kanyenda1; R. Maruza1; S. Jenkins1;
M. Chatani5; Max Nicolai Appenroth; Immaculate Mugo; Tshepo
P. Haimbe1; H. Shakwelele1; R.L. Kamboyi3 and S.C. Simwanza3
Ricki Kgositau; Manju Chatani, and Cindra Feuer 1
Clinton Health Access Initiative, Lusaka, Zambia, 2University of Zam-
1
Universit€atsmedizin Berlin, Institute of Public Health, Berlin,
Charite
bia, Lusaka, Zambia, 3Ministry of Health, Lusaka, Zambia
Germany, 2Accountability International, Cape Town, South Africa,
3
Gender Dynamix, Cape Town, South Africa, 4AVAC, New York, Uni-
ted States, 5AVAC, Washington, United States Background: Community engagement is a vital component of effec-
tive public health programs as it strengthens systems and addresses
the needs and values of the target population [1]. Within the Volun-
Background: Globally, trans and gender-diverse (TGD) people are at
tary Medical Male Circumcision (VMMC) program, community leaders
disproportionately high risk for HIV, but there’s a limited understand-
have been central in facilitating the acceptance of VMMC, especially
ing of best methods to decrease acquisition. Few studies have focused
in non-circumcising communities. To date, there has been inadequate
on interventions to prevent new HIV infections or improve health out-
evidence of the influence, types and roles of relevant stakeholders at
comes specifically among TGD people, though the scientific literature
community level in Zambia. As the VMMC program begins to transi-
is growing.
tion to sustainability, the role of the community will be essential in
Methods: A thorough literature review of trans-inclusive peer review
promoting ownership and sustaining uptake of services. The objective
journal articles and research reports focused on biomedical and beha-
of this study was to adequately map and provide insights for the role
vioural HIV prevention research was conducted on publications from
of stakeholders at community level, particularly considering their
2010 to 2020.
power and interest in making the VMMC program sustainable.
Additionally, oral and written interviews with predominantly trans acti-
[1] Morgan LM, Community participation in health: perpetual allure,
vists, researchers, and providers were completed worldwide. The
persistent challenges. Health Policy and Planning. 2011; 16 (3): 21-
interviews were evaluated with a qualitative content analysis and the
230.
outcomes cross-examined with the results of the literature review.
Methods: A case study design was used to generate in-depth under-
Results: Preliminary findings show trans-inclusive HIV research is
standing of the community stakeholders in the VMMC program in
scarce. A total of 164 articles were found, mentioning mostly trans-
Lusaka, Copperbelt and Muchinga provinces in Zambia. Data was col-
women but not as primary trial populations, and hardly reflective of
lected using document review, in-depth interviews (n=35) and focus
the full spectrum of gender diverse populations.
group discussions (n=35) using thematic analysis with various commu-
Other reported deficits include: a dearth of trans-authored studies
nity stakeholders, including health workers, health center committees,
and trial designs; the grouping of trans women in MSM research; min-
counsellors, teachers, community volunteers as well as parents/care-
imal studies of PrEP with gender-affirming hormones; assumptions
givers of past/future clients.
around lack of viral load suppression; unknown differences between
Results: Differences were noted between rural and urban sites for
cohorts with gender-affirming health care and those who do not
the power/influence and interest rating of community stakeholders for
access hormones; absence of studies in the global south; limited litera-
the sustainability phase of the VMMC response.
ture on risk through needle sharing; and structural barriers such as
discrimination and violence against TGD people pose impediments to
Abstract PE05.13LB-Table 1.
research participation.
Conclusions: Combination HIV prevention studies designed exclu- First rank (highest power + Third rank (lowest power
sively for, and led by, trans people are warranted. The collection of rel- influence) Second rank + influence)
evant data regarding gender identity and the diversity within the TGD
Urban Health care workers, Teachers, Religious Musicians/artists, civic
community broadly is crucial to determine commensurate HIV preven- Neighborhood Health Leaders, leaders, ward
tion interventions. Further, findings recommend a need for a nuanced Committees (NHCs), Parents chairpersons and
and non-cis-hetero lens that would enable researchers to fully capture Community Health Workers private sector
(CHWs), Radio/TV, Social managers
the ways in which TGD bodies engage sexually not only with cis-het-
Media, Club Leaders
ero bodies but with all other diverse persons e.g. intra-trans sexual Rural Health care workers, NHCs, Teachers, Councilors, farmers, civic
relations, etc. Research should also encapsulate the experiences of CHWs, Drama, Radio Traditional leaders
pre-op and post-op TGD persons, both on and off of hormone Leaders,
Religious
replacement therapy. Until then, trans people will continue leading in
Leaders,
HIV risk, while trailing in research representation and engagement. Parents
Conclusions: As the VMMC Program in Zambia strives for sustain-

ability, effective community engagement will be vital. By consulting
with the relevant First Rank stakeholders, program implementers can
ensure that sustainable program approaches and models leverage
existing community structures and consider the community needs and
values.
96
Conclusions: Use of pre-screening strategies provides valuable insight

Contraception, pregnancy and HIV into AGYW’s contraceptive preferences and allows provision of ade-
quate and suitable contraceptives.
prevention (incl. PMTCT)
PE06.02
Low pregnancy incidence and high PrEP uptake among
PE06.01 HIV-exposed women in urban KwaZulu-Natal, South Africa
Contraceptive uptake among adolescent girls and young M. Jaggernath1; Y. Kriel1; M. Mathenjwa1; B. Qiya1; C. Psaros2;
women pre-screened for the MTN-034/REACH study P. Smith3; K. Bennett4; J.E. Haberer5; J.M. Baeten6; N.C. Ware7;
Y. Naidoo1; J. Nabisere2; K. Reddy1; H. Mposula1; I. Lukas1; K. Wirth8; D.R. Bangsberg9; J.A. Smit1 and L.T. Matthews3
1
R. Stuurman1; M. Otim2; B. Kamira2; R. Nakalega2; C. Akello2 and University of Witwatersrand, Department of Gynecology and Obstet-
T. Palanee-Phillips1 rics, Faculty of Health Sciences, Durban, South Africa, 2Harvard Medi-
1
Wits Reproductive Health and HIV Institute, Faculty of Health cal School, Department of Psychiatry, Boston, United States,
3
Sciences, Johannesburg, South Africa, 2Makerere University-John Hop- University of Alabama at Birmingham, Department of Medicine, Divi-
kins University Research Collaboration, Faculty of Health Sciences, sion of Infectious Disease, United States, 4Bennett Statistical Consult-
Kampala, Uganda ing, Inc, Ballston Lake, United States, 5Massachusetts General
Hospital, Center for Global Health, United States, 6University of
Washington, Department of Global Health, Seattle, United States,
7
Background: MTN-034/REACH is an 18-month cross-over study of oral Harvard Medical School, Department of Global Health and Social
Truvada and monthly Dapivirine ring among adolescent girls and young Medicine, Boston, United States, 8Harvard T.H. Chan School of Public
women (AGYW) with a choice period. As eligibility criteria includes use of Health, Department of Biostatistics, Boston, United States, 9Oregon
reliable contraceptives for at least two months prior to enrolment, AGYW Health and Science University, Dean’s Office, Portland State Univer-
were offered choices of long (LARC) and short acting reversible contra- sity School of Public Health, Portland, United States
ception (SARC) as part of recruitment and pre-screening efforts. We
define the pre-screening and contraceptive initiation strategies imple-
mented at the Ugandan and Johannesburg sites conducting the REACH Background: HIV-exposed women planning to conceive require
study and compare contraception uptake among minors (16 to 17 years) strategies to reduce HIV acquisition risks. We are conducting a longi-
and young women (18 to 21) in different African settings. tudinal study in Ethekwini, South Africa to evaluate use of TDF/FTC
Methods: Analysis included data from 205 sexually active 16 to 21- as PrEP among HIV-exposed women planning a pregnancy.
year old AGYW pre-screened in Johannesburg (n = 89) and Uganda Methods: We enroll 18 to 35 year-old HIV-uninfected women
(n = 116) between January 2019 and March 2020. A pre-screening reporting plans for pregnancy with a partner who is living with HIV or
questionnaire was implemented to explore previous contraceptive his- of unknown serostatus. Women are counselled on a spectrum of safer
tory and current contraception needs of AGYW followed by individual- conception strategies, including PrEP. They are followed for one year
ized contraceptive counselling and contraceptive method initiation. with quarterly pregnancy testing; women with incident pregnancy are
Chart-notes were used to document contraceptive challenges. followed until pregnancy outcome. An electronic pill cap is used to
Results: At the Johannesburg site, 76.5% of AGYW preferred LARC detect bottle openings. Adherence is defined as the number of pill cap
(Table 1). Minors favoured LARC over SARC (92.6% vs 7.4%) as did openings divided by number of days of expected PrEP use. Here we
the young women cohort (69.3% vs 30.7%). Similarly, Uganda’s data present interim pregnancy incidence and PrEP adherence data.
also indicated a preference for LARC (80.2%) vs SARC (19.8%). Results: Among 330 women enrolled between October 2017 and
February 2020, 49 participants conceived during a total of 190.1 per-
Abstract PE06.01-Table 1. son-years of follow-up for an annualized pregnancy incidence of 25.8%.
Pregnant and non-pregnant women shared the same predominant
Johannesburg Uganda
demographic and HIV risk characteristics (Table 1). HIV risk was high
Contraceptive Minors Adults Total Minors Adults Total regarding the pregnancy partner among women with and without preg-
Method (n = 27) (n = 62) (n = 89) (n = 41) (n = 75) (n = 116) nancy, with most women not knowing their partner’s HIV status, not
completing couples based HIV-counselling and testing, definitely or
LARC Implanon (Implant) 21 (77.8%) 24 (38.7%) 45 (50.6%) 24 (58.6%) 35 (46.7%) 59 (50.9%)
Jadelle (Implant) N/A N/A N/A 6 (14.6%) 5 (6.6%) 11 (9.5%) probably thinking their partner had other partners and using condoms
Copper T 380A 4 (14.8%) 16 (25.8%) 20 (22.5%) 7 (17.1%) 13 (17.3%) 20 (17.2%) some or none of the time. More than half of women initiated PrEP, with
(IUD)
Mirena (Hormonal 0 3 (4.8%) 3 (3.4%) 1 (2.4%) 2 (2.7%) 3 (2.6%) comparable mean monthly adherence rates among women who did (av-
IUD) erage monthly adherence to 67% [95% CI 61%,72%] of prescribed pills)
SARC Depo-Provera 1 (3.7%) 12 (19.4%) 13 (14.6%) 3 (7.3%) 20 (26.7%) 23 (19.8%)
Nur-Isterate 1 (3.7%) 7 (11.3%) 8 (8.9%) N/A N/A N/A
and did not (65% [95% CI 63%,68%]) become pregnant.
Oral 0 0 0 0 0 0
Contraceptives
Abstract PE06.02-Table 1. Demographic characteristics, HIV risk, and
PrEP uptake among N = 330 women reporting plans for pregnancy
Common challenges related to contraceptive method uptake by N (%), Mean (95% CI)
AGYW included influence of family members, partners, peers and the
community along with associated myths and misconceptions with use With
of these methods. AGYW cited lack of knowledge around contracep- Without Pregnancy
Overall Pregnancy (n = 49) p-value
tion and fear of LARC insertions as key barriers to uptake. Use of
pre-screening questionnaires and education sessions assisted in Enrolment mean age in 24.5 (24.2,25.0) 24.6 (24.2,25.1) 24.2 (23.3,25.1) 0.49
addressing these issues, whilst the accompanying extensive counselling years (n = 330)
and reassurance was key to sustained use. These sessions also pro- Completed some level 204 (62) 175 (62) 29 (59) 0.75
of Basic Education
vided opportunity to develop rapport with AGYW without the pres-
(n = 330)
sure of being enrolled in the study. Unemployed (n = 330) 245 (74) 207 (74) 38 (78) 0.72
(Continued)
97
Table 1. (Continued) to reach them, 18% after two attempts, 19% after 3 attempts, and 37%
after more than three attempts. Median days between elicitation and ini-
N (%), Mean (95% CI) tial contact of the sexual partner was 10 (interquartile range [IQR], 3–
21 days), and median days between initial contact and testing was 6 (IQR,
With
Without Pregnancy
2–13 days). Median time from initial contact and testing did not differ sig-
Overall Pregnancy (n = 49) p-value nificantly by age, sex, or marital status.
Conclusions: aPNS is a promising strategy for identifying new HIV-
Unknown HIV 316 (96) 270 (96) 46 (96) 0.72 positive clients with a positivity rate of 21% in this study. However,
serostatus of
nearly three-quarters of sexual contacts required numerous attempts
pregnancy partner
(n = 328) to reach them before undergoing HIV testing, and median time from
Has not completed 307 (93) 262 (94) 45 (92) 0.75 contact elicitation to testing was 16 days. These findings may inform
couples-based HIV- effective planning and utilization of resources for aPNS.
counselling and
testing with
pregnancy partner PE06.04
(n = 329)
Pregnancy partner 204 (68) 176 (69) 28 (65) 0.72
Biological differences modify the effects of hormonal and
definitely or intrauterine contraceptives on genital inflammation
probably has other N. Radzey1; R. Harryparsad1; B. Meyer1; P.-L. Chen2; X. Gao2;
partners (n = 299)
Uses condoms with 278 (85) 235 (84) 43 (90) 0.39
C. Morrison2; O. Taku1; A.-L. Williamson1; C. Mehou-Loko1;
pregnancy partner F. Carayon-Lefebvre d’Hellencourt2; G. Buck3; J. Smit4; J. Strauss5;
some or none of the K. Nanda6 and K. Ahmed7
time (n = 328) 1
University of Cape Town, Institute of Infectious Diseases and Molec-
PrEP Uptake (n = 330) 192 (58) 159 (57) 33 (67) 0.21
Adherence to PrEP 66% (63%, 68%) 65% (63%, 68%) 67% (61%, 72%) 0.73 ular Medicine (IDM), Cape Town, South Africa, 2FHI 360, Durham,
(n = 171 with at United States, 3Virginia Commonwealth University, Department of
least 1 month, Microbiology and Immunology, Richmond, United States, 4MatCH
n = 150 w.
Research Unit, Department of Obstetrics and Gynaecology, Durban,
2 months, n = 123
w. 3 m, n = 104 w. South Africa, 5Virginia Commonwealth University, Department of
4 m, n = 93 w. 5 m, Obstetrics and Gynecology, Richmond, United States, 6FHI 360,
n = 74 w. 6 m) Department of Clinical Sciences, Durham, United States, 7Setshaba
Research Centre, Pretoria, South Africa
Conclusions: In this cohort of HIV-exposed women planning to con-
ceive, pregnancy incidence is low. HIV risk, PrEP uptake, and adher-
Background: Hormonal and intrauterine contraceptives are used by
ence were high among all women. These data demonstrate high
millions of women worldwide. Previous studies have reported inconsis-
demand for PrEP among women desiring pregnancy in South Africa.
tent associations between contraceptives and changes in female geni-
tal tract immune mediators that have in turn been associated with
PE06.03 HIV risk. One possible explanation is that pre-existing biological differ-
Median time to HIV testing and number of attempts to ences influence the magnitude and/or direction of immune mediator
reach sexual contacts of HIV-positive index clients via changes in response to contraceptives.
assisted partner notification services in western Kenya Methods: This study included 166 South African women assigned to
C. Ochieng1; O. Musau1; M. Achieng1; P. Musingila2; C. Kambona2; injectable depot medroxyprogesterone acetate (DMPA-IM), copper
M. Kiruki1; P. Mwimali1; P. Masaulo1 and L. Otiso1 intrauterine device (IUD), or levonorgestrel (LNG) implant in the Evi-
1 dence for Contraceptive Options and HIV Outcomes trial. We mea-
LVCT Health, Research and Strategic Information, Kenya, 2US CDC
sured 13 cytokines and antimicrobial peptides in vaginal swabs in
and Prevention, Division of Golobal HIV & TB, Atlanta, Kenya
duplicate using Luminex and ELISA at baseline, one and three months
following contraceptive initiation. Women were grouped according to
Background: Assisted partner notification service (aPNS) is an effective baseline inflammatory profile using factor analysis.
approach for identifying HIV-positive sexual partners of people living with Results: Both copper IUD and LNG implant were associated with
HIV (PLHIV). In aPNS, PLHIV identify sexual contacts for HIV-testing ser- rapid increases in inflammatory markers. No significant changes were
vice counselors for follow-up testing. However, aPNS requires planning observed following DMPA-IM initiation. However, in all three groups,
and effective use of resources. We analyzed aPNS data from an HIV pre- particularly the DMPA-IM arm (Figure 1), women with low baseline
vention program serving key populations in western Kenya to assess the inflammation experienced significantly greater increases in immune
number of attempts to trace a contact and time to test. mediators compared to women with high baseline inflammation. In cop-
Methods: We retrospectively abstracted service delivery data (January per IUD users, increases in IL-6 were significantly higher (adjusted
2018–December 2019) for all key population types offered aPNS from p = 0.04) in women with low baseline inflammation one-month follow-
standardized aPNS registers and entered the data into an aPNS data- ing insertion after adjusting for multiple comparisons, while TNF-a, IL-
base. The data were from 12 service delivery drop-in centers in Migori, 8, MIP-1a, IP-10 and MIP-3a showed the same trend after three
Kisii, and Kisumu counties. Variables collected were date of sexual part- months (adjusted p = 0.02, 0.001, 0.006, 0.02 and 0.04, respectively).
ner(s)’s elicitation, date of initial aPNS contact, number of aPNS contact Increases in IL-1b levels were significantly greater in women with low
attempts before testing, date of HIV testing, and sexual partner test baseline inflammation at one month (adjusted p = 0.04) and IL-1b, IL-8,
outcome. Stata version 14 was used for descriptive analysis and time- MIP-1a, IP-10 and MIP-3a (adjusted p = 0.01, p = 0.02, 0.01, 0.04 and
to-event analysis to calculate median time to test sexual partners. 0.02, respectively) at three months following LNG implant insertion.
Results: A total of 493 index PLHIV identified 1074 sexual partners (elici- Conclusions: Baseline genital cytokine concentrations alter the
tation ratio, 1:2.2). The average age of index PLHIV was 30.3 8.6 years effects of contraceptive use on genital immune mediators associated
and 31.7 8.3 for sexual contacts. Of the 630 (58.7%) sexual partners with HIV acquisition. Continued research to understand these effects
contacted, 569 (90.3%) were tested, and 21.1% (120/569) had an HIV- can improve our understanding of contraceptive safety as new prod-
positive test result. Of the 569 tested, 26% were tested after one attempt ucts are developed.
98
PE06.05 do they receive health promotion content that could prevent STIs,
including HIV. Group healthcare is an innovative model that provides
A randomized group antenatal care pilot showed increased
care for eight to twelve women in 120 minutes, which equates to an
partner communication and partner HIV testing during
average visit of 10 to 15 minutes per woman. Each 2-hour group visit,
pregnancy in Malawi and Tanzania with the same eight to twelve women with similar due dates, includes
E. Chirwa1; E. Kapito2; K. Norr3; X. Mei3; L. Liu3; D. Patel3; 80 to 90 minutes of interactive learning. This longer time devoted to
L. McCreary3 and C. Patil4 health promotion allows for the integration of STI/HIV prevention
1
Kamuzu College of Nursing, College of Nursing, Blantyre, Malawi, skills-building for communication and encouragement of partner test-
2
Kamuzu College of Nursing, Blantyre, Malawi, 3University of Illinois ing. We completed a randomized pilot (n = 218) comparing a 4-visit
at Chicago, United States, 4University of Illinois at Chicago, College of group ANC to traditional individual focused ANC and examine the
Nursing, United States impact on partner communication and HIV testing.
Methods: From the late pregnancy surveys (n = 192) we assessed
Background: Integration of prevention of maternal-to-child transmis-
the impact of group ANC on the number of reproductive health topics
sion into antenatal care (ANC) has greatly reduced HIV transmission.
discussed with partner (safer sex, HIV testing, and family planning;
However, the majority of pregnant women are not HIV positive, nor
99
range 0 to 3) and if their partner was tested for HIV during this preg- being unable to reach participants via mobile numbers, lack of privacy
nancy. We used multivariate logistic regression controlling for sociode- for participants in their homes and mobile network difficulties.
mographics and country. For partner discussion, we added ANC Conclusions: By providing close supervision, adapting tools and pro-
attendance and baseline discussion and for partner testing we added viding airtime and data peer delivered interventions can be adapted
partner discussion in late pregnancy. rapidly to provide virtual peer-mentorship and health promotion.
Results: In the final model women in group ANC were 3.75 times These adaptations require ongoing evaluation to understand reach,
more likely to discuss all topics (95% CI = 1.99, 7.06). Discussing and impact during different phases of pandemic response.
more topics at baseline and not having an independent income source
were also predictors. Women in group ANC were twice as likely to PE06.07
report that their partner got an HIV test during this pregnancy (OR
Is long-acting reversible contraceptive method use
1.98; 95% CI: 1.06, 3.70). An increase in topics discussed with partner
also strongly related to partner testing (OR 1.75; 95% CI: 1.26, 2.44).
associated with decreased HIV testing frequency in
Other factors positively related to testing included country and having KwaZulu-Natal, South Africa and Lusaka, Zambia?
a partner. M. Beksinska1; J. Smit1; B. Maphumulo1; M. Kasaro2; J. Tang3;
Conclusions: Evidence from this pilot demonstrated that group M. Chinyama2; E. Chabu2; A. Cartwright4; M. Fawzy4 and R. Callahan3
1
healthcare increased partner communication and HIV testing. Group University of the Witwatersrand, MRU, Dept of O&G, Durban, South
ANC offers a unique opportunity to integrate lifelong STI/HIV preven- Africa, 2University of North Carolina, Division of Global Women’s
tion strategies for pregnant women while still providing complete cov- Health, Lusaka, Zambia, 3University of North Carolina, Division of Glo-
erage of health promotion and maintaining the integrity of ANC. bal Women’s Health, Chapel Hill, United States, 4FHI 360, Durham, Uni-
ted States
PE06.06
Covid-19 non-pharmacological public health response: Background: Long-acting reversible contraceptives (LARCs) are pro-
Adapting virtual support to optimize peer (Thetha Nami) moted in countries to reduce unmet need for contraception. LARC use
delivery of HIV prevention and care to adolescents and relieves the burden on women to make frequent clinic visits for resup-
young adults in rural KwaZulu-Natal ply; however, the impact of fewer clinical contacts on HIV testing fre-
T. Zuma1; S. Hlongwane2; S. Xulu2; N. Okesola2; S. Msane2; quency has not been assessed in countries with high HIV prevalence.
C. Herbst2; J. Dreyer2; O. Odeagbo2; N. Chimbindi2; N. McGrath3; Methods: As part of the longitudinal Contraceptive Use Beyond
G. Harling4; L. Sherr4; J. Seeley5 and M. Shahmanesh4 ECHO (Evidence for Contraceptive Options and HIV Outcomes) study
1
Africa Health Research Institute, Social Science and Research Ethics, of contraceptive continuation, we measured HIV testing rates among
Durban, South Africa, 2Africa Health Research Institute, Durban, South women using intramuscular depot medroxyprogesterone acetate
Africa, 3University of Southampton, United Kingdom, 4Institute for Glo- (DMPA-IM), levonorgestrel implant, or copper IUD. Women were
bal Health, University College London, London, United Kingdom, 5Lon- recruited from three sites: two in KwaZulu-Natal, South Africa and
don School of Hygiene and Tropical Medicine, London, United Kingdom one in Lusaka, Zambia. Women who were HIV positive at ECHO trial
exit or who reported current PrEP use were excluded from the analy-
sis. We used logistic regression, stratified by country, to assess the
Background: In South Africa, the non-pharmacological public health relationship between contraceptive method use and HIV testing at 6
response to COVID-19 has made sustaining reductions in HIV inci- and 12 months.
dence challenging. We describe how we adapted our Thetha Nami Results: After 6 months, 489 of 584 women were still using their con-
(talk to me) peer-led HIV intervention to continue to support adoles- traceptive method, which fell to 378 at 12 months. At 6 months, rates
cents and youth in rural KwaZulu-Natal during national lockdown. of HIV testing were 84% (DMPA-IM), 72% (IUD), and 73% (implant); at
Methods: Thetha Nami is delivered by community-based peer naviga- 12 months, rates were 86% (DMPA-IM), 79% (IUD), and 78% (implant).
tors (12 men, 40 women aged 18 to 30), as part of a trial to assess The odds of HIV testing at 6 months post ECHO trial exit were signifi-
the effectiveness of serostatus neutral peer-support on HIV outcomes cantly lower in the implant group in South Africa (OR: 0.53; 95% CI,
in young people aged 16 to 29. It included: creating safe spaces for 0.28 to 0.99) and the IUD group in Zambia (OR: 0.29; 95% CI, 0.10 to
youth; peer-led sexual health promotion; youth-friendly clinical ser- 0.82) compared to DMPA-IM. At 12 months, no differences in testing
vices; and peer-mentorship to improve retention in HIV prevention. were found between the contraceptive groups in either country.
Our adaptation was to transform the peer-support from face-to-face Conclusions: LARC users may be at higher risk of undetected HIV
to virtual support using programme data, meeting notes, training infection than DMPA-IM users because of less frequent testing and
schedules and peer navigator activity logs. required clinic visits. LARC users should be reminded about the need
Results: (At time of lockdown 349 participants (174 men, 175 for regular HIV testing as per country guidelines and the option of
women) aged 16 to 29 had been recruited, with 174 randomised to HIV self-testing in the home.
Thetha Nami. We set up four virtual Microsoft Teams groups to
supervise peer navigators (13 per group). The weekly virtual meetings PE06.08
covered how to: provide virtual support; refer urgent clinical issues; A functional performance and acceptability study of the
and respond to Covid-19 questions. The study team sent weekly voice
Wondaleaf female condom
notes via WhatsApp to recap important points. Peer-support from
M. Beksinska; B. Maphumulo; N. Mphili and I. Beesham
navigators to participants was moved to telephone calls, SMS and
WhatsApp messages. The redcap tool used by peer navigators to University of the Witwatersrand, MRU, Dept of O&G, Durban, South
record and guide their community-based activities was adapted to Africa
assist remote support of participants.
After eight weeks of lockdown, peer navigators had met every week
Background: Male and female condoms are currently the only effec-
and made: 318 contact attempts; five clinical referrals or follow-ups;
tive method of dual protection against unintended pregnancy and the
and offered support to 130 (74.7%) of assigned participants, with only
transmission of STIs including HIV. Since 2000, other new female con-
six refusing virtual contact. Each peer navigator used 274 Zar ($16)
doms have become available or are in development to lower cost,
of data and airtime per week. Virtual support challenges included
and/or improve acceptability.
100
Methods: This research study was a two-period, cross-over random- Department of Family Health, Nairobi, Kenya, 5Ministry of Health and
ized controlled trial to determine the functional performance, safety Child Care, Department of AIDS and TB, Harare, Zimbabwe, 6Pangaea
and acceptability of two female condoms (Wondaleaf and FC2). Women Zimbabwe AIDS Trust, Independent Consultant, Zimbabwe, 7AVAC,
aged 18 to 45 were recruited from one site in Durban, South Africa New York, United States
and were asked to use five condoms of each type. Primary analyses
centered on total clinical failure and total female condom failure. Rates
of non-clinical and clinical breakage, total breakage, slippage, misdirec- Background: Delivery of oral pre-exposure prophylaxis (PrEP) is pri-
tion, and invagination were calculated as well. Acceptability measures marily via HIV clinics in Kenya and Zimbabwe, missing an opportunity
for evaluation included the frequency of key acceptability endpoints. to reach adolescent girls and young women (AGYW) seeking family
Wondaleaf is a polyurethane female/male condom that has folded planning (FP) and other sexual and reproductive health (SRH) services.
extended adhesive shields which at unfolding covers the entire external The HIV Prevention Market Manager (PMM) and Ministries of Health
genitalia to prevent direct skin contact between partners during inter- (MOH) in Kenya and Zimbabwe conducted rapid assessments to iden-
course. The FC2 is an FDA approved female condom and has been pre- tify strategies that promote HIV/SRH integration and uptake of PrEP/
qualified by UNFPA/WHO. The condom lines the vagina with an outer FP among AGYW.
ring remaining outside the vagina and covers the external genitalia dur- Methods: In 2019 to 2020, 20 health facility assessments, 6 dia-
ing intercourse. An internal polyurethane ring is removable and serves logues with AGYW and 73 key informant interviews with national and
as the insertion mechanism and anchors the device within the vagina. county/district-level MOH officials, HIV and FP providers, imple-
Results: The study enrolled 220 women and 210 (96%) women com- menters and donors in rural and urban settings across five regions in
pleted both study follow-up visits. The analysis population included Kenya and four provinces in Zimbabwe were conducted. Standardized
210 women who used at least one of each type. Few clinical break- data collection and management tools were developed and data ana-
ages were reported for both condoms, there were 4 (1.5%) clinical lyzed thematically.
breakages reported for the Wondaleaf FC and 1 (0.8%) reported for Results: HIV/SRH integration varies by facility type and level of exter-
the FC2. Slippage occurred in 22 (1.1%) with FC2 compared to 27 nal funding. Primary health facilities are integrated by default (with
events in Wondaleaf (2.6%) where the FC slipped completely out of few providers offering all services in one space), but may not offer
the vagina. Rates for misdirection (4.6% vs 0.9%) and invagination specialized or youth-friendly (YF) services. Integration at higher-level
(6.4% vs 1.0%) respectively were higher in FC2 compared to Won- facilities is achieved through referral between service areas. YF clinics
daleaf. Overall the Wondaleaf Condom had a lower clinical failure rate and “corners” showed the highest level of integration (Figure 1). HIV
compared to FC2. Both female condoms were acceptable to women. testing is well-integrated with FP services in Zimbabwe, less so in
Conclusions: The design of the Wondaleaf condom which incorpo- Kenya; yet neither regularly offers PrEP in SRH service areas, with
rates an adhesive shield ensures condom stability has potential for limited providers capacitated on PrEP education or referral. Promising
future development. strategies include: accompanied referral; mainstreaming YF services in
public clinics; “whole site training” to sensitize supportive staff; inte-
grating registers; and enhancing county/district-level coordination to
PE06.10 cascade integration to facilities. Training and supervision are crucial
Integration of oral PrEP and family planning in Kenya and for FP/SRH providers to gain confidence in PrEP and YF service deliv-
Zimbabwe: assessment of HIV prevention and sexual and ery.
reproductive health services to strengthen access for Conclusions: PrEP/SRH integration must start with operational man-
adolescent girls and young women dates and capacitation of providers by facility type. Governments and
M.S. Dunbar1; B. Ncube2; V. Otindo3; M. Otieno3; R. Kamau3; donors should invest in demand generation for AGYW and YF service
C. Bodi4; C. Ngugi3; S. Kaliti4; J. Murungu2; T. Bhatasara5; A. Miti6; delivery with PrEP as the “gold standard” across the health system.
K. Segal7; J. Rodrigues7; M. Warren7 and M. Mugambi3
1
Independent Consultant, AVAC, Product Introduction and Access,
United States, 2Pangaea Zimbabwe AIDS Trust, Harare, Zimbabwe,
3
National AIDS and STI Control Programme (NASCOP), Ministry of
Health, Republic of Kenya, Nairobi, Kenya, 4Ministry of Health,
101
al, Canada, 10Harvard T. H. Chan School of Public

University, Montre
COVID research: Applying lessons from I, Yaounde,
Health, Boston, United States, 11University of Yaounde
Cameroon
HIV prevention to SARS CoV-2
Background: HIV prevalence has declined in Cotonou (Benin) and
Yaounde (Cameroon) following the scale-up of HIV prevention/treat-
PE07.01 ment (40% of people living with HIV are virally suppressed) and
COVID-19 and associated disruptions may indirectly affect increases in condom use. The COVID-19 pandemic and responses to
HIV outcomes in two capital cities in Western/Central it may disrupt HIV services such as antiretroviral therapy (ART) deliv-
Africa: a modelling study ery and condom distribution, but this negative impact could be attenu-
ated by temporary decreases in sexual risk behaviours due to
R. Silhol1; L. Geidelberg1; K. Mitchell1; S. Mishra2; A. Bowring3;
compulsory social distancing or reduced access to commercial sex. We
C. Mukandavire4; L. B ehanzin5; F. Guedou6; S. Diabate7; D. Dimitrov8;
9
€nn10; N. Soni1; I.M. Njindam3 and explored the potential effects of these changes on HIV outcomes in
M. Maheu-Giroux ; M. Ro
the two cities.
S. Billong11
1 Methods: We used deterministic mathematical models of HIV trans-
Imperial College London, Medical Research Council Centre for Global mission calibrated to available city-specific demographic, behavioural,
Infectious Disease Analysis, London, United Kingdom, 2University of and HIV epidemic data. We calculated the relative difference in 1-year
Toronto, Department of Medicine, Division of Infectious Disease, cumulative new HIV infections and HIV-related deaths (median, 95%
Canada, 3Johns Hopkins School of Public Health, Department of Epi- uncertainty interval), between a base-case scenario assuming no
demiology, Baltimore, United States, 4London School of Hygiene and COVID-19 and combined scenarios assuming no ART initiations, a 10/
Tropical Medicine, Department of Infectious Disease Epidemiology, 25/50% reduction in HIV prevention/treatment services, and
London, United Kingdom, 5Universite
de Parakou, Ecole Nationale de decreased numbers of casual/commercial sexual partnerships over a
Formation des Techniciens Supe rieurs en Sante Publique et en
e 6-month period.
Surveillance Epid miologique, Benin, 6Centre de Sante Communal de
Results: An estimated 50% increase in new HIV infections (Figure 1a-
Cotonou 1, Dispensaire IST, Cotonou, Benin, 7Centre de Recherche b) and 20% increase in HIV-related deaths (Figure 1c-d) would be
du CHU de Que bec – Universite Laval, Quebec City, Canada, 8Fred
induced by combined 6-month 50% reductions in HIV prevention/
Hutchinson Cancer Research Center, Seattle, United States, 9McGill treatment use (red boxes). The estimated increase in new HIV
102
infections would be much lower (2-fold in Yaounde, 3-fold in Cotonou) Methods: This is an ongoing prospective cohort study of PWID, pur-
but still substantial (20% to 30%) if 50% decreases in casual/commer- posefully recruited from another large cohort. Bi-weekly interviews
cial partnerships occur, with the impact on HIV-related deaths remain- are conducted using an online questionnaire platform.
ing high (dark-blue boxes). The estimated impact on new infections Results: Fifty-one PWID were recruited on April 7 to 9; 29% are
and HIV deaths is similar in the two cities but uncertain. women, median age is 38.
Conclusions: A temporary reduction in HIV prevention/treatment The use of illicit lab-manufactured methadone prior to March 2020
services may have substantial impact on HIV outcomes in these two was reported 71% of participants, and decreased to 57% by the end
West/Central African cities, which would only be partially offset by of June. Instead, the use of methadone purchased by prescription
people having fewer casual and commercial sexual partnerships. It is increased more than three-fold, from 12% to 39%. Use of other drugs
important that HIV prevention/treatment services are sustained dur- fluctuated (Figure 1).
ing the COVID-19 pandemic. The proportion of PWID reporting harder access to drugs decreased
from 39% in April, to 8% in July. Higher prices and poorer quality was
PE07.02 reported by 18% and 29% at baseline, decreasing to 2% and 15% in
June, respectively. The proportion experiencing harder than before
The impact of the COVID-19 pandemic on substance use
access to HIV prevention decreased from 26% at baseline to 6% in
and access to HIV prevention in Ukraine June. Nevertheless, the syringe sharing in the past 30 days increased
K. Dumchev1; T. Kiriazova1; O. Chernova1; I. Kirtadze2 and from 8% to 13%.
D. Otiashvili2 Conclusions: Overall, the availability of drugs and access to harm
1
Ukrainian Institute on Public Health Policy, Research, Ukraine, reduction are returning to pre-COVID era, whereas the shift from ille-
2
Addiction Research Center Alternative Georgia, Tbilisi, Georgia gal to medical methadone is not. Our findings confirm the rapid and
radical changes in the drug scene in Ukraine, with significant implica-
tions for HIV prevention programming.
Background: The first case of COVID-19 was reported in Ukraine on
March 3, and national lockdown was declared on March 11. It had a
profound impact on the availability of illicit drugs, HIV prevention and
drug treatment services. People who inject drugs (PWID) is a key pop-
ulation with highest HIV prevalence (23%) in Ukraine and reduction in
access to prevention services may lead to a new wave of HIV trans-
mission. This study is aiming to monitor the trends in drug use, risk
behavior and prevention access in the context of COVID-19 pandemic
and respective containment measures.
103
Methods: Between April 6 and July 21, 2020, we conducted 42

PE07.03 semi-structured telephone interviews with FSW from 24 sites across
In silico down-selection of T and B cell SARS-CoV-2 Zimbabwe’s nationally scaled HIV prevention programme for FSW. We
epitopes for improved dendritic cells targeting vaccine report evolving dynamics in sex work, access to HIV prevention ser-
platform vices and perceptions of SARSCoV2 risk.
M. Surenaud1; S. Cardinaud1; S. Zurawski2; G. Zurawski2; Results: All the women reported decreases in demand for sex with
M. Centlivre1; C. Lacabaratz1 and Y. Levy1 reduced client numbers. Clients were reported to fear contracting
1
INSERM U955/Vaccine Research Institute, Institut Mondor de SARSCoV2 and experience logistic difficulties meeting with FSW due
Recherche Biome dicale, France, 2Baylor Institute for Immunology to travel and socialising restrictions. Closure of the informal economic
Research/Vaccine Research Institute, Center for Human Vaccines, Dal- sector reportedly reduced clients’ income and therefore capacity to
las, United States pay for sex. Where sexual exchange happened, clients preferred rear-
entry sex positions and refused kissing or oral sex to minimise contact
perceived to increase chances of contracting SARSCoV2. Costs per
Background: With no licensed vaccines and only limited therapy sex act plummeted from an average of US$5 to US$1 per ‘short time’.
options against SARS-CoV-2, there is an urgent need to develop a vac- “I go as low as US$0.50c, clients are fewer. . .” FSWs reported willing-
cine able to prevent COVID-19. Several candidate vaccines are under ness to have sex on credit, condomless (anal) sex, or exchanging sex
development, a majority targeting the Spike (S) or Region Binding for food to alleviate financial and food insecurity. Women fear hunger,
Domain (RBD) of SARS-CoV-2. We have developed a vaccine platform inability to pay rent and returning to rural homes to face stigma and
aimed to target antigens to specific receptors on DCs via fused mono- ostracization more than SARSCoV2. “I would rather die of COVID than
clonal antibodies allowing delivery of limited amounts of antigens with see my children go to bed hungry. . .” FSWs who rely on mobile clinics
a stimulation signal to DCs. (unable to operate during the first phase of lockdown) struggled to
Methods: We screened three structural proteins (S, N, and M) of access HIV tests, PrEP refills, STI treatment, and family planning
SARS-CoV-2 for identification of T cell epitopes, using NetMHC 4.0 needs.
and NetMHCII 2.3 softwares predicting peptides binding to a large Conclusions: Reduced demand for and cost of commercial sex com-
panel of HLA class-I and -II, respectively. Linear B cell epitopes were pounded existing income and food insecurity, making already vulnera-
predicted using BepiPred 2.0. Selected peptides were further ble FSWs increasingly desperate and therefore willing to take greater
screened for their homology with T and B cell epitopes described in risks with clients, including contracting SARSCoV2, HIV, and STIs.
other b coronaviruses, including SARS-CoV and focusing on those gen- FSWs who live in precarious conditions, with little social protection,
erating neutralizing antibodies. face difficult choices that potentially undermine HIV prevention invest-
Results: We mapped a total set of 9-mers binding to 80 HLA-class I ments.
molecules and 15-mers binding to 54 HLA-class II molecules as well as
all linear B cell epitopes. We evaluated amino acid (aa) regions encom- PE07.05
passing both the highest number of epitopes and the largest coverage
Development of a probe to identify SARS-CoV2 infected
of HLA and included regions overlapping S1/S2 and S2/S2’ cleavage
sites. We selected 8 T and B cell epitope-enriched regions (2 from M, 2
cells in rhesus macaques
from N and 4 from S; 1415 aa total), with 29, 5485 and 7198 predicted P. Madden1; M.S. Arif1; M. McRaven1; K. Kotnik Halavaty1; E. Potter2;
SARS-CoV-2 B cell, CD8+ and CD4+ T cell epitopes, respectively. T and A. Carias1; M. Roederer2; M. Lewis3 and T.J. Hope1
1
B cell SARS-CoV epitopes associated with protection and long-term Northwestern University, Cell and Developmental Biology, Chicago,
responses in humans or animal models are present in the selected set, United States, 2Vaccine Research Center, NIAID, NIH, ImmunoTech-
including six described SARS-CoV B cell neutralizing epitopes. nology Section, Bethesda, United States, 3Bioqual, Inc, Rockville, Uni-
Conclusions: We designed an epitope-based vaccine against SARS- ted States
CoV-2 including both T and B cell regions covering a high diversity of
HLA molecules for worldwide application. Selection of conserved aa
Background: The novel coronavirus, SARS-CoV2, emerged in late
sequences between b coronaviruses increased the chances of achiev-
2019 and quickly spread throughout the world. Understanding of the
ing cross-protective immunity against other coronavirus infections.
pathogenesis of this virus has been increasing rapidly. There is little
These findings are key outputs for the development of innovative and
efficient vaccines, including DC-targeting vaccines.
PE07.04
Sex work in the wake of SARSCoV2 in Zimbabwe:
A qualitative study
F. Machingura1; G. Jamali1; M. Makamba1; J. Busza2 and F.M. Cowan3
1
Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSH-
HAR Zimbabwe), Key Populations, Harare, Zimbabwe, 2London School
of Hygiene and Tropical Medicine, Centre for Evaluation, London, Uni-
ted Kingdom, 3Liverpool School of Tropical Medicine, Department of
International Public Health, Liverpool, United Kingdom
Background: Female sex workers (FSW) in Zimbabwe have an HIV

prevalence (58%) four times higher than women of reproductive age
in the general population, making tailored prevention and treatment
services critical. Recent SARSCoV2 lockdowns may have affected both
sex work and FSW’s risk behavior and engagement with HIV preven-
tion and care. We aimed to investigate the impact of SARSCoV2 lock-
downs on the dynamics of sex work in Zimbabwe. Abstract PE07.05-Figure 1.
104
known about the exact cell types that support viral replication as well PE07.06
as the anatomical distribution of viral replication. We set out to adapt
An organotypic airway culture model for studying SARS-
an IgG-F(ab’)2 system developed to detect sites of ongoing HIV/SIV
CoV-2 infection
replication in rhesus macaques to SARS-CoV2 to elucidate the sites of
viral replication. M. Becker1; L. Riva2; X. Yin2; J. Hultquist3; S. Chanda2 and T.J. Hope1
1
Methods: We acquired the antibody CR3022 after it was shown to Northwestern University, Cell & Developmental Biology, Chicago,
bind tightly to SARS-CoV2. CR3022 was digested into a F(ab’)2 and United States, 2Sanford Burnham Prebys Medical Discovery Institute,
labeled with fluorescent dye. Rhesus macaques were given the F(ab’)2 Infectious & Inflammatory Disease Center, San Diego, United States,
3
probe intravenously after inoculation with SARS-CoV2 via the intratra- Northwestern University, Chicago, United States
cheal and intranasal routes and necropsied 48- or 72-hours post-infec-
tion. Tissues were harvested and fixed in formalin for at least 72-
Background: Like the other human respiratory coronaviruses, SARS-
hours to inactivate the virus. Tissues were processed using an intravi-
CoV-2 has limited replication potential in most conventional tissue cul-
tal-imaging-system (IVIS) to locate the areas that contained the most
ture models. Here we present an organotypic model of the bronchial
fluorescent signal. All tissues were imaged and analyzed using stan-
epithelium that supports SARS-CoV-2 replication, captures the unique
dard epifluorescent imaging techniques.
features of this site of infection, and is amenable to genetic manipula-
Results: IVIS imaging identified both discrete and diffuse fluorescence
tion.
signals in tissues. Targeted imaging based on IVIS signal allowed us to
Methods: Primary human bronchial epithelial cells were differentiated
pinpoint areas that contain probe. Spectral imaging validated probe
at an air-liquid interface under previously established conditions
generated signal.
(PMID:31,640,299). These cells can be nucleofected with CRISPR-
In the lungs, we found foci that contained many probe-positive cells as
Cas9 ribonucleoprotein complexes to knock out genes prior to differ-
well as areas that had few or no probe-positive cells. Probe-positive
entiation (see Figure 1, demonstrating efficient knockout of cyclophilin
cells were also found in the upper respiratory tract, nasopharynx, and
A protein by immunoblotting). Well-differentiated cultures were
deep cervical lymph nodes.
infected with SARS-CoV-2 via the apical surface. At designated time-
Conclusions: We have successfully developed a F(ab’)2 probe that
points post-infection, samples of apical rinsate and basolateral media
can detect cells infected with SARS-CoV2. This system allows us to
were collected to assess infection by qPCR and cultures were fixed
further study the pathogenesis of this novel virus and help uncover
for immunofluorescence imaging.
the basis for the clinical symptoms seen. We have begun to extend
Results: Preliminary experiments indicate that these differentiated
the use of this probe for live imaging using PET/CT technology to fol-
primary epithelium-derived cultures can sustain SARS-CoV-2 infection,
low viral replication over time in individual macaques.
shown by immunofluorescent staining of viral proteins. Figure 2 high-
lights infected cells with apical polarization of the viral spike protein
Abstract PE07.06-Figure 1. Abstract PE07.06-Figure 2.
105
and distinct localization of nucleoprotein, particularly in the intact Methods: HCP participating in ARMOR (natural history study of
columnar epithelium of the top field of view. SARS-CoV-2 seroprevalence and HCP behavior/well-being) were fol-
Conclusions: This organotypic model supports infection and consists lowed bimonthly starting 4/16/20. At the month-2 visit, a 10-item sur-
of primary human cells with native-like columnar morphology and vey on perception of COVID-19 vaccines and preventative antibodies
mucociliary differentiation, but also allows efficient gene editing. was administered. Descriptive analysis was performed for responses
Because of this, it offers an opportunity to investigate the host contri- through 7/22/20.
bution to and mechanism of SARS-CoV-2 replication and pathogenesis Results: 535 HCP had enrolled in ARMOR by 7/22/20. 173 had com-
in context. Experiments to identify critical host factors and map the pleted their month-2 visit; of those, 70% (N = 121) completed the
kinetics of infection are underway. questionnaire. Mean age was 42.2 years (12.1 SD), majority were
female (65%), white (70%), non-Hispanic (93%), and patient care provi-
PE07.07 ders (85%). 64% had heard of COVID-19 prevention studies
(N = 73); of those, 97% had heard of COVID-19 VT and 46% of mon-
COVID-19 vaccine attitudes among healthcare workers in
oclonal antibodies. 54% were interested in receiving information about
New York City: Preliminary findings from the Antibody VT (N = 65), and 46% had been asked by patients about VT (N = 47).
Response Monitoring for Occupational Resilience (ARMOR) Interestingly, 60% (N = 62) were uncomfortable discussing COVID-19
study VT with patients, but the majority (68%,N = 70) were likely to recom-
D.A. Theodore1; D. Castor2; B. Sovic2; M. Castellon2; A. De2; B. Gray2; mend VT to patients. Only 37% (N = 45) would be likely to join a VT
S. Palmer2; R. Greene2; C. Freibott2; Y. Wu2; J. Zucker2; J.Y. Chang2; themselves. Overall, 78% (N = 94) indicated willingness to receive an
P. Loughlin2; M.L. McNairy2 and K. Meyers2 FDA-approved vaccine. Common concerns among HCP regarding VT
1
Columbia University Irving Medical Center, Department of Medicine, participation were side effects (40%), limited safety data (17%), and
Division of Infectious Diseases, New York, United States, 2Columbia potential for COVID-19 exposure through study participation (13%).
University Irving Medical Center, New York, United States Conclusions: Despite feeling uncomfortable discussing COVID-19 VT
with patients, most HCP were willing to recommend VT to their
patients. Strengths of these findings include high percentage of female
Background: An effective COVID-19 vaccine is critical for pandemic HCP; limitations include low number of non-white HCP. These early
containment. Recent reports about vaccine hesitancy suggest that findings indicate need for significant HCP education to increase VT
public acceptance of a COVID-19 vaccine may be challenging. Well- knowledge and vaccine uptake.
informed healthcare personnel (HCP) will be essential for vaccine trial
(VT) enrollment and vaccine uptake. We describe COVID-19 vaccine
awareness and attitudes among HCP in NYC.
106
(aCD40-RBD). Immunogenicity was tested in humanized NGS mice (hu-

PE07.08 mice) receiving either i) DREP-S (10 lg, i.m.) + aCD40-RBD (10 lg, i.p.)
COVID-19: a major challenge to sex work in Nairobi, Kenya (n = 19) (Gr 1); ii) aCD40-RBD (10 lg, i.p.) + Poly (IC) (n = 10) (Gr 2)
M. Akolo1; J. Kimani1; F. Muriuki2 and L. Gelmon1 or; iii) PBS (n = 5) or poly (IC) (n = 5) alone (pooled into a control
1
Partners for Health and Development in Africa, Research and Clini- group). Blood hu-Memory T-cells, hu-Ab-secreting (ASC) and S-specific
cal, Nairobi, Kenya, 2Partners for Health and Development in Africa, IgG+ huB-cells were monitored 3 weeks after one boost of vaccines.
Monitoring and Evaluation, Nairobi, Kenya Results: In the two vaccine groups, but not in controls, an expansion
of central memory CD4+ and CD8+ T cells, with a similar magnitude,
was noted. As compared to controls a significant expansion of ASC
Background: Sex workers outreach program of Kenya (SWOP) based was noted in Gr 1 (p < 0.001) and Gr 2 (p < 0.01). Likewise, we
in Nairobi County offers HIV treatment and prevention services to observed the induction of S-specific IgG+ huB-cells in both vaccine
16,000 female sex workers (FSW) and 1400 men who have sex with groups with a higher magnitude in the DREP-S+aCD40-RBD group
men of which18% and 29% of them are HIV positive respectively. (p < 0.01).
Kenya reported its first COVID-19 patient in March 13th and the gov- Conclusions: A single dose of the candidate vaccines elicited cellular
ernment implemented night curfews, closure of all hot spots among and humoral responses against SARS-CoV-2 S protein. Analysis of neu-
other measures from the 17th of March to date, currently running tralizing function and epitopic characterization of elicited IgG after a
from 9 pm to 4 am and has adversely affected sex workers’ liveli- second homologous boost of vaccines will be presented.
hoods. The program management decided to collect data on how the
sex workers were coping with the new normal in addition to monitor-
ing a few key services utilization indicators.
PE07.10LB
Methods: Both HIV positive and negative sex workers active in the Characterizing SARS-CoV-2 spread on college campuses
program were followed prospectively during the COVID-19 period G. Moreno1; K. Braun2; I. Pray3,4; K. Grande5; A. Jovaag6; D. Baker1;
(April to June 2020). Data was collected on honoring of facility J. Baczenas1; M. Accola7; G. Kelly6; W. Rehrauer7; S. O’Connor1,8;
appointments, ARV pick up, initiation of PrEP and PEP and was com- R. Westergaard4,9; T. Friedrich2,8 and D. O’Connor1,8
1
pared to data collected prior to COVID-19 period (January-March). University of Wisconsin - Madison, Department of Pathology and
Virtual indepth Interviews were carried out to get qualitative informa- Laboratory Medicine, Madison, United States, 2University of Wiscon-
tion on effects of COVID-19 on sex workers livelihoods. sin - Madison, Department of Pathobiological Sciences, Madison, Uni-
Results: Of the 2800 HIV positive sex workers on treatment, 2747 ted States, 3Centers for Disease Control and Prevention, Epidemic
(98.1%) honored their appointments pre-COVID-19 period while 2752 Intelligence, Madison, United States, 4Wisconsin Department of
(98.2%) honored their appointments during the COVID-19 period. Of Health Services, Division of Public Health, Madison, United States,
5
the 14,600 HIV negative sex workers only 3358 (23%) honored their Public Health Madison and Dane County, Madison, United States,
6
appointment during COVID 19 period compared to 10,658 (73%) pre University of Wisconsin - Madison, University Health Services, Madi-
COVID. Out of 14,096 not on PrEP 238 (1.7%) were initiated on PrEP son, United States, 7University of Wisconsin School of Medicine and
Pre-COVID compared to 62 (0.04%) during COVID-19. 427 took up Public Health, Department of Medicine, Division of Infectious Dis-
PEP pre-COVID-19 compared to 302 during COVID-19. The indepth eases, Madison, United States, 8University of Wisconsin - Madison,
interviews revealed many of our sex workers had experienced violence Wisconsin National Primate Research Center, Madison, United States,
9
(physical, sexual and verbal) from their client’s. Some had resorted to University of Wisconsin School of Medicine and Public Health,
washing clothes for a fee and/or selling sanitizers as an alternative way Department of Medicine, Madison, United States
of earning a living since clients were few and had no money.
Conclusions: The HIV positive sex workers were better in service
uptake during the COVID-19 period compared to the HIV negative Background: Over 1700 universities have reported more than
sex workers. Sexual violence worsened during the COVID-19 period. 200 000 SARS-CoV-2 cases since the beginning of the fall 2020
semester, highlighting an urgent need to understand how these out-
breaks begin and continue to spread. The combination of reduced dis-
PE07.09 ease severity, susceptibility to infection, and the propensity of young
Elicitation of SARS-CoV 2 Spike protein-specific human adults to engage in behavior that increases transmission risk may
IgG+ B cells following one dose of DNA-derived DREP and/ amplify transmission in ways that will be difficult to interrupt, despite
or anti-CD40 Dendritic Cell (DC) targeting vaccine in a substantial institutional investment in testing and risk mitigation. In
humanized mice model Dane County, the University of Wisconsin - Madison is home to the
V. Godot1; L. Dupaty1; S. Zurawski2; I. Szurgot3; S. Cardinaud1; second-largest college outbreak of SARS-CoV-2 in the United States.
C. Fenwick4; G. Pantaleo4; M. Centlivre1; P. Liljestrom3; G. Zurawski2 By September 9th, the university placed two centrally located high-
vy1
and Y. Le rise dorms on a two week quarantine due to the alarmingly high test
1
Vaccine Research Institute, INSERM U955, France, 2Baylor Scott and positivity rate. Here, we use genomic epidemiology to understand
White Research Institute, Dallas, United States, 3Karolinska Institutet, SARS-CoV-2 transmission patterns within the UW-Madison student
Stockholm, Sweden, 4CHUV, Lausanne, Switzerland population and between students and broadly Dane County.
Methods: We obtained and sequenced 256 nasopharyngeal swabs
from the two dorms that were placed on lockdown, ranging from
Background: With no licensed vaccines and only limited therapy September 9th through September 24th. To contextualize and under-
options against SARS-CoV-2, there is an urgent need to develop a vac- stand the amount of mixing between campus and Dane County, we
cine able to prevent COVID-19. The Spike (S) protein and the Region sequenced 10% of all known SARS-CoV-2 positive samples from Dane
Binding Domain (RBD) of SARS-CoV-2 represent major targets of neu- County (9100 cases) through mid-September. All samples were
tralizing and protective antibodies (Ab). sequenced by Oxford Nanopore Technologies (ONT) GridION. We
Methods: We have developed two candidate vaccines known to elicit used consensus sequencing data to compare the university-associated
strong and durable T and B cell responses; the DNA-derived DREP plat- SARS-CoV-2 outbreak to the broader Dane County community.
form encoding for the S protein (DREP-S) and the Dendritic Cell (DC) Results: We identified patterns of viral spread in the dorms, consis-
targeting vaccine composed of a humanized aCD40 monoclonal anti- tent with multiple SARS-CoV-2 introductions, likely arising through
body (mAb) fused via its C-terminal Fc-domains to the RBD protein freshman move in, that resulted in two to three larger transmission
107
clusters. These clusters were not discrete to a single dorm, but mixed to bind to FccRIIIa, suggesting a potential role for ADCC in disease
throughout the two undergraduate dorms evaluated. Surprisingly, we outcome.
find that the majority of UW-Madison viruses tend to be isolated from Conclusions: These data highlight divergent SARS-CoV-2 humoral
other viruses circulating within Dane County, indicating the campus responses associated with clinical outcome and HIV co-infection. Deci-
outbreak has not spilled over into the broader community. phering these is pivotal to understanding the role of antibodies in
Conclusions: Expanded efforts to isolate and contain SARS-CoV-2 COVID-19, with these humoral markers providing early opportunities
cases, specifically in the case of university outbreaks, can arrest the to identify and intervene in individuals with poor prognoses.
spread of the virus and prevent the establishment of new transmis-
sion clusters that spillover into the nearby community. PE07.12LB
Neutralization and Fc-mediated effector function against
PE07.11LB SARS-CoV-2 of engineered ACE2-Fc fusion
Distinct humoral trajectories associated with both HIV co- Y. Chen1; S. Ding2,3; A. Hederman4,5; R. Sherburn1; S.P. Anand2,3,6;
infection and COVID-19 survival in a hospitalized South G. Beaudoin-Bussieres2,3; D. Nguyen1; W. D. Tolbert1;
African SARS-CoV-2 cohort M.E. Ackerman4,5; A. Finzi2,3,6 and M. Pazgier1
S.I. Richardson1,2; N. Manamela1; T. Moyo1,2; T. Hermanus1; 1
Uniformed Services University of the Health Sciences, Department of
P. Kgagudi1; F. Ayres1; Z. Molaudzi1; B. Motsoeneng1,2; Z.van der Walt; Medicine, Bethesda, United States, 2Universite de Montreal, 3Depart-
Z.van der Walt3; T.de Villiers3; W.van Hougenhouck-Tulleken4; ment of Microbiology, Infectious Diseases and Immunology, Montreal,
V. Ueckermann4; L. Morris1,2,5; T. Rossouw6; M.T. Boswell4 and Canada, 3Universite de Montre al, Centre de Recherche du Centre
P.L. Moore1,2,5 al, Canada, 4Dartmouth College, Department of
Hospitalier, Montre
1 Microbiology and Immunology, Geisel School of Medicine at Dart-
National Institute of Communicable Diseases, Centre for HIV and
STI’s, Johannesburg, South Africa, 2Faculty of Health Sciences, Univer- mouth, Hanover, United States, 5Dartmouth College, Thayer School of
sity of the Witwatersrand, Antibody Immunity Research Unit, Johan- Engineering, Hanover, United States, 6McGill University, Department
nesburg, South Africa, 3Tshwane District Hospital, Department of of Microbiology and Immunology, Montreal, Canada
Family Medicine, Pretoria, South Africa, 4University of Pretoria,
Department of Internal Medicine, Pretoria, South Africa, 5University
of KwaZulu Natal, Centre for the AIDS Programme of Research in Background: Effective therapeutic strategies are urgently needed to
South Africa (CAPRISA), Durban, South Africa, 6Faculty of Health control the spread of severe acute respiratory syndrome coronavirus
Sciences, University of Pretoria, Department of Immunology, Pretoria, 2 (SARS-CoV-2). Because the interaction between human angiotensin
South Africa converting enzyme 2 (ACE2) and the receptor binding domain (RBD)
of SAR2-CoV-2 spike is a vital step for viral entry, molecules that
block ACE2-spike engagement are a promising approach to reduce
Background: SARS-CoV-2 has resulted in over a million deaths and viral infection.
47 million infections worldwide. The association between co-morbid- Methods: Molecular cloning, recombinant protein expression, X-ray
ities, clinical severity and antibody function is increasingly well- crystallography, transmission electron microscopy, surface plasmon
described. However the effect of HIV co-infection on the humoral resonance, luciferase-based in vitro neutralization assay, ELISA, Flow-
response to SARS-CoV-2 remains largely unknown. Understanding this cytometry based ADCP assay. Mass photometry.
is vital to the deployment of SARS-CoV-2 vaccines in high HIV inci- Results: Here, by performing structural analysis of the ACE2-RBD
dence areas. interface, we designed a series of engineered ACE2 variants with
Methods: We examined a longitudinal cohort of 62 SARS-CoV-2 mutations in the RBD binding motif that confer improved affinity
patients including 14 HIV-infected and 8 deceased individuals from toward the RBD. Mutations that disrupt the metal binding site were
the Steve Biko Academic Hospital in South Africa. Patients were sam- also introduced to eliminate ACE2 peptidase activity. The recombinant
pled an average of 9 days post-symptom onset at hospital admission fusion of the engineered ACE2 with a human IgG1 or IgG3 backbone
and approximately seven days thereafter. We measured Fc effector was generated and the binding kinetics to SARS-CoV-2 RBD and spike
functions (Fc receptor binding, phagocytosis, trogocytosis and comple- measured by surface plasmon resonance (SPR). The best ACE2-Fc
ment deposition), binding responses against the SARS-CoV-2 spike variant (M56Q) has a dissociation constant (Kd) of 0.89 nM against
and receptor binding domain (RBD) and neutralizing antibody titers. RBD and 0.26 nM against spike. These ACE2-Fc fusions neutralize
Using multivariate analysis, these measures were associated with dis- SARS-CoV-1 or SARS-CoV-2 pseudotyped viruses in vitro. To further
ease severity, survival and HIV status. investigate the Fc-mediated effector mechanism of ACE2-Fc, we fused
Results: Binding, neutralizing and Fc effector responses were signifi- ACE2 variants to modified human IgG1 Fc variants with increased or
cantly increased 7-9 days post hospital admission, showing the rapid decreased binding affinity to FccRIIa and FccRIIIa (Fc-effector enhanc-
elicitation of co-ordinated polyfunctional antibodies. However, approxi- ing and Fc-effector null mutants) and tested for Fc-effector activities
mately 25% of patients displayed no increase in their antibody activity, including antibody-mediated phagocytosis, antibody-dependent cellular
suggesting a delayed humoral response in these individuals. Severity cytotoxicity, NK cell receptor ligation and complement activation.
of disease at admission correlated with increased spike binding levels Finally, structural evidence for enhanced ACE2-RBD affinity is pro-
and enhanced ability of antibodies to mediate trogocytosis. HIV- vided by X-ray crystallography.
infected individuals showed a unique immunological profile compared Conclusions: Taken together, these engineered ACE2-Fc variants pro-
to HIV-uninfected individuals, with significantly stronger associations vide a promising route to control SARS-CoV-2 infection in prophylaxis
between phagocytosis, complement deposition and trogocytosis. There and treatment with the advantages of broad-spectrum activity, limited
was also a distinct dysregulation between RBD binding and the ability viral resistance and reduced angiotensin mediated side effects.
of RBD-specific antibodies to engage both FccRIIa and FccRIIIa among
those with HIV infection suggesting an impaired ability to elicit phago-
cytosis and antibody-dependent cellular cytotoxicity (ADCC). Similarly,
individuals who died from COVID-19 (only one of whom was HIV-
infected) showed distinct profiles compared to those who survived. Of
these, most striking was the limited ability of spike-specific antibodies
108
a growing library of converged SARS CoV2 binding peptides. IgG gly-

PE07.13LB cosylation was measured through heavy chain tryptic digestion fol-
Learning from digital health in curtailing coronavirus lowed by Orbitrap high-resolution mass spectrometry and peptide-
epidemic: review of HIV/AIDS mobile apps or chatbots in glycoform assignment.
Nigeria Results: RBD binding ELISA significantly correlated with SARS-CoV2
M. Adesina; I. Olufadewa; R. Oladele; F. Abudu; M. Oladoye; neutralization (Spearman correlation, p <0.0001). In addition, we were
T. Ayorinde and F. Adeyemo able to characterize neutralizing antibody responses from dried blood
Slum and Rural Health Initiative, Research Academy, Ibadan/Oyo, spot cards. There were RBD-specific IgG1 and IgG3 responses in both
Nigeria groups which were elevated in the COVID-19 hospitalized individuals.
Hospitalized individuals had significantly (t-test p <0.05) increased
fucosylated agalactosylated (G0F) IgG glycoforms (inflammatory)
Background: The HIV/AIDS epidemic has led to death of over 32.7 whereas mild individuals had significantly (t-test p <0.05) increased
million people since its first reported case in 1981. More than 37.9 fucosylated galactosylated (G2F) IgG glycoforms (anti-inflammatory).
million people are living with HIV/AIDs presently of which 1.9 million Conclusions: We have found that there are distinct immunological
reside in Africa’s most population nation, Nigeria. Digital health inter- differences that exist between mild and hospitalized COVID-19
ventions have played a lot of roles in curbing this epidemic; however, patients. Through both IgG subclass and glycosyation profiling we have
its effects have not been fast enough or adequate in developing coun- elucidated markers indicative of disease severity. Importantly these
tries such as Nigeria. From this stance point, this study aims to review markers can be assessed from at home mailed in dried blood spot
and identify high quality HIV/AIDS mobile applications and chatbot in cards, which are critical for predicting disease severity during this sec-
order to aid development of effective and efficient coronavirus mobile ond surge and inevitable lockdown. The results from this study have
apps and chatbots for use in developing countries. the potential to inform vaccine design strategy through a better
Methods: A systematic search for HIV/AIDS mobile applications or understanding of the neutralizing antibody response seen in individu-
chatbot was conducted using Google and Google Play store using als that recovered compared to those that are hospitalized.
search words such as “HIV”, “AIDS”, “HIV/AIDS”. The quality of all rele-
vant apps or chatbot available for use in Nigeria was rated using the PE07.15LB
Mobile App Rating Scale.
Shelter-in-place but at what cost? Barriers to healthcare
Results: A total of 245 applications or chatbot were identified
through the search; however only 58 relevant ones were found.
and other social determinants of health among young
Majority of the apps or chatbot were focused on sex education women under South Africa’s COVID-19 lockdown
(39.6%), sexually transmitted infection (8.6%), HIV/AIDS testing J Ndirangu1; W. Wechsberg1; N. Shangase1; F. Browne2 and
(13.7%). Only 7 high-quality applications or chatbot were identified M. Gichane1
1
after the screening and in-depth content analysis. Majority (6) of these RTI International, Durham, United States, 2University of North Caro-
high quality applications were developed by international organiza- lina at Chapel Hill, Chapel Hill, United States
tions.
Conclusions: This study has shown that only about 12% of relevant
HIV/AID mobile apps/chabots available for use in Nigeria are high Background: In early March 2020, South Africa implemented tough
quality and this might be responsible for the slow pace in curbing this lockdown restrictions to limit the rapid spread of COVID-19. The
epidemic. Learning from this, more high quality mobile applications effect of these measures on adolescent girls and young women
and chatbots need to be developed to combat the spread of the (AGYW) in economically disadvantaged communities has not been fully
COVID-19. documented. To address this gap, a COVID-19 sub-study was embed-
ded in a National Institutes of Health study reaching AGYW (aged 16
to 24 years) to increase pre-exposure prophylaxis (PrEP) and sexual
PE07.14LB reproductive health (SRH). The purpose of the sub-study was to docu-
Characterization of the neutralizing antibody response in ment the impact of the COVID-19 lockdown on the social determi-
SARS-CoV-2 infected individuals nants of health among AGYW in Tshwane, South Africa.
J. Mamede1; M. Ash1; S. Gambut1; R. Melani2; A. Dharan3; I. Tarhoni1; Methods: AGYW enrolled in the parent study were recruited for a
C. Fhied1; Y. Ah Goo2; E. Campbell3; L. Al-Harthi1; N. Kelleher2; telephonic survey two months into the lockdown. Information col-
J. Borgia1 and J. Schneider1 lected included current living conditions, COVID-19 knowledge and
1
Rush University, Chicago, United States, 2Northwestern University, prevention practices, access to SRH and PrEP services, ability to con-
Evanston, United States, 3Loyola University, Maywood, United States tinue with school, mental health, and food security. Data were ana-
lyzed using descriptive statistics and logistic regression.
Results: A total of 177 of 350 participants enrolled in the parent
Background: The COVID-19 pandemic has claimed the lives of over study completed the COVID-19 survey. Among AGYW who tried to
1.2 million people worldwide and there is no vaccine currently avail- seek health services, 38% found it difficult to go to the clinic, 35%
able. A better understanding of anti-SARS-CoV-2 immune responses is were unable to access contraceptives, while 33% of those on PrEP
critical to the development of an effective vaccine. Through a combi- were unable refill their prescription due to the lockdown measures.
nation of traditional and novel approaches to assess antibody neutral- Of those enrolled in school, 73% were unable to continue attending
ization, we ultimately aim to understand the quandary of why certain virtually. Fifty-three percent of AGYW reported having difficulties
individuals recover and other go on to more severe COVID-19 symp- finding food to eat. Seven AGYW reported experiencing physical
toms. abuse during the lockdown and 38% requested mental health coun-
Methods: Plasma and dried blood spot samples from mild (n=20) and selling services. Logistic regression revealed that AGYW who lived
hospitalized (n=20) COVID-19 patients were obtained from Rush two or more in a room at home or lived in informal housing were four
biorepository. We developed a SARS-CoV-2 Receptor Binding Domain times more likely to report inability to practice COVID-19 prevention
(RBD) binding ELISA for bulk and subclass specific IgG. Neutralization measures (p <0.001).
was determined using SARS-CoV-2 Spike pseudotyped virus on ACE2- Conclusions: Strict containment measures may prevent the rapid
overexpressing HELA cells. In addition neutralization was measured spread of COVID-19; however, AGYW living in resource poor settings
through mass spectrometry through CDR3 region sequencing against are unable to physically distance, continue with their education, seek
109
services that may avert HIV or unplanned pregnancies and need men-
tal health support. Policy makers should provide resources to mitigate PE08.02
these unintended consequences of COVID-19 which may have long- Formulation development of an ethylene vinyl acetate ring
term implications to young women’ resilience and their future. for sustained release of the experimental entry inhibitor
DS003
D. Murphy1; C. McCoy1; Y. Dallal Bashi1; B. Devlin2; J. Nuttall2;
Delivery technologies: Novel approaches, W. Blanda2; K. Malcolm1 and P. Boyd1
formulation and multi-purpose 1
Queen’s University Belfast, School of Pharmacy, Belfast, United King-
dom, 2International Partnership for Microbicides, Silver Spring, United
States
PE08.01 Background: DS003 is an entry inhibitor being developed as a vaginal

Preferences for implantable pre-exposure prophylaxis microbicide for HIV prevention. We report the development and
products among adolescent girls, young women, and female in vitro testing of ethylene vinyl acetate (EVA) vaginal rings containing
sex workers in South Africa DS003 in support of pharmacokinetic/efficacy testing in macaques.
K. Little1; H. Hanif2; S. Anderson2; M. Clark2 and G.F. Doncel2 Methods: Matrix-type EVA rings containing 40% w/w DS003 were
1
Population Services International, HIV/TB, Washington, United States, manufactured on a Babyplast injection molding machine. Initial drug
2
CONRAD, Eastern Virginia Medical School, Norfolk, United States content was measured by dissolving ring segments in dichloromethane
(72hr, 37˚C) and determining the DS003 concentrations using UV spec-
troscopy at 350 nm. In vitro release testing was performed into 100 mL
Background: Adherence barriers, including stigma and difficulties tak- sodium acetate buffer (pH 4.2) containing 2% w/w Kolliphor® HS15,
ing a daily pill, may limit the effectiveness of daily oral PrEP, especially with daily sampling (except weekends) and complete media replace-
for adolescent girls (AG) and young women (YW). We explored prefer- ment. Drug release was quantified by reverse-phase HPLC. Residual
ences for an ARV implant (“PrEP implant”) that may address some of DS003 content was measured following efficacy testing in macaques.
these barriers. Results: Two ring batches were prepared with initial content values
Methods: We conducted mixed methods research including qualita- of 629 18 and 617 10 mg DS003 per ring, respectively. In vitro
tive in-depth interviews (IDIs) and a quantitative survey with AG (ages release testing showed linear cumulative release vs. time profiles indi-
15 to 17), YW (18 to 34), and female sex workers (FSW; ≥18) in rural cating solubility-limiting release kinetics. The daily release rate (95%
and urban areas of South Africa. Qualitative data were analyzed using confidence interval) was 39.3 (37.8, 40.9) μg/day for rings tested
a thematic approach. The quantitative survey included a discrete immediately after manufacture, and 21.5 (20.7, 22.3) μg/day for rings
choice experiment. Quantitative data were analyzed in STATA 15.0. tested after one month on storage at 4˚C, a release rate decline of
Results: We conducted 24 IDIs with women and girls. Participants ~45%. The mean total amount of DS003 released over 28 days
valued the long-acting, discreet nature of the PrEP implant, and in vitro was 1.1 mg for rings tested immediately and 0.66 mg for rings
expressed preferences for a dissolvable product. While respondents tested after one month storage. Mean residual content of rings
would be willing to tolerate some side effects in order to have “safety” returned from the macaque study was 628 16 and 629 32 mg
from HIV, they wanted to be fully counselled on what to expect and DS003 per ring. Based on these values, it was not possible to deter-
how to deal with side effects. Others recommended a “leading dose”. mine definitively that DS003 was released from the rings in the maca-
We recruited 600 respondents for the quantitative survey. After que study.
effectiveness, respondents expressed the strongest preferences for a Conclusions: In vitro release of DS003 was solubility constrained,
PrEP implant that caused only minor insertion pain (OR: 1.95), or reflecting the poor water solubility of DS003. A substantial reduction
insertion pain and headache lasting days (OR: 1.22) relative to inser- in release rate was observed following ring storage, likely due to time-
tion pain and headaches lasting weeks. Respondents also significantly dependent crystallisation of DS003 and/or the EVA polymer. Initial
preferred a product that provided HIV protection for 24 months (OR: and residual DS003 content measurements of rings following testing
1.42) versus six months, and that required a single insertion (OR: in macaques suggested that no or only very small quantities of DS003
1.44). Insertion location was not significantly associated with product are released in vivo.
preferences. Respondents would be willing to pay an average of 234
Rands (~US$13; 95% CI: R210 to 258) for a PrEP implant. Overall
78% of respondents said they would be likely (33%) or very likely PE08.03
(45%) to use a PrEP implant were one available. Custom silicone elastomers for improved mechanical
Conclusions: AG, YW, and FSW in our survey reported a strong will- performance and reduced hormone binding in a dapivirine/
ingness to use PrEP implants to reduce their risk of HIV were they to levonorgestrel vaginal ring
be made available in South Africa. Respondents expressed preferences K. Malcolm1; Y. Dallal Bashi2; C. McCoy2; D. Murphy2; P. Boyd2;
for long-acting dissolvable single-insertion PrEP implants that were B. Devlin3; K. Kleinbeck3; P. Spence3; B. Dangi3; B. Hansraj3;
highly effective and caused mild insertion pain and side effects. N. McMullen4; L. Brown4; F. Martin4 and M. Kihara4
1
dom, 2Queen’s University Belfast, Belfast, United Kingdom, 3Interna-
tional Partnership for Microbicides, Silver Spring, United States,
4
Elkem Silicones, United States
Background: We previously reported the chemical binding of levonor-

gestrel (LNG) to vaginal rings manufactured from addition-cure sili-
cone elastomers. Here, three custom silicones were evaluated for
manufacture of a multipurpose technology (MPT) vaginal ring (VR)
releasing dapivirine (DPV) and LNG with the aim of reducing LNG
binding and improving mechanical performance.
110
Methods: Silbione® Biomedical D160 silicone elastomers (Lots Background: Over 50% of HIV infected individuals are women, and
07117-13, 14 and 15) were supplied by Elkem Silicones. Matrix-type ~50% of all pregnancies are unplanned. Protection of women from
VRs containing 200 mg DPV and 320 mg non-micronised LNG unplanned pregnancy and infection by STIs remains imperative with
(nmLNG) were manufactured by injection molding (100°C/95 sec). increased attention to multipurpose technologies (MPTs) being essen-
Elastomer 14 was also used to prepare VRs containing 200 mg DPV tial. A successful MPT IVR should embody ‘good’ drugs, design, protec-
with 240, 160 or 8 0 mg nmLNG. Various mechanical tests were per- tive performance and manufacturing. We propose a new, next
formed on the VRs and assay values for DPV and LNG were deter- generation MPT IVR that is prospectively designed, tested and manu-
mined. In vitro release testing was performed for the VRs using two factured, in a rational development path that implements clinically pro-
different media – IPA:water (1:1 v/v) and sodium acetate buffer with ven drugs and performance evaluation. Particular advantages to our
2% Solutol® HS15. device and methodology are:
Results: All three silicones showed similar cure profiles and viscosities 1) it is manufactured using state-of-the-art Continuous Liquid Inter-
conducive to practical ring manufacture and performance (Table 1). face Production (CLIPTM) 3D printing; this enables diverse device
DPV+LNG rings manufactured from Silicone 14 (selected for further geometry, efficient drug loading and controlled release, and automated
study due to its relatively long working time) showed high LNG recov- manufacturing with good process control;
ery and good mechanical properties (Table 2). 2) the antiretroviral drug (ARV), Islatravir, is acknowledged as cutting
Conclusions: These new silicone materials, and particularly variation edge and is extremely potent and retained by target host cells for
07117-14, offered desirable mechanical performance and acceptable long times in combination with the already established etonogestrel
LNG recovery values for further development of a silicone based (ENG)/ethinyl estradiol (EE) contraceptive combination.
MPT ring. Methods: IVRs with optimized complex geometries were fabricated
with the CLIP technology. In vitro release kinetics of ARV Islatravir
PE08.04 and 2 contraceptives (ENG/EE) were assessed. In vitro and in vivo
safety, including effect on the ex-vivo human associated vaginal epithe-
Next generation multipurpose intravaginal ring technology
lial cell/vaginal microbiome (VEC-VMB) co-culture system was
using innovative CLIP 3D printing assessed with mouse size (3 mm OD) placebo IVRs in vitro, ex-vivo,
R. Benhabbour1; R. Janusziewicz1; R. Shrivastava1; I. Young1; and in vivo in mice; and with human size (55 mm OD) placebo IVRs in
A. Medina-Colorado2; R. Pyles2 and K. Vincent3 sheep.
1
University of North Carolina, Biomedical Engineering, Chapel Hill, Results: IVRs with optimized designs, surface area, and mechanical
United States, 2Unversity of Texas Medical Branch, Galveston, United properties were fabricated in three sizes (human, macaque, mouse)
States, 3Unversity of Texas Medical Branch, Department of Obstetrics using the CLIP technology. We have demonstrated the ability to fine-
& Gynecology, Galveston, United States tune release kinetics of contraceptive drugs (EE, and ENG) and a
highly potent ARV (Islatravir). We have demonstrated the ability to
co-formulate all three drugs in a single IVR at target drug loading.
111
Placebo 3D printed IVRs were safe in vitro and in vivo in mice over was observed on some ring samples. To investigate the potential
60 days and in sheep over five weeks, including limited impact on causes of this discoloration, four different silicone VR formulations
transplanted human vaginal microbiomes that colonized vaginal muco- were exposed to SVF and SMF solutions for up to 60 days.
sal cultures. Methods: Placebo, 25 mg DPV, 200 mg DPV, and 200/320 mg
Conclusions: 3D printing allows rapid manufacturing of custom-sized DPV+LNG silicone rings were prepared. SVF media containing either
IVRs and IVRs that can integrate potent and a clinically proven drug 20 lM H2O2, 20 lM H2O2 + copper IUD, methyl red, toluidine blue,
combination Islatravir/ENG/EE providing a novel cost-effective and or crystal violet were prepared, with SVF-only and ultrapure water as
translational MPT IVR platform. controls. SMF-based media (SMF-only, SMF+20 lM H2O2 or
SMF+20 lM H2O2+IUD) were prepared using a 1:1 mixture of horse
PE08.05 blood and SVF containing 0.5% w/v xanthan gum. Single rings were
placed in 100 mL of each media. Flasks were incubated (37°C/
Anti-CCR5 siRNA-loaded polymeric nanoparticles for topical
60 rpm) for 30 and 60 days with media replenished weekly. At sched-
pre-exposure prophylaxis uled timepoints, rings were removed, rinsed, dried and photographed
R. Ribeiro; B. Sarmento and J. das Neves alongside controls. Cross-sections of VRs were examined for interior
i3S – Instituto de Investigac~ao em Sa
ude & INEB – Instituto de staining using microscopy.
Engenharia Biome dica, Universidade do Porto, Nanotechnologies and Results: After 60 days, rings soaked in SVF-only, SVF+H2O2,
Translational Drug Delivery, Porto, Portugal SVF+H2O2+IUD media showed no surface discoloration. Rings soaked
in SVF+dye media showed uniform surface staining. Methyl red and
toluidine blue exposed rings showed significant colour ingression
Background: Post-transcriptional silencing of host factors involved in
throughout the ring. Crystal violet exposed rings showed minimal col-
HIV-1 cell infection, such as CCR5, present the potential to be used
our ingression. After 60 days, the surfaces of all SMF-treated rings
in preventing sexual transmission of the virus. However, intracellular appeared yellow compared to controls. Colour intensity correlated
delivery of siRNA yielding safe and effective silencing poses a consid-
with duration of SMF exposure. After 14 days, IUD-containing sam-
erable challenge. In this work, we produced anti- CCR5 siRNA-loaded
ples showed black/dark surface markings consistent with direct IUD
polymeric nanoparticles (siRNA@NPs) and tested these nanosystems
contact. Additional non-uniform red-brown staining was observed on
for relevant physicochemical and in vitro biological properties regard- the surface of all rings exposed to SMF-only and SMF+H2O2 media
ing putative development as a microbicide candidate.
and was demonstrated to be blood debris. No significant staining of
Methods: siRNA@NPs were produced using SMARTpool siGENOME
the ring interior was observed.
CCR5 siRNA (M-004855-03-0050, Dharmacon, USA) and polycapro-
Conclusions: SVF+dye media were shown to cause ring staining after
lactone as polymer through a W/O/W emulsion-evaporation method.
30 and 60-day exposure. Depending on the dye, either surface staining
siRNA@NPs were characterized by Dynamic Light Scattering (DLS),
or complete dye ingression was achieved. Staining was also observed on
Electrophoretic Light Scattering (ELS) and Transmission Electron
rings exposed to SMF after 30 and 60 days. The yellowing of the ring
Microscopy (TEM) for colloidal properties. The siRNA association effi- with dark streaks and/or spots was consistent with the appearance
ciency were determined by extracting nucleic acid material from siR-
observed in post-clinical use VRs. Discolorations were not deemed to be
NA@NPs and quantification using SYBR Gold staining. The ability of
related to adverse events but may affect ring use behaviour.
siRNA@NPs to silence CCR5 expression in HOS CD4+CCR5+ cells
was assessed by flow cytometry at different time points after an initial
period of 12 h of incubation with nanosystems. Toxicity to the same PE08.07
cell line was evaluated using the MTT assay. A new multipurpose vaginal ring for prevention of HIV and
Results: siRNA@NPs featured average diameter of 104 10 nm, treatment of bacterial vaginosis
polydispersity index of 0.125 0.012, zeta potential of K. Malcolm1; X. Zhao1 and P. Boyd2
3.8 0.9 mV, and association efficiency of 33.5% 5.0%. TEM 1
imaging confirmed the size and relative monodisperse nature of siR- dom, 2Queen’s University Belfast, Belfast, United Kingdom
NA@NPs. Cytotoxicity of siRNA@NPs to HOS CD4+CCR5+ cells was
low (CC50 > 100 nM in siRNA). Nanosystems were able to partially
reduce, in a dose dependent manner, the levels of CCR5 expression Background: With the dapivirine (DPV) matrix-type vaginal ring (VR)
by HOS CD4+CCR5+ cells at 24 h post-incubation: ~30% and ~45% currently under regulatory review for HIV risk reduction, there is a
reduction in the amount of membrane associated co-receptor at strong scientific rationale for developing new multipurpose prevention
siRNA concentrations of 2 nM and 10 nM, respectively. technology (MPT) VRs. Bacterial vaginosis (BV) is a common dysbiosis
Conclusions: Proposed siRNA@NPs were shown safe and partially of the human vaginal microbiome that has been strongly correlated
effective in silencing CCR5 expression in vitro, thus supporting further with increased risk of HIV acquisition in women. Here, we describe
development of these nanosystems as a microbicide candidate. formulation efforts to develop an MPT VR offering simultaneous
release of two or more of the following actives: dapivirine (DPV; an
PE08.06 antiretroviral); metronidazole (MET; an antibiotic drug); sucrose (pro-
motes lactobacilli growth); and boric acid (BA; an antimicrobial and
In vitro modelling of in vivo discoloration of the dapivirine-
anti-biofilm agent).
levonorgestrel vaginal ring using a range of simulated Methods: Matrix-type silicone elastomer VRs containing various com-
vaginal and menstrual fluids binations of DPV, MET, sucrose and BA were manufactured. In vitro
K. Malcolm1; C. McCoy2; D. Murphy2; Y. Dallal Bashi2; P. Boyd2; testing of rings included: rheological assessment of cure properties;
P. Spence3; B. Devlin3; K. Kleinbeck3; B. Dangi3 and T. Derrick3 drug release; thermal analysis (DSC, TGA); mechanical testing (com-
1
Queen’s University Belfast, School of Pharmacy, Belfast, United King- pression, Shore Hardness); swelling studies in aqueous medium; sur-
dom, 2Queen’s University Belfast, Belfast, United Kingdom, 3Interna- face imaging using scanning electron microscope; and time-kill kinetics
tional Partnership for Microbicides, Silver Spring, United States assay against Gardnerella vaginalis.
Results: All four active agents – singly and in various combinations –
were successfully incorporated into rings. Mechanical properties of ring
Background: During clinical trials of the dapivirine+levonorgestrel formulations were acceptable. Increasing sucrose loadings correlated
(DPV+LNG) silicone elastomer vaginal ring (VR), surface discoloration with increased MET release. DPV release was increased by changing
112
the drug loading or combining with MET. Incorporation of MET

increased the solubility of DPV in silicone elastomer due to the reduced PE08.09LB
melting transition of DPV in the formation of the eutectic compound Anti-HPV and anti-HSV activity in rectal enema effluents
between DPV and MET. Release of sucrose and boric acid from the collected from subjects receiving PC-1005: a dual
rings caused surface roughness. Incorporation of sucrose and boric acid compartment multipurpose prevention technology
caused the vaginal ring to swell in proportion to their loading, and by up formulation
to 70% of the original weight. MET release from vaginal rings showed J.A. Fernández Romero1,2; N. Cornejal3; C. Melo3; S. Alsaidi4;
bacteriostatic activity against Gardnerella vaginalis. P. Barnable2; N. Teleshova2; T.M. Zydowsky2; K. Ho5; C. Hoesley6;
Conclusions: These data demonstrate the formulation feasibility of P.L. Anderson7; C. Kelly8; Y. Jiao8; S. Edick5; R.M. Brand9; R.P. Kunjara
VRs containing different combinations of MET, DPV, sucrose and/or Na Ayudhya10; B.A. Friedland2; J. Piper11; R. Scheckter12;
boric acid for simultaneous prevention of HIV infection and treatment I. McGowan5 and C.W. Hendrix13
of BV. 1
Borough of Manhattan Community College, New York, United States,
2
Population Council, New York, United States, 3Brooklyn College,
PE08.08LB New York, United States, 4Lehman College, New York, United States,
5
Design of enzyme responsive microspheres of maraviroc University of Pittsburgh Medical Center, Pittsburgh, United States,
6
and tenofovir in a smart vaginal gel for pre-exposure University of Alabama at Birmingham, Birmingham, United States,
7
prophylaxis of HIV-1 University of Colorado School of Pharmacy, Colorado, United States,
8
Fred Hutchinson Cancer Research Center, Seattle, United States,
S. Ekama1; M. Ilomuanya2; C. Azubuike2; M. Fowora1; O. Ezechi1 and 9
University of Pittsburgh, Pittsburgh, United States, 10Magee-Womens
C. Igwilo2
1 Research Institute and Foundation, Pittsburgh, United States,
Nigerian Institute of Medical Research, Clinical Sciences, Lagos, Nige- 11
National Institute of Allergy and Infectious Disease, DAIDS,
ria, 2University of Lagos, Pharmaceutics and Pharmaceutical Technol-
Bethesda, United States, 12FHI 360, Durham, United States, 13Johns
ogy, Lagos, Nigeria
Hopkins University, Baltimore, United States
Background: Smart drug delivery systems targeting antiretroviral

Background: MTN-037 is a Phase 1 dose-ranging trial evaluating the
drugs to the site of action with the goal of achieving controlled drug
rectal safety and pharmacokinetics of PC-1005 (MIV-150, zinc acetate,
release have been explored; to combat the challenges of low resi-
carrageenan), a peri-coital gel designed for vaginal and rectal use.
dence time in the vagina associated with conventional systems. A
Pharmacodynamic studies are focused on anti-HIV activity; however,
smart vaginal bigel with a capacity to accommodate a lipophilic (teno-
the active pharmaceutical ingredients in PC-1005 also have activity
fovir) and lipophobic(maraviroc) drug was formulated. Acid phos-
against other sexually transmitted viral infections, making it a promis-
phatase enzyme is a component of the seminal fluid whose influence
ing multipurpose prevention technology (MPT). In an ancillary study,
on the drug loaded chitosan-tripolyphosphate polymer crosslink was
we tested the activity of PC-1005 against human papillomavirus type
evaluated.
16 pseudovirus (HPV16 PsV) and herpes simplex 2 (HSV-2) using the
This study aims to evaluate the efficacy, safety, and test the hypothe-
rectal enema effluents collected in MTN-037.
sis that a triggered release of maraviroc and tenofovir can be
Methods: Healthy HIV-negative research participants in MTN-037
achieved from microspheres incorporated in a vaginal bigel in the
sequentially received escalating single doses (4 mL, 16 mL and
presence of acid phosphatase enzyme.
32 mL) of PC-1005 rectally and rectal enema effluents were collected
Methods: Maraviroc and tenofovir were loaded into a chitosan-tripo-
at baseline, early (0.5-5 hours) and late (24 hours) time points. There
lyphosphate polymer matrix via ionic gelation to form microspheres;
was a washout period (14 to 42 days) between single doses. The anti-
with subsequent incorporation into a bigel which was formulated from
HPV and anti-HSV activity of enema effluents from 6 participants
a 1:1 ratio of organogel and hydrogel. Enzyme degradation assay was
were evaluated using (1) the HPV16 PsV luciferase assay to estimate
used to assess the effect of acid phosphatase enzyme on the release
half-maximal effective concentrations (EC50) based on rectal enema
profile of maraviroc and tenofovir from the microspheres. HIV efficacy
effluent dilution and (2) the HSV-2 plaque reduction assay after incu-
and cytotoxicity of the microspheres were assessed using HIV-1 BaL
bation of rectal enema effluents with HSV-2 for 30 minutes at 37oC.
virus strain and HeLa cell lines respectively.
Results: Rectal enema effluents in the HPV 16 PsV assay had EC50
Results: Maraviroc and tenofovir release kinetics followed a zero-
values between 0.16 and 2.4 9 105 (dilution factor). EC50 values
order (R2 = 0.9409) and Higuchi model (R2 = 0.9034) kinetics respec-
from enema effluents collected at early (0.5 to 5 hours) time points
tively in the absence of the enzyme. However, under the influence of
post PC-1005 gel application were significantly lower from enema
the enzyme, maraviroc release was governed by the first order model
effluents collected at baseline (p < 0.04). The HSV-2 assay resulted in
kinetics (R2 = 0.8922) while tenofovir followed a super case II
66% to 87% decrease in HSV-2 plaque forming units. The anti-HSV-2
(n = 0.8971) transport mechanism. The assay of the microspheres on
activity was significantly different between enema effluents collected
the HeLa cells did not show signs of cytotoxicity at a concentration of
at early time points (0.5 to 5 hours) post gel application and those
10 lg/mL. The bigel elicited a progressive decline in HIV infectivity
collected at baseline (p < 0.02). There was correlation between anti-
until at a concentration of 0.1 lg/mL.
HPV and anti-HSV activity (Spearman r = 0.7409; p < 0.0001).
Conclusions: The candidate bigel containing antiretroviral micro-
Conclusions: Our results support the further evaluation of PC-1005
spheres intended for use as a vaginal microbicide has potentials for a
as an on-demand formulation to prevent HPV and HSV infections.
triggered release by acid phosphatase enzyme present in the seminal
fluid thus serving as a strategic point to prevent HIV transmission. Its
efficacy on the HIV-1 BaL virus strain and safety on HeLa cells sug-
gests further in-vivo studies might pave way for promising results.
113
Background: Oral pre-exposure prophylaxis (PrEP) is a highly effective

PE08.10LB method of preventing HIV, yet uptake of and adherence to PrEP
High resolution and 3D ultrasound imaging of implant and remains low. Clinical trials, market research, and acceptability studies
intravaginal ring drug delivery devices during HIV pre- suggest women would prefer an HIV prevention method that also pre-
exposure prophylaxis (PrEP) preclinical and clinical studies vents unintended pregnancy. The objective of this report is to estimate
J.A. Moss1; Y. Zhu2; G. Vargas2; R.B. Pyles2; M.M. Baum1; the potential market size in priority sub-Saharan African countries for a
M. Motamedi2 and K.L. Vincent2 28-day dual prevention pill regimen containing the active pharmaceuti-
1
Oak Crest Institute of Science, Monrovia, United States, 2University cal ingredients in oral pre-exposure prophylaxis and oral contraceptive
of Texas Medical Branch, Galveston, United States pills for the prevention of HIV and unintended pregnancy.
Methods: Fifteen countries in sub-Saharan Africa were selected for
analysis. United Nations population data from 2019 were used to esti-
Background: Clinical trials support the use of daily HIV pre-exposure mate the number of women of reproductive age in each country. Low,
prophylaxis (PrEP), however compliance with frequent dosing sched- medium, and high rates (range 0.25% to 25%) of estimated conversion
ules as well as plasma fluctuations can be limitations. Longer acting from current contraceptive method to the dual prevention pill were
formulations can address these limitations by providing long-term applied by country based on; HIV prevalence (=10% vs. <10%), cur-
steady state drug release through devices such as subdermal implants rent contraceptive method (oral contraceptive pill, condom, unmet
and intravaginal rings (IVRs). Clinically, ultrasound (US) imaging has need for contraception), and age group (15 to 24 or 25 to 49).
been used to locate nonpalpable contraceptive implants while 3D
reconstruction has been utilized for vaginal foreign body (mesh) local- Abstract PE09.01-Table 1. Estimated Conversion Rates
ization. These techniques can be applied to evaluate drug-delivery
devices designed to release PrEP. The goal of these studies is to uti- Total HIV
lize ultrasound imaging for anatomic mapping and observation of HIV negative Low range Mid range High range
PrEP-releasing devices during preclinical and clinical studies. population conversion conversion conversion
Methods: PrEP-releasing silicone subdermal implants were evaluated
HIV prevalence lower than 10%
in sheep (n = 4) with a high-resolution US system, Visualsonics Vevo
Age group 15 to 25 to 15 to 25 to 15 to 25 to
2100 (22 to 55 MHz linear probe). Images were obtained at the
24 49 24 49 24 49
implant insertion site for assessment of implant location and tissue
HIV () oral 2.5% 1% 5% 2.5% 12.5% 6%
irritation, including edema (interstitial fluid, increased echogenicity),
contraceptive
and hypervascularity (increased flow by Doppler). In the clinical study,
pill Users
a GE Voluson 730PRO US system (convex 2 to 5 MHz, endocavitary
HIV () male 1% 0.5% 2.5% 1% 5% 2.5%
4 to 9 MHz probes) was utilized for 2D/3D imaging of vaginal rings
condom users
in women (n = 10) using placebo or PrEP drug-releasing IVRs in a 28-
HIV () women 0.5% 0.25% 1% 0.5% 2.5% 1.5%
day crossover study. Image volume sets were obtained and recon-
with an unmet
structed to produce views of the IVR in relation to the uterus, cervix,
need for
bladder, and pubic symphysis.
family planning
Results: Subcutaneous implants were visualized best in the transverse
HIV prevalence greater than or equal to 10%
plane, similar to human contraceptive implants. The implants were lin-
Age group 15 to 25 to 15 to 25 to 15 to 25 to
ear and located 2 to 4 mm deep. One implant was visualized within
24 49 24 49 24 49
the muscle layer, a finding not detectable by palpation. No signs of tis-
HIV () oral 5% 2.5% 10% 5% 25% 12.5%
sue irritation were present. In the clinical study, IVRs, visible via
contraceptive
abdominal and trans-perineal scanning, were hypoechoic, while the
pill users
pods containing drug or placebo were hyperechoic. The IVRs were
HIV () male 2.5% 1% 5% 2.5% 12.5% 6%
non-compressed, located in the posterior fornix extending to the level
condom users
of the mid bladder, with the distal IVR edge located 2.3 to 3.5 cm
HIV () women 1.5% 0.75% 2.5% 1.25% 6% 2.5%
from the pubic symphysis.
with an unmet
Conclusions: US imaging can enhance preclinical and clinical PrEP
need for
studies, providing vital information about device placement, location,
family planning
and deformity in situ. It also has potential to detect signs of toxicity
during use of subdermal implants.
Results: Between 250,000 and 1.25 million women could switch from
their current contraceptive method to the dual prevention pill. Given
Demand creation, market research, that current PrEP use in the 15 countries combined is estimated to be
human-centred design 113,250 (women and men), the most conservative market size estimate
would more than double the number of women currently using PrEP.
Conclusions: By leveraging the existing market for oral contraceptive
pills and assuming modest conversion from condom users and women
PE09.01 with an unmet need for contraception, the dual prevention pill could
dramatically increase PrEP usage among women at risk of HIV acquisi-
Estimating the market size for a dual prevention pill: adding
tion. In addition, the dual prevention pill would increase women’s
contraception to PrEP to increase uptake and adherence
choice within the contraceptive method mix, an important goal for
L. Begg1; R. Brodsky2; B. Friedland1; S. Mathur2; J. Sailer1 and achieving improved sexual and reproductive health outcomes world-
G. Creasy1 wide.
1
Population Council, Center for Biomedical Research, New York, Uni-
ted States, 2Population Council, New York, United States
114
high HIV incidence. This study analysed barriers and drivers of effec-
PE09.02 tive HIV prevention from the perspective of AGYW and co-created
Bridging the insight to action gap: using HCD Methods to solutions with AGYW and other stakeholders.
design organizational tools for stakeholders in South Africa Methods: Multi-method research was conducted in 2018 to 2019 in
in order to improve effectiveness of AGYW prevention KwaZulu-Natal and Mpumalanga provinces. We began with qualitative
programs research incorporating ethnography, journey mapping and focus group
J. Mulhausen1; P. Noble-Campbell2; A. Gangaramany3; Y. Croucamp3 discussion with 240 AGYW aged 15 to 24. Findings informed develop-
and P. Manchi3 ment of a quantitative survey with a random sample of 2069 AGYW,
1
Upstream Thinking, Co-Founder, Austin, United States, 2Upstream using cluster modelling analysis to derive actionable segments for
Thinking, Austin, United States, 3Final Mile Consulting, Chicago, Uni- future programs. The user-centred design phase began with a three-
ted States day workshop with 18 AGYW and 12 other stakeholders (funders,
government, implementers) to prioritise challenges, generate ideas
and prototype solutions. We then assessed solutions for desirability,
Background: Despite significant excitement for leveraging Human- feasibility and scalability, and synthesized several concepts into a sin-
Centered Design (HCD) methods to develop solutions to global health gle prototype for piloting by two implementing partners.
problems, organizations still struggle to effectively convert behavioral Results: We found that AGYW at high risk of HIV infection prioritise
insights into interventions. As part of a larger study on AGYW preven- relationship management over HIV prevention and reject HIV preven-
tion behaviors, the objective of this sub-phase of the project was to tion strategies that may cause relationship conflict or tension. We fur-
systematically apply these same HCD methods to identify and address ther identified three distinct AGYW segments, differentiated by
operational challenges faced by implementing partners (IPs) Govern- relationship needs, degree of control within relationships, HIV risk
ment Agencies (GAs) and donors in South Africa in using behavioral perception, and emotional associations with HIV.
insights for developing new prevention interventions. We also mapped a five-phase relationship and sexual health journey,
Methods: In-depth individual interviews were conducted with 18 with the key milestone to stable, healthy prevention habits being the
stakeholders across the 3 user groups. Interviews used a structure shift from focusing on external pressures and expectations to internal
that explored the functional goals of their role, steps in the interven- preferences and priorities.
tion development process and the typical barriers experienced along Building on the nexus between HIV prevention and relationship man-
the way. Responses were synthesized and coded against these factors agement, AGYW and key stakeholders then co-created a ‘relationship
to reveal the most prominent barriers. bootcamp’ prototype to help AGYW progress through the journey by
Results: Four operational barriers that prevented the effective trans- identifying characteristics of healthy relationships, navigating relation-
lation of quality research findings into effective interventions were ship challenges, and aligning relationship goals with HIV prevention.
identified. (1) EDUCATION – a lack of a shared vision of the challenge The intervention is tailored by segment and focuses on the earlier
and goal limited stakeholder alignment (2) COORDINATION – a lack journey stages.
of collaboration and silo structures limited focus and prioritization (3) Conclusions: By acknowledging and aligning with AGYW relationship
ACTIVATION – a lack processes to develop interventions limited the goals and tailoring approaches to differences among AGYW across
opportunity to optimize solutions (4) UNDERSTANDING – a lack of segments and journey stages, we can increase the relevance of HIV
access to data and reliance on existing assumptions limited the ability prevention to high-risk AGYW and increase the likelihood of them
to identify target customers and avoid one-size-fits-all solutions. forming a healthy mindset and developing stable, healthy habits in
Conclusions: To address the operational challenges, we continued the relation to sexual health including effective HIV prevention.
process of HCD to develop an organizational tool to overcome each
barrier. Four Organizational Tools were developed to include (1) EDU-
CATION: Foundation Tool - designed to build empathy with 3 seg-
ments of AGYW and identify key behavioral barriers that need to be Epidemiology of HIV
overcome, (2) COORDINATION: Prioritization Tool - designed to find
programmatic gaps and opportunities for new interventions, (3) ACTI-
VATION: Intervention Design Tool - designed to generate new inter-
ventions for barriers identified, and 4) UNDERSTANDING: PE11.01
Classification Tool - designed to guide applications for accurately iden- Rates of undiagnosed HIV infection among racial/ethnic
tifying target segments. subgroups in a large nationwide cohort study of sexual
The tools were disseminated with stakeholders serving on the Advi- minority men in the U.S.: Evidence for reframing from
sory Board for the wider project. Two IPs are applying the tools to
disparities to inequities
support the development of a new intervention scheduled for pilot
H.J. Rendina1; A. Talan1; K.M. Sizemore1; N.F. Tavella1; B. Salfas1;
this year.
O. Shalhav1; B. Mustanski2 and C. Rodriguez-Dıaz3
1
Hunter College, CUNY, Psychology, United States, 2Northwestern
PE09.03 University, Evanston, United States, 3George Washington University,
Understanding HIV prevention from the perspective of United States
adolescent girls and young women at high risk of HIV
infection
S. Malone1; A. Gomez2; R. Prasad3; A. Gangaramany3; Y. Croucamp4; Background: Sexual minority men (SMM) are disproportionally
P. Kramer5; J. Mulhausen5 and P. Noble-Campbell5 affected by HIV in the U.S., particularly SMM of color. However, few
1 studies have had both adequate measures and sufficient sample size
AVAC, PMM, New York, South Africa, 2AVAC, PMM, New York, Uni-
to examine sociodemographic and behavioral subgroups among mem-
ted Kingdom, 3Final Mile, United States, 4Final Mile, Research, South
bers of the same race/ethnicity that may shed light on sociostructural
Africa, 5Upstream, United States
inequities driving such disparities.
Methods: We used a large and diverse nationwide cohort of SMM
Background: Despite a decline in recent years, adolescent girls and enrolled in an observational study in 2017. We analyzed rates of undi-
young women (AGYW) in South Africa still have disproportionately agnosed HIV infections from self-collected, lab-verified testing at the
115
Abstract PE11.01-Table 1. Subgroup unadjusted prevalence estimates for undiagnosed HIV infection at study entry (N = 8105)
Other
Overall Black Latino White Multiracial Identification
N = 8105 n = 906 n = 1606 n = 4159 n = 967 n = 467
Factors/test statistic n % n % n % n % n % n %
Age group G2 (3) = 2 76, p= 43 G2 (3) = 1777, p G2 (3) = 769, G2 (3) = 488, G2 (3) = 365,
<001 p = 05 p = 18 p = 30
16 to 24 27 13% 6 26% 3 06% 9 10% 7 23% 2 14%
25 to 34 60 19% 22 51% 16 24% 14 09% 4 09% 4 19%
35 to 49 50 26% 8 43% 17 49% 23 22% 2 10% 0 00%
50+ 17 19% 3 50% 2 28% 10 14% 2 56% 0 00%
Region G2 (3) = 10.92, G2 (3) = 1.51, G2 (3) = 4.77, G2 (3) = 4.64, G2 (3) = 6.36,
p = 01 p = 68 p = 19 p = 20 p = 10
Northeast 23 17% 10 63% 4 18% 5 07% 2 14% 2 26%
Midwest 22 15% 4 25% 2 13% 16 17% 0 00% 0 00%
South 66 23% 24 54% 13 25% 24 16% 5 18% 0 00%
West 41 18% 1 07% 17 26% 11 12% 8 20% 4 20%
Puerto Rico 2 32% – – – – – – – – – –
Military Overseas 0 00% – – – – – – – – – –
College degree G2 (1) = 2.76, G2 (1) = 1.20, G2 (1) = 0.43, G2 (1) = 3.93, G2 (1) = 1.28,
p = 10 p = 27 p = 51 p = 05 p = 26
No 107 23% 30 51% 28 27% 32 15% 13 21% 4 20%
Yes 47 14% 9 28% 10 18% 24 12% 2 06% 2 08%
Insurance status G2 (2) = 4.09, G2 (2) = 4.55, G2 (2) = 13.12, G2 (2) = 10.52, G2 (2) = 2.76,
p = 13 p = 10 p = 001 p = 01 p = 25
None 45 27% 9 37% 11 27% 20 28% 5 20% 0 00%
Private 69 13% 18 36% 16 17% 28 09% 3 05% 4 12%
Public 40 34% 12 75% 11 40% 8 16% 7 42% 2 29%
Sexual identity G2 (1) = 0.40, G2 (1) = 0.18, G2 (1) = 0.75, G2 (1) = 5.18, G2 (1) = 0.13,
p = 53 p = 68 p = 39 p = 02 p = 72
Gay 133 20% 32 47% 33 25% 49 14% 14 18% 5 13%
Queer 2 09% – – – – – – – – – –
Bisexual 19 15% 7 36% 5 20% 6 10% 0 00% 1 19%
Relationship status G2 (1) = 0.23, G2 (1) = 0.88, G2 (1) = 0.28, G2 (1) = 0.50, G2 (1) = 0.52,
p = 63 p = 35 p = 59 p = 48 p = 47
Single 115 2.0% 32 45% 30 26% 38 13% 10 14% 5 15%
Partnered 39 18% 7 37% 8 18% 18 15% 5 20% 1 07%
Most recent HIV test G2 (2) = 14.12, G2 (2) = 9.43, G2 (2) = 10.45, G2 (2) = 13.13, G2 (2) = 11.22,
p = 001 p = 009 p = 005 p = 001 p = 004
In last 6 mo 62 12% 17 29% 16 16% 25 10% 3 05% 1 03%
last 6 to 12 months 24 19% 5 35% 7 29% 11 15% 1 08% 0 00%
more than 1 yr ago 58 45% 15 112% 13 51% 19 27% 8 46% 3 83%
Never 10 21% – – – – – – – – – –
Major metropolitan area G2 (1) = 198, G2 (1) = 102, G2 (1) = 051, G2 (1) = 002, G2 (1) = 181,
p = 16 p = 31 p = 48 p = 90 p = 18
No 56 19% 7 28% 16 29% 23 15% 6 16% 4 22%
Yes 98 19% 32 49% 22 21% 33 12% 9 15% 2 07%
Sexual position G2 (2) = 351, G2 (2) = 217, G2 (2) = 700, G2 (2) = 207, G2 (2) = 151,
p = 17 p = 34 p = 03 p = 36 p = 47
Top 18 14% 5 23% 4 19% 8 12% 1 07% 0 00%
Versatile 98 18% 29 51% 24 21% 31 11% 10 15% 4 13%
Bottom 38 29% 5 41% 10 36% 17 25% 4 28% 2 18%
History of incarceration G2 (1) = 422, G2 (1) = 1286, G2 (1) = 677, G2 (1) = 007, G2 (1) = 075,
p = 04 p < 0001 p = 01 p = 79 p = 39
No 118 16% 29 37% 26 18% 44 12% 13 15% 6 14%
Yes 36 43% 10 81% 12 71% 12 29% 2 19% 0 00%
time of enrollment. Specifically, we used stratified contignency tables Black and Latino men both underscore that these apparent disparities
to examine sociodemographic and behavioral subgroups within each are driven by experiences with the medical and criminal justice sys-
race/ethnicity to calculate subgroup-specific rates of infection that tems among specific subgroups of Black and Latino SMM. Taken
have been largely missing from the literature. together, these findings highlight that disparities in HIV infection in
Results: We found significantly elevated rates of undiagnosed HIV the U.S. are inequities likely driven by structural and social injustices,
among participants who had tested more than one year ago across all including structural racism.
racial/ethnic groups, though the effect was particularly pronounced for
Black men. Additional findings showed no impact of insurance status PE11.02
among any racial/ethnic group except White SMM, suggesting a lack of
Switching from F/TDF to F/TAF for HIV pre-exposure
protective benefits for men of color, and an impact of incarceration for
Black, Latino, and White participants, but more pronounced among
prophylaxis: an analysis of the real-world data
Black and Latino participants. Full results are presented within the table L. Tao1; V. Shvachko2; R. Mera2; M. Das2; C. Carter2 and
below. D. Magnuson2
1
Conclusions: Though rates of HIV infection were higher for Black Gilead Sciences, Epidemiology, Foster City, United States, 2Gilead
and Latino SMM, they did not differ by behavioral characteristics Sciences, Foster City, United States
other than HIV testing frequency. The lack of difference in undiag-
nosed HIV by insurance status for any group except White partici-
Background: F/TAF (emtricitabine/tenofovir alafenamide fumarate)
pants and the substantially higher impact of incarceration among
for HIV pre-exposure prophylaxis (PrEP) demonstrated non-inferior
116
efficacy compared to F/TDF (emtricitabine/tenofovir disoproxil fuma- lived in an urban area, to have been married or cohabitated, and to have
rate) with less impact on renal function and bone mineral density. It engaged in riskier sexual behavior compared with AGYW in age-concor-
was approved for PrEP in the United States (US) on October 3, 2019. dant sex partnerships. The prevalence of HIV was 6.1% among AGYW
This study assessed the number of people taking F/TAF or F/TDF for with a partner ≥ 5 years older and 11.9% in AGYW with a part-
PrEP in 2019 and the factors associated with switching from F/TDF ner ≥ 10 years older, compared with 3.2% in age-concordant sex part-
to F/TAF. nerships (p < 0.001). Adjusting for age, marital status, and risky
Methods: We identified 28,977 HIV-1 negative individuals who initi- behavior, AGYW in age-disparate sex partnerships did not have signifi-
ated F/TAF and 76,361 who initiated F/TDF for PrEP between January cantly greater odds of being HIV positive compared with AGYW in age-
1, 2019 and December 31, 2019 from a de-identified prescription concordant sex partnerships. Among AGYW who endorsed inequitable
claims database in the US. We used Cox regressions adjusting for multi- gender norms, those with a partner ≥ 5 years older had 3.7 (95% CI:
ple demographic and clinical characteristics to estimate the switching 1.1 to 12.8) greater odds of being HIV positive compared with AGYW in
rate from F/TDF to F/TAF. age-concordant sex partnerships; however, AGYW with a part-
Results: At initiation the 28,977 F/TAF for PrEP users had a median ner ≥ 10 years older were no more likely to be HIV positive.
age of 37 years of age (interquartile range 2949), 97% were males, Conclusions: Age-disparate sex partnerships are associated with HIV
and 81% had used F/TDF previously. The number of F/TAF users infection among AGYW in Malawi. These findings highlight inequitable
increased substantially after October 2019, mostly among males who gender norms as a potential driver of infection. Prevention services
previously took F/TDF. Multivariate analysis showed that among all should tackle structural and socio-cultural constraints faced by AGYW
76,361 individuals who initiated F/TDF for PrEP use in 2019, older in age-disparate partnerships.
age, male sex, and Hispanic ethnicity were associated with higher
rates of switching to F/TAF for PrEP. Similarly, we found higher rates PE11.04
of switching to F/TAF if the F/TDF for PrEP was prescribed by inter-
Time for change: fluctuations in sexual behavior and
nal medicine (IM), infectious disease (ID) physicians or nurse practi-
tioners (NP) compared with family medicine (FM) physicians, and
determinants associated with behavior change in men who
among individuals utilizing mail-order prescription services compared have sex with men
with retail pharmacies. Finally, history of sexually transmitted infec- D. van Wees1; M. Basten1; A. Matser2; A. Boyd3; G. Rozhnova1;
tions was associated with switching from F/TDF to F/TAF, while his- C. den Daas4; M. Kretzschmar1 and J. Heijne4
1
tory of bone fracture or renal dysfunction were not. University Medical Center Utrecht, Julius Center for Health Sciences
Conclusions: In 2019, ~29,000 individuals took F/TAF for PrEP. Char- and Primary Care, Netherlands, 2Public Health Service of Amsterdam,
acteristics most strongly associated with switching to F/TAF were pre- Department of Infectious Diseases, Research and Prevention, Amster-
scriber specialty (IM, ID or NP vs. FM), older age, use of mail-order dam, Netherlands, 3Stichting HIV Monitoring, Netherlands, 4National
pharmacy, geographic region (South vs. Northeast), and Hispanic eth- Institute for Public Health and the Environment, Center for Infectious
nicity. We observed no associations with bone fracture and renal dys- Diseases Control, Netherlands
function. This real-world data analysis demonstrates how prescription
claims data can be utilized to evaluate PrEP use as new medications
become available, and to track trends among PrEP users and Background: Sexual behavior is variable during an individuals’ lifetime,
providers. and appropriate timing of interventions might be vital to reduce HIV
transmission among men who have sex with men (MSM). We aimed to
investigate how sexual behavior fluctuates over time among MSM,
PE11.03 and identify determinants associated with behavior change.
Age-disparate sex partnerships and HIV infection among Methods: We used data from a longitudinal cohort study of HIV-
adolescent girls and young women in Malawi negative MSM (Amsterdam Cohort Studies). During biannual visits
D. Reed1; E. Radin1; A. Jahn2; G. Bello2; T. Kalua3 and J. Justman4 between 2008 and 2017, participants completed questionnaires about
1
Columbia University, Mailman School of Public Health, Department their sexual behavior. Based on latent classes of behavior, MSM were
of Epidemiology, New York, United States, 2Ministry of Health, Inter- assigned to different risk levels associated with HIV acquisition. We
national Training and Education Center for Health, Lilongwe, Malawi, modelled transitions between risk levels, and identified determinants
3
Ministry of Health, Department of HIV and AIDS, Lilongwe, Malawi, measured at the previous visit associated with these transitions using
4
ICAP at Columbia University, New York, United States multi-state Markov models.
Results: We classified three risk levels of acquiring HIV (N = 767, n
visits = 7865): low (73% of visits), medium (22%), and high risk (5%).
Background: Age-disparate sex partnerships are a hypothesized dri- Transition probabilities between six-month visits showed that MSM
ver of HIV infection in adolescent girls and young women (AGYW) were more likely to remain at the same risk level if their risk was low
due to the increased HIV prevalence in older men and riskier sexual (89%) compared to medium (59%) or high risk (57%). Between visits,
behavior within these partnerships. These relationships are associated increase in risk level was observed in 11% of MSM at low risk and 8%
with a greater risk of gender inequities resulting in power imbalances at medium risk, whereas decrease in risk level was observed in 33% at
that make it difficult for women to assert agency over their health. medium risk and 43% at medium risk. Transition towards increasing risk
We assessed whether age-disparate sex partnerships were associated was associated with reporting chemsex, sexual performance enhance-
with HIV infection in Malawi and if this association was modified by ment drugs, increased HIV risk perception, anal sexually transmitted
endorsement of inequitable gender norms. infection (STI) or syphilis in the past six months, and non-anal STI in the
Methods: We analyzed data from the 2015 to 2016 Malawi Population- past six months.
based HIV Impact Assessment (MPHIA) Project, a nationally represen- Conclusions: Although the majority of MSM showed no behavior
tative, household survey. We used logistic regression models with change, a considerable proportion of MSM increased HIV risk within
cross-multiplicate interaction terms to assess the association of six-month intervals. Determinants associated with behavior change
interest and the effect of our proposed modifier. may identify MSM who are likely to increase HIV risk within a short
Results: The analysis included a total of 1958 AGYW, 459 of whom period of time, suggesting that interventions could be targeted
were in age-disparate sex partnerships with a male ≥ 5 years older and towards these individuals to prevent HIV transmission.
131 who were in partnerships with a male ≥ 10 years older. AGYW in
age-disparate sex partnerships were slightly older, more likely to have
117
acquisition, to identify those at greatest risk, and to reduce disease

PE11.05 burden.
Gaps in racial and ethnic diversity in phase III HIV clinical trials Methods: A systematic review of factors predictive of HIV serocon-
F. Dickson1 and J. Anderson2 version in heterosexual adolescent girls and young women, living in
1
Florida A&M University, College of Pharmacy and Pharmacuetical sub-Saharan Africa was conducted using 10 major databases: MED-
Sciences, Davie, United States, 2Gilead Sciences, HIV Prevention Med- LINE, EMBASE, PubMed, EBSCO Host-CINAHL, PsycINFO, OVID,
ical Affairs, Foster City, United States POPLINE, Web of Science, SCOPUS and the Cochrane Central Regis-
ter of Controlled Trials. Search terms included: “Women, Female, HIV
Seroconversion, HIV Acquisition, HIV Transmission, Risk prediction,
Background: HIV disproportionately affects Black and Latinx popula- ROC curve, AUC, sensitivity and specificity. Search parameters were
tions, which together accounted for ~68% of HIV diagnoses in 2017. limited to English peer-reviewed journals from 1 January 2008 to 1
However, racial and ethnic minorities continue to be underrepre- May 2020. Inclusion criteria: randomized controlled trials, HIV predic-
sented in HIV clinical trials. We aimed to assess the disparity between tors assessment, and HIV sero-conversion outcome.
racial/ethnic minority representation in clinical trials and the racial/ Results: The search returned 3733 non-duplicate citations; after
ethnic distribution of HIV and AIDS diagnoses. inclusion and exclusion criteria were applied, 103 articles were
Methods: Study design: Retrospective review and Cross-Sectional retained, and a narrative synthesis was conducted. Most studies
Survey. Methods: Racial distribution data of HIV incidence from 1993 (n = 100) measured variables associated with HIV seroconversion.
to 2017 was collected from CDC surveillance data. We also con- Only 3 studies included an assessment of predictability of the derived
ducted a retrospective review of phase 3 clinical trials of HIV drugs risk score and hazard ratios were calculated. Not cohabitating with a
approved from 1987 to 2019 to assess the racial and ethnic distribu- regular sex partner was predictive of incident infection in 3 studies
tion of trial participants. A survey of pharmaceutical companies (aHRs = 1.82 to 3.62, 95% CIs = [1.18, 2.80]-[2.49, 5.25]). Age <
involved in HIV clinical research to evaluate current efforts to 25 years was predictive in 2 studies (aHRs = 1.66 to 2.93, 95%
increase racial diversity in clinical trials was also done. Data collected CI = [1.22,2.24]-[2.17,3.96]). Other predictive variables included in
were analyzed using descriptive statistics. Means and standard devia- risk scores were: baseline genital epithelial disruption (aHR = 3.35,
tion were calculated to compare the racial distribution in HIV,AIDS 95% CI = [1.45,7.77], parity = 0 to 1 (aHR = 2.62, 95% CI =
and the clinical trials. [1.82,3.77], high risk behavior (aHR = 1.96, 95% CI = [1.02,2.67], >3
Results: A total of 62 clinical trials met the inclusion criteria. The lifetime male partners (aHR = 1.93, 95% CI = [1.10,3.51], partners
mean racial distribution in HIV clinical trials from 1987 to 2019 was having other sex partners (aHRs = 1.65 to 1.82, 95% CI = [1.04,2.61]-
64% white, 21% Black and 19% Hispanic. The mean racial distribution [1.29,2.56]), HSV-2 status (aHR = 1.65, 95% CI = [1.28,2.14], >3 sex
of HIV incidence from 1993 to 2017 was 35% white, 45.5% Black partners in past 3 months (aHR = 1.61, 95% CI = [1.25,2.07], dis-
and 14.9% Hispanic. Black and Hispanic populations constituted a charge (aHR = 1.60, 95% CI = [1.02,2.53], curable (diagnosed) STI
higher percentage of HIV diagnoses than white individuals each year (aHR = 1.47 (1.57), 95% CI = [1.13,1.91]([1.29,1.92])), injectable con-
from 1993 to 2017. The mean racial distribution of AIDS diagnoses traceptive use (aHR = 1.43,95% CI = [1.20,1.71], any alcohol use in
from 1987 to 2017 was 43% White, 33.2% Black and 17% Hispanic. the past 3 months (aHR = 1.41, 95% CI = [1.07,1.86], <age 16 at sex-
Conclusions: Significant disparities between racial representation in ual debut (aHR = 1.38, 95% CI = [1.02,1.86]), and partner providing
HIV clinical trials and racial distribution of HIV and AIDS diagnoses financial support (aHR = 1.37, 95% CI = [1.03, 1.82].
were observed and largely driven by underrepresentation of Black Conclusions: HIV prevention research studies targeting higher risk
populations in clinical trials despite Black individuals constituting the women in sub-Saharan Africa should focus on younger women non-
largest proportion of reported HIV and AIDS diagnoses since 1993 cohabiting with a regular sex partner, with STIs or other genital tract
and 1996 respectively. The proportion of Latinx HIV and AIDS diag- abnormalities, and other reported predictive variables. Standardization
noses continues to rise each year, further widening the minority rep- of risk assessment will allow for improved interpretation of prevention
resentation gap in HIV clinical trials. More intentional efforts are intervention results.
needed from researchers, including pharmaceutical companies, to
bridge the representation gap.
PE11.07
HIV testing access outside a trial centre among vaccine
PE11.06 recipients despite counselling on possible vaccine induced
Variables predictive of HIV seroconversion among sub- sero positivity (VISP): experience from a research centre in
Saharan African heterosexual women: a systematic review western Uganda
M. Andrasik1; L. Oseso1; S. Wallace1; J. Dietrich2; H. Van Tieu3; D.J. Asio1,2; F. Mukasa Kibengo1,2; K.V. Chinyenze3; S. Ding4; M. Price5
M. Atujuna4; S. Buchbinder5; K.H. Mayer6 and Z. Moodie7 and P. Kaleebu1,2
1
Fred Hutch, Vaccine and Infectious Disease Division, Seattle, United 1
Medical Research Council/Uganda Virus Research Institute London
States, 2Perinatal HIV Research Unit Chris Hani Baragwanath Hospi- School of Hygiene and Tropical Medicine, HIV Intervention, Entebbe,
tal, Soweto, South Africa, 3New York Blood Center, Laboratory of Uganda, 2London School of Hygiene and Tropical Medicine, London, Uni-
Infectious Disease Prevention, New York, United States, 4Desmond ted Kingdom, 3International AIDS Vaccine Initiative (IAVI), HIV Interven-
Tutu Health Foundation, Social Behavioural Science Division, Cape tion, Nairobi, Kenya, 4Eurovacc Foundation, HIV Intervention,
Town, South Africa, 5San Francisco Department of Public Health, Amsterdam, Netherlands, 5University of California at San Francisco,
Bridge HIV, Population Health Division, San Francisco, United States, Department of Epidemiology and Biostatistics, San Francisco, United
6
The Fenway Institute, Boston, United States, 7Fred Hutch, Vaccine States
and Infectious Disease Division/ublic Health Sciences Division, Seattle,
United States
Background: VISP has potential to cause anxiety in the event it
occurs. Despite counselling volunteers to receive HIV Counselling and
Background: Sub-Saharan African adolescent girls and young women Testing (HCT) at trial sites, they may seek HCT elsewhere. We inves-
are at particularly high risk of HIV acquisition. It is important to tigated occurrence of and reasons for volunteers receiving HCT out-
understand the characteristics associated with or predictive of HIV side trial site.
118
Methods: Between November 2014 and April 2015, under the collab- (aOR: 0.45, 95% CI: 0.34, 0.59) and Zambia (aOR: 0.632, 95% CI:
oration between FP7 IDEA program, MRC/UVRI & LSHTM and IAVI, a 0.46, 0.860). However, men who were circumcised had a greater num-
phase 1 double blind placebo-controlled trial was conducted to evaluate ber of lifetime sexual partners. Multivariate analysis showed an associ-
the safety & immunogenicity of a combination of DNA-HIV-PT123 & ation between MC status and testing for HIV in Eswatini (aOR: 4.26,
AIDSVAXB/E vaccines in HIV-1-uninfected adults with/without underly- 95% CI: 3.31, 5.48) and Zambia (aOR: 2.03 95% CI: 1.70, 2.41). In
ing S.mansoni infection in S.Western Uganda. Volunteers received vacci- Zambia, circumcision was also associated with increased odds of visit-
nation at 01 and 6 months with 12 scheduled visits. At each visit, ing a healthcare facility in the last 12 months.
volunteers were counseled on the need to have HCT performed only at Conclusions: After adjusting for age, prevalence of VMMC was most
the trial site during the trial period for concern over VISP. HCT was pro- common among young men and in this group it is associated with
vided at months 0, 1,6&9. At screening, HCT was done following lower HIV prevalence. While there was evidence that VMMC is asso-
Uganda HCT guidelines. Post-vaccination, ELISA VIRONOSTIKA Ag/Ab ciated with uptake of HIV testing, there also seem to be risk compen-
was used and if reactive, repeat ELISA VIRONOSTIKA Ag/Ab was done sation. Integrating HIV counseling and sexual education to VMMC
in duplicate and if one/both were reactive, HIV RNA PCR was done. programs is vital to reduce HIV infection and increase awareness of
Reasons for seeking HCT outside trial site were collected using a stan- MC limitations to prevent risky sexual behavior.
dardized questionnaire at unblinding. Data were entered into excel and
analyzed using Stata version 12.0 and descriptive statistics. PE11.10
Results: 42 (mean age 29 years) were enrolled, of these 35 received
Using nationally representative surveillance data to
active vaccine, of which 22 had VISP on ELISA. 10 (26%) sought HCT
outside the site (age range 18 to 27 years), of which 4 had VISP
understand the relationship between HIV incidence,
although the test outside was negative using Uganda HIV testing algo- prevalence, and prevention interventions in high HIV
rithm. Reasons for testing outside were: perceived risk of exposure to prevalence settings
HIV (n = 6), curiosity about VISP (n = 3) and febrile illness (n = 1). B. Wamuti1; M. Mahy2 and K. Ortblad1
1
Conclusions: A high proportion of volunteers tested outside the trial University of Washington, Global Health, Seattle, United States,
2
centre, although there was no reported HIV seropositive result from UNAIDS, Strategic Information, Switzerland
outside centres. The findings highlight the challenges faced by investiga-
tors when conducting HIV vaccine trials with potential to cause VISP.
Background: Recent randomized trials suggest that high levels of
population ART coverage and viral load suppression (VLS) might not
PE11.09 result in large population reductions in HIV incidence. An exploration
Sexual behavior associated with circumcision status among of nationally representative survey data in high HIV prevalence set-
males aged 15 to 49 in Zambia and Eswatini: evidence of tings might offer insights into the relationship between national HIV
risk compensation? incidence, prevalence, coverage of prevention interventions, and risk
A. Chansakul; A. Low and T. Carpino of HIV transmission.
Columbia University, ICAP at Columbia University, New York, United Methods: For this analysis, we utilized seven population-based HIV
States impact assessment (PHIA) surveys from 2015 to 2018. We conducted
a descriptive, gender-stratified analysis of data from Eswatini, Lesotho,
Kenya, South Africa, Uganda, Zambia and Zimbabwe. We assessed the
Background: Voluntary medical male circumcision (VMMC) has been coverage of HIV interventions intended to prevent HIV acquisition
recommended by the WHO as an HIV prevention strategy in coun- (e.g., condom use and voluntary medical male circumcision [VMMC])
tries with high prevalence such as Eswatini and Zambia. Recent stud- and the risk of HIV transmission (e.g., using VLS among people living
ies suggest upscaling VMMC increases testing and condom use, while with HIV [PLWH] of the opposite sex).
some studies show concern of risk compensation following circumci- Results: National HIV incidence was high in all countries and consis-
sion. This study aims to understand the effects of VMMC on sexual tently higher among females (range: 0.2 - 1.4%) versus males (range:
behavior and utilization of healthcare services. 0.1 - 1.0%), Figure 1. Higher HIV incidence was associated with higher
Methods: This study utilized the Swaziland HIV Incidence Measure- condom use, with the exception of Zambia. Most countries had low
ment Survey 2 (SHIMS2) 2016–2017 and Zambia 2016 Population- VMMC coverage (range: 12 - 36%), with the exception of Kenya
based HIV Impact Assessment (ZAMPHIA) 2016–2017. We studied where VMMC coverage was 55%. There was not much heterogeneity
males aged 15 to 49 in 10-year age bands and used multiple logistic in the risk of HIV transmission across countries (VLS among females,
models to assess the relationships between VMMC, HIV status, sexual range: 60 - 75%; VLS among males, range: 54 - 68%). However, coun-
behavior (condom use, number of sexual partners) and HIV testing. tries with higher HIV incidence tended to have higher VLS among
Co-variates including age, education, urbanicity, wealth quintile and PLWH of the opposite sex, with Kenya again being an exception. Limi-
marital status were incorporated into each model. tations of this analysis include the cross-sectional nature of the survey
Results: This study included 3929 and 8472 men aged 15 to 49 from data.
Eswatini and Zambia, respectively, with an overall MC prevalence of Conclusions: National HIV incidence remains high in a number of
30.49% (95% CI: 28.34, 32.64) and 28.76% (95% CI: 27.17, 30.35), sub-Saharan African countries, thus room remains for the expansion of
respectively. Those aged 15 to 24 had the highest MC prevalence in HIV prevention interventions, including condom use, VMMC, and ART.
both countries. 19.93% (720) of men were HIV positive in Eswatini Developing and testing novel models for the delivery of these inter-
and 8.56% (624) were HIV positive in Zambia. Weighted analyses ventions may help increase uptake and decrease national HIV acquisi-
showed that circumcised men had lower HIV prevalence in Eswatini tion and transmission.
119
2019. A comprehensive HIV risk reduction package, including free

PE11.11 access to oral pre-exposure prophylaxis was provided. Vaccinations
High HIV incidence among women in the HVTN 702 were halted in February 2020 and participants unblinded after non-
vaccine trial with limited ability to elucidate drivers of HIV efficacy criteria were met (HIV HR = 1.04, p = 0.78). Baseline demo-
risk graphics, sexually transmitted infections (STIs), and self-reported risk
H. Janes1; C. Innes2; D. Kalonji3; D. Grove4; F. Laher5; J. Jin Kee4; behaviors (over 30 days prior to screening) were evaluated for associ-
L.-G. Bekker6; M. Allen7; M. Andrasik4; M. Atujuna6; M. Malahleha8; ations with HIV acquisition over 24 months follow-up using Cox pro-
N. Grunenberg4; N. Singh3; N. Naicker9 and P. Kotze 10 portional hazards regression. A baseline HIV risk score was derived
1
Fred Hutchinson Cancer Research Center, Vaccine and Infectious using Cox regression with Lasso penalty, and the C-index was used for
Disease Division, Seattle, United States, 2The Aurum Institute, South evaluation.
Africa, 3South Africa Medical Research Council, South Africa, 4Fred Results: Most female-at-birth participants were black (99.2%), young
Hutchinson Cancer Research Center, Seattle, United States, 5Perinatal (median age, 24 years), and married/had main partner (88.6%). Com-
HIV Research Unit, Johannesburg, South Africa, 6Desmond Tutu HIV mon risk behaviors were inconsistent condom use (94.4%), not living
Centre, Cape Town, South Africa, 7United States National Institutes of with main partner (74.5%), and main partner possibly or definitely
Health, Bethesda, United States, 8Shetsaba Research Centre, South having other partners (71.0%). High HIV incidence was observed
Africa, 9Centre for the AIDS Programme of Research in South Africa, (4.3% annually). Young age was weakly associated with increased risk
Durban, South Africa, 10Qhakaza Mbokodo Research Clinic, South (HR = 1.24 for age ≤ 25, 95% CI: 0.94 to 1.63), as was main partner
Africa possibly or definitely having other partners (HR = 1.43, 95% CI:0.98
to 2.10) and unprotected sex with alcohol use (HR = 1.17, 95%
CI:0.91 to 1.51). Geographic region (HR = 1.91 for Kwa-Zulu Natal vs.
Background: HIV remains a public health crisis in South Africa, with Central South Africa, 95% CI: 1.44 to 2.53; HR = 1.44 for Western/
young women disproportionately affected. The HIV vaccine efficacy Eastern Cape, 95% CI:0.99 to 2.08), a prevalent lab-confirmed STI at
trial HVTN 702 provides an opportunity to characterize risk factors baseline (HR = 1.56, 95% CI:1.18 to 2.05), and sex with an HIV-
for HIV acquisition. positive partner (HR = 1.53, 95% CI:1.18 to 1.97) were stronger
Methods: This randomized, placebo-controlled, double-blind trial predictors. Factors not associated with increased risk included incon-
enrolled 5404 HIV-uninfected high-risk South African adults including sistent condom use (HR = 0.76, 95% CI: 0.47 to 1.21) and not being
3786 females-at-birth (1:1 vaccine:placebo) October 2016 – June married/having a main partner (HR = 0.71, 95% CI: 0.36 to 1.38). A
120
multivariate risk score was modestly associated with HIV (HR = 1.6
per standard deviation, 95% CI:1.4 to 1.8); however predictive capac- PE11.13
ity in independent test data was low (cross-validated C-index = 0.60). Transmission clusters play an important role in the
Conclusions: Women in South Africa remain at considerable risk of epidemiology of HIV-1 infections in Northern Spain (2013
HIV. Clear, consistent drivers of HIV risk and strategies to mitigate to 2018)
their effects remain to be elucidated. H. Gil; E. Delgado; S. Benito; M. Sanchez; J.E. Can ~ada;
E. Garcıa-Bodas; M. M Thomson and I Spanish Group for the Study of
PE11.12 New HIV Diagnoses
Origin, diversity, and spread of HIV-1 infection in Kenya Instituto de Salud Carlos III, HIV Biology and Variability Unit, Madrid, Spain
G. Nduva1; A. Hassan2; F. Otieno3; E. Wahome2; J. Kimani4;
L. R McKinnon5; M. Majiwa6; G. Mutua4; M. Masika4; O. Anzala4;
Background: HIV-1 sequences from individuals whose transmission is
V. Mudhune6; S. Graham7; L. Gelmon4; M. Price8 and A. Smith9
related group phylogenetically in transmission clusters (TC). Phyloge-
1
Lund University, Translational Medicine, Sweden, 2Kenya Medical netic studies of these viruses, combined with associated clinical and
Research Institute-Wellcome Trust Research Programme, Nairobi, epidemiological factors, are essential to analyze the HIV-1 epidemic.
Kenya, 3Nyanza Reproductive Health Society, Kenya, 4University of In this study, we analyze the role of TCs in the epidemiology of HIV-1
Nairobi, Kenya, 5University of Manitoba, Canada, 6Kenya Medical infection in Galicia and the Basque County, two regions of Northern
Research Institute - Centre for Diseases and Control, Nairobi, Kenya, Spain, during 2013 to 2018.
7
University of Washington, Seattle, United States, 8United States, Methods: Partial HIV-1 pol sequences from 1158 newly HIV-1-
9
University of Oxford, United Kingdom diagnosed patients (ND) from Galicia and the Basque Country during
2013 to 2018 were analyzed. To assign and determine the TCs size,
we performed phylogenetic analysis by approximately maximum likeli-
Background: High-risk groups including men who have sex with men
hood with FastTree 2, including 10,920 additional sequences from
(MSM), female sex workers (FSW) and injecting drug users (IDU) are
Spain analyzed in our laboratory (1999 to 2019). TCs were defined as
presumed to be the major source of HIV-1 transmission to the gen-
those comprising viruses from ≥ 4 individuals, with more than 50% of
eral heterosexual (HET) population in Kenya but evidence on spread
them Spaniards and with a node support ≥ 0.95 in the phylogenetic
and transmission dynamics is limited. We aimed to delineate the ori-
tree. Factors associated to TCs were evaluated using odds ratio (OR)
gin, diversity, spread, and transmission dynamics of HIV-1 infection
and its 95% confidence interval (CI).
within and between risk groups and geographic locations in Kenya.
Results: 51% of ND grouped in 162 TCs. Male patients (OR: 2.6;
Methods: Partial HIV-1 pol (1020 bp) sequences (N = 4058, includ-
95% CI: 1.5 to 4.7) and men having sex with men (MSM) (OR: 2.1;
ing newly generated [n = 755] and published [n = 3303] sequences)
95% CI: 1.4 to 3.2) had higher odds of belonging to a TC compared
sampled between 1986 and 2019 were analysed by maximum-likeli-
to female or heterosexual patients. Individuals from Latin America
hood and Bayesian phylogenetics.
(OR: 0.3; 95% CI: 0.2 to 0.4), North Africa (OR: 0.4; 95% CI: 0.2-1-0)
Results: Overall, sequences were from HET (79%), MSM (9%), FSW
and especially Sub-Saharan Africa (OR: 0.02; 95% CI: 0.003 to 0.2)
(6%), infants (4%) and IDU (1%) populations. HIV-1 sub-subtype A1
were inversely associated to belonging to TCs compared to Spaniards.
(60%), recombinants (14%), subtype D (11%), and subtype C (7%)
Differences regarding the genetic forms distribution, related to their
were circulating in Kenya with no evidence of increasing or decreasing
differential circulation in TCs in Galicia and the Basque Country were
trends over time. In total, 409 phylogenetic clusters (involving
observed.
n = 1832, 45% of Kenyan sequences) were identified. Majority of the
Conclusions: TCs play an important role in the spread of HIV-1 infec-
clusters were risk-group exclusive (HET [72%], MSM [9%], FSW [2%]
tion in the two Spanish regions studied. Transmission between MSM is
and IDU [<1%]). The remaining 16% were mixed clusters comprising
predominant in TCs. The majority of foreign patients are infected by
perinatal transmission (5%), MSM/HET (4%), FSW/HET (4%), MSM/
viruses not associated with TCs that expand in Spain. Molecular epi-
FSW/HET (2%), MSM/FSW (1%), MSM/IDU/FSW/HET (<1%), and
demiology is essential to identify local peculiarities of HIV-1 infection.
IDU/HET (<1%). The majority of IDU sequences (80%) clustered sepa-
The early detection of TCs and prevention of their dissemination,
rately from other groups, indicating an independent sub-epidemic in
implementing effective control measures, could reduce HIV-1 infec-
Kenya. Phylodynamic analyses revealed multiple local introductions of
tions by decreasing its expansion in TCs.
HIV-1 in Kenya. HIV-1 sub-subtype A1 was introduced in 1978 (95%
higher posterior density [HPD] interval: 1971 to 1990) for HET, 1987
(1985 to 1990) for IDU, and 1991 (1974 to 2004) for MSM. HIV-1 PE11.14
subtype C was introduced in 1977 (1968 to 1985) for HET. Phylogeo- Relationship between lifetime and recent experiences of
graphic analyses provided strong support (Bayes Factor (BF) > 100) violence on HIV-related health-seeking behavior among
for West-to-East virus dissemination, specifically from high HIV-1 women in Malawi and Zambia as captured in the
prevalence regions (former Nyanza province) to comparatively lower Population-based HIV Impact Assessment (PHIA) Surveys
HIV-1 prevalence regions (i.e. former Rift Valley, Nairobi, and Coast
S. Inoue; T. Carpino and A. Low
provinces). HIV-1 transmission from HET to MSM (BF > 100), HET to
Columbia University, ICAP at Columbia University, New York, United
IDU (BF > 100), and HET to FSW (BF > 100) was most common.
States
Conclusions: We did not find any support for high-risk groups in
Kenya being the net source of HIV-1 transmission to the HET popula-
tion. Overall, our findings may have implications for future HIV-1 pre- Background: Experiences of physical and sexual violence among
vention programs in Kenya. women impact HIV-related health outcomes, notably HIV acquisition.
This study looked at the relationship between experiences of violence
among women and HIV-related health seeking behavior such as
healthcare facility utilization and HIV testing.
Methods: Cross-sectional, household-based survey data from the
Population-based HIV Impact Assessment (PHIA) datasets that were
conducted in Zambia from 2016 to 2017 (ZAMPHIA) and Malawi
from 2015 to 2016 (MPHIA) were utilized for this analysis. In each
121
household, one woman aged 15 to 59 in Zambia and 15 to 64 in transmission route for CRF01_AE. In total, 30 TCs containing ≧3
Malawi were selected to complete the module on violence in the strains and 48 pairs were identified. 243 (40%) patients belonged to a
PHIA survey. A total of 8207 women from Zambia and 8640 women TC or pair. MSM were more likely to belong to a TC compared to
in Malawi were included in this study. Logistic regression analyses heterosexuals. Among TCs, MSM clusters were the most frequent,
were conducted with violence as a predictor and health-seeking while pairs were mainly composed of heterosexuals. The tMRCA esti-
behavior variables as outcomes, adjusting for age, education, wealth mations suggested that the number of MSM cluster increased
quintile, and urbanicity, along with number of pregnancies and HIV recently.
status when applicable. Conclusions: The phylodynamic analysis revealed complexity of the
Results: In both countries, women who had experienced physical vio- transmission dynamics of CRF01_AE in Japan. Male to male sexual
lence were at increased odds of being HIV+ with an adjusted OR of contact has become the major transmission route and began to play a
1.41 [95% CI: 1.19, 1.66] in Malawi and 1.45 [1.20, 1.77] in Zambia. vital role in the spread of CRF01_AE in 2010s. At the same time,
Women who had experienced sexual violence also had increased odds transmissions are still spreading among heterosexuals and IVDUs. To
of being HIV+ in Zambia (aOR = 1.72 [1.37, 2.16]) and in Malawi prevent the spread of CRF01_AE, various backgrounds of patients
(1.29 [1.05, 1.59]). The odds of visiting a healthcare facility in the last should be considered.
12 months for those who had experienced lifetime and recent vio-
lence were significantly greater in Zambia (lifetime: 1.53[1.34, 1.73]; PE11.16
recent: 1.45[1.16, 1.80]) and in Malawi (lifetime: 1.30[1.16, 1.45];
It’s time to broaden combination prevention access in
recent: 1.40 [1.15, 1.70]). Despite increased odds of visiting a health-
care facility, women who had experienced lifetime and recent violence
Brazil: Outcomes of a community-based approach among
did not have significantly greater odds of being offered an HIV test key populations
when at the healthcare facility or testing for HIV in the last D.A. Calixto; C. Sousa; N. Correia; G. da Silva and G. Pereira
12 months. Ministry of Health of Brazil, Department of Diseases of Chronic Con-
Conclusions: Experiences of physical and sexual violence are associ- ditions and Sexually Transmitted Infections, Brasılia, Brazil
ated with increased odds of HIV prevalence among women in Malawi
and Zambia, supporting previous literature. Data from this study
shows that women who have experienced violence are at increased Background: In Brazil, part of the national HIV prevention program
odds of visiting a healthcare facility but are not more likely to be for key populations (KPs) is implemented through targeted interven-
offered an HIV test or be tested for HIV. tions (TIs) run by non-governmental organizations (NGOs). Brazilian
government, in close collaboration with NGOs, deliverers HIV testing
in the context of a combination prevention strategy designed to KPs
PE11.15 called Project “Live Better Knowing” (LBK). Our aim is to present the
The changing transmission dynamics of HIV-1 CRF01_AE in profile and proportion of positive HIV rapid tests of tested KPs within
Japan: increased presence of men who have sex with men the scope of LBK.
(MSM) Methods: We use secondary data collected through the Monitoring
M. Otani-Inoue1; T. Shiino2; M. Kondo3; A. Hachiya4; M. Nishizawa1; and Evaluation System Registration Form (SIMAV-Pro) from Septem-
T. Kikuchi1 and T. Matano1 ber 1st, 2018 to September 31st, 2019. 45 Brazilian NGOs adminis-
1
National Institute of Infectious Diseases, AIDS Research Center, tered the form and offered rapid oral fluid HIV tests (DPP HIV-1/2
Tokio, Japan, 2National Institute of Infectious Diseases, Tokio, Japan, Bio-Manguinhos/Fiocruz) and combination prevention packages to sex
3
Kanagawa Prefectural Institute of Public Health, Division of Microbi- workers, men who have sex with men (MSM), trans people, people
ology, Japan, 4National Hospital Organization Nagoya Medical Center, who use drugs and persons deprived of liberty. HIV testing was
Clinical Research Center, Japan offered in public places where these key populations commonly meet.
Results: Among the 39,996 people who attended the project, 65.1%
were nonwhite, 36% reported drug use, 21% practiced commercial
Background: Among HIV-1 patients in Japan, CRF01_AE is the sec- sex, 8% were homeless, and 2.5% were deprived of liberty. Overall,
ond major subtype, which has different epidemiological characteristics 50% reported condom use during the last sexual intercourse and 47%
from subtype B being dominant in Japan. The previous research using had never been tested for HIV. The general HIV prevalence found
the cases detected in 2003 to 2009 showed that IVDUs and non- was 1.2% and its distribution among populations was: 20% cis women,
Japanese patients played important roles in CRF01_AE transmission, 6% transvestites, 6% trans women, 1% trans men, 46% MSM and
while MSM patients played a limited role. However, in recent years, it 20% heterosexual men.
is pointed out that this trend has been changing. To elucidate the cur- Conclusions: LBK project is important in order to contribute with the
rent transmission trend of CRF01_AE in Japan, we conducted a phylo- reduction of new HIV infections in KPs and to broaden their access to
dynamic analysis of patients newly diagnosed with HIV-1 CRF01_AE combination prevention. Our analysis suggests the need of implement-
from 2003 to 2016. ing the project as a health public policy.
Methods: We analyzed sequences of the protease and reverse-tran-
scriptase coding regions from registered patients in Japanese Drug PE11.17
Resistance HIV-1 Surveillance Network. After subtyping, phylogenetic
Factors related to STI and HIV prevalence among house
analysis using Distance-matrix method, Maximum Likelihood estima-
tion, and Bayesian Coalescent Markov Chain Monte Carlo (MCMC)
and ball youth in two US cities
inferences was performed. Transmission clusters (TCs) were identified B. Gwiazdowski1; M. Castillo1; S. Hosek2; C. Balthazar2; K. Davis2 and
based on topology consistency, value of posterior probability, genetic R. LaBoy3
1
diversity. The times of the most recent common ancestors (tMRCAs) Children’s Hospital of Philadelphia, The Adolescent Initiative, Philadel-
were estimated using the Bayesian MCMC approach. phia, United States, 2Stroger Hospital of Cook County, United States,
3
Results: There were 614 CRF01_AE patients. Of these, Japanese Children’s Hospital of Philadelphia, Philadelphia, United States
(65%) and male (72%), was dominant. Median age of the individuals
was 39. In terms of transmission route, heterosexual contact
accounted for 51%, followed by male to male contact (24%). In recent Background: Black young men who have sex with men (BYMSM) and
Black transgender youth are at high risk for contracting and
years, male to male sexual contact has become the predominant
122
transmitting HIV, and represent a priority population for developing million copies/mL (average: 189,518 copies/mL). Most sequences were
effective interventions. HIV stigma in the Kiki scene and House Ball obtained from samples with PVL > 5000 copies/mL. At this point, 60
Community (HBC), subcultures of the LGBQTI community, coupled participants were studied, 34 (56.7%) from Akwa-Ibom state and 26
with high HIV prevalence rates and elevated levels of undiagnosed/un- (43.3%) from Cross River state. Thirty-one (31) samples, (19 from
treated HIV infection, places BYMSM in these communities at risk for Akwa-Ibom State and 12 from Cross River State) were successfully
HIV infection. The POSSE Project studies these health disparities genotyped. Subtype G predominated (35.5%), followed by URF_A1F2
using an adaptation of the Popular Opinion Leader (POL) Effective (25.8%), CRF02_AG (19.4%), A1 (3.2%), B (3.2%), C (3.2%), CRF09_cpx
Behavioral Intervention. (3.2%), CRF63_02A1 (3.2%) and URF_02A1F2 (3.2%). Unique recom-
Methods: POSSE Project is a study examining the effectiveness and binant forms (URFs) comprised a dominating group of viruses (32.3%),
implementation of a community-level HIV prevention intervention genotypically identified in 10 samples (8x URF_A1F2, 1x URF_02A1
based on POL models across two cities with similar HBCs, Chicago and 1x URF_02A1F2). URF02_A1F2, A1, B and C were only found in
and Philadelphia. Every 6 months over 2.5 years BYMSM aged 15 to females. In the same vein, URF_02A1, and CRF09_cpx were only
24 were surveyed and offered optional HIV and STI screenings at found in males.
social events sponsored by POSSE. Survey questions included risk Conclusions: The preliminary results of the study indicate a complex
behaviors, housing status, health care access, and HIV stigma. Partici- HIV-1 diversity pattern in Old Cross Rivers State, Nigeria, and possi-
pants were shown how to self-administer anal swabs for STI screen- ble sex differences in subtype distribution. While subtype G was the
ing.. Study staff conducted rapid HIV tests. 580 participants opted in dominating lineage, we also observed a high number of CRFs and
to STI testing, HIV results were collected from 428 participants and URFs. Thus, continued molecular and clinical surveillance in diverse
103 participants self-reported HIV status. regions of Nigeria will reveal whether the intermixing of HIV-1 vari-
Results: STI rates in both cities were similar (18.2% Philadelphia, ants in Nigeria proceeds and what clinical consequences it brings in
25% Chicago). This remained consistent throughout data collection. its wave.
Rates were similar for youth 15 to 17 and 18 to 24 (23.3% and 22%).
23% of male participants, 19% of trans female participants and 33% PE11.19LB
of trans male participants who opted into STI testing received a posi-
Phylodynamic analysis of HIV-1 non-B subtypes suggests
tive result. Overall, chlamydia was slightly more prevalent (66%) than
gonorrhea (54%). However, Philadelphia reported no new sero-conver-
divergent North and South American virus lineages
sions while Chicago had 42. Additional indicators for STI/HIV risk O. Taylor1 and D. Tully2
1
include exchange sex (34.6%), unknown status of partner (15.6%), con- London School of Hygiene and Tropical Medicine, London, United
domless vaginal sex (26%). and condomless anal sex (33.7%). Kingdom, 2London School of Hygiene and Tropical Medicine, Depart-
Conclusions: POSSE Project launched when there was a national ment of Infectious Disease Epidemiology, London, United Kingdom
push for PrEP uptake and adherence. Local context is key to under-
standing trends. Philadelphia saw the rebirth of prevention navigation
programs but Chicago did not. Chicago youth were more likely to use Background: The HIV-1 epidemic in the Americas is characterized by
predominantly subtype B infections, however an increasing prevalence
research visits for health care and testing. Ease of access to preven-
of non-B subtype infections are being documented. Infections with
tion and testing services can lead to increased knowledge of HIV sta-
non-B subtype viruses may be associated with differences in rates of
tus.
transmission, disease progression and anti-retroviral resistance. There-
fore, knowledge of the underlying subtype distribution and evolution-
PE11.18 ary dynamics in the region is essential to HIV prevention efforts. This
Epidemiology and genetic diversity of HIV-1 variants study uses phylodynamic analysis to investigate the distribution, epi-
detected among HIV-infected individuals in Old Cross River demic growth rate and dispersal pattern of HIV-1 non-recombinant,
State, Nigeria non-B subtype viruses in the Americas.
I. Okonko1; H. Innocent-Adiele2; O. Ogbu2 and R. Duerr3 Methods: All non-recombinant, non-B HIV-1 subtype sequences sam-
1
University of Port Harcourt, Virus Research Unit, Department of pled from the Americas and representing gag, pol PRRT and env
Microbiology, Port Harcourt, Nigeria, 2Ebonyi State University, Depart- gp120 genomic regions, were retrieved from the Los Alamos HIV
ment of Applied Microbiology, Abakaliki, Nigeria, 3New York Univer- Database in July 2020. Maximum Likelihood (ML) phylogenies for
sity School of Medicine, Department of Pathology, New York, United each genomic region were inferred from 1328 sequences sampled
States between 1987 and 2018. A Bayesian skyline coalescent prior under a
relaxed molecular clock model was used to estimate age of most
recent common ancestor (TMRCA), mean rate of evolution and growth
Background: This study describes the epidemiology and genetic rate of the virus population. Phylogeographic analysis was conducted
diversity of HIV-1 variants circulating among HIV infected individuals to assess each subtype’s dispersal pattern through the Americas.
in old Cross River State, Nigeria. There is an on-going need to monitor Results: The mean TMRCA of non-recombinant, non-B HIV-1 subtypes
the circulating strains and the emergence of novel HIV-1 variants in in the Americas was estimated to be 1937 (95% HPD:1918 to 1954),
the country, specifically in the understudied Southeastern regions inferred from pol PRRT region. Subtypes C and F were the most fre-
close to Cameroon. quently sampled subtypes, and both appeared to have divergent
Methods: Four hundred and seventeen (417) HIV-1-infected patients “North American” and “South American” sub-lineages in both Bayesian
were enrolled in this study in the age range 4 to 72 years (average: and ML phylogenies. North American sequences were more likely to
39.1 years), approved by the Institutional Ethics Committee. HIV-1 group with Caribbean and Central American sequences than with
pol and env sequences were generated and phylogenetic analyses South American sequences. In addition, several putative transmission
performed. CD4 counts were measured using the Partec CyFlow® clusters were identified, suggesting trans-border transmission net-
Counter. Plasma viral loads (PVL) were determined using the Abbott works, though epidemiological linkages could not be confirmed.
Real-Time HIV-1 Assay US protocol. Conclusions: In a large collection of HIV-1 non-B subtype viruses in
Results: The CD4 counts of the 417 study participants ranged from the Americas, phylogenetic relationships appear to reflect geo-political
5 – 2139 cells/μl (average: 455.6 cells/μl). Fifty-six percent yielded and social-cultural links in the region. The rise in subtype diversity in
detectable and quantifiable HIV-1 RNA in the range of 20 to > 18 the Americas has potential implications for HIV management and pre-
Mio copies/mL, including six specimen with a PVL of more than 1 vention strategies and warrants further exploration. This study
123
illustrates how molecular phylogenetic methods are useful for investi-

gating HIV transmission dynamics at the individual and population PE12.02
levels, and will continue to serve as important tools for public health “It’s almost as if stakeholder engagement is the annoying
surveillance. ‘have-to-do. . .” recognizing ‘tokenism’ in stakeholder
engagement - Perceptions of key role-players in HIV
prevention
Ethics in HIV prevention research A. Wilkinson1; C. Slack1; S. Thabethe1; J. Salzwedel2 and
D. Wassenaar1
1
University of KZN, School of Applied Human Sciences, Pietermar-
itzburg, South Africa, 2AIDS Vaccine Advocacy Coalition, New York,
PE12.01 United States
Integration of gender-based violence screening and support
into the research clinic setting: experiences from an HIV
prevention open label extension trial in sub-Saharan Africa Background: Ethics guidance encourages researchers to engage
1 2 2 3
M. Garcia ; A. Mayo ; R. Scheckter ; S. Roberts ; L. Mansoor ; 4 stakeholders, and REC/IRBs to review engagement plans (CIOMS,
T. Palanee-Phillips5; K. Reddy5; Y. Naidoo5; C. Akello6; S. Siva7; 2016; UNAIDS-AVAC, 2011; UNAIDS 2012). This could be strength-
C. Rushwaya8; J. Jambaya8; R. Makoni8; E. Kachale9 and M. Ndovie10 ened by understanding how “tokenistic” engagement is perceived, and
1 how it can be avoided. We explore characterizations of tokenistic
FHI 360, Science Facilitation, Durham, United States, 2FHI 360, Dur-
engagement in clinical trials, as part of a study exploring how to facili-
ham, United States, 3RTI, United States, 4CAPRISA, Durban, South
tate engagement during the ethics review process.
Africa, 5Wits RHI, Johannesburg, South Africa, 6MU-JHU, Kampala,
Methods: We conducted in-depth interviews with 23 representatives
Uganda, 7SA MRC, South Africa, 8UZCHS-CTRC, Zimbabwe, 9JHU-
of key stakeholder groupings, between April 2019 and June 2020 (13
Blantyre, Blantyre, Malawi, 10UNC Project Lilongwe, Malawi
female; 10 male). We used purposive and snowball sampling to iden-
tify key stakeholders from countries conducting HIV prevention trials.
Background: HIV and gender-based violence (GBV) are often co- We conducted Thematic Analysis (UKZN REC BE 38/19).
endemic among women in sub-Saharan Africa, with shared risk factors. Results: The following practices were linked to tokenism - when
Research sites working with vulnerable populations have an ethical engagement is too late or infrequent (“like a speed dating thing, here
obligation to provide GBV support. Standard operating procedures today, gone tomorrow” P8); when it is poorly resourced (“engagement
(SOPs) were implemented in MTN-025/HOPE, an open-label exten- isn’t free” P6); when it is not inclusive (“not just the gatekeepers but
sion study of the dapivirine vaginal ring for HIV prevention, to system- the quiet voices”, P1); when stakeholders are co-opted (“part of the
atically guide GBV identification, management, and referral. SOP machine” P11); when it is exclusively CAB-centric (“the default posi-
development, implementation, and evaluation is described here to tion” P13); when it is not responsive to inputs (“concerns are not
inform integration of GBV response in research and programmatic being heard” P9); when engagement ignores contextual conditions (“ig-
settings. norant of daily lives” P6), and when engagement practices are not eth-
Methods: Site staff (n = 32) and leadership (n = 17) completed a ically grounded (“something you have to get done to move a project
questionnaire assessing GBV knowledge, resources, and referral capa- forward” P13) nor rooted in collaborative partnership (researchers
bilities to supplement WHO guidelines and other literature in inform- “paint themselves as saviours” P7). However, there were additional
ing the development of a GBV response SOP template. Sites tailored categories of worrisome engagement beyond tokenism, namely harm-
and implemented the SOP through ~1.5 years of study implementa- ful engagement (“reinforces power inequalities” P7) or engagement
tion. At closeout, a questionnaire assessed SOP implementation expe- that is poorly tailored to the study at hand (“intensity of engagement
riences among staff (n = 35) and leadership (n = 17), including must match the risks of the study” P10). There were concerns about
recommendations regarding staff training and support mechanism inadequate indicators to recognize excellent engagement, both in clini-
needs, processes for identifying and maintaining suitable referral net- cal trials and other non-interventional studies (“shortage of explicit cri-
works, and confidence in quality of staff GBV response. Participant teria” P10).
report of baseline and follow-up experiences of GBV and participant Conclusions: RECs may be well placed to address all 3 worrisome
engagement activity (PEA) reports were also reviewed. forms of engagement (tokenistic or harmful or one size fits all) in an
Results: Among 1360 participants at sites where the SOP was imple- ethics review process that is itself non-tokenistic. We describe empiri-
mented, 104 (7.65%) reported experiencing GBV in the year prior to cally and theoretically informed ‘indicators’ to assist, including for
enrollment, and 86/1353 (6.36%) reported any GBV during follow-up, COVID-19 studies. Using a ‘reflexivity-based’ review model (rather
with 52/86 (60.47%) reporting GBV after SOP implementation. At than ‘compliance’-based), we recommend insightful inquiries RECs
study end, staff reported increased training 32/35 (91.43%); improved could raise.
confidence in GBV response (18/26; 69.23%); and increased compas-
sion fatigue prevention on-site (17/28; 60.71%). Leadership reported
increased staff competence with SOP implementation. Strength of
referral networks depended on availability of referral organizations
and varied by site, with less than 20% (3/16) of leadership reporting
improvements and PEA reports revealing differing partner organiza-
tion engagement. Site-reported obstacles to comprehensive GBV care
included: limited local referral organizations, limited time for partici-
pant follow-up, continued staff training needs, and prevailing cultural
norms and misconceptions surrounding GBV.
Conclusions: Development and implementation of an SOP is a feasi-
ble, effective strategy to build a systematic GBV response that can
improve health system capacity and participant health. Adequate com-
munity-based referral networks are essential to effective GBV
response and were limited in some settings.
124
High-throughput datasets in prevention HIV sequencing insights including viral

science diversity and antiretroviral resistance
PE13.01 PE14.01
What happened to my stock? Management and tracking of Broadly neutralizing plasma antibodies effective against
HIV self-testing (HIV-ST) kit distribution in rural diverse autologous circulating viruses in infants with
KwaZulu-Natal multivariant HIV-1 infection
J. Dreyer1; N. Chimbindi2; C. Herbst2; O. Adeagbo2 and N. Mishra1; S. Sharma1; A. Dobhal1; S. Kumar1; H. Chawla2;
M. Shahmanesh3 M. Makhdoomi3; R. Lodha4 and K. Luthra1
1 1
Africa Healthy Research Institute (AHRI), KwaZulu Natal, Research All India Institute of Medical Sciences, Biochemistry, New Delhi, India,
Data Management, Durban, South Africa, 2Africa Healthy Research 2
University of Southampton, Biological Sciences and the Institute for
Institute (AHRI), KwaZulu Natal, Durban, South Africa, 3University Life Sciences, Southampton, United Kingdom, 3Government College
Collage London, Global Health, United Kingdom for Women, Cluster University, Biochemistry, Srinagar, India, 4All India
Institute of Medical Sciences, Pediatrics, New Delhi, India
Background: Management and tracking of research stock in commu-

nity-based trials is complex. We describe the development of an elec- Background: Due to the extensive antigenic diversity of HIV-1,
tronic system to track distribution of HIV-self screening kits (HIV-SS) broadly neutralizing antibodies (bnAbs) develop in a subset of infected
by community-based peer navigators in a cluster randomised trial in a individuals over 2 to 3 years of infection. Interestingly, infected infants
rural area in KwaZulu-Natal (KZN), South Africa. have been shown to develop plasma bnAbs frequently and as early as
Methods: Between March-December 2019, we conducted a cluster one-year post-infection, with features atypical than adult bnAbs, sug-
randomized control trial comparing two models of peer delivery gesting the factors governing bnAb induction in infants are different
(57peer navigators) of HIV-SS, through incentivized respondent driven than those in adults. Understanding the antigenic features in infants
peer networks and direct distribution by peer navigators compared to with early bnAb responses will provide key information on the anti-
standard of care (referral to HIV testing, prevention and care services genic triggers driving B cell maturation pathways towards induction of
by peer navigators) in improving the uptake of HIV prevention and bnAbs.
care amongst older adolescent girls and young women (18 to 24) in Methods: HIV-1 RNA was isolated from plasma samples of infants,
KZN. The respondent driven sampling arm provided airtime as incen- and full-length envelope genes were amplified, sequenced and cloned.
tive for distributing HIV-SS to peers, and each arm also provided a Viral diversity, recombination, and phylogeny analysis were performed
package containing: clinic referral slips, condoms, information leaflets using MEGAX, RAPR, HIV AnalyzeAlign and SimPlot. Plasma neutral-
and HIV-SS kits, all which were electronically tracked and accounted ization activity and bnAb susceptibility and binding profile were
for using REDCap software. Each package was labelled with a unique assessed by TZM-bl based neutralization assays and HEK293T cell-
Quick Response (QR) Code. Utilizing a REDCap Survey project, with a based flow cytometry.
Microsoft Structured Query Language database back-end, each pack- Results: Herein, we evaluated the characteristic features of circulat-
age was classified based on contents. Each time a package changed ing viral strains in infants that show an early bnAb response to under-
hands a record was created, information containing: type of package, stand the antigenic triggers that drive B cell maturation pathways
nature of distribution, chain of custody and date/time. Tablet comput- towards the induction of bnAbs. The presence of plasma bnAbs in a
ers were used for data collection. cohort of 51 HIV-1 clade C perinatally infected infants of Indian origin
Results: Peer navigators distributed approximately 3000 HIV-SS. was assessed with the 12-virus global panel. Plasma bnAbs targeting
Recording transactions as described allowed for tracking of stock dis- V2-apex on the env were predominant in infant elite and broad neu-
tribution occurring anywhere within the surveillance area. QR Codes tralizers. Multi-epitope dependency, a feature of chronic antigenic
scanned with mobile device’s camera improved efficiency and limited exposure, was observed as early as one-year post-infection. Circulating
entry errors. The system allowed up to 50 packages of the same type viral variants in infant elite neutralizers were susceptible to known
and destination to be allocated in single transaction. ~12,500 transac- bnAbs against V2-apex while varied resistance profile to other bnAb
tions were processed with 0.4% error rate. Accountability was classes was observed. In infant elite neutralizers, multivariant infection
strengthened by requiring electronic signatures from persons dis- was associated with plasma bnAbs targeting diverse circulating autolo-
tributing and receiving stock, and recording any packages distributed gous viruses.
to participants in real-time. Conclusions: Our data add to a growing body of literature suggesting
Conclusions: This approach enabled reporting the complete history infants may have different immunological tolerance mechanisms and
chain of custody for each package from Storeroom to Participant’s may be permissive for the development of bnAbs. Further, the pres-
hands. Real-time viewing of stock quantities at each step of distribu- ence of autologous plasma bnAbs targeting divergent viruses provides
tion provided overall picture of stock quantities, location and acted as information supportive of polyvalent vaccination approaches capable
early warning system for restocking for monitoring and evaluating of inducing V2-apex bnAbs against HIV-1.
HIV programmes.
125
Conclusions: NNRTI resistant-HIV-1 in HOPE seroconverters was

PE14.02 common but selection of DPV specific mutations was not observed.
HIV drug resistance assessment among seroconverters from Ongoing monitoring of NNRTI resistance is important to further
the MTN-025/HOPE Open-Label Dapivirine Vaginal Ring understand the potential risk of resistance in the community.
Study
U. Parikh1; A. Heaps1; K. Penrose1; R. Sethi2; B.J. Goetz1; D. Szydlo3;
U. Chandran2; T. Palanee-Phillips4; N. Mgodi5; J. Baeten6; J. Mellors Humoral immunity
and MTN-025 Study Team1
1
University of Pittsburgh, Medicine, Pittsburgh, United States,
2
University of Pittsburgh, Biomedical Informatics, Pittsburgh, United
States, 3Fred Hutchinson Cancer Research Center, SCHARP DAU- PE15.01
SRA, Seattle, United States, 4Wits RHI, Johannesburg, South Africa, Transient viral exposures drive humoral responses in HIV-1
5
University of Zimbabwe, College of Health Sciences Clinical Trials post-treatment controllers
Research Centre, Harare, Zimbabwe, 6University of Washington, Seat- L.M. Molinos-Albert1; V. Lorin2; V. Monceaux3; A. Essat4; J. Dufloo5;
tle, United States O. Schwartz5; C. Rouzioux6; L. Meyer4; L. Hocqueloux7;
A. Saez-Cirion3 and H. Mouquet2
1
Laboratory of Humoral Immunology, Institut Pasteur-Inserm U1222,
Background: A concern about dapivirine (DPV) for HIV prevention is
Immunology, France, 2Laboratory of Humoral Immunology, Institut
potential selection of resistant virus with breakthrough infection that
Pasteur-Inserm U1222, France, 3HIV, Inflamation and Persistence
could contribute to spread of NNRTI resistance and reduced effec-
Unit, Institut Pasteur, France, 4Universite Paris Sud, INSERM CESP
tiveness of 1st-line-NNRTI-based ART. The frequency of NNRTI resis-
U1018, France, 5Virus and Immunity Unit, Institut Pasteur-CNRS
tance in seroconverters from the placebo-controlled MTN-020/
UMR 3569, France, 6CHU Necker, Laboratoire de Virologie, Universite
ASPIRE Phase-III trial of DPV vaginal ring was high (11%) but did not
Paris Descartes, Paris, France, 7Centre Hospitalier Regional d’Orle
ans,
differ by arm, suggesting that resistance profiles detected were likely ans, France
Orle
transmitted and not selected by DPV ring use. To further evaluate
resistance risk, we tested samples from seroconverters in the MTN-
025/HOPE open-label-extension of DPV ring for HIV drug resistance. Background: Rare HIV-1-infected individuals treated early by
Methods: In MTN-025, HIV-1-uninfected women from MTN-020 were antiretroviral therapy (ART) can successfully control the infection fol-
offered 12 months of access to DPV ring for HIV prevention at 14 sites lowing treatment interruption (TI). Identifying immune correlates asso-
in Malawi, South Africa, Uganda, and Zimbabwe between July 2016 and ciated with post-treatment control of HIV-1 would help developing
August 2018. Plasma from the 35 women who seroconverted during effective vaccine and cure strategies. Decoding the immune response
the study was tested by population genotyping and next generation mediated by B-cells and their secreted antibodies in post-treatment
sequencing with unique molecular identifiers (NGS-UMI) targeting HIV- controllers (PTCs) offers a unique opportunity to assess the potential
1 RT aa81-149 and 152 to 212. Drug resistance mutations (DRM) were role of antibodies in HIV-1 remission.
defined by 2019-IAS-USA and reported if their frequency was ≥ 1% of Methods: We performed a comprehensive humoral immunoprofiling
the virus population. Bulk-cloned plasma-derived recombinant HIV-1 of serological and cellular parameters orchestrating the antibody B-cell
from samples with NNRTI mutations and a matched number without response to HIV-1 in PTCs (median 12.65 [2.8 to 18] years under
NNRTI mutations was phenotyped for susceptibility to DPV. control, n = 22) from the ANRS VISCONTI cohort. Analyzed humoral
Results: Seven of 35 (20%) samples had NNRTI-DRM detected by parameters included:
both population genotyping and NGS-UMI including A98G,K103N,
V106M,E138A and V179D. Only 1 sample had a low frequency DRM (i) IgG and IgA titers to various HIV-1 antigens,
detected (2.8%Y188H) that was missed by standard genotyping. (ii) epitope IgG seromapping,
Major NNRTI mutations previously selected by DPV in vitro including (iii) HIV-1 cross-neutralization,
L100I,E138K,V179F or Y181C/I were not detected, even at low fre- (iv) cross-binding to infected cells,
quency. Samples with K103N had varying susceptibility to DPV, rang- (v) auto-/poly-reactivity,
ing from fully susceptible (1.4-FC) to moderate reduction in (vi) circulating follicular helper T-cell (cTFH) and B-cell flow-cytometric
susceptibility (17-FC) (Table 1). immunophenotyping.
126
Data combined with clinical, virological and T-cell immunological mea- following the second protein boost. The common feature of all three
surements were analyzed using multiparametric statistical tools includ- serum samples is the presence of two non-neutralizing responses;
ing principal component analyses. gp41 base and an N611 glycan hole (resulting from inefficient post-
Results: PTCs displayed divergent antibody serological profiles, being translational modification). The serum samples collected at weeks 12
quantitatively and qualitatively superior in some PTCs with transient vire- and 22 demonstrated a C3/V5 directed antibody response, while the
mic episodes after TI (exposed, ePTCs), and resembling humoral responses week 22 sample demonstrated a fourth antibody response that indi-
typically found in early-treated HIV-infected individuals experiencing viral cated “V1/V3” and “V2-like” antibody responses. However, these did
rebound post-TI (n = 22). Serum IgG antibodies able to cross-neutralize not appear the same as that of canonical bnAb “V1/V2-apex” or “V3-
multiple viral strains and efficiently bind target cells infected by T/F glycan supersite.” The potent autologous neutralization conferred by
viruses were detected in one-third of ePTCs (4/12), but not in stably vaccinated serum was mapped to C3/V4 region of viral Env, consistent
aviremic individuals (n = 10). Higher exposure (post-TI) to viral antigens with the generalized “C3/V5 epitope” response seen by EMPEM.
was generally associated with higher frequencies of activated memory Conclusions: We report three-fold symmetrical shape of a novel
B-cells, and with HIV-1 Env-specific memory B-cells in a subgroup of clade C SOSIP and identified subtle local differences that revealed
ePTCs with highly functional antibody responses. In addition, transient new insights about its relative breathability in solution. EM imaging
viremic episodes after TI were associated with an expansion of revealed diversity of epitopes targeted by polyclonal antibodies eli-
PD1hiCXCR3+CXCR5+ cTFH. Moreover, Th2-like cTFH (CCR6CXCR3 cited by this novel SOSIP including ones that potently neutralized
CXCR5+) frequencies correlated with most humoral immune parameters sequence matched and unmatched autologous viruses.
but only in ePTCs. Principal component analyses allowed individualizing
ePTCs as a PTC subset through associations with: PE15.03
(i) activated cTFH; Analysis of IgG1 and IgG3 humoral response against the
(ii) tissue-like and activated memory B-cells; membrane proximal external region of HIV-1 envelope
(iii) IgG antibody magnitude and functionality. glycoprotein
Conclusions: PTCs form a group of immunologically heterogeneous E. Pradenas1; M.L. Rodrıguez de la Concepcio n2; C. Rovirosa2;
individuals characterized by distinct viral dynamics. Transient viremia S. Marfil2; B. Clotet2; J. Blanco2 and J. Carrillo2
1
episodes mobilized activated cTFH and HIV-specific B-cells resulting in IrsiCaixa AIDS Research Institute, Cell Virology and Immunology,
superior humoral antibody responses in ePTCs, whereas stably avire- Badalona, Spain, 2IrsiCaixa AIDS Research Institute, Badalona, Spain
mic PTCs displayed more “silent” humoral profiles.
Background: The membrane proximal external region (MPER) is an

PE15.02 attractive HIV-1 vaccine target and several broadly neutralizing mono-
Structural features of a novel HIV-1 Indian clade C trimeric clonal antibodies (bNAbs) against MPER have been isolated from HIV
soluble Env SOSIP and the polyclonal neutralizing antibody infected individuals. Interestingly, whereas IgG1 dominates the anti-
responses developed in vaccinated rabbits Env humoral response in HIV-chronically infected individuals, the most
J. Bhattacharya1; A. Singh Chandrawacar2; K. Dhiman2; L. M. Sewall3; potent anti-MPER bNAbs are IgG3. The role of the IgG3 subclass in
G. Ozorowski3; C. A. Cottrell3; N. Hingankar1; R. Kumar1; this type of neutralizing antibodies is still unknown and the factors
S. Deshpande1; K. G. Murugavel4; A. Ashish2 and A. B Ward3 that determine its generation have not been established. Our aim is to
1
Translational Health Science & Technology Institute, HIV Vaccine understand the contribution of IgG1 and IgG3 antibody subclasses to
Translational Research Laboratory, Faridabad, India, 2CSIR - Institute the neutralizing and non-neutralizing anti-MPER humoral response.
of Microbial Technology, Chandigarh, India, 3The Scripps Research Methods: We have analyzed the presence of anti-MPER IgG1 and
Institute, Department of Integrative Structural and Computational IgG3 responses by ELISA in 800 plasma samples obtained from 680
Biology and the Skaggs Institute for Chemical Biology, Scripps Consor- HIV-1 infected individuals (on ART and ART-na€ıve). We have devel-
tium for HIV/AIDS Vaccine Development (CHAVD), La Jolla, United oped a unique dual ELISA standard that allows for the direct compar-
States, 4YRG Center For AIDS Research & Education, Chennai, India ison between IgG1 and IgG3 quantitative responses. Total neutralizing
activity was assayed against the HIV-1 global panel. MPER-specific
neutralizing activity was determined using HIV-2 viruses (7312A and
Background: Induction of protective immune response to genetically its HIV-1 MPER engrafted variant 7312A-C1).
diverse HIV-1 remains a challenge. In the present study, we examined Results: Anti-MPER antibodies were observed in 87% of plasma sam-
the structural and antigenic features of an HIV-1 clade C soluble ples, mainly in viremic subjects. Anti-MPER IgG1 response was pre-
envelope protein (Env; 1PGE-THIVC), prepared from primary sent in 93% of viremic and in 81% of aviremic individuals. Anti-MPER
sequence obtained from an Indian elite neutralizer, in solution and by IgG3 responses were only observed in 8% of viremic and 2% of avire-
polyclonal antibodies that it induced in rabbits. mic subjects. When present, the levels of anti-MPER IgG3 antibodies
Methods: Codon optimized HIV-1 Indian clade C (1PGE-THIVC) were similar to the IgG1 ones.
gp140 SOSIP trimeric protein was subjected to small angle X-ray scat- Although a high prevalence of anti-MPER antibodies was observed,
tering (SAXS) data analysis and the experimental model was compared only a small fraction of them (mainly in the ART-na€ıve group) showed
with a homology model by inertial axes alignment of the two models. neutralizing activity against the 7312A-C1 virus. Moreover, no correla-
Polyclonal antibody specificity was analyzed using electron microscopy tion was observed between the levels of anti-MPER IgG1 or IgG3
polyclonal epitope mapping (EMPEM), in which purified Fab:SOSIP antibodies and the MPER-specific neutralizing activity. In addition, no
complexes were prepared, deposited onto EM grids, imaged and pro- association was observed between the MPER neutralizing activity and
cessed using 2D and 3D methods. Virus neutralization was carried out the neutralization against the HIV-1 global panel.
using TZM-bl reporter cells. Conclusions: Our results indicate that despite the vast majority of
Results: SAXS analysis of 1PGE-THIVC confirmed that molecules HIV-1 infected individuals generate anti-MPER antibodies, the neutral-
occupy a monodisperse globular profile in solution and shape restora- izing response against this region is low. IgG1 dominates the anti-
tion confirmed presence of 3-fold symmetry, albeit with some degrees MPER humoral response while anti-MPER IgG3 antibodies are elicited
of inherent molecular mobility which possibly regulate recognition by rarely. Anti-MPER IgG subclasses were not associated with the neu-
mAbs. EMPEM analysis was carried out with serum samples collected tralizing activity of plasma samples.
at weeks 6 and 12 following the first protein boost and at week 22
127
Background: Vaccine Induced Seropositivity/Reactivity (VISP/R) occurs

PE15.04 in some participants of HIV vaccine studies in which vaccine-induced
Association of HIV vaccine construct and VISP/R in 70 HIV
antibodies interfere with the interpretation of results from commercial
vaccine trials HIV diagnostic kits. Over two decades of HIV vaccine trials have
N. Espy resulted in a population with VISP/R that requires long term follow-up
HIV Vaccine Trials Network, Laboratory Center, United States for proper HIV diagnosis and monitoring of social harm.
128
Methods: We defined VISP/R as reactivity on any Ag/Ab FDA- and Cytotoxic T Lymphocyte study (CTL; 1999 to 2002), to examine
approved or CE-marked commercial HIV diagnostic test and no detec- passively-acquired antibodies shortly after birth in breastfeeding
tion of HIV viral load by RT-PCR. In 70 Phase I/II AIDS Vaccine Evalu- infants who tested HIV negative at delivery and positive during fol-
ation Group (AVEG) and HIV Vaccine Trials Network (HVTN) studies, low-up. Infant samples from the first week of life were tested for
we collated these data for 7436 vaccinees: end-of-study VISP/R ADCC activity against clade A/D gp120 via the RFADCC assay and
results. We determined the association of VISP/R with vaccine vector an ELISA with dimeric versions of FccRIIa (H131) and FccRIIIa
type, gene insert type, protein boost, and peak antibody titers. Tables (V158), which are expressed by neutrophils/monocytes and NK cells/
show the response rates and corresponding 95% confidence intervals CD16+ monocytes, respectively. We used Cox proportional hazards
calculated by the Wilson score method (Agresti and Coull 1998). models adjusted for maternal viral load to assess the relationship
Results: Of vaccinees who had received only protein boosts, VISP/R between assay activity and infant survival.
was present in 5/74 (6.8%) participants who had received gp120 pro- Results: Passively-acquired ADCC was associated with improved sur-
tein and 144/147 (98.0%) participants who had received gp140 protein. vival in CTL (p = 0.017), consistent with prior results from NBT. In
Of vaccinees who had received viral vectors, VISP/R was present in analysis combining both cohorts, the association between passively-
939/1903 (49.3%) participants who had received no HIV env gene acquired ADCC activity and infant survival was statistically significant
insert, 200/390 (51.3%) participants who had received a gp120 gene (p = 0.005). There was a significant association between dimeric
insert, and 1563/1739 (89.9%) participants who had received a gp140 FccRIIa binding and infant survival in the combined cohorts
insert. (p = 0.0017) and in NBT (p = 0.020), but not in CTL (p = 0.11).
Conclusions: The inclusion of gp140 as a gene insert in a vaccine Dimeric FccRIIIa activity was associated with HIV+ infant survival in
vector or as a protein boost to a vaccine regimen is associated with the individual cohorts (NBT, p = 0.024; CTL, p = 0.017), and the com-
VISP/R in participants. These data inform the potential impact of a bined cohorts (p < 0.001).
successful HIV vaccine on the HIV diagnostic landscape. Future work Conclusions: Passively-acquired ADCC activity, whether measured by
will investigate correlates and duration of VISP/R. the RFADCC assay or dimeric FccR ELISA, was associated with
improved HIV+ infant survival in two cohorts. These results suggest
PE15.05LB that pre-existing, ADCC-mediating antibodies contribute to improved
HIV clinical outcome in infants. The finding that engagement of
Improved HIV+ infant survival is correlated with high levels
FccRIIa and FccRIIIa both correlate with infant survival further sup-
of passively-acquired ADCC activity in two breastfeeding ports a role of multiple cellular effectors in this process.
cohorts
Z. Yaffe1,2,3; N. Naiman1,2,3; J. Slyker4,5; B. Wines6,7,8;
B. Richardson4,9,10,11; P.M. Hogarth6,7,8; R. Bosire12; C. Farquhar4,5,13; PE15.06LB
D. Mbori-Ngacha14,15; R. Nduati15; G. John-Stewart4,5,13,16 and Fusion peptide priming reduces immune responses to the
J. Overbaugh1,11 HIV-1 envelope trimer base and leads to enhanced broadly
1
Fred Hutchinson Cancer Research Center, Human Biology Division, neutralizing antibody responses
Seattle, United States, 2University of Washington, Molecular and Cel- A. Corrigan1; H. Duan1; C. Cheng1; C. Gonelli1; L. Ou1; K. Xu1;
lular Biology Program, Seattle, United States, 3University of Washing- M. DeMouth1; H. Geng1; S. Narpala1; M. Basappa1; Y. Tsybovsky2;
ton, Medical Scientist Training Program, Seattle, United States, J.van Schooten3; J. Todd1; N. Doria-Rose1; K. Foulds1; R. Koup1;
4
University of Washington, Department of Global Health, Seattle, Uni- A. McDermott1; M.van Gils3; P. Kwong1 and J. Mascola1
ted States, 5University of Washington, Department of Epidemiology, 1
Vaccine Research Center, National Institute of Allergy and Infectious
Seattle, United States, 6Burnet Institute, Immune Therapies Labora- Disease, National Institutes of Health, Bethesda, United States, 2Elec-
tory, Centre for Biomedical Research, Melbourne, Australia, 7Monash tron Microscopy Laboratory, Cancer Research Technology Program,
University, Department of Immunology and Pathology, Central Clinical Leidos Biomedical Research Inc., Frederick National Laboratory for
School, Melbourne, Australia, 8The University of Melbourne, Depart- Cancer Research, Frederick, United States, 3Department of Medical
ment of Pathology, Parkville, Australia, 9University of Washington, Microbiology, Amsterdam UMC, University of Amsterdam, Amsterdam
Department of Biostatistics, Seattle, United States, 10Fred Hutchinson Institute for Infection and Immunity, Amsterdam, Netherlands
Cancer Research Center, Vaccine and Infectious Disease Division,
Seattle, United States, 11Fred Hutchinson Cancer Research Center,
Public Health Sciences Division, Seattle, United States, 12Kenya Medi- Background: The vaccine elicitation of protective broadly neutralizing
cal Research Institute, Centre for Public Health Research, Nairobi, antibody (bNAb) responses against highly diverse viruses remains a
Kenya, 13University of Washington, Department of Medicine, Seattle, critical goal of HIV research. Soluble ‘SOSIP’-stabilized envelope (Env)
United States, 14United Nations Children’s Fund, HIV Section, New trimers are promising HIV-vaccine immunogens. However, they induce
York, United States, 15Kenyatta National Hospital, Department of Pae- high titer antibody responses against the glycan-free trimer base,
diatrics, University of Nairobi, Nairobi, Kenya, 16University of Wash- which is occluded on native virions. To delineate the impact on base
ington, Department of Pediatrics, Seattle, United States responses of priming with immunogens targeting the fusion peptide
(FP) site of vulnerability, we quantified the prevalence of trimer-base
antibody responses in 49 non-human primates (NHPs) immunized with
Background: Defining immune responses that protect against diverse various SOSIP-stabilized Env trimers and FP-carrier conjugates.
HIV strains in humans has been elusive. Studying humoral correlates Methods: We characterized and identified anti-base antibodies that
of protection in HIV-exposed infants provides insights into mecha- can block BG505 DS-SOSIP base recognition by NHP plasma, but do
nisms of protection because passively-transferred, HIV-specific anti- not impact bNAbs targeting major sites of Env vulnerability. With
bodies are present during breastfeeding HIV exposure. A previous these anti-base antibodies, we developed three competition-based
study illustrated that passively-acquired ADCC activity was associated methods, i.e., ELISA, Biolayer Interferometry and MSD, and quantified
with improved infant survival, whereas neutralization was not. We the prevalence of trimer-base antibody responses in NHP plasma. We
extended this study, expanding to a second cohort and another mea- analyzed the base-responses based on three immunization categories:
sure of ADCC, to determine the broad contribution of passively- trimer only, cocktail of trimer and FP-conjugate, and FP prime-trimer
acquired ADCC to HIV+ infant survival. boost.
Methods: We utilized samples from two mother-infant studies in Results: We found that anti-base responses accounted for approxi-
Nairobi, Kenya: the Nairobi Breastfeeding Trial (NBT; 1992 to 1998) mately 90% of the overall trimer response in animals immunized with
129
trimer only, approximately 70% in animals immunized with a cocktail Results: From interviews with eight prescribers and eight non-pre-
of SOSIP-trimer and FP-conjugate, and approximately 30% in animals scribers, unmet need was identified in all 14 domains of the TDF.
primed with FP-conjugates prior to trimer immunization. Notably, neu- Table 1 presents the nine domains in which the greatest diversity of
tralization breadth in FP-conjugate-primed animals on a 10-strain need was recognised. CSTIPs expressed a wider range of barriers to
panel sensitive to FP-targeting antibodies also correlated inversely opportunity and motivation than to capability. There was a marked
with trimer-base responses, suggesting that reducing the immunodom- lack of reflective motivations, including: professional confidence; prof-
inant base response could increase the neutralization outcome. More- itability of PrEP services in the Taiwan CDC project; low burdens of
over, we found that the reduction of base response and enhancement medical claim reviews and governmental programmes; belief in posi-
of neutralization activity and breadth appeared to be further improved tive sexual health outcomes; non-judgemental professional attitudes
by increasing the length of the interval between FP prime and trimer towards MSM clients; and optimism about service sustainability.
boost.
Conclusions: Overall, our data provide three methods to quantify the
prevalence of trimer-base responses and reveal that FP-conjugate Abstract PE16.01-Table 1. Themes and quotes from 16 interviews
priming, either alone or as part of a cocktail, can reduce the trimer- with Community-based Sexually-Transmitted-Infection-Friendly
base response and improve the neutralization outcome. Our results physicians in Taiwan.
indicate that non-neutralizing base responses should be assessed COM-B components
whenever trimers are utilized as immunogens and that this assess- (TDF domains) Themes Quotes
ment may be critical to efforts geared towards developing an effective
Psychological capability Misunderstandings of the “I don’t think I can provide PrEP services if I
HIV-1 vaccine and could apply to other soluble trimeric immunogens.
(Knowledge) eligibility of PrEP service am not an Infectious Disease physician.” (I-
providers 05, non-prescriber)
Physical opportunity The high cost of PrEP “If there are few [STI] patients interested in
Implementation science, including struc- (Environmental

context and
procurement and
limitations on clinic drug
buying PrEP, the cost of drug stocking and
management cost from PrEP procurement
will challenge the operations of my clinic.” (I-
tural interventions, PrEP & VMMC resources) stocks
01, prescriber)
Social opportunity (Social No requests for PrEP from “Those PrEP users have their own social
influence) clients network, so they won’t come to see me for
PrEP as I’m not currently providing PrEP.”
(I-15, non-prescriber)
PE16.01 Reflective motivation

(Belief about
Lack of professional
confidence
“Because we are not professional, I asked many
Infectious Disease physicians. I feel that I
Barriers to prescribing pre-exposure prophylaxis by capabilities) was not above asking questions [about
PrEP].” (I-03, prescriber) “If today I would
community-based sexually-transmitted-infection-friendly like to participate in this [PrEP] project, at
physicians in Taiwan least I must persuade myself that I have
certain understandings of this project, so I
I.Y.-H. Chu1; C. Strong2; C.-W. Li3; H.-J. Wu2; S.W.-W. Ku4; N.-Y. Ko5; can persuade others [patients to use PrEP].”
A. Bourne6; H. Burchett1 and F. Hickson1 (I-12, non-prescriber)
1 Reflective motivation Unprofitability of PrEP “. . .when the government started to promote
London School of Hygiene and Tropical Medicine, Department of (Belief about services in the Taiwan this [Taiwan CDC PrEP] project, it is
Public Health, Environments and Society, Faculty of Public Health and consequences) CDC project definitely not a motivation for frontline
physicians. When [PrEP] was purely self-
PolicyFaculty of Public Health and Policy, London, United Kingdom, paid, basically [I] would have some
2
National Cheng Kung University Hospital, College of Medicine, motivation, but now it’s more like a service
[than a motivation].” (I-07, prescriber)
National Cheng Kung University, Department of Public Health, Tainan, Reflective motivation Medical claim reviews and “I had joined in a governmental project on
Taiwan, Province of China, 3National Cheng Kung University Hospital, (Belief about disputes in governmental providing HIV testing to patients diagnosed
consequences) programmes with [other] STIs, but the authorities ended
College of Medicine, National Cheng Kung University, Department of
up neither reimbursing me nor giving me
Internal Medicine, Tainan, Taiwan, Province of China, 4Taipei City chances to appeal. Who knows whether
Hospital Renai Branch, Division of Infectious Diseases, Department of PrEP [projects] will be like this?” (I-05, non-
prescriber)
Medicine, Taipei, Taiwan, Province of China, 5National Cheng Kung Reflective motivation Perception of PrEP increasing “Homosexuals have complicated sexual
University Hospital, College of Medicine, National Cheng Kung (Belief about partner turn-over and STIs relationships. Once they started to abuse
consequences) medication [PrEP], they will hardly control
University, Department of Nursing, National Cheng Kung University sexual behaviour, so this kind of
Hospital, College of Medicine, Tainan, Taiwan, Province of China, 6La transmission [of STIs] will be inevitable.” (I-
14, non-prescriber)
Trobe University, Australian Research Centre in Sex, Health & Society,
Reflective motivation Unprofessional attitudes “. . .some senior physicians viewed those who
Bundoora, Australia (Social/professional towards MSM clients want to use this (PrEP) as debauched,
role and identity) indecent, or as having problems in their
sexual identity or dirty thoughts.” (I-04,
prescriber)
Background: PrEP can end the HIV epidemic in Taiwan, where men Reflective motivation Pessimism in STI patients’ “After all, you [the government] cannot support
who have sex with men (MSM) account for 80% of new infections. (Optimism) healthcare-seeking them [PrEP users] forever, half-year or one-
behaviour year [free pills] at most (. . . .) when the
Community-based sexually transmitted infection friendly physicians Taiwan CDC project terminates, many
(CSTIPs) are certificated by Taiwan Centres for Disease Control people will go back to their old habits; he
[PrEP user] wouldn’t like to undertake HIV
(CDC) to provide sexual health services outside hospitals. CSTIPs are prevention actively.” (I-16, prescriber)
potentially the most appropriate PrEP service providers in Taiwan but
only two per cent (15 of 750) are currently prescribing PrEP. We pre-
sent a qualitative assessment of the barriers to CSTIPs’ PrEP service Conclusions: Unmet needs for PrEP prescribing among CSTIPs in
delivery. Taiwan are diverse. Quantitative measurement of CSTIPs’ PrEP pre-
Methods: Sixteen face-to-face in-depth semi-structured interviews scribing must be sensitive to a wide range of needs. Increasing oppor-
were conducted with CSTIPs from three medical specialities and four tunity and reflective motivations of CSTIPs may be pivotal to upscale
regions in Taiwan. We used stratified random sampling among both PrEP service delivery in Taiwan.
PrEP prescribers and non-prescribers to increase interviewee diversity.
Interviews were audio-recorded and transcribed. We conducted a the-
matic analysis using the Theoretical Domains Framework (TDF), an
extension of the COM-B model (Michie et al.) for implementation
assessment.
130
reliability of the HEART scales across three CHARISMA research

PE16.02 phases (formative, pilot, and RCT), all conducted at Wits RHI in Johan-
Null effect of financial incentives or social media support nesburg, South Africa.
on PrEP adherence in a randomized controlled trial of Methods: We compared the reliabilities of baseline scores on the five
young men who have sex with men of colour HEART scales: traditional values (TV), partner support (PS), partner
C. Ware1; A. Sparks2; M. Levy3; H. Wolf4 and M. Siegel2 abuse & control (PAC), partner resistance to HIV (PR) & HIV preven-
1
The GW Medical Faculty Associates, Infectious Diseases, United tion readiness (HPR) and conducted a confirmatory factor analysis
States, 2The GW Medical Faculty Associates, United States, 3The (CFA) for each sample. To assess construct validity, we examined cor-
George Washington University, Public Health, United States, 4US relations among HEART scale scores and between scales and indepen-
Office of Global AIDS, Washington, United States dent measures of partner communication, disclosure and intimate
partner violence (IPV) within the RCT sample. Using RCT scale scores,
we also identified latent classes of participants and assessed whether
Background: Pre-exposure prophylaxis (PrEP) using emtricitabine/ classes exhibited different demographic, risk or behavioral characteris-
tenofovir disoproxil fumarate (FTC/TDF) effectively reduces HIV tics.
transmission, with efficacy being dependent on adherence. We evalu- Results: Internal reliability in four RCT scales was strong (a = .85-
ated the effect of either social media-based support or financial incen- .86), similar or higher than in formative and pilot samples. CFA statis-
tives on PrEP adherence among young MSM of color in Washington, tics were acceptable. As in formative and pilot samples, the PAC scale
DC. in the RCT had a strong inverse relationship with PS (0.61- .71)
Methods: MSM aged 18 to 29 were randomized 1:1:1 to standard of and strong positive correlation with PR (0.48 to 0.68). PAC, PS and
care (SOC) PrEP (Control group), SOC PrEP + invitation to a bidirec- PR were strongly correlated with independent measures of IPV. The
tional Facebook group supervised by two clinicians (Social Media latent class analysis produced two distinct groups with significant dif-
group), or SOC PrEP + $50 gift card at each of two follow-up visits ferences on partner communication, decision-making and IPV behav-
(Financial Incentive group). Participants were asked to return at 3 and iors. Further, 96% of participants had a high probability (.8 or higher)
6 months. Adherence was monitored with predefined dried blood of belonging to a single class.
spots (DBS) TFVdp levels with <490, 490 to 979, 980 to 1749
and ≥ 1750 fmol/punch correlating with average of <2, 2 to 4, 4 to 6, Abstract PE16.03-Table 1.
and 7 doses per week.
Class A Class B
Results: Among 53 MSM, mean age was 22.5 years and 72% were “Supportive” “Conflictual”
Black. At enrollment, 96% had previously heard of PrEP, 17% had ever Expansion study treatment arm (n = 93) (n = 110) p-value
taken PrEP but none had taken PrEP in the prior 6 months. 92% of
participants reported condomless anal sex in the prior 3 months, 36% Scale mean scores (range 1 = disagree a lot; 6 = agree a lot)
Traditional Values (TV) 13 items, a = 0.85 1.3 2.0 <0.001
with an HIV-positive man or man of unknown HIV status. 81% of par-
Partner Support (PS) 10 items, a = 0.86 5.7 4.7 <0.001
ticipants returned for their 3-month visit and 70% for their 6-month Partner Abuse & Control (PAC) 9 items, a = 0.86 1.1 1.8 <0.001
visit. Mean self-reported PrEP adherence over the previous 3 months Partner Resistance to HIV (PR) 5 items, a = 0.85 1.0 2.1 <0.001
was 78% with no difference in adherence between the three groups Socio-demographics
Age (years) 28.6 28.3 0.76
at either visit. Based on DBS TFVdp levels, protective PrEP adherence
Education/some college or more 37.7% 27.3% 0.38
(≥4 doses/week) was measured in 46% of the Financial Incentive Decision-making (8 items, scale 0 to 8)
group and in 57% of the Social Media group compared to in 67% of Partner-only 1.3 2.15 <0.001
the Control group (p = 0.38). Only 16% of TFVdp levels corresponded Both 4.9 4.25 0.01
Self-only 1.7 1.6 0.48
to taking PrEP 7 days a week. There was no change in sexual risk
WHO “Violence Against Women” measures
activity over the course of the study. 38 sexually transmitted infec- Partner communication (4 items, scale 0 to 4) 3.8 3.45 0.001
tions were diagnosed in 26 participants but there were no HIV sero- IPV controlling behaviors (7 items, scale 0 to 7) 0.8 1.7 <0.001
conversions. IPV abusive behaviors (4 items, scale 0 to 4) 0.3 0.8 <0.001
IPV physical violence (6 items, scale 0 to 6) 0.2 0.8 0.001
Conclusions: Our study showed no impact of either offering financial
IPV sexual violence (3 items, scale 0 to 3) <0.1 0.2 0.01
incentives or providing access to a supervised Facebook-based sup- HIV risk perception
port group on PrEP adherence. Financial compensation based on level Not at all worried 34.4% 29.1% 0.36
of PrEP adherence and using a more age-appropriate social media Somewhat worried 50.5% 46.4%
Very worried 15.1% 24.5%
platform may have a greater impact on adherence.
Independent PrEP Disclosure, Support and Opposition mean scores
Disclosed PrEP use to partner (yes) 69.9% 54.5% 0.08
PE16.03 PrEP Support (5 items, scale 0 to 5)
PrEP Opposition (7 items, scale 0 to 7)
1.14
0.03
0.75
0.10
0.02
0.10
Validating HEART: a HEAlthy relationships assessment tool Class probability (mean) 0.97 0.98
for PrEP use
E. Tolley1; A. Martinez1; T. Palanee-Phillips2; F. Mathebula2;
M. Hartmann3; D. Wagner3; S.T. Roberts3 and E.T. Montgomery3
1 Conclusions: This multidimensional tool offers an efficient, integrated
FHI 360, Global Health & Population Research, Durham, United
measurement of social support and IPV. These data offer further evi-
States, 2University of the Witswatersrand, Wits Reproductive Health
dence for HEART reliability and validity and support its utility in IPV
& HIV Institute, Johannesburg, South Africa, 3RTI International,
and PrEP-related services.
Women’s Global Health Imperative, Berkeley, United States
Background: HEART is a counselor-administered tool, first developed

through formative research and then piloted within a clinic-based
intervention (CHARISMA) to reduce social harms and increase healthy
relationship dynamics for PrEP use. The tool assesses participants’
levels of partner support, control or abuse, suggesting module-based
content for counselor delivery. This analysis assessed the validity and
131
PE16.04 PE16.05
Assessing the use of surveillance data to estimate HIV pre-exposure prophylaxis (PrEP) uptake among alcohol
reductions in HIV incidence achieved by combination HIV users in rural South Africa
prevention programs: a mathematical modelling study M. Grammatico1; A. Moll2; K. Choi3; S. Springer4 and S. Shenoi4
1 2 3 2 4 1
K. Mitchell ; D. Dimitrov ; J. Hughes ; J. Moore ; M. Maheu-Giroux ; Fogarty International Center, NIH, Global Health Equity Scholar,
M. Cohen5; C. Beyrer6; D. Donnell2 and M.-C. Boily1 Bethesda, United States, 2Church of Scotland Hospital, Tugela Ferry,
1
Imperial College London, Department of Infectious Disease Epidemi- South Africa, 3Yale University Department of Medicine, New Haven,
ology, London, United Kingdom, 2Fred Hutchinson Cancer Research United States, 4Yale University Department of Medicine, Section of
Center, Seattle, United States, 3University of Washington, Seattle, Uni- Infectious Diseases, New Haven, United States
ted States, 4McGill University, Montreal, Canada, 5University of North
Carolina at Chapel Hill, Chapel Hill, United States, 6Johns Hopkins
Bloomberg School of Public Health, Baltimore, United States Background: South Africa, home to the world’s largest HIV epidemic,
has made great strides in improving access to HIV testing and
antiretroviral therapy (ART), but young men remain difficult to engage
Background: Surveillance data on new HIV diagnoses are frequently in the HIV care cascade. Alcohol use increases risk behavior and com-
used as a proxy for HIV incidence when assessing HIV intervention plicates engagement. Congregate settings where alcohol is served,
programs. We used mathematical modelling to determine when known as shebeens, are ideal places to engage men for HIV services
changes in diagnoses or other surveillance measures could reliably and prevention including pre-exposure prophylaxis (PrEP). Here we
approximate HIV incidence changes for evaluation of combination HIV report on feasibility of engaging young men who drink alcohol for
prevention programs. PrEP.
Methods: We used a calibrated model of HIV transmission, antiretrovi- Methods: In the rural Msinga sub-district of Kwazulu-Natal province,
ral therapy (ART) and pre-exposure prophylaxis (PrEP) among men who our all-male field team offered TB symptom screening, automated
have sex with men in Baltimore, US, to simulate ten-year combination blood pressure measurement, random finger-stick blood glucose, rapid
prevention programs expanding ART, PrEP and HIV testing together, HIV test, and STI symptom screening outside of shebeens. Positive
with a one-year scaleup period. We determined how well modelled rela- screening results were referred for follow-up at local primary care
tive changes in annual HIV incidence (compared with pre-program clinics. Participants also completed the AUDIT scale, with hazardous
levels) could be reflected by relative changes in total annual HIV diag- drinking defined as score >6 for women and >8 for men. Participants
noses or other surveillance measures – diagnoses with acute infection, who tested negative for HIV were offered PrEP (TDF/FTC) according
diagnoses adjusted for testing volume, the proportion virally non-sup- to local guidelines. All PrEP initiators had a dried blood spot (DBS)
pressed - at different timepoints. We report the median (95% credible analysis for phosphatidylethanol (PEth), a biomarker for alcohol con-
interval) absolute bias of each measure in percentage points (pp). sumption.
Results: Modelled changes in total HIV diagnoses underestimated Results: Between January and May 2020, prior to interruption by
declines in new HIV infections, by 25 pp (with substantial variability: COVID-19, among 89 shebeen patrons provided with primary health
116, 5 pp) in the second year of the prevention program, 3 pp screenings, 68 (76.4%) were eligible for PrEP, and 16 (23.5%) initiated
(17, 1) in year 5, and 1 pp (5, +1) in year 10. The extent of the PrEP, a median of 14.5 days (IQR 12.5 to 19) after HIV testing.
bias was positively correlated with the increase in levels of diagnosis Among PrEP initiators (n = 16), 93.8% were male, median age was
achieved by the program. Declines in diagnoses with acute infection 29.5 years (IQR 22.3 to 37), 31.2% were employed, 56.3% had run-
always underestimated declines in incidence (by 27 pp in year 2 and ning water, and 68.8% had AUDIT score indicating hazardous alcohol
10 pp in year 10) with considerable variability. Adjusting diagnoses use. PEth results were positive (>8 ng/mL) for 12/16 (75%) of partici-
by test volume somewhat reduced biases in year 2 although they pants. Among those with negative PEth results (4/16, 25%), only one
remained variable [bias + 9 pp (6, +24)], and overestimated inci- participant met AUDIT criteria for hazardous drinking. Higher median
dence declines in year 10 [by + 14 pp (+3, +34)]. Changes in the pro- number of lifetime sexual partners was a predictor of PrEP uptake
portion virally non-suppressed gave unbiased but variable estimates of (p = 0.001).
incidence declines in year 2 [2 pp (19, +11)], but underestimated Conclusions: Engagement in PrEP at shebeens is feasible and a
incidence declines in year 10 [10 pp (31, +0)]. promising novel approach to reach difficult-to-engage young men.
Conclusions: When evaluating combination HIV prevention programs Young men in particular were interested and willing to engage in PrEP
which expand HIV testing, changes in annual total diagnoses do not through a community-based model. There was a low discrepancy
reflect incidence reductions well until several years into the program. between self-reported alcohol use and alcohol biomarkers. Alcohol
Changes in diagnoses adjusted for testing volume or the proportion consumption was not a barrier to PrEP uptake.
virally unsuppressed can give less biased (although still variable) esti-
mates of incidence changes earlier on in the program.
132
Conclusions: If effective in increasing PrEP adherence among young

PE16.06 women, SMS text message reminders may be an affordable and cost-
The incremental cost of oral pre-exposure prophylaxis effective intervention. Efforts to reduce the cost of intervention sup-
adherence monitoring and dose reminders for young plies would increase the financial feasibility and sustainability of PrEP
women adherence monitoring and reminder interventions.
K. Peebles1; C. Kiptinness2; K. Kamolloh3; L. Garrison4; K. Ngure5;
E. Bukusi5; N. Mugo5; J. Baeten5; J. Haberer4 and R. Barnabas5 PE16.07
1
University of Washington, Global Health, Seattle, United States, Understanding the characteristics of HIV seroconverters
2
Partners in Health and Research Development, Nairobi, Kenya, and circumstances around seroconversion in Zimbabwe
3
Kenya Medical Research Institute, Nairobi, Kenya, 4Harvard University,
with PrEP use
Boston, United States, 5University of Washington, Seattle, United States
N. Ndlovu1; U.M. Parikh2; L. Berner Kudrick2; M. Dunbar3;
J. Murungu1; I. Mahaka1; L. Levy4; A. Heaps2 and O. Mugurungi5
1
Background: Young women are a priority population for HIV preven- Pangaea Zimbabwe AIDS Trust, Non-Governmental Organisation,
tion. Pre-exposure prophylaxis (PrEP) is a highly effective HIV preven- Harare, Zimbabwe, 2University of Pittsburgh, Infectious Diseases,
tion method, offering greater than 90% risk reduction when used with Pittsburgh, United States, 3Pangaea Zimbabwe AIDS Trust, Non-Gov-
high adherence. However, PrEP adherence among young women has ernmental Organisation, Oakland, United States, 4FHI 360, Durham,
been sub-optimal. Affordable interventions to improve adherence are United States, 5Ministry of Health and Child Care, AIDS and TB Unit,
needed to maximize the potential impact of PrEP. Harare, Zimbabwe
Methods: We estimated the incremental economic cost from the
Ministry of Health perspective of interventions that aim to improve
PrEP adherence: Background: When used as part of combination HIV prevention, pre-
(1) adherence monitoring with Wisepill electronic devices coupled with exposure prophylaxis (PrEP) substantially reduces HIV acquisition
SMS text message reminders and among people at risk of HIV infection. Zimbabwe launched oral PrEP
(2) SMS text message reminders only. rollout in June 2018, and to date, approximately 17,000 clients from
We used micro-costing methods, including twenty time-and-motion obser- 187 sites have initiated PrEP. Despite its effectiveness it is possible to
vations, to estimate all activities and resources required for these interven- acquire HIV while on PrEP. This analysis aims to describe the charac-
tions. We evaluated the cost per person-month of interventions for the teristics associated with HIV seroconversion among PrEP users as
(1) observed program volume and PrEP goes to scale throughout the country.
(2) scale-up to achieve at-capacity program volume. Methods: The Ministry of Health and Child Care (MoHCC) and the
USAID-funded Global Evaluation of Microbicide Sensitivity (GEMS) pro-
Results: Wisepill adherence monitoring coupled with SMS text messages ject collected demographic, adherence and recent PrEP use data on
had an incremental cost of $12.64 per month for the observed program case report forms from September 2018 to June 2020, from consenting
volume (Figure). At scale, this amount was nearly halved ($7.57), as fixed clients who had access to PrEP throughout Zimbabwe, and who had
start-up costs were distributed across a greater number of months of been identified as HIV infected as per the national testing algorithm.
intervention coverage. Providing only SMS text message reminders cost Results: Twenty-one seroconversions have been reported from
less, with an incremental cost of $7.69 at observed program volume and approximately 17,000 clients on PrEP. The median age among sero-
$2.76 with at-scale program volume. The incremental staff time per PrEP converters was 27 years. Eleven (52%) were males and 10 (48%)
visit for adherence monitoring interventions was minimal, adding approxi- were females. The majority of seroconverters (9; 43%) were men who
mately two minutes to each encounter. In all intervention scenarios, the have sex with men (MSM), five (24%) had serodiscordant partners, 4
majority of costs were attributable to supplies, including Wisepill devices, (19%) were female sex workers (FSW), 2 (9%) were adolescent girls
software platforms, and cell phone airtime. and young women (AGYW), and 1 (5%) was transgender. Ten (48%)
133
seroconverters self-reported that they were adherent to PrEP, 6 Table 1. (Continued)

(28%) reported being somewhat adherent and 5 (24%) reported being
non-adherent. The median time from PrEP initiation to HIV serocon- HIV
version was 4.5 months after initiating PrEP; most participants (15, HIV Infected Uninfecteda Total
(n = 28) (n = 20) (n = 48)
71%) seroconverted within 6 months of PrEP initiation.
Conclusions: In the first two years of Zimbabwe’s PrEP program, the Permanent 46.4% (13) 35.0% (7) 41.7% (20)
proportion of seroconversions was low relative to the number of PrEP Homeless 10.7% (3) 15.0% (3) 12.5% (6)
clients. The majority of seroconversions occurred within the first Other Housing 42.9% (12) 50.0% (10) 45.8% (22)
Median years since HIV onset (IQR) 2.4 (0.3. 4.3) – –
6 months of PrEP use, therefore, further analysis is needed to deter-
Virally Suppressed (<200) at baseline 47.6% (10)b – –
mine the possibility of clients having been initiated on PrEP whilst in the Median ART prescriptions (IQR) 2 (2.3) – –
acute HIV infection phase. Ongoing analyses within this study will assess Median PrEP prescriptions (IQR) – 2 (1.4) –
HIV drug resistance and drug levels on these clients, to better under- On PrEP before mobile – 45% (9) –
On PrEP at/after mobile – 50% (10) –
stand PrEP use and inform the roll out of PrEP in similar settings.
Chlamydia diagnoses 14.3% (4) 20.0% (4) 16.7% (8)
Gonorrhea diagnoses 10.7% (3) 20.0% (4) 14.6% (7)
PE16.08 Syphilis diagnoses
Median mobile visits in 2019 (IQR)
3.6% (1)
1 (1.2)
0% (0)
1 (1.2)
2.1% (1)
1 (1. 2)
No place like home: engaging HIV and sexual health care Median follow-up visits 2019, excluding 1 (0.2) 1 (0.4) 1 (0.3)
through a mobile medical unit initial mobile visit (IQR)
Median months since first mobile visit 6.5 (3.2. 9.5) 9.4 (5.9. 10.6) 7.6 (4.3.
A. Hazra; M. Pyra and J. Schneider (IQR) 9.9)
Howard Brown Health, Medicine, United States
a
No patients seroconverted during follow-up.
b
Baseline VL were only available for 21 patients. 10 patients also had
Background: Disengagement from HIV treatment and prevention ser- a VL at a later visit and 90% were virally suppressed.
vices is a serious threat to ending the epidemic. In an effort to deliver
high quality, patient-centered care to vulnerable populations, our Fed- Conclusions: Delivery of off-site sexual health services is feasible via
erally Qualified Health Center (FQHC) invested in a Health Outreach a mobile medical unit for patients considered high-risk for disengage-
Mobile Engagement (HOME) medical unit to provide off-site HIV pri- ment. HOME visits are a promising alternative care model for our vul-
mary care and sexual health services. nerable patients, facilitating our HIV elimination efforts.
Methods: Persons living with HIV (PLWH) were eligible for HOME
visits if the last documented viral load was ≥ 200 copies/mL and there
were no visits in the previous 4 months. Pre-Exposure Prophylaxis PE16.10
(PrEP) patients were eligible if they did not have any follow-up visits Adherence to the event-driven PrEP regimen within the
in the previous 6 months. Patients identified by our supportive ser- Amsterdam PrEP demonstration project: analysis based on
vices staff as high-risk for disengagement were also referred. The online diary data
mobile unit was utilized a half-day weekly and staffed with a medical V. Jongen; E. Hoornenborg; M. van den Elshout; H. Zimmermann;
provider, medical assistant, and at times, a supportive services team L. Coyer; U. Davidovich; H. de Vries; M. Prins and M. Schim van der
member. Loeff
Results: Between January 2019 and December 2019, 48 patients Public Health Service Amsterdam, Department of Infectious Diseases,
were seen for HOME visits. Patients were predominantly cis-male Amsterdam, Netherlands
(87.5%), African-American (72.9%), and self-identified as gay/bisexual
(62.5%) with a median age of 29. Most patients were publicly insured
(50%) or uninsured (31.3%) and less than half (41.7%) reported per- Background: Daily and event-driven (i.e. before and after sex) pre-
manent/stable housing. Twenty-eight patients were PLWH, of which exposure prophylaxis (PrEP) regimens are effective against HIV acqui-
10 (47.6%) were virally suppressed at baseline. Of the HIV-uninfected sition. However, data about adherence to event-driven PrEP (edPrEP)
patients, 9 (45%) had started PrEP prior and 10 (50%) started PrEP are scarce and predominantly based on recall at 3-monthly study vis-
at or after their first mobile visit. From their first mobile visit up to its. We used a mobile-based diary application to assess adherence on
December 2019, 14.6% of patients were subsequently diagnosed with a daily basis among edPrEP users participating in the Amsterdam
gonorrhea, 16.7% with chlamydia, and 2.1% with syphilis. The cohort PrEP demonstration project (AMPrEP).
had a median of one subsequent follow-up visit during the observed Methods: Participants could choose and switch between daily and
period. Mobile Health: Descriptive Follow-Up 2019. edPrEP regimens every 3 months. They used a mobile application to
record their sexual behaviour and pill use on a daily basis. We studied
Abstract PE16.08-Table 1. adherence to edPrEP by assessing the proportion of condomless anal
sex (CAS) acts covered by PrEP. Good adherence was defined as at
HIV
HIV Infected Uninfecteda Total least one tablet before a CAS act and one tablet within 48 hours after
(n = 28) (n = 20) (n = 48) that CAS act. Determinants of good adherence were assessed using
multilevel logistic regression analysis (using participant as cluster vari-
Mean age (SD) 29.9 (8.9) 29.3 (7.8) able), stratified by type of sex partner (i.e. steady partners (SP), known
African-American 67.9% (19) 80% (16) 72.9% (35)
Cismen 82.1% (23) 95.0% (19) 87.5% (42)
casual partners (KCP) and unknown casual partners (UCP)).
Cis/transwomen 10.7% (3) 5.0% (1) 8.3% (4) Results: Between September 2015 and February 2019, 138 of 376
Orientation (36.7%) participants used edPrEP for at least one 3-month period. In
Gay 57.1% (16) 35.0% (7) 47.9% (23) this period, a total of 6282 CAS acts were reported during edPrEP
Bisexual 10.7% (3) 20.0% (4) 14.6% (7)
Straight 14.3% (4) 5.0% (1) 10.4% (5)
use. Good adherence was more common with KCP (92.8%) and UCP
Other/unspecified 17.9% (5) 40.0% (8) 27.1% (13) (90.6%), than with SP (56.8%; p < 0.001). Being in a steady relation-
Insurance ship at baseline increased the odds of good adherence around CAS
Private 21.4% (6) 15.0% (3) 18.8% (9) with KCP (adjusted odds ratio (aOR) 3.6, 95% confidence interval (CI)
Public 46.4% (13) 55.0% (11) 50.0% (24)
Self-pay/uninsured 32.1% (9) 30.0% (6) 31.3% (15)
1.7 to 7.9) and UCP (aOR 3.4, 95% CI 1.4 to 8.2). High education (i.e.
Housing university level) was associated with good adherence around CAS with
134
KCP (aOR 3.1, 95% CI 1.2 to 8.5). No determinants were significantly women, while the remaining 17% were either TG men or gender non-
associated with good adherence around CAS with SP. conforming, 67.4% (1105/1639) were unemployed, 15% (347/2302)
Conclusions: In this PrEP demonstration study, adherence to edPrEP reported sex in exchange for money/goods, 31% (705/1639) had con-
was very high for CAS acts with casual partners. For sex acts with domless receptive anal sex in the last year, 74% (1712/2302) had >4
both known and unknown causal partners being in a steady relation- glasses of alcohol in a day in the prior 30 days.
ship was associated with good adherence. This might indicate that par- Prior to accessing our sites, of those who were known HIV-positive,
ticipants estimate their risk for HIV acquisition and that protecting only 72% (106/147) were taking ART, for those with a recent nega-
their partner against HIV might be an extra motivator for good adher- tive test, only 7% (26/380) were on PrEP. Just 4% of clients (62/
ence. 1639) had ever sought gender-affirming care hormones, surgery, psy-
chosocial, off-label contraception), and of these, only 39% (24/62) suc-
PE16.11 cessfully accessed care.
Conclusions: The program reached over 40% of the estimated TG
Baseline evaluation of a novel model for gender affirming
population (1786/4195) in our districts with clinical services in the
healthcare and HIV prevention and treatment services for first 16 months and continues to grow. Hormone therapy provision
transgender communities in four South African cities began in February 2020, a key healthcare priority for the TG commu-
P. Mataboge1; C. O’Connor1; A. Malaza1; V. Shiba1; N. Hill1; nity. These early experiences demonstrate that programmes tailored
J. Lawrence2 and G. Maimela1 to meet the needs of underserved gender minorities in Africa can con-
1
Wits Reproductive Health and HIV Institute, Key Populations Pro- tribute to controlling the HIV pandemic.
gramme, Johannesburg, South Africa, 2USAID Southern Africa, Preto-
ria, South Africa
PE16.12
Initial Results of PrEP Implementation in a MSM Sexual
Background: Transgender (TG) people face high levels of discrimina- Health Clinic in Hanoi, Vietnam
tion, violence, mental health issues and substance use, placing them at R. Bhatia1; T.C.D. Khoa2; B.T.M. Hao2; H.T.H. Van2; T.T. Hieu2;
high risk for HIV. In South Africa, where the estimated HIV prevalence L.B. Ngoc2; V.D. Hoa2 and L.M. Giang2
among TG women is 46%, the Wits Reproductive Health and HIV 1
Centers for Disease Control and Prevention, DGHT, Atlanta, United
Institute launched TG clinics and community outreach in four South States, 2Hanoi Medical University, Hanoi, Vietnam
African districts (Johannesburg, Cape Town, Nelson Mandela Bay, and
Buffalo City) in 2018 to 2019 with support from PEPFAR.
Methods: This retrospective cohort study utilized routine data col- Background: Men who have sex with men (MSM) in Hanoi are at risk
lected between October 2018 and January 2020. Descriptive statis- for HIV. PrEP delivery started in Vietnam in 2017 and remains largely
tics summarized patient characteristics, access to gender-affirming limited to ART clinics, which may be stigmatizing and deter MSM from
healthcare, and engagement with HIV prevention and treatment ser- PrEP uptake. The MSM-friendly Sexual Health Promotion (SHP) Clinic
vices. at Hanoi Medical University Hospital is the largest PrEP site in the
Results: Sociodemographic data was available for 1639 beneficiaries, city and the first academic, non-ART sexual health center to provide
risk assessments for 3202, and clinical data for 1786. 50.5% (827/ PrEP in the country. We describe results of the first year of imple-
1639) of beneficiaries were aged <25, 82.2% (1347/1639) were TG mentation.
135
Methods: Clients were recruited from an existing observational study Results: Discovery of HIV serodiscordance threatened partnered
of adult MSM at SHP and through community outreach. PrEP eligibil- relationships for many SDCs in the qualitative subsample. Infection in
ity was defined by national guidelines. Routine program data from one partner raised the question of separation to keep the other part-
May 2019 to June 2020 were abstracted from the medical records. ner free of HIV. Demoralized at the prospect of being alone and of
Results: Of 1244 recruited to clinic, 97% (1165/1207) tested HIV committing to life-long medication, some partners living with HIV were
negative and were offered PrEP; 86% (1002/1165) enrolled. Average reluctant to initiate ART. Many HIV-negative partners ultimately
age was 26 years (SD = 6.9) and 96% (960/1002) were MSM. The decided to remain in the relationship, and accepted PrEP as a way of
most common eligibility criterion was high-risk sex partner (869/1002, signaling this decision. Partners living with HIV felt affirmed and val-
87%), and 40% (405/1002) had >1 criterion. Most (882/1002, 88%) ued by their spouses’ PrEP acceptance, and were inspired to recipro-
initiated PrEP on the same day. Of the 951 expected to complete cate by accepting ART. Through these reciprocal commitments,
one-month follow-up, 65% (621) returned. Continuation rates at 3, 6, relationships were renewed. Renewed relationships facilitated mutual
9, and 12 months were 76% (478/626), 68% (297/434), 65% (146/ ART and PrEP adherence, as many couples then took daily doses of
223), and 42% (15/36), respectively. Adherence was reported as good antiretrovirals together.
to perfect by 89% (555/621) at month 1, 87% (418/478) at month 3, Conclusions: PrEP acceptance may facilitate ART initiation and adher-
88% (262/297) at month 6, and 91% (133/146) at month 9. Baseline ence for SDCs because of its perceived meaning as a reinvestment in
rate of syphilis was 10% (88/906), similar to that of gonorrhea (12% the partnered relationship. Greater emphasis on PrEP’s significance as
(48/390)), and chlamydia (12% (48/390)); at month 6, rates of syphilis, a way of strengthening serodiscordant relationships could help foster
gonorrhea, and chlamydia were 5% (13/268), 18% (15/84), and 12% demand for PrEP in sub-Saharan Africa.
(10/84), respectively. There were six seroconversions and no discon-
tinuations from renal toxicity. PE16.14
Conclusions: PrEP delivery in a non-ART sexual health clinic resulted
Targeted index partner HIV self-testing Results in high
in high rates of initiation, retention, and adherence, indicating this
approach is feasible, effective, and safe for MSM. Exploring barriers to
positivity yield and reach for exposed HIV-uninfected
enrollment and continuation among MSM is needed to promote con- contacts at elevated ongoing risk of HIV acquisition in
tinuation along the PrEP cascade. Differentiated PrEP delivery models Kenya
outside of ART clinics should be rapidly adopted to enhance PrEP K. Mugwanya1; C. Kiptinness2; K. Ngure3; E. Irungu4; N. Kipkurui2;
options and uptake among MSM in Vietnam. F. Ambiyo2; N. Wairimu2; G. Maina2; G. O’Malley1; N. Mugo4 and
J. Baeten5
1
PE16.13 2
University of Washington, Global Health, Seattle, United States,
Partners in Health Research and Development, Nairobi, Kenya,
How PrEP acceptance facilitates ART initiation and 3
Jomo Kenya University of Agriculture and Technology, Kenya, 4Kenya
adherence for Ugandan serodiscordant couples: an
Medical Research Institute, Nairobi, Kenya, 5University of Washington,
explanation derived from qualitative data Global Health, Seattle, United States Minor Outlying Islands
N. Ware1; T.R. Muwonge2; M.A. Wyatt1; V. Kasiita2; B. Kamusiime2;
A. Nalumansi2; C. Twesige2; S. Namanda2; E. Pisarski1; R. Heffron3 and
A. Mujugira2 Background: HIV testing is a key entry point to effective treatment
1
Harvard Medical School, Global Health & Social Medicine, Boston, and prevention strategies, but data are limited on how to best syner-
United States, 2Infectious Diseases Institute, Kasangati Centre, gize these three interventions to achieve maximum public health
Uganda, 3University of Washington, Dept. of Global Health, Seattle, impact.
United States Methods: Beginning July 2019, we conducted a pilot study of the
impact of HIV self-test (HIVST) kit distribution on identification of
individuals who could benefit from PrEP. We sequentially implemented
Background: HIV transmission in heterosexual serodiscordant couples two partner engagement strategies at two Kenyan HIV clinics:
(SDCs) accounts for up to 30% of new infections in sub-Saharan
Africa. The optimal long-term strategy for HIV prevention in SDCs is 1) invitation for clinic-based testing (historical control-period) and
viral suppression in the partner living with HIV through sustained 2) followed by HIVST kits distribution (intervention-period) to index
antiretroviral therapy (ART). Treatment programs in East Africa have HIV-positive persons (index).
accelerated ART initiation in SDC partners living with HIV when time- During each period, we enrolled consecutive indexes with partners of
limited PrEP is offered to negative partners as a “bridge” to ART. We unknown HIV status and with elevated HIV transmission risk defined
report qualitative research explaining how PrEP use may facilitate as either not on ART or on ART <6 months or a detectable viral load
ART initiation and adherence among Ugandan SDCs. (i.e., targeted engagement). Outcomes (partner engagement and test-
Methods: The Partners PrEP Program (PPP) is a stepped-wedge clus- ing, yield, and ART or PrEP initiation ascertained through index report)
ter randomized trial evaluating the impact of an integrated strategy of were compared between invitation and HIVST periods using seg-
ART and PrEP delivery on ART and PrEP initiation and adherence in mented regression methods.
public health clinics in Kampala, Uganda (ClinicalTrials.gov NCT03586128). Results: Of 249 indexes enrolled (145 invitation, 104 HIVST), 75%
Qualitative data collection includes interviews with each partner in a sub- were female and median age was 32 years (IQR 26 to 40). The major-
sample of 50 SDCs. Interview topics include: ity (58%) were newly diagnosed (≤3 months), 46% not on ART and
23% <6 months on ART, and 63% reported condomless sex with a
1) discovery of serodiscordance;
partner in the prior month. Overall, 73% (182/249) reported engaging
2) relationship quality and dynamics;
partners in discussion about HIV testing: 77% (111/145) invitation vs
3) PrEP/ART initiation;
68% (71/104) HIVST; p = 0.66. Among partners engaged, 59% (108/
4) experiences taking PrEP/ART; and
182) tested (77% HIVST vs 48% invitation; p = 0.008) with a 27%
5) clinic experiences.
(28/105) positivity yield. Partner testing occurred more frequently via
In this content analysis, qualitative data were examined inductively to HIVST engagement (adjusted prevalence ratio (aPR):1.68, 95% CI
identify and characterize concepts shedding light on the relationship 1.14 to 2.46) and when index was not yet on treatment (aPR: 1.66
of ART initiation to PrEP use. 95% CI 1.16 to 2.39), but testing frequency did not differ by sex, age,
relationship duration, or education (p > 0.05 for all). Among partners
136
with index-reported test results (n = 105), 82% (23/28) who tested either distributed HIVST kits (arm 1) or coupons to obtain HIVST kits
positive initiated treatment (80% HIVST vs 92% clinic-based; from local clinics (arm 2) to FSWs. FSWs (n = 30) and PEs (n = 28)
p = 0.60) and 20% (15/76) who tested negative initiated PrEP (16% from these intervention arms were randomly sampled to complete in-
HIVST vs 23% clinic-based; p = 0.57). depth interviews and focus group discussions, respectively. Verbatim
Conclusions: HIVST kit distribution to newly diagnosed HIV-positive transcripts were analyzed thematically using inductive and deductive
individuals effectively increased sexual partner testing, had high posi- codes.
tivity yield and linkage to treatment. One-fifth of HIV-uninfected part- Results: The median age of FSWs was 28 years (IQR: 24 to 32) and
ners initiated PrEP – thus innovations to link to prevention services PEs was 33 years (IQR: 29 to 37). We found that peer dynamics,
are urgently needed. including social hierarchies, communication networks, economic power,
and HIV status disclosure, acted both as facilitators and barriers to
PE16.15 HIVST uptake, Figure 1. For example, communication networks facili-
tated HIVST uptake by effectively relaying accurate information about
Understanding how peer relationships influence peer-
HIVST procedures, but these networks were vulnerable to misinfor-
delivered HIV prevention interventions among Ugandan mation and rumors, thus hindering HIVST uptake.
female sex workers: a case study from HIV self-testing Conclusions: In Uganda, FSW peer networks have complex existing
M. McGowan1; S. Roche2; A. Nakitende3; J. Wachinger1; dynamics that act as facilitators and barriers to peer-delivered HIV
D.K. Musoke3; C.E. Oldenburg4; T. Bӓrnighausen1 and K. Ortblad2 prevention interventions. Future peer-delivered HIV prevention inter-
1
Heidelberg University, Heidelberg Institute of Global Health (HIGH), ventions should be carefully designed around existing dynamics within
Heidelberg, Germany, 2University of Washington, Department of Glo- peer networks to maximize initial and repeat intervention uptake.
bal Health, Seattle, United States, 3International Research Consortium,
Kampala, Uganda, 4University of California, Francis I. Proctor Founda-
tion, San Francisco, United States
PE16.16
Loss to follow-up among MSM on PrEP in West Africa
(CohMSM-PrEP ANRS12369–Expertise France)
Background: Female sex workers (FSWs) have tightly connected peer A. Eubanks1; M. Mimi1; B. Dembe le Keita2; C. Anoma3; T.T.E. Dah4;
networks and are at high risk of HIV infection. Studies demonstrate E. Mensah5; G. Maradan6; M. Bourrelly1; M. Mora1; L. Riegel7;
that uptake and continuation of HIV prevention interventions increase D. Rojas Castro7; I. Yaya8; B. Spire1; C. Laurent8 and L. Sagaon-
when they are peer-delivered. We analyzed qualitative data from a Teyssier1
peer-delivered HIV self-testing (HIVST) intervention among FSWs in 1
Aix-Marseille University, INSERM, IRD, SESSTIM, Marseille, France,
urban Uganda to understand how underlying peer dynamics can facili- 2
ARCAD-SIDA, Bamako, Mali, 3Espace Confiance, Cote D’Ivoire, 4Cen-
tate or hinder the uptake of HIVST delivered by peers. tre Muraz, Bobo-Dioulasso, Burkina Faso, 5Espoir Vie Togo, Togo,
Methods: Between October and November 2016, 960 FSWs were 6
ORS PACA, Marseille, France, 7Coalition Plus, Pantin, France, 8IRD,
enrolled in a four-month randomized trial testing different peer- INSERM, Univ Montpellier, TransVIHMI, Montpellier, France
delivered HIVST models in Kampala. An additional 120 FSWs were
trained as peer educators (PEs) to deliver HIVST. FSWs were >=
18 years old, self-reported exchanging sex for money or goods (past Background: Access to PrEP for men who have sex with men (MSM)
month) and had not recently tested for HIV (past 3 months). PEs is a public health priority. PrEP rollout for MSM in West Africa is
137
confronted by unknowns concerning the feasibility in this context, due Background: In eastern and southern Africa in 2018, HIV infections
to the highly vulnerable nature of MSM (stigma, precarity, high-risk among adolescent girls aged 15 to 19 and young women (YW) aged
sex). We aimed to estimate the attrition rate and identify the factors 20 to 24 were 5 times and 1.6 times higher than among adolescent
associated with loss to follow-up (LTFU) in a cohort of MSM on PrEP boys, respectively. Feasible and effective HIV prevention interventions
in West Africa. for YW are limited, and those that are available, such as PrEP, are
Methods: Since 2017, CohMSM-PrEP has offered a comprehensive underutilized for various reasons, including objection by or lack of sup-
prevention package for MSM in Mali, Cote d’Ivoire, Burkina Faso, and port from male partners. We explored YW’s and male peers’/partners’
Togo. Quarterly follow-up includes PrEP (daily or event-driven) and views on how men can support YW’s PrEP use.
socio-behavioral data collection. Participants from a previous MSM Methods: We used photovoice to capture views among:
cohort and new participants were enrolled. LTFU was defined as not
attending the last two scheduled follow-up visits. The Kaplan-Meier 1) YW taking PrEP aged 20 to 24 who were enrolled in the
technique and log-rank test were used to estimate time to LTFU and DREAMS program, and
to test for significance between groups. The Cox proportional hazards 2) male peers/partners aged ≥ 18 years who were either a friend or
regression model was used to determine predictors of LTFU and sexual partner of a YW.
adjusted by confounders. Participants completed several photo assignments focused on YW’s
Results: 585 participants were recruited from November 2017- PrEP adherence and persistence, including influential factors among
January 2020. The median follow-up time was 15.6 months. During males and how men could support YW. Photographs were presented
this period, 119 participants were LTFU (20%). The median follow-up and discussed in same-gendered groups using the SHOWeD method.
time for LTFU participants was 3 months. The attrition rate was 1.8/ Discussions were audio recorded, translated and transcribed into
100 person-years. Newly enrolled participants left the cohort at a English, and analyzed using applied thematic analysis. Here we focus
higher rate than former CohMSM participants (p-value:<0.001). Fac- on overall themes that describe males’ influences on YW’s use of
tors associated with LTFU can be found in Table 1. PrEP, identified across all photo assignments on adherence and persis-
tence.
Abstract PE16.16-Table 1. Cox model for loss to follow-up in Results: Twenty-two YW (average age 22.5) and 17 men (average
CohMSM-PrEP age 28.1) participated in the photo assignments. The majority were
married and living with their partners (YW: n = 14; men: n = 10).
Hazard ratio[CI95], YW’s photographs and discussions typically depicted negative male
Covariate p-value influences on YW’s PrEP use—i.e., men were more often viewed as
barriers than as supporters. YW also described having little autonomy
Burkina Faso 0.81 [0.71 to 0.92], 0.001
over their sexual lives, explaining that men tend to dictate when and
Togo 0.51 [0.45 to 0.58], <0.001
how sexual encounters occur. Men’s photographs and discussions sug-
Tertiary education level 1.10 [1.01 to 1.20], 0.027
gested that men would support YW’s PrEP use if PrEP was better
Sexually attracted more to women than 1.40 [1.11 to 1.78], 0.005
promoted in the community and if men were more knowledgeable
to men
about PrEP in general. Men also explained that YW’s PrEP use is hin-
Group sex in the previous 3 months 1.34 [1.09 to 1.66], 0.006
dered by stigmatizing peer and community attitudes.
High sexual risk perception with casual 1.26 [1.12 to 1.42], <0.001
Conclusions: Currently, men appear to hinder more than help YW’s
male partner
PrEP use. However, with greater male and community engagement
Self-esteem score not very low 0.57 [0.45 to 0.71], <0.001
about PrEP, men could play an important role in facilitating and nor-
(Rosenberg scale)
malizing PrEP use among YW.
Moderate to severe depression score 0.88 [0.76 to 1.00], 0.053
(PHQ-9)
High perceived stigma score 0.75 [0.69 to 0.82], <0.001 PE16.18
“Out” to family 1.21 [1.09 to 1.33], <0.001 Integrating oral pre-exposure prophylaxis services to public
Only PrEP use during most recent 0.84 [0.72 to 0.98], 0.031 HIV care clinics in Kenya: Results from a pragmatic
receptive anal sex stepped-wedge randomized trial
Newly enrolled participant 2.21 [2.01 to 2.43], <0.001 E. Irungu1; K. Mugwanya1; N. Mugo2; E. Bukusi3; D. Donnell4;
J. Odoyo3; E. Wamoni2; S. Peacock1; J. Morton1; K. Ngure5;
M. Mugambi6; I. Mukui6; G. O’Malley1 and J. Baeten1
1
Conclusions: Our study showed a relatively high attrition rate among University of Washington, Global Health, Seattle, United States,
2
MSM taking PrEP in West Africa. Newly enrolled participants left at a Kenya Medical Research Institute, Centre for Clinical Research, Nair-
higher rate and were more likely to leave the study than those who obi, Kenya, 3Kenya Medical Research Institute, Centre for Microbiol-
participated in the previous MSM cohort. Increased support should be ogy Research, Nairobi, Kenya, 4Fred Hutchinson Cancer Research
given to new participants who have less experience in the cohort and Center, Vaccine and Infectious Disease Division, Seattle, United States,
5
with study staff. Tailoring PrEP programs to different MSM profiles is Jomo Kenyatta University of Agriculture and Technology, School of
essential for optimizing the PrEP care cascade. Public Health, Kenya, 6National AIDS & STI Control Program, Nairobi,
Kenya
PE16.17
How men can support women in taking PrEP: perspectives Background: Implementation of oral pre-exposure prophylaxis for
from young women, male partners and peers in Siaya HIV prevention (PrEP) has begun in multiple settings globally. Data on
County, western Kenya models to integrate PrEP delivery in public health systems in Africa
K. Agot1; B. Perry2; D. Ngoje3 and A. Corneli2 are limited.
1 Methods: As part of Kenya’s national PrEP roll-out, we conducted a
Impact Research and Development Organization, Research, Kisumu,
stepped-wedge cluster-randomized pragmatic trial to catalyze scale up
Kenya, 2Duke University, Department of Population Health Sciences,
of PrEP delivery integrated in 25 public health HIV care clinics in
Durham, United States, 3Impact Research and Development Organiza-
Kenya (The Partners Scale-Up Project). The project team conducted
tion, Kisumu, Kenya
case-based PrEP training of clinic staff, provided ongoing technical
138
support, and abstracted data from client records. All PrEP provision whom returned at 1 month for a refill; of those who returned at
was done by existing clinic staff without additional financial support 1 month, 21% persisted with PrEP for 6 months and 9% for 12 months.
and PrEP medication was provided as part of routine Ministry of Of 1972 who returned after a refill gap of ≥ 1 month, 509 (26%)
Health supply chains. Key outcomes included PrEP initiation, adher- restarted PrEP. Fifteen HIV seroconversions were observed over 730
ence, and remaining HIV free. person-years of follow-up for an HIV incidence of 2.1 per 100 person-
Results: Between February 2017 and June 2019, 4898 persons initi- years (95% CI 1.2, 3.4). Six seroconverted early (months 1 to 3) and nine
ated PrEP, accounting for ~10% of total PrEP initiations in Kenya dur- later. Eleven of the 15 seroconverters reported poor adherence or
ing that period. The mean monthly PrEP initiations per clinic stopped PrEP prior to seroconversion. Of 12 with resistance results, 2
increased significantly from 0.1 (standard deviation [SD] 0.5) prior to of 5 early seroconverters and none of 7 late seroconverters had
7.5 (SD 2.7) after intervention introduction (relative risk: 23.7, 95% M184V mutations associated with emtricitabine; none had tenofovir-
CI 14.2, 39.5, p < 0.001). Of those initiating, 2640 (54%) were associated mutations.
women, median age was 31 (IQR: 25 to 39) years, 4092 (84%) Conclusions: PrEP initiation was high among Kenyan and South Afri-
reported a partner living with HIV, and 2817 (58%) reported incon- can AGYW. Although only a fifth persisted with PrEP through
sistent condom use. Of all initiating PrEP 57%, 44% and 34% 6 months, one-quarter restarted PrEP, suggesting that women can
returned for refill at 1, 3, and 6 months, respectively; when excluding recognize when they need PrEP. Strategies to simplify PrEP delivery,
individuals known to have intentionally discontinued PrEP (e.g. after support adherence and/or provide different PrEP options for African
antiretroviral therapy initiation by their partner), return for PrEP was AGYW could improve persistence and protection.
74%, 68% and 63% at 1, 3 and 6 months and approximately 10% of
those who missed a refill returned later for PrEP re-initiation. Teno- PE16.20
fovir diphosphate was detected in 96% of blood samples collected
Pre-exposure prophylaxis (PrEP) uptake and adherence in
from a randomly selected subset of clients (n = 71). Six HIV infec-
tions were observed over 2550 person-years of observation (inci-
gays, bisexuals and transgender women (GBT): qualitative
dence 0.2 per 100 person-years), three of which occurred at the first insights from PrEP users, providers and GBT leadership in
visit after PrEP initiation. coastal Kenya
Conclusions: In Kenya’s large programmatic delivery of PrEP in HIV M. Kimani1; E. Sanders2; E. Van der Elst2; D. Operario3; T. Rinke
care clinics, we observed high uptake, reasonable continuation with high DeWit4; S. Graham5; O. Chiro2 and N. Mukuria2
1
adherence, frequent PrEP restarts, and low HIV incidence. Integration KEMRI-Wellcome Trust Research Program, Training, Kilifi, Kenya,
2
of PrEP services within public HIV care clinics in Africa is feasible. KEMRI-Wellcome Trust Research Program, IAVI, Kilifi, Kenya, 3Brown
University, Public Health, Providence, United States, 4University of
PE16.19 Amsterdam, Global Health, Amsterdam, Netherlands, 5University of
Washington, Global Health, Seattle, United States
PrEP initiation, persistence, and HIV seroconversion rates in
African adolescent girls and young women (AGYW) from
Kenya and South Africa: The POWER demonstration Background: Gays, Bisexuals, and Transgender Women (GBT) in
project Kenya, are among the populations most affected by HIV and would
C. Celum1; E. Bukusi2; L.-G. Bekker3; S. Delany-Moretlwe4; benefit most from PrEP. Therefore, opinions and attitudes about PrEP
L. Kidoguchi5; V. Omollo2; E. Rousseau3; D. Travill4; J. Morton1; of GBT, healthcare providers (HCP) in public facilities and GBT lead-
F. Mogaka2; G. O’Malley1; G. Barnabee1; A. van der Straten6; ership in community-based settings are crucial to implementing PrEP
J. Haberer7 and R. Heffron1 programmes successfully. We conducted focus groups discussions
1
University of Washington, Global Health, Seattle, United States, (FGD) with HCP and GBT leadership to explore their opinions and
2
Kenya Medical Research Institute, Nairobi, Kenya, 3Desmond Tutu perspectives before, and their experiences one year after PrEP roll-
Health Foundation, Cape Town, South Africa, 4Wits RHI, University of out. Additionally, from an ongoing PrEP cohort, we invited GBT to in-
the Witwatersrand, Johannesburg, South Africa, 5University of Wash- depth interviews (IDI) to understand their experience with PrEP
ington, United States, 6Women’s Global Health Imperative, RTI Inter- access and use to capture suggestions for improvement.
national, Research Triangle Park, United States, 7Massachusetts Methods: Eleven HCP and ten GBT leaders, purposively selected,
General Hospital, United States participated in two separate FGD related to PrEP programming for
GBT prior to PrEP rollout and twelve months later (January 2018 to
2019).
Background: HIV incidence remains high among African adolescent Nineteen GBT (11 gays, bisexuals and 9 transgender women), with
girls and young women (AGYW) despite increased HIV testing, treat- varied PrEP adherence patterns, participated in IDIs. FGD topic
ment and improved viral suppression in Africa. Pre-exposure prophy- guides explored PrEP knowledge, appreciation of differential HIV
laxis (PrEP) delivery is expanding among African AGYW, and data on acquisition risk among GBT, and PrEP dispensing venue preferences
initiation, continuation, and HIV acquisition can inform broader scale- and challenges. The IDI topic guide explored issues including, self-
up of PrEP delivery. assessment of HIV acquisition risk, motivation for PrEP uptake and
Methods: POWER is a PrEP implementation study among sexually adherence, and reasoning behind varies adherence patterns. Data
active HIV negative AGYW ages 16 to 25 in Kisumu, Kenya and Cape were managed in NVivo-11, Braun and Clarke thematic analysis was
Town and Johannesburg, South Africa. Follow-up visits occur at applied.
1 month and then quarterly for up to 36 months. PrEP initiation and Results: The desire to remain HIV negative strongly motivated GBT
persistence were assessed using Kaplan-Meier survival analysis; per- to start PrEP. Poor or failed PrEP adherence was attributed to lack of
sistence was defined as uninterrupted PrEP refills through 6 and comprehension, travel, non-disclosure and stigma. GBT expressed sen-
12 months among women who attended their 1-month visit. timent on public hospitals being inappropriate PrEP dispensing venues.
Results: From June 2017-May 2020, 2469 AGYW were enrolled with HCP felt unprepared to provide PrEP to GBT, because of sexuality
1000 from Kisumu, 763 from Johannesburg, and 706 from Cape Town. stigma and poor PrEP baseline knowledge. One year after PrEP roll-
The median age was 21 years (IQR 19, 23) and 344 (14%) were mar- out, GBT leadership remained skeptical about HCP’s commitment to
ried. All women reported a current sexual partner, for 1599 (65%) their provide PrEP to GBT. Both HCP and GBT leadership felt public hospi-
partner’s HIV status was unknown and only 102 (4%) reported a known tals inappropriate venues for PrEP provision.
HIV-positive partner. Overall, 2315 (94%) initiated PrEP, 688 (30%) of
139
Conclusions: HCP improved PrEP preparedness and exposure assess-

ment are of primary importance for GBT PrEP uptake and adherence. PE16.22
HCP’s tactical reluctance, and GBT leadership’s persistent distrust Starting and staying on PrEP: a scoping review of strategies
towards HCP’s commitment to offer PrEP to GBT seemed to impede for supporting and improving effective use of PrEP
success of PrEP. HCP require GBT sensitivity training. Alternative and J. Rodrigues1; W. Mukoma2; J. Reed3; R. Eakle4; J. Presley5 and
specific GBT-PrEP dispensing platforms are needed to optimise PrEP M. Warren6
uptake and adherence among GBT. 1
AVAC, Product Introduction and Access, New York, United States,
2
Independent Consultant, Kenya, 3Jhpiego, Baltimore, United States,
PE16.21 4
USAID, United States, 5Bill and Melinda Gates Foundation, Washing-
HIV risk perceptions and receptiveness to PrEP among ton, United States, 6AVAC, New York, United States
AGYW accessing post-abortion care
E. Casmir1; K. Ngure2; L. Aswani3; B. Kwach3; C. Kiptinness4; Background: Oral pre-exposure prophylaxis (PrEP) is highly effica-
D. Thomas5; E. Ossome3; F. Ambiyo4; H. Machafu3; N. Wairimu4; cious, but effectiveness is dependent on continued use during seasons
V. Ogello3; Y. Zia6; C. Scoville5; T. Barker7 and E. Bukusi8 of HIV risk. Rates of continued use, where available, decline over time
1
Center for Clinical Research, Kenya Medical Research Institute, Cen- across populations and settings. While individual and structural barri-
ter for Clinical Research, Nairobi, Kenya, 2Jomo Kenyatta University ers to continued use of oral PrEP have been identified, strategies to
of Agriculture and Technology, Department of Community Health, support continuation are less known.
Juja, Kenya, 3Research Center for HIV Care Treatment and Preven- Methods: We analyzed existing evidence on strategies to improve
tion, Kisumu, Kenya, 4Center for Clinical Research, Kenya Medical PrEP continuation. We searched PubMed, clinical trials databases,
Research Institute, Nairobi, Kenya, 5University of Washington, Depart- international conferences and bibliographies of identified articles for
ment of Global Health, Seattle, United States, 6University of Washing- studies published between 2015 and 2020. Of 1095 studies retrieved,
ton, Department Epidemiology, Seattle, United States, 7Children’s 12 specifically assessed PrEP continuation interventions. Semi-struc-
Investment Fund Foundation, London, United Kingdom, 8Center for tured interviews were conducted with 18 key informants.
Microbiology Research, Kenya Medical Research Institute, Nairobi, Results: Ten studies were categorized by type of intervention: (1)
Kenya mhealth (n = 5), (2) peer-based (n = 1), (3) provider-initiated/counsel-
ing (n = 3) and (4) expanded access (n = 1). Two studies examined
program and survey data. Most of the studies were conducted among
Background: Adolescent girls and young women (AGYW) accessing men who have sex with men (MSM) and transgender women in the
care following pregnancy loss (including induced abortions) are likely United States. Race-and-age-based disparities were reported with
to continue having condomless sex, putting them at risk of HIV acqui- lower rates of continued use among young people globally and black
sition, unintended pregnancy and other sexual and reproductive health MSM in the United States. Reminders and follow-up messages via
complications. Using mixed-methods, we sought to understand experi- SMS between PrEP users and providers increased adherence among
ences with pregnancy loss and willingness to use HIV prevention, par- MSM and women, and reduced missed doses. ART-adapted counseling
ticularly PrEP, among AGYW accessing pregnancy loss care. interventions and peer-based strategies showed mixed results across
Methods: We enrolled AGYW aged 15 to 30 years accessing preg- different populations. Younger people and marginalized populations
nancy loss care from health facilities in Central and Western Kenya. require more structured and tailored support such as flexible visit
At enrollment, each participant completed a survey assessing behavior, schedules, frequent check-ins and personalized communication. Key
alcohol/drug use, salience and perception of HIV and pregnancy, informants advocated for a range of PrEP delivery options to suit user
reproductive and medical history, and PrEP knowledge and willingness preferences and ease access by building social acceptability and elimi-
to use. Urine samples were collected to assess for Neisseria gonor- nating unnecessary clinical monitoring.
rhea (NG) and chlamydia trachomatis (CT). We conducted in-depth Conclusions: Further research is needed to evaluate and adapt
interviews among 30 participants, using semi-structured guide with promising strategies to improve PrEP continuation and adherence.
purposively sampled participants based on a validated risk score for Mhealth, counseling strategies, and differentiated delivery of PrEP are
incident HIV infection. Quantitative data were descriptively analyzed highly acceptable, feasible and have potential for impact across popu-
and qualitative data were thematically analyzed. lations and locations. Applying behavioral economics to inform continu-
Results: Among the 200 AGYW enrolled, the median risk score was ation interventions is underexplored and can expand understanding of
5 (IQR 3 to 6) which would equate to expectations of HIV incidence how PrEP users make decisions. Strategies that support users to stay
of >7.0 per year. The median age of participants was 21 years; CT on PrEP, restart PrEP after stopping, or effectively switch methods
prevalence was 18.2% and NG was 2.0%. Nearly half of the AGYW during periods of risk are critical to maximizing the impact of HIV
had prior PrEP knowledge, (2.5%) had previously used PrEP; 46.5% biomedical prevention.
expressed interest in initiating PrEP and 33% received PrEP referral.
Following a PrEP counseling session, 89.8% believed PrEP would keep
them healthy and 93.1% expressed interest in learning more about PE16.23
PrEP alongside sexual and reproductive health services. HIV risk per- Decreased 3-month pre-exposure prophylaxis (PrEP)
ception assessed through in-depth interviews, was low. Participants continuation and adherence during COVID-19 in Hanoi,
expressed willingness to access PrEP information and initiate PrEP as Vietnam
part of pregnancy loss care services, but expressed desire to access K. Tran1; H. Bui Thi Minh1; R. Bhatia2; H. Nguyen Thi1; K. Nguyen
refills and follow-up services from a different service point, to avert Duc1; N. Lung Bich1 and G. Le Minh1
stigma and trauma associated with abortion and desire to avoid 1
Hanoi Medical University, Center for Training and Research on Sub-
returning to post-abortal clinics. stance Abuse – HIV, Hanoi, Vietnam, 2US Centers for Disease Control
Conclusions: A significant proportion of AGYW had biological and and Prevention, CDC-PEPFAR Vietnam, Vietnam
behavioral risk for HIV acquisition and reported willingness to initiate
PrEP. Post-abortal care services provide an opportunity to integrate
HIV prevention services and reach a population with ongoing vulnera- Background: Vietnam recorded its first case of COVID-19 on Jan-
bility. uary 23, 2020 and declared an epidemic on February 1, 2020. The
“all-of-country” response enlisted healthcare workers including those
140
from the Sexual Health Promotion (SHP) Clinic, the largest PrEP site and relative saturation score, which was a function of estimated male
in Hanoi. Nationwide social distancing and a halt on public transport population, HIV prevalence, and total prior VMMCs reported. The
were implemented for three weeks, from April 1, 2020 to April 22, median annual target for urban health centers was ~400, compared to
2020, though SHP remained open. We determined impact of COVID- ~100 for rural health centers, and ~60 for health posts. Facility tar-
19 on the PrEP program at SHP. gets rolled up to province aggregates ranged from a low of ~18,000
Methods: We utilized routinely collected clinic data and applied (North Western) to ~106,000 (Lusaka).
descriptive statistics. Continuation was defined as the ratio of the Conclusions: We executed an iterative feedback process such that
number of clients who returned and refilled PrEP within 30 days of facilities could update data after verifying physical records on site,
their follow-up appointment over the total number of clients who had and targets would then be adjusted based on new data feeds. In
a follow-up appointment in a given time period. cases where significant gaps were observed, majority was due to (a)
Results: As of February 1, 2020, there were 823 PrEP clients (mean under-reporting of procedures; and (b) substantial misattribution of
age 26 6.8), and 97% were men who have sex with men. In January procedures performed in one facility to another affiliate. This iterative
and February, on average 51 clients initiated PrEP per month. Initia- process is still in its nascent stage, but holds promise of raising facility
tions fell to 39 in March and 23 in April, followed by an increase to accountability and data accuracy going forward.
58 in May. In the 4-month period before February 1, 2020, 3- and 6-
month continuations were 79% (269/342) and 74% (115/156), PE16.25
respectively; in the 4-month period after February 1, 2020, continua-
Increasing the uptake of VMMC services among men
tions were 77% (107/139) at 3-month and 71% (183/259) at 6-
month. Three-month continuation was 89% (33/37) in February, 79%
15 – 49 using commercial farming platforms: Lessons learnt
(31/39) in March, 64% (18/28) in April, and 66% (23/35) in May. from Zambia
Three-month self-reported adherence was good to perfect by 97% W. Khondowe1; D. Dixon2; M. Chanda3; W. Kanjipite4; F. Tembo1;
(32/33) in February, 84% (26/31) in March, 78% (14/18) April and G. Lingenda5; E. Gold6 and V. Kiggundu7
1
78% (18/23) in May. JSI, USAID SAFE, Programs, Lusaka, Zambia, 2JSI, USAID SAFE,
Conclusions: During the period of distancing in April, PrEP initiations Leadership, Lusaka, Zambia, 3JSI, USAID SAFE, Technical, Lusaka,
fell by over half but rebounded quickly. In contrast, 3-month continua- Zambia, 4JSI, USAID SAFE, Strategic Information, Lusaka, Zambia,
5
tion declined steadily from February, which persisted through May. USAID, ZAMBIA, Programs, Zambia, 6John Snow Inc, Programs, Uni-
This may reflect the relatively larger contribution of virtual and com- ted States, 7USAID, Technical, United States
munity support for PrEP recruitment as compared to continuation,
which is managed by the clinic. Explorations of patient-level and other
factors contributing to decreased continuation are warranted to miti- Background: The World Health Organization (WHO) recommends
gate further loss-to-follow-up and prepare for a potential second wave Voluntary Medical Male Circumcision (VMMC) as a priority interven-
of COVID-19. tion for combination HIV prevention in countries with high HIV preva-
lence and low levels of male circumcision. However, most VMMC
programs experience insufficient VMMC service uptake among males
PE16.24 15 and older. We describe the use of commercial farming platforms in
Building targets from the ground up: How local Zambia to improve VMMC uptake among older adolescents and men.
performance data can help reach HIV prevention goals Methods: The USAID Supporting an AIDS-Free Era (SAFE) project
L. Chang1; P. Funsani2; R. Kamboyi2; T. Mwamba3; P. Odawo4; has been supporting the Ministry of Health since October 2017.
A. Rosen3; S. Kretschmer5; A. Samona6 and T. Chisenga2 Between October 2019 and May 2020, USAID SAFE identified five
1
Independent Consultant, South Africa, 2Ministry of Health, Zambia, farm blocks around Mkushi in Central Province as sites where VMMC
3
CHAI, Lusaka, Zambia, 4Bill & Melinda Gates Foundation (BMGF), services could be provided to increase uptake in males 15 and older.
Nairobi, Kenya, 5DESIRELine, Turkey, 6DESIRELine, Zambia A farm block is a group of 6 to 10 commercial farms in a defined geo-
graphic location. These five farm blocks consist of more than 60%
male workers aged 15 and older. SAFE’s outreach services were
Background: The Zambia Ministry of Health requested support for viewed as an opportunity to provide VMMC to farm workers in rural
modeling targets for Voluntary Medical Male Circumcision (VMMC) settings. Data showed more VMMC uptake in farms compared to
that are necessary to develop a sustainable program, while maintain- industrial workplaces. Therefore, SAFE, in partnership with Mkushi
ing program visibility nationwide. Since program inception in 2006, Farmers Association, engaged farm owners for key meetings, including
over 2.7 million males have been circumcised, and the Ministry is in discussions about when to provide services. Demand generation
the process of developing the 2021 to 2025 National VMMC Opera- approaches included: use of satisfied clients; engagement of health
tional Plan, which requires updated targets. The goal was to produce focal point persons employed by farm owners; and involvement of
targets for each MC facility, regardless of volume. influential women, especially in the peak months, June-August and
Methods: A deep dive into all available data sources was undertaken September-December, when farms have more seasonal workers. Ser-
to develop a comprehensive calculation algorithm for sustainable and vices were provided in a phased approach as mutually agreed with
realistic targets for each facility. Data streams included the Ministry farm management to prevent workplace productivity disruption.
service delivery database (HMIS-2) of nearly 2000 facilities since Results: The proportion of men aged 15 to 49 receiving VMMC ser-
2018, population estimates from the Central Statistical Office, large vices in five farm blocks increased from 87% in October 2019 to 98%
scale sample surveys (e.g., ZDHS, PopART), and other ancillary in May 2020. This increase was sustained and more pronounced
resources. between February and June 2020. The overall quality was very high
Results: There was wide variation across facilities in the volume and with an adverse event rate of under 1%.
regularity of VMMCs performed. Some facilities reported hundreds of Figure 1: VMMC Uptake among men 15 to 49 years in Mkushi, Cen-
procedures every month, while other facilities reported under 10 pro- tral Province, Zambia.
cedures in one month ever. Hence, past performance was computed Conclusions: Bringing VMMC services to farm blocks, through collab-
based on all sequential 12 months loops of VMMC reports. This oration with farm associations and owners, can increase service
approach minimized the impact of facilities opening and closing over uptake among underserved sub-populations, especially men aged 15
time, and accounted for the considerable variance in volume. Targets to 49. SAFE plans to scale up this model in other provinces.
were computed for each facility based on capacity, past performance,
141
PE16.26 71% to 87%.Women exposed to the program were no more likely to

use condoms with main partners than women in control communities
Effects of the Asibonisane Community Responses program
(odds ratio = 0.82, 95% CI: 0.54 to 1.24). Men exposed to the pro-
on sexual partnerships and condom use for men and
gram were more likely (than control group) to use condoms with main
women in informal settlements in KwaZulu-Natal, South partners (OR = 1.81, 95% CI: 0.94 to 3.47), as well as casual partners
Africa (OR = 6.02, 95% CI: 0.97 to 37.48), although the sample size was
M. Beksinska1; S. Psaki2; J. Pulerwitz2; B. Zieman2 and P. Hewett2 small for the latter comparison.
1
University of the Witwatersrand, MRU, Dept of O&G, Durban, South Conclusions: South Africa’s National Strategic Plan focuses both on
Africa, 2Population Council, New York, United States provision of comprehensive HIV prevention and care services, as well
as addressing the social and structural drivers of HIV infection. The
CR program was designed to take a similar approach in informal set-
Background: KwaZulu-Natal province has large informal settlements, tlements. Building the global evidence base on the effectiveness of
which may create unique challenges for HIV prevention programs. We these approaches is vital to improving outcomes.
conducted a quasi-experimental evaluation of the Asibonisane Com-
munity Responses (CR) program, an HIV and violence prevention
intervention that included Stepping Stones as a key component and PE16.27
was implemented in informal settlements. PrEP initiation and continuation among adolescent key
Methods: Timing of program rollout was randomized across evalua- population in Brazil: a cascade analysis
tion sites in 18 informal settlements. Using a two-stage random sam- I. Dourado1; L. Magno2; F. Soares1; P. Caires1; M. Eusto rgio1;
pling approach, we interviewed 768 women ages 18–24 and 758 men U. Tupinambas3; D. Greco3; M. Westin3; P. Massa4 and A. Grangeiro4
ages 18–35 in early 2017 and conducted three cohort follow-up 1
Federal University of Bahia, Collective Health Institute, Salvador, Bra-
rounds at seven-month intervals, with the last round in 2019. We zil, 2State University of Bahia, Health Life Department, Brazil, 3Federal
report trends and effects of the CR program on sexual partnerships University of Minas Gerais, School of Medicine, Brazil, 4State Univer-
and condom use. sity of S~ao Paulo, School of Medicine, Brazil
Results: At baseline, 72% of women and 60% of men reported sex
with a primary partner in the last six months, which increased signifi-
cantly during follow-up, to 79% for women and 72% for men. At base- Background: PrEP initiation/continuation among adolescents MSM
line, slightly more than half of men (55%) and women (54%) reported and TGW (AKP) is a challenge to implementation science and health
using condoms at last sex with main partners, which declined during services. Our goal is to analyze PrEP initiation and continuation among
follow-up to 50% for women and 43% for men. At baseline, 1% of AKP.
women and 17% of men reported sex with a casual partner in the last Methods: PrEP1519 study is the first PrEP demonstration study ongo-
six months, which remained stable for women and increased for men ing in 3 Brazilian cities among AKP aged 15 to 19 yo. Participants are
to 22%. Condom use with casual partners increased for men from actively recruited by peer educators (PE) who engage with AKP at venues
142
and schools, at online platforms/apps/transgender chatbot, and by refer- Abstract PE16.28-Table 1.

rals from NGO/health services. AKP were recruited, screened for risk
N (%) or median (IQR)
(≥15 to 19 yo and reporting anal sex) and enrolled between 1 April/2019
to 29 May/2020. Those interested in PrEP received counselling/clinical/ Variable HIV-uninfected HIV-infected Total
laboratory eligibility screening. If eligible, same-day PrEP initiation offered
and they received a 30-day supply of TDF/FTC. A PrEP care continuum Participants enrolled 56 43 99
Demographics
developed to report proportions for seven steps associated with 1- Link
Age (years, IQR) 32 (26.5 to 42.5) 47 (35 to 53) 36 (29 to 50)
to PrEP care, 2- PrEP uptake and 3- PrEP continuation. Race 37 (74.0%) 28 (66.7%) 65 (70.7%)
Results: A total of 538 AKP were recruited, HIV prevalence at base- White 3 (6.0%) 2 (4.8%) 5 (5.4%)
line of 5%. Among HIV negatives, 96% engaged in the PrEP1519 clin- Black 4 (8.0%) 3 (7.1%) 7 (7.6%)
Asian 1 (2.0%) 1 (2.4%) 2 (2.2%)
ics and received eligibility screening. Of those, 91% were eligible to
Native American/Alaska Native 1 (2.0%) 2 (4.8%) 3 (3.3%)
start PrEP. The majority (89%) initiated PrEP at same day. 92 eligibles Multiple races 4 (8.0%) 6 (14.3%) 10 (10.9%)
decided to enroll in other HIV prevention method and continued to Other 19 (33.9%) 18 (41.9%) 37 (37.4%)
be followed as well. A high proportion (82%) returned 1-month after Ethnicity
Hispanic
PrEP initiation. Of those, 85% returned for their 3 months follow-up
Highest level of education 0 3 (7.0%) 3 (3.0%)
visit (Figure 1). The care continuum proportions did not differ by age Never graduated high school 4 (7.1%) 9 (20.9%) 13 (13.1%)
or by subgroups of AKP. High school graduate or GED 18 (32.1%) 15 (34.9%) 33 (33.3%)
Conclusions: Recruitment strategies were effective in reaching AKP Some college 28 (50.0%) 13 (30.2%) 41 (41.4%)
College graduate 6 (10.7%) 3 (7.0%) 9 (9.1%)
at high risk of HIV infection and promoting high engagement in PrEP
Any postgraduate studies
clinics. High proportions of AKP who can benefit from PrEP do initiate Sexual behaviors, last 3 months
and continues on PrEP within 3 months of follow-up. These reassuring Number of partners 7.5 (4.0 to 21.5) 5 (3 to 16) 7 (3 to 20)
findings are most likely due to innovative and creative ways of recruit- HIV-positive partners 19 (36.5%) 31 (81.6%) 50 (55.6%)
Number of partners, insertive sex 4 (1 to 12) 2 (1 to 8) 3 (1 to 9)
ing AKP and maintain into the PrEP care continuum.
Number of partners, receptive sex 3.5 (1.0 to 10.0) 4.5 (2.0 to 9.0) 4 (1 to 10)
STI diagnoses
PE16.28 STIs diagnosed in the past year
Syphilis
7 (12.5%)
36 (64.3%)
4 (9.3%)
27 (62.8%)
11 (11.1%)
63 (63.6%)
Evaluation of doxycycline post-exposure prophylaxis to Chlamydia 34 (60.7%) 25 (58.1%) 59 (59.6%)
reduce sexually transmitted infections in men who have sex Gonorrhea
STIs diagnosed at enrollment 11 (19.6%) 21 (48.8%) 32 (32.3%)
with men and transgender women living with HIV or using Syphilis 7 (12.5%) 9 (20.9%) 16 (16.2%)
HIV PrEP: the pre-COVID cohort Chlamydia 6 (10.7%) 9 (20.9%) 15 (15.2%)
R. Perkins1; C. Celum2; S. Cohen3; J. Dombrowski4; J. Fairbanks2; Gonorrhea
C. Grabow2; C. Malinski4; L. Reyes-Umana5; M. Nasser3; S. Yassin3;

C. Kimsey2; D. Havlir5; S. Buchbinder3; H. Scott5 and A. Luetkemeyer5 Conclusions: The DoxyPEP study has demonstrated the feasibility of
1
University of Washington, Global Health, Seattle, United States, enrolling a diverse population of sexually active MSM with a high
2
University of Washington, Seattle, United States, 3San Francisco prevalence of syphilis, chlamydia, and gonorrhea into a randomized
Department of Health, City Clinic, United States, 4Seattle King County evaluation of the safety and effectiveness of doxycycline PEP.
STD Clinic at Harborview Medical Center, United States, 5Zuckerberg
San Francisco General, UCSF, HIV/ID and Global Medicine Division,
San Francisco, United States
PE16.30
Prevalence of syphilis among adolescents’ men who have
sex with men (MSM) and transgender women (TGW) in
Background: Sexually transmitted infection (STI) rates among men who Brazil
have sex with men (MSM) and transgender women (TGW) in the US are F.S. Gomes1; I. Dourado1; L. Magno1; M. Eustorgio Filho1; T. Fonseca1;
at an all-time high. Interventions to reduce STIs are needed, including P. Caires1; F. Mateus Duarte1 and F. Lima2
the safety and effectiveness of doxycycline post-exposure prophylaxis 1
Federal University of Bahia, Institute of Collective Health, Salvador,
(PEP) among MSM TGW living with HIV (PLWH) and on HIV PrEP. Brazil, 2Federal University of Bahia, Pharmacy Department, Salvador,
Methods: DoxyPEP is a randomized open-label trial that will enroll Brazil
sexually active MSM TGW living with HIV (n = 390) or on PrEP
(n = 390) in Seattle and San Francisco. MSM reporting condomless
sex and a bacterial STI in the past year are randomized 2:1 to take Background: Syphilis seroprevalence is high in key populations (KP)
200 mg open-label doxycycline within 72 hours of sex vs. no doxycy- and on the rise among adolescents MSM and TGW (AKP). Our goal is
cline. STI testing for gonorrhea, chlamydia, and syphilis was conducted to estimate syphilis seroprevalence and associated factors among par-
quarterly and when symptomatic to evaluate 12 month STI incidence ticipants of the first PrEP demonstration study among AKP aged 15
between the arms. Characteristics of the population enrolled before to 19 yo in Latin America, ongoing in three Brazilian cities (PrEP1519
the COVID-19 study hold are analyzed. Study).
Results: From November 2019-March 2020, 99 MSM were enrolled Methods: We analyzed baseline data from participants´ PrEP enrol-
(56 PrEP users and 43 PLWH) with a median age of 36 years, 5% ment between March-December, 2019 for Salvador site. Syphilis was
Black, 37% LatinX, and 84% with some college education. PLWH detected by Rapid Tests (RT), Venereal Disease Research Laboratory
reported a median of 7.5 partners in the prior 3 months and MSM on (VDRL) and Treponemal Elisa Tests (TET). Prevalence of two syphilis
PrEP reported a median of 5 partners with 31 (82%) having HIV- outcomes estimated: 1) lifetime syphilis (RT+) and 2) active syphilis
infected partners. STI diagnoses in the 12 months before enrollment (VDRL ≥ 1/2 and TET positive). Predictors of syphilis infection
were chlamydia (64%), gonorrhea (59%), and early syphilis (11%). At selected from baseline data. Descriptive, bivariate (p-value at 10% sig-
enrollment, STIs were more common among PLWH: 49% with syphilis, nificance level), and multivariate analysis using logistic regression were
21% with chlamydia, and 21% with gonorrhea compared to 21%, 13%, conducted.
and 11%, among MSM on PrEP, respectively. No TGW have enrolled Results: Complete syphilis results were available for 110 participants
to date; increased efforts to recruit TGW are underway. out of 130 (84.6%) enrolled in PrEP within 10 months. Of those,
90% MSM and 10% TGW, 87.3% 18 to 19 yo, 85.4% blacks. Lifetime
143
and active syphilis prevalence at baseline were 16.8% and 11.9% CI:7.03 to 21.38, p < 0.001). We saw a similar pattern in the interper-
respectively. And differ by subgroups: 14.3% and 9.6% for MSM, and sonal and communication skills sub-scores.
38.5% and 30.8% for TGW, respectively (p < 0.05). Lifetime and Conclusions: Simulated patient training improved provider knowledge
active prevalences were greater among AKP with lower levels of and interpersonal communication skills for offering PrEP to AGYW.
schooling (≤8 years) and with a history of commercial sex (p < 0.10). Improvement was achieved following at least three simulated case
Those reporting unprotected sex at first sexual intercourse and an encounters between HCWs and SPs. Findings suggest SP training is
episode of STI in the last 12 months had a higher prevalence of life- useful to strengthen provider PrEP knowledge and interpersonal skills
time syphilis (p < 0.10). Besides, those reporting experiences of dis- to engage and counsel AGYW on PrEP for HIV prevention as sub-
crimination and violence based on sexual orientation had a higher Saharan Africa strives toward global elimination targets.
prevalence of active syphilis (p < 0.10). In multivariable analysis, AKP
with a lower level of schooling had higher odds of lifetime syphilis PE16.32
and active syphilis (OR 20.8; 95% CI: 3.8 to 112.3) and (OR 6.6; 95%
Multipurpose prevention technologies: Strategy
CI: 1.7- 26.4).
Conclusions: PrEP access and enrolment increased STI screening and
recommendations to guide the most promising products
management. The estimated syphilis prevalences highlight the need to from the lab to hands of women
incorporate points of care model to AKP, especially TGW, enabling the B. Young Holt1; S. Moore1; A. Hemmerling2; K. Nanda3; G. Kopf3;
immediate treatment, link to healthcare, and reduction of syphilis T. Palanee4 and S. Achilles5
1
transmission chains. The higher prevalence among AKP with low levels CAMI Health, Initiative for MPTs (IMPT), Oakland, United States,
2
of schooling indicates the importance of discussing STI prevention and University of California San Francisco, Bixby Ctr for Global Health,
sexual health among youth at an earlier age, and schools. San Francisco, United States, 3FHI360, Durham, United States, 4Wits
RHI, Johannesburg, South Africa, 5Magee- Womens Hospital, ObGyn,
Pittsburgh, United States
PE16.31
Number of training scenarios required to achieve
competence in PrEP delivery for adolescents: a Background: Multipurpose prevention technologies (MPTs) are prod-
standardized patient actor intervention in Kenya ucts designed to prevent a combination of HIV, other sexually trans-
A. Larsen1; J. Sila2; K. Wilson3; F. Abuna2; V. Kemunto2; G. Owiti2; mitted infections (STIs), and/or pregnancy. Recent results from long
J. Pintye4; B. Richardson5; J. Kinuthia6; G. John-Stewart3 and acting HIV prevention trials in parallel with the MPTs in the pipeline
P. Kohler4 herald an exciting time for the MPT field. However, given finite
1
University of Washington, Department of Epidemiology, Seattle, Uni- resources and technical challenges to advance products from preclini-
ted States, 2University of Nairobi, Kenya, 3University of Washington, cal through clinical evaluation, objective benchmark criteria would be
Department of Global Health, Seattle, United States, 4University of useful to identify and guide the most promising pre-clinical MPT can-
Washington, School of Nursing, Seattle, United States, 5University of didates through the pipeline. This presentation describes MPTs in
Washington, Department of Biostatistics, Seattle, United States, development and a strategy for bridging funding and development
6
Kenyatta National Hospital, Obstetrics and Gynecology, Kenya gaps.
Methods: The Initiative for MPTs conducted the annual update of
the MPT Product Development Database between February - June
Background: Uptake of pre-exposure prophylaxis (PrEP) among ado- 2020 using the following benchmarks: availability of preclinical or clini-
lescent girls and young women (AGYW) in sub-Saharan Africa is insuf- cal test results suggestive of efficacy for two or more indications (con-
ficient to reach global HIV elimination targets. Poor quality of PrEP traception, or prevention of HIV and/or other STIs). Resources used
counseling, including guideline non-adherence and judgmental commu- to update the database included: published peer-reviewed literature,
nication, contributes to low uptake in AGYW. We evaluated changes in relevant scientific conferences, product developer updates, and pub-
quality of PrEP services among healthcare workers (HCW) following a licly available funding data. To guide the advancement of the most
standardized patient actor (SP) training intervention. promising candidates we convened a group of experts to outline a
Methods: We used SPs to improve HCW skills in AGYW PrEP deliv- process for establishing benchmark criteria to move promising candi-
ery in Kisumu, Kenya. Six trained actors (SPs) role-played encounters dates forward.
with HCWs, following case scripts depicting common AGYW PrEP- Results: As of June 2020, of the 25 MPT candidates in the search-
seeking scenarios. The order in which HCW participated in role-played able database, most are in pre-clinical development (17/25) and com-
encounters was randomized. SPs used a checklist to report domains bine contraception and HIV prevention (14/25). Two candidates are in
of HCW adherence to guidelines (binary) and communication skills late clinical stages (III or IV) of development. Several non-hormonal
(Likert scales), created by content experts to reflect adherence to contraceptive MPTs are in development (7/25) as well as some with
national PrEP guidelines. Interpersonal skills (Likert scales) checklists non-HIV anti-infective indications (e.g. HSV-2, chlamydia) (16/25).
were adapted using validated scales. Mean scores were compared Delivery methods include: intravaginal rings (IRVs); dissolving inserts;
using ANOVA test and generalized linear regression, clustering by vaginal and rectal gels; implants; injectables; microarray patches; and
HCW and adjusting for training date and repeated analyses by domain pills. To advance the most promising MPT candidates through the
sub-score. pipeline, the expert group recommended convening a global authorita-
Results: During 360 individual training encounters among 60 HCW, tive committee comprised of independent multi-disciplinary experts
the overall mean score was 86% (standard deviation [SD]:8.5) and with a broad range of expertise to establish clear scientific and regula-
scores improved across encounters (p < 0.001). The first case encoun- tory driven benchmarks. Products meeting these non-biased, standard-
ter had the lowest mean score of 82.6% (SD:9.4); the fourth had the ized evaluative benchmarks, could then be presented to product
highest (88.5%, SD:5.4) (Table 1). Compared to the first case encoun- developers and funders for further development.
ter, mean scores for the fourth were six points higher (fourth vs. first Conclusions: Developing clear, standardized benchmarks for product
case coef:5.92, 95% CI:3.51 – 8.33, p < 0.001), and mean scores pla- evaluation would help expedite development of the most promising
teaued from the fourth to the sixth case. The sub-score for HCW MPTs candidates and stimulate ongoing MPT support and scientific
adherence to PrEP guidelines significantly improved by 14 points from innovation.
the first to the fourth case (fourth vs. first case coef:14.21, 95%
144
PE16.33 adherence and retention in care through MMD contributes to preven-

tion of onward transmission by maintaining viral suppression. We eval-
STI rates in PrEP programs: the importance of comprehensive
uate the effect of MMD on patient clinic attendance at the 68
sexual and reproductive health (SRH) services
Nigerian Army Reference Hospital Yaba (68NARHY) in the one-year
L. Fitch1; F. Riaz2; K. Segal2; J. Rodrigues2 and M. Warren2 period post-implementation in December 2018.
1
AVAC, Product Introduction & Access, New York, United States, Methods: We explored the relationship between MMD implementa-
2
AVAC, New York, United States tion and number of clinic visits using an uncontrolled before-and-after
design. We reviewed clinic attendance records for patients on ARVs,
and recorded the months of drugs dispensed to all patients meeting
Background: Oral pre-exposure prophylaxis (PrEP), currently offered
the national eligibility criteria for MMD: age 15 years or above; at
in 78 countries, is highly effective at preventing transmission of HIV
least 6 months on ART; on first-line regimen; no opportunistic infec-
when taken as prescribed. Programmatic data and systematic reviews
tion; good drug adherence; and viral load < 200 copies/mL. We also
report high rates of sexually transmitted infections (STIs) among peo-
compared number of visits for twelve months prior to December
ple using oral PrEP. Given that risk factors for HIV and STIs are
2018 (pre-MMD period) to the corresponding period after December
shared, there are missed opportunities to intentionally integrate STI
2018 (post-MMD period), using a dependent samples t-test in SPSS
screening and treatment into PrEP programs.
v23.
Methods: AVAC has maintained the Global PrEP Tracker, a compre-
Results: 4150 patients enrolled into MMD were included in the pre-
hensive database of ongoing, completed and planned PrEP demonstra-
MMD group and 4190 post-MMD, while clinic attendance was
tion projects, implementation initiatives and national programs, since
30 407 visits (16 111 pre- MMD visits and 14 296 post-MMD visits).
2014. Data is collected from projects through a quarterly survey
There was an overall non-significant mean appreciation of
including, but not limited to, PrEP initiations, demographics, and STI
326.58 861.81 (95% CI = 874.15 220.98) drugs dispensed per
rates. For this analysis, programs were selected that reported screen-
month; t(11) = 1.31, p = 0.22. Mean monthly clinic attendance
ing high-risk groups for STIs.
declined from 1342.8 220.10 visits pre-MMD to
Results: In 2020, 191 PrEP programs were surveyed, of which 45 were
1191.33 309.10 visits post-MMD but was not statistically signifi-
collecting information on STIs. The STIs most commonly screened for
cant, t(11) = 1.601, p = 0.14. The total HIV client population at
were syphilis (33%), chlamydia (25%) and gonorrhea (17%). Fewer pro-
68NARHY was maintained after implementation of MMD, and no
jects reported screening for hepatitis B (9%), trichomoniasis (6%), hep-
stock outs were observed.
atitis C (5%), herpes (4%) and hepatitis A (1%). Of these projects, 35%
Conclusions: MMD can be an important tool for reducing clinic vol-
included men who have sex with men (MSM), 17% included transgender
umes, improving ARV access, and preventing onward transmission
women (TGW) and 11% included adolescent girls and young women
through maintenance of viral suppression. It is particularly important
(AGYW). Of programs with information on STI screening, 19 provide
for care continuity in the military health system where service mem-
data on client STI rates, covering 23,594 total PrEP users (59% MSM,
bers may deploy or may be transferred with dependents to other
23% AGYW, 11% TGW and 6% female sex workers). All projects
bases. Further study is needed to ascertain the effect of MMD on
observed STI rates of at least 1% to 10%; of these, two projects had
service provider-patient ratios, its impact on patient enrollment and
rates of 10% to 20%, four between 20% and 30%, two between 30%
retention in care.
and 40% and one from 40% to 50%. The populations with highest
observed STI rates overall were MSM and AGYW. Two programs enrol-
ling AGYW in sub-Saharan Africa each reported STI rates between 20% PE16.35LB
and 40%. For MSM, three programs (in Western Europe and Oceania) Baseline demographics, coverage and first regimen choice
each reported STI rates ranging from 20% to 50%. of participants in the HIV Pre-Exposure Prophylaxis (PrEP)
Conclusions: Our analysis supports the provision of comprehensive Impact trial
SRH services for PrEP users that include STI screening and treatment, A. Sullivan1; J. Saunders2; A. Cartier1; S. Jaffer1; A. Milinkovic1;
with an emphasis on underserved populations, such as AGYW and C. Priestley3; K. Manavi4; L. Waters5; E. Mason2; M. Hibbert2;
TGW. These findings underscore the need for greater reporting on C. Chiavenna2; A. Charlett2; C. Estcourt6; C. Sabin7; A. Rodger7;
STI rates and research to identify effective strategies for reducing D. Gold8; A. McOwan1; N. Gill2; M. Desai9 and Impact Study Group
HIV and STI risk, including point of care diagnostics. 1
Chelsea and Westminster Hospital NHS Foundation Trust, HIV and
Sexual Health, London, United Kingdom, 2Public Health England, Blood
PE16.34LB Safety, Hepatitis, STIs & HIV, London, United Kingdom, 3Dorset
Effect of multi-month ARV dispensing on HIV clinic County Hospital, HIV Medicine, Dorchester, United Kingdom, 4Univer-
attendance at 68 Nigerian Army Reference Hospital Yaba, sity Hospitals Birmingham NHS Foundation Trust, HIV Medicine, Birm-
Lagos ingham, United Kingdom, 5CNWL Trust, Mortimer Market Centre,
N. Harrison1; I. Lawal2; K. Aribisala1; K. Oruka1; N. Okeji3; London, United Kingdom, 6Glasgow Caledonian University, School of
L. Chittenden4; P. Agaba5 and E. Lee5 Health and Life Science, Glasgow, United Kingdom, 7University Col-
1 lege London, Institute for Global Health, London, United Kingdom,
68 Nigeria Army Reference Hospital, Yaba, CID, Lagos, Nigeria, 2U.S. 8
National AIDS Trust, London, United Kingdom, 9National Institute of
Army Medical Research Directorate-Africa, Care and Treatment,
Health and Care Excellence, Manchester, United Kingdom
Abuja, Nigeria, 3Nigerian Ministry of Defense-Health Implementation
Program, Program, Abuja, Nigeria, 4U.S. Army Medical Research Direc- Background: The PrEP Impact trial is a non-interventional, non-ran-
torate-Africa, Abuja, Nigeria, 5U.S. Military HIV Research Program, domised trial providing a pragmatic health technology assessment of
Walter Reed Army Institute of Research, Silver Spring, MD, United PrEP uptake in sexual health clinics across England. We describe trial
States participant demographics and, for MSM, uptake and regimen chosen
at enrolment.
Methods: Participants were recruited between 13/10/2017 and 12/
Background: Multi-month dispensing (MMD) of antiretroviral (ARV) 7/2020; eligibility was in line with national PrEP guidelines. Trial data,
drugs has demonstrated benefits for HIV patients and health service collected via electronic case report forms and national surveillance
delivery systems including reduced frequency of hospital visits, data, were linked using date of birth and basic demographic data, most
improved retention. Ensuring stable, virally suppressed patient ARV recently with data submitted through September 2019.
145
Results: A total of 24 255 individuals were recruited to July 2020; populations are known to be at elevated risk for substance use and
23 217 (95.7%) were MSM, 359 (1.48%) trans women, 333 (1.37%) mental health disorders, both of which are known risk factors for
cis women, 150 (0.62%) cis heterosexual men(cHM), 152 (0.62%) HIV/AIDS. Research conducted in Thailand has also provided evidence
trans men(tM) and 35 (0.14%) non-binary. Median age was 33 years that those who use illicit drugs and have mental health/alcohol use
(range 16 to 86); cHM were older, median 39y and tM younger med- disorders are at increased risk of exhibiting suicidal behaviors, high-
ian 28y. The majority were of white ethnicity across all groups (range lighting the need for comprehensive substance use and psychiatric dis-
50.5% for cHM – 76.2% for MSM). order screening and treatment services.
The matched data set demonstrates MSM were broadly representa- Methods: To address this gap in knowledge, our analysis aimed to
tive of the attending HIV negative MSM population apart from those characterize the prevalence, correlates, and co-occurrence of sub-
aged 16 to 24 who were under-represented (Table 1). stance use, alcohol use disorder, and depression among young MSW
and TSW participating in an HIV prevention trial in Thailand. Using
Abstract PE16.35LB-Table 1. Demographics and PrEP uptake and baseline data collected as part of the Combination Prevention Effec-
coverage in HIV negative MSM attendees through September 2019 tiveness (COPE) study, we described the prevalence and correlates of
substance use in the past 3 months, alcohol use disorder (AUDIT-C),
All SHC
attendeesa Eligibleb Enrolledc
and depressive symptoms (STOP-D).
n (%) n (%) n (%) Results: Baseline data from 890 participants were analyzed. Of the
165 157 31 139 15 432 % % three conditions central to our study, 73 (8.2%) self-reported using
(100) (100) (100) Uptaked Coveragee
substances, nearly half (49.2%) had symptoms indicative of alcohol use
disorder, and over a quarter (26.4%) had depressive symptoms. Addi-
Age group
16 to 24 35171 (21.3) 5451 (17.5) 2036 (13.2) 37.4 5.8 tionally, 17.6% of the sample had symptomatology of at least two of
25 to 29 34496 (20.9) 6553 (21.0) 3237 (21.0) 49.4 9.4 these conditions.
30 to 34 28038 (17.0) 5704 (18.3) 3031 (19.6) 53.1 10.8
35 to 39 20374 (12.3) 4379 (14.1) 2350 (15.2) 53.7 11.5
Abstract PE16.36LB-Table 1. Demographic characteristics, sub-
40+ 47046 (28.5) 9049 (29.1) 4778 (31.0) 52.8 10.2
Ethnic group: stance use, alcohol use disorders, and depression among cis-gender
White 123567 (74.8) 23856 (76.6) 11758 (76.2) 49.3 9.5 men who have sex with men and transgender women who sell sex
Black African or 5333 (3.3) 988 (3.2) 480 (3.1) 48.6 9.0 in Thailand (N = 890)
Black
Caribbean Alcohol
Asian/Asian 8358 (5.1) 1661 (5.3) 775 (5.0) 46.7 9.3 Use Substance Depressive
British Total disorder use symptoms
Unknown/ 27 899 (16.9) 4634 (14.9) 2419 (15.8) 52.2 8.7 sample OR (95% OR (95% OR (95%
missing) (N = 890) CI) CI) CI)
a
All HIV negative/unknown SHC attendees, aged ≥ 16 from clinic start Demographic characteristics
date through 30 September 2019; (%) = % of total Gender
b Cisgender men 788 (88.5) – – –
coded as eligible, offered and declined, or not coded but recruited to
Transgender women 78 (8.8) -0.73 0.42 (0.13, 0.99 (0.58,
the trial (0.46, 1.38) 1.68)
c
inked trial participant (i.e. enrolee) 1.17)
d
% Uptake = % trial enrolees/eligible SHC attendees Other/do not know 24 (2.7) 0.84 (0.37, 0.96 (0.22, 2.04 (0.89,
1.91) 4.18) 4.67)
e
% Coverage = % trial enrolees/all SHC attendees.
Age
18 to 20 200 (22.5) – – –
Of MSM recruited to September 2019, 37.5% were classified as pre- 21 to 23 381 (42.8) 1.26 (0.89, 1.09 (0.56, 1.08 (0.74,
defined level 3 risk (negative HIV test, bacterial STI in past 1.77) 2.12) 1.58)
24 to 28 308 (34.6) 1.17 (0.82, 1.43 (0.74, 0.69 (0.46,
12 months); 43.6% as level 2 (negative HIV test in past 12 M) and 1.67) 2.78) 1.04)
18.9% as level 1 (neither). Daily regimen was initially chosen by 85% Completed university education
MSM (11185/13150). Uptake was lower than predicted in MSM how- Yes 471 (52.9) 0.91 (0.70, 1.15 (0.71, 0.89 (0.66,
ever this may have been influenced by variable availability of trial 1.19) 1.86) 1.20)
No 418 (47.0) – – –
places. Primary income from sex work in
Conclusions: We found high need for PrEP amongst MSM attending the past 30 days
SHC; coverage in other groups remains low. For MSM there was equi- Yes 51 (5.7) 2.60 (1.40, 3.92 (1.95, 1.30 (0.71,
table representation across ethnicity and country of birth and under- 4.82)** 7.87)*** 2.40)
No 839 (94.3) – – –
representation of those under 25. Any income from full-time
employment in the past
PE16.36LB Yes
30 days
348 (39.1) 1.01 (0.77, 0.70 (0.42, 0.77 (0.56,
Substance use, alcohol use disorder, and depressive 1.32) 1.16) 1.05)
symptoms among young men who have sex with men and No 542 (60.9) – – –
Any income from part-time
transgender women who sell sex in Thailand employment in the past
H. Jin1; S.H.H. Mon1; B. Weir2; C. Dun2; A. Wirtz1 and C. Beyrer1 30 days
1 Yes 264 (29.7) 1.21 (0.91, 1.43 (0.87, 1.13 (0.82,
Johns Hopkins Bloomberg School of Public Health, Department of 1.62) 2.36) 1.56)
Epidemiology, Baltimore, United States, 2Johns Hopkins Bloomberg No 626 (60.3) – – –
School of Public Health, Department of Health, Behavior, and Society, Alcohol use disorders
Baltimore, United States Yes 438 (49.2) 1.53 (0.94, 1.12 (0.83,
2.48) 1.50)
No 452 (50.8) – –
Substance use in the past
Background: Little is known about men who have sex with men who 3 months
sell sex (MSW) and transgender women who sell sex (TSW) in Thai-
land with respect to substance use and mental health, however, these (Continued)
146
Table 1. (Continued)
PE16.38LB
Alcohol Applying statistical control processes to characterize the
Use Substance Depressive variations in occurrence of adverse events in VMMC
Total disorder use symptoms
sample OR (95% OR (95% OR (95%
delivery in Zimbabwe
(N = 890) CI) CI) CI) N. Chagoma1; T. Kanyenda1; N. Nyathi2; B. Pindiwe2; A. Rosen1;
R. Maruza1; S. Jenkins1; A. Svisva2; A. Mangwiro2; H. Nyika3 and
Yes 73 (8.2) 1.53 (0.94, 1.06 (0.62, S. Xaba3
2.48) 1.82) 1
No 817 (91.8) – – Clinton Health Access Initiative, Boston, MA, United States, 2Clinton
Depressive symptoms Health Access Initiative, Harare, Zimbabwe, 3Ministry of Health and
Yes 235 (26.4) 1.12 (0.83, 1.06 (0.62, Child Care, Harare, Zimbabwe
1.50) 1.82)
No 655 (73.6) – –
No conditions
Total 314 (35.3) Background: Voluntary Medical Male Circumcision (VMMC) is a
One condition highly effective HIV prevention intervention which lowers the risk of
Total 419 (47.1) male-to-female transmission of HIV by approximately 60% (Bailey
Substance use in the past 23 (5.5)
et al. 2010). Following the WHO recommendation to scale up VMMC
3 months
Alcohol use disorders 288 (68.7) in settings with high HIV burden, Zimbabwe adopted VMMC as a pri-
Depressive symptoms 108 (25.8) ority HIV prevention strategy in 2009. Although VMMC is a minor
Two conditions procedure, risks and complications can be severe, making prevention,
Total 144 (34.4)
management, and monitoring of adverse events (AEs) critical. While
Substance use in the past 30 (20.8)
3 months + Alcohol use the VMMC program has consistently reported < 2% of AEs, it is
disorders important to interrogate program data to understand drivers of AEs
Substance use in the past 7 (4.9) to inform development of strategies for improving quality and safety
3 months + Depressive
of VMMC procedures. We applied the Shewhart Control Charts to
symptoms
Alcohol use disorders + 107 (74.3) characterize whether variations in AEs are driven by common or spe-
depressive symptoms cial causes on Zimbabwe VMMC data.
Three conditions Methods: Statistical Process Control methods were applied on the
Total 13 (1.5)
recent routine service delivery data collected through the Health
Column totals may not add up to the total sample size due to missing- Management Information System for the period January to December
ness. Column percentages may not add up to 100% due to rounding. 2019. An Excel-based SPC (C-chart) plot was utilized to characterize
*<0.05. the nature of AEs over time.
**<0.01. Results: In 2019, a total of 354 819 VMMCs, with 140 (0.39%) clas-
***<0.001. sified as AEs; 115 (82%) were moderate while 25 (18%) were severe.
While males aged 10 to 12 only accounted for 28% of all VMMCs,
they had the highest number 57 (41%) of all AEs reported. Of these,
Conclusions: Our study found a high prevalence of substance use,
46 (80.7%) cases were classified as moderate and 11 (19.3%) as
alcohol use disorder, and depressive symptoms among MSW and TSW
severe. Given the data, occurrences of AEs between February- March
in Thailand, with a significant proportion burdened with more than
and August - November were characteristically driven by special
one of these conditions. These findings suggest that many may benefit
causes that need further investigation. The control chart showed that
from integrated treatment services that address both substance use
two points were above the Upper Control Limits while four points
and mental health disorders to reduce the risk of HIV/AIDS.
were consecutively below the mean. This suggests that the VMMC
delivery system was unstable and occurrence of AEs was driven by
factors atypical to the process.
Abstract PE16.38LB-Figure 1.
147
Conclusions: We find that variations in AEs may be driven by factors associated with immediate PrEP initiation compared to delayed or no
such as timing and age. As implementation continues, the VMMC pro- PrEP uptake. Major factors include recent sexual risk, STI infection,
gram needs to identify underlying causes of variation, learn from the condom use, recent HIV testing, and prior experience with PrEP at
process and develop strategies to improve the delivery process. This both the individual and community levels.
will be vital to maintaining quality and safety of VMMC services. Conclusions: Awareness and immediate uptake of PrEP was high in
this cohort of young, at-risk Thai MSM and TGW who exchange sex.
PE16.39LB Immediate uptake was predominantly associated with frequent, risky
sexual behavior. Strong associations were also found with protective
Immediate PrEP uptake in the COPE4YMSM cohort of
behaviors, reflecting the acceptability of PrEP for HIV risk mitigation
young MSM and TGW who exchange sex in Bangkok and within this population. Additionally, individual and community experi-
Pattaya, Thailand ence with PrEP influenced same-day initiation, pointing to opportuni-
B.W. Weir1; C. Dun1; S.H.H. Mon2; A.L. Wirtz2; C. Beyrer2 and ties for PrEP engagement through peer and social networks. For this
Combination Prevention Effectiveness(COPE) Study Team population, ensuring low-barrier same-day access to PrEP may be key
1
Johns Hopkins Bloomberg School of Public Health, Health, Behavior to increasing uptake, and the COPE4YMSM study demonstrates the
& Society, Baltimore, United States, 2Johns Hopkins Bloomberg School feasibility and acceptability of this approach.
of Public Health, Center for Public Health and Human Rights, Epi-
demiology, Baltimore, United States
PE16.40LB
Sexual behavior and sexually transmitted infections are
Background: HIV incidence among young (18 to 21) male sex work- increased after PrEP initation: results from a longitudial
ers in Bangkok is estimated at 11.1 per 100 PY (95% CI: 6.7 to 17.4). study among MSM who initiated PrEP during follow-up
Engagement of these at-risk young persons who might benefit from L. Coyer1; A. Boyd1,2; U. Davidovich1,3; M.F Schimvan der Loeff1,4;
PrEP is therefore an urgent priority. This analysis evaluates immediate M. Prins1,4 and A. Matser1,4
PrEP uptake in a cohort (N = 846) of young (18 to 26) Thai men who 1
Public Health Service of Amsterdam, Department of Infectious Dis-
have sex with men (MSM) and transgender women (TGW) enrolled in eases, Amsterdam, Netherlands, 2HIV Monitoring Foundation, Amster-
the COPE4YMSM study who exchanged sex in the past year. dam, Netherlands, 3University of Amsterdam, Department of Social
Methods: Participants were offered PrEP at study enrollment with Psychology, Amsterdam, Netherlands, 4Amsterdam UMC, University of
the option to start or stop PrEP throughout study participation. Data Amsterdam, Department of Infectious Diseases, Amsterdam Infection
was collected between October 2017 and August 2020. Characteris- and Immunity (AII), Amsterdam, Netherlands
tics associated with immediate PrEP initiation (vs. delayed or no initia-
tion) were identified using logistic regression with fixed effects for
study site. Background: People initiating HIV pre-exposure prophylaxis (PrEP)
Results: Immediate PrEP initiation was common, with 523 of 846 may increase condomless anal sex (CAS), and consequently, more
participants (62%) starting PrEP within 1 week of enrollment. 106 often acquire sexually transmitted infections (STI). We assessed
participants (38%) subsequently started PrEP, with a median delay of changes in CAS and STI before and after PrEP-initiation among men
6 weeks (IQR: 4 to 17 weeks). Figure 1 describes some factors who have sex with men (MSM) from the Amsterdam Cohort Studies
148
(ACS), and compared these with a comparable group of MSM who did findings support regular and intensified STI screening and counseling
not initiate PrEP. in MSM using PrEP.
Methods: MSM reported on sexual behavior in the preceding
6 months and were tested for HIV/STI (chlamydia, gonorrhea, syphilis) PE16.41LB
biannually. We matched HIV-negative MSM who initiated PrEP
Understanding caregivers as key to success of early infant
between 1 January 2015 and 31 December 2019 (PrEP initiators)
1:1 to MSM who did not (controls) using time-dependent propensity
male circumcision scale-up: characteristics and perspectives
scores based on recent sexual behavior, STI and age. We used logistic of legal adult representatives of infants enrolled in the
regression with generalized estimating equations to model (1) CAS ShangRing versus Mogen Clamp Trial
and (2) receptive CAS (rCAS) with casual partners, (3) any STI, and Q. Nang1; S.P. Basourakos1; N. Punjani1; O. Al Hussein Al Awamlh1;
(4) anal STI over time during the 4 years before and 2 years after M.A. Barone1; M. Goldstein1; P.S. Li1 and R.K. Lee1
1
PrEP-initiation (for PrEP initiators) or hypothetical PrEP-initiation (for Weill Cornell Medicine, Urology, New York, United States
controls). We compared, for each endpoint, (1) changes over follow-up
Background: Early infant male circumcision (EIMC) uptake will be criti-
periods per group, (2) overall changes before and after PrEP-initiation
within each group, and (3) overall difference between groups within cal in the future sustainability of Voluntary Medical Male Circumcision
(VMMC) efforts. The ShangRing is the only male circumcision (MC)
follow-up periods.
device pre-approved for use in males over 10 years of age by the World
Results: 232/850 (27.3%) MSM with a visit since 1 January 2015 ever
Health Organization (WHO) and the United States President’s Emer-
used PrEP, of whom 198 (85%) were matched to a control. Median age
gency Plan for AIDS Relief (PEPFAR) that only requires topical anesthe-
of included PrEP initiators at PrEP-initiation was 42 years (IQR = 34 to
sia and is capable of use across the lifespan in 2020. We are conducting
49). Before PrEP-initiation, the proportion engaging in CAS and rCAS
a Phase I Randomized Controlled Trial in Kenya, Uganda, and Tanzania
increased over time in both groups. In PrEP initiators, the proportion
engaging in CAS was on average higher after PrEP-initiation aimed at comparing EIMC with ShangRing versus the standard Mogen
Clamp (MGC) in early infants. As such, we sought to identify character-
(OR = 1.62, 95% CI = 1.11 to 2.36), as was rCAS (OR = 1.62, 95%
istics and assess views of thepatients’ legal adult representatives (LAR)
CI = 1.15 to 2.27) and more were diagnosed with anal STI (aOR = 2.46,
on EIMCto better inform future initiatives.
95% CI = 1.38 to 4.38). This remained stable after PrEP-initiation.
Overall, there was no statistical difference in endpoints between groups Methods: LARs of the healthy 0 to 60 days old male infants enrolled
in the trial and randomized 1:1 to ShangRing versus MGC were sys-
before PrEP-initiation. After PrEP-initiation, PrEP initiators had higher
tematically interviewd during the initial study enrollment visit.
odds of CAS (OR = 4.89, 95% CI = 3.41 to 7.01), rCAS (OR = 4.00,
Results: All 1378 participants’ LARs were surveyed. They were majo-
95% CI = 2.79 to 5.73), any STI (aOR = 1.92, 95% CI = 1.31 to 2.83)
rily married, Christian mothers in their second decade. Primary moti-
and anal STI (aOR = 1.81, 95% CI = 1.17 to 2.79) than controls.
vations were disease prevention, hygiene, and social/religious
Conclusions: The proportion of MSM with CAS, rCAS and anal STI
justifications (Table 1). Highest completed education levels ranged
increased after PrEP-initiation compared to the period before and
compared to matched control MSM who did not initiate PrEP. These from post-doctoral to none (Figure 1).
149
Conclusions: Future efforts to implement EIMC strategies should regression stacking. The cross-validated area under the receiver oper-
focus on addressing LARs’ motivations using culturally- and religiously- ating characteristics curve (CV-AUC) was used as the prediction per-
sensitive methods appropriate for the spectrum of education levels. formance metric.
Results: Overall, 50.3%, 29.9%, 36.0%, and 14% of participants were
categorized as elite for gp140 IgG, gp120 IgG, gp41 IgG and CD4+
Env responses, respectively. There was minimal overlap in elite
Innate and trained immunity responder status across the immune responses, with the greatest
agreement between gp120 IgG and gp140 IgG (kappa = 0.474). The
23 baseline characteristics collectively were found to at most moder-
ately predict elite responder status for IgG gp120 with a CV-AUC of
PE17.01 0.71 (95% CI: 0.66, 0.75), IgG gp140 with a CV-AUC of 0.73 (0.69,
Baseline host determinants of robust human HIV vaccine 0.76), IgG gp41 with a CV-AUC of 0.69 (0.64, 0.73), and ICS response
responses – a meta-analysis of 26 vaccine regimens with a CV-AUC of 0.59 (0.53, 0.75). Higher creatinine level, mean cor-
puscular volume, and number of total white blood cells were signifi-
Y. Huang1; L. Zhang2; K. Seaton3; S. De Rosa2; A. Randhawa2;
cant predictors for at least one of the binding antibody immune
L.R. McKinnon4; P. McLaren4; E. Viegas5; K. Cohen2; J. McElrath2;
responses. Participants being from the Americas (vs. Africa) was a sig-
G. Tomaras3; J. Thakar6 and J. Kobie6
1
nificant predictor for CD4+ Env responses.
Fred Hutchinson Cancer Research Center, Vaccine and Infectious Dis- Conclusions: Diversity in vaccine-induced immune responses among
eases, Seattle, United States, 2Fred Hutchinson Cancer Research Cen- individuals may reflect heterogeneity in processes that regulate HIV
ter, Seattle, United States, 3Duke Human Vaccine Institute, Durham, Env-specific antibody responses and CD4+ T-cell responses. Identi-
United States, 4University of Manitoba, Canada, 5Instituto Nacional de fied features should be studied further to determine which may pre-
Saude, Mozambique, 6University of Rochester, Rochester, United States dict immune responses adequate for preventing HIV infection after
vaccination.
Background: Vaccination leads to continuum of immune responses
among individuals. To elucidate pre-existing host factors that are associ- PE17.02
ated with robust immune responses to preventive HIV vaccines, we con- Recombinant human (rh)ERAPs anti-HIV effect relies on
ducted a meta-analysis of 9 HIV vaccine trials with a total of 26 vaccine activation of innate immunity
regimens evaluated in 838 healthy HIV-uninfected participants. I. Saulle1; I. Maraventano2; M. Saresella2; D. Trabattoni3; M. Clerici2
Methods: Vaccine-induced serum IgG binding antibodies to HIV and M. Biasin3
Envelop (Env) gp120, gp140 and gp41 antigens were measured by 1
University of Milan, Biomedical and Clinical Sciences, Italy, 2IRCCS
the binding antibody multiplex assay. Vaccine-induced CD4+ T-cells
Don Gnocchi Foundation, Firenze, Italy, 3University of Milan, Italy
secreting IL-2 and/or IFN-c were measured by intracellular cytokine
staining. Participants were categorized as elite responders if their
immune response measured at 2 weeks post final vaccination was Background: Recombinant human (rh)-ERAP2 (E2)-treated peripheral
within the top quartile of positive responders within each vaccine regi- blood mononuclear cells (PBMCs) are less susceptible to in vitro HIV-
men or above the upper quantification limit of the assay. Twenty-three 1 infection. This antiviral mechanism is partially preserved even when
baseline characteristics, including demographic, vital signs, safety labo- CD8+ T cells are depleted, suggesting that other immunocompetent
ratory, and baseline HIV-specific immunity, were assessed as predic- cells are positively sensitized by E2 treatment. Based on these obser-
tors of elite responder status by the SuperLearner approach using vations we investigated whether E2 can trigger monocytes and
150
monocyte derived macrophages (MDMs), boosting their antiviral

potential. As ERAP1 and ERAP2 share similar functions and a high Mathematical modelling: Impact and
sequence homology, which allows them to work even as heterodimers,
functional analyses were performed on rhERAP1 (E1) and E1 + E2 effectiveness
treated cells as well.
Methods: MDMs differentiated from PBMCs of 11 healthy donors
were in vitro HIV-1 infected in presence/absence of 100 ng/ml E2.
Six-days post infection mRNA expression and protein production of PE18.01
proinflammatory cytokines were assessed by Real-Time PCR and Estimating the impact of PrEP regimens containing long-
ELISA, respectively, while viral replication was quantified by p24 viral acting injectable cabotegravir or daily oral tenofovir/
antigen measurement. We next investigated the molecular mechanism emtricitabine among men who have sex with men in the
induced by E1, E2 and E1 + E2 treatment by analysing: 1) inflamma- United States: mathematical modelling for HPTN 083
some activation (FlowSight AMNIS) in monocytes and human THP1 K. Mitchell1; M.-C. Boily1; B. Hanscom2; J. Moore2; J. Todd3;
macrophages (hTm); 2) monocyte and Natural Killer activation (flow G. Paz-Bailey4; C. Wejnert5; A. Liu6; E. Vittinghoff7; D. Donnell2;
cytometry); and 3) phagocytosis in THP and monocytes. B. Grinsztejn8; R. Landovitz9 and D. Dimitrov2
Results: E2 treatment resulted into a seven-fold reduction of HIV-1 1
Imperial College London, HPTN Modelling Centre, London, United
replication in MDMs (p < 0,05). This antiviral activity was associated
Kingdom, 2Fred Hutchinson Cancer Research Center, Seattle, United
with an increased mRNA expression of CD80, IL-1b, IL-18, TNF-a,
States, 3Georgia Department of Public Health, United States, 4Centers
(p < 0.01 for cytokine) during in vitro E2-treated HIV-1-infected
for Disease Control and Prevention, San Juan, Puerto Rico, 5Centers
MDMs. This was mirrored by IL-1b, TNF-a,IL-6, IL-8 protein release
for Disease Control and Prevention, Atlanta, United States, 6San Fran-
(p < 0.01 for each cytokine). Notably, E1, E2 and E1 + E2 addition also
cisco Department of Public Health, Bridge HIV, United States,
induced the functional assembly of inflammasome components (ASC 7
University of California San Francisco, United States, 8Fundac~ao
and NLRP3) in monocytes (p < 0,01) and THP1 (p < 0,01) as well as a
Oswaldo Cruz, Brazil, 9University of California Los Angeles, David
rise in the percentage of activated classical monocytes (CD14+ CD16-
Geffon School of Medicine, United States
HLADRII+CCR7+ CD80+) (p < 0,02) and NK cells (CD3-CD16+
CD56+ CD107+) (p < 0,02). Finally, THP and human monocytes
showed an increased phagocytosis following all ERAP treatments. Background: The HPTN 083 trial demonstrated superiority of a regi-
Conclusions: The discovery that ERAPs are able to trigger several men containing long-acting injectable cabotegravir (CAB) to daily oral
antiviral mechanisms in monocyte-macrophagic and NK cells suggests tenofovir/emtricitabine (TDF/FTC) for HIV pre-exposure prophylaxis
that their anti-HIV potential is not exclusively dependent on their (PrEP) among men who have sex with men (MSM) and transgender
canonical role in antigen presentation and CD8+ T cell activation. women. We estimated and compared the potential impact of TDF/
These findings pose the premises to further investigate the role of FTC and CAB use among MSM in Atlanta, Georgia, US, where 21% of
ERAPs in both innate and adaptive immunostimulatory pathways, and HIV-negative MSM used oral PrEP in 2018.
suggests their potential use in novel preventive and therapeutic Methods: An age-, race- and risk-stratified HIV transmission model
approaches against HIV-1 infection. for MSM (risk based on PrEP eligibility criteria) was parameterised
151
and calibrated with Atlanta-specific behavioural, HIV prevalence and credible interval. We predict that a TFV-DP associated with taking 2,
PrEP usage data, assuming PrEP was only offered to eligible high-risk 4, and 7 pills per week reduces HIV risk by 62% (99% Credible Inter-
MSM (~60% of MSM). We estimated the proportion of new HIV infec- val 32 to 92), 87% (55 to 100), and 97% (76 to 100), respectively.
tions averted over one/five years if TDF/FTC use were maintained, or Conclusions: Our analysis suggests that partial adherence to PrEP
if all TDF/FTC users switched to CAB in January 2021, compared may provide similar or only slightly lower protection in women as in
with no PrEP use. CAB scenarios with 10% and 20% more users were men. Our derived curve can be used to estimate TDF-FTC PrEP effec-
also considered. CAB effectiveness (efficacy9adherence; 92%) was tiveness in future prevention studies in women and predict the impact
estimated through back-calculations from HPTN 083 data. TDF/FTC of interventions in mathematical models.
efficacy and race-/age-specific adherence (≥4 doses/week; 96%, 73%
to 94%) were based on iPrEx trial and US PrEP Demo project data.
Results: Our model predicted that TDF/FTC at current uptake levels
would avert 32.4% of new HIV infections (95% credible interval Microbiome & STI: Impact on prevention
26.2% to 41.5%) among Atlanta MSM over 2021, vs. no PrEP. Switch-
ing to CAB may prevent 27% more infections than TDF/FTC, for a
total 41.2% (27.8% to 45.3%) infections prevented. Increasing CAB
usage by 10 or 20% increased infections averted by 13% and 34%, to PE19.01
46.3% and 55.0% overall vs. no PrEP, respectively. Predicted five-year Population-level correlation between incidence of selected
impacts (vs. no PrEP) were 13% to 17% greater than one-year sexually transmitted infections and HIV-1 among women
impacts across scenarios (Figure 1).
participating in HIV pre-exposure prophylaxis trials in Africa
Conclusions: TDF/FTC and CAB could both prevent many new HIV
P. Hunidzarira1; E.R. Brown2; ZM. Chirenje3; S.L. Hillier4;
infections among Atlanta MSM, with CAB likely to prevent more infec-
J.M. Marrazzo5; T. Palanee-Phillips6; B. Makanani7; F.M. Kiweewa8 and
tions than TDF/FTC at similar or greater reported usage, due to
J. Baeten9
higher sex-act coverage achieved by bi-monthly injections. 1
University of Zimbabwe College of Health Sciences Clinical Trials
Research Centre (UZCHS-CTRC), Seke South Clinical Research Site,
PE18.02 Harare, Zimbabwe, 2Statistical Center for HIV/AIDS Research and
Predicting PrEP efficacy in women with partial adherence Prevention, Fred Hutchinson Cancer Research Center, Seattle, United
to tenofovir disoproxil fumarate/emtricitabine States, 3University of Zimbabwe College of Health Sciences Clinical
J. Moore1; D. Dimitrov1; D. Donnell1; M.C. Boily2; K. Mitchell2; Trials Research Centre (UZCHS-CTRC), Obstetrics & Gynecology,
C. Celum3; L.-G. Bekker4; S. Delany-Moretlwe5 and N. Mgodi6 Harare, Zimbabwe, 4University of Pittsburgh Medical Center and
1 Magee-Womens Research Institute, Obstetrics, Gynecology and
Fred Hutchinson Cancer Research Center, Vaccine and Infectious
Disease, Seattle, United States, 2Imperial College, Infectious Disease Reproductive Sciences, Pittsburgh, United States, 5University of Ala-
Epidemiology, London, United Kingdom, 3University of Washington, bama at Birmingham School of Medicine, Medicine, Birmingham, Uni-
Global Health, Medicine and Epidemiology, Seattle, United States, ted States, 6Wits Reproductive Health and HIV Institute (WRHI),
4
University of Cape Town, Desmond Tutu HIV Centre, South Africa, University of Witswatersrand, Hillbrow, South Africa, 7College of Med-
5
University of Witswatersrand, Wits RHI, South Africa, 6University of icine-John Hopkins University Research Project Queen Elizabeth Cen-
Zimbabwe, College of Health Sciences Clinical Trials Research Centre, tral Hospital, Blantyre, Malawi, 8Makerere University-Johns Hopkins
Harare, Zimbabwe University Research Collaboration Research Collaboration, Kampala,
Uganda, 9University of Washington, Global Health, Medicine, and Epi-
demiology, Seattle, United States
Background: Pre-exposure prophylaxis (PrEP) with daily oral Tenofovir
disoproxil fumarate and emtricitabine (TDF-FTC) has been proven safe
and effective for HIV prevention. Measures of adherence using intracel- Background: Biomedical strategies for HIV pre-exposure prophylaxis
lular tenofovir diphosphate (TFV-DP) in men suggest that partial adher- (PrEP) have been developed and many African countries have incorpo-
ence leads to reduction in HIV incidence of 76%, 96%, and 99% with rated access to daily oral PrEP into their national guidelines. Because
two, four and seven pills per week. Randomized placebo-controlled trials uptake of effective PrEP will influence the design and interpretation
(RCTs) in women have had conflicting results, although substantial of future clinical trials of novel PrEP agents, surrogate indicators of
reduction in HIV risk is associated with increasing proportions of HIV incidence in HIV prevention trials may prove to be valuable. For
women with detectable Tenofovir in plasma. We aimed to estimate per- men who have sex with men, the incidence of rectal gonorrhea has
cent HIV risk reduction in sub-Saharan African women as a function of been proposed as a strong surrogate for HIV incidence. While sexually
TFV-DP concentration, which was used as a biomarker of adherence. transmitted infections have long been recognized as risk factors for
Methods: We assume an exponential relationship between efficacy HIV acquisition at the individual level, whether their incidence at the
and TFV-DP, which has provided a good fit to HIV risk reduction by population level correlates with HIV incidence is not established. The
TDF-DP in men. We use observed efficacy in three RCTs of TDF-FTC objective of this analysis was to assess whether incidence of sexually
in women: VOICE, FEM-PrEP and Partners PrEP (N = 520) in which transmitted infections was correlated with HIV incidence among Afri-
plasma tenofovir concentrations were measured, but TFV-DP was not. can heterosexual women.
TFV-DP concentrations were inferred by bootstrap re-sampling from Methods: Data was included from the placebo arms of two HIV PrEP
concurrent plasma tenofovir and TFV-DP measurements in HPTN based trials among African women: MTN-003/VOICE and MTN-020/
082, an open label study of TDF-FTC PrEP in women. Samples were ASPIRE. These were multi-site, double-blind, placebo-controlled ran-
drawn from the HPTN 082 dataset by dichotomizing the data with domized trials enrolling healthy sexually active HIV-uninfected women
the same criteria for detectability used in each RCT. The exponential at risk of HIV acquisition. Women were screened and treated for STIs
parameter was fit using Markov chain Monte Carlo. TFV-DP concen- (Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vagi-
trations associated with 2, 4 and 7 pills per week was inferred from nalis) at baseline and throughout study participation. HIV serologic
directly observed dosing studies. testing was performed monthly. Regression modelling was used to
Results: Our model showed good agreement with the available data: assess the correlation between incident STIs and incident HIV, with
the observed efficacy associated with the proportion of women with each site for each study representing a data point.
detectable plasma tenofovir in each RCT fell within the predicted 99%
152
Results: In total 3314 women were enrolled across 18 sites in 4 Conclusions: Lactobacillus isolates from women with optimal versus
countries (Malawi, South Africa, Uganda, Zimbabwe). Overall STI and non-optimal microbiota differed functionally, producing more lactic
HIV incidences were high: HIV 4.9, Neisseria gonorrhoeae 5.2, acid and inducing lower cytokine responses. These findings suggest
Chlamydia trachomatis 14.5, and Trichomonas vaginalis 7.1 per 100 that the immunomodulatory properties of vaginal lactobacilli are likely
person-years. There was limited correlation between HIV incidence multifactorial and may be associated with metabolic activity and lactic
and the incidence of individual STIs with R-squared values generally acid production.
low: Neisseria gonorrhoeae (R2 = 0.001), Chlamydia trachomatis
(R2 = 0.256), and Trichomonas vaginalis (R2 = 0.011). HIV incidence PE19.03
was greatest in South Africa; however, analysis limited to South Afri-
Lactic acid produced by an optimal vaginal microbiota
can sites similarly did not show a strong correlation between site-level
HIV and STI incidence.
promotes cervicovaginal epithelial barrier integrity:
Conclusions: The incidence of sexually transmitted infections did not implications for HIV transmission
reliably predict HIV incidence at the population level amongst at-risk B. Jesaveluk; D. Delgado-Diaz; D. Tyssen; A. Johnson; J. Hayward;
African women participating in two large HIV PrEP trials. R. Gugasyan; A. Hearps and G. Tachedjian
Burnet Institute, Disease Elimination Program and Life Sciences Disci-
pline, Melbourne, Australia
PE19.02
Immunomodulatory properties of cervicovaginal
Lactobacillus isolates are associated with lactic acid Background: Women with a Lactobacillus spp.-dominated vaginal
production and bacterial proteome profiles microbiota have a decreased risk of HIV acquisition compared to
M. Manhanzva1; A. Alisoltanidehkordi2; A.G. Abrahams3; L. Bell4; women colonized with ‘non-optimal’ vaginal microbiota, the latter
M. du Plessis4; B. Calder3; H. Gamieldien3; R. Froissart5; H. Jaspan3; being associated with decreased cervicovaginal epithelial barrier integ-
S.Z. Jaumdally3; S.L. Barnabas3; S. Dabee3; J.M. Blackburn3; rity. Lactic acid (LA) is a key metabolite of Lactobacillus spp. with
L.-G. Bekker6 and G. Gray7 antimicrobial and anti-inflammatory properties that is differentially
1
Institute of Infectious Disease and Molecular Medicine, University of produced by Lactobacillus species as L- and D- isoforms. However, the
Cape Town, Pathology, Cape Town, South Africa, 2University of Cali- impact of LA in promoting epithelial barrier integrity through effects
fornia Division of Biomedical Sciences, United States, 3Institute of on junctional molecules is unknown.
Infectious Disease and Molecular Medicine, University of Cape Town, Methods: The effect of L- and D-LA on epithelial barrier integrity
Cape Town, South Africa, 4Centre for Proteomic and Genomic was analysed by culturing cervicovaginal epithelial (Ect) cells in a tran-
Research, Durban, South Africa, 5French National Centre for Scientific swell system. Ect cells were treated apically for 1 h with either 0.3%
Research, France, 6Desmond Tutu HIV Centre, Cape Town, South L-LA or D-LA (at pH 3.9 or pH 7.0), or acidity alone control (pH 3.9,
Africa, 7University of Witwatersrand, Johannesburg, South Africa HCl adjusted). Transepithelial electrical resistance (TEER) across the
cell monolayer was determined prior to and 24 h post-treatment.
Expression of junctional molecule mRNA after L or D-LA treatment
Background: Bacterial vaginosis (BV) and non-optimal microbiota are was determined by RNASeq and qRT-PCR, and protein levels were
associated with female genital tract (FGT) inflammation which determined by Western blot.
increases HIV acquisition risk in women. Lactobacilli are thought to Results: Treatment of Ect cells with L- or D-LA significantly increased
protect against pathogens by modulating immune responses in the TEER by 1.5 fold (n = 4; p < 0.05), in contrast to treatment with
FGT. We aimed to characterize the immunomodulatory properties of neutralized L- or D-LA (pH 7.0), or the pH 3.9 control. RNASeq and
vaginal Lactobacillus isolates and determine the mechanisms underly- gene ontology enrichment analysis were consistent with the TEER
ing these relationships. functional data demonstrating that L- and D-LA caused significant dif-
Methods: We isolated 64 non-iners vaginal Lactobacillus species from ferential expression (FDR < 0.05) of at least 11 genes associated with
South African women. Growth rates, adhesion to vaginal epithelial intracellular junctions and barrier function, including claudin-1
(VK2) cells, culture acidification and D/L-lactate production were (CLDN1, Log2 fold change L-LA 1.12/ D-LA 1.17), claudin-4 (CLDN4,
evaluated. The production of cytokines (IL-6, IL-1a, IL-1b IL-8, IP-10, Log2FC 1.47/1.63) and occludin (OCLN, Log2FC 0.49/0.55), with no
MIP-3a, MIP-1a, MIP-1b and IL-1RA) by VK2 cells in response to lac- differential gene expression between isoforms. These findings were
tobacilli was measured using Luminex. Proteome profiles of 22 Lacto- confirmed by qRT-PCR. In addition, tight junction protein levels (such
bacillus isolates that induced higher inflammatory cytokine production as CLDN1 and TJP2), were significantly increased by L-LA treatment
and 22 isolates that induced low levels of cytokine production were (CLDN1 FC = 1.56, TJP2 FC = 1.42) but not with the pH 3.9 control
analysed using liquid chromatography tandem mass spectrometry (LC- (n = 5; p < 0.05).
MS/MS) to investigate underlying mechanisms leading to different Conclusions: LA significantly increases cervicovaginal epithelial bar-
inflammatory profiles. rier integrity by increasing the expression of junctional molecules,
Results: Lactobacilli isolated from women with non-optimal microbiota which has implications for the paracellular penetration of HIV through
produced less lactic acid and induced greater inflammatory cytokine cervicovaginal tissue and subsequent HIV acquisition.
production by VK2 cells than those from women with optimal micro-
biota. A total of 5087 Lactobacillus proteins were identified by LC- PE19.04
MS/MS, with 164 proteins differentially abundant between the non-
Correlates of STI acquisition during the first years after
inflammatory and relatively inflammatory isolates. The majority of the
protein molecular function gene ontologies that were underabundant
sexual initiation: a longitudinal cohort study of sexually
in inflammatory isolates were enzymatic pathways, suggesting that inexperienced adolescent girls and young women in Kenya
more inflammatory isolates had less metabolic activity. D-lactate pro- M. Wang1; K. Tapia2; L. Oluoch3; M. Micheni2; S. Selke2;
duction by the isolates correlated positively with D-lactate dehydroge- C. Kiptinness2; B. Chohan2; A. Wald2; K. Ngure3; N. Mugo2 and
nase relative abundance and D-lactate dehydrogenase was inversely A. Roxby2
1
associated with IL-6, IL-8, IP-10 and MIP-1a production by VK2 cells University of Washington, Department of Global Health, Seattle, Uni-
in response to the isolates (adjusted p = 0.001, 0.001, 0.029 and ted States, 2University of Washington, Seattle, United States, 3Kenya
0.014, respectively). Medical Research Institute, Nairobi, Kenya
153
PE19.05
Background: Adolescent girls and young women (AGYW) have high Cervicovaginal microbiota affects the human ectocervical
rates of sexually transmitted infections (STIs) in sub-Saharan Africa. epithelial barrier as determined by in situ image analysis
Studying key life course events, including incidence of sexual initiation, and protein profiling
could determine factors associated with STIs, specifically incident gon- €m2; J. Lajoie3; J. Xu4;
G. Edfeldt1; F. Bradley1; S. Bergstro
orrhea (GC), chlamydia (CT), and HSV-2. V. Kaldhusdal1; A. Ahlberg1; B. Binicy1; C. Mattsson2; A. Manberg2;
Methods: This prospective cohort study enrolled 400 AGYW aged C. W€ahlby5; J. Kimani6; J. Oyugi7; P. Nilsson2 and K. Fowke3
16 to 20 in Thika, Kenya. Eligible AGYW were HIV and HSV-2 1
Karolinska Institutet, Department of Medicine, Stockholm, Sweden,
seronegative and reported only one or no prior sexual partners. Quar- 2
KTH Royal Institute of Technology, Department of Protein Science,
terly visits assessed sexual behaviors, GC and CT by nucleic acid test-
Sweden, 3University of Manitoba, Department of Medical Microbiol-
ing, HIV by ELISA, HSV-2 by PCR, and bacterial vaginosis (BV) from
ogy and Infectious Diseases, Canada, 4Ragon Institute of MGH, MIT
Gram stains over 4 years. Incident STI was estimated using Kaplan-
and Harvard, Boston, United States, 5Uppsala University, Department
Meier curves. Hazard ratios were estimated using Cox regression and
of Information Technology, Sweden, 6Partners for Health and Develop-
adjusted for BV, condom use, having new sexual partners, and time
ment in Africa, Nairobi, Kenya, 7University of Nairobi, Kenya
between menarche and sexual initiation.
Results: Among 400 AGYW, 227 participants were at-risk for inci-
dent STI infection during the study period. The median age of menar- Background: A Lactobacillus-dominant vaginal microbiome is corre-
che was 14 years (IQR: 13 to 15) and enrollment was 18 years (IQR: lated with genital health for women, while a low-Lactobacillus abun-
17 to 19). Over 490 person-years of follow-up, the STI incidence rate dant microbiome is associated with an increased risk of acquiring HIV
was 17.7/100 person-years. Within 3 years of sexual activity, 43.2% and other sexually transmitted infections (STIs). Increased genital
acquired an STI; by 4 years, that rose to 51.1%. inflammation and disrupted epithelial barrier are hypothesized to con-
Multivariate analysis demonstrated that participants with BV had over tribute to such increased risk, although the mechanisms remain largely
2-fold higher risk of STI acquisition (HR: 2.49; 95% CI: 1.55 to 4.02; unknown.
p < 0.001). Shorter time between menarche and sexual initiation was Methods: In a HIV high-risk cohort of Kenyan female sex workers
associated with higher risk of STI (HR: 1.17; 95% CI: 1.04 to 1.31; (n = 110), we characterized the cervicovaginal microbiome by 16S
p < 0.01). Higher STI risk was observed for AGYW reporting a new rRNA gene sequencing to investigate links to mucosal markers of
sexual partner (HR: 3.10; 95% CI: 1.54 – 6.24; p < 0.01). Contracep- epithelial integrity and HIV target cell localization. These markers
tive use was low (35% of all visits) and not correlated with STI risk. were assessed by digital image analysis of immunostained ectocervical
Conclusions: Sexually inexperienced AGYW demonstrated high STI tissue samples. In addition, 74 pre-selected proteins were measured
incidence. Behavioral strategies to lengthen time between menarche in corresponding cervicovaginal lavage samples by using a bead-based
and first sex, reducing number of partners, as well as prevention and protein profiling assay to investigate secreted markers of mucosal
treatment of BV, should be investigated further to reduce STI acquisi- epithelial integrity and inflammation. A second matched ectocervical
tion. biopsy was assessed by RNA transcriptomics to investigate micro-
biome associated host response.
Results: Image analysis of the tissue sections, stained for the epithe-
lial junction protein E-cadherin and the HIV co-receptor CD4, showed
signs of a stable epithelium for women with a non-iners Lactobacillus
community. Protein profiling analysis indicated that women with Lacto-
bacillus dominant communities exhibited higher levels of the anti-pro-
teases CSTA/B, PI3 and SPINK5 as well as the epithelial barrier
154
1
proteins KRT1, SPRR3 and TACSTD2. Transcriptomic data analysis is Seattle Children’s Research Institute, Center for Global Infectious
ongoing. Disease Research, United States, 2Institute of Human Virology Nigeria,
Conclusions: This study defines that higher levels of anti-proteases Nairobi, Nigeria, 3University of Glasgow, United Kingdom, 4University
and epithelial barrier proteins, combined with a computationally robust of Maryland, United States, 5University of Cape Town, South Africa,
6
epithelial barrier, were associated with a Lactobacillus-dominant cervi- Seattle Children’s Research Institute, United States
covaginal community. Several of these anti-proteases have been known
to have anti-HIV activity and have been associated with resistance to
HIV infection. This study represents a novel approach of combining tis- Background: Microbial marker gene datasets are compositional in
sue image analysis and protein profiling to investigate possible mecha- nature, conveying only relative information about the taxa detected
nistic links for how the cervicovaginal microbiome can affect HIV and precluding statistical inference in their native state. To enable
infection risk. accurate statistical inference, we introduce pico, a supervised learning
transformation that converts compositional microbiome datasets into
Cartesian coordinates constructed from ratios of bacterial taxa (ter-
PE19.06 med ‘balances’) that maximize the variance across the dataset. We
Female genital tract secretions obtained in the setting of employ pico to reveal shifts in the composition of fecal microbiota
bacterial vaginosis enhance HIV infection associated with altered oral polio vaccine (OPV) response in a longitu-
R. Hunte1; J. Serebrenik2; R. Barnett2; M. Keller2 and B. Herold2 dinally sampled cohort of HIV-exposed uninfected (iHEU) and HIV
1 unexposed (iHU) Nigerian infants.
Albert Einstein College of Medicine, Department of Microbiology &
Immunology, New York, United States, 2Albert Einstein College of Methods: The main driver of the pico package, which we term the
Medicine, New York, United States ‘penalized isometric log ratio transformation’, consists of three steps.
First, we transform marker gene datasets into Cartesian coordinates
by performing a centered log ratio transformation. Second, we use
Background: We evaluated the impact of vaginal microbiota on HIV supervised learning models to identify ratios of microbial taxa that dis-
risk by measuring the effects of female genital tract (FGT) secretions play the greatest variance in the dataset. Third, we perform cross vali-
obtained from women with bacterial vaginosis (BV) before and after dation to optimize the number of balances and the taxa included in
treatment on susceptibility of cells to HIV ex vivo. We hypothesized each balance. This results in the construction of a Cartesian coordi-
that BV will be associated with increased HIV susceptibility. nate system suitable for statistical hypothesis testing. We validate this
Methods: Vaginal swabs and cervicovaginal lavage (CVL) were col- approach by sequencing publicly available mock community samples
lected from 20 women with symptomatic BV at time of diagnosis and along the V3-4 region of the bacterial 16S ribosomal rRNA gene.
1 week and 4 weeks after completion of a 7 day course of oral Results: Pico accurately builds compositional balances that maximize
metronidazole. The ability of the secretions to inhibit or enhance HIV the distance between known even and staggered mock community
infection were assayed by infecting TZM-bl cells with HIVBaL (R5) or samples. Applying pico to the Nigerian cohort dataset described
HIVIIIB (X4) in the absence or presence of secretions. The microbiome above, we identify balances that discriminate fecal communities of
was assessed by quantitative PCR for select species and levels of iHEU versus iHU infants during weeks 1, 4, 15, and 36. Furthermore,
cytokines and other immune molecules were measured by Luminex or we find that the week 1 ratio of specific fecal taxa correlates with
ELISA. OPV titer responses at week 4, and shape the compositon of the gut
Results: FGT secretions from women with BV enhanced HIV infection community during early life.
significantly by 23% (median 126%; IQR 99%, 228%) and enhance- Conclusions: Pico enables robust statistical inference of composi-
ment decreased significantly 1 month after metronidazole treatment tional microbiome data with taxon-level resolution. Our data reveal
(p < 0.05). Enhancement correlated positively with Nugent score shifts in the composition of infant fecal microbiota that are signifi-
(r = 0.48), Gardnerella vaginalis (r = 0.55), Atopobium vaginae cantly associated with HIV exposure and highly predictive of humoral
(r = 0.48), BVAB2 (r = 0.40), Sneathia (r = 0.62), and Megasphaera responses to OPV. Collectively, these data illustrate the consequences
Type 2 (r = 0.50) and negatively with L. crispatus (r = 0.40). of HIV exposure on the infant fecal microbiota and vaccine response,
Enhancement also correlated positively with IL-1a (r = 0.50) but nega- which are relevant to clinical outcomes.
tively with MIP-1b (r =0.43), CXCL9 (r =0.43), and CXCL10
(r =0.40) (all p < 0.002). To assess mechanisms, we generated pools
of CVL from women with high enhancing activity. The pools increased
PE19.08
the binding of both R5 and X4 viruses to cells (p < 0.01 R5, Gardnerella subgroups exhibit divergent associations with
p < 0.001 X4). HIV infection was further enhanced when the CVL cervicovaginal cytokines in a longitudinal cohort of Kenyan
pool was heated (56˚C) and filtered (0.22 μm) (700% increase in rela- women: Implications for HIV susceptibility
tive luciferase units compared to control, p < 0.0001). Fractionation E. Shvartsman1; C. Perciani2; M. Richmond3; S. Vancuren4; J.E. Hill4;
studies mapped the enhancing activity to <100 kD. Mass spectroscopy L.R. McKinnon1; P. Sandstrom5 and K.S. MacDonald6
of fractionated samples is ongoing. 1
University of Manitoba, Department of Medical Microbiology and
Conclusions: Genital secretions from women with BV enhanced HIV Infectious Disease, Canada, 2University of Toronto, Immunology,
infection ex vivo, which correlated with concentrations of select anaer- Canada, 3University of Manitoba, Medical Microbiology and Infectious
obes. Metronidazole treatment led to a reduction in the enhancing Disease, Canada, 4University of Saskatchewan, Department of Veteri-
activity and a shift to a Lactobacillus-dominant microbiome. These nary Microbiology, Saskatoon, Canada, 5JC Wilt Infectious Diseases
findings have implications for adolescents and women of color who Research Center, National HIV Retrovirology Laboratory, Winnipeg,
have higher rates of non-Lactobacillus-dominant microbiomes. Canada, 6University of Manitoba, Departments of Medicine and Medi-
cal Microbiology and Infectious Disease, Canada
PE19.07
HIV exposure alters the fecal microbiome in Nigerian Background: Vaginal microbial communities associated with bacterial
infants vaginosis (BV), including those dominated by Gardnerella vaginalis, have
B. Brown1; S. Osawe2; E. Havyarimana3; A. Abimiku4; C. Gray5 and been linked to increased susceptibility to HIV, possibly by altering the
H. Jaspan6 mucosal immune milieu. We characterized the vaginal microbiome of
Kenyan women at low risk to HIV by metagenomic sequencing of the
155
cpn60 universal target. This method is capable of resolving the four Conclusions: These findings experimentally demonstrate that intesti-
Gardnerella subgroups, allowing a higher resolution assessment of nal dysbiosis contributes to alteration to gastrointestinal tract immu-
microbial associations with soluble and cellular markers of inflammation nity and lentiviral acquisition across the epithelial barrier.
and immune activation in the lower female genital tract.
Methods: Reproductive age Kenyan women (ages 19 to 47) were
enrolled into the KAVI-VZV-001 clinical trial (N = 41). Participating Mucosal immunity
women contributed multiple (~8 to 10) cervical cytobrush and cervico-
vaginal secretion samples over 48-weeks. Cervicovaginal secretions
and pellets were used for the quantification of cytokines using the
MSD-UPLEX assay and microbial profiling using the cpn60 universal PE20.01
target. Flow cytometry was used for analysis of cervical immune cell The impact of progestin-based contraceptive initiation on
subsets. Cytokine concentrations were log transformed for analyses. the cervicovaginal proteome in participants from the ECHO
Results: Microbial profiles were classified into six microbial clusters as trial
follows: Lactobacillus iners dominated community, a community dominated H. Ayele1; L.N. Romas1; K. Birse1; S. Horne1; M. Onono2; G. Nair3;
by the other Lactobacilli (LD), three microbial communities dominated by T. Palanee-Phillips4; R. Tanko5; R. Bunjun6; K.B. Arnold7;
either G. vaginalis subgroup A, B, or C, and a polymicrobial-mixed commu- S. McCorrister8; G. Westmacott8; C. Scoville9; K. Heller9 and
nity. Using LD microbial communities as comparator we found that J.M. Baeten9
polymicrobial and G. vaginalis subgroups A, B, or C dominant microbial 1
University of Manitoba, Medical Microbiology and Infectious Dis-
communities were associated with increases in most markers of inflamma-
eases, Canada, 2Kenya Medical Research Institute, Nairobi, Kenya,
tion (including IL-1b) in both adjusted and unadjusted models. We found 3
Desmond Tutu HIV Center, Cape Town, South Africa, 4Wits Repro-
divergent associations of G. vaginalis subgroups with the chemokine IP-10
ductive Health and HIV Institute, Johannesburg, South Africa, 5Univer-
whereby only G. vaginalis subgroup A dominance and polymicrobial-mixed
sity of Cape Town, Institute of Infectious Diseases and Molecular
microbial communities were associated with lower vaginal mucosal con-
Medicine, South Africa, 6National Health Laboratory Services, South
centrations of IP-10 (p < 0.0001), even after adjusting for confounders
Africa, 7University of Michigan, Biomedical Engineering, United States,
including the use of hormonal contraception. 8
Public Health Agency of Canada, Ottawa, Canada, 9University of
Conclusions: Gardnerella subtypes and mixed microbial communities
Washington, Seattle, United States
are associated with increased concentrations of inflammatory mucosal
cytokines in the lower female genital tract, however exhibit divergent
associations with the chemokine IP-10. Therefore, defining these asso- Background: The recent ECHO trial (Evidence for Contraceptive
ciations between the different Gardnerella subtypes and mucosal options and HIV Outcomes) assessed whether HIV incidence differed
immunity can expand our understanding of how these factors con- with use of three contraceptives [intramuscular depot medroxyproges-
tribute to HIV risk and BV and thus improve prevention efforts. terone acetate (DMPA-IM), Levonorgestrel (LNG)-implant, and Copper
intrauterine device (IUD)]. While no differences were reported in HIV
PE19.09LB infection rates between study arms, further evaluation of mucosal
Experimental microbial dysbiosis enhances rectal SIV samples taken during the trial will provide a deeper understanding of
acquisition in male rhesus macaques molecular effects with DMPA-IM, LNG-implant, and Copper IUD use.
Methods: Mass spectrometry-based analysis was performed on cervi-
A. Ortiz1; P. Baker1; C. Langner1; J. Simpson1; J. Flynn1; C. Starke1;
covaginal secretions collected by disposable menstrual cups from a
C. Vinton1; B. Keele2 and J. Brenchley1
1 subset of women in the ECHO cohort. Women from 3 trial sites who
National Institutes of Health, National Institute of Allergy and Infectious accepted their randomly assigned contraceptive method were ran-
Diseases, Bethesda, United States, 2Frederick National Laboratory for Can- domly selected for inclusion in this ancillary study [DMPA-IM (n = 67),
cer Research, AIDS and Cancer Virus Program, Frederick, United States LNG Implant (n = 66) or the Copper IUD (n = 64)]. Samples were col-
lected before (baseline) and after (1-month) contraceptive initiation.
Background: Alteration to the composition of the vaginal and rectal Statistical significance was determined by paired studentt-test with
bacterial microbiomes are associated with localized inflammation and Benjamini Hochberg correction. Pathway analysis was conducted using
correlate with acquisition of some sexually transmitted pathogens such Ingenuity Pathways Analysis (IPA), DAVID gene ontology, and Consen-
as HIV. susPathDB.
Methods: To directly assess the contribution of bacterial dysbiosis to Results: After multiple hypothesis testing correction, proteome
rectal lentiviral acquisition, we induced dysbiosis in rhesus macaques changes were observed in all study arms from baseline to month 1,
prior to repeated, lose-dose intra-rectal challenge with SIVmac239X, but most significantly with Copper IUD, followed by DMPA-IM and
utilizing the antibiotic vancomycin. LNG (49%, 3.0%, and 0.20%, respectively). DMPA-IM associated with
Results: Although no difference was noted in the number of chal- decreased proteins in the innate immune response including mucins
lenges required for SIV acquisition, vancomycin administration led to (MUC5A/5B), BPIB1, and CLUS (p < 0.001). DMPA-IM associated
significantly increased numbers of transmitted-founder variants with increased regulation of programmed cell death and endopepti-
detected upon SIV acquisition. Vancomycin-treated animals displayed dase inhibitor activity (p < 0.001). Only one protein changed with
decreased intestinal T-cell activation during acute SIV infection; how- LNG implant which precluded pathway analysis. Copper IUD use asso-
ever, these features did not distinguish between animals that acquired ciated with the largest changes, including increased immune cell
SIV at early versus late challenge. Early acquisition - irrespective of chemotaxis (z = 2.46; including matrix metalloproteinases (i.e. MMP9))
experimental dysbiosis - was associated with significantly reduced fre- and complement activation (CO3, CFAB), with decreases to cell-cell
quencies of rectal Th22 cells and IgA+ B-cells, with vancomycin-trea- adhesion and keratinocyte differentiation factors (p < 0.001; ZO-1,
ted animals displaying a trend towards reduced Th22 frequencies. SPB3, SPR1A, and ECM1).
Th22 frequency correlated with the number of challenges required Conclusions: DMPA-IM and Copper-IUD initiation resulted in the lar-
for infection. Significant differences in Ruminococcaceae, Gammapro- gest changes to the vaginal mucosal proteome. DMPA-IM associated
teobacteria, and Prevotellaceae genera distinguished between early with changes to innate immunity, while Copper IUD associated with
and late acquisition and were additionally perturbed in vancomycin- effects on epithelial barrier function and inflammation pathways. How
treated animals. these pathways interact with the vaginal microbiome, HIV target cells
156
and infection risk are a future area of investigation adding to the body Background: Zika virus (ZIKV) has emerged as a novel human
of knowledge regarding the impact of contraceptives on the vaginal pathogen linked with neurological disorders, targeting lymphoid, neu-
mucosal environment and overall vaginal health. rological and reproductive sites. Clinical cases of ZIKV sexual trans-
mission have been described. ZIKV and HIV-1 have large
PE20.02 overlapping areas of occurrence increasing the possibility of co-infec-
tion. With clinical reports of ZIKV sexual transmission, we assessed
The effect of HPV-associated anal dysplasia on HIV
the ex vivo infectibility of non-human primate (NHP) and human tis-
susceptibility in men who have sex with men sue explants with ZIKV as a surrogate of in vivo challenge, and the
Y. Choi1; I. Salit2; M. Sano2; E. Weiss2 and R. Kaul1 impact of HIV-1/ZIKV co-infection on the mucosal environment and
1
University of Toronto, Immunology, Canada, 2University Health Net- viral replication fitness.
work, Canada Methods: Eight cynomolgus macaques were challenged subcuta-
neously or intra-vaginally with different doses of ZIKVPRVABC59. Muco-
sal vaginal and colorectal explants from these and control animals, as
Background: HPV-associated anal dysplasia is common among men
well as from healthy humans, were challenged ex vivo or not with two
who have sex with men (MSM), and epidemiology studies suggest that
different lineages of ZIKV; ZIKVPRVABC59 or ZIKVH/PF/2013. Human
it may increase HIV susceptibility. Therefore, we collected anal biop-
explants were also challenged with HIV-1BaL for co-infection studies.
sies from both healthy and dysplastic mucosae of HIV-uninfected
Tissue explants were cultured for up to 21 days, and cytokine profile
MSM and characterized T cell populations. We hypothesized that dys-
and viral replication assessed by multiplex bead immunoassay, qRT-
plastic tissue would be associated with increased CD4+ T cell activa-
PCR, p24 ELISA, plaque assay and RNAscope.
tion.
Results: Vaginal challenge with ZIKVPRVABC59 of NHPs demonstrated
Methods: Twenty HIV-negative MSM were recruited, of whom 7 had
delayed viraemia compared to subcutaneous and elicited a mucosal
confirmed dysplasia. Anal biopsies were collected from both healthy
pro-inflammatory cytokine profile not observed with subcutaneous
(stain-negative) and dysplastic (pathology-confirmed) tissue sites dur-
challenge. Productive infection and similar up-regulation of inflamma-
ing high-resolution anoscopy. Lymphocytes isolated from the biopsies
tory cytokines were observed ex vivo in NHP and human explants
were characterized using flow cytometry with the previously-defined
with ZIKVPRVABC59. HIV-1BaL/ZIKVPRVABC59 co-infection resulted in
cellular HIV susceptibility markers CD38/HLA-DR co-expression (acti-
increased levels of HIV-1 replication. However, co-infection of human
vation), CCR5 (HIV co-receptor), CCR6 (Th17 cells) and CD69 (tissue
explants with HIV-1BaL/ZKVH/PF/2013 resulted in a significant decrease
residency). Participants with and without dysplasia were compared
of HIV-1 replication and an increased level of ZKVH/PF/2013 infection.
using Mann-Whitney test, while intraindividual comparisons of healthy
Infection with ZKVH/PF/2013 alone induced a down-regulation of inflam-
vs dysplastic tissues were performed by Wilcoxon signed-rank test
matory cytokines.
(SPSS).
Conclusions: The viraemia profile and mucosal cytokine secretome
Results: Dysplasia-positive and dysplasia-negative groups were similar
induced by ZIKV infection are dependent of the route of challenge
with respect to age (p = 0.218), history of PrEP use (p = 0.356), cur-
and of the viral strain. Co-exposure of colorectal and cervicovaginal
rent PrEP use (p = 1.000), rectal douching (p = 0.642) and recent his-
tissue to ZKV and HIV-1 affects viral replication of each virus and the
tory of receptive anal intercourse (p = 0.174). CD4+ T cell immune
early mucosal responses elicited.
characteristics were similar within the healthy (dysplasia-free) ano-rec-
tal mucosa of dysplasia-positive and dysplasia-negative groups, with no
differences in the expression of CCR5 (p = 0.861), CCR6 (p = 0.693), PE20.04
CD38/HLA-DR (p = 0.930) and CD69 (p = 0.273). Within the dys- The impact of TGF-b on the genital immune environment
plasia-positive group, we then compared T cell characteristics within associated with HIV risk in young women
healthy and dysplastic mucosa: contrary to our hypothesis, dysplastic S. Masondo1; J. Jewanraj2; S. Ngcapu2; F. Osman2; A. Mtshali2;
tissues were not associated with any increase in activated CD4+ T L. Mansoor2; S. Abdool Karim2; Q. Abdool Karim2; J.-A. Passmore2 and
cells (p = 0.286; 2.2% vs 1.9%), although there was an increase in tis- L. Liebenberg2
sue resident memory CD69+ CD4+ T cells (p = 0.028; 63.2% vs 1
CAPRISA, Medical Microbiology, Durban, South Africa, 2CAPRISA,
41.8%) and regulatory T cells as defined by CD25(high) Durban, South Africa
FoxP3 + (p = 0.028; 10.0% vs 3.1%).
Conclusions: HPV-associated anal dysplasia is not associated with
widespread T cell alterations in the anal mucosa, but CD69+ CD4+ T Background: Seminal fluid contains an array of bioactive molecules
cells were enriched within dysplastic tissues. This lesion-specific that not only aid in transporting spermatozoa and but also induce
increase in HIV-susceptible CD4+ T cells may have important implica- alterations in the female genital tract (FGT) to promote conception.
tions for dysplasia management strategies and HIV susceptibility Semen-associated signalling molecules such as transforming growth
among HIV-negative MSM. factor-beta (TGF-b) can induce both pro-inflammatory and anti-inflam-
matory responses in the FGT, and these may have a significant impact
PE20.03 on the susceptibility of women to HIV. Here we investigated the con-
tribution of semen-associated TGF-b to the proinflammatory cytokine
Mucosal responses to HIV-1 co-infection with an emerging
environment linked to increased risk of HIV infection in women.
pathogen, Zika virus Methods: This study included a subset of 181 CAPRISA 008 trial
C. Herrera1; A. Gallagher2; D. Ferguson3; Y. Fen2; M. Stein1; C. Ham3; participants with biannual sampling of genital specimens (N = 650
E.S. Giotis1; M.A. Skinner1; S. Kempster3; J. Hall3; E. Giles3; tests). Multiplex ELISA assays were used to assess genital concentra-
N. Almond3; J. Dıez4 and N. Berry3 tions of TGF-b and 48 additional cytokines in cervicovaginal lavage
1
Imperial College London, Department of Infectious Diseases, London, (CVL) specimens. Biomarkers of semen exposure were measured in
United Kingdom, 2Imperial College London, London, United Kingdom, CVL by ELISA (prostate specific antigen, PSA) and PCR (Y chromo-
3
National Institute for Biological Standards and Control, United King- some DNA, YcDNA), and represented semen exposure within 2 (YcD-
dom, 4Universidad Pompeu Fabra, Department of Experimental and NA+PSA+) and 14 days (YcDNA+PSA-) of sampling. Multivariable
Health Sciences, Spain linear mixed models assessed associations between semen exposure,
cytokine concentrations and TGF-b concentrations. Regression models
157
controlled for age, STI, cohabitating with partners and number of sex- Conclusions: Overall, these data suggest that GAS by penile-
ual acts; and considered multiple comparisons by FDR adjustment. skin-inversion increases neovaginal immune activation which might be
Results: Preliminary data suggest that, relative to no evidence of driven by the microbiome, and that exogenous hormones may impact
recent semen exposure (YcDNA-PSA-; n = 433 tests), genital cytoki- expression of CCR5 on gut mucosal CD4+ T cells. Further characteri-
nes were generally increased in women classified as YcDNA+PSA+ zation of biological risk factors connected to neovaginal and anal sex
(n = 124 tests; IL-12p70 (b = 0.32), IL-13 (b = 0.21), IL-7 (b = 0.25), in TGW is warranted in larger longitudinal studies to better inform
and VEGF concentrations (b = 0.40; all p =< 0.001). Although statisti- HIV preventive strategies.
cally significant observations were associated with YcDNA+PSA-
[n = 93 tests ; IP-10 (b = 0.21); IL-3 (b = 0.07); and MIP-1b PE20.06
(b = 0.11; all 0.01 < p < 0.05)], these did not withstand adjustments
Acute sexual violence exposure dysregulates HIV
for multiple comparisons. TGF-b associations are being validated and
the contribution of TGF-b to the genital cytokine environment associ-
associated cervical immune biomarkers in women
ated with condomless sex will be presented. E. Capozzi1; J. Danields1; C. Joy1; A. Aldous1; M. Jais1; M. Magnus1;
Conclusions: Semen-associated alterations to the female genital cyto- A. Roberts2; C.H. Schultz3; M. Zumer3; E. Meyer1; H. DeVore4;
kine environment are most profound soon after exposure. It is likely T. Moriarty5; G. Simon2 and M. Ghosh1
1
that the anti-inflammatory properties of TGF-b may have contributed George Washington University, Epidemiology, United States, 2School
to the relative absence of proinflammatory and chemotactic cytokines of Medicine and Health Sciences, George Washington University, Divi-
associated with semen exposure in this study. Understanding the reg- sion of Infectious Diseases, United States, 3Medical Faculty Associates
ulation of genital inflammation may inform on the design of biomedical Inc., George Washington University, United States, 4District of Colum-
interventions to prevent HIV infection in women. bia Forensic Nurse Examiners, United States, 5MedStar Washington
Hospital Center, United States
PE20.05
Impact of gender affirmation surgery and exogenous Background: There is considerable overlap between the epidemics of
hormones on mucosal immune responses and risk of HIV violence against women and HIV/AIDS, both of which adversely and
transmission in transgender women disproportionately affect women’s health. Sexual violence is associated
A. Schuetz1; C. Sacdalan2; M.J. Corley3; B. Slike4; N. Ratnaratorn2; with increased risk of HIV acquisition/transmission in women, yet the
Y. Phuangngern5; N. Tragonlugsana5; S. Krebs4; D. Hsu1; immune biological mechanisms linking the two are poorly understood.
R. Rerknimitr6; J. Ananworanich7; E. Kroon2; L.C. Ndhlovu3; Specifically, it is unknown how mucosal immune biomarkers associated
N. Phanuphak2 and S. Vasan4 with HIV infection and pathogenesis are affected following sexual
1
MHRP Thailand, Retrovirology, Thailand, 2SEARCH, Thailand, 3Weill trauma.
Cornell Medicine, United States, 4MHRP, United States, 5AFRIMS, The objective of this study was to compare the levels of inflammatory
Bangkok, Thailand, 6Chulalongkorn Hospital, Bangkok, Thailand, cytokines/chemokines and protective/anti-inflammatory/HIV inhibitory
7
University of Amsterdam, Netherlands factors, in the genital tract of women exposed to sexual violence, com-
pared to those who have never been exposed.
Methods: Recruitment was performed in the District of Columbia
Background: Transgender women (TGW) are disproportionally metro area from 2014 to 2016 and consisted of HIV uninfected
affected by HIV infection, with a global pooled estimated prevalence women aged 18 and above. After administering informed consent, eli-
of 19.1% often attributed to increased behavioral risk factors. Here gibility was determined using a brief survey, with Recent Cases being
we assessed whether biological factors such as gender affirmation sur- defined as women having experienced forced vaginal penetration
gery (GAS) and exogenous hormone treatment may potentially impact (FVP) during the preceding 12-weeks. Controls were defined as
sexual HIV transmission risk by altering mucosal immune responses. women who had never experienced FVP. Acute Cases were defined as
Methods: A cross-sectional study was conducted in 30 HIV negative women having experienced FVP during the past 4 days. Those eligible
volunteers, including 10 TGW post GAS by penile-skin-inversion and provided biological samples including ectocervical swabs for biomarker
taking exogenous hormones (estrogen and/or progesterone), 10 cis- analysis. ELISA was used to analyze protective/anti-inflammatory/HIV
gender women (CW, not taking hormonal contraceptives), and 10 inhibitory biomarkers Serpin A1, Elafin, Secretory Leukocyte Protease
MSM. All volunteers underwent phlebotomy, with optional sigmoid Inhibitor (SLPI), and Human Beta-Defensin-2 (HBD2) and inflamma-
colon biopsy, cervical/neovaginal cytobrush and vaginal/neo-vaginal tory cytokines/chemokines IL6, IL1b, IL1a, TNFa, MIP3a, IL8, and
and/or rectal secretion collection. Immune responses were assessed IP10. One-way ANOVA and Kruskal-Wallis tests were used to deter-
by flow cytometry, soluble biomarkers markers by Luminex and micro- mine differences in biomarker levels in Recent Cases, Acute Cases,
biome analysis was done using 16s rRNA sequencing. and Controls using GraphPad Prism.
Results: The frequency of CD4+ T cells was significantly lower in the Results: In Acute Cases, 4 days post event, we observed significant
neovagina (2.8%) compared to the vagina (48.3%; p = 0.001). However, upregulation in levels of inflammatory cytokine/chemokines IL1a
activation of CD4+ T cells measured by Ki67-expression was increased (p < 0.0001), MIP3a (p = 0.0001), IL8 (p = 0.0149), as well as anti-
in the neovagina (neovaginal: 28.0%, vaginal: 1.9%; p = 0.05). In addition, inflammatory Serpin A1 (p = 0.0002), Elafin (p = 0.0012) and SLPI
we observed higher levels of C-reactive protein (CRP) in neovaginal (p = 0.0351) compared to Controls. In contrast, inflammatory cytokine
secretion (8038 pg/μg IgA) compared to vaginal secretion (480 pg/μg IL6 (p = 0.0048) and chemokine IP10 (p = 0.0393) were significantly
IgA; p = 0.007). CRP levels in neovaginal/vaginal secretion directly cor- downregulated in Acute Cases compared to Controls. None of these
related with microbial species diversity measured by the Shannon biomarkers were significantly different in Recent Cases (12 weeks
Diversity Index (r = 0.62, p = 0.01) and the abundance of Prevotella post event), compared to Controls.
phyla (r = 0.52, p = 0.03). Moreover, we observed a higher frequency Conclusions: Our data points to immune dysregulation in the female
of CD4+CCR5+ T cells in the sigmoid colon of TGW (70.0%) and CW genital tract following exposure to acute sexual violence, which has
(64.5%) compared to MSM (53.0%; p = 0.007 and p = 0.002, respec- the potential to increase HIV risk in this population.
tively). The frequency of sigmoid CD4+CCR5+ T cells correlated inver-
sely with Testosterone levels (r =0.67, p = 0.001). However, there
was no increase in the Ki67-expression of sigmoid colon CD4+CCR5+ T
cells in TGW (0.4%) and CW (1.1%) compared to MSM (3.4%).
158
Background: Characterization of the targets and kinetics of HIV

PE20.07 infection within rectal and genital tissues is central to the assessment
Effects of continued Progestin-based contraceptive usage of novel prevention agents. The ex vivo models have been helpful for
in the adolescent genital tract: implications for HIV studying the early steps in HIV-1 infection, such as defining the main
acquisition target cells and the factors that influence viral kinetics and can be
M. Nasr1; J. Daniels2; C. Joy2; E. Capozzi2; P. Moriarty3; V. Emmanuel- used to evaluate candidate topical microbicides.
Baker3; S. Malcolm4; V. Gomez-Lobo5 and M. Ghosh2 Methods: Five HIV-1 clade C, 1 clade A and 1 clade A/D HIV-1 TF
1
George Washington University, Department of Epidemiology, United variants were isolated from IAVI Protocol C; a prospective acute infec-
States, 2George Washington University, United States, 3Medstar tion cohort, and their infection of PBMCs (n = 7), and rectal (n = 59)
Health Research Institute, United States, 4Children’s National Medical and endo- and ecto-cervical (n = 49) tissue explants assessed relative
Center, Washington, United States, 5National Institute of Health, to HIV1BaLover 15 days in culture.
Bethesda, United States Results: There was no difference in the rates of replication of the
HIV-1 variants relative to HIV-1BaL in endo- and ectocervical tissues
Background: The progestin-based contraceptive DMPA has been with the exception of HIV-1K4791 which replicated significantly more
associated with enhanced HIV acquisition in adult women. However, in ectocervix than endocervix. Interestingly, HIV-1 variants with “high
effects have not been assessed in adolescent girls, a population bear- replicative capacity” (RC) replicated to similar rates as those with
ing a disproportionate burden of both the HIV epidemic and often- low RC in cervical tissues. Despite high levels of inter-donor varia-
unintended pregnancies. Currently, the impact of progestin-based con- tion, we detected HIV-1 replication in PBMC, rectal and cervical tis-
traceptives on the genital immune milieu of adolescent girls in the sues cut at varied kinetics.HIV-1 variants infected both CD3+ Th17
United States is largely undetermined. The overall objective of this cells as well as non-T cells within the rectal and cervical tissues
study was to evaluate the impact of continued use of three types of 2 days after infection. The infected non-T cells were large and irreg-
progestin-based contraceptives, levonorgestrel intrauterine device ularly shaped; a phenotype consistent with myeloid dendritic or
(LNG-IUD), subdermal etonogestrel (ETNG), and injectable Depot macrophages.
medroxyprogesterone acetate (DMPA), in adolescent girls from the Conclusions: We have successfully established an explant culture sys-
Washington DC metro area, a region of high HIV prevalence. tem for studying early events of HIV-1 transmission in mucosal tissues
Methods: Following IRB approval, 59 sexually active, HIV-uninfected of the human female reproductive tract, mainly from the cervix and
adolescent girls (ages 15 to 19) were recruited from Children’s colorectal, and can be applied to placental and penile tissues. They are
National Medical Center and Medstar Washington Hospital Center in valuable tools to test the efficacy of microbicides in the prevention of
Washington, DC during 2017 to 2019. After contraceptive counseling, HIV-1 transmission study HIV-1, as well to evaluate HIV-1 vaccine
participants self-selected into different treatment arms: Control (con- candidates.
doms only), combined oral contraceptive pills (COC), LNG-IUD, ETNG
and DMPA groups (10 per group). Vaginal swabs were collected at
baseline prior to contraceptive use, and again at a 3-month follow-up Novel vaccine and other prevention
visit. Vaginal secretions were tested for pro-inflammatory (IL-1a, IL-1b,
TNFa, IL-6, IL-8, MIP-3a,) and anti-inflammatory/anti-HIV (Serpin-A1, approaches
Elafin, Beta-Defensin-2) immune mediators using ELISA. Vaginal micro-
biome was analyzed using 16s rRNA sequencing. Biomarker and micro-
biome data were then analyzed using Wilcoxon Rank Sum Test and
Kruskal Wallis Test (SAS Version 9), and Bray-Curtis analysis respec- PE21.01
tively, to evaluate differences between visits across treatment groups. gp120-mediated CD4+ T cell activation is inhibited by
Results: There were no significant changes in mean biomarker levels non-neutralizing V2 loop antibodies
between the baseline and follow-up visit for any treatment group. S. Vimonpatranon1; L. Goes2; D. Van Ryk3; D. Wei3; C. Cicala3;
Participants in the control, COC, LNG-IUD and DMPA groups did C.K. Wibmer4; L. Morris4; M. Soares5; A. Fauci3 and J. Arthos3
not show statistically significant differences in microbiome composi- 1
NIH/NIAID, Laboratory of Immunoregulation, Bethesda, United States,
2
tion between follow-up and baseline visits. However, ETNG implant Universidade Federal do Rio de Janeiro, Brazil, 3NIH/NIAID, Bethesda,
users showed significant differences in beta diversity 3-months post United States, 4National Institute for Communicable Diseases, Johan-
usage. nesburg, South Africa, 5Instituto Nacional de Câncer, Brazil
Conclusions: Our study demonstrated that the genital immune milieu
in adolescent girls was not significantly altered by 3-months of use of
any of the progestin-based contraceptives investigated. Additionally, Background: HIV and SIV gp120 bind directly to integrin a4b7, one
we show feasibility of research in this population which highlights the of the principal gut-homing receptors. This interaction is mediated
need for future studies with larger sample size and longer follow-up primarily by amino acids in the gp120 V2 loop. In a previous study
to evaluate safe and effective contraceptives in adolescent girls. we reported that MAdCAM costimulation through a4b7 promotes
CD4+ T cell activation and proliferation and supports increased HIV
replication. Based on these observations we evaluated the capacity
PE20.08 of gp120 V2-mediated signaling to costimulate primary CD4+ T cells.
The impact of human immunodeficiency virus-1 viral
replicative capacity on infection of human cervical and Methods: Bulk CD4+ T cells from healthy donors were stimulated
rectal tissue explants ex vivo with anti CD3 and a cyclic gp120 V2 domain peptide a panel of
R. Langat1; M. McRaven2; S. Joseph3; R. Lorenzo Redondo2; A. Marie gp120 V2 mAbs. Cellular activation, proliferation and HIV infection
Carias2; M. Mureithi4; L. Murungi5; O. Anzala4; J. Gilmour3 and T. were measured by flow-cytometry.
J. Hope2 Results: We determined that gp120 V2 can promote the activation
1
University of Nairobi, KAVI-ICR, Nairobi, Kenya, 2Northwestern and proliferation of primary a4b7high/CD4+ T cells. This activation can be
University, Cell and Molecular Biology, Chicago, United States, 3Impe- inhibited by the inclusion of an anti a4b7 mAb. Most importantly, gp120-
rial College London, Human Immunology Laboratory, London, United mediated activation can also be inhibited by anti V2 domain antibodies,
Kingdom, 4University of Nairobi, Medical Microbiology, Nairobi, Kenya, including non-neutralizing mAbs that recognize an epitope in V2 that
5 has been linked to reduced risk of acquisition in the RV144 vaccine trial.
IAVI, Nairobi, Kenya
159
Conclusions: The ability for the V2 domain of gp120 to mediate sig- Life Sciences, Department of Chemistry, Vienna, Austria, 4Simon Fra-
naling through a4b7 on CD4+ T cells most likely impacts early events ser University, Health Sciences, Burnaby, Canada, 5Simon Fraser
in infection following transmission. The ability of an anti a4b7 mAb University, Department of Molecular Biology & Biochemistry, Burnaby,
and/or anti-V2 to block this activity may identify therapeutic targets Canada
that can potentially reduce HIV -mediated damage to gut tissues.
These data reveal a novel way in which non-neutralizing anti V2 mAbs
might impact both transmission and pathogenesis. Background: One of the sites of interest for targeting by an HIV vac-
cine designed to elicit broadly neutralizing antibodies (bnAbs) is a clus-
ter of oligomannose-type glycans on the envelope spike (Env).
PE21.02 Clustered synthetic oligomannosides have yielded antibodies that bind
CD40-targeted vaccine increases magnitude of HIV-Env synthetic oligomannose (or partial structures thereof) but these anti-
specific responses bodies typically have been unable to engage natural oligomannose as
R. Marlin1; S. Tricot1; F. Relouzat1; C. Moog2; L. Bossevot1; on the virus. Although the reason for this difference remains unclear,
S. Zurawski3; G. Zurawski3; A. Salazar4; C. Chapon1; N. Dereuddre- one possibility is immune tolerance restriction. To overcome this hin-
Bosquet1; M. Centlivre5; Y. Levy5 and R. Le Grand1 drance, we are exploring the use of a bacterially inspired glycoside to
1
CEA, IDMIT, Paris, France, 2INSERM U1109, Universite de Stras- elicit the desired antibodies. We have reported previously on BSA
bourg, France, 3Baylor Institute for Immunology Research, Dallas, Uni- conjugates of this analog, which mimics mammalian oligomannose.
ted States, 4Oncovir, Inc., United States, 5Vaccine Research Institute, Here, we report on the antigenicity of the same glycoside conjugated
Universit
e Paris-Est Cre teil, France to the more clinically relevant carrier protein CRM197 and immuno-
genicity of this neoglycoconjugate when formulated in different adju-
Background: The development of DC-targeted vaccines aims to vants.
increase immunogenicity of proteins through improved delivery of the Methods: We evaluated the antigenicity of the glycoconjugate by
antigens to specific antigen-presenting cells playing a key role in ELISA and SPR using a series of oligomannose-specific bnAbs
inducing and regulating immune memory. CD40 signaling is essential (PGT125, PGT126, PGT128, PGT130, BF520.1, BG18, PCDN-33A,
for T cell-dependent humoral responses and targeting vaccine antigen PGDM12, PGDM21, VRC41.01) and their inferred germline precur-
to CD40 expressing APC seems therefore an attractive option to pro- sors. Immunogenicity was evaluated following subcutaneous immuniza-
mote anti-HIV antibody development. tion of human-antibody transgenic mice with the glycoconjugate
Methods: To determine the impact of DC targeting on immune formulated with adjuvants from three distinct classes: Alhydrogel
responses, we analyzed cellular changes at site of anti-CD40 vaccine (Th2-inducing), squalene-based AddaVax (Th1/Th2-inducing), and glu-
injection. Twelve cynomolgus macaques were immunized with homolo- copyranosyl lipid adjuvant-stable emulsion (GLA-SE) (Th1-inducing).
gous prime-boost strategy by HIVgp140 protein (ZM96) fused with Sera were evaluated for binding to the glycoside antigen and HIV-1
anti-CD40 targeting module or with IgG4 irrelevant control. Cellular SOSIP trimers and for HIV-neutralizing activity.
trafficking was analyzed at injection site and in draining lymph node Results: We found that members of the oligomannose-patch specific
by in vivo imaging after vaccine injections. Impact on T and B cell PGT128/130 bnAb family bind strongest to the glycoconjugate, with
responses was evaluated over time. binding affinities matching those reported for recombinant Env. Other
Results: Combination of in vivo imaging techniques (near infrared oligomannose patch-specific bnAbs bind less avidly. We found that the
imaging, probe-based confocal laser endomicroscopy and two-photon glycoconjugate is recognized also, albeit with the expected low avidity,
microscopy) demonstrate that a significantly higher number of by inferred germline precursors of the aforementioned antibodies.
vaccine-targeted APC migrate in draining LN of NHPs immunized by Immunizations revealed that only the GLA-SE-adjuvanted glycoconju-
anti-CD40.Env-gp140 (mean of 184 cells/mm²) compared to control gate evoked antibodies that could bind HIV SOSIP trimers. SOSIP
animals (mean of 69 cells/mm²) immunized with not targeted gp140. binding was relatively modest and insufficient to exert HIV-neutraliz-
The magnitude of HIV-Env specific IFN-c T cell response is correlated ing activity.
to the number of vaccine-targeted cells observed in vivo in the LN. Conclusions: Collectively, this work supports the potential of our cur-
Following the boost, HIV-Env specific T cell responses in anti-CD40 rent mimetic to trigger oligomannose-specific antibodies. Specifically, it
vaccinated animals was significantly superior (p = 0.041) to the con- has allowed for the identification of an adjuvant formulation that is
trol group. Specific antibody titers against subtype C and subtype E conducive to evoking the desired type of antibodies. Perhaps most sig-
Env proteins were also greater in anti-CD40 group (202 and 1700 nificantly, this study informs on potential next steps for improving on
EC50, respectively) than in controls (77.5 and 840.8 EC50, respec- the elicited response.
tively) at 5 weeks post boost.
Conclusions: Altogether these results show that CD40 targeting
increase antigen uptake by presenting cells in the draining LN, result- PE21.05LB
ing in stronger T and B cells responses. We also demonstrate that Immunization with HIV-1 fusion peptide carrier conjugate
CD40 targeting in presence of adjuvant significantly improves vaccine in a cocktail with HIV-envelope trimer elicits potent and
immunogenicity without requiring priming with recombinant vectors. cross-clade neutralization activity in guinea pigs
The safety and efficacy of the CD40-targeted vaccine justify further E. Sarfo; C. Cheng; X. Chen; A. Changela; A. Corrigan; S. O’Dell;
development for future human clinical trials. K. Xu; L. Ou; M. Sastry; F. Arnold; N. Doria-Rose; P. Kwong and
J. Mascola
PE21.04LB Vaccine Research Center, National Institutes of Allergy and Infectious
Advances in the use of a bacterially derived glycoside for Diseases, National Institutes of Health, Bethesda, United States
inducing oligomannose-targeted neutralizing antibodies to
HIV-1 Background: The quest for an effective vaccine for HIV-1 remains a
J.-F. Bruxelle1; T. Kirilenko1; N. Trattnig2; Y. Yang1; M. Cattin3; critical public health goal. Insights from the characterization of mono-
P. Kosma3 and R. Pantophlet4,5 clonal antibodies isolated from HIV-1 infected patients have revealed
1
Simon Fraser University, Faculty of Health Sciences, Burnaby, Canada, many vulnerable epitopes on the HIV-Envelope (Env) trimer. One such
2
Utrecht University, Department of Chemical Biology and Drug Dis- epitope, the fusion peptide (FP) at the N-terminal of the gp41 subunit
covery, Utrecht, Netherlands, 3University of Natural Resources and of the HIV Env has recently been shown to be immunogenic. Our
160
group has shown that priming with FP coupled to carrier conjugates

and boosting with Env trimer elicited antibodies that neutralize up to Pharmacology/PK and PD studies
60% of HIV-1 strains, but serum neutralizing activity was only
observed in a small subset of animals.
Methods: We utilized a prime-boost format to test two vaccine regi-
mens consisting of priming with FP coupled to recombinant tetanus PE22.01
toxoid heavy chain (FP-rTTHC) either alone or in a cocktail with HIV- Directly observed therapy (DOT) can be implemented
Env trimers in guinea pigs. To evaluate the immune responses, serum
successfully in research settings to evaluate PrEP PK
was collected two weeks after each immunization for ELISA and pseu-
dovirus neutralization assay. Fluorescence activated cell sorting (FACS)
among pregnant and postpartum adolescents and young
was also performed using FP and Env trimer probes to analyze B-cell women in Africa
development. E. Brown1; L. Stranix-Chibanda2; B. Johnston3; S. Huang4;
Results: Serum from five out of ten guinea pigs that received cocktail D. Kacanek4; L. Mungate2; A. Sango2; S. Mambiya5; W. Longwe
immunization achieves more than 50% cross-clade neutralization on a Mwenda5; V. Korutaro6; S. Nanyunja6; P. Kibalama Ssemambo7;
panel of 19 diverse HIV-1 strains with different FP sequences post A. Ssekasi Miwanda7; H. Kowo8 and S. Nelwamondo8
1
five immunizations. Additionally, B-cell analysis shows a correlation FHI 360, Science Facilitation, Durham, United States, 2University of
between the dual binding FP+ Env+ B-cells and the neutralization Zimbabwe, Harare, Zimbabwe, 3Frontier Science & Technology
breadth on a 10 FP-sensitive virus panel. Research Foundation, Inc, Amherst, United States, 4Center for Bio-
Conclusions: The cross-reactive FP directed responses elicited by statistics in AIDS Research, Harvard TH Chan School of Public Health,
immunization with FP-rTTHC in a cocktail format with HIV-Env trimer, Boston, United States, 5College of Medicine-Johns Hopkins Research
leads us a step closer toward achieving an effective HIV-vaccine regi- Project, Blantyre, Malawi, 6Baylor College of Medicine Children’s
men. Currently, the FP-rTTHC and timer immunogens are being pro- Foundation-Uganda, Kampala, Uganda, 7Makerere University Johns
duced for a phase 1 clinical trial in 2021. Hopkins University MU-JHU Research Collaboration, Mulago Hill, Kam-
pala, Uganda, 8Wits RHI Shandukani Research Centre, Johannesburg,
South Africa
PE21.07LB
HIV-1 fusion peptide (FP) conjugate and envelope trimer
cocktail immunization elicit diverse FP-directed neutralizing Background: Daily oral FTC/TDF as pre-exposure prophylaxis (PrEP)
antibodies in non-human primates can effectively reduce HIV acquisition. However, PrEP efficacy and
H. Wang; C. Cheng; H. Duan; K. Xu; C.-H. Shen; S. O’Dell; B. Zhang; pharmacokinetics (PK) are poorly understood among pregnant and
L. Ou; J. Dal Santo; A. Corrigan; E. Sarfo; T. Zhou; N. Doria-Rose; postpartum women, complicated by the physiological changes women
P. Kwong and J. Mascola undergo during this period and poor adherence observed in previous
Vaccine Research Center, NIAID, NIH, Bethesda, United States oral PrEP studies. Research studies designed to create conditions of
near-perfect adherence are advantageous when studying PrEP PK in
this population as they eliminate adherence as a confounding variable
Background: The linear fusion peptide (FP) region of the HIV envel- in PK analysis. We assessed the feasibility of directly observed therapy
ope (Env) glycoprotein is a target of HIV-1 neutralizing antibodies (DOT), the gold standard metric for adherence, within a clinical
(NAbs). We previously showed that FP-directed NAbs can be elicited research context.
in some non-human primates (NHPs) immunized with FP conjugated Methods: The PK Component of IMPAACT 2009 evaluated the PK
to the carrier protein KLH (FP-KLH) and boosted with a stabilized characteristics of daily oral PrEP (FTC 200 mg/TDF 300 mg) among
envelope trimer. Here, we compared the anti-FP response in NHPs pregnant (enrolled at 14 to 24 weeks gestation, n = 20) and postpar-
primed with FP-KLH alone (Group 1) to the response elicited by prim- tum (enrolled six to twelve weeks after delivery, n = 20) young
ing with a cocktail of FP-KLH and BG505 DS-SOSIP trimer (Group 2). women (16 to 24 years) in Malawi, South Africa, Uganda, and Zim-
Methods: Using FP and Env-trimer as probes, we sorted individual babwe. Daily FTC/TDF was administered under direct observation for
FP-specific B cells and isolated monoclonal antibodies (mAbs). 12 weeks. Acceptable methods of observation included in-person dos-
Results: After boosting with Env trimer, cross-reactive plasma neu- ing by study staff, real-time video (e.g., WhatsApp), or recorded times-
tralization was observed in 1 of 5 NHP in Group 1 and 3 of 5 NHPs tamped video. DOT implementation was supported through careful
in Group 2. We isolated 12 and 83 heavy and light chain paired mAbs staff assignment and training, enhanced participant screening and
from Group 1 and Group 2 NHPs respectively. Combined with previ- recruitment, promotion of disclosure to household members, and
ously published mAbs isolated from three NHPs (N = 75), a total of development of individual, participant-centered, DOT plans.
87 anti-FP mAbs were cloned from Group 1. These 87 mAbs were Results: Forty adolescents and young women (median age: 20 years)
derived from 9 VH and 20 VL gene alleles forming 2 VH and 6 VL were enrolled from March to June 2019; 20 during pregnancy (me-
gene families, respectively. In contrast, the 83 anti-FP mAbs isolated dian gestational age: 18 weeks) and 20 postpartum (median time after
from Group 2 were derived from 19 VH and 19 VL gene alleles, delivery: 7 weeks). Of 3360 expected PrEP doses, 3352 (>99%) were
which belonged to 4 VH and 6 VL gene families. Therefore, the heavy directly observed; five doses (<1%) were missed and three (<1%)
chain V-gene usage of the Abs from cocktail primed group (Group 2) were taken but not observed. Of the directly observed doses, 3335
were more diverse than those from FP alone primed group (Group 1). (99%) were observed in-person, 13 (<1%) were observed by real-time
8 of the 26 clonal lineages from Group 1 had cross-reactive neutral- video, and 4 (<1%) were observed by recorded timestamped video. Of
ization activity; these all derived from 2 VH gene alleles and belonged the 40 participants, 34 (85%) achieved perfect adherence (i.e. 100%
to the same VH gene family (IGHV4). However, 11 of the 42 clonal of expected doses were taken and directly observed).
lineages from Group 2 eventually developed into cross-reactive neu- Conclusions: With appropriate staff preparation and participant sup-
tralizing Abs which were derived from 5 VH gene alleles and belonged port strategies, PK studies with daily DOT can be implemented suc-
to 4 VH gene families (IGHV2, IGHV3, IGHV4 and IGHV5). cessfully among African pregnant and postpartum adolescents and
Conclusions: We are currently evaluating structural features and lin- young women. Given the complexities in establishing protective PrEP
eage evolution of these NHP Abs in more detail. Our results suggest drug levels during pregnancy, this rigorous methodology should be
that FP and trimer cocktail prime vaccine regimen can elicit diverse considered in the design of future clinical trials.
clonal lineages of FP-directed neutralizing antibodies in NHPs.
161
PE22.02 Results: Drug depot locations varied: 1 injection depot was identified
in the retroperitoneal cavity, 1 in SC compartment, 2 in IM compart-
MRI examination of cabotegravir long-acting formulation
ment, and 4 in combined IM/SC compartments (Fig. 1). Most depots
depot kinetics in healthy adult volunteers
consisted of drug and inflammatory infiltrates, identified as signal
E.J. Fuchs1; B.M. Jucker2; S. Lee3; V. Damian2; P. Galette2; enhancement on MRI, with increasing depot size throughout the 1-
R. Janiczek2; M. Solaiyappan4; M.A. Jacobs4; K.J. Macura4; week imaging period (Fig. 1). Day 1 total depot surface area corre-
R. D’Amico5; J. Sadik Shaik2; K. Bakshi2; K. Han2; S.L. Ford2 and lated with plasma CAB Cmax and area under the curve (AUC) through
D. Margolis5 Week 8 (Fig. 2).
1
John Hopkins University School of Medicine, Department of Conclusions: MRI delineated injection site location and depot kinet-
Medicine - Clinical Pharmacology, Baltimore, United States, ics. While there was injection site variability, surface area of the total
2
GlaxoSmithKline, Research Triangle Park, United States, 3Amallis depot appeared to drive both plasma Cmax and partial AUC indepen-
Consulting LTD, London, United Kingdom, 4John Hopkins University dently of anatomic distribution.
School of Medicine, Baltimore, United States, 5ViiV Healthcare,
Research Triangle Park, United States
PE22.03
Background: Cabotegravir (CAB) long-acting (LA) intramuscular (IM) Impact of UGT induction by rifampin and rifabutin on
injection is being investigated for HIV pre-exposure prophylaxis (PrEP) cabotegravir long-acting pharmacokinetics for HIV pre-
due to its potent antiretroviral activity and infrequent dosing require- exposure prophylaxis (PrEP) using population
ment. A subset of healthy adults participating in a Phase I study
pharmacokinetic modeling and simulation
assessing CAB tissue pharmacokinetics underwent serial magnetic res-
K. Han1; M. Baker2; D. Margolis3; W. Spreen3 and S.L. Ford4
onance imaging (MRI) scans to assess drug depot localization and 1
kinetics following a single CAB LA IM injection. GlaxoSmithKline, Clinical Pharmacology & Pharmacometrics, Research
Methods: Eight participants (4M/4F) were administered CAB LA Triangle Park, United States, 2ViiV Healthcare, Switzerland, 3ViiV
600 mg IM under ultrasound-guided injection targeting the gluteal Healthcare, Research Triangle Park, United States, 4GlaxoSmithKline,
muscles. MRI was performed to determine injection site location in Research Triangle Park, United States
muscle (IM), subcutaneous (SC) fat, and combined IM and SC fat (IM/
SC) and to quantify drug depot volumes, surface area, T2 and appar-
Background: Cabotegravir (CAB) long-acting (LA) is undergoing
ent diffusion coefficient, immediately following injection (Day 1), and 3
Phase 3 evaluation as a single-agent HIV PrEP regimen. CAB is
and 8 days post-injection. Linear regression analysis was performed
metabolized by UGT enzymes, primarily UGT1A1. HIV PrEP recipients
to examine correlations between derived MRI and plasma CAB
may require co-administration with UGT inducers rifampin and rifabu-
parameters.
tin, which increase CAB oral clearance 2.4- and 1.3-fold, respectively.
162
163
The potential for rifampin and rifabutin co-administration with CAB and ESC counties. However, providers were more equitably distributed
LA was evaluated using population pharmacokinetic (PPK) simulation. across P and ENC counties (median density (IQR): testing-P: 0.79
Methods: A robust PPK model was developed to describe CAB oral (0.73); ENC: 0.74 (0.66); SA: 2 (2); ESC: 1.80 (2.89); PrEP/PEP- P: 0.13
and LA PK. CAB LA PK profiles were simulated in 500 virtual subjects (0.17); ENC: 0.14 (0.41); SA: 0 (0.21); ESC: 0 (0)). In SA and ESC regions,
using PPK model by assuming increased clearance of 2.4-fold (ri- PrEP/PEP providers were largely unavailable in non-metropolitan coun-
fampin) and 1.3-fold (rifabutin) during the first 6 months of PrEP regi- ties; 79% of SA non-metropolitan and 100% of ESC non-metropolitan
men. Results were compared to simulated uninduced profiles counties did not have LBGTQ+/youth-friendly PrEP/PEP providers.
(Figure 1a) wherein 95% of subjects maintain concentrations above Conclusions: Wide geographic disparities exist in HIV testing and
0.65 μg/mL (benchmark in treatment Phase 3 studies). Modified dos- PrEP/PEP provider locations in regions with high HIV prevalence, par-
ing regimens were explored (Table). ticularly non-metropolitan counties in the ESC corridor. YGBMSM in
Results: During rifampin co-administration, 36% of subjects were pre- these underserved areas may be at higher risk of acquiring and trans-
dicted to reach benchmark following the first injection (Figure 1b), mitting HIV given the lack of key HIV services.
increasing to 76% of subjects by modifying dosing regimens (Table).
During rifabutin co-administration, 84% of subjects were predicted to PE23.02
reach benchmark, increasing to 88% by increasing dose quantity (Fig-
Adoption of WHO’s HIV retesting policy for HIV-negative
ure 1c) and to 91% by doubling dosing frequency (Table, Figure 1d).
Conclusions: Co-administration of CAB LA and the strong inducer
women during the breastfeeding period in 10 high
rifampin would result in significant decreases in CAB trough concen- HIV-burden African countries
trations, which was not significantly improved with dosing regimen B. Burmen1 and M. Omolo2
1
modifications. Doubling CAB LA dosing frequency is predicted to allow Kenya Medical Research Institute, Center for Respiratory Disease
co-administration with rifabutin, a strategy that warrants further eval- Research, Nairobi, Kenya, 2Kenya Medical Research Institute, HIV
uation. Benchmark requires validation in PrEP Phase 3 studies. Implementation Science and Services, Kisumu, Kenya
Background: We evaluated how the 2016 WHO recommendation for

HIV retesting for HIV-negative breastfeeding women and their HIV-
Policy and advocacy negative sexual partners in the postpartum period to reduce the risk
of mother to mother-to-child transmission of HIV, was adopted in 10
high HIV-burdened African countries.
Methods: An online search was used to retrieve 10 country-specific
PE23.01 HIV treatment guidelines dated 2015 to 2019 from Kenya, Zambia,
Identifying regional disparities in access to HIV and sexual Tanzania, Uganda, Zimbabwe, Malawi, Lesotho, Botswana, Namibia,
health resources for young men who have sex with men in and Rwanda. Each guideline had to specify that the WHO 2016 guide-
the United States: The iREACH Study lines (launched in 2015) were used to guide its’ development. Fre-
A. Walsh1; T. Chavanduka2; G. Sallabank2; J. Bauermeister3; quency summaries were used to document how different countries
P. Sullivan4; J. Guest4; R. Filipowicz4; J. Wolfe3; K. Horvath5; B. Hailu6 adapted WHO guidelines into their country-specific guidelines.
and R. Stephenson2 Results: All (100%) countries had adopted the WHO HIV-resting pol-
1
University of Michigan School of Nursing, Systems, Population and icy for breastfeeding women in their HIV treatment guidelines with
Leadership, Ann Arbor, United States, 2University of Michigan School variations in: timing for initial testing in the postnatal period (50% at
of Nursing, Ann Arbor, United States, 3University of Pennsylvania the 6th-week postpartum immunization visit, 40% at 6 months’ post-
School of Nursing, Philadelphia, United States, 4Rollins School of Pub- partum and 10% with test-timing unspecified); frequency of repeat
lic Health, Emory University, Atlanta, United States, 5University of testing (60% recommended retesting 3-monthy, 20% 6-monthly, 10%
Minnesota, United States, 6National Institute on Minority Health and as per the general population, and 10% with schedule of repeat test-
Health Disparities, United States ing unspecified); and in timing of the last HIV test during the postpar-
tum period (30% recommended the last test be at the end of
breastfeeding, 30% three months after cessation of breastfeeding,
Background: In the United States, 21% of incident HIV cases are 10% yearly and 10% had the timing of last HIV test unspecified).
among youth (aged 13 to 24), and most of these infections occur in Only 40% of the guidelines had recommendations for repeat HIV-test-
gay, bisexual, and other young men who have sex with men ing for the mother’s sexual partner, at a schedule akin to that that rec-
(YGBMSM). HIV testing, PrEP/PEP, and LGBTQ+ well-being resources ommended for the breastfeeding mother (25%), recommended only
are key to reducing risk in vulnerable YGBMSM. This study aimed to offering HIV testing for the male partner (50%) and encouraged male
assess the distribution of YGBMSM-friendly HIV resource in four US partner involvement (25%).
regions heavily impacted by HIV. Conclusions: Despite the time lapse between reviewed guidelines
Methods: Using a database of verified LGBTQ+ and youth-friendly and updated clinical guidelines, and the absence of detailed informa-
public and private service providers, we assessed HIV testing and tion on rationale for country-specific recommendations and actual clin-
PrEP/PEP availability across 4 major interstate corridors in four US ical practices, HIV retesting schedules for HIV-negative breastfeeding
Census regions: (East-North-Central (ENC), South-Atlantic (SA), East- mothers in high-HIV burden settings during the postpartum period
South-Central (ESC), Pacific (P); 109 counties). County-level provider are suboptimal for timely identification of new infection. This is further
per capita densities (per 10,000 youth) were used as proxies of avail- worsened by limited guidance on HIV retesting for their sexual part-
ability. Densities were compared across corridors and metropolitan/ ners. We recommend the routine policy and practice assessments to
non-metropolitan counties using Kruskal-Wallis tests. align HIV health policies to country-specific HIV statistics.
Results: 893 providers offering at least one HIV service were identi-
fied: 79.8% offered HIV testing and 20.2% offered PrEP/PEP. Counties
had approximately 5 3 times more HIV testing than PrEP/PEP provi-
ders; in non-metropolitan counties, testing providers were 12.5 4
times denser than PrEP/PEP providers. On average, P and ENC counties
had lower testing (p > 0.05) and PrEP/PEP (p = 0.02) densities than SA
164
transmission; 2. Risk of emerging pathogens that follow similar trans-

PE23.03 mission pathways as HIV, such as HBV, HCV, and emerging patho-
Ten years of the AVAC Advocacy Fellows Program: An gens; 3. Risk posed by false-negative testing results from individuals
evaluation taking pre-exposure prophylaxis (PrEP) therapy or antiretroviral ther-
V. Tayler1 and D. Jogi2 apy (ART). We have assessed how PR has been viewed by FDA as an
1
Tayler Associates Ltd, NA, United Kingdom, 2Tayler Associates Ltd, alternative to donor deferral or testing requirements and its applica-
Australia bility to HIV, especially with newly documented risk factors such as
undisclosed PrEP and ART use.
Methods: We reviewed current FDA regulations for blood safety to
Background: The AVAC Advocacy Fellows Program was founded, determine if PR is used as an alternative to testing and deferrals.
“to expand and strengthen the capacity of civil society advocates Results: Four current FDA regulations specify PR as a standalone
and organisations to monitor, support and help shape HIV preven- option to address risks associated with transfusion transmission infec-
tion research and rapid rollout of new effective interventions in tion (TTI) due to bacteria, malaria, babesia, and Zika. FDA held a pub-
LMIC with high HIV burdens.” The annual Fellowship sees selected lic meeting in March 2019 on the use of PR to replace the MSM
applicants develop and implement an advocacy project with mentor- deferral. In April 2020, regulations were revised by FDA to lower
ship from AVAC and a local host organisation. The objective is to MSM donor deferral times from 12 to 3 months but did not incorpo-
expand the pool of ‘fearless’ HIV prevention advocates engaging rate PR as an alternative or complimentary risk mitigation strategy.
with their local HIV landscape. 10 years on, AVAC commissioned a Conclusions: FDA has recognized the capacity of PR to eliminate
program evaluation to measure its effectiveness, relevance, impact donor deferrals and testing for some key TTI risks. PR with effective
and sustainability. viral reduction can appropriately mitigate the risks associated with
Methods: The evaluation was carried out by independent consultants window-period HIV TTI, arguably better than a donor questionnaire
between March and August 2020 using a participatory approach in that relies on the proper recollection of the respondent.[1],[2]Robust
which stakeholders co-created the evaluation framework. The mixed- PR processes can facilitate broader inclusion of potential blood donors
methods assessment consulted all relevant data and stakeholders while proactively mitigating the risk of TTI not captured by deferral
(alumni fellows, hosts, donors, the AVAC team, external CSO and gov- and testing policies.
ernment stakeholders) via online surveys, in-depth interviews and [1] Custer B, et al. Blood. July 9, 2020. https://doi.org/10.1182/blood.
focus group discussions. The specific experiences in four ‘case study’ 2020,006,890
countries (Kenya, South Africa, Uganda and Zimbabwe) were high- [2] Lanteri M, et. al. Transfusion. 2020. https://doi.org/10.1111/trf.
lighted. All evaluation activities took place virtually due to COVID-19. 15,807
Results: Fellowship Alumni were overwhelmingly (78%) satisfied with
the program design, reporting increases in their advocacy skills (both
technical and personal), that they attributed in part to AVAC’s men-
PE23.05
torship. Hosts reported increased organisational capacity, advocacy
AVAC’s Fellows Program: A growing civil society advocacy
profile and network. Fellows’ work clearly contributed to changes at movement hastens the pace of HIV prevention from
the community and national level, although advances in the HIV land- research and development through delivery
scape could not be solely attributed to projects. Recommendations C. Feuer1 and M. Chatani2
1
included enhancing the three-way relationship between fellow, host AVAC, Global Movement, New York, United States, 2AVAC, New
and AVAC, strengthening the existing cadre of alumni, and giving more York, United States
responsibility to alumni and local CSOs to reinforce an appropriate
South-South development approach.
Conclusions: AVAC’s Advocacy Fellowship demonstrates the efficacy Background: There have been several results from key clinical trials
of providing funding, access and technical support to the individual to that pivoted the field of HIV prevention from a wilderness of uncer-
impact the HIV landscape at the organisational, community and tainty to a foreseeable future of epidemic control. Generating political
national level. However, such a large-scale program with its short pro- will, demand creation, health infrastructure and funding are the chal-
ject duration cannot fully respond to country-specific issues. In design- lenges more likely to threaten progress towards ending AIDS.
ing Fellowship Programs in LMIC, organisations should ensure they Methods: Since 2010, AVAC has annually supported a new group of
seek input from local stakeholders and utilize this knowledge to con- Fellow advocates to work across HIV prevention modalities to triage
textually and sustainably capitalize on existing successes, such as HIV prevention policy, research and implementation most critical in
AVAC’s Advocacy Fellowship. high-burdened countries. Ongoing training in advocacy and prevention
science enables Fellows to work with governments, researchers, fun-
ders, normative agencies and community to push for combination pre-
PE23.04 vention policy and implementation.
Pathogen reduction (PR) as an alternative to donor deferral Results: Fellows’ advocacy has manifested in various ways over the
to mitigate the risk of transfusion-transmitted HIV past 10 years, including: the drafting of national guidelines on PrEP,
K. Rowe1; J. Hanover1 and R. Benjamin2 HIV-self testing and partner notification; the provision of PrEP on uni-
1
Cerus Corporation, Government Affairs, Concord, United States, versity campuses, and the training of health workers in how to do cul-
2
Cerus Corporation, Medical Affairs, Concord, United States turally competent PrEP rollout for key populations; the generation of
IEC materials for civil society, particularly in places where the govern-
ment’s response was too slow; convening of diverse stakeholders and
Background: Reducing HIV transmission through blood transfusion drafting of policy briefs, enabling bidirectional dialogue among scien-
currently relies on nucleic acid testing and donor history for screening tists, policy makers and community; ongoing relationships with broad-
out high-risk donors. Defining men-who-have-sex-with-men (MSM) cast and print media to keep them informed and thereby educate
donors as high-risk sparks outcries of discrimination and can unneces- communities or shame lagging governments through media; the mobi-
sarily cull otherwise fit donors while allowing donors with a newly lization and leadership of HIV prevention advocacy coalitions in their
acquired infection to donate if they fail to reveal a high-risk activity. respective countries—coalitions that often work directly with Min-
Interventions to protect the blood supply from HIV should address istries of Health; involvement in Global Fund and PEPFAR COP pro-
the following: 1. Risk of window period HIV, as well as HBV, and HCV cesses, ensuring funding is allocated to HIV prevention; and the
165
education and mobilization of civil society on the latest prevention

science and the local research landscape, often working side-by-side PE23.07LB
with researchers to seed a research-positive environment. Planning for voluntary medical male circumcision (VMMC)
Conclusions: AVAC Fellows continue to lead advocacy for research program sustainability: generating evidence to support
and potential future interventions such as vaginal rings, implants, targeted transition planning in Zambia and Zimbabwe using
injectables, vaccines and more. Each year sees an increase in the the VMMC Transition Assessment Dashboard-VTAD
power and breadth of civil society coalitions that are supported and T. Kanyenda1; A. Rosen1; N. Nyathi2; T. Mwamba3; M. Silondwa3;
frequently led by Fellows whose work must continue in order to help B. Pindiwe2; M. Chilembo3; N. Chagoma1; R. Maruza1; S. Jenkins1;
usher in science-based policy and access to HIV prevention for all. A. Svisva2; P. Haimbe3; H. Shakwelele3; A. Mangwiro2; H. Nyika4;
R. Kamboyi5; J. Zulu5 and S. Xaba4
PE23.06LB 1
Clinton Health Access Initiative, MA, United States, 2Clinton Health
HIV prevention research and development funding trends Access Initiative, Harare, Zimbabwe, 3Clinton Health Access Initiative,
2000 to 2019: investment priorities to fund innovation in a Lusaka, Zambia, 4Ministry of Health & Child Care, Harare, Zimbabwe,
5
challenging global health landscape Ministry of Health, Lusaka, Zambia
F. Riaz1; K. Fisher1; J.A. Izazola-Licea2; J. Maple3; D. Mattur2 and
M. Warren1 Background: Zambia and Zimbabwe have made significant progress
1
AVAC, New York, United States, 2The Joint United Nations Pro- toward the VMMC scale-up targets outlined in the respective country
gramme on HIV/AIDS (UNAIDS), Geneva, Switzerland, 3International strategic plans. To maintain the gains achieved, VMMC programming
AIDS Vaccine Initiative, New York, United States must be implemented through sustainable strategies in the scale-up,
maintenance, and transition to sustainability phases. To plan for an
effective transition process, both countries have developed sustainabil-
Background: Since 2004, the Resource Tracking for HIV Prevention
ity roadmaps and strategic plans that define the “ideal sustainability
Research and Development Working Group (“Working Group”) has
state” for each VMMC program pillar [1] and outline actionable strate-
tracked trends in research and development (R&D) investments and
gies for transitioning to sustainable program implementation. The
expenditures for biomedical HIV prevention options. These options
VTAD assessments were conducted to measure the progress towards
include HIV vaccines, microbicides, PrEP, treatment as prevention
the country-defined sustainability ideal states.
(TasP), voluntary medical male circumcision (VMMC) and female con-
[1] (1) Leadership, Management & Coordination, (2) Service Delivery,
doms and Multipurpose Prevention Technologies.
(3) Demand Generation, (4) Service Quality, (5) Supply Chain, (6) Data
Methods: To estimate annual investment in HIV prevention R&D
& Quality Assurance, and (7) Financing.
data are collected via annual surveys and direct outreach on: disburse-
Methods: The Ministries of Health in Zambia and Zimbabwe, in col-
ments by public, private and philanthropic funders for product devel-
laboration with the Clinton Health Access Initiative (CHAI) and in-
opment, clinical trials, implementation, behavioral research, and policy
country stakeholders, developed and conducted baseline VTAD assess-
and advocacy. Investment trends were assessed and compared by
ments at the national, provincial, and district level using a set of quan-
year, prevention type, research phase, funder category and geographic
titative and qualitative indicators across programmatic pillars. A
location. Out of a total 215 surveyed organizations across multiple
predetermined scoring system for indicators fed into automated dash-
countries and sectors, 400 relevant grants were allocated to the
boards to visualize national, provincial, and district progress towards
resource tracking analysis for 2019.
sustainability. In Zambia, assessments were conducted at the national
Results: The Working Group collated and analyzed 2019 data in US
level, 10 provincial offices, and 40 districts across the country. In Zim-
dollars for all areas of HIV prevention R&D. While overall funding fell
babwe, assessments were completed at the national level, 10 provin-
by two percent from 2018 levels to US$1.12 billion, United States
cial offices, and 63 districts.
public-sector funding rose by US$19 million due to increased invest-
Results: In both countries, the majority of districts were in the inter-
ment from the National Institutes of Health and the Centers for Dis-
mediate-phase for sustainability.
ease Control and Prevention. Commitments from surveyed European
countries decreased, with the steepest declines observed from Ger-
many, Denmark and the Netherlands. This contributed to the seventh
consecutive year of declining microbicide funding--coming in at US Sustainability phase ZAMBIA (% of districts) Zimbabwe (% of districts)
$128 million in 2019, the lowest level observed since 2003. Philan-
Early (0% to 59%) 10% 33%
thropic funding decreased by 3 percent to US$158 million, with the
Intermediate (60% to 79%) 72% 57%
Bill & Melinda Gates Foundation making up 92 percent of those Mature (>80%) 18% 10%
investments.
Conclusions: European investments have been declining since at least
2013 and have contributed to a funding imbalance of a small number Analysis by pillars shows sustainability progress in M&E in Zambia,
of large investors. Currently, 89 cents out of every dollar spent on and Strategic Information; Quality; Demand Generation in Zimbabwe.
HIV prevention R&D comes from the US public sector and the Gates Ongoing work will need to focus on strengthening all pillars.
Foundation. Diversifying the funding base is critical to cushion against
shifting donor priorities, emergent needs such as COVID-19 research, Abstract PE23.07LB-Table 2.
and to safeguard the scientific gains and progress made from US$20
Sustainability
billion invested across seven diverse HIV prevention interventions phase Zambia Zimbabwe
since 2000.
Early (0% to Demand Generation; Supply Leadership, Management &
59%) Chain Resource Mobilization; Coordination; Service Delivery
Service Delivery; Leadership,
Governance & Coordination
Intermediate Monitoring & Evaluation Strategic Information; Quality;
(60% to 79%) Demand Generation
Mature (>80%) None None
166
Conclusions: The results from the VTAD process are currently uti-
lized by country and global stakeholders to inform VMMC sustainabil- PE24.02
ity planning processes. Subsequent assessments are planned to ensure Transport and permeability properties of dapivirine:
ongoing tracking of progress. The VTAD method provides a systematic understanding potential drug-drug interactions
approach to measuring sustainability progress that can inform and R. Zheng and L. Rohan
provide evidence for other health programs planning for transitions. University of Pittsburgh, Pharmaceutical Sciences, School of Pharmacy,
Pittsburgh, United States
Preclinical studies for HIV prevention Background: Dapivirine (DPV), a potent non-nucleoside reverse tran-
scriptase inhibitor, was shown to reduce HIV risk among women who
used a vaginal ring containing 25 mg dapivirine in two large clinical
trials. A clinical study conducted by the International Partnership for
PE24.01 Microbicides showed that concomitant use of DPV and vaginal
miconazole (MIC), an antifungal treatment for Candidiasis, decreased
Efficacy of a vaginal ring containing the gp120 blocker
DPV levels in the vaginal fluid while increasing DPV systemic expo-
DS003 in pigtailed macaques
sure. However, the reason behind the DPV-MIC interaction remains
J. Nuttall1; J. Goss1; D. Murphy2; P. Boyd2; K. Malcolm2; D. Little3; unknown and a program of work is in progress to try and determine
J. Lipscomb3; Y. Pan3; J. Zhang3; P. Srinivasan3; W. Heneine3 and the mechanism. The work described here evaluated the interactions
J. Smith3 between DPV and the drug transporters highly expressed in the
1
International Partnership for Microbicides, Product Development, Sil- human female genital tract. Additionally, the impact of DPV-MIC on
ver Spring, United States, 2Queen’s University Belfast, School of tight junction integrity and the effect of MIC on DPV tissue perme-
Pharmacy, Belfast, United Kingdom, 3Centers for Disease Control ability were assessed.
and Prevention, Division of HIV/AIDS Prevention, Atlanta, United Methods: The interactions between DPV and several transporters,
States including MRP1, MRP4, P-gp, BCRP, and ENT1, were evaluated using
Background: DS003, a gp120 blocker that inhibits binding of HIV-1 vesicular and cellular (MDCKII and HEK293) systems. The impact of
to CD4 receptors, is being developed as a vaginal microbicide. We DPV-MIC on tight junctions was evaluated by monitoring transepithe-
previously reported on the pharmacokinetics of DS003 in pigtailed lial electrical resistance of HEC-1-A cell monolayer with the Ussing
macaques when formulated as vaginal tablets (1 and 10 mg) or a vagi- chamber apparatus. The impact of MIC on DPV tissue permeability
nal ring (VR) containing 40% DS003. Based on these data, a ring for- was evaluated using excised human ectocervical tissue with the In-Line
mulation that releases DS003 in vaginal fluids about 3-logs over the Cell apparatus.
in vitro IC50 was selected for evaluation of efficacy in a macaque study Results: DPV uptake in MRP1/MRP4 vesicles was ATP-independent
using repeated low dose SHIV exposures. and similar to that in control vesicles. Also, cellular permeability/up-
Methods: Two groups of pigtailed macaques (6 in the DS003 group take of DPV in the overexpressing cell lines (P-gp, BCRP, and ENT1)
and 5 in a placebo group) received VRs at Weeks 0, 4, 8, and 12. The was similar to that in control cell lines and was not affected by known
first ring was inserted 10 days prior to the first of 12 weekly vaginal transporter inhibitors. These results indicate that DPV is not a sub-
exposures to a low dose of SHIV162p3 (50 TCID50). Infection was strate of the transporters evaluated. Additionally, DPV has no inhibi-
monitored based on plasma viral load and cell-associated DNA in tory effect on the uptake or permeability of known transporter
PBMCs. Macaques that were determined to be positive by two con- substrates. DPV, MIC, and their combination do not disrupt cellular
secutive positive plasma viral load assays did not receive additional tight junctions. MIC has no significant impact (p = 0.94) on DPV tissue
virus exposures but retained a VR to the end of the study. Additional permeability.
investigations included analysis of proinflammatory cytokines, CD4/ Conclusions: Our findings suggest that the observed DPV-MIC inter-
CD8 levels, viral drug resistance mutations in plasma and vaginal fluid, action is not due to altered DPV transport or permeability. Studies on
and residual DS003 levels in used rings. DPV metabolism are in progress to evaluate if altered enzymatic
Results: The DS003 VR had an efficacy of 66.5% (95% CI = 38.6%, activities cause the DPV-MIC interaction.
91.9%; not statistically significant) with 3/6 DS003 animals and 4/5
placebo animals infected. Peak and overall viral loads during the first PE24.03LB
weeks of infection were reduced in the DS003 group relative to pla- Efficacy of a tenofovir alafenamide fumarate subcutaneous
cebo (not statistically significant), and normal CD4/CD8 ratios after pre-exposure prophylaxis nanofluidic implant in SHIV-
infection were maintained in the DS003 group compared to placebo. challenged nonhuman primates
Macaques maintained normal menstrual cycles, and there were no
F.P. Pons-Faudoa1,2; A. Sizovs1; K.A. Shelton3; Z. Momin4; J.A. Niles5;
adverse changes in cytokines, suggesting that the DS003 VR is safe.
L.R. Bushman6; J. Xu7,8; C.Y.X. Chua1; S. Demaria9,10; M.M. Ittmann11;
Although mutations were detected in gp120 sequences of infected
T. Hawkins12; J.F. Rooney12; M.A. Marzinke13; J.T. Kimata4;
macaques, the changes were not specific to the DS003 group. Resid-
P.L. Anderson6; P.N. Nehete3,14; R.C. Arduino15; M. Ferrari16;
ual drug analysis indicated that drug release was too low to be deter-
K.J. Sastry3,17 and A. Grattoni1,18,19
mined accurately. 1
Conclusions: Despite low drug release, DS003 was shown to have Houston Methodist Research Institute, Department of Nanomedicine,
the potential to prevent infection when delivered from a VR. Opti- Houston, United States, 2Tecnologico de Monterrey, School of Medi-
mization of the VR formulation to achieve higher release levels may cine and Health Sciences, Monterrey, Mexico, 3MD Anderson Cancer
potentially improve the level of protection. Center Michael E. Keeling Center for Comparative Medicine and
Research, Department of Comparative Medicine, Bastrop, United
States, 4Baylor College of Medicine, Department of Molecular Virology
and Microbiology, Houston, United States, 5University of Texas Medical
Branch, Division of Infectious Diseases, Department of Internal Medi-
cine, Galveston, United States, 6Skagss School of Pharmacy and Phar-
maceutical Sciences, University of Colorado-Anschutz Medical Campus,
Department of Pharmaceutical Sciences, Aurora, United States,
167
7
Houston Methodist Research Institute, Center for Outcomes
Research and DeBakey Heart and Vascular Center, Houston, United PE24.04LB
States, 8Weill Medical College of Cornell University, New York, United Dose response to tenofovir disoproxil fumarate and
States, 9Weill Cornell Medicine, Department of Radiation Oncology, tenofovir released via intravaginal ring in the sheep vaginal
New York, United States, 10Weill Cornell Medicine, Department of safety and pharmacokinetics model
Pathology and Laboratory of Medicine, New York, United States, 11Bay- G. Vargas1; J.A. Moss2; R.B. Pyles1; B. Herold3; M. Keller3;
lor College of Medicine, Department of Pathology and Immunology, M.M. Baum2; M. Motamedi1 and K.L. Vincent1
Houston, United States, 12Gilead Sciences, Inc., Foster City, United 1
University of Texas Medical Branch, Galveston, United States, 2Oak
States, 13Johns Hopkins University School of Medicine, Departments of Crest Institute of Science, Monrovia, United States, 3Albert Einstein
Pathology and Medicine, Baltimore, United States, 14The University of College of Medicine, Bronx, United States
Texas MD Anderson Cancer Center UTH Health Graduate School of
Biomedical Sciences, Houston, United States, 15McGovern Medical
School at the University of Texas Health Science Center, Division of Background: Preclinical and Phase 1 trials of intravaginal ring (IVR)
Infectious Diseases, Department of Internal Medicine, Houston, United delivery of tenofovir (TFV) or tenofovir disoproxil fumarate (TDF)
States, 16University of Washington, School of Pharmacy, Seattle, United have yielded variable safety results; one study of a polyurethane (PU)-
States, 17University of Texas MD Anderson Cancer Center, Depart- TDF IVR prematurely terminated because 8 of 12 women assigned to
ment of Thoracic Head and Neck Medical Oncology, Houston, United TDF IVR developed vaginal ulcers. Sheep, with vaginal anatomy and
States, 18Houston Methodist Research Institute, Department of Sur- size similar to humans, allow for safety and pharmacokinetic (PK) test-
gery, Houston, United States, 19Houston Methodist Research Institute, ing of human vaginal products. Study objectives were to evaluate
Department of Radiation Oncology, Houston, United States whether PU-TDF IVR toxicity was reproduced in sheep and to explore
the mechanisms underlying toxicity.
Methods: Nonpregnant yearling Merino sheep had random blinded
Background: HIV PrEP with antiretrovirals (ARVs) is effective at pre- assignment to PU-TDF clinical IVRs (n = 6), high release TDF (n = 7)
venting HIV transmission if individuals strictly adhere to daily oral dos- and TFV (n = 8) pod-IVRs (10 pods per IVR), or placebo IVRs (n = 7)
ing requirement. As such, long-acting (LA) antiretroviral formulations for up to 90 days. Sheep vaginal tracts were assessed longitudinally
or delivery systems have emerged to address the challenge of pill fati- in vivo by colposcopy, confocal micro-endoscopy, and vaginal biopsy for
gue. While numerous LA ARV strategies have emerged for tenofovir H&E staining. Plasma and cervicovaginal secretions (CVS) were ana-
alafenamide (TAF), none have undergone preventative efficacy assess- lyzed for drug and cytokine (IL-8 and IL-1ß) concentrations.
ment. In this work, we assessed the efficacy of sustained subcuta- Results: Five of six PU-TDF treated sheep had focal deep mucosal dis-
neous delivery of TAF fumarate via nanofluidic implant (nTAF) as a ruption detected by colposcopy, similar to ulcerations seen in the clinical
single-agent PrEP regimen for protection from simian HIV (SHIV) trial. Similarly, seven of eight sheep had mucosal disruption while using
infection in rhesus macaques. the 10-pod TFV IVR. In contrast, TDF pod-IVRs and placebo IVRs did
Methods: PrEP efficacy was assessed using multiple weekly rectal not produce signs of toxicity. CVS IL-8 and IL-1ß were higher in IVRs
challenges of SHIVSF162P3 in rhesus macaques implanted with nTAF. associated with mucosal disruption compared with placebo. Confocal
Fourteen (14) animals were used: 8 received nTAF, and 6 control endomicroscopy showed focal sites with surface infiltrates and minor
received a PBS-loaded nanofluidic (nPBS) implant. The pharmacoki- cellular disorganization. Histology findings included intermittent inflam-
netic profile of TFV-DP in peripheral blood mononuclear cells (PBMC) mation. The results of paired analyses of safety findings with drug and
s and TAF and TFV in plasma was evaluated in the PrEP group before drug metabolite concentrations, as well as other metadata, are dis-
nTAF implantation and for 4 months until device retrieval (n = 4), as cussed in an attempt to identify mechanisms of toxicity.
well as for an additional 2-month drug-washout period after device Conclusions: The sheep model for safety and PK assessment of vagi-
retrieval (n = 3). Once preventive intracellular TFV-DP levels in nal TDF delivery closely approximated findings from a clinical trial
PBMCs were reached, we used the repeat low-dose rectal using the same TDF IVR. Vaginal toxicity was noted with higher doses
SHIVSF162P3 transmission model with up to 10 weekly virus chal- of TDF and TFV, regardless of type of IVR used for drug delivery.
lenges. Results demonstrate that the sheep model provides opportunities for
Results: We showed that the novel TAF subcutaneous nanofluidic exploration of mechanisms of drug toxicity and rapid iterative drug
implant (nTAF) confers partial protection from SHIV transmission. We development.
demonstrate that sustained subcutaneous delivery through nTAF in
rhesus macaques maintained tenofovir diphosphate concentration at a
median of 390.00 fmol/106 peripheral blood mononuclear cells, 9 PE24.05LB
times above clinically protective levels. In a non-blinded, placebo-con- Induction of neutralization breadth and broadly neutralizing
trolled rhesus macaque study with repeated low-dose rectal antibody lineage responses in HIV envelope BG505 SOSIP
SHIVSF162P3 challenge, the nTAF cohort had a 62.50% reduction immunized infant macaques
(95% CI: 1.72% to 85.69%; p = 0.068) in risk of infection per expo- A. Nelson1; M. Dennis1; C.C. LaBranche2; J. Eudailey1;
sure compared to the control. Further we showed that nTAF was well D.C. Montefiori2; R.W. Sanders3,4; J.P. Moore4; G. Fouda5,1; K.K. Van
tolerated by the animals. Rompay6; K. De Paris7 and S.R. Permar5,1
Conclusions: Our finding mirrors that of tenofovir disoproxil fumarate 1
Duke University School of Medicine, Human Vaccine Institute, Dur-
(TDF) monotherapy, where 60.00% protective efficacy was observed ham, United States, 2Duke University Medical Center, Dept of Sur-
in macaques, and clinically, 67.00% reduction in risk with 86.00% pre- gery, Durham, United States, 3University of Amsterdam, Dept of
ventive efficacy in individuals with detectable drug in the plasma. Medical Microbiology, Amsterdam, Netherlands, 4Weill Medical Col-
Overall, our nanofluidic technology shows potential as a subcutaneous lege of Cornell University, Dept of Microbiology and Immunology,
delivery platform for long-term PrEP and provides insights for clinical New York, United States, 5Duke University Medical Center, Dept of
implementation of LA TAF for HIV prevent. Pediatrics, Durham, United States, 6University of California, Davis,
California National Primate Research Center, Davis, United States,
7
University of North Carolina at Chapel Hill, Dept of Microbiology
and Immunology and Center for AIDS Research, Chapel Hill, United
States
168
Background: A HIV vaccine that induces protective antibodies prior (IVRs) are promising as a multi-purpose prevention technology
to sexual debut is critical to eliminate the ~460,000 new infections (MPT).
annually that occur among youth ages 15 to 24 years worldwide. Methods: Embedded within a phase 1 randomized, placebo-controlled
Induction of broadly active neutralizing antibodies (bnAbs) will be key safety trial, we examined acceptability of continuous versus inter-
to a successful HIV vaccine. Native conformation envelope (Env) tri- rupted use of a 90-day MPT IVR containing Tenofovir and Levonor-
mers are ideal immunogens given their enhanced ability to elicit anti- gestrel among 47 women at low risk for pregnancy and HIV in
body responses against vulnerable sites of the HIV Env that are the Norfolk, Virginia and the Dominican Republic. A baseline survey
targets of bnAbs. As HIV-infected children develop bnAbs earlier and assessed menstruation attitudes, risk perceptions and trial-related
at a higher frequency than adults, the infant immune landscape may motivations. Surveys at one and three months (M1/M3) examined
be more amenable to the induction of bnAb B cell lineages. Therefore, user experiences with and preferences for IVR attributes. A subset of
the goal of our study was to assess the ability of a B cell lineage- 18 women participated in two in-depth interviews.
designed HIV Env trimer to induce bnAb lineages in early life. Results: Most women rated the IVR’s flexibility and smoothness
Methods: Infant rhesus macaques (RMs) received 50 mg of either (86%) and ease of insertion/removal (76%) as very acceptable. Fewer
the BG505 wild type (WT) or germline-targeting (GT1.1) SOSIP tri- women gave similar ratings to IVR size (57%) and changes in color
mer (n = 5/group) with the 3M-052-SE adjuvant at 0, 6, and due to menstruation (52%). While most participants experienced no
12 weeks of age. All 10 infant RMs were then boosted with the changes or less bleeding, those reporting more/heavier bleeding (20%
BG505 WT SOSIP trimer at weeks 26, 52 and 78, mimicking a pedi- M1, 15% M3) disliked the change. Overall, women preferred a 3-
atric immunization schedule of multiple vaccine boosts within the first month (75%) to a 1-month IVR (7.5%) or a bimonthly injectable (10%).
two years of life. In qualitative interviews, women were willing to continuously use an
Results: Both immunization strategies induced durable, high magni- IVR for six to twelve months, providing it didn’t “degrade” inside the
tude binding antibody responses. Plasma neutralization responses body. Women’s reasons for joining the trial, menstrual attitudes, per-
against BG505 tier 1 and 2 viruses were enhanced after the 4th and ceived IVR benefits and doubts, and reasons for prevention prefer-
5th immunizations at week 28 and 54 compared to week 14 in both ences varied by site.
groups. Two GT1.1 SOSIP-immunized infants exhibited a plasma HIV
neutralization signature reflective of CD4 binding site-specific bnAb Abstract PE25.01-Table 1. Pregnancy/HIV prevention product pref-
precursor development. Interestingly, these two infants also had more erences by regimen, site and agent at Month 3
potent plasma tier 2 virus neutralization responses (ID50: 4498 and Regimen Site
3213) compared with other GT1.1 immunized infants, and neutralized Agent
1 to 3 viruses of a global panel of 10 HIV-1 viruses suggesting some Total Continuous Interrupt DR US Active Placebo
(n = 40) (n = 21) (n = 19) (n = 24) (n = 16) (n = 30) (n = 10)
neutralization breadth development. Importantly, the bnAb precursor
neutralization signature continued to rise following each immunization Opinion of VR (%)
while other neutralization responses declined, indicating continued Disliked a lot 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Disliked a little 15.0 14.3 15.8 4.2 31.3 13.3 20.0
maturation of this lineage. Liked a little 20.0 9.5 31.6 20.8 18.8 23.3 10.0
Conclusions: A multi-dose immunization regimen in infants with bnAb Liked a lot 65.0 76.2 52.6 75.0 50.0 63.3 70.0
Interest in future VR use (%)
lineage designed SOSIP trimers is a promising strategy for inducing
Not at all 0.0 0.0 0.0 0.0 0.0 0.0 0.0
protective HIV bnAb responses in childhood prior to adolescence, interested
when sexual HIV exposure risk begins. Some interest 12.5 14.3 10.5 8.3 18.8 13.3 10.0
Very interested 87.5 85.7 89.5 91.7 81.3 86.7 90.0
Preferred product (%)
Doesn’t matter 5.0 4.8 5.3 0.0 12.5 3.3 10.0
Daily oral pill 2.5 4.8 0.0 0.0 6.3 3.3 0.0
1-month VR 7.5 0.0 15.8 4.2 12.5 10.0 0.0
Product acceptability and adherence 3-month VR
2-month Injection
75.0
10.0
81.0
9.5
68.4
10.5
87.5
8.3
56.3
12.5
70.0
13.3
90.0
0.0
Reasons for VR preferences (%)
(n = 33) (n = 17) (n = 16) (n = 22) (n = 11) (n = 24) (n = 9)
Discreet use 30.3 29.4 31.3 40.9 9.1 37.5 11.1
Easier than other 54.6 47.1 62.5 54.6 54.6 54.2 55.6
PE25.01 methods
Doesn’t interrupt 57.6 70.6 43.8 77.3* 18.2* 62.5 44.4
What women want in a multipurpose vaginal ring: sex
findings from a phase 1 trial in the U.S. and the Dominican Under my control 42.4 52.9 31.3 54.6* 18.2* 45.8 33.3
Less likely to cause 42.4 52.9 31.3 50.0 27.3 41.7 44.4
Republic harmful side
E. Tolley1; H. Hanif2; S. Zissette3; S. Ju2; M.L. Adams2; J. Schwartz2; effects
M.R. Clark4; A.R. Thurman4; V. Brache5 and G.F. Doncel4

1 a=Categories not mutually exclusive.
FHI 360, Global Health & Population Research, Durham, United
*p < 0.05 for comparisons across groups.
States, 2CONRAD, Arlington, United States, 3University of Notre
Dame, South Bend, United States, 4CONRAD & Eastern Virginia Med-
ical School, Norfolk, United States, 5Profamilia, Santo Domingo, Conclusions: Findings provide strong evidence of demand for an
Dominican Republic MPT IVR that protects from pregnancy and HIV/STIs, lasts longer
than one month, minimally disrupts menstrual bleeding, and is in
women’s control.
Background: Women worldwide face unintended pregnancy, compli-
cations from repeated pregnancy and childbirth, pregnancy at too
early an age, HIV and other sexually transmitted infections (STIs).
Although a range of effective contraceptive methods exist, uptake,
consistent and long-term use is challenged by numerous factors. To
date, highly effective contraceptive methods provide little-to-no pro-
tection from HIV and other STIs and HIV prevention products pro-
vide inadequate or no protection from pregnancy. Intravaginal rings
169
PE25.02 PE25.03
Impact of women’s home environment on use of the Patterns of adherence among South African women in a
dapivirine ring for HIV prevention in MTN-025/HOPE phase III randomized controlled trial of a dapivirine vaginal
M. Gichane1; A. Katz2; T. Palanee- Phillips3; R. Scheckter4; ring for HIV-1 prevention
K. Woeber5; K. Ngure6; T. Tauya7; K. Reddy3; J. Etima8; C. Zimba9; E.N. Browne1; E.R. Brown2; T. Palanee-Phillips3; K. Reddy3; L. Naidoo4;
N. Mangxilana10 and A. van der Straten2 N. Jeenarain4; G. Nair5; M.J. Husnik6; D. Singh7; R. Scheckter8;
1
RTI International, Substance Use Gender and Applied Research Pro- L. Soto-Torres9; J.M. Baeten10 and A. van der Straten1
gram, Research Triangle Park, United States, 2RTI International, 1
Women’s Global Health Imperative, Research Triangle Park, United gle Park, United States, 2University of Washington, Department of
States, 3Wits RHI, Johannesburg, South Africa, 4FHI 360, Durham, Biostatistics, Seattle, United States, 3University of the Witwatersrand,
United States, 5South African Medical Research Council, South Africa, Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg,
6
Jomo Kenyatta University of Agriculture and Technology, Kenya, South Africa, 4South African Medical Research Council, HIV Preven-
7
University of Zimbabwe College of Health Sciences Clinical Trials tion Research Unit, Durban, South Africa, 5Centre for the AIDS Pro-
Research Centre, Harare, Zimbabwe, 8Makerere University - Johns gramme Of Research In South Africa (CAPRISA), Durban, South
Hopkins University Research Collaboration, Kampala, Uganda, 9UNC Africa, 6Fred Hutchinson Cancer Research Center, Seattle, United
Project-Malawi, Malawi, 10Desmond Tutu Foundation, Cape Town, States, 7University of Pittsburgh, Magee–Women’s Research Institute,
South Africa Pittsburgh, United States, 8FHI 360, Durham, United States, 9National
Institutes of Health, Division of AIDS, National Institute of Allergy and
Infectious Diseases, National Institutes of Mental Health, and Eunice
Background: The monthly dapivirine vaginal ring was shown to Shriver Kennedy, National Institute of Child Health and Human Devel-
reduce HIV risk in two Phase 3 clinical trials. When considering the opment, Bethesda, United States, 10University of Washington, Depart-
potential future availability of the ring to the public, key questions ment of Global Health, Medicine, and Epidemiology, Seattle, United
remain about the feasibility of integrating the ring as an HIV preven- States
tion intervention into women’s lives. We examined how women’s home
environments influenced ring use, storage and disclosure in MTN-
025/HOPE, an open-label trial of the dapivirine vaginal ring conducted Background: We explored dapivirine vaginal ring (DVR) adherence
in Malawi, South Africa, Uganda and Zimbabwe. among South African women randomized to the active arm in the
Methods: We conducted 66 qualitative in-depth interviews with MTN-020/ASPIRE phase III, randomized placebo-controlled trial
women who accepted (n = 35) and did not accept the vaginal ring (NCT01617096) to understand adherence patterns in the last year of
(n = 31) in MTN-025/HOPE. In HOPE, participants were given the follow-up and identify characteristics influencing adherence.
option to take home three rings at a time for monthly replacement. Methods: Acetone extraction and high-pressure liquid chromatography
During interviews, participants drew and labeled a map of their were used to measure remaining dapivirine in returned rings of study
homes, indicating ring storage and changing areas. Maps and debrief participants. A monthly adherence measure was defined as the ratio of
reports were summarized and analyzed using matrices. dapivirine released to the number of days since ring dispensation. High
Results: Most women lived in crowded households, with over a third adherence was defined as ≥ 4 mg dapivirine released per month.
(n = 27) sharing a bedroom with children or family members. Most ring- Enrollment start times differed across countries, hence the analysis only
acceptors stored their rings in personal wardrobes which were locked included women enrolled in South Africa (n = 626). We used group-
or restricted from household members. Several stored them in con- based trajectory modeling to identify clusters of participants with simi-
cealed bags or suitcases to keep safe from others. Some participants lar longitudinal patterns of adherence during their last year of ring use
reported fearing that children would play with rings, however, there and potential predictors of group membership.
were minimal incidents of this occurring. A few reported concerns that Results: Women were on average aged 25 at enrollment (range 18
rats could eat them. These concerns led a few women to replace and dis- to 44 years) and were followed for a median of 26 months (range 12
pose of rings at study clinics monthly. Although nearly all ring acceptors to 33). Five adherence patterns were identified, see Figure 1: (1) con-
had disclosed ring use to at least some household members, some sistently high, [34%], (2) consistently moderate [34%], (3) increasing
emphasized waiting until they were home alone for ring replacement. [7%], (4) decreasing [9%], (5) consistently low [16%]. Women classified
Women who lived in homes with indoor toilets often replaced rings in as high adherers (1) were more likely to be older (>21 years) com-
the bathroom, whereas those with outdoor toilets replaced rings in their pared to low adherers (5) [OR 1.87, 95% CI: 1.10, 3.18], parous com-
bedrooms. Ring non-acceptors described similar living arrangements to pared to decreasing adherers (4) [OR 3.57, 95% CI: 1.58, 8.02] and
ring acceptors; however, they tended to report less secure locations, less likely to have.
such as bags, where they could store rings if they were to accept them. completed secondary education compared to moderate adherers (2)
Conclusions: Though vaginal rings are discreet, women’s ability to [OR 0.59, 95% CI: 0.38, 0.92]. Income, alcohol use, and condom use
properly store and change rings varies across contexts. Efforts to were not associated with adherence group classification (p ≥ 0.30).
improve feasibility of vaginal rings for home use should focus on Conclusions: Most South African women successfully persisted with
secure disposal and storage. at least some ring use during their last year in the trial. Young and
nulliparous women may benefit from additional targeted adherence
support efforts in future ring trials.
170
Results: Of the 22,020 individuals initiating TDF/FTC for PrEP, 1065

PE25.05 (4.8%) developed HIV within the first year, with the median time to HIV
Utilization patterns and HIV incidence within the first year diagnosis of 4.4 months. Those who acquired HIV were comparatively
of initiation of FTC/TDF for HIV pre-exposure prophylaxis older (median: 38 years vs 35 years, p-value < 0.001), reside in rural
(PrEP) among insured persons in the US areas (14% vs. 11%, p-value < 0.006), live in the South (37% vs 32%, p-
Y. Whiteside1; T. Gulati2; M. Mesa-Frias1; N. Kathe2; K. Mirchandani2; value < 0.001) or Northeast (24% vs 21%, p-value < 0.001), insured
R. Markan2 and A. Singh2 with a commercial program (94% vs 91%) and have higher adherence
1
Merck & Co., Inc., Center for Observational and Real-World Evidence (median proportion of days covered: 0.93 vs. 0.89) than those who did
(CORE), Philadelphia, United States, 2CHEORS, North Wales, United not acquire HIV. Only 31% of users who acquired HIV re-initiated TDF/
States FTC for PrEP post discontinuation, whereas 46% re-initiated among
those who did not acquire HIV. The risk for HIV acquisition was not sig-
nificantly lower for those who were covered by a PrEP prescription;
Background: When taken as prescribed, pre-exposure prophylaxis however, age, geographic region and health plan type were.
(PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) Conclusions: This study found that younger individuals had a
is effective in preventing Human Immunodeficiency Virus (HIV) infec- decreased risk of acquiring HIV. More research is needed to study uti-
tion in high-risk individuals. However, little is known regarding factors lization patterns and HIV acquisition in individuals who initiate TDF/
associated with HIV acquisition in its users. The objective of the study FTC for PrEP.
was to describe individuals who initiated TDF/FTC for HIV PrEP but
were diagnosed with HIV within one year of initiation. PE25.06
Methods: This retrospective study used 2011 to 2017 IBM® Mar-
PrEP adherence is associated with periods of HIV risk
ketScan® commercial and Medicaid plan data. The study sample con-
sisted of individuals aged ≥ 15 years initiating TDF/FTC for PrEP
among adolescent girls and young women in South Africa
without a history of HIV and followed them for up to one year to and Zimbabwe
assess usage and HIV acquisition. Descriptive analyses were used to J. Velloza1; D. Donnell2; P. Anderson3; S. Hosek4; M. Chirenje5;
characterize PrEP users’ demographic characteristics and treatment N. Mgodi5; L.-G. Bekker6; S. Delany-Moretlwe7 and C. Celum2
1
patterns including: adherence (proportion of days covered, PDC); per- University of Washington, Department of Global Health, Seattle, Uni-
sistence (time from initiation to discontinuation); discontinuation (pre- ted States, 2University of Washington, Seattle, United States, 3Univer-
scription gap of more than 14 days); and re-initiation (re-starting sity of Colorado, United States, 4Stroger Hospital of Cook County,
Truvada for PrEP after discontinuation). Time to HIV incidence was United States, 5University of Zimbabwe, Harare, Zimbabwe, 6The Des-
modelled using time-dependent cox proportional hazard with patient mond Tutu HIV Centre, Cape Town, South Africa, 7University of the
characteristics as fixed and adherence as time-varying predictors. Witwatersrand, Johannesburg, South Africa
171
Background: HIV pre-exposure prophylaxis (PrEP) uptake is increas- retrievability (per indication) were discussed. Data was analyzed using
ing among adolescent girls and young women (AGYW) but adherence Dedoose software and summarized into emerging themes.
remains a challenge. There has been limited consideration of dynamic Results: Women were 24 years old on average, 58% were from Zim-
changes in AGYW’s HIV risk which could impact PrEP decision-making babwe, 29% were implant experienced, 47% were nulliparous, and
over time. Understanding PrEP use during periods of HIV risk (“pre- 31% engaged in sex work. Women tended to prioritize an implant that
vention-effective adherence”) is critical to support PrEP adherence had the longest duration offered, an easily reversible contraceptive
among AGYW. component, while maintaining the HIV prevention component. End-
Methods: HPTN 082 was an open-label PrEP study among AGYW users voiced concerns regarding removability of a biodegradable
(ages 16 to 24) in South Africa and Zimbabwe from 2016 to 2018. implant in the event of adverse events or desire to return to fertility.
PrEP adherence was measured at Weeks 13, 26, and 52 via tenofovir Implant experienced women were most interested in insertion and
(TFV)-diphosphate (DP) in dried blood spots and TFV in plasma. removal systems that minimized pain and scarring. Implant na€ıve
Behavioral and STI data were collected quarterly. We categorized vis- women also raised concerns around scarring and desired an implant
its into a binary “any HIV risk” variable, defined by South African and they could use discreetly with minimal side effects. Women who
Zimbabwean PrEP guidelines (condomless sex, partner with HIV not engaged in sex work raised concerns that centered around side
taking antiretrovirals, partner with unknown HIV status, ≥1 partner, effects, with particular emphasis on irregular bleeding as a major con-
STI, transactional sex, drug/alcohol use around sex). We used general- cern. For this reason, they also welcomed the idea of having an
ized estimating equations to estimate longitudinal associations implant with an easily reversible contraceptive component in cases
between any HIV risk and detectable TFV-DP. We also estimated where irregular bleeding was intolerable.
associations between any risk and high PrEP adherence (intracellular Conclusions: A biodegradable implant with dual HIV prevention and
TFV-DP ≥ 700 fmol/punch; plasma TFV ≥ 40 ng/mL). We explored contraceptive properties was accepted by most women because it
the relationship between number of risk factors and continuous TFV- would alleviate pain and scarring associated with implant removal. Par-
DP with linear models. ticipants found independent retrievability for the HIV and contraceptive
Results: Among 398 AGYW, 85.4% reported ≥ 1 HIV risk factor at component to be highly desirable. Addressing these suggestions will
enrollment. 60.3%, 65.1%, and 64.3% reported ≥ 1 risk factor at cater to women’s needs which have not been met by existing implants
Weeks 13, 26, and 52, respectively. Any HIV risk was associated with and avoid anticipated barriers to roll-out of a novel MPT implant.
greater likelihood of detectable TFV-DP (adjusted relative risk
[aRR]:1.15; 95% confidence interval [95% CI]: 1.03 to 1.29). Similar
associations were observed with TFV-DP ≥ 700 fmol/punch (aRR:
PE25.08
PrEP use in the HVTN 702 HIV vaccine efficacy trial
1.57; 95% CI: 1.09 to 2.25), and TFV ≥ 40 ng/mL (aRR:1.36; 95% CI:
1.11 to 1.65). Compared to visits when no risk factors were reported,
conducted in South Africa
those with 1 risk factor had TFV-DP levels 54.0 fmol/punch higher, J. Odhiambo1; Y. Huang2; M. Malahleha3; F. Laher4; N. Grunenberg2;
those with 2 risk factors had TFV-DP levels 94.5 fmol/punch higher, H. Janes2; Z. Moodie2; A. Ward5; S. Kassim6; P. Mda7; N. Naicker8;
and those with ≥ 3 risk factors had TFV-DP levels 223 fmol/punch D. Kalonji9; M. Nchabeleng10; E. Lazarus4 and D. Grove2
1
higher (p-value < 0.001). Fred Hutchinson Cancer Research Center, Vaccine and Infectious
Conclusions: The strong association between HIV risk and PrEP Disease Division, South Africa, 2Fred Hutchinson Cancer Research
adherence among African AGYW indicates that participants were able Center, Seattle, United States, 3Setshaba Research Centre, South
to assess their risk and use PrEP effectively during periods of risk. Africa, 4Perinatal HIV Research Unit, Faculty of Health Sciences,
These findings support the concept of prevention-effective PrEP University of the Witwatersrand, Johannesburg, South Africa, 5Infec-
adherence during “seasons” of risk. tious Diseases and Molecular Medicine, University of Cape Town,
South Africa, 6Desmond Tutu HIV Centre, University of Cape Town,
Cape Town, South Africa, 7Walter Sisulu University, Department of
PE25.07 Family Medicine, South Africa, 8Centre for the AIDS Programme of
End-users’ hypothetical acceptability of a biodegradable Research in South Africa (CAPRISA), University of KwaZulu–Natal,
implant to prevent HIV and unplanned pregnancy: Durban, South Africa, 9South African Medical Research Council, HIV
qualitative insights from South Africa and Zimbabwe Prevention Research Unit (HPRU), South Africa, 10Medunsa Clinical
S. Nkomo1; I. Mahaka2; E. Luecke3; A. van der Straten3; M.-K. Shapley- Research Unit (MeCRU), Sefako Makgatho Health Sciences University,
Quinn3; W. Makoni2; K. Ahmed4; E. Mbatsane4 and L. Johnson3 South Africa
1
Pangaea Zimbabwe AIDS Trust, Community Health, Harare, Zim-
babwe, 2Pangaea Zimbabwe AIDS Trust, Harare, Zimbabwe, 3Research
Triangle Institute, United States, 4Setshaba Research Centre, South Background: The HVTN 702 HIV vaccine trial commenced as oral
Africa pre-exposure prophylaxis (PrEP) became part of the South African
national HIV prevention standard. In February 2020 the study vaccine
regimen proved non-efficacious in preventing HIV-1 infection in 18 to
Background: The incidence of HIV and unintended pregnancies 35 year olds in South Africa. Pooled HIV incidence of 4.3% females (-
among young Sub-Saharan African women remains a high priority. The at-birth) and 1.3% males (-at-birth) was observed over the primary
SCHIELD (Subcutaneous Contraceptive and HIV Implant Engineered 24-month follow-up (country incidence in 15 to 49 year olds was
for Long-Acting Delivery) program aims to develop a Multipurpose 0.8% in 2017). We describe PrEP use in HVTN 702.
Prevention Technology (MPT) implant with dual HIV prevention and Methods: Between October 2016-June 2019, HVTN 702 enrolled
contraception functions. An end-user evaluation was undertaken to 5404 adults at high-risk of HIV acquisition. At each visit, participants
improve modifiable implant attributes based on end-users’ preferences were offered HIV prevention standard as indicated: risk reduction
and needs. counselling, HIV and sexually transmitted infection (STI) testing, STI
Methods: Thirteen focus group discussions were conducted with 110 treatment, condoms and lubricant, male circumcision, post-exposure
women aged 18 to 30 years in Harare, Zimbabwe and Soshanguve, prophylaxis (PEP) and PrEP. PrEP was available at all sites (investiga-
South Africa. The purposively stratified sampled women were either tors received PrEP clinical management training) and by referral
implant experienced or na€ıve and categorized in three groups: nulli- where available and preferred. Self-reported PrEP/PEP use was cap-
parous, post-partum, or engaged in sex work. The concepts of duration tured at all visits. One day each month, we randomly collected dried
(6mo – 3 yrs), biodegradability, removability, and independent rod blood spot (DBS) samples for tenofovir diphosphate (TFV-DP) levels.
172
Results: Median age was 24 years amongst 3786 females and likely to return (vs. not) but then also more likely to return late (vs.
26 years amongst 1618 males. By February 2020, 3.2% (120/3786) on-time). Additional research is needed to identify client-centered
of females and 3.2% (52/1618) of males reported using PrEP while on interventions to mitigate loss-to-follow-up and follow-up delays after
study; 2.4% (91/3786) of females and 4.9% (80/1618) of males first starting PrEP to further normalize future use.
reported using at least one course of PEP while on study. Among
1671 females’ DBS samples, 32 had detectable TFV-DP levels, with PE25.10
12 self-reporting PrEP/PEP use at any point during the study. Among
“Men will never take a pill every day if they don’t have to”:
734 males’ DBS samples, 19 had detectable TFV-DP levels, with 9
self-reporting any PrEP/PEP use.
assumptions and realities around acceptability of PrEP
Conclusions: PrEP/PEP use was low, evidenced by self-report and among heterosexual men
TFV-DP levels among HVTN 702 participants burdened by high HIV S. Malone1; N. Hasen2; K. Little2; M. Hlongwa3; S. Sharma4; J. Bell4;
incidence. PrEP and PEP use was comparably low in South Africa at M. Levy4; J. Reast4; P. Pitsillides5; C. Searle6; C. Smith6; S. Ebrahim6
the time. Reasons might include the novelty of PrEP, acceptability and and E. Dorsamy6
1
adherence challenges, stigma, poor oral PrEP motivation among vac- PSI, HIV/TB, Johannesburg, South Africa, 2PSI, Washington, United
cine trial volunteers, or other unclear reasons. Discrepancies between States, 3PSI, Johannesburg, South Africa, 4Ipsos, London, United King-
self-report data and TFV-DP levels also warrant further evaluation. dom, 5Matchboxology, Johannesburg, South Africa, 6MatCH, Durban,
These observations may highlight the need for multiple HIV preven- South Africa
tion options, especially for young women in South Africa who remain
most at risk.
Background: Heterosexual men in South Africa have only recently
become eligible for PrEP. In part, there has been an assumption that
PE25.09 heterosexual men would not find a daily pill acceptable, particularly
Predictors of PrEP discontinuation and refill delays among for prevention. We explored that assumption as well as men’s overall
over 47,000 clients first starting PrEP in Kenya, Lesotho attitudes towards PrEP.
and Tanzania: Implications for programs Methods: A mixed-methods study was conducted from 2018 to 2020
J. Reed1; P. Shrestha2; B. Wakhutu3; D. Were3; A. Musau3; J. Mutegi3; with men 20 to 34 years old in KwaZulu-Natal and Mpumalanga pro-
T. Chakare4; A. Rozario4; N. Nonyana4; A. Christensen5; J. Daud5; vinces. This comprised in-depth interviews (n = 58) with purposively
R. Eakle6; K. Curran1 and D. Mohan2 recruited men, analysed thematically; followed by a quantitative sur-
1
Jhpiego, HIV-Infectious Diseases, Baltimore, United States, 2Johns vey (n = 2019) with randomly selected men, analysed using descrip-
Hopkins Bloomberg School of Public Health, Baltimore, United States, tive and inferential statistics, canonical correlation, hierarchical
3
Jhpiego, Nairobi, Kenya, 4Jhpiego, Maseru, Lesotho, 5Jhpiego, Dar es clustering and factor analysis; concluding with further in-depth inter-
Salaam, Tanzania, United Republic of, 6United States Agency for Inter- views with PrEP-experienced (n = 18) and PrEP-inexperienced
national Development, United States (n = 10) men, analysed thematically.
Results: Few men surveyed (n = 2019) were aware of PrEP (11%).
However, once aware, 62% indicated that they were likely (30%) or
Background: Evidence indicates that HIV oral pre-exposure prophy- very likely (32%) to try PrEP. Men reported inconsistent condom use
laxis (PrEP) is both highly efficacious and effective. Though no single (57% sometimes, 11% never) and multiple partners (mean = 2.4, with
dosing strategy is best for all, given variability in risk typology and 13 percent reporting 4 to 8) over the past 12 months yet also
temporality, minimizing early discontinuation and prescription delays in reported being fearful of contracting HIV. Two of the five segments
the interest of normalizing use may be a preferred public health identified in the quantitative analysis appeared particularly well-suited
approach. We examined both phenomena in Jhpiego-supported PrEP to PrEP. Segment 2 men are responsible, civic-minded, optimistic, and
programs in Kenya, Lesotho and Tanzania. amenable to health-seeking. Their motivation for PrEP stems from a
Methods: We analyzed demographic and clinical data, including pre- sense of responsibility and desire to protect their reputation. They
scription data, routinely collected during client visits between 2017 report moderately fewer HIV risk factors but may serve as a catalyst
and 2019. Returning for first follow-up prescription 0 to 14 days of for making PrEP socially acceptable. 42% reported being ‘very likely’
running out was classified as a “refill”; a >14 day delay was classified to use PrEP. While sharing Segment 2’s optimism and openness to
as a discontinuation followed by a “restart.” We used a two-step Heck- health-seeking, Segment 4 men prioritize a fun-loving and carefree
man probit model to analyze factors associated with clients returning lifestyle. They report more HIV risk behaviours, including more casual
for a refill vs. a restart. The first step models the probability of return- partners and less consistent condom use. Their motivation for PrEP is
ing vs. not, while the second step models the probability of refilling vs. to enjoy sexual freedom while avoiding HIV. 36% reported being ‘very
restarting, given the condition that the client returns. Probit estimates likely’ to use PrEP.
are presented along with 95% confidence intervals. Interviews with men currently taking PrEP also found them to share
Results: Among 47,537 clients initiating PrEP in three countries, an optimistic outlook and openness to health-seeking, and generally
26,243 (55.2%) did not return, 14,153 (29.8%) retruned for refill, and greater socio-economic stability.
7163 (15.1%) stopped and restarted. The Heckman sample model for Conclusions: A significant proportion of heterosexual men with multi-
Kenya showed an increased probability of returning vs. not by older ple HIV risk factors expressed strong interest in PrEP. Heterosexual
age groups (>=20 yrs. vs. <20 yrs.) and among key and vulnerable men, particularly certain segments, should be targeted for PrEP use,
population (KVP) groups vs. the general population. After accounting leveraging motivations such as social responsibility, reputation, free-
for their increased probability of returning vs. not, the older age dom and peace of mind.
groups (>=25 yrs.) and KVP were less likely to return on-time for fol-
low-on prescription (refilling) vs. delayed return (restarting). Predictors
varied by country.
Conclusions: Early discontinuation and delays in obtaining a follow-on
PrEP prescription were common, with variations noted by country and
clients’ characteristics, which are measurable. Identifying and intensify-
ing support for those more likely to return late or not return at all
may improve PrEP coverage and impact, noting some may be more
173
PE25.11 Testing: Technology, coverage, viral load,

Mapping HIV prevention product preferences among
adolescent girls and young women at high risk of HIV: point of care, CD4 count
Results from a discrete choice experiment in South Africa
S. Malone1; A. Gomez2; R. Prasad3; A. Gangaramany3; Y. Croucamp4;
P. Kramer5; J. Mulhausen5 and P. Noble-Campbell5
1
AVAC, PMM, New York, South Africa, 2AVAC, PMM, New York, Uni-
PE26.01
ted Kingdom, 3Final Mile, United States, 4Final Mile, Research, South
Surge strategies improve HIV testing efficiency and linkage
Africa, 5Upstream, United States to treatment among female sex workers in Nairobi, Kenya
S. Mwangi1; J. Gacheru2; R. Mwendwa3; A. Olawo4; C. Agunga4;
N. Njuguna4 and C. Akolo5
Background: Several new HIV prevention options are in the pipeline, 1
Bar Hostess Empowerment and Support Program (BHESP), HIV Pro-
in oral, injectable, implant and ring format. While expanding the range gram, Nairobi, Kenya, 2Bar Hostess Empowerment and Support Pro-
of prevention options is necessary, it will prove insufficient if user gram (BHESP), Clinical, Nairobi, Kenya, 3Bar Hostess Empowerment
preferences are not well understood in product design and delivery. and Support Program (BHESP), Clinical, Nairobi, Kenya, 4FHI 360,
Methods: A discrete choice experiment was conducted with a strati- Nairobi, Kenya, 5FHI 360, Durham, United States
fied random cluster sample of 15-to-24-year-old women (n = 1002) in
high-prevalence districts of Mpumalanga and KwaZulu-Natal, South
Africa. Eligible participants self-reported being HIV-negative and sexu- Background: Kenya has made significant progress in the fight against
ally active, having had or knowing their partner to have had more than HIV/AIDS but is unlikely to achieve epidemic control by 2020—hence,
one sexual partner in the previous 12 months, and having had unpro- the need for accelerated optimized testing and treatment strategies.
tected sex during that period. We sought to optimize case finding and linkage to treatment among
Weighted sample data were fitted to conditional logic models, control- female sex workers (FSWs) in Nairobi, Kenya through the implementa-
ling for subject error variances, to derive relative product appeal, as tion of surge strategies.
well as relative importance, main effects, additive and interaction Methods: Bar Hostess Empowerment and Support (BHESP), a key
effects of varying product attributes. population (KP)-led organization working with the USAID/PEPFAR-
Variables included product format, frequency of dosing, site of admin- funded LINKAGES project led by FHI 360, implements KP program-
istration, side effects (headache, nausea/diarrhea/stomach pain, site ming for FSWs by providing comprehensive HIV services at the drop-
pain); and provider and facility type (doctor, nurse, community health in center (DIC) or through outreach as part of differentiated service
worker or pharmacist in a clinic, mobile clinic or pharmacy). delivery models. In July–November 2019, the program initiated a
Results: A 3-monthly injection was the most preferred format and surge strategy to accelerate case identification through the adoption
frequency. A monthly pill was preferred, however, over a 2-monthly or of risk network referral (RNR), whereby FSWs at high risk for or living
6-monthly injection. Familiarity with injectable contraceptive methods with HIV were asked to mobilize members of their social networks
may have influenced this preference, as 39% of participants reported with similar risk profiles to access HIV testing at the organization’s
having used Depo Provera for contraception. A nurse in a mobile clinic DIC or outreach locations. To ensure prompt linkage to HIV treatment
was preferred across formats. Side effects and site of administration among those testing HIV positive, service providers undertook individ-
(where relevant) were not strongly significant. Within each format, the ualized follow-up through phone calls and escorted referrals to the
most appealing profiles were as follows: linkage facilities/DIC.
Results: BHESP increased HIV case-identification rates from 2.1%
Abstract PE25.11-Table 1. (64/3,043 FSWs who tested January–June 2019) to 9.7% (220/2,275
FSWs who tested July–November 2019), representing a four-fold
Pill Injection Implant Ring
increase in the case-identification rate. Of the 220 new cases identi-
Frequency of Monthly Every Every Every fied, 193 (88%) resulted from RNR and 12% from routine outreach
dosing 3 months 6 months 3 months and testing. During the same period, the linkage rate increased from
Side effects Nausea/ Nausea/ Nausea/ Nausea/ 65% to 98%. Creating buy-in from the FSWs living with HIV in identi-
diarrhea/ diarrhea/ diarrhea/ diarrhea/
fying their higher-risk social networks was instrumental in identifying
stomach stomach stomach stomach
pain pain pain pain more cases. Involvement of clinical staff was also key, as the staff took
Site of (No alternative) Injection in Implant in arm (No alternative) ownership of the surge strategy, including setting weekly targets and
administration thigh (vs (vs reviewing results.
buttocks) abdomen)
Conclusions: Surge approaches enable programs identify implementa-
Provider & Nurse in Nurse in Nurse in Nurse in
location mobile clinic mobile clinic mobile clinic mobile clinic tion gaps and put in place more effective approaches. The lessons
learned from these approaches should be built into routine program
activities, thus optimizing outcomes. BHESP will continue to use these
Conclusions: From an end-user perspective, a 3-monthly injection approaches with the aim of further improving case identification and
and a monthly pill should be given priority by product developers, linkage to HIV treatment.
while implant and vaginal ring formats should be a lower priority.
Nurses in a mobile clinic should be considered the primary channel
for product delivery.
174
Background: Despite the advances made the past few decades in the
PE26.02 treatment of HIV-infected individuals, the need for prevention of HIV-
Effect of a novel HIV-1 RNA testing intervention to detect 1 acquisition remains evident. Body mass index (BMI) has been shown
acute and prevalent HIV infection in young adults and reduce to hinder vaccine responses in a number of commercially available
HIV transmission in Kenya: A randomized controlled trial vaccines; however, the impact of BMI on vaccine-induced immuno-
E.j. Sanders1; C. Agutu1; E. van der Elst1; A. Hassan1; E. Gichuru1; genicity to HIV antigen is not clear, with inconsistent findings in prior
P. Mugo1; C. Farquhar2; J.B. Babigumira2; S.M. Goodreau2; studies. Thus, further studies are needed to resolve whether body
D.T. Hamilton2; T. Ndung’u3; M. Sirengo4; W. Chege5 and mass index (BMI) hinders or improves vaccine response. We analyzed
S.M. Graham6 the association between BMI and vaccine-induced adaptive immunity
1
KEMRI-Wellcome Trust, Kilifi, Kenya, 2University of Washington, in HIV Vaccine Trial Network (HVTN) 106 phase 1 trial.
Seattle, United States, 3Africa Health Research Institute, Durban, Methods: Vaccine-induced adaptive immune responses were mea-
South Africa, 4National AIDS & STI Control Program, Nairobi, Kenya, sured by intracellular cytokine staining (ICS) assay and binding anti-
5
National Institutes of Health, Bethesda, United States, 6University of body multiplex assay (BAMA) from participants receiving vaccinations.
Washington, 1. Departments of Medicine, Global Health, and Epidemi- Analyses were performed on baseline demographics [sex, age, BMI]
ology, Seattle, United States and vaccine-induced immune responses. The classification of World
Health Organization (WHO) of adult BMI has been adopted for this
analysis: underweight (BMI< 18.5 kg/m2); normal (BMI range 18.5–
Background: Diagnosis is the crucial first step in the HIV care cas- 24.9 kg/m2); overweight (BMI of 25–29.9 kg/m2); obese (30–39.9 kg/
cade, but few adults are offered HIV testing at care-seeking in Sub- m2) and morbidly obese (BMI ≥ 40 kg/m2). We tested for association
Saharan Africa, and acute HIV infection (AHI) cannot be diagnosed between BMI and HIV-1 immunogenicity using logistic regression.
using current testing approaches. We evaluated a targeted opt-out Results: Our analysis pertains to the 90 vaccinated individuals in HVTN
RNA-based testing approach in Kenya. 106. Multivariate analysis controlling for age, sex and vaccine type par-
Methods: In this proof-of-concept study, we evaluated the yield of an ticipants received, found that obesity is associated (p-value < 0.01) with
HIV testing intervention using point-of-care HIV-1 RNA testing and reduced IgG for both gp120 and gp41 antigens. There was no statisti-
standard rapid tests to diagnose both AHI and prevalent HIV. Adult cally significant association between BMI categories and IgA responses.
patients aged 18 to 39 years who presented for care at 6 public or The specific category overweight (BMI 25 to 30) was associated with
private outpatient clinics in coastal Kenya were evaluated by a vali- better CD4+ and CD8+ T cell responses (p-value < 0.05), both rate and
dated AHI risk score algorithm (1 point each for age 18 to 29 years, magnitude responses towards the following antigens: gp120, gp41 and
fever, fatigue, body pains, diarrhea, and sore throat; 3 points for geni- potential T-cell epitope peptides (PTE-g).
tal ulcer disease). Patients with a risk score ≥2 and no previous HIV Conclusions: Our study found associations between overweight BMI
diagnosis were enrolled in a stepped-wedge trial of the HIV testing and vaccine-induced T-cell responses. Obesity, in contrast, is associ-
intervention compared to standard provider-initiated HIV testing in ated with reduced vaccine-induced humoral responses. Our findings
the observation period. The primary outcome was the number of new point to the complex relationship that may exist between BMI and
diagnoses in each study period. Generalized estimating equations with HIV-1 immunogenicity and the need to further expand and explore
a log-binomial link and robust variance estimates were used to this relationship in larger meta-analysis clinical trials.
account for clustering by health facility. The trial is registered with
ClinicalTrials.gov NCT03508908. PE27.02
Results: Between December 2017 and March 2020, 13 (0.9%) of
The influence of HIV-1 subtype C LTR genotype on latency
1374 participants in the observation period and 37 (2.5%) of 1500
participants in the intervention period were diagnosed with HIV infec-
potential
tion. Of the 37 newly diagnosed cases in the intervention period, 2 D.S. Doolabh1; P. Selhorst2; D. Chopera3; C. Williamson1 and
(5.4%) had AHI. The odds of an HIV diagnosis in the intervention per- M.-R. Abrahams1
1
iod were 2.21 (95% confidence interval: 1.39 to 3.51), after adjust- University of Cape Town, Pathology, Cape Town, South Africa, 2Insti-
ment for factors that were imbalanced across study periods. tute of Tropical Medicine, Outbreak Research Team, Antwerp, Bel-
Conclusions: An opt-out HIV testing intervention using a POC HIV-1 gium, 3Sub-Saharan African Network For TB/HIV Research Excellence
RNA and rapid test algorithm resulted in a greater odds of HIV diag- (SANTHE), Durban, South Africa
nosis. Targeted HIV-1 RNA-based case detection in health facilities
may be an important strategy to increase case finding in settings with
Background: The persistence of latent viral reservoirs, that are insen-
ongoing HIV-1 transmission, if it proves cost-effective given increasing
sitive to antiretroviral therapy (ART), remains the greatest barrier to
availability of point of care HIV-1 RNA testing.
HIV-1 eradication. Multiple mechanisms influence latency establish-
ment, with one of the least explored being the role of the long termi-
nal repeat (LTR). Previous evidence suggests subtype-level genotypic
LTR variation, with notable differences in the core promoter elements,
Therapeutic vaccines, viral reservoirs and affects latency establishment. However, this has not been investigated
eradication/remission on an intra-subtype level. We investigated the influence of inter-parti-
cipant subtype C LTR genotypic variation on latency establishment in
a reporter HIV-1 plasmid model and evaluated potential correlates of
this latency potential.
PE27.01 Methods: Participant-specific 3’LTRs from 11 ART-na€ıve, acutely sub-
Association between Basal Metabolic Index and vaccine- type-C infected women from Durban were cloned into a doubly fluo-
induced HIV-1 adaptive immunity rescent HIV-1 vector expressing eGFP and mCherry under the
H. Magale1; K. Mngadi2; K. Mayer-Blackwell3; A. Fiore-Gartland3 and control of the LTR and a CMV promoter respectively. These clones
J. Kublin3 were used to generate pseudovirions. Latency potential was expressed
1
University of Arizona College of Medicine - Tucson, College of Medicine, as the ratio of mCherry only (latent) to eGFP and mCherry (active
United States, 2The Aurum Institute for Health Research, South Africa, replication), as measured by flow cytometry after infection of Jurkat
3
Fred Hutchinson Cancer Research Center, Seattle, United States E6-1 cells before and after T cell activation with PMA/Ionomycin.
175
Participant LTRs were cloned into a pGL4.10 luciferase expression p = 0.02), time to viral suppression (HR = 1.04, p = 0.01) and area
vector to measure basal and Tat-induced LTR expression. under viral load curve (VL AUC) (HR = 1.35, p = 0.03)).
Results: Average LTR inter-participant pairwise DNA distance was Conclusions: Viral load specific variables at baseline (higher VL peak
7.6%. Infection of Jurkat cells resulted in a range of latent:active infec- and AUC, longer time to viral suppression,) were associated with a
tion ratios with a median of 1.97 (range 0.86 to 2.83; three experi- shorter time to rebound, providing evidence that greater initial seed-
ments) after 8 days. Latency was reversible in a proportion of cells ing of the HIV latent reservoir prior to ART initiation leads to faster
with the median latent:active infection ratio decreasing to 0.55 (range rebound viremia post-ATI. Quantification of the latent viral reservoir
0.46 to 0.78) post-activation. The median basal participant LTR activity will be critical to identifying biomarkers that can predict time to
was approximately two times higher than the BaL isolate (IQR: 1.38 rebound for individuals prior to ATI initiation.
to 2.14), and approximately nine times higher than BaL (IQR: 6.16 to
10.33) after Tat induction. Latency potential did not correlate with
basal or Tat-induced activity (Spearman correlation tests, basal
p = 0.25, r = 0.38, Tat-induced p = 0.42, r = 0.27). Transmission of HIV
Conclusions: Our data suggest that intrinsic properties associated
with the LTR genotype influence the proportion of latently infected
cells early post-infection. However, since differences were indepen-
dent of LTR activity, other factors such as regulatory element interac- PE28.01
tion and the efficiency of recruitment of latency-inducing molecules, An analysis of gender-based violence and HIV risk among
may play a role. Identification of these factors, could provide insights adolescents and youth across 10 countries
into treatment targets and latency reversal.
C. Lenz1; M. Ombija2; R. Van de Ven3; J. Jelagat Odionyi4;
M. Marathane5 and T. Musukwa6
PE27.03 1
Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Technical Lead-
Impact of baseline variables on time to viral rebound after ership and Program Optimization, United States, 2EGPAF, United
treatment interruption in acutely treated HIV-1 infected States, 3EGPAF Tanzania, Tanzania, United Republic of, 4EGPAF Kenya,
participants Kenya, 5EGPAF Lesotho, Lesotho, 6EGPAF Malawi, Malawi
T. Mdluli1; A. Yates2; S. Pinyakorn2; J. Intasan3; S. Tipsuk3;
N. Phanuphak3; C. Sacdalan3; D.J. Colby3; E. Kroon3; T.A. Crowell2;
Background: Gender-based violence (GBV) is a global challenge in
M.L. Robb2; J. Ananworanich4; M. de Souza3; P. Phanuphak5 and
scope and consequence. Survivors are exposed to several sexual and
L.V. Francisco2
1 reproductive health (SRH) risks including unintended pregnancies and
US Military’s HIV Research Program (MHRP) - HJF, MHRP-HJF, HIV. GBV can be both a cause and consequence of HIV-infection. In
Bethesda, United States, 2US Military’s HIV Research Program recognizing the role GBV plays in the HIV landscape, the Elizabeth
(MHRP) - HJF, Bethesda, United States, 3Thai Red Cross AIDS Glaser Pediatric AIDS Foundation (EGPAF) implements integrated
Research Centre - SEARCH, Thailand, 4University of Amsterdam, GBV prevention, linkage and post-violence care in programming with
Department of Global Health, Amsterdam Medical Center, Amster- provider trainings, one-stop-shops, and post-violence care kits for chil-
dam, Netherlands, 5Thai Red Cross AIDS Research Centre, Thailand dren, adolescents, and adults including emergency contraception, post
exposure prophylaxis (PEP) for HIV prevention.
Background: Analytic treatment interruption (ATI) studies evaluate Methods: An evaluation of routinely reported PEPFAR program data
strategies that can mediate long-term remission in people living with from EGPAF-supported regions in 10 countries (Cameroon, Cote
HIV but are often limited to small sample sizes. We combined data d’Ivoire, Democratic Republic of Congo, Eswatini, Kenya, Lesotho,
from four ATI studies conducted with participants from the RV254 Malawi, Mozambique, Tanzania, and Uganda) was conducted to under-
cohort in Thailand to evaluate correlates of time to viral load (VL) stand the scope and shortcomings of GBV care and HIV prevention,
rebound. particularly among adolescents/youth. Post-GBV clinical care based on
Methods: Participants began antiretroviral therapy (ART) during a minimum package and PEP services, provided throughout 2019,
acute HIV infection and were virally suppressed for over 2 years prior were analyzed and disaggregated by age, sex, and violence type.
to enrollment into four ATI studies: 1) early ART only (RV411, n = 8); Results: 51,816 individuals received post-GBV clinical care; 38%
2) randomized controlled trial (RCT) testing vorinostat/hydroxychloro- (n = 19,685) were 10 to 24 years-old. 3,377 adolescent boys and
quine/maraviroc prior to ATI (RV409, n = 14, open label); 3) RCT with young men (ABYM) (10 to 24) received post-GBV care; 20% (n = 676)
Ad26/MVA vaccination prior to ATI (RV405, n = 27, double blind); 4) reported sexual violence. 16,308 adolescent girls and young women (10
RCT with VRC01 antibody infusion during ATI (RV397, n = 18, double to 24) received post-GBV care; 51% reported sexual violence. Post-rape
blind). Fourteen variables including VL, Fiebig stage and CD4 counts, care was provided to 12,765 individuals; 70% (n = 8,998) were adoles-
were evaluated at diagnosis prior to ART initiation and prior to ATI. cents/youth (10 to 24). Of all those receiving post-violence care, 11%
Pairwise correlations between parameters, stepwise regression, and (n = 1,416) were girls 10 to 14, 47% (n = 5,965) girls 15 to 19, and
Cox survival models were used to identify factors associated with time 3.6% (n = 452) boys 10 to 19. Across countries, Uganda reported the
to viral rebound. highest number of post-rape care cases (n = 5,197), particularly among
Results: All 67 participants were homogenous for demographic vari- adolescent girls 15 to 19 (68%; n = 3,527), followed by Tanzania
ables and for some clinical variables but significantly different for Fie- (n = 4,628), with a similar trend among adolescent girls (31%;
big stages at ART initiation (p < 0.01). We found no significant n = 1,438). Of all survivors of sexual violence who received post-rape
difference in the median and variance of time to rebound in 27 partic- care, 35.7% received and completed PEP. Among youth 15 to 24, this
ipants with no intervention (p ≥ 0.15) and in 40 participants with was 21%; 14% were adolescents 15 to 19 and 8% were youth 20 to 24.
interventions (p ≥ 0.22), An antiviral effect was identified in RV397 Conclusions: Physical/emotional and sexual violence were reported
(p = 0.02), thus participants who received VRC01 were excluded from across all countries and ages. Adolescents and youth (10 to 24) make
the pooled analysis. Based on the 53 remaining participants, correla- up a significant proportion of those receiving post-violence care. Com-
tion analysis identified degrees of association across pre-ART and prepared to other age cohorts, a lower percentage of youth receiving
ATI variables. Time to viral rebound was significantly associated with post-violence care, received and completed PEP, highlighting gaps in
highly correlated baseline variables: pre-ART VL (HR = 1.35, prevention and need for tailored solutions.
176
PE28.02 8 weeks for ≥8 months from Aug 2017 to Dec 2018. At study visits,
participants completed questionnaires, received HIV and STI (pharyn-
Variable HIV seroincidence rates in a cohort of high-risk
geal, urethral, and rectal gonorrhea [GC], chlamydia [CT], syphilis)
men who have sex with men (MSM) and transgender
testing and a comprehensive risk reduction package. Reactive rapid
women (TGW) in China HIV tests were confirmed per CDC algorithms. A Poisson regression
F. Zhang1; H. Shang2; H. Lu3; W. Cai4; H. Wang5; M. Wang6; S. He7; model with study exposure as the offset was used to assess correla-
B. Zhu8; K. Meyers9; S. Wu10; D.J. Liu11; P. Wannamaker12; tions between STIs and HIV acquisition.
D. Margolis12; W. Spreen12 and M. Markowitz9 Results: Of 690 participants screened, 578 were enrolled and accu-
1
Beijing Ditan Hospital, Capital Medical University, Clinical and mulated 532 patient-years (PY) of follow-up. Cohort characteristics
Research Center of Infectious Diseases, Beijing, China, 2The First are shown in the table. Overall HIV-1 incidence rate was 2.44 (95%
Affiliated Hospital of China Medical University, China, 3Shanghai Public CI: 1.42 to 4.21) per hundred PY (PHPY), with 13 confirmed infec-
Health Clinical Center, China, 4Guangzhou Eighth Municipal People’s tions. Rates varied from 0 to 9.2/PHPY by site. Overall, HIV-1 sero-
Hospital, China, 5The Third People’s Hospital of Shenzhen, China, 6The conversion was associated with unprotected receptive anal
First Hospital of Changsha, China, 7Chengdu Public Health Clinical intercourse (aHR = 7.96, 95% CI: 1.74 to 36.38, p = 0.008), rectal
Center, Chengdu, China, 8The First Affiliated Hospital, School of Medi- GC (aHR = 6.87, 95% CI: 1.71 to 27.56, p = 0.007), and urethral GC
cine, Zhejiang University, China, 9The Aaron Diamond AIDS Research (aHR = 6.98, 95% CI: 1.20 to 40.55, p = 0.03). Overall rate of rectal
Center, United States, 10GlaxoSmithKline, Research Triangle Park, Uni- GC, 2.82 PHPY, predicted an HIV-1 seroincidence of 2.36 PHPY as
ted States, 11GlaxoSmithKline, China, 12ViiV Healthcare, Research Tri- per Mullick and Murray (JID, 2019), nearly identical to the observed
angle Park, United States rate of 2.44 PHPY.
Conclusions: Seroconversion rates were highly variable by study site,
suggesting vastly differing local HIV-1 transmission dynamics and
Background: MSM and TGW are at high risk of HIV infection. micro-epidemics. These estimates may be useful for designing HIV
Assessing efficacy of ARVs in HIV prevention requires estimates of prevention trials in Chinese MSM and TGW. The observed correlation
HIV incidence rates. This prospective study investigated incidence of between rectal GC and HIV-1 incidence in this study may also sup-
HIV-1, sexually transmitted infection (STI), and behavioral factors asso- port the use of this marker as a predictor of HIV-1 incidence in MSM
ciated with HIV-1 seroconversion among MSM and TGW in China. and TGW.
Methods: High-risk HIV-uninfected MSM and TGW were enrolled at
9 clinical sites in 8 Chinese cities. Participants were followed every
177
PE28.03 were correlated with site-level observed HIV incidence rates (Figure 1;
meta-regression slope: GC = 0.19 95% CI (0.03 to 0.35), p = 0.018;
Site-level prevalence of gonorrhea and chlamydia is
CT = 0.08 95% CI (0.05 to 0.12), p < 0.001); correlation with either
correlated with site-level HIV incidence in African women
GC or CT was 0.08 95% CI (0.04 to 0.11), p < 0.001. In case-control
seeking contraception analyses, odds of individual HIV infection was strongly associated with
D. Donnell1; J. Deese2; N. Philip3; K. Zewdie4; K. Ahmed5; J. Batting6; concurrent infection with GC (adjOR = 4.69 9% CI (3.29 to 6.67))
M. Beksinska7; V. Edward8; C. Louw9; M. Onono10; T. Palanee- and more weakly with concurrent CT (adjOR = 1.36 95% CI (1.08 to
Phillips11; J. Smit7; H. Rees11; T. Mastro2 and C. Morrison12 1.69)).
1
Fred Hutchinson Cancer Research CEnter, VIDD, Seattle, United Conclusions: For both site-level and individual-level risk, increased
States, 2FHI 360, Durham, United States, 3Columbia University, New prevalence of bacterial STIs were associated with increased HIV inci-
York, United States, 4University of Washington, Department of Global dence, with stronger association noted for GC. Bacterial STIs may be
Health, International Clinical Research Center, Seattle, United States, a useful marker of HIV exposure in populations enrolling into future
5
Setshaba Research Centre, South Africa, 6University of the Witswa- PrEP trials.
tersrand, Effective Care Research Institute, South Africa, 7University
of the Witswatersrand, MatCH Research Unit, Department of Obstet-
rics & Gynaecology, South Africa, 8The Aurum Institute, South Africa,
PE28.04
9
Madibeng Centre for Research, South Africa, 10Kenya Medical
Circulating South African transmitted/founder HIV-1
Research Institute, Center for Microbiology Research, Nairobi, Kenya, subtype C uses CCR5 and not CXCR4 or CCR3 for cell
11
University of the Witswatersrand, Wits Reproductive Health and entry
HIV Institute, South Africa, 12FHI 360, Behavioral, Clinical & Epidemi- K. Sojane1; K. Gounder2; D. Chopera2; K. Dong3 and T. Ndung’u4
1
ologic Sciences, Durham, United States HIV Pathogenesis Programme, University of KwaZulu-Natal, School
of Laboratory Medicine and Medical Sciences, Durban, South Africa,
2
Africa Health Research Institute, University of KwaZulu-Natal, Dur-
Background: Reliable correlates of HIV exposure may be needed for ban, South Africa, 3Ragon Institute of Massachusetts General Hospital,
future trials of new HIV prevention agents, where comparison may be Massachusetts Institute of Technology, Boston, United States, 4HIV
against effective PrEP and low numbers of HIV infections are Pathogenesis Programme, University of KwaZulu-Natal, Durban, South
expected. Bacterial STIs in women are well-established risk factors for Africa
HIV acquisition at the individual level; whether bacterial STI infections
are reliable indicators of HIV risk exposure within a site’s trial popula-
tion is unknown. Background: The efficacy of maraviroc, an FDA approved CCR5
Methods: In the ECHO trial, 7829 HIV-uninfected African women antagonist, may be undermined by variants of HIV-1 which use core-
seeking effective contraception were followed for up to 18 months at ceptors other than CCR5. HIV-1 subtype C (HIV-1C) generally uses
12 sites in South Africa (9 sites), Eswatini, Zambia and Kenya. Tests CCR5, but transmitted/founder (T/F) variants of HIV may be evolving
and treatment for gonorrhea (GC) and chlamydia (CT) occurred at in their coreceptor usage. We sought to clarify the coreceptor usage
baseline, possible HIV infection and the last study visit. To assess the of T/F HIV-1C in hyperacute infection using in silico prediction tools
relationship between site-level HIV incidence and STI prevalence, as well as in vitro functionality assays.
meta-regression was used, analyzing data from each site’s population Methods: Twelve women with hyperacute HIV-1 infection were iden-
as a group. To assess the relationship between STIs and HIV at the tified from a cohort of individuals at high-risk for infection from Dur-
individual level, associations between prevalent STI exposure and HIV ban, South Africa. Participants were screened for HIV-1 RNA PCR
acquisition and were assessed using multivariate case-control analysis, twice weekly by finger-prick blood draw. A single plasma T/F HIV-1C
matching on month of seroconversion. variant from each participant was identified by single-genome amplifi-
Results: HIV incidence varied across trial sites from 0.58 to 6.80/100 cation and Sanger sequencing of env genes. A consensus prediction of
person-years; baseline prevalence of GC varied from 3% to 9%, and coreceptor usage for each envelope (Env) was determined using pub-
CT from 5% to 28%. Baseline site prevalence of each of GC and CT licly available in silico tools (Geno2pheno, WebPSSM subtype C sinsi,
178
and PhenoSeq). The full-length or 2.1 kb env fragment of each virus

was cloned into pcDNA3.1/V5-His-TOPO or pSVIIIenv, respectively. PE28.06
Luciferase reporter pseudoviruses were subsequently generated by HIV gp120-V2 loop costimulation in presence of retinoic
cotransfecting recombinant env plasmids with pHIV-1Luc and acid promotes HIV infection of CD4+ T cells
pCMVDP1DenvpA into 293T cells. Lastly, we measured luciferase L. Ramos Goes1; A. Sajani2; F. Nawaz2; D. Van Ryk2; J. Yolitz2; D. Wei2;
expression in U87-CD4 cells expressing either CCR5, CXCR4 or R. Mason3; M. Roederer3; X. Kong4; L. Morris5; C. Cicala2; A.S. Fauci2
CCR3, 72 hours after the cells were incubated with each pseudovirus. and J. Arthos2
Results: Using consensus in silico predictions of coreceptor tropism, 1
Laboratory of Immunoregulation, NIAID, Immunopathogenesis Sec-
we identified 8 out of 12 (~66.6%) T/F HIV-1C Envs that were pre- tion, Bethesda, United States, 2Laboratory of Immunoregulation,
dicted to use CCR5. The remaining 4 out of 12 (~33.3%) Envs were NIAID, Bethesda, United States, 3Vaccine Research Center, NIAID,
predicted to use CXCR4 alone or in combination with CCR5. In con- Bethesda, United States, 4NYU School of Medicine, Department of
trast, in vitro functionality tests revealed that all 12 Envs were able to Biochemistry and Molecular Pharmacology, United States, 5Centre for
efficiently enter U87-CD4 cells expressing CCR5 and not CXCR4 or the AIDS Programme of Research in South Africa (CAPRISA), Univer-
CCR3. sity of KwaZulu-Natal, Durban, South Africa
Conclusions: Our results suggest CCR5 antagonists like maraviroc
may be sufficient to block the transmission T/F HIV-1C. Although in
silico coreceptor prediction tools are advantageous in resource-con- Background: HIV acute infection is characterized by the rapid viral
strained settings, they may require refinement for reliable predictions seeding of gut inductive sites followed by a severe depletion of gut
of T/F HIV-1C variants. Our study has improved our understanding of CD4+ T cells. CD4+ T cell migration to gut inductive sites is mediated
HIV-1C pathogenesis and may inform the design of prophylactics and by a4b7 /MAdCAM interactions on CD4+T cells and on HEVs respec-
treatment strategies that include coreceptor antagonists. tively. The HIV envelope protein binds directly to integrin a4b7. This
interaction is mediated primarily by amino acids in the V2 loop of
gp120. gp120 V2 mimics MAdCAM, the natural ligand of a4b7, in the
PE28.05 way that it binds to a4b7. We previously reported that MAdCAM sig-
Calcitriol decreases HIV-1 transfer from monocyte-derived naling through a4b7, when combined with retinoic acid (RA), promotes
dendritic cells to CD4+ T lymphocytes HIV replication in recently activated na€ıve CD4+T cells. In this study,
W. Aguilar Jimenez; N. Alvarez and M.T. Rugeles we asked whether gp120 V2-mediated signaling could similarly co-
Grupo Inmunovirologia, Universidad de Antioquia, Facultad de Medic- stimulate CD4+ T cells and support viral replication.
ina, Medellin, Colombia Methods: Bulk CD4+ T cells from healthy donors were stimulated
with combinations of anti CD3, a cyclic gp120 V2 domain peptide and
RA. Cellular activation, proliferation and HIV infection were measured
Background: Dendritic cells (DCs) promote HIV-1 transmission by by flow-cytometry.
acting as Trojan horses, capturing and transporting infectious viral par- Results: gp120 via its V2 loop, in combination with anti-CD3
ticles, facilitating the infection of CD4+ T cells. Vitamin D (VitD) activated CD4+ T cells. Activation was inhibited by addition of an
decreases HIV-1 infection of CD4+ T cells in vitro, most likely by anti-a4b7 mAb, indicating that V2 can stimulate CD4+ T cells in a
decreasing activation and thus the susceptibility to infection; however, a4b7.-dependent manner. Combining V2 costimulation with RA
it is unknown if active form of VitD could also decrease viral transfer enhanced the level of HIV infection. The inclusion of RA resulted in a
from DCs to CD4+ T cells. significant increase in the number of CD4+ T cells expressing a high
Methods: In this observational in vitro study, we co-cultured HIV-1- level of a4b7. It also induced an increase in the surface expression of
pulsed immature (iDCs) and mature (mDCs) monocytes-derived den- CCR5. Thus, RA increased the expression of two surface receptors
dritic cells, differentiated or not in the presence of calcitriol (VitD that bind directly to gp120. Of note, both anti-a4b7 -mAbs and anti-
active form), with VitD-untreated PHA-activated autologous CD4+ T V2 mAbs block V2-mediated costimulation and viral infection. These
cells from 16 healthy donors and quantify the frequency of infected results identify a unique function for the V2 loop of gp120 in the
p24+ CD4+ T cells by flow cytometry. Some genes involved in HIV interaction of HIV with CD4+ T cells.
transfer were quantified in VitD-treated and untreated DCs by qRT- Conclusions: The V2 domain of gp120 can deliver a costimulatory
PCR and by Flow cytometry. HIV transfer and gene expression signal to CD4+ T cells that promotes HIV infection. RA enhances this
between VitD-treated and untreated DCs to CD4+ T cells were com- effect. We propose that V2, in combination with RA contributes to
pared by using a paired T-test. HIV gut tropism.
Results: We observed that co-cultures performed with VitD-treated
iDCs and mDCs significantly decreased the frequency of infected
CD4+ T cells. Although VitD-treated iDCs and mDCs exhibit a similar PE28.07
mRNA expression of genes involved in viral transfer, probably related Exploring HIV and STI prevalence, sexual practices and drug
to a transcriptional balance achieved after VitD treatment, SIGLEC-1 use among self-identified women who have sex with
was consistently reduced by VitD in both iDCs and mDCs. Finally, we women in Blantyre, Malawi
found that DCs differentiated with VitD reduced the surface expres- W. Botha
sion of DC-SIGN and SIGLEC-1 receptors, widely associated with HIV- University of Malawi, College of Medicine, Public Health, Blantyre,
1 transfer. Malawi
Conclusions: VitD decreased viral transfer from DCs to CD4+ T cells
in vitro, its effects on surface expression of DC-SIGN and SIGLEC-1
receptors are the most likely mechanisms by which VitD affects viral Background: The conclusion that WSW in Malawi are not at risk of
transfer. HIV and STI acquisition, as evidenced by their exclusion from policies
and programing on HIV and STIs, lack scientific backing. However, epi-
demiological studies conducted elsewhere show that Women who
have sex with women (WSW) can transmit STIs through female-female
sex. WSW are mostly not included HIV and STI prevention interven-
tions since female-female sex is presumed to be a low risk. However,
179
studies from other countries have reported significant STI burden in placebo (n = 29). No significant changes in expression levels were
WSW. No study has been done in Malawi. observed in either group. Interestingly, in PWID (n = 49 cases, 143
Methods: This was a cross-sectional study using quantitative method. controls), cases had significantly lower levels of a4b7 expression com-
Snowball sampling technique was used to recruit study participants. pared to their matched controls (adjOR = 0.80, 95% CI = 0.68, 0.93;
Participants were recruited through the Center for the Development p = 0.004). Among HIV-positive PWID (n = 47), there was no signifi-
of People (CEDEP), Non-Governmental Organization working with cant association between the median level of a4b7 expression and
sexual minorities in Malawi. 42 WSW aged 18 to 49 were recruited. A HIV disease progression (log-rank p = 0.84).
structured questionnaire was administered which focused on (a) Conclusions: In contrast to findings in heterosexual women, higher
demographic characteristics, (b) exploring self-reported HIV and STI a4b7 expression is not associated with HIV acquisition in MSM, nor
prevalence and (c) drug usage and WSW sexual practices. predicts disease progression in PWID. It is unclear why lower a4b7
Results: 42 participants were recruited with a median age of expression was associated with acquisition in PWID, but this may be
23 years (range 18 to 33). Self- reported HIV prevalence was 2% (1/ related to more frequent drug use in these individuals.
42). Prevalence for Candida albicans infection was 29% (12/42) and
genital warts 7% (3/42). One participant (2%) self-reported having PE28.09
syphilis in the past one year and had no history of sexual contact with
Characterization of the kinetics of early cellular targets of
men. Sexual practices in the past one-year were also accessed. All
study participants (100%) reported to have engaged in fingering and
infection after an intra-vaginal inoculation of simian
clitoris to clitoris sexual contact; (59%) had multiple female sex part- immunodeficiency virus into rhesus macaques
ners and (26%) were involved in female-male sex. (36%) reported M.S. Arif1; S. Xiao1; D. Thakkar1; G.C. Cianci1; R. Lorenzo-Redondo2;
using unsterilized sex toys and (28.5%) were involved in oral sex. Drug M. Halkett1; K.K. Halavaty1; M. Becker1; A.M. Carias1; D. Maric1;
use in the past one year was also assessed. No participants reported R. Veazey3 and T.J. Hope1
1
injected drug use. However non-injectable drugs like Marijuana (50%), Northwestern University, Department of Cellular and Developmental
Cuba (7.14%) and Cocaine (12%) were reported. Biology, Evanston, United States, 2Northwestern University, Depart-
Conclusions: This was the first robust study on WSW in Malawi. It ment of Medicine, Evanston, United States, 3Tulane National Primate
has demonstrated a low prevalence of self-reported HIV infection in Research Center, Tulane University School of Medicine, United States
WSW. However, STIs reported suggest that WSW are vulnerable to
blood borne infections (syphilis). Episodes of warts and syphilis in a
woman who had no history of sex with men suggest that female- Background: Prevention of sexual acquisition of HIV in women
female sex can transmit STIs. requires a substantial increase in our knowledge about the HIV tar-
gets of infection in the first days after exposure and is critical to
design effective prevention strategies. Using a rhesus macaque (RM)
PE28.08 vaginal challenge model, here we analyzed the distribution and pheno-
The association of a4b7 expression with HIV acquisition type of SIV-infected cells early after infection and as the infected cell
and disease progression in people who inject drugs and phenotype changes over time.
men who have sex with men Methods: 12 female RMs were challenged intravaginally with a mix-
A. Martin1; E. Patel2; C. Kirby2; J. Astemborski2; G. Kirk2; S. Mehta2; ture of non-replicative luciferase reporter, LiCH, and SIVmac239. Ani-
K. Marshall3; H. Janes3; A. Clayton3; L. Corey3; S. Hammer4; mals were sacrificed 48-, 72-, or 96-hours post-challenge. Macroscopic
M. Sobieszczyk4; J. Arthos5; C. Cicala5 and A. Redd5 luciferase signal detected by in vivo imaging system (IVIS) allowed us
1
NIAID, Bethesda, United States, 2Johns Hopkins, Baltimore, United to identify FRT regions likely containing infected cells. IVIS positive
States, 3Fred Hutchinson Cancer Research Center, Seattle, United and negative tissues were serially cryosectioned for immunofluores-
States, 4Columbia University, New York, United States, 5NIAID, LIR, cence staining and RNA isolation. Infected cells were phenotyped
Bethesda, United States microscopically to identify Th17s (CD3+ CCR6+), other T-cells (CD3+
CCR6), immature dendritic cells (iDCs)(CD3-CCR6+), and other cells
(CD3-CCR6). RNA was extracted from infected and non-infected
Background: a4b7 is a gut-homing integrin heterodimer that can act adjacent tissue sections for RNA-Seq.
as a non-essential binding molecule for HIV. A previous study in Results: Phenotyping of >5300 SIV-infected cells in FRT of eight RMs
heterosexual African women found that individuals with higher pro- sacrificed at 72 hr and 96 hr post-challenge identified infection
portions of a4b7 expressing CD4+ T cells were more likely to become throughout FRT in 3/4 and 4/4 of 72 hr and 96 hr animals, respec-
infected with HIV, as well as present with faster disease progression. tively. Comparing the two time points, proportion of infected Th17s
It is unknown if this phenomenon is also seen in men who have sex remains constant (85 vs. 70%), however, we can detect an increase in
with men (MSM) or people who inject drugs (PWID). infection rate of iDCs (from 10 to 30%) and other T-cells (from 1 to
Methods: MSM who acquired HIV during the HVTN 505 HIV vaccine 3%) as infection progressed. Also, imaging and phenotyping of infected
trial and PWID who seroconverted during the ALIVE prospective cells from serial sections allowed us to visualize the spatial pattern of
cohort study were selected as cases and matched to HIV-uninfected infection and to follow the dissemination away from portal of entry.
controls from the same studies (1:1 and 1:3, respectively). Pre- The spread of infection was identified across multiple cryosections of
seroconversion PBMC samples from cases and controls in both the same tissue.
studies were examined by flow cytometry for levels of a4b7 expres- Conclusions: Our findings shed light on the very earliest steps of
sion on CD4+ T cells. Multivariable conditional logistic regression was mucosal SIV infection in vivo and support previous data demonstrating
used to compare a4b7 expression levels between cases and controls. that entire FRT is susceptible to infection and that Th17s are the pre-
Kaplan-Meier curves were used to examine the association of a4b7 dominant early targets. In our future work, we hope to compare the
expression with HIV disease progression in PWID. distribution of infected cells together with the transcriptome profiles
Results: In MSM and transgender individuals (n = 103 cases, 103 between infected and non-infected tissues at different time points and
controls), there was no statistically significant difference in the levels may guide the design of effective strategies to block local transmission
of a4b7 expression on CD4+ T cells between cases and controls (ad- and prevent HIV-1 spread.
justed odds ratio [adjOR]=1.10, 95% confidence interval [CI]=
0.94,1.29; p = 0.246). In a portion of these MSM, changes in a4b7
expression were examined before and after vaccination (n = 33) or
180
PE28.10LB PE28.11LB
The FCGR2C allele that associates with protection against Sexual behaviors and the HIV gender gap amongst young
HIV-1 acquisition in the Thai RV144 HIV-1 vaccine trial is adults: implications for prevention strategies
associated with increased risk of perinatal HIV-1 acquisition E. Daniels1; G. Gaumer1 and F. Newaz1
1
in South African children Brandeis University, Heller School of Social Policy, Schneider Insti-
J. Ebonwu1,2; R. Lassauniere3; M. Paximadis4,2; M. Goosen4,2; tutes for Health Policy, Institute for Global Health and Development,
R. Strehlau ; G.E. Gray ; L. Kuhn8,9 and C.T. Tiemessen4,2
5,2 6,7 Waltham, United States
1
National Institute for Communicable Diseases, Division of Public
Health Surveillance and Response, Johannesburg, South Africa, Background: While multiple studies have shown that risky sexual
2
University of the Witwatersrand, Faculty of Health Sciences, Johan- behaviors drive the HIV/AIDS epidemic and the disease gender gap
nesburg, South Africa, 3Statens Serum Institut, Department of Virus between males and females in Sub-Saharan Africa, the majority of lit-
and Microbiological Special Diagnostics, Virus Research and Develop- erature glossed over the manner in which such drivers affect the gen-
ment Laboratory, Copenhagen, Denmark, 4National Institute for Com- der gap. In addition, some quantitative HIV studies pooled data across
municable Diseases, Centre for HIV & STIs, Johannesburg, South several countries, wherein explicit or implicit assumptions about coun-
Africa, 5Empilweni Services and Research Unit, Rahima Moosa Mother tries’ similarity vis-a-vis multiple issues were made.
and Child Hospital, Department of Paediatrics and Child Health, Gaut- Methods: We use Population-based HIV Impact Assessment (PHIA)
eng, South Africa, 6University of the Witwatersrand, Perinatal HIV data on Malawi, Tanzania, and Zambia to explain the relationship
Research Unit, Faculty of Health Sciences, Johannesburg, South Africa, between HIV prevalence and sexual behaviors, namely multiple part-
7
South African Medical Research Council, Cape Town, South Africa, ners and having an older partner, using logit models. We then proceed
8
Gertrude H. Sergievsky Centre, College of Physicians and Surgeons, to conduct an Oaxaca-Blinder decomposition analysis to better under-
New York, United States, 9Columbia University, Department of Epi- stand the gap drivers.
demiology, Mailman School of Public Health, New York, United States Results: Our logit model results are persistent across countries and
are consistent with the literature. We find statistically significant gen-
der gaps in HIV prevalence which vary greatly across countries, rang-
Background: In the Thai RV144 HIV-1 vaccine trial – the only vac-
ing from 2.8 to 6.8 percent, with females showing three times the
cine trial to demonstrate some efficacy to date – a three-variant hap-
probability of having HIV. The Oaxaca-Blinder decomposition results
lotype within the Fc gamma receptor 2C gene (FCGR2C) modified risk
indicate that while the gender gap is driven by higher levels of risk
of HIV-1 acquisition. A follow-on trial of a similar vaccine candidate,
associated with sexual behavior and other risk factors for females in
HVTN702, found no efficacy in South Africa, where the predominant
some countries, it remains largely unexplained in other countries. We
population is polymorphic for only a single variant in the haplotype,
also find that different sexual behaviors vary in risk across countries.
c.134-96C>T (rs114945036). Using the model of maternal-infant HIV-
Conclusions: Country-specific conditions drive the HIV gender gap in
1 transmission, we investigated the association between the c.134-
different ways. In two countries (Malawi, Tanzania) the gender gap is
96C>T variant and HIV-1 acquisition in South African children born to
largely explained by the differential magnitude of riskiness of the risk
HIV-1-infected mothers.
factors for women, while in one country (Zambia) the gender gap is
Methods: A nested case-control study was conducted comparing
completely unexplained by the Oaxaca-Blinder decomposition. In one
infants who acquired HIV-1 through the perinatal route (cases) to
country (Zambia) the gender gap is partially explained by gender dif-
HIV-1-exposed infants who did not acquire HIV-1 (controls), recruited
ferences in the presence (or absence) of risk factors. Policy makers
as part of past studies at two sites in Johannesburg, South Africa. All
should be mindful of these differences, and adjust prevention policies
infants received nevirapine for prevention of mother-to-child transmis-
and program accordingly.
sion; maternal antiretroviral therapy was not used routinely at the
time. The FCGR2C c.134-96C>T genotype was determined using San-
ger sequencing for 148 HIV-1-infected cases and 129 HIV-1 exposed-
uninfected controls. The genotype and allele carriage were compared
Treatment as prevention
between groups using univariate and multivariate logistic regression
analyses.
Results: The FCGR2C c.134-96C>T genotype distribution differed sig- PE29.01
nificantly between HIV-1 cases and exposed-uninfected controls
CCR5 antibody blockade protects rhesus macaques from
(p = 0.001). The RV144 c.134-96T-allele was over-represented in the
HIV-1-infected infants compared to the exposed-uninfected infants
rectal SHIV acquisition
(60% vs. 40%). The adjusted odds ratio (AOR) of perinatal HIV-1 X. Chang1; G. Webb1; J. Reed1; C. Pessoa1; H. Wu1; N. Burnett2;
acquisition associated with the c.134-96T-allele after adjusting for M. Fischer3; C. Moats2; J. Smedley2; S. Hansen1; D. Burger4;
birth weight and breastfeeding was AOR = 2.36; 95% CI 1.43 to N. Pourhassen4; T. Brown5; L. Ndhlovu6 and J. Greene1
1
3.90; p = 0.001. Oregon Health & Science University, Vaccine and Gene Therapy Insti-
Conclusions: The variant FCGR2C c.134-96T-allele which was associ- tute, Portland, United States, 2Oregon Health & Science University,
ated with protection in the Thai RV144 trial, was associated with Oregon National Primate Research Center, Portland, United States,
3
increased risk of HIV-1 acquisition through the perinatal route in Oregon National Primate Research Center, Portland, United States,
4
South African children. We previously found this variant to be associ- CytoDyn, Vancouver, United States, 5Palm Springs, United States,
6
ated with HIV-1 disease progression in South African adults. Collec- Weill Cornell Medicine, Division of Infectious Diseases, United States
tively, these intriguing results highlight the need for further
mechanistic studies to establish the functional relevance of this variant
Background: Adherence remains a challenge to the success of pre-
in different populations and in different contexts. This includes in
exposure prophylaxis (PrEP) in preventing HIV acquisition. Thus, new
South African adults actively immunized in the HVTN702 trial where
approaches are urgently needed. The primary use of the CCR5 corecep-
the vaccine failed to provide protection, and in individuals passively
tor by mucosally transmitted virus, together with the resistance to
immunized with the broadly neutralizing VRC01 antibody in the
infection observed in CCR5-delta 32 homozygous people, suggests that
HVTN703 trial.
CCR5-blocking reagents might be effective PrEP agents. Leronlimab is
181
a CCR5-specific monoclonal antibody with excellent safety and adher- PE29.02

ence profile used in over 800 HIV+ people. We hypothesize that leron-
Viral Suppression and CD4 counts with transition to
limab can protect from the sexual transmission of HIV.
TDF/3TC/DTG (TLD)
Methods: To determine if subcutaneous leronlimab at the lowest and
highest doses tested in clinical trials (10 mg/kg or 50 mg/kg in rhesus D. Chang1; N. Dear1; A. Esber1; M. Iroezindu2; E. Bahemana3;
macaques via allometric scaling) could prevent sexual transmission of H. Kibuuka4; J. Owuoth2; J. Maswai2; T. Crowell1; C. Polyak1 and
SHIV, we conducted a study in macaques using low-dose intra-rectal J. Ake1
1
SHIVSF162P3 challenges. Three groups of six macaques received either Walter Reed Army Institute of Research, Military HIV Research Pro-
no treatment or leronlimab at 10 mg/kg weekly or 50 mg/kg bi- gram, Silver Spring, United States, 2Henry Jackson Foundation MRI,
monthly. We monitored longitudinally for plasma viremia, CCR5 occu- Kenya, 3Henry Jackson Foundation MRI, Tanzania, United Republic of,
4
pancy, cell-associated virus, and anti-SHIV immune responses. Makerere University Walter Reed Project, Kampala, Uganda
Results: Following eight weekly challenges, all animals treated with
50 mg/kg were protected from acquisition, while all control animals
Background: The introduction of integrase strand inhibitors (INSTIs)
became infected (p = 0.0005). Four animals treated with 10 mg/kg
has improved treatment of human immunodeficiency virus (HIV).
were fully protected, while two animals were infected following the
Dolutegravir (DTG) is a second generation INSTIs and is part of the
last two challenges (p = 0.001). Of these two infected animals, one
antiretroviral regimen TLD (Tenofovir[TDF], Lamivudine[3TC], DTG).
developed anti-leronlimab antibodies resulting in rapid leronlimab
TLD is a potent antiretroviral regimen and the addition of DTG offers
clearance, while the other maintained CCR5 occupancy with the low-
a high genetic barrier to resistance when compared to older non-
est longitudinally viral loads. Colon and duodenum biopsies taken from
nucleoside reverse transcriptase inhibitors. In 2018 the World Health
the protected animals after completion of all challenges showed full
Organization recommended TLD as a first line regimen given the
CCR5 occupancy and absence of cell-associated viral DNA and RNA.
advantages over older regimens. We present data on viral suppression
Following leronlimab uncoating from CCR5, protected animals
and CD4 counts with TLD transition.
remained aviremic and lacked anti-SHIV immune responses for at least
Methods: The African Cohort Study (AFRICOS) is a prospective
six weeks before sacrifice, indicating sterilizing protection from rectal
cohort study that enrolls adults with HIV. The clinical sites are part of
SHIV acquisition.
the US Military HIV Research Program (MHRP) President’s Emer-
Conclusions: These results support the efficacy of leronlimab as PrEP,
gency Plan for AIDS relief (PEPFAR) and are located in Kenya, Tanza-
with the potential development of long-acting leronlimab to improve
nia, Uganda and Nigeria. TLD transition across the clinical sites began
drug adherence.
182
October 2018. Data was collected from Jan2013 to 1Mar2020. Viral change in CD4 count after TLD switch was 9 cells/mm3 (range: 63
suppression is defined as HIV RNA <1000 copies/mL. to 82 cells/mm3).
Results: Within AFRICOS, 1187 participants transitioned to TLD and Conclusions: After transition to TLD, most patients maintained or
28 initiated TLD at enrollment. We included 1187 participants (677 gained viral suppression which decreases risk of transmission. How-
males, 510 females) who had viral load data before and after TLD ever 1.7% of patients lost viral suppression with the majority of cases
transition. Of those that transitioned, the majority (n = 1128, 95%) transitioning from TDF/3TC/EFV. Follow-up testing is needed to char-
remained suppressed, 35 (2.9%) attained suppression, 20 (1.7%) lost acterize the loss of viral suppression particularly regarding any acqui-
suppression, and 4 (0.3%) remained unsuppressed. Of those that lost sition of DTG resistance–associated mutations. Transition to TLD is
viral suppression: 15 participants switched from TDF/3TC/Efavirenz generally safe without loss of viral suppression, but VL monitoring
(EFV), 2 from Zidovudine (AZT)/3TC/Nevirapine (NVP), 1 from TDF/ continues to be important to identify and treat patients who are not
3TC/NVP, and 1 from a protease-inhibitor based regimen. The median suppressed and therefore at risk for HIV transmission.
183
PUBLICATION ONLY ABSTRACTS
Behavioural and social science research PU01.02

Post exposure prophylaxis for HIV infection after sexual
assault: understanding the trend of uptake in a Nigerian
tertiary healthcare Institution
PU01.01 E. Ilesanmi
Sexuality and HIV education begins in the homes of AB Global Health Initiative, Nursing Director, AB Global Health Initia-
adolescents tive, Sagamu, Nigeria
G. Mdlalose and V. Dubula-Majola
Stellenbosch University, Africa Centre for HIV/AIDS Management, Background: Antiretroviral post exposure prophylaxis (PEP) may be
Cape Town, South Africa underutilized in sexual assault cases in Nigeria. This study evaluated
the characteristics of survivors of sexual violence attending the Presi-
dent’s Emergency Plan for AIDS Relief (PEPFAR) Center at the
Background: In the context of the schools’ health and life skills inter-
Adeoyo Hospital and reviewed the uptake, adherence, and outcomes
ventions for school-going and out-of-school adolescents, primary care-
of those initiated on PEP.
givers have a critical contribution to make towards life skills support
Methods: In a retrospective cohort, data from charts of the assaulted
for young people in terms of sexuality and HIV education. Sexuality
seen at the PEPFAR unit at Adeoyo Hospital from January to July
and HIV education are complex, sensitive topics requiring effective
2019 were abstracted. Data were collected describing sociodemo-
communication skills. The pivotal role of effective communication
graphic characteristics, nature of sexual assault, HIV serostatus, and
between caregivers and children’s healthy and responsible life choice
aspects of the PEP care cascade. Data gotten were analysed using
decision making cannot be underplayed. Caregivers’ communication
descriptive statistics (SPSS IBM V 19).
about sexual-related matters is a key element in modifying adolescent
Results: 278 were enrolled, assaulted persons who were not HIV
sexual behaviour. Good decision making about life choices for adoles-
positive before the assault; 88.1% (n = 245) were female; 12%
cents has the potential to decrease the chances of engaging in risky
(n = 33) were male. 61.9% of the total population are singles and
sexual behaviours.
33.1% are married. Risk assessment was used to know if they qualify
Methods: The study applied explorative qualitative methods with a
for PEP regimen. Adolescents and young adults of less than 30 years
sample of 15 primary caregivers at UMlalazi Municipality, Eshowe
of age which are mostly students are at more risk of being raped as
(KwaZulu-Natal). The study explored the role of primary caregivers in
they have the highest frequency. The median age of the assaulted per-
education on sexuality and HIV for girls in early adolescence. The pri-
sons was 25 years with interquartile range of 15 years. Of 278
mary data were collected through focus group discussions with the
assaults with descriptions, 90% were vaginal assaults and 10% were
use of an interview guide with open-ended questions to facilitate the
penile-anal assaults. All assaulted persons were offered HIV testing
discussions. Thematic analysis was used to organise and understand
and 278 accepted testing; 100% of assaulted persons tested HIV neg-
the emerging themes from the data.
ative. In total, 100% of 278 sexual assault survivors initiated PEP.
Results: The study found that 87% of caregivers were young women.
100% completed required days of PEP, and 278 (100%) returned for
They were aware of HIV sexual risk behaviours amongst adolescent
repeat HIV test at 3 months. In conclusion, PEP was initiated in 100%
girls. The majority (93%) of the caregivers demonstrated understand-
of sexual assault cases.
ing and knowledge of HIV transmission risks and prevention. On the
Conclusions: The result indicated that those that came for PEP are
other hand, they circumvented communication related to sexuality
compliance and the regime was effective with no victim tested to be
with the adolescents, to the extent that 87% of the participants
positive to HIV infection. Most people still find it difficult to speak up
reported that they never communicated with the adolescents in their
about being raped as a significant number were hospital impatients
care on the topics of sexuality and HIV, because these topics are diffi-
before they were referred for HIV Testing and Counseling. The atti-
cult and uncomfortable to discuss with children. In addition, 46% of
tude of parents toward PEP regimen is commendable. There is need
the caregivers emphasised that adolescents were still too young for
to leverage on referral system by using more effective methods.
sex education, while 26% alluded to delaying sexual conversations until
the adolescents become curious and asked questions about the topic.
Conclusions: In sum, communication between the primary caregiver PU01.05
and the adolescent is one of the most important elements of parent- Establishing communication challenges and preferences
ing, especially communicating about risk-related factors leading to HIV among clinical trial participants in an under-resourced
infection. In addition, more training and educational workshops are setting to enhance adherence to study visits and participant
needed for primary caregivers on culturally, age-appropriate, language- retention
sensitive tools and skills to tackle issues relating to sexuality and HIV K. Mapetla1; N. van Niekerk2; M. Malahleha2 and A. Dilraj2
prevention with young people within their sphere of care and support. 1
Setshaba Research Centre, HIV Vaccine Trials, Soshanguve, South
Africa, 2Setshaba Research Centre, South Africa
Background: Ensuring protocol visit compliance and maintaining high

participant retention remain critical elements of clinical trials. How-
ever, Setshaba Research Centre (SRC) in Soshanguve, Tshwane, South
Africa, experienced challenges in communicating with participants to
remind them about their study visits. In order to improve participant
184
adherence to their study visits and retention, we aimed to identify In terms of willingness to use HIVST kits, 86% were willing to use this
challenges in cellphone communication and primary forms of commu- innovation because it is simpler and easier. The remaining 14%
nication, and to establish preferences in communication methods and wouldn’t use it because the test might not show the actual result or
interest in receiving study information via cellphones. they would not be able to manage the test result on their own and
Methods: Study Period: February-May 2019. would need a counselor to support them during the test.
Setting and location: Soshanguve, Tshwane. Conclusions: MSM communities in southeastern Nigeria are not well
Study design: Mini-survey Study Population: HVTN 702 Vaccine trial informed about HIVST and should therefore be the focus of increased
participants. Data Collection and methods of analysis: Questionnaires awareness to the minority populations. During the study, participants
with dichotomous and scaling questions were used to capture infor- expressed concerns on the need for support at the time of testing. It
mation from 90/360 (23.7%) participants. Results were expressed as is important that HIVST interventions also find ways to provide sup-
proportions of participants that experienced different communication port to participants who test for HIV given their concerns about
method challenges. learning their results alone.
Results: The majority (67.8%) were 2635 years old and 73.3% were
female. Almost all (99%) had a personal cellphone. Half of the partici- PU01.07
pants experienced challenges related to cellphones, these mainly being
Exposure to Truvada class-action lawsuit advertisements
poor network signal at home (12.2%), battery running flat (11.1%),
sharing phone (8.9%), lack of data (8.9%), and challenges with use of
among young men who have sex with men and transgender
applications (5.6%). Annually, 20% of participants made single/multiple women in Chicago, Illinois, USA
network changes. Communication preferences were calls by site staff K. Macapagal1; K. Buehler2; C. Hall2; M. Newcomb1 and B. Mustanski1
1
(80%), SMS (15.6%) and WhatsApp (3.3%). Most preferred to be con- Northwestern University, Department of Medical Social Sciences,
tacted in the morning (48.9%) or afternoon (31.1%). Site contact was Chicago, United States, 2Northwestern University, Institute for Sexual
rated as ‘very helpful’ (86.7%), and 96.7% were interested in receiving and Gender Minority Health and Wellbeing, Chicago, United States
regular general study information updates via their cellphone.
Conclusions: Despite participants owning cellphones, there are still
technical challenges e.g. network signals, battery-charging, applications, Background: PrEP medications like Truvada and Descovy are potent
etc. The majority of participants preferred being called rather than HIV prevention tools whose use is low among high-risk communities
communicating by text messages or WhatsApp. Future studies need in the U.S. (e.g., racial/ethnic minority young MSM/transgender women
to include addressing participant challenges and training of partici- [YMSM/TW]). Misleading online advertisements that promote class-
pants on use of cellphone applications to optimise communication. action lawsuits against the manufacturer of these medications and
Noting the time of day that participants would like to be called will overemphasize Truvada’s side effects may undermine PrEP use in
improve the likelihood of making contact with them. The willingness to these groups. To date, no empirical research has assessed YMSM/
receive updates will aid in keeping participant interest high and TW’s exposure to these ads.
enhance retention. Methods: Participants were part of an ongoing longitudinal cohort
study of multilevel factors influencing HIV risk among YMSM/TW in
Chicago. The 202 participants who completed study visits during Jan-
PU01.06 uary-April 2020 (mean age = 24.5 years; 90.6% cisgender male,
Evaluation of the awareness, knowledge and use of HIV 65.8% racial/ethnic minority) answered survey questions on exposure
self testing among men who have sex with men in to Truvada lawsuits, as well as PrEP intentions, use, and norms. Data
southeast Nigeria were analyzed descriptively and using binary and multinomial logistic
E. Onwe regressions.
Foundation for Better Health and Human Rights (FBHR), Project Man- Results: All participants had heard of PrEP, 44.6% had ever taken
ager, Abakaliki, Nigeria PrEP, and 21% were currently taking PrEP. Half (49.5%) reported hav-
ing seen articles, advertisements, or social media about the Truvada
lawsuits; 28.7% reported speaking with friends and 12.9% reported
Background: Despite global actions to end AIDS, gaps in HIV testing speaking with a healthcare provider about these lawsuits. Exposure to
persist among minority populations which negatively affect our ability these ads was associated with older age (OR=1.189, p = 0.002), but
to reach 90-90-90. HIV self testing (HIVST) is an innovation that is not other demographic characteristics. Ad exposure also was linked
intended to reduce gaps in HIV testing and could serve men who have with the perception that more gay and bisexual men in the U.S. use
sex with men (MSM) who because of privacy concerns, stigma, dis- PrEP (B = 0.286, p = 0.007) and that more of their friends used PrEP
crimination, or other barriers do not use facility-based, standard HIV (B = 0.508, p = 0.004), greater odds of having ever taken PrEP (OR =
testing. This study purpose is to understand knowledge, availability 2.545, p = 0.001), and high intentions to start taking PrEP (OR =
and uptake of HIVST, in order to maximize testing and especially the 6.10, p = 0.030).
use of self-testing among MSM in Southeastern Nigeria. Conclusions: Exposure to Truvada lawsuit advertisements was not
Methods: The study was conducted between March and September uncommon among this sample of YMSM/TW. Although exposure was
2019 among 400 MSM in the 5 states (Abia, Anambra, Ebonyi, Enugu linked cross-sectionally with having taken PrEP and more positive
and Imo State) that makeup Southeastern region of Nigeria. social norms, individuals more receptive to PrEP in the first place may
Participants were selected through respondent-driven sampling and be more likely to notice such advertisements. Longitudinal studies
were interviewed using a standard questionnaire about knowledge should examine the extent to which exposure to such ads is associated
and use of HIVST. Data was analyzed using SPSS 23.0. Descriptive with PrEP use/discontinuation and perceptions over time, which can
statistics were calculated and presented as frequencies and percent- inform public health messaging combating PrEP misinformation.
ages.
Results: Of 400 study participants, 90% had no idea what HIVST is.
Only 10% knew what HIVST is all about. Among these, only 6% have
actually seen and used the HIVST Kit while 94% had no idea what it
looks like. Also, 30% and 23% got the information about HIVST from
friends and local NGOs respectively, whereas the remaining 47% were
informed through social media.
185
Methods: Prior to REACH implementation, formal trainings were held

PU01.08 for counselors on adherence support required for AGYW. Materials
Current needs and future concerns among an ageing used included flip charts, product use instructions, adherence menu
population of people living with HIV in Australia options and manuals to guide the audio recorded sessions. Bi-weekly
J. Gunn1; I. Elsum1; M. Stoove 1; R. Keane2; S. Ruth3; K. Ryan4; H. von de-brief sessions are held with the counselling teams to discuss best
Doussa5; G. Brown5 and J. Power5 practices and challenges in supporting participants to adhere to daily
1
Burnet Institute, Public Health Discipline, Melbourne, Australia, 2Liv- oral PrEP. Additionally, counsellors share experiences in engaging par-
ing Positive Victoria, Australia, 3Thorne Harbour Health, Australia, ticipants in weekly meetings and also document feedback from peer
4
Burnet Institute, Melbourne, Australia, 5La Trobe University, Australia review sessions in detailed reports.
Results: Of 23 participants, 44% adhered to daily oral PrEP well while
54% required more support. Of these, 31% had poor adherence,
Background: The widespread availability of antiretroviral therapies claimed to be swallowing their tablets correctly and that the study team
means that people living with HIV (PLHIV) are experiencing less HIV- used poor adherence testing methods and were not relating well with
related health issues and living longer. Nearly half of all PLHIV in Aus- them. After Informed consent discussion, the team learnt that about
tralia are now aged 50 or above and little is known about the needs 10% were joining due to peer pressure and had partial understanding of
of this ageing population. We aimed to identify current psychosocial, oral PrEP. Education sessions were conducted prior to randomization
health and support needs of people aged 50+ living with HIV, includ- and subsequent correct understanding of the study was documented.
ing their perceived concerns for the future. The team has learned that dealing with adolescents requires patience
Methods: Data was collected between December 2018 and May and active listening while being non-judgemental. These skills have been
2019 through HIV Futures 9; the latest in a series of national cross- integrated in the various counselling sessions that have been useful to
sectional surveys assessing the health and wellbeing among PLHIV. improve adherence. Additionally, integration of peers that have used
Alongside questions relating to health and wellbeing, quality of life, Truvada for PrEP or HIV treatment in group sessions to share their
stigma, and support networks, Futures 9 was the first to include a lived experience, is also useful to help AGYW adhere to daily oral PrEP.
specific module on perceptions of ageing. Conclusions: Supporting adolescents to adhere to oral PrEP is chal-
Results: 303 people aged 50 years or older and living with HIV com- lenging and can be resolved if counsellors are adequately equipped
pleted the survey; 274 (90%) were male and 229 (76%) identified as with the skills and knowledge.
gay. The median age of participants was 59 years (IQR = 54 to 65),
the median time living with HIV was 22 years (IQR = 6 to 30), 65%
were single, 56% lived alone, and 50% reported currently experiencing
PU01.11
financial stress. Almost half (43%) reported ever being diagnosed with
Girl power, real talk & LGBT stigma: outcomes of
a mental health condition, most commonly depression (27%) and anxi- educational groups for HIV/AIDS prevention in the
ety (20%), and most participants (81%) reported comorbid physical Caribbean
health conditions, most commonly hypertension (29%) and asthma J. Varney1; N. Humphrey2; G Van Osch2; J. Miller2; G Jackson2;
(22%) and osteoarthritis (21%). Twenty-seven percent of participants L. Montross2; A. Van Der Waag2; J Bell2 and L Busby2
1
were current smokers and 19% smoked daily. Almost half of the par- American University of the Caribbean, Behavioral Department, Coral
ticipants reported experiencing stigma relating to HIV (49%) in the Gables, United States, 2American University of the Caribbean, Coral
last 12 months. Participants’ most common concerns for the future Gables, United States
centred on other illnesses (77%), loneliness (68%), needing help at
home (68%), and finances (67%) and accessing aged care that is HIV
and LGBTIQ-friendly (63%). Background: Despite a significant decline in new Human Immunodefi-
Conclusions: Older PLHIV in our sample reported several competing ciency Virus (HIV) infections in North America, countries in the Dutch
health and wellbeing needs and concerns for the future. In Australia Caribbean continue to face increasing rates of HIV new infections. On
and many other countries, the aging population of PLHIV will require the Dutch Caribbean Island of St. Maarten, those at highest risk for
targeted care and support services that are informed by appropriate HIV transmission are youth aged 20 to 24. HIV prevention
needs analyses. approaches that have proven effective for youth include education
regarding risk behaviors and skill building for safe decision-making.
Girl Power and Real Talk are standardized six-hour interventions
PU01.09 designed to increase STI transmission knowledge and address stigma
Supporting adolescent girls and young women to adhere to related to HIV/AIDS among adolescent girls and boys. This study eval-
oral PrEP; experiences of counsellors at the Kampala site uated the outcome of the Girl Power and Real Talk after implementa-
H. Kalule Nabunya1; R. Nakalega2; F. Asiimwe Biira2; E. Mulumba2; tion among secondary school students in St. Maarten.
B. Gati Mirembe2; C. Nakabiito2; E. Kyomukama2; D.K. Kemigisha2; Methods: A convenient sample of 469 students from seven sec-
J. Etima2 and C. Agwau Akello2 ondary schools participated in the program throughout the academic
1
Makerere University-John Hopkins University Research Collabora- year of 2017 to 2018. Students were asked to respond to pretest
tion, Psycho-social, Kampala, Uganda, 2Makerere University-John Hop- questionnaires describing HIV/AIDS transmission knowledge, stigma
kins University Research Collaboration, Kampala, Uganda regarding lesbian/gay peers and attitudes regarding sexual activity.
After completion of the three-day workshop, participants were asked
to complete similar post-test questionnaires.
Background: Depending on adherence to medication, overall oral Results: Pretest data indicated that prior to program implementation,
PrEP efficacy has been shown to range from no efficacy to that above the participants had gaps in knowledge regarding how HIV/AIDS is
90% in large clinical trials. Several studies have shown that adherence transmitted, resources for prevention and access to testing. Results
is influenced by different factors including; fear of side effects, stigma from paired-sample t-tests indicated significant improvements in over-
of taking ARVs and community myths and misconceptions. Counsellors all HIV/AIDS knowledge after participation in the program. However,
and study teams have to be well equipped to support adolescents’ group differences were found. Specifically, at pre-test, youth who
adherence to daily oral PrEP. We aim to describe the experiences of reported that they were unwilling to be friends with gay or lesbian
counsellors as they support the adolescent girls and young women peers had lower knowledge regarding HIV/AIDS transmission. Youth
(AGYW) to adhere to daily oral PrEP in the MTN-034/REACH study.
186
with higher LGBT stigma remained lower in knowledge than their anxious participants. We describe the strategies that have been insti-
counterparts with less stigma, even after participation in the program. tuted in the MTN-034 clinic at the Kampala site to improve visit effi-
Conclusions: Overall, this study demonstrated positive outcomes after ciency.
implementation of an educational program among youth in St. Maarten. Methods: Visit flow assessments are done at different time points for
However, youth with higher levels of LGBT stigma showed less improve- the screening, enrollment, monthly, quarterly, and crossover visits, with
ment. LGBT stigma is high in prevalence in Caribbean countries, a factor a mixture of adolescents and adults. Visit length is calculated using a
found to increase vulnerability to HIV transmission in other settings. tool provided by FHI 360 and a visit efficiency report created. The
Thus, future initiatives to prevent HIV transmission among youth in St. clinic has a flow manager who ensures smooth clinic operations and is
Maarten should directly address LGBT stigma to optimize outcomes. charged with resolving any issues in real time. Challenges are also dis-
Follow-up studies could also improve measurement of LGBTstigma, with cussed during weekly study meeting or impromptu meetings with the
consideration for family, community and cultural factors. clinic team to obtain appropriate strategies.
Results: Summary of visit efficiency reports overtime in the REACH
PU01.12 study clinic at MU-JHU (Abstract PU01.12-Table 1.);
Conclusions: More efficient visits have resulted in great participant
Improving clinic visit efficiency to support retention of
satisfaction. Visit efficiency therefore continues to be a priority and
adolescent girls and young women in the MTN-034 study conducting regular visit flow assessments is key in identifying “bottle
at Kampala site, Uganda necks” and develop strategies to overcoming them.
C.V. Nagawa1; R. Nakalega2; M. Babirye Otim2; B. Kiiza2;
J. Nakyeyune2; B. Gati Mirembe2; C. Nakabiito2 and C. Agwau Akello2
1
Makerere University-John Hopkins University Research Collaboration,
PU01.13
Transgender women’s perspectives on streamlined
Nursing/Quality controller, Kampala, Uganda, 2Makerere University-
John Hopkins University Research Collaboration, Kampala, Uganda strategies to administer long-acting injectable PrEP:
Recommendations for product development
C. Tagliaferri Rael1; J. Lopez-Rıos1; S. McKenna2; W. Bockting3;
Background: Maximizing study clinic visit efficiency for a prospective C. Dolezal1; D. Das4; I. Balan1; A. Carballo-Die
guez1 and
cohort of adolescent girls and young women (AGYW) is critical in avoid- 5
J. Bauermeister
ing long waiting times and enhancing participant retention. A persistent 1
Columbia University, HIV Center for Clinical and Behavioral Studies,
and multi-disciplinary approach can help improve recruitment, sustain New York, United States, 2Consultant, United States, 3Columbia
participation, and help participants adhere to study visits which moti- University, New York, United States, 4University of California, Berke-
vates a participant to continue with study participation resulting in bet- ley, United States, 5University of Pennsylvania, Family and Community
ter protocol implementation. MTN-034 is implemented at the MU-JHU Health, Philadelphia, United States
site from February 2019 and the study team realized that study visits
were very long with long wait times which resulted in agitated and
Abstract PU01.12-Table 1.
Visit type August 2019 December 2019 Challenges/bottle necks
Screening Visit
Average Total Visit Length (hrs) (Normal Range) 5.00 (3.00 to 3.45) 3.45 (3.00 to 3.45) Longest wait time was for lab results which has improved by
Average Total Procedure Time (hrs) (Normal Range) 4.00 (2.30– 3.00) 3.00 (2.30– 3.00) having 2 lab technicians in the stat labLongest single procedure
Average Total Wait Time hrs) (Normal Range) 1.00 (0.30 to 0.45) 0.45 (0.30 to 0.45) was the Informed Consent Process, which improved after
Longest Single ProcedureTime (hrs) 2.50 1.50 counsellors gained experience in engaging parents/guardians of
Longest Wait Time (hrs) 0.45 0.30 minorsOverall Improvement in December attributed to staff
being familiar with study procedures.
Enrolment Visit
Average Total Visit Length (hrs) (Normal Range) 5.50 (4.00 to 4.30) 4.30 (4.00 to 4.30) Longest single procedure was product counselling (involves audio
Average Total Procedure Time (hrs) (Normal Range) 4.5 (3,00– 4.00) 3.45 (3,00– 4.00) recording and watching the REACH video) markedly improved
Average Total Wait Time (hrs) (Normal Range) 1.00 (0.30 to 0.50) 0.45 (0.30 to 0.50) after counsellors were more familiar with procedureStandard
Longest Single ProcedureTime (hrs) 0.40 0.30 Lab test time is about 30 minutesTo optimize visit efficiency,
Longest Wait Time (hrs) 0.45 0.30 participants have lunch as they wait for lab results or some
other procedures are done during this time
Monthly Visits
Average Total Visit Length (hrs) (Normal Range) 3.30 (1.50– 3.00) 2.00 (1.50– 3.00) Longest single procedure was lab testing which improved after
Average Total Procedure Time (hrs) (Normal Range) 2.30 (1.20 to 2.15) 1.30 (1.20 to 2.15) another lab technician was brought on board in the stat lab.
Average Total Wait Time (hrs) (Normal Range) 1.00 (0.30 to 0.45) 0.30 (0.30 to 0.45) Standard Lab test time is about 30 minutesTo optimize visit
Longest Single ProcedureTime (hrs) 0.50 0.30 efficiency, participants have lunch as they wait for lab results or
Longest Wait Time (hrs) 0.45 0.30 some other procedures are done during this timeOverall
Improvement in December attributed to staff being familiar with
study procedures
Other Visits:Quarterly Visits visit length was on average 4 hrs in August which improved to 3 hrs in December due to the study team being more familiar with the
procedures. They are longer than monthly visits due to more procedures like ACASI and pelvic exams Crossover and Choice visit length were on average 4 hrs.
More procedures than the quarterly visit are done which include behavioral assessments, new product counselling, instructions for new product and additional
Case Reports Forms Note: When participants come in early (at about 9:00 hrs) they are seen quickly however those that come after 11:00 hrs usually face some
delays as the study team are already engaged with the earlier participants. Participants are always reminded to come in as early as possible for their visits. Average
participants scheduled per day is about 5, however some days may have about 7– 8 participants when delays may occur in case most come in at the same time.
Participants have also reported great satisfaction with the more efficient visits.
Some of the impediments occurred when participants arrived on dates that were not their scheduled appointments or came in late after
11:00 hrs, however, they are seen as fast as possible.
187
Background: Transgender women (TW) shoulder a disproportionate recommend that scientists explore alternative sites on the body to
burden of the HIV epidemic (e.g., prevalence in the United States is deliver injections, reduce injection volume (which could reduce injec-
~14%). Daily oral PrEP uptake in this community remains low due to a tion-site pain), and increase community and provider-level sensitivity
myriad of issues, including limited availability of tailored services that to TW’s needs regarding HIV prevention, which could reduce stigma.
meet TW’s unique needs. Transgender women are amenable to alter-
native PrEP delivery strategies (e.g., long-acting injectable PrEP). With PU01.14
long-acting injectable PrEP on this horizon, this is a unique opportu-
Validating tools to screen for and monitor oral PrEP
nity to improve TW’s uptake and adherence to this prevention modal-
ity by understanding their preferences.
adherence
Methods: We completed in-depth interviews (IDIs) with N = 15 sexu- E. Tolley1; H. Hanif2; S. Zissette3; A. Martinez1; K. Gill4; N. Mugo5;
ally active, HIV-negative TW in New York City to understand their L. Myers4; K. Ngure6 and G.F. Doncel7
1
preferences regarding long-acting injectable PrEP. We also assessed FHI 360, Global Health & Population Research, Durham, United
TW’s ideas regarding how to streamline delivery methods for long-act- States, 2CONRAD, Norfolk, United States, 3University of Notre Dame,
ing injectable PrEP (e.g., self-injection, injection during drop-in hours). United States, 4Desmond Tutu HIV Centre, Cape Town, South Africa,
5
We employed thematic analysis to code the IDIs. Synthesized themes Kenya Medical Research Institute, Nairobi, Kenya, 6Jomo Kenyatta
included participants’ likes and dislikes about each streamlined deliv- University of Agriculture and Technology, Kenya, 7Eastern Virginal
ery method, and their recommendations for further development. Medical School, United States
Results: With respect to self-injections, many participants liked that:
(1) the process was similar to that used to self-inject hormones, Background: Low adherence challenges successful product evaluation
(2) TW could inject themselves without relying on others (including in clinical trials. We previously developed two tools to screen for and
providers, which also increased privacy and body autonomy), monitor adherence in HIV prevention intravaginal ring (IVR) trials. This
(3) self-injection eliminated a routine doctor’s visit, study further validated the screener and adapted and validated the
(4) injections could be administered in the comfort of one’s own monitoring tool for oral PrEP studies.
home. Methods: We surveyed 193 women, ages 18 to 30, between June-
In their narratives, however, participants recognized that self-injections October 2018 in trial sites near Cape Town, South Africa and Thika,
Kenya. Both trial-experienced and trial-na€ıve participants were
could carry a higher margin of error. With respect to injections during
recruited who had used daily oral contraceptive or PrEP pills. Screen-
drop-in hours, many TW liked:
ing items (n = 54) comprising six subscales were administered to all
(1) the convenience of short wait/visit times and the flexibility of not women. IVR monitoring items (n = 45), adapted for PrEP or contra-
needing an appointment, and ceptive pill use, were administered per participants’ product experi-
(2) that it felt like for some people, injections given by providers ence. We fit confirmatory factor analysis (CFA) models on the
were safer. screening items to assess our previously hypothesized subscale struc-
ture and conducted exploratory factor analysis (EFA) of oral PrEP
On the other hand, participants disliked that they might see others
monitoring items to determine the underlying subscale structure. We
from the community during drop-in hours.
assessed construct validity by comparing each tools’ subscale psycho-
Conclusions: Overall, TW remained amenable to streamlined injection
delivery strategies and felt that these alternatives offered benefits, metric properties and correlations between screening and monitor
subscales from the current study with our original sample.
amid some concerns. Based on their experiences shared, TW
Abstract PU01.14-Table 1. Comparison of Vaginal Ring (VR) and Oral Pill (OP) Adherence Tool Constructs
# of Items Reliability
Subscale Original Current Original Current Item example
Screening scale results

Commitment to Research 8 8 0.61 0.59 The idea of participating in research is appealing.
Personal & health benefits 5 5 0.59 0.56 I want to participate in HIV prevention research because I want free health care.
Distrust of research 11 11 0.78 0.75 I do not trust research in general.
Trial Incompatibility 8 8 0.69 0.51 People who participate in HIV prevention research may be rejected by others.
Partner disclosure 5 5 0.80 0.68 My partner knows that I am participating in the research.
Visit adherence 3 3 0.67 0.62 I have never been late for an appointment.
Monitoring scale EFA results
Original Current Original Current Original Current Original Current
VR doubts OP challenges 8 12 0.78 0.80 It is hard to believe that the VR will There is a chance that the study pill will
help me. harm me.
Concerns Concerns about 7 5 0.61 0.78 Side effects make it difficult to keep Side effects make me want to stop using the
about side Side Effects using the VR. study pill.
effects
VR removal OP Adherence 9 8 0.82 0.71 Sometimes, if I felt worse when I I am completely sure that I can continuing to
had the VR in my body, I stopped use the study pill on days when I do not
using it. feel well.
n/a Social Difficulties n/a 3 n/a 0.73 n/a It is difficult to explain the research to my
with Trial family.
Participation
VR benefits OP Benefits 4 9 0.75 0.68 I believe that the VR will reduce my I believe that the study pill will reduce my
chance of getting HIV. chance of getting HIV.
188
Results: Participants’ mean age was 22. Almost 80% previously par- Background: Through a holistic approach to HIV prevention,
ticipated in trials and >80% had used PrEP through a clinical trial or DREAMS aims to enhance psycho-social factors that can strengthen
routine services. In CFA models, screening subscales measuring Dis- resilience and reduce HIV risk among adolescent girls and young
trust of Research, Trial Incompatibility and Partner Disclosure showed women (AGYW). This study estimates the impact of DREAMS on
good fit to original study data. Monitoring item EFAs produced five social support among AGYW in 3 settings where DREAMS rolled-out
factors (Positive Adherence, Pill Benefits, Pill Challenges, Side Effects, from 2016.
Social Difficulties with Trial Participation) that aligned well with our Methods: Cohorts of ~1500 AGYW were randomly selected from
previous IVR monitoring subscales and had good psychometric proper- demographic platforms in 2 Kenyan settings (Nairobi informal settle-
ties. Most correlations between screening and monitoring subscales ments; rural Gem sub-county) and South Africa (uMkhanyakude, Kwa-
from current versus original samples were similar in magnitude and Zulu-Natal). AGYW aged 13 to 22 years (15 to 22 in Nairobi) were
direction. enrolled in 2017 (Nairobi, uMkhanyakude) or 2018 (Gem), with annual
Conclusions: The ability to reliably screen and monitor adherence follow-up to 2019. Social support was based on positive responses to
over time using easy-to-administer tools could support safe and effec- questions on female networks and access to a safe and private place.
tive product use in trial and routine settings. This study provides fur- We described proportions of AGYW who reported social support in
ther construct validation for two such tools. 2018 and 2019, and associations between DREAMS (self-reported
invitation to participate during 2016 to 2018) and social support. We
PU01.15 conducted multivariable logistic regression, and estimated the causal
effect of DREAMS on social support under counter-factual scenarios
Impact of the DREAMS Partnership on social support
in which all, versus no, AGYW were DREAMS beneficiaries.
among adolescent girls and young women: causal analysis Results: Levels of social support were highest in Nairobi (56% overall,
of population-based cohorts in Kenya and South Africa 2019) and lowest in Gem (40%), and higher among DREAMS benefi-
A. Gourlay1; S. Floyd1; F. Magut2; S. Mulwa1; N. Mthiyane3; ciaries versus non-beneficiaries (e.g. aOR 1.5 [95% CI 1.1,2.1], Nairobi,
M. Otieno2; V. Kamire2; J. Osindo4; N. Chimbindi3; A. Ziraba4; 2018). In 2018, DREAMS increased social support in all settings and
D. Kwaro2; M. Shahmanesh5 and I. Birdthistle1 age-groups, e.g., from 28% if none were DREAMS beneficiaries to
1
London School of Hygiene and Tropical Medicine, Epidemiology and 43% if all were beneficiaries (+15% [95% CI 10,20%]) in Gem (Fig-
Population Health, London, United Kingdom, 2Kenya Medical Research ure 1).
Institute, Center for Global Health Research, Kisumu, Kenya, 3Africa Effects were strongest in Kenya (+21% [10,32%] in AGYW aged 15 to
Health Research Institute, KwaZulu-Natal, South Africa, 4Africa Popu- 17 in Nairobi in 2018), but weakened in 2019, particularly among
lation and Health Research Center, Nairobi, Kenya, 5University Col- older AGYW, and in uMkhanyakude (+2% [3,7%]).
lege London, Institute for Global Health, London, United Kingdom
Abstract PU01.15-Figure 1.
189
Conclusions: Across diverse settings and age-groups, we found evi- PU01.18

dence of an effect of DREAMS on social support. Dilution of the
Self-reported sexual behavior and prostate specific antigen
effect may reflect changes in social support as participants age, and
detection among women randomized to injectable depot-
withdrawal of DREAMS from uMkhanyakude in 2019, highlighting the
importance of programme sustainability. medroxyprogesterone-acetate, copper intrauterine device
and levonorgestrel implant in the Evidence for
Contraceptive Options and HIV Outcomes
PU01.16 M. Onono1; G. Nair2; T. Palanee-Phillips3; K. Reddy4; P. Lien Chen5;
Baseline associations between psychological distress, IPV X. Gao5; R. Heffron6; M. Hobbs7; H. Jaspan8; A. Miller5; M. Steiner5
and HIV risk behaviour - an analysis of women enrolled in and J. Deese9
the CHARISMA study 1
Kenya Medical Research Institute, Center for Microbiology Research,
N. Triplett1; S. Roberts2; M. Hartmann3; D. Wagner2; K. Reddy4; Nairobi, Kenya, 2University of Cape Town, South Africa, 3Desmond
F. Mathebula4; E. Tolley5; J. Baeten6; T. Palanee-Phillips4 and Tutu HIV Foundation, Cape Town, Cape Town, South Africa, 4Wits
E. Montgomery2 Reproductive Health and HIV Institute, Johannesburg, South Africa,
1 5
University of Washington, Department of Psychology, Seattle, United FHI 360, Durham, United States, 6University of Washington, Seattle,
States, 2RTI International, Women’s Global Health Imperative, United States, 7University of North Carolina at Chapel Hill, Chapel
Research Triangle Park, United States, 3RTI International, Women’s Hill, United States, 8Seattle Children’s Research Institute, Seattle, Uni-
Global Health Imperative, South Africa, 4Wits Reproductive Health & ted States, 9RTI International, Biostatistics and Epidemiology, Research
HIV Institute, Johannesburg, South Africa, 5FHI 360, Behavioral, Epi- Triangle Park, United States
demiological & Clinical Sciences, Durham, United States, 6University of
Washington, Department of Global Health, Seattle, United States
Background: Self-reported sexual behavior data collected in clinical
trials to assess sexually transmitted infection (STI) and HIV exposure
Background: Intimate partner violence (IPV) has been associated with risks are often inaccurate due to recall and social desirability biases.
poorer mental health outcomes and increased human immunodeficiency Prostate specific antigen (PSA) is a reliable biomarker of recent con-
virus (HIV) risk behaviors. CHARISMA was a randomized controlled trial domless vaginal sex that can be used to corroborate sexual behavior
of a clinic-based counseling intervention to increase women’s agency to self-reported by heterosexual women.
consistently and safely use oral pre-exposure prophylaxis (PrEP) and Methods: Nested within a trial of contraception and HIV incidence,
mitigate relationship challenges, including IPV. We explore associations we longitudinally measured concordance between self-reported con-
between IPV, psychological distress (PD) and HIV risk behaviors to bet- dom use and presence of PSA in vaginal swabs among 107 women
ter understand where and how to prevent HIV infection. randomized to use injectable depot medroxyprogesterone acetate,
Methods: Baseline data from interviewer-administered questionnaires copper T intrauterine device and levonorgestrel implant at sites in
completed with 407 participants was analyzed. Measures included PD Cape Town and Johannesburg, South Africa and Kisumu, Kenya. We
(Self-Reporting Questionnaire [SRQ-20]), IPV exposure, alcohol use, compared vaginal specimens with PSA detected among women
and engagement in HIV risk behaviors. Associations between PD, IPV, expected to have PSA undetected by virtue of self-reporting:
and HIV risk behaviors were examined with multivariate logistic
regression. (1) no vaginal sex, or only condom protected vaginal sex in the prior
Results: Twenty-seven women (6.6%) reported clinically meaningful 7 days, and
PD (i.e., SRQ-20 scores >7); 79 (19.4%) reported lifetime history of (2) last vaginal sex act ≤3 days ago with a condom or ≥4 days ago
IPV, and 49 (12.0%) reported recent IPV (i.e., in the last three regardless of condom use, at month 6 and 12 follow-up visits.
months). Recent IPV was associated with PD, and those who reported We evaluated concordance using Cochran-Mantel-Haenszel test and
recent IPV were more likely to report ever engaging in transactional adjusted logistic regression using generalized estimating equa-
sex (see Table). These women, and those with higher frequency of tion methods.
alcohol use, were also less likely to report testing for HIV with their Results: A total of 80 month 6 and 107 month 12 specimens had
partner. Neither PD nor past IPV were associated with self-reported detectable PSA. Among specimens with detectable PSA, 12 (19%) and
condom use, HIV testing with partner, partner HIV status discussion, 20 (25%) participants reported having no vaginal sex, or only condom
or engagement in transactional sex. protected vaginal sex in the prior 7 days at month 6 and 12 respec-
Conclusions: We found no evidence for an association between PD tively. Similarly, 20 (30%) and 30 (37%) reported their last vaginal sex
and HIV risk behaviors; however, recent IPV exposure was associated being ≤3 days ago with a condom or ≥4 days ago regardless of con-
with both PD and HIV risk behaviors. Our data may be limited by dom use at month 6 and 12 respectively. There were no statistically
self-report or observer biases. Investigation of follow-up data will con- significant differences in misreporting at month 6 vs. 12 in both
tribute to our understanding and interpretation of these associations. groups (aOR 1.34 95% CI 0.60 to 3.02) and (aOR 1.26 95% CI 0.64
190
to 2.51) respectively. Misreporting between contraceptive arms was Department of Infectious Disease Epidemiology, London, United King-
similar, though the power to detect differences was low. dom, 5UCL, South Africa
Conclusions: These results suggest substantive discordance between
detectable PSA and self-reported sexual behaviour, which has impor-
tant implications for studies that rely solely on self-report to assess Background: Insufficient or inaccurate knowledge about sexual and
STI/HIV exposure risks. reproductive health issues exposes adolescents to risks including preg-
nancy, HIV, and STIs. Edutainment– multimedia material intended to
be both educational and enjoyable– has been suggested as a means to
PU01.19 promote accurate and accessible information to adolescents and
Attitude of men who have sex with men to HIV testing in young people in South Africa. MTV-Shuga is an edutainment interven-
Russia tion that features storylines related to sexual and reproductive health,
A. Kalinin1; A. Pokrovskaya2 and K. Barskiy1 transactional sex, intimate partner violence, and abortion. We explore
1
Regional Charitable Foundation ‘Steps’, Social Work, Moscow, Russian the impact of the programme on adolescents’ sexual and reproductive
Federation, 2Central Research Institute of Epidemiology of Rospotreb- health knowledge.
nadzor, Rospotrebnadzor, Russian Federation Methods: Between May and November 2019, we conducted eight
(n = 4 in schools and n = 4 in community settings) 22-minute screen-
ings of episodes of MTV-Shuga Down South in five communities in
Background: In 2018, the percentage of men who have sex with men rural KZN. Following these, and using a semi-structured topic guide,
(MSM) among all tested for HIV in Russia decreased by 9.6% com- we conducted 13 FGDs, 25 IDIs, and structured observations with
pared to the previous year. At the same time, the number of newly female and male participants aged 15 to 30 years. IDIs and FGDs
diagnosed HIV infections in this group increased by 21%. were conducted in isiZulu, audio recorded and transcribed verbatim.
Goal: To study attitude of MSM in Russia to HIV testing. Data analysis was thematic.
Methods: From August to November 2019 Foundation “Steps” con- Results: In general, girls in particular described feeling uncomfortable
ducted anonymous online survey in social networks, MSM thematic discussing sex-related issues with parents and other adults, with some
groups and communities. relying on peers for this information. Through watching MTV-Shuga,
Results: 732 respondents (males – 723, transgender people – 9) participants described acquiring knowledge about important sexual
aged from 18 to 60 years. 17% had sexual contacts with men and and reproductive health issues including the value of delayed sexual
women, 19% were HIV positive. Among respondents who indicated debut; risks associated with unprotected sex; the negative role and
HIV negative (n = 594) 40% regularly tested for HIV (not less than 1 consequences of drinking alcohol or having sex while drunk; risks
time in 6 months), 36.5% tested once a year and less frequently, associated with intergenerational sex, and the knowledge that while
4.2% got HIV test only after risk contact, other 19.3% didn’t get there is no cure for HIV, HIV can be prevented, including through
tested at all. Of those who have ever been HIV tested (n = 617) PrEP. While some adolescents had been exposed to this information
85.4% had HIV test in medical organizations, 11% in NGO, 3.6% from other sources, consuming it in a new and engaging way through
respondents did self-testing. 63.7% participants trust only HIV the programme, made the information more salient. Many adolescents,
screening by venous blood, 26.1% consider trustworthy tests of however, described lacking the means to avoid some risks for example
thumb blood and saliva, 5 (0.8%) of respondents don’t trust any HIV transactional sex relationships.
testing methods. 54,8% MSM who had HIV test in the medical orga- Conclusions: MTV-Shuga appears to have had particular salience
nizations mentioned that they haven’t been counseled or informed amongst adolescents, enabling them to acquire important and accurate
about HIV infection and prevention before or after HIV testing. Only information related to their sexual and reproductive health. Such edu-
24.2% respondents consider health facilities as main source of infor- tainment interventions could usefully complement adolescent and
mation about HIV, the same number of MSM (23.2%) trust informa- youth-friendly health services and interventions that seek to improve
tion from NGO and communities, and from mass media (22.4%). adolescents’ sexual and reproductive health and behaviour.
Others get information from friends (6.5%) or think that they don’t
need it (16.7%). Only 31% respondents use condoms regularly and
38% use condoms time to time. 13% MSM who didn’t get HIV test
PU01.22
mentioned regular condom use. Linking people who inject drugs and participate in syringe
Conclusions: Regular HIV testing is not high among MSM. It is prob- services programs to PrEP services
ably explained by underestimating of individual HIV risks, insufficient A. Corneli1; B. Perry1; M. Bordeaux2 and M. McKellar3
1
trust to existing methods of diagnostic and low awareness about pre- Duke University, Population Health Sciences, Durham, United States,
2
vention measures. It is necessary to develop and implement informa- North Carolina Harm Reduction Coalition, United States, 3Duke
tion programs for MSM aimed to HIV prevention, increase availability University, Infectious Diseases, Durham, United States
of HIV testing including in non-medical institutions.
Background: Syringe services programs (SSP) legally provide people

PU01.21 who inject drugs (PWID) with sterile syringes to reduce transmission
What did you learn from MTV-Shuga? The salience of an of HIV and hepatitis C. SSPs also typically provide other services, such
edutainment programme on adolescent sexual and as linkages to addiction treatment and housing assistance. We imple-
reproductive health knowledge in rural KwaZulu-Natal, mented formative research to identify potential models of integrating
South Africa PrEP services into SSPs.
N. Kyegombe1; T. Zuma2; S. Hlongwane2; M. Nhlenyama2; Methods: We conducted a two-stage, qualitative descriptive study
N. Chimbindi2; J. Seeley1; I. Birdthistle3; S. Floyd4 and using in-depth interviews (IDIs) and focus group discussions (FGDs).
M. Shahmanesh5 We first conducted IDIs with eight key informants—i.e., staff at SSPs,
1
London School of Hygiene and Tropical Medicine, Department of Glo- community-based organizations, and health clinics/departments. We
bal Health and Development, London, United Kingdom, 2Africa Health explored informants’ perspectives on providing PrEP services to PWID
Research Institute, Durban, South Africa, 3London School of Hygiene using a pile sorting methodology where informants reflected upon the
and Tropical Medicine, Department of Population Health, London, Uni- feasibility of various PrEP-SSP integration activities. Based on key
ted Kingdom, 4London School of Hygiene and Tropical Medicine, informants’ suggestions, we identified three potential PrEP-SSP
191
integration models, and then explored their feasibility with 24 PWID For the implementation process, they recommend the design of
during four FGDs. All IDIs and FGDs were audio-recorded, tran- national, local, and institutional plans including engaging key internal
scribed, and analyzed used applied thematic analysis. and external leaders.
Results: The three PrEP-SSP integration models were: 1) a PrEP Conclusions: The health providers interviewed perceive a favorable
counseling/navigation model, where SSP staff offer PrEP information, environment for the adoption of PrEP in Colombia. The CFIR is useful
incorporate HIV risk reduction counseling into existing harm reduction to identify facilitators and recommendations to guide key implementa-
counseling, screen for PrEP eligibility, and refer, schedule appoint- tion strategies.
ments, and accompany interested PWID to PWID-trusted PrEP clinics;
2) a visiting PrEP provider model, where a PrEP provider visits the PU01.25LB
SSP once a week to provide comprehensive PrEP services, including
Role of online educational video intervention to improve
all testing, counseling, and prescriptions; and 3) a mobile outreach
model, where SSP staff visit areas frequented by PWID, offer PrEP
perceived access to HIV testing among international
information, provide HIV testing—and if accompanied by a PrEP pro- students studying in language schools in Japan: a
vider, offer additional services, including PrEP prescriptions and distri- longitudinal study
bution of refills. Key informants and FGD participants were extremely P. Shakya1; T. Sawada2; D. Gautam3; H. Zhang4 and T. Kitajima4
1
supportive of integrating PrEP services into SSPs, and FGD partici- Save the Children- Nepal, The Global Fund, Kathmandu, Nepal, 2Min-
pants described benefits and challenges of each PrEP-SSP integration atomachi Medical Center, Yokohama, Japan, 3WHO-Nepal, Kathmandu,
model. Overall, FGD participants expressed most enthusiasm for the Nepal, 4Kyorin University, Tokyo, Japan
visiting PrEP provider model, explaining that the approach is similar to
PWID treatment outreach programs and that SSPs are viewed as a
trusted source for health information. Background: Japan has been recognized for its excellent universal
Conclusions: Key informants’ and PWIDs’ perspectives provided guid- health coverage system. However, the migrant population faces many
ance on potential strategies for integrating PrEP services into SSPs. barriers in accessing healthcare. Japan hosts around 260,000 interna-
Demonstration projects are needed to identify effective models of tional students, mostly from developing countries. Among them, lan-
linking PWID to PrEP services via SSPs. guage school students have tripled from 2011 to 2017, against the
backdrop of labor force shortage in Japan. Most of these students are
also engaged as cheap labors and are high risk population with poor
PU01.24LB access to healthcare. Several socio-economic and behavioral factors
The CFIR application on PrEP implementation: facilitators may increase their vulnerability to HIV and also prevent them to
and recommendations by HIV-care clinic administrators in access HIV testing in Japan. Globally evidence is scarce on effective
Colombia interventions to improve access to HIV testing among international
S.A. Gomez1; J.L. Martınez-Cajas2; H.F. Mueses3,4; B. Alvarado-Llano2; migrants. We examined the role of online educational video interven-
X. Galindo3,4; P. Camargo2; E. Martınez5,4; J.A. Torres6 and tion on perceived access to HIV testing among international students
M. Arrivillaga1 studying in language schools in Japan.
1
Pontificia Universidad Javeriana, Cali, Colombia, 2Queen’s University, Methods: We conducted a longitudinal study among 183 Chinese,
Kingston, Canada, 3Corporacio n de Lucha contra el Sida, Cali, Colom- Vietnamese and Nepalese students studying in Japanese language
bia, 4Red VIH-Col, Cali, Colombia, 5Universidad del Valle, Cali, Colom- school in Japan. Out of them, 85 students watched the online educa-
bia, 6Montefiore Medical Center, New York, United States tional video about HIV testing services in Japan and 98 students
watched the control video about TB diagnosis. To measure perceived
access to HIV testing, we asked the students if they know about i)
Background: Research on PrEP often neglects to address the percep- place to go for HIV testing and ii) free and anonymous HIV testing in
tions of health service administrators. This study uses the Consoli- Japan. During Nov. 2018-Feb. 2019, we collected data at the baseline
dated Framework for Implementation Research (CFIR) to examine and the follow up after 7 days. We used Generalized Estimating Equa-
facilitators of implementation and issue recommendations on the tions to analyze the data.
adoption of PrEP in Colombia. Results: At baseline, the intervention and control groups had similar
Methods: This is a qualitative study with semi-structured interviews characteristics for age (mean 22.4 vs. 23.3, p = 0.108) and being male
of twenty health care administrators from eight HIV care organiza- (66% vs. 64%, p = 0.821). The intervention significantly improved the
tions in Colombia. We used the CFRI to guide the data collection and students’ knowledge on i) place to go for HIV testing (AOR = 4.37,
analysis and the Atlas.ti to conduct the content analysis which encom- 95% CI 1.92 to 9.95) and ii) free and anonymous HIV testing
passed four of the five CFIR domains. (AOR = 5.12, 95% CI 2.12 to 12.35) in Japan among the intervention
Results: In terms of the characteristics of the intervention, the man- group compared to control group.
agers recognize that PrEP is an innovative intervention with proven Conclusions: The online educational video on HIV testing services is
effectiveness, needed in the Colombian setting to promote HIV pre- effective to increase the perceived access to HIV testing among inter-
vention. They recommend that PrEP be implemented as a national national students in Japanese language schools in Japan. The findings
program guided by the Ministry of Health rules and regulations which can help to design interventions for improving access to HIV testing
should include the centralized purchase of PrEP medications and among international migrants in Japan.
adjustments to diverse regional contexts. They also recommend articu-
late PrEP to preventive sexual health programs led by capable inter-
disciplinary teams. Regarding the outer setting, they recommended to
PU01.26LB
reinforce collaboration with local health units, Profamilia, and the
Barriers to condom use among female sex workers in the
LGTBI community, modify the contractual conditions of health man- city of Colombo, Sri Lanka
agement organizations, cover PrEP for partners of HIV-positive per- W.N. Widanage and G. Weerasinghe
sons, and fund PrEP for people who cannot afford it. Regarding the National STD/AIDS Control Programme Sri Lanka, Colombo, Sri Lanka
inner setting, they perceived the structural characteristics, culture, cli-
mate, and availability of implementation were all favorable for PrEP
adoption. They also felt that PrEP training needs to reach all health Background: Transmission dynamics amongst key population groups
care workers to reduce organizational tensions brought by change. can affect HIV epidemic patterns within a country. Along with
192
individual-level factors, it is vital to understand social, contextual, envi-

ronmental and structural-level barriers perceived by female sex work- PU01.27LB
ers (FSWs) as likely barriers to condom use. Knowledge of HIV epidemic and safe sex practices in
Objectives: To describe barriers and the factors associated with lack Zambia - Does empowerment matter?
of condom use among female sex workers in the city of Colombo. R. Sherafat-Kazemzadeh1,2; G. Gaumer2; F. New1 and A. Nandakumar2
Methods: We conducted a community-based cross-sectional cluster- 1
Brandeis University, Heller School for Social Policy and Management,
sampling survey (February 2020- June 2020 - extended due to Covid Waltham, United States, 2Brandeis University, Institute for Global
-19) to assess barriers to condom use among 455 FSWs in the city of Health and Development, Waltham, United States
Colombo. We used a pre-tested interviewer administered question-
naire to collect survey data, and conducted data analysis using SPSS
version 20. Background: The campaigns for increasing knowledge about HIV/
Results: The majority (62%) of the participants were below 40 years AIDS have shown mixed impacts on practice of safe. We hypothesize
of age with most falling in the 20 to 29 year age group (32.1%). that individual’s empowerment mediates the ability to act based on
Nearly half (47.5%) the participants were street based sex workers this knowledge and engage in safe sex practices.
and 52.5% were establishment-based (i.e. brothel, home/slum, lodges, Methods: We used data from Population-based HIV Impact Assess-
hotels, massage/beauty parlours and casino-based) FSWs. The mean ment (PHIA) nationally representative survey of 2016 in Zambia. We
number of clients on the last day of sex work of the sample was 3.38 limited the analysis on a subsample of adults selected for the HIV-
(SD = 2.052). Consistent condom use (CCU) defined as using a con- knowledge module and created scalar variables for empowerment,
dom for every act of vaginal, anal and oral sex in the last three HIV knowledge and sexual behavior. We used regression analysis to
months was 89.6%. FSWs who were reached by a STD/HIV pro- assess the impact of empowerment on condom use, having single part-
gramme were more likely to have a good negotiation skills score as ner and composite behavior score.
compared to FSWs not reached by a STD/HIV outreach programme Results: Among 9,544 responders (57% female), 9.1% (men) and
(p < 0.05). CCU amongst younger FSWs (<29 years) was significantly 15.3% (women) were HIV+. Men and women reported condom use at
higher as compared to older FSWs (p < 0.05). CCU was significantly 21% vs. 16%, and single partner at 67% vs. 83%, respectively. Mean
associated with correct identification of condom use pictorial behavior score was 2.34 0.02 (men) and 2.87 0.02 (women).
sequence, duration of work as a FSW, good negotiation skills score, Having single partner in previous year and behavior score showed sig-
perceived gate-keeper support, ever reached by STD/HIV outreach nificant positive association with empowerment. When modeling for
programme, monthly income of FSW and venue of soliciting sex empowerment effect, knowledge was associated with better behavior,
(p = 0.000, p = 0.003, p = 0.000, p = 0.015, p = 0.005, p = 0.001, but not with single partner. Wealth attenuated the impact of empow-
p = 0.003 respectively). erment or knowledge on condom use.
Conclusions: Our results reveal that the main barriers to condom Education was significantly associated with higher condom use and
use for FSWs in Colombo are: poor negotiation skills, lack of per- better behavior, but not having single partner. Not living in a union
ceived gate-keeper support and client refusal of condoms. Intensified reduced behavior score. Middle wealth quintiles showed positive asso-
training of FSWs on condom use negotiation skills is important to ciation with practice of safer sex. Those living in higher inequality
ensure CCU. STD clinics should engage closely with gate-keepers to regions showed lower rate of having single sexual partner.
promote condom use in establishments. Conclusions: Individual’s empowerment is playing a role in improving
safe sex practices. Successful policies to increase behaviors preventing
HIV/AIDS requires incorporating strategies to improve individual’s
agency in decision making.
Abstract PU01.27LB-Table 1.
Condom condom Single sexual Single sexual Single sexual Behavior Behavior
use condom use use partner partner partner score Behavior score score
covariate empowerment complete covariate empowerment complete covariate empowerment complete
Model Specification model model modela model model modela model model modela
Age– not shown

Female 0.158* 0.131 0.157 1.482*** 1.544*** 1.542*** 0.498*** 0.517*** 0.520***
Secondary 0.594*** 0.551*** 0.357*** 0.00150 0.0379 0.0334 0.141*** 0.124*** 0.114***
education and
higher
Working 0.181* 0.183* 0.139 0.0827 0.0751 0.0744 0.0372 0.0383 0.0365
Union type (Ref: polygamous)
In a union (non- 0.0349 0.0520 0.0249 1.590*** 1.568*** 1.568*** 0.270*** 0.263*** 0.262***
polygamous)
Not married or in a 1.317*** 1.524*** 1.453*** 1.132*** 1.396*** 1.399*** 0.899*** 0.808*** 0.816***
union
Rural/urban – not shown
Wealth quintile – not shown
Inequality (gini quintile) – not shown
Empowerment 0.133* 0.0933 0.165*** 0.167*** 0.0604*** 0.0556***
Knowledge 0.105 0.0202 0.0459**
Coefficients indicate log (Odds Ratio). Standard errors in parentheses.

a
Complete model includes covariates, knowledge and empowerment.
*p < 0.05; **p < 0.01; ***p < 0.001.
193
3
YRG Care, Chennai, India, 4International AIDS Vaccine Initiative, New
PU01.28LB Delhi, India
Healthcare professionals and patients in COVID-19 context:
Self-assessment of risk of infection
M. Goliusova; V. Belyaeva; U. Kuimova and N. Kozyrina Background: Neutralizing antibodies capable of dissecting heterolo-
gous HIV-1 subtypes mounts selective pressure on circulating viral
“Central Scientific Research Institute of Epidemiology” Federal Bud-
envelope protein resulting in viral escape with altered sensitivity to
getary Scientific Institution of the Russian Federal Service for Surveil-
neutralizing antibodies. In the present study, we examined association
lance on Consumer Rights Protection and Human Wellbeing
between variation in env sequences isolated at two different time
(Rospotrebnadzor), Moscow, Russian Federation
points from broadly cross neutralizing plasma of a slow progressing
Indian patient (G37112) and their sensitivity to broadly neutralizing
Background: To study the assessment of the risk of coronaviral infec- monoclonal antibodies (bnAbs) with distinct epitope specificities.
tion with healthcare professionals (HCP), HIV-infected individuals and Methods: Virus neutralization was assessed using TZM-bl reporter
respondents of the experimental group. cells. Viral RNA was isolated from the HIV+ plasma and gp160 ampli-
Methods: In the period from May to June 2020, a questionnaire- fied by PCR was cloned into pcDNA3.1 Topo. Env-pseudotyped
based survey was conducted in three groups of respondents.Group 1: viruses were prepared in 293T cells by co-transfection of gp160-
67 healthcare professionals.The average age of the respondents was expressing plasmid and env-deficient pSGDenv. Complete gp160
44 years. 7.46% of the respondents had coronaviral infection. Group sequences were obtained by Sanger sequencing and analysis done
2 consisted of 79 HIV-infected individuals. The average age of the using HIV Los Alamos database and MEGA software. Donor plasma
respondents was 38 years. 2 respondents had coronaviral infection. samples were sourced from IAVI’s Protocol G cohort in India.
The experimental group (3) included 46 respondents. The average age Results: While env clones obtained at baseline were found to possess
of the respondents was 42.6 years. shorter V1 loop length with fewer N-linked glycans compared to those
The results were evaluated using the technique of descriptive statis- obtained from second visit, longer V2 loop length with one additional
tics. All respondents gave their voluntary consent to the participation N-glycan found in envs from baseline compared to those obtained in
in the survey. subsequent time point. N160, a key glycan in V2 apex targeted by
Results: The respondents were asked to answer a semi-closed-ended both PGDM1400 and CAP256.VRC26 bnAbs was present in envs
indicator question “How do you assess your current risk of infection obtained at baseline but found absent in envs obtained in second visit;
with coronavirus?”. Possible answers: “High”, “Not higher than for however, no correlation on degree of virus neutralization observed.
others”, “Zero risk of infection”, and “Other (please specify)”. Interestingly, envs with same V1V2 loop lengths containing N332 gly-
can supersite in V3 differed in their sensitivity to PGT121, highlight-
- 34.32% of healthcare professionals assessed their risk of infection ing new modality of HIV-1 resistance to PGT121. Moreover, variation
as high, whereas in Groups 2 and 3 such response was given by in signature motif (LDI/PDI) in the V2 reported to facilitate gp120
5.06% and 8.69%, respectively. attachment to a4b7 integrin on CD4+T cells for productive infection.
- 72.15% of the respondents in Group 2, and 78.26% of the respon- Finally, resistance to VRC01 of envs obtained from second visit was
dents in Group 3 considered that their risk of infection with coron- could be associated with presence of N234/N276 glycans and subtle
avirus is not higher than that of the others. In the HCP group such insertion/deletion in V5 loop.
response was given by 50.74%. Conclusions: Our study highlighted new insights of distinct mecha-
- Only 4.48% of healthcare professionals denied the risk of infection, nism associated with diversities in sensitivity of HIV-1 to bnAbs. Such
whereas in Groups 2 and 3 the “Zero risk” option was selected by information will help understand basis for immune evasion of circulat-
18.98% and 26.08%, respectively. ing viruses in individuals who develops potent cross neutralizing anti-
- The “Other” option was selected by 10.5% of the respondents in bodies relevant for designing appropriate intervention strategies.
Group 1, 3.8% of the respondents in Group 2, and 4.3% of the
respondents in Group 3. The responses were often based on PU02.03
COVID-19 in the past medical history. One respondent from Group Isolation of new CAP256-VRC26 lineage members reveals
2 indicated that he/she “does not believe in coronavirus”. determinants of breadth and potency
Conclusions: The highest rate of self-assessment of the risk of infec-
N. Doria-Rose1; L. Damron1; J. Gorman1; C. Schramm1; Y.-T. Lai1;
tion with coronavirus was registered in the HCP group, which may be
R. Rawi1; G.-Y. Chuang1; D. Ambrozak1; J. Bhiman2; K. Zhou1; E. Cale1;
attributed to contacts with patients infected with SARS-CоV-2, as well
N. Garrett3; S. Abdool Karim3; P. Kwong1 and P. Moore2
as higher awareness of the COVID-19 situation. 1
National Institutes of Health, Vaccine Research Center, Bethesda,
United States, 2National Institute of Communicable Diseases, South
Africa, 3CAPRISA, Durban, South Africa
Broadly neutralizing antibodies
Background: Broadly neutralizing antibodies (bNAbs) may be an
important component of a future vaccine for HIV-1, and are being
tested for prevention. Donor CAP256 of the CAPRISA cohort in
PU02.01 South Africa developed the VRC26 lineage of V1V2-directed bNAbs,
Subtle variations in HIV-1 subtype C env sequence features which have been studied extensively. The best of the 33 published
obtained from a slow progressing Indian donor and their VRC26 lineage members, CAP256-VRC26.25, is exceptionally potent,
association with sensitivity to neutralizing antibodies with with 70% breadth for clade C but only 15% breadth against clade B.
distinct epitope specificities We sought to isolate additional lineage members with the aims of
S. Deshpande1; R. Mullick2; J. Sutar2; S. Patil2; K.G. Murugavel3; finding an antibody with greater breadth, and to further characterize
A.K. Srikrishnan3; R. Goyal4 and J. Bhattacharya1 the genetic determinants of neutralization.
1 Methods: B cells from donor CAP256 were sorted with a native tri-
Translational Health Science and Technology Institute, HIV Infection
mer probes generated from the autologous lineage-triggering Env,
and Immunology, Faridabad, India, 2Translational Health Science and
CAP256wk34c80, using the repair-and-stabilize approach. To identify
Technology Institute, Infection and Immunology, Faridabad, India,
194
V1V2-directed antibodies, we included a probe bearing a K169E bound efficiently to VRC01 in dot blot analysis. The rest of the phago-
mutation which abolishes binding by all previous VRC26 lineage mem- topes, as well as wild-type M13, did not activate any of the sensor cell
bers; and a BG505.SOSIP trimer with the V1V2 of clade B strain lines.
WITO, to look for broader antibodies. We sorted B cells from week Conclusions: We identified highly specific mimotopes that bind to the
193 post infection, the same time point from which we previously iso- mature form of bnAb VRC01 and provide selective activation of the
lated CAP256-VRC26.25. corresponding sensor line. In our opinion, these peptides can be used
Results: Eight VRC26 heavy chain sequences were recovered, of as a booster, but not a priming component of a HIV vaccine or as a
which 6 were IgG and 2 were IgA. The VH genes showed a range of diagnostic tool for HIV infection.
7.3% to 18.1% mutation from germline, and CDRH3 lengths between This work was supported by the RFBR grant #18-29-08051.
37 and 39 amino acids (IMGT numbering), consistent with other
members of the lineage. Five had matched light chains, were
expressed as IgG1, and were characterized for binding to Env via
octet and TZM-bl neutralization assays. The best of these showed Cellular immunity
64% breadth against clade C, and 40% breadth on a 46 virus multi-
clade panel. Variations that reduced the probability of tyrosine sulfa-
tion correlated with reduced breadth and potency. One heavy chain
lacked multiple conserved residues at the tip of the CDRH3 and the PU03.01
expressed antibody was non-neutralizing. Comparisons with CAP256- Generation of HIV-specific CD4 and CD8 T-cell clones for
VRC26.25 and its cryo-EM structure in complex with trimer suggest use in HIV viral inhibition assays
the structural basis of these effects.
N. Fernandez; J. Makinde; P. Hayes; L. Black; D. King and J. Gilmour
Conclusions: These data improve our understanding of critical resi-
dues in VRC26 antibodies. This can guide future efforts to improve IAVI Human Immunology Laboratory, Imperial College London, Lon-
the breadth of these highly potent antibodies. don, United Kingdom
PU02.04LB Background: HIV-specific CD8 T-cell lines and matched CD4 T-cell
Peptides imitating the epitope of a broadly HIV-neutralizing lines are currently being used as a critical controls for the standardis-
antibody VRC01 are capable of stimulating human sensor B ation of Viral Inhibition Assays (VIA) at the IAVI Human Immunology
cell lines Laboratory (IAVI-HIL) and across IAVI Clinical Research Centres.
Establishing peptide-specific human CD4 and CD8 T-cell clonal popu-
A. Chikaev1; A. Rudometov2; L. Mechetina1; T. Belovezhets1;
lations from these T-cell lines will enable the investigation of the
A. Ilyichev2; A. Taranin1 and L. Karpenko2
1 molecular signatures that govern CD8 T-cell-mediated inhibition of
Institute of Molecular and Cellular Biology SB RAS, Laboratory of viral replication in infected CD4 T-cells. Here, we generated CD8 T-
Immunogenetics, Novosibirsk, Russian Federation, 2State Research cell clones that recognise antigen and inhibit HIV replication in autolo-
Center of Virology and Biotechnology VECTOR, Department of Bio- gous infected CD4 T-cell clones.
engineering, Koltsovo, Russian Federation Methods: We isolated clonal T-cell populations from previously estab-
lished CD4 and CD8 T-cell lines by limiting dilution. CD4 and CD8 T-
Background: The key component of an effective HIV vaccine is an cell clones were tested by IFN-c ELISpot and polychromatic flow
immunogen capable of inducing broadly neutralizing antibodies (bnAb). cytometry (PFC) to determine cell phenotype, antigen-specificity and
Such antibodies recognize structurally conserved regions of HIV envel- cytokine secretion. Furthermore, CD8 T-cell clones were tested in the
ope proteins and neutralize up to 95% to 99% of all known virus iso- Renilla reniformis luciferase (LucR) VIA to asses CD8 T-cell-mediated
lates. inhibition of HIV replication in CD4 T-cell clones.
Previously, we screened phage peptide libraries Ph.D-12 and Ph.D- Results: Six CD4 T-cell clones and ten CD8 T-cell clones were gener-
C7C (NEB) to identify mimotopes of the gp120 epitope recognized by ated, and a bank of healthy cell stocks was established. CD8 T-cell
bnAb VRC01. Polyepitope constructs carrying selected peptides eli- clones responded to the combined HIV-1 gag 15mer peptides by IFN-
cited neutralizing antibodies in immunized rabbits (Chikaev et al., c ELISpot and were capable of recognising cognate antigen based on
2015). secretion of IFN-c, IL-2 and TNF-a by PFC. Ten CD8 T-cell clones
However, the question remains whether the same neutralizing activity inhibited HIV replication of two infectious molecular clones (IMC)
could be achieved in human as immunoglobulin genes encoding for LucR viruses clades A1/D and C, in three CD4 T-cell clones.
bnAbs are markedly diverged between humans and laboratory animals. Conclusions: We demonstrated the successful generation of peptide-
To answer this question, we performed a comprehensive in vitro vali- specific CD4 and CD8 T-cells clones, which will provide more precise
dation of the obtained mimotopes in the context of phage particles. benchmarking tools to understand CD8 T-cell-mediated HIV inhibition
Methods: Phage-display library selection of VRC01-specific clones mechanisms and will facilitate the harmonisation and standardisation
and dot blot hybridization were performed as previously described of the LucR VIA across IAVI Clinical Research Centres for use in
(Chikaev et al., 2015). B-cell sensor lines expressing germline-reverted future HIV vaccine clinical trials.
and mature versions of VRC01 in membrane-bound IgG1 form were
generated using lentiviral transduction of human DG75 cell line. Cal-
flux was performed according to BD calcium flux protocol.
Results: Dot blot revealed that all 11 recombinant bacteriophages,
but not wild-type phage, bind exclusively to the mature form of
VRC01. Next, we checked whether selected phagotopes are able to
induce VRC01-based BCR clustering. Activation of sensor lines was
evaluated using Ca-flux assay. Three of 11 clones (ITIQEITAWPES and
GEERAMMWDAWA from the Ph.D-12 and CNWEFWKYC from the
Ph.D-C7C libraries) activated sensor line expressing the mature form
of VRC01. At the same time, we did not observe activation of
glVRC01-expressing cells. It should be noted that these clones also
195
Background: Youth ages 15 to 24 in Malawi account for 37% of new

Community engagement in prevention infections in 2018, and the rate for young women is twice that of
young men. Low knowledge contributes to vulnerability. Only 42% of
research Malawian youth had adequate HIV prevention knowledge, defined as
correctly answering all five UNAIDS questions. In our implementation
research, rural communities are delivering an evidence-based peer
group intervention for HIV prevention. Here we report the interven-
PU05.01 tion’s impact on adequate HIV knowledge.
Fostering transgender inclusion in HIV prevention research Methods: Three communities in southern Malawi are sequentially roll-
R. Siskind1; C. Collins2; R. Campbell3 and B. Minalga3 ing out the intervention. Youth ages 13 to 19 were surveyed at Time 1
1
National Institute of Allergy and Infectious Diseases, Division of (T1.Baseline, n = 576), T2, when one community finished rollout of the
AIDS, United States, 2Microbicide Trials Network, Communications intervention (I = 170; C = 334), and T3, when two communities finished
and External Relations, United States, 3Fred Hutch Cancer Center, rollout (I = 338; C = 155). The retention rate at T3 was 88.7%. General-
Office of HIV/AIDS Network Coordination, United States ized Estimating Equation models (GEE) were used to model Adequate
Knowledge over time. Intervention effectiveness was examined by test-
ing the interaction between group and time, adjusted for other factors
Background: HIV disproportionately affects transgender people, par- (gender, age, education, religious involvement, married/living with part-
ticularly transgender people in racial and ethnic minority communities. ner; if currently in school). We used backward selection to produce a
As such, transgender people need to be included in HIV research so final model of significant factors. The adjusted group odds ratio for cor-
that prevention and treatment strategies are relevant to their commu- rectly answered UNAIDS questions was estimated at each time point.
nities and address their specific needs. Widespread stigma and dis- Results: The baseline sample was 51.6% female, 13.5% married,
crimination, however, often keep transgender people from seeking 53.8% had not finished primary school, 70% were still in school and,
needed medical care, let alone participating in research. And the lack and 64% were “highly involved” in religious activities. Adequate knowl-
of information among research staff and clinicians often perpetuates edge at baseline was 38.9%. Knowledge increased over time for all,
the discrimination and negative encounters transgender people experi- but the increase was greater post-intervention. At T3, 58.6% of the
ence. This session highlights various training tools that can foster gen- intervention group had adequate knowledge, compared to 48.4% in
der-affirming practices, facilitate recruitment and retention of the control group (OR, T2 = 1.23, 95% CI 1.04 to 1.45; OR, T3 =
transgender participants, and identify ways to help promote inclusion 1.52, 95% CI 1.09 to 2.12). Education related positively to knowledge,
of gender diverse communities. while high involvement in religious activity was negatively associated
Methods: A group of transgender, gender non-conforming, and cis- to knowledge (OR = 0.73, 95% CI .56 - .96). Gender was not a predic-
gender researchers and subject matter experts developed a transgen- torm.
der training curriculum and other tools to help cultivate Conclusions: This peer group intervention delivered by community
responsiveness and cultural humility among all staff working through- volunteers increased youth HIV knowledge to a level substantially
out the NIAID-funded HIV/AIDS clinical trials networks and research higher than the national average. Community implementation is an
sites. They developed a comprehensive, five-part training curriculum, innovative and effective strategy to scale-up prevention. The relation-
as well as two guidance documents to help increase general aware- ship between knowledge and religious involvement warrants further
ness, understanding, and knowledge. The guidance documents address research.
gender-inclusive practices for protocol development, data collection,
and data reporting and analysis.
Results: There has been a great deal of support for the transgender
PU05.03
training curriculum. The modules have been well-received and widely Community engagement and volunteer recruitment
viewed by staff within the NIAID-funded networks and by stakehold- experiences in a HIV vaccine preparedness study in
ers in HIV and other fields of research. Steps to more broadly dissem- Masaka, Uganda
inate them and encourage implementation have been supported by S. Masawi1,2; S. Nabukenya1,2; J. Mugisha1,2; J. Kitonsa1,2;
investigators and staff throughout the research enterprise. S. Nakamanya1,2; A. Kabarambi1,2; S. Kusemererwa1,2; E. Ruzagira1,2
Conclusions: The comprehensive transgender training curriculum and and P. Kaleebu1,2
guidance documents have increased awareness of the need for gender 1
Medical Research Council/Uganda Virus Research Institute and Lon-
diversity and inclusion, and are being used to help reduce the lack of don School of Hygiene and Tropical Medicine, Uganda Research Unit,
information that perpetuates misgendering, stigma, mistreatment, and HIV Intervention, Entebbe, Uganda, 2London School of Hygiene and
trauma often experienced by transgender people in health care and Tropical Medicine, HIV Intervention, London, United Kingdom
research settings. Cultivating awareness, knowledge, and understand-
ing of transgender communities is a vital step in providing transgen-
der-responsive HIV care and services, and in supporting transgender Background: Community engagement is widely accepted as an essen-
inclusion in all aspects of HIV research. tial component for successful recruitment of volunteers into HIV pre-
vention studies. However, literature on how community engagement is
done in practice is limited. We describe community engagement and vol-
PU05.02 unteer recruitment strategies for an HIV vaccine preparedness study.
Community-led HIV prevention increases HIV-related Methods: The MRC/UVRI and LSHTM Uganda Research Unit
knowledge for youth in rural Malawi Masaka site is part of the PrEPVacc partnership that will undertake a
L.C. Kumbani1; D.L. Jere2; L.L. McCreary3; L. Liu4; C.L. Patil3; multi-country phase IIb HIV vaccine trial in Africa. The initial compo-
T. Zhang4 and K.F. Norr3 nent of this work involves the recruitment of a cohort of HIV-negative
1
Kamuzu College of Nursing, University of Malawi, Maternal-Child, adult (18 to 45 years) participants at risk of HIV acquisition and
Blantyre, Malawi, 2University of Malawi, Kamuzu College of Nursing, preparing them for participation in a HIV preventative vaccine trial. At
Blantyre, Malawi, 3University of Illinois at Chicago, College of Nursing, Masaka, we used the following recruitment strategies: 1) consultative
Chicago, United States, 4University of Illinois at Chicago, School of meetings with key stakeholders such as community advisory board
Public Health, Chicago, United States members (CAB), village health teams (VHTs), local council leaders and
peer educators; 2) community meetings to create awareness about
196
HIV and HIV prevention research; 3) Identified HIV “hot spots” in col- risk between women randomised to injectable depot medroxyproges-
laboration with community leaders. The identified “hot spots” included terone acetate (DMPA-IM), copper intrauterine device (Cu-IUD) or
highway trading centres with high concentrations bars, lodges, hotels, the levonorgestrel (LNG) implant. However, post-randomization differ-
and restaurants and fishing communities along the shores of Lake Vic- ences in some self-reported sexual behaviors by randomized contra-
toria; 4) provision of community HIV counselling and testing (HCT) to ceptive method were reported.
residents in the identified “hot spots” and preliminary risk screening Methods: This three-site (Cape Town, Johannesburg, Kisumu) study
as part of post-HIV test counselling for those who tested HIV- nested within the ECHO trial evaluated whether women randomized
negative; 5) Referral of individuals who tested HIV negative and who to DMPA-IM had more or less frequent condomless vaginal sex post-
were determined to be at risk of HIV acquisition for study screening randomization than women randomized to Cu-IUD or LNG implant by
and possible enrolment. testing for prostate-specific antigen (PSA), a validated biomarker for
Results: In total, 10 meetings were held, 7 with key community stake- condomless vaginal sex. PSA was measured in vaginal swabs collected
holders and 3 with community residents. 12 “hotspots” and 9 fishing at month 6 and final visits from 458 of 7829 randomized participants
villages were identified. 8762 individuals received HCT: 8387 (96%) who continuously used their assigned contraceptive method. We com-
tested HIV-negative and of these, 687 were referred for study pared PSA detection frequency by randomized group using the
screening between July 2018 and February 2020. 441 (63%) individu- Cochran-Mantel-Haenszel test and an adjusted generalized logistic
als of those screened were enrolled. The commonest reason for growth curve model.
screen-failure was low risk for HIV infection (97%). Results: PSA was detected less frequently in the DMPA-IM group,
Conclusions: Engagement of community stakeholders is essential for compared to the IUD and implant groups, although results were not
successful identification and recruitment of target populations for HIV statistically significant when accounting for pre-specified multiple-test-
prevention studies. ing criteria (Table 1). However, multivariable modeling not accounting
for multiple comparisons found significant differences between the
DMPA-IM and implant groups.
Conclusions: These data from a small sub-study of the ECHO trial
Contraception, pregnancy and HIV suggest that the frequency of condomless sex may have differed by
randomized contraceptive method among participants. These possible
prevention (incl. PMTCT) differences may be a result of biological changes induced by the con-
traceptive methods (e.g., decreased libido, bleeding patterns) and/or
differential participant concerns about HIV risk in the trial.
PU06.02
Post-randomization differences in condomless vaginal sex
among women randomized to DMPA-IM, copper IUD and COVID research: Applying lessons from
levonorgestrel implant in the ECHO trial
J. Deese1; P. Lien Chen2; X. Gao2; R. Heffron3; A. Miller4; M. Steiner1;
HIV prevention to SARS CoV-2
M. Hobbs5; H. Jaspan3; T. Palanee-Phillips6; K. Reddy6; M. Onono7
and G. Nair8
1
FHI 360, Product Development and Introduction, Durham, United
States, 2FHI 360, Biostatistics, Durham, United States, 3University of
PU07.01
Learning from HIV prevention research: how
Washington, Seattle, United States, 4FHI 360, Science Facilitation,
Durham, United States, 5University of North Carolina at Chapel Hill, hydroxychloroquine modifies the immune response and
Chapel Hill, United States, 6Wits Reproductive Health and HIV Insti- what could be the implications for prophylactic treatment
tute, Johannesburg, South Africa, 7KEMRI, Nairobi, Kenya, 8Desmond of COVID-19
Tutu HIV Foundation, Cape Town, South Africa J. Lajoie1; M. Kowatsch1; J. Oyugi2; J. Kimani3 and K. Fowke1
1
University of Manitoba, Medical Microbiology and Infectious Dis-
eases, Winnipeg, Canada, 2University of Nairobi, UNITID/Microbiology,
Background: The Evidence for Contraceptive Options and HIV Out- Nairobi, Kenya, 3University of Nairobi, Microbiology, Nairobi, Kenya
comes (ECHO) trial found no substantial difference in HIV acquisition
197
Background: Hydroxychloroquine (HCQ) is being used to treat auto- clustered around four themes: 1) experience having lived through a pan-
immune diseases. Recently, its use for the treatment/prophylaxis of demic, 2) experience coping with stigma, 3) familiarity with public health
COVID-19 has been widely debated. How HCQ might impact the protocols, and 4) belief in collective action.
immune response remains mostly unknown. We have previously con- Conclusions: This study provides early data on the ways in which
ducted a study to determine if HCQ or aspirin can reduce inflamma- individuals who have experience with the HIV/AIDS epidemic are
tion and HIV target cells to protect against HIV. using those experiences to cope with the COVID-19 pandemic. Study
Methods: A randomized open-labeled pilot study was conducted in participants, including those living with and without HIV, described
2014 in Nairobi, Kenya. Thirty-nine HIV seronegative women were experience and confidence in following public health protocols, fighting
randomized into the HCQ study arm. Blood (PBMC, plasma) and vagi- stigma, and coping with public health crises. Our data suggest that
nal samples were collected at three time points from all the partici- public health approaches centered on resilience and collective action
pants: baseline (Visit 1), two weeks post-drug initiation (Visit 2) and could be particularly helpful in responding and coping with COVID-19
six weeks post-drug initiation (Visit 3). Flow cytometry and multiplex —especially if the pandemic persists over longer periods of time.
bead array were used to determine the level of T cell immune activa-
tion and inflammation. PU07.03
Results: In the blood, we observed that at V2 there was an increase
Epidemiological, clinical and immunological profile in
in the level of pro-inflammatory cytokines IL-8, TNF-a and MIP-3a
compared to baseline. Interestingly, after six weeks (V3) the level of
SARS-CoV-2 co-infected HIV-positive young individuals
those cytokines returned to baseline levels. Level of total IgG was C. Vanetti1; D. Trabattoni2; M. Stracuzzi3; M. Biasin2; V. Rubinacci3;
lower compared to baseline at each following visit. A. Dighera3; C. Fenizia1; L. Gianolio4; M. Clerici1; G.V. Zuccotti4;
Among PMBCs, we observed that at V2 there was an increase in the A. Amendola5 and V. Giacomet3
1
proportion of CD4+ T cells and decreased of Th17 (CD4+ CD161+), University of Milano, Chair of Immunology - Department of Patho-
Tc17 (CD8+ CD161+) and Tc17CD95+ (CD8+ CD161+ CD95+) physiology and Transplantation, Italy, 2University of Milano, Chair of
compared to baseline. After six weeks, the percentage of CD4+ was Immunology - Department of Biomedical and Clinical Sciences “Luigi
still higher compared to baseline, however, the proportion of CD4+ Sacco”, Italy, 3University of Milano, Paediatric Infectious Disease Unit,
CCR5+, Th17CCR5+, CD8+ CCR5+, Tc17CCR5+, Tc1795+ and CD4+ L. Sacco Hospital, Italy, 4University of Milano, Department of Paedi-
CD25+ FoxP3+ TIGIT+ was decreased. Furthermore, following CEF atric, Buzzi Hospital, Italy, 5University of Milano, Department of
peptide pool stimulation, we found decreased in T cells co-expressing Biomedical Sciences for Health, Italy
IFNc and TNFa with corresponding increases in the number of cells
expressing only one of the cytokines.
Background: The role of antiretroviral therapy and the possibility of
Conclusions: Herein, we showed that inflammatory markers
an increased risk of severe disease in HIV-infected children and ado-
increased temporally after two weeks on HCQ but returned to base-
lescents are still unanswered questions, whose investigation is manda-
line level after six weeks. However, HCQ use showed sustained
decreases T cell activation and increases Treg function. The results of tory. This study reports epidemiologic, clinical and immunological
evaluations in a cohort of HIV-infected young patients followed at the
this study demonstrate a reduction in immune activation and inflam-
Unit of Paediatric Infectious Disease at Sacco Hospital, Milan.
mation among participants.
Methods: 72 HIV-infected young patients (31 M/41 F) were enrolled
in the study. Realtime PCR was performed to detect SARS-CoV-2 on
PU07.02 sputum and plasma samples were tested for anti-SARS-CoV-2-specific
It’s not the time to be selfish: applying lessons learned from antibodies IgG (Euroimmun). RNA expression quantification of genes
the HIV epidemic to COVID-19 involved in the anti-viral immune response was performed on PBMCs
K.G. Quinn; J.L. Walsh; S.A. John and A.G. Nyitray upon stimulation with SARS-CoV-2 antigens as well as with Aldrithiol-
Medical College of Wisconsin, Center for AIDS Intervention Research, 2-inactivated HIV (Quantigene Plex Gene expression assay). Secreted
United States cytokines/chemokines were quantified on plasma and cell culture
supernatants (Multiplex Cytokine Array).
Results: HIV-infection was vertically transmitted in all but 5 of the
Background: As communities struggle with how to cope with the patients enrolled. Mean age was 21.7 years (range 1 to 37 years);
health and social consequences of coronavirus disease 2019 (COVID- HIV-RNA < 20 cp/ml in 67 on 72 patients; the mean of CD4 T cells
19), sexual and gender minority men living with or affected by the HIV/ was 741 mm3 (range 187 to 2554 mm3). All the HIV-infected patients
AIDS epidemic have important insights into how to cope with uncer- were undergoing antiretroviral treatments with INI (33), PI (28), or
tainty, public health protocols, and grief. This qualitative analysis of free- NNRTI (11). SARV-CoV-2 co-infection was documented only in 4
response data from a survey of 156 sexual minority men provides patients, 3 of whom were IgG seropositive and one resulted positive
insight into how they are applying experiences with HIV to COVID-19. in sputum sample.During lockdown 14 patients declared not having
Methods: We recruited sexual and gender minority men using online stayed at home, mainly for working reasons. Among them only 2
networking apps from April 18 to 24, 2020 to enroll a longitudinal resulted positive for SARS-CoV-2-specific IgG. None of them was hos-
cohort. We analyzed baseline qualitative data from open-ended pitalized for coronavirus-related symptoms. HIV-infected SARS-CoV-2-
responses using content analysis to examine how the HIV/AIDS epi- positive subjects showed an increase in MCP-1, IL-6, and IL-10 com-
demic has helped sexual minority men with the current COVID-19 pared to SARS-CoV-2-negative patients both at RNA and protein level,
pandemic. Data were coded and analyzed using MAXQDA qualitative (p < 0.05). Notably, the concentration of the same factors was upregu-
analysis software. lated following both SARS-CoV-2 and HIV-specific stimulation.
Results: Of the 442 participants who completed the survey, 156 (35%) Conclusions: The immune activation profile of SARS-CoV-2 HIV-co-
indicated that HIV/AIDS had helped them cope with COVID-19. Among infected patients resembles the one depicted for other SARS-CoV-2
the 156 who indicated HIV had helped them cope with COVID-19, the HIV-negative subjects. However, hyper production of IL-10 distin-
average age of participants was 45 (SD = 11.69). Most participants guishing SARS-CoV-2 HIV-co-infected subjects could protect them
(96%) identified as men (96%), gay (87%), and white (69%). Nearly half from detrimental immune activation and could justify the absence of
(44%) reported living with HIV. Open-ended responses about how par- severe clinical manifestations despite the presence of an immunocom-
ticipants’ experiences with HIV helped them to cope with COVID-19 promised setting.
198
1
AHRI, Social Science, Durban, South Africa, 2UCL, United Kingdom,
PU07.04LB 3
AHRI, Statistics, Durban, South Africa, 4AHRI, Clinical Reserach, Dur-
Exploring how stay-at-home orders during the COVID-19 ban, South Africa, 5Harvard Medical School, Medicine, Boston, United
pandemic impedes engagement along the HIV/AIDS care States
continuum in Jimma University Medical Center, Southwest
Ethiopia: a qualitative study
Background: The potential for antiretroviral therapy (ART) and Pre-
A. Gizaw1; H. Hailesilassie2 and People living with HIV/AIDS
1
Exposure Prophylaxis (PrEP to eliminate transmissible HIV, has not
Jimma University, Health, Behavior and Society, Jimma, Ethiopia, been realized due to challenges of identifying and retaining those
2
Jimma University, Department of Psychiatry, Jimma, Ethiopia most at risk. We describe an HIV status and gender-neutral approach
to community PrEP delivery in rural South Africa.
Background: Immediately after the first confirmed case of COVID-19 Methods: Between March to December 2019, 24 peer navigator
in Ethiopia in March 2020, the government of Ethiopia took several pairs in rural Kwa-Zulu Natal promoted sexual health, PrEP and ART
public health measures to prevent increased levels of infection, includ- to youth aged 18 to 30 and referred them to mobile and accessible
ing closing all schools and restricting large gatherings and movements clinical services. The Isisekelo Sempilo clinics delivered adolescent-
of people. Hand washing, social distancing and stay at home order friendly, nurse-led HIV testing, prevention and care, integrated with
were the main prevention measures that the government has commu- sexual health services to all youth aged 18 to 30 who attended.
nicated to the general public through various media platforms. There- Everyone was offered HIV counseling and point-of-care testing, imme-
fore, this study aimed to explore how Stay-at-home orders during the diate initiation and follow-up with ART if positive and PrEP if negative
COVID-19 pandemic impedes engagement along the HIV/AIDS care and eligible according to South African National guidelines.
continuum in Jimma University Medical Center, Southwest Ethiopia: A Results: During six months of outreach, peer navigators provided
Qualitative Study. health promotion to 8071 (89%) of the 16,473 residents aged 15 to
Methods: A descriptive qualitative study was conducted using semi- 30-year-olds of which 566 (7%) men and women aged 18 to 30
structured, in-depth interviews from May 20 to June 3, 2020 in attended the clinic. N = 327 (58%) were PrEP eligible, of which 51.4%
Jimma University Medical Center, Southwest Ethiopia. Twenty-seven (n = 168) identified as male and 2 as transgender. Of the eligible men
study participants were recruited from purposively selected people liv- and women respectively, 97% (n = 163) and 96% (n = 153) started
ing with HIV/AIDS (PLWHA) who had delayed, declined or discontin- PrEP, mean age of 23. After adjustment being male, condom-less sex
ued after COVID-19 had been confirmed in Ethiopia (March 13 and ever having received an HIV result were positively associated
2020). The participants were engaged in phone interviews and audio- with PrEP uptake while symptoms of a sexually transmitted infection
recorded. Data were transcribed verbatim, translated, and analyzed were negatively correlated with uptake of PrEP (Table). Of the 316
using inductive thematic analysis in Atlas ti.7.1 software package. that initially adopted PrEP 15% (n = 48) overall and 17% (n = 28) of
Results: The combination and complexity of factors affecting the HIV/ men remained on PrEP at three-month follow-up.
AIDS care continuum during COVID-19 stay home orders were cate-
gorized in the main themes and sub-themes. The factors affected the Abstract PU08.01-Table 1. Factors associated with PrEP uptake
continuum of HIV/AIDS care were Psychosocial (depression, hopeless- during the first three months of the study
ness, and fear) risk perception (high risk, susceptibility, and severity), Univariable Models Multivariable Models
forceful stay-home-order enforcement (police beating , community
leaders disgracing and families and relative influence) socioeconomic Uptake OR (95% CI) p-value AOR (95% CI) p-value
factors (stigma, religion and transportation cost), misinformation about

Sex (Female) 0.1 (0.04 to 0.29) 0 0.10 (0.03 to 0.36) 0
COVID-19 (US fund cuts on ART, lockdown and ART stock out) and Age 18 to 20 [reference] [reference] [reference] [reference]
health care factors (inadequate health information and distance). Age 21 to 25 0.45 (0.19 to 1.10) 0.081 0.49 (0.18 to 1.38) 0.179
Conclusions: Overall, these findings were similar to the challenges Age 26 to 30 0.76 (0.26 to 2.23) 0.613 5.62 (2.55 to 12.37) 0.252
Currently have 0.25 (0.11 to 0.58) 0.001 0.10 (0.74 to 0.83) 0.021
experienced by PLWHA in adhering to the recommended continuum
STI symptoms?
of care. However, there are additional factors due to COVID-19 like Ever received 3.81 (1.59 to 9.10) 0.003 2.22 (0.74 to 6.65) 0.155
misinformation, and forceful stay-home-order implementation also HIV test
impeded the continuum of care. The most problematic factor identified result?
Have ever had 6.35 (3.15 to 12.79) 0 5.62 (2.55 to 12.37) 0.000
was police beating when they were out for seeking care (going to hos-
condom-less
pital) and community leaders disgracing. Therefore, strengthening sex?
information, education, and communication targeting high-risk popula- Current knows 1.18 (0.59 to 2.34) 0.637 N/A N/A
tions and emphasizing the risk of contracting COVID-19 if PLWHA partners HIV
status
are not on the HIV/AIDS continuum of care.
Currently in HIV 1.61 (0.20 to 13.20) 0.658 N/A N/A
discordant
relationship
(partner has
Delivery technologies: Novel approaches, HIV)?

Ever exchanged a 1 N/A N/A N/A
formulation and multi-purpose gift for sex
Current Smoker 3.11 (0.92 to 10.54) 0.069 0.76 (0.16 to 3.72) 0.738
Currently uses a 1.66 (0.48 to 5.77) 0.427 N/A N/A
recreational
drug
PU08.01 Ever fathered a
child (Male
0.24 (0.025 to 2.42) 0.227 N/A N/A
HIV status neutral community delivery of HIV pre-exposure specific)

prophylaxis to young men and women in rural KwaZulu- Ever been 2.30 (0.31 to 17.05) 0.414 N/A N/A
circumcised
Natal: a pilot (Male specific)
C. Herbst1; M. Shahmanesh2; J. Dreyer1; E. Shumbullo3; N. Okesola4;
N. Chimbindi1 and S. Mebane5 (Continued)
199
Table 1. (Continued) Background: The effectiveness of pre-exposure prophylaxis (PrEP) in

preventing HIV infection is dependent on taking an oral pill daily. We
Univariable Models Multivariable Models explored the severity of depressive symptoms and prevalence of likely
depression, which have been associated with poor PrEP adherence,
Uptake OR (95% CI) p-value AOR (95% CI) p-value
among a population at HIV risk using PrEP in Kenya.
Ever been 0.89 (0.40 to 2.00) 0.784 N/A N/A Methods: From May 2018 to February 2020, we enrolled 495 partic-
pregnant ipants (165 men and 130 women in a HIV serodiscordant couple, 200
(Female women at HIV risk) in a randomized trial testing if HIV self-testing
specific)
could support PrEP delivery. Eligible participants were ≥ 18 years,
Currently using 0.82 (0.39 to 1.70) 0.593 N/A N/A
any form of HIV uninfected (confirmed with rapid testing), and using PrEP (for
contraception? 1 month). At enrollment, all participants completed the 9-item Patient
Currently using 0.35 (0.05 to 2.57) 0.301 N/A N/A Health Questionnaire (PHQ-9), a depression screening tool that
oral
includes items on somatic and cognitive depressive symptoms as well
contraceptive
pill as suicidal ideation. We measured the severity of depressive symp-
Identifies as 1 toms using the continuous PHQ-9 score (range: 0 to 27) and preva-
transgender lence of likely depression using PHQ-9 scores ≥ 10.
Results: The median age of enrolled participants was 34 years (IQR:
AOR, Adjusted Odds Ratio, STI, Sexually Transmitted Infection.
27 to 40). The severity of depressive symptoms among all participants
was low (median PHQ-9 score: 1, IQR: 0 to 4), as was the overall
Conclusions: A gender and HIV status neutral approach to PrEP prevalence of likely depression (6%, n = 28), Figure 1. Few partici-
delivery is able to identify and counsel those most at risk of HIV in a pants reported thoughts of suicide (5%, n = 26). The prevalence of
rural community. The gender differences in adoption and retention in likely depression varied by study sub-populations; men in serodiscor-
PrEP indicate the need to better understand barriers to PrEP adop- dant couples had a lower prevalence of likely depression (2%, n = 4)
tion amongst young women. compared to women in serodiscordant couples (8%, n = 10) and
women at HIV risk (7%, n = 14).
PU08.02 Conclusions: The severity of depressive symptoms and prevalence of
Low prevalence of likely depression among PrEP users in likely depression were low among individuals at HIV risk using PrEP
Kenya in Kenya. Regardless, depression screening services should be inte-
grated in the delivery of PrEP in Kenya so that individuals at HIV risk
P. Mogere1; K. Ortblad2; D. Mangale2; S. Ongachi3; G. Ndungu3;
with depressive symptoms can be identified, linked to timely interven-
C. Kiptinness3; N. Mugo4; J. Baeten2 and K. Ngure5
1
tions, and benefit from improved PrEP retention and adherence out-
KEMRI-CCR PHRD (THIKA) Project, Pharmacy, Nairobi, Kenya, comes.
2
University of Washington, Seattle, United States, 3KEMRI-CCR
PHRD (THIKA) Project, Nairobi, Kenya, 4Kenya Medical Research
Institute, Nairobi, Kenya, 5Jomo Kenyatta University of Agriculture
and Technology, Kenya
200
PU08.03 Demand creation, market research,

New in vitro release test Methods for the dapivirine vaginal
ring human-centred design
D. Murphy1; Y. Dallal Bashi1; C. McCoy1; P. Boyd1; B. Devlin2 and
K. Malcolm1
1
dom, 2International Partnership for Microbicides, Silver Spring, United
PU09.01
States “If I knew about that, I wouldn’t have stopped”: increasing
flexibility in PrEP use as a key to getting and keeping men
on PrEP
Background: In vitro release testing (IVRT) methods for vaginal rings S. Malone1; N. Hasen2; M. Hlongwa3; K. Little2; S. Sharma4; J. Bell4;
often lack bio-relevance due to the large volumes of media used and/ M. Levy4; J. Reast4; P. Pitsillides5; A. Khosla6; C. Searle7; C. Smith7;
or the addition of a cosolvent or surfactant. Here, we assess and com- S. Ebrahim7 and E. Dorsamy7
pare two different in vitro release methods for a dapivirine (DPV)- 1
PSI, HIV/TB, Johannesburg, South Africa, 2PSI, Washington, United
releasing ring.
States, 3PSI, Johannesburg, South Africa, 4Ipsos, London, United King-
Methods: A 25 mg DPV matrix-type silicone elastomer ring was
dom, 5Matchboxology, Programs, Johannesburg, South Africa, 6Maver-
tested for IVRT using: (i) 100 mL isopropanol (IPA) + water media
ick Collective, Washington, United States, 7MatCH, Durban, South
containing between 0–50% IPA; (ii) biphasic mixtures comprising
Africa
100 mL of pH 4.2 acetate/pH 7 phosphate buffer and 20 mL octanol.
The IPA/water media were sampled and completely replaced daily
except weekends (200 mL used day one and at weekends); each Background: South Africa’s expansion of PrEP eligibility to all high-
phase of the biphasic system was sampled daily (1 mL) and replaced risk individuals provides an opportunity to assess the potential of
with 1 mL of fresh buffer or octanol. Dapivirine release was quantified PrEP for heterosexual men and to tailor messages and services to this
by HPLC. Cumulative release was compared to the amount of dapivir- population in order to maximize uptake and continuation.
ine released over 28 days in vivo [1]. Methods: A mixed-methods study was conducted from 2018 to 2020
Results: Cumulative release parameters following 28 day release are with men 20 to 34 years old in KwaZulu-Natal and Mpumalanga,
presented in Table 1. Cumulative release and release rate (from slope South Africa. This comprised in-depth interviews (n = 58) with purpo-
of cumulative release vs time plots) increased proportionally with IPA sively recruited men, analysed thematically, followed by a quantitative
for the IPA/water mixtures. For 0 and 10% IPA, release was partition- survey (n = 2019) with randomly selected men, analysed using
controlled, whereas for 20–50% IPA release was predominantly diffu- descriptive and inferential statistics, and concluding with further in-
sion-controlled. A 20:80 IPA/water ratio provided release of approxi- depth interviews with PrEP-experienced (n = 18) and PrEP-inexper-
mately 3.34 mg dapivirine, closest to the reported ~4 mg released ienced (n = 10) men, analysed thematically.
over 28-day clinical use. Results: While 62% of men surveyed (n = 2019) found PrEP appeal-
ing (“likely” or “very likely” to take it), 50% also expressed concerns
Abstract PU08.03-Table 1. In vitro release characteristics for dapi- about taking a pill every day.
virine release from 25 mg rings. For the two phase system, cumula- For some men, a daily pill felt too similar to ART, prompting associa-
tive release rates and amounts are given for the accumulation of tions with illness and treatment rather than wellness and prevention.
dapivirine in the octanol phase only Some men also spoke of the ‘stress’ or ‘pressure’ of always remember-
Release rate Mean cumulative
ing to take a daily pill. Second-round qualitative interviews revealed
(µg/day1/2 or amount released on day that among PrEP-experienced men, those who had discontinued PrEP
Release medium *µg/day) (95% CI) 2
R value 28 (mg) SD use reported doing so because they were not frequently sexually
active, making the cost-benefit ratio of taking a daily pill too high. 34%
0:100 IPA:water 6.37 (6.23, 6.50)* 0.9913 0.18 0.00
of survey respondents (n = 2019) said they would be more likely to
10:90 IPA/water 23.20 (22.73, 23.67)* 0.9919 0.70 0.03
20:80 IPA/water 732.1 (690.9, 773.2) 0.9415 3.34 0.30 take PrEP if they had the option of cycling onto PrEP only when sexu-
30:70 IPA/water 1623 (1616, 1631) 0.9995 7.71 0.07 ally active and then cycling off. 22% of respondents said they would
40:60 IPA/water 1826 (1802, 1850) 0.9967 9.19 0.19 be more likely to take event-driven PrEP (2-1-1). All men who had dis-
50:50 IPA/water 1939 (1922, 1957) 0.9985 9.97 0.11
continued PrEP indicated in the second-round qualitative interviews
pH 7 buffer + octanol 30.98 (22.22, 39.73)* 0.3895 0.83 0.81
pH 4.2 buffer + octanol 65.01 (54.62, 75.40)* 0.6661 1.51 0.67 that they would almost certainly have continued if they had known
about event-driven PrEP.
For the biphasic systems, release was consistent with a partition-con- Conclusions: A significant proportion of heterosexual men expressed
trolled mechanism, with the greater solubility of dapivirine in pH 4.2 interest in taking PrEP but also viewed a daily pill regimen as a bar-
buffer increasing the total amount accumulated in the octanol phase. rier. While communication of multiple options for taking PrEP would
be more complex, it may also increase uptake and continuation among
Conclusions: A 20:80 IPA/water system provided cumulative release this population. Policy makers should assess the advantages of draw-
similar to values observed following 28 days of clinical use of the backs of endorsing and promoting more flexible options for PrEP use,
25 mg dapivirine ring. A two-phase system showed a clear impact of and consider whether greater flexibility would assist in reducing inci-
pH on release but did not reach levels observed clinically. dence within an acceptable level of complexity and risk.
[1] Spence P et al., Journal of Pharmaceutical and Biomedical Analysis
(2016) 125:94–100.
201
infection and diabetes is not well understood. This study aims to

PU09.02 review data to evaluate the incidence of diabetes in HIV-infected pop-
“PrEP makes HIV irrelevant”: The effect of PrEP on ulations and its association with HIV.
reducing HIV stigmas Methods: We searched PUBMED, Web of Science, WANFAGN, and
S. Malone1; N. Hasen2; K. Little2; M. Hlongwa3; S. Sharma4; J. Bell4; CNKI to identify peer-reviewed cohort studies being published
M. Levy4; J. Reast4; P. Pitsillides5; A. Khosla6; C. Searle7; C. Smith7; between 1 January, 2000 and 20 November, 2019. DerSimonian and
S. Ebrahim7; J. Phillip7 and E. Dorsamy7 Laird random models were used to pool the incidence of diabetes in
1
PSI, HIV/TB, Johannesburg, South Africa, 2PSI, Washington, United HIV-infected populations and hazard ratio of diabetes associated with
States, 3PSI, Johannesburg, South Africa, 4Ipsos, London, United King- HIV infection. Heterogeneity was assessed by Cochrane’s Q test.
dom, 5Matchboxology, Programs, Johannesburg, South Africa, 6Maverick Study quality was assessed by Newcastle-Ottawa score.
Collective, Washington, United States, 7MatCH, Durban, South Africa Results: We identified and included 48 articles, 85.4% of which had a
low risk of bias, and none of low quality. The Cochrane’s Q test
showed high heterogeneity between studies of incidence of diabetes
Background: PrEP in South Africa has previously targeted key and and hazard ratio of diabetes associated with HIV infection. The Pooled
priority populations, including adolescent girls and young women incidence rate and cumulative incidence of diabetes amongst HIV-
(AGYW). However, some programs targeting AGYW have reported infected populations was 13.54/1000 person years of follow-up (95%
significant numbers of men requesting PrEP, often at the prompting of CI: 12.97 to 14.11), and 13% (95% CI: 9%-18%), respectively. The
their female partners. In some cases, as many as 40% of those pre- hazard ratio for diabetes was 1.55 (95% CI: 1.07 to 2.26). Subgroup
senting for PrEP at AGYW-focused sites are men. analysis showed the pooled incidence of diabetes in studies published
Methods: A mixed-methods study was conducted from 2018 to 2020 before 2013 was 17.49/1000 person years of follow-up (95% CI:
with men 20 to 34 years old in KwaZulu-Natal and Mpumalanga, 13.06 to 21.89), and was 11.70/1000 person years of follow-up (95%
South Africa. This comprised in-depth interviews (n = 58) with purpo- CI: 11.04 to 12.36) in that after 2013.
sively recruited men, analysed thematically, followed by a quantitative Conclusions: HIV-infected populations suffer high burden of diabetes,
survey (n = 2019) with randomly selected men, analysed using and are 1.6 times higher of developing diabetes comparing with HIV
descriptive and inferential statistics, and concluding with further in- seronegative people. More researches are needed to study key factors
depth interviews with PrEP-experienced (n = 18) and PrEP-inexper- associated with diabetes in HIV-infected populations.
ienced (n = 10) men, analysed thematically. PrEP-experienced respon-
dents were recruited from a PrEP program targeting AGYW.
Results: In the initial qualitative interviews, men cited disclosure to
PU11.02
their main partner as the primary barrier to engaging with HIV ser-
Maraviroc less sensitive HIV-1 variants in a region where
vices, anticipating that disclosure would result in loss of the relation- multiple non-B subtypes co-circulate
ship or, at best, sustained conflict and tension. G.P.J. Ndossi1; G. Barabona1; D. Kamori2; M. Mahiti2; T. Kuwata3;
45% of quantitative survey respondents agreed (34% agree, 11% strongly B. Sunguya4; E. Lyamuya2 and T. Ueno1
1
agree) that someone with HIV will find it difficult to find a long-term part- The Joint Research Center for Human Retrovirus Infection, Infection
ner, with only 32% disagreeing (15% disagree, 17% strongly disagree). and Immunity, Kumamoto, Japan, 2Muhimbili University of Health and
Yet interviews with PrEP-experienced men revealed that common entry Allied Sciences, Microbiology and immunology, Dar es Salaam, Tanza-
points to PrEP use included referral by a female partner living with HIV nia, United Republic of, 3The Joint Research Center for Human Retro-
or learning in some other way that a female partner was HIV-positive. virus Infection, Clinical Retrovirology, Kumamoto, Japan, 4Muhimbili
Some men were also referred by a female partner on PrEP. University of Health and Allied Sciences, School of Public Health and
Men in these relationships indicated that PrEP had neutralised HIV as Social Sciences, Dar es Salaam, Tanzania, United Republic of
an issue for them in partner selection and relationship management. It
removed the fear and stigma around both having HIV and having sex
with someone with HIV. Men wanted to stay in relationship with their Background: Since the approval of maraviroc as an antiretroviral
female partners, and PrEP gave them peace of mind in doing that. drug, clinical trials are underway for its use as pre exposure prophy-
Conclusions: While the primary benefit of PrEP may be HIV preven- laxis (PrEP). Maraviroc sensitivity and co-receptor tropisms of cur-
tion, we should not neglect the additional benefit that PrEP may con- rently co-circulating non-B HIV strains is largely unexplored. Here, we
vey in terms of stigma reduction, which in turn benefits testing, determined coreceptor tropism and maraviroc sensitivity of HIV-1
linkage, retention and adherence. Policies and programs should pro- envelopes isolated from patients in Tanzania where multiple non-B
mote PrEP for heterosexual men based on the multiple benefits subtypes co-circulate.
potentially generated. Methods: We recruited 52 newly diagnosed, treatment-na€ıve, HIV-1-
infected patients (median plasma viral load of 5.13 log copies/ml [IQR
4.66 to 5.66]) from Muhimbili National Hospital and Mnazi Mmoja
Hospital, Dar es Salaam, Tanzania. The envelope genes were amplified
Epidemiology of HIV from plasma viral RNA by nested RT-PCR, cloned into plasmid, and
sequenced. The envelope clones were co-transfected with envelope-
deficient proviral clone and the resultant pseudo viruses were
exposed to TZM-bl cells in the absence or presence of Maraviroc to
PU11.01 determine their sensitivity. For phenotypic co-receptor tropism, infec-
Association between HIV infection and Diabetes Mellitus: a tivity in U87.CD4 cell line expressing either CCR5 or CXCR4 was
determined.
systematic review and meta-analysis
Results: A total of 94 envelope clones were isolated from 52 sub-
Q. Luo1 and X. Cheng2
1
jects. Phylogenetic and subtype analyses revealed that envelope clones
Binzhou Medical University, School of Nursing, Yantai, China, 2Yantai from same individuals clustered together and that 15 (28.8%), 12
Center for Disease Control and Prevention, Yantai, China (23.1%), 7 (13.5%), and 18 (34.6%) subjects were infected with sub-
types A1, C, D and inter-subtype recombinants, respectively. Among
them, 86 (91.5%) clones exclusively infected CCR5-expressing
Background: Noncommunicable diseases become a main burden
U87.CD4 cells; whereas 5 (5.3%) clones infected exclusively CXCR4-
amongst HIV-infected populations. The association between HIV
202
expressing target cells and the rest 3 (3.2%) could infect both cells. found (76.5% recombinants/23.5% pure subtypes). Following EWI,
Of note, 4 of 8 clones showing X4 and dual tropic infection were pre- HIVDR driving factors were delayed drug pick-up (81.7%), drug stock
dicted as R5 by currently available genotype tools including Geno2- outs (75%) and poor viral suppression (71.1%).
pheno, WebPSSM, and PhenoSeq. Three subjects were infected with Conclusions: Among Cameroonian ALPHI on ART, immunological fail-
HIV-1 variants harbouring envelopes with different tropisms. Interest- ure is consistent with poor adherence, late age and female adoles-
ingly, while majority of R5 clones were highly sensitive to maraviroc, cents. VF is high due to very high HIVDR rates, driven by poor
seven (8.1%) clones showed much reduced sensitivity to maraviroc adherence and first-line ART use. TDF and PI/r appear highly active
inhibition. for managing ART failure. For successful transition of ALPHI to adult
Conclusions: Our results reveal a highly diverse nature of HIV-1 care: improving drug supply,enhancing adherence to ART,use of newer
envelope in currently co-circulating strains with some limitation of innovative drugs and early detection of therapeutic failure, targeting
genotypic tropism prediction tools in Tanzania. Identification of mar- mainly female and late age adolescents on first-line ART.
aviroc less sensitive strains warrants caution in the use of this drug in
Tanzania. PU14.02
Analysis of pre-ART MiSeq multiplexed longitudinal
datasets demonstrated the env gene region as the most
HIV sequencing insights including viral reliable for timing the entry of the virus into the reservoir
L. Tyers1; M.-R. Abrahams1; S. Joseph2; N. Garrett3; M. Moeser2;
diversity and antiretroviral resistance D. Doolabh1; D. Matten1; S. Zhou2; C. Anthony1; S. Karim3;
R. Swanstrom2 and C. Williamson1
1
University of Cape Town, Division of Medical Virology, Cape Town,
South Africa, 2University of North Carolina, Chapel Hill, United States,
PU14.01 3
CAPRISA, Durban, South Africa
Virological failure is consistent with acquired HIV drug
resistance among adolescents living with perinatal HIV
infection: evidence from the EDCTP-READY study Background: A latent viral reservoir is present in HIV-1 infected indi-
1 1 1 1
D. Njume ; J. Fokam ; T.P. Willy Leroi ; D. Takou ; L. Mbuagbaw ; 2 viduals on antiretroviral therapy (ART). We have recently shown that
V. Tala1; C. Chenwi1; G. Beloumou1; S. Djupsa1 and A. Ndjolo3 the majority (71%) of this reservoir likely originated around the time
of ART initiation. This was determined by phylogenetically comparing
1
‘Chantal BIYA’ International Reference Centre for Research on HIV/
sequences of replication-competent viruses induced from on-ART rest-
AIDS Prevention and Management, Virology, Yaounde , Cameroon,
2 ing CD4+ T cells to viruses in blood pre-ART in rapidly evolving gag,
Faculty of Health Sciences, University of Buea, Paediatrics, Buea,
env and nef gene regions. We explored diversification of alternate
Cameroon, 3‘Chantal BIYA’ International Reference Centre for
gene regions for use in reservoir timing.
Research on HIV/AIDS Prevention and Management, Yaounde , Camer-
Methods: Fourteen gene regions across the genome were amplified on
oon
average every six months from acute infection to ART initiation (approx.
4 years) for 15 individuals in the CAPRISA002 cohort using Illumina
Background: With recent increase antiretroviral therapy (ART) MiSeq with Primer ID. Identical consensus sequences were collapsed
uptake and subsequent global HIV-associated mortality decrease, ado- within each time-point. Mean between and within group pairwise dis-
lescents living with perinatal HIV infection (ALPHI) continue experi- tance analyses were performed using MEGA-X. Rates of divergence and
encing high mortality rates.This burden is borne more in Sub-Saharan diversification were determined by linear regression, followed by one-
Africa (SSA), Cameroon inclusive. We aimed to assess response to way ANOVA with Tukey correction for multiple comparisons in Prism 8.
ART, acquired HIV Drug resistance (HIVDR) and its underpinning fac- Results: On average five gene regions per participant (range: 1 to 12)
tors among ALPHI. with an average of 83 consensus sequences (range: 18 to 559) per
Methods: Cross-sectional and analytical study was conducted time-point were analysed. In a subset of six individuals who had at
amongst consenting ALHIV in two reference urban facilities and at least one region of gag, pol and env represented, four had sequence
the ‘Chantal Biya’ International Reference Centre for research on HIV divergence rates from the earliest sampled time-point that were sig-
(CIRCB), Yaounde , Cameroon. WHO clinical staging, adherence, nificantly higher for env regions, excluding C0C1, compared to gag
immunological status (CD4 count) and plasma viral load (PVL) were and pol (p-values: 0.0311 to <0.0001), with two showing no significant
assessed. Cases of virological failure (VF:PVL > 1000 copies/ml had difference across regions (p-values: >0.1). Rates of diversification
genotypic resistance testing performed and drug resistance mutations showed no significant difference between regions for viruses from
interpreted with Standford HIVdbv8.8. Seven early warning indicators three of the individuals, while two had significantly higher rates for at
(EWIs) for HIVDR were evaluated. Data analysed with EpiInfo least one env region (p-values: 0.0357 to <0.0001) and one showed
v7.2.2.6,using Chi-square or Fisher exact test for categorical data and significantly higher rates in vif (p-value: 0.044).
Student t test for quantitative data; with p < 0.05. Conclusions: This dataset provides a unique opportunity to investi-
Results: Of 196 ALPHI, 56.1% (110) were female, median age was gate the suitability of various regions across the HIV-1 genome for
16[IQR: 14 to 18] years, 61.7%(121) were on non-nucleoside reverse timing the establishment of the latent reservoir. Although env gene
transcriptase inhibitors (NNRTI)-based regimens and 30.1%(59) poorly regions stand out as having more rapid divergence rates over time, no
adherent. Clinical failure rate (WHO-stage III/IV) was 9.2%. Median clear trends could be found for diversification. This may indicate that
CD4 was 541[330.5 to 772] cells/mm3, immunological failure rate in some individuals alternate genome regions may prove equally as
(CD4 < 250cells/mm3) was 15.8%, associated with late adolescence informative and should be further investigated.
(OR = 1.24 [1.03 to 1.50], p = 0.02), female gender (p = 0.04) and
poor adherence (p = 0.04). VF rate was 34.2% (67/196), associated
with poor adherence (p = 0.02) and NNRTI-based ART (p = 0.02).
HIVDR rate was 92.2%, higher with first-line ART (95.9%/OR = 5.66
[0.58 to 74.82]. 89.1% had NNRTI-DRMs, 78.1% NRTI-DRMs and
4.7% PI/r-DRMs; with 81.3% dual-class resistance. Most potent drugs
were tenofovir (72.0%) for NRTI and all PI/r. 12 viral strains were
203
being the predominant strains. In recent years, a steady increase in

PU14.03 URFs and clade F2 viruses was monitored through partial genome
Increased frequency of inter-subtype HIV-1 recombinants sequencing. There is a dearth of characterizing emerging URFs along
identified by near full-length virus sequencing in a Rwanda the full genome, which is needed to address the challenges URFs pose
acute heterosexual transmission cohort towards diagnosis, treatment, and HIV-1 vaccine design. Therefore,
L. Yue1; G. Umviligihozo2; E. Muok2; R. Xu1; D. Dilernia3; K. Herard1; this study describes the genetic diversity of HIV-1 CRF37_cpx vari-
K. Brooks1; H. Song1; P. Farmer1; J. Hare4; M. Price5; E. Karita2; ants circulating among ART-naive HIV infected individuals in Rivers
S. Allen3; J. Gilmour4 and E. Hunter3 State, Nigeria.
1
Emory University, Emory Vaccine Center, Atlanta, United States, Methods: Blood samples were collected from 106 consenting ART-
2
Projet San Francisco, Kigali, Rwanda, 3Emory University, Pathology naive HIV infected individuals in Rivers State, Nigeria. The age range
and Laboratory Medicine, Atlanta, United States, 4IAVI, United King- of the participants was 18 to 70 yrs (mean age: 45.7 yrs); 51.9% were
dom, 5IAVI, New York, United States males and 48.1% were females. Sixty (50.0%) sequences from the 106
ART-na€ıve individuals were successfully amplified and analysed.
Results: Of the 60 successfully generated sequences, 3 pure HIV-1
Background: A majority of studies of HIV-1 transmission have variants/subtypes, 3 circulating recombinant forms (CRFs) and one
focused on subtypes B and C. In this study, we determined the nature unique recombinant forms (URFs) were identified as; A1 (23.3%), F2
of the transmitted founder (TF) virus in the IAVI protocol C acute and (3.3%), G (18.3%), CRF02_AG (36.7%), CRF37_cpx (3.3%), CRF56_cpx
early infection cohort from Rwanda, where subtype A is prevalent. (1.7%) and URF_A1F2 (13.3%). However, subtype F2 and its recombi-
Methods: We have utilized near full-length single genome (NFLG) nant forms accounted for 16.6% of all sequences obtained. There was
amplification to generate over 300 HIV-1 amplicons from 26 acutely evidence of circulation of HIV-1 subtype F2, URF_A1F2, CRF37_cpx
infected seroconvertors identified within a median of 23 days of the and CRF56_cpx in Nigeria, and multiple circulations of HIV-1 subtypes,
estimated date of infection. Using PacBio SMRT technology combined with the predominance of HIV-1 CRF02_AG.
with the MDPseq work flow, we performed multiplex sequencing to Conclusions: This is apparently the first report of CRF37_cpx and
obtain high accuracy sequences for each amplicon. Infectious molecu- CRF56_cpx, and probably the second report of subtype F2 and its
lar clones (IMC) have been constructed from the TF NFLG amplicons recombinant (URF_A1F2) in Nigeria. The occurrence of F2 and its
of 19 individuals by In-Fusion HD Cloning. Replicative capacities of recombinants (>16%) reflects a recent emergence of the subtype in
IMCs were determined by infecting healthy single donor PBMCs and Nigeria. Close clustering of the phylogeny signified high rate of recombi-
quantitating reverse transcriptase activity over 10 days. nation between subtypes A, G, and F2, indicating a complex and evolving
Results: Phylogenetic analyses showed that 23% (6/26) of HIV-1 pattern of circulating HIV-1 among the ART-naive participants.
infections in this cohort were established by 2 or more TF viruses.
Two C subtype variants (8%) as well as 5 A/C (19%) and 1 C/D
inter-subtype (4%) recombinants were identified in this A1 subtype
dominant (70%) cohort. Each recombinant was unique with distinct Humoral immunity
breakpoints. The frequency of recombinants (23%) identified by full-
genome sequencing contrasts with only 6.5% of recombinants and
82% pure subtype A defined previously by pol sequencing. From those
individuals infected by a single transmitted founder virus, we con- PU15.03
structed 19 TF virus authentic IMC and an analysis of replicative An enveloped virus-like particle (VLP) platform with high-
capacity showed a range of RC values from 0.2 to 4.0 (median 1.2) density antigen display induces a strong and functional
relative to the R5 tropic, subtype C MJ4 virus.
humoral immune response
Conclusions: A significantly higher frequency of inter-subtype recombi-
F. Tarres-Freixas1; C. Aguilar-Gurrieri2; L.M. Molinos-Albert2;
nation is occurring in this acute heterosexual HIV transmission cohort,
I. Varela2; R. Ortiz2; M.L. Rodrıguez de la Concepcio n2; E. Pradenas2;
previously classified as predominantly subtype A. The identification of the
; S. Marfil ; C. Avila-Nieto ; L. Cervera ; S. Gutie
B. Trinite 2 2 2 3
rrez-
genotype of the TF virus allowed construction of a novel panel of subtype
Granados3; M.M. Segura3; F. Go dia3 and B. Clotet2
A IMCs with diverse replicative capacities. These results demonstrate 1
the importance of defining NFLG sequences in order to fully understand IrsiCaixa Aids Research Institute-HIVACAT, IGTP, Hospital Universi-
the genetic and biologic characteristics of TF viruses and in particular the tari Germans Trias i Pujol, Cell Virology and Immunology, Badalona,
prevalence of unique recombinant forms in transmission cohorts. As such Spain, 2IrsiCaixa Aids Research Institute-HIVACAT, IGTP, Hospital
they have clear implications for future HIV-1 vaccine design. Universitari Germans Trias i Pujol, Badalona, Spain, 3Grup d’Enginyeria
Cellular i Bioprocessos, Departament d’Enginyeria, Quımica, Biolo gica
i Ambiental, Universitat Auto noma de Barcelona, Barcelona, Spain
PU14.04
Epidemiology and diversity of HIV-1 CRF37_cpx detected
among ART-naive HIV-infected individuals in Rivers State, Background: HIV-1 Gag-based enveloped Virus-Like Particles (VLPs)
Nigeria stand as a safe and promising vaccine platform to induce potent
I. Okonko1; O. Opaleye2; P. Okerentugba1; B. Okonko3; J. Bimela4 and humoral and cellular immune responses against HIV-1. However, low
R. Duerr4 incorporation of immunogens at the VLP surface is a major obstacle
1 to their optimisation. The aim of this work is to develop VLPs express-
University of Port Harcourt, Virus Research Unit, Department of
ing a high density of Env-derived immunogens on their surface and
Microbiology, Port Harcourt, Nigeria, 2Ladoke Akintola University of
test their immunogenicity in mice. To do so, HIV-1 p55Gag was fused
Technology, Department of Medical Microbiology and Parasitology,
with a gp41-derived protein (Min) that contains the transmembrane
Ogbomosho, Nigeria, 3Ebonyi State University, Department of Applied
and MPER region.
Microbiology, Abakaliki, Nigeria, 4New York University School of Medi-
Methods: HEK293F cells were transfected with plasmids coding for
cine, Department of Pathology, New York, United States
p55Gag (control) or the fusion protein MinGag. VLPs were collected
48 h post-transfection and purified by crossflow filtration and chro-
Background: In Nigeria, a manifold genetic diversity of HIV variants matography. VLP expression was verified by flow cytometry, ELISA
exists with circulating and unique recombinant forms (CRFs and URFs) and western blot. VLP immunogenicity was assessed in C57bl/6 mice
204
following two approaches: a) four doses of purified VLPs (VVVV; of genetic diversity within this population. The polymorphisms associ-
90 ng p24Gag/dose in PBS) and b) two doses of electroporated DNA ated with novel alleles may lead to altered effector function by influ-
(20 μg DNA in PBS) followed by two doses of VLPs (DDVV). Addition- encing Fc-receptor binding. Ultimately, this study will provide insights
ally, C57Bl/6 mice injected with a Min-expressing syngeneic melanoma into how genetic diversity can be exploited to improve antibody func-
cell line (B16F10) were employed to assess the functionality of the tion, with implications for passive immunization for HIV prevention.
MinGag-induced humoral response.
Results: MinGag-VLPs induced a robust antibody response in the
VVVV group, reaching plateau after one immunisation. Interestingly, a
10-fold increase in anti-Gag and anti-Min antibodies was achieved in the Implementation science, including struc-
DDVV regimen. Immunisation did not induce neutralising antibodies;
however, anti-Min response was characterised by a strong bias to tural interventions, PrEP & VMMC
IgG2c, a Th1-like IgG subclass that can efficiently mediate effector anti-
body functions. Therefore, C57Bl/6 mice were vaccinated twice with
VLPs and then injected with a poorly immunogenic melanoma line
(B16F10) that stably expressed Min on their surface. A statistically sig- PU16.01
nificant delay in tumour growth and longer survival was observed in An integrated approach to customary male initiation
MinGag-VLP immunised mice, compared to control groups (p < 0.05). practices improves access to male circumcision services in
Conclusions: Altogether, these results demonstrate that our HIV- Eastern Cape, South Africa
based VLP platform with a high-antigen display induces a strong anti- N. Igaba
gen-specific Th1-like humoral response that delays the growth of a Right to Care, VMMC, Pretoria, South Africa
Min-expressing tumour cell-line in vivo. Further studies will unveil the
platform’s versatility to present other immunogens, such as trimeric
Env, and its potential to induce broadly protective responses, a pre- Background: We assessed the effect of an integrated model of CMI
requisite to develop a vaccine against HIV-1. support in five districts supported by Right to Care (RTC) and Popula-
tion Service International (PSI) in EC in delivering high quality, safe
MC services to 15 to 34 years old males also known as “age pivot”.
PU15.04 Methods: The integrated model of CMI support involved several com-
High levels of diversity in IgG3 constant region antibody
ponents: community entry through stakeholder engagement; community
genes advocacy campaigns on Safe MC, pre-screening of prospective initiates
H. Spencer1; S. Richardson2; B. Lambson2; L. Morris2; P. Moore2 and for chronic illnesses; MC procedure performed as per National Depart-
C. Scheepers2 ment of Health (NDoH) guidelines, follow-up, and adverse events man-
1
University of the Witwatersrand, School of Pathology, Johannesburg, agement. As per programmatic performance requirements, data on
South Africa, 2National Institute for Communicable Diseases, Centre Voluntary Medical Male Circumcision (VMMC) and (HIV Testing Ser-
for HIV and STIs, Johannesburg, South Africa vices (HTS) cascades were collected using standardized NDoH tools.
The data were captured and stored in a cloud data storage system
called Data for Accountability Transparency Impact Monitoring (DATIM)
Background: Antibody Fc effector function contributes to the control and later analyzed using descriptive data analysis. Data from Financial
of HIV infection and can slow disease progression. Furthermore, the Year (FY) 2016 to FY 2018-before implementation of integrated model
Fc region can enhance the protective efficacy of some HIV broadly of CMI support and FY 2019- after implementation were compared. We
neutralizing antibodies. IgG3 antibodies have the widest range of Fc reviewed changes in population of males aged 15 to 34 years in these
effector functions and were associated with reduced risk of infection districts to assess if changes in circumcision numbers could be attribu-
in the RV144 vaccine trial. Multiple allelic variants of IgG3 exist which ted to population changes.
differ in their ability to mediate immune functions such as antibody- Results: In the period of this study, a cumulative number of 137,759
dependent cellular cytotoxicity. Here we describe allelic variation in MCs were performed in the five EC districts with 95,828 (70%) MCs
IGHG3 (the gene that encodes IgG3) in a group of Zulu-speaking performed after implementation of the integrated model of CMI sup-
HIV-infected women from the CAPRISA cohort in South Africa. port (FY2019). Among 117,928 males aged 15 to 34 years circum-
Methods: IGHG3 is typically sequenced in segments due it its highly cised in this period, only 30,403 (26%) were circumcised before
repetitive nature and sequence similarity to other IGHG genes, limit- implementation of this model (FY2016-FY2018) compared to 87,525
ing haplotype linkage. We designed primers that bind 45nt upstream (74%) circumcised after implementation of this model. We found a
of CH1, and 77nt downstream of CH3 to sequence full-length IGHG3 188% increase in the total number of MCs performed among males
in a single fragment for Sanger and PacBio sequencing. This was used aged of 15 to 34 years after implementation of this model. There was
to generate full-length IGHG3 sequences from nine CAPRISA partici- a reduction of 19,090 (3%) in the population of 15 to 34 year old
pants, for comparison with sequences in IMGT (the reference data- males in these five districts over the period of this study, which is not
base for immunoglobulin genes). statistically significant (Chi = 0.1762, p = 0.675).
Results: Fourteen of the eighteen alleles identified in these nine Afri- Conclusions: This study found a large increase in circumcisions among
can individuals matched those in IMGT. However, four novel IGHG3 males 15 to 34 years, also known as age pivot. The integrated model of
alleles were identified based on nucleotide variations. Two of these CMI support presents an opportunity to reach sexually active males for
novel alleles each contained a single intronic SNP that differed from circumcisions leading to reduction of HIV incidence in EC.
their closest matching IMGT alleles, IGHG3*01 and IGHG3*03. The
other two novel alleles, which differed from the most closely matched
IGHG3*11 allele in IMGT by six and seven SNPs, respectively, shared
two identical amino acid changes in the CH2 (L234F and F296Y). One
of these changes (L234F) is proximal to the receptor binding sites for
FccRIIIA and C1q, a region responsible for inducing cellular cytotoxic-
ity and complement deposition, respectively.
Conclusions: We have identified four novel IGHG3 alleles within a
limited number of South African donors, underscoring the high level
205
Results: We interviewed 12 male partners of the 49 AGYW who par-

PU16.02 ticipated in the pilot study intervention arm. Men were aged 19 to 43,
PrEP uptake and continuation among AGYW initiating PrEP with 10 (83%) married and 3 (25%) in polygamous marriage. Rumors
in public HIV care clinics in Kenya and suspicions about PrEP were common; most men believed PrEP was
I. Wanyoike an ARV, led to promiscuity, made women barren, and became ineffective
KEMRI, CCR PHRD, Nairobi, Kenya after extended use. Misinformation underlied the lack of men’s support
for PrEP, a perception that changed for most men after adequate teach-
ing: “If men are taught [about PrEP], they can get it well and support it.”
Background: Adolescent girls and young women (AGYW) in Africa Following the teachings, nine men were willing to convince their peers
bear a disproportionately high burden of new HIV infections and are a to allow their partners to use PrEP. For wider reach with PrEP educa-
priority population for oral pre-exposure prophylaxis (PrEP), an effec- tion, men suggested that programs should tap into forums popular with
tive HIV prevention method. Data on delivery approaches of PrEP for men, such as sports and community cinema.
AGYW in sub-Saharan Africa are limited. Conclusions: Lack of male partner support for PrEP use among
Methods: The Partners Scale-Up Project is a prospective, pragmatic AGYW in SSA is largely driven by inadequate knowledge of PrEP. To
implementation evaluation of PrEP delivery integrated in 25 public increase PrEP use among AGYW, research is needed on strategies to
HIV care clinics in central and western Kenya. PrEP is offered accord- increase PrEP knowledge and support among their male partners.
ing to national guidelines by Ministry of Health staff. Medical records
of those initiating PrEP in the facilities were abstracted. We analyzed
the subset comprising of females aged 18 to 24 years. We present
PU16.04
PrEP uptake and continuation and contraceptive use. Data were ana-
Challenges of conducting a simulated vaccine efficacy trial
lyzed using Stata. (SiVET) in fishing communities of Lake Victoria in Uganda
Results: Between February 2017 and June 2019, of 4898 people ini- T. Nakaweesa1; A. Ssetaala2; A. Nanvubya3; D. Okodan4; E. Keneema3;
tiating PrEP in the 25 clinics, 673 (13.7%) were young women aged U. Nkuutu4; J. Odenyo1; G. Basalirwa1; B. Okech4; J. Mpendo4 and
less than 25 years [18 to 19 years 99 (19%); 20 to 24 years (85%)]. M. Price5
1
Most, but not all, reported sex with a HIV positive partner (n = 478, UVRI-IAVI HIV Vaccine Programe, Statistics and Data Management,
71%), most were married (n = 574; 82%), and the majority (n = 408; Entebbe, Uganda, 2UVRI-IAVI HIV Vaccine Programe, Community
61%) reported inconsistent or no condom use. At PrEP initiation, 16% Studies, Entebbe, Uganda, 3UVRI-IAVI HIV Vaccine Programe,
(n = 65) were pregnant and 24% (n = 103) were breastfeeding a Entebbe, Uganda, 4UVRI-IAVI HIV Vaccine Programe, Clinic Trials
child. More than half (57%) had at least one visit in the 3 months Unit, Entebbe, Uganda, 5International AIDS Vaccine Initiative, Epidemi-
post-PrEP-initiation. Those aged 20 to 24 years (OR: 1.6, 95% CI 1.1 ology & Biostatistics, UCSF, United States
to 2.5), those who were married (OR: 4.5, 95% CI 3.0 to 7.1), those
who had a known HIV positive partner (OR: 4.4, 95% CI 3.1 to 6.4),
those who were pregnant (OR: 2.3, 95% CI 1.3 4.0), and those who Background: Fishing Communities (FCs) have previously been cate-
had immediate fertility desires (OR: 3.6, 95% CI 1.8 to 6.9) were gorized among the most at risk populations for HIV and hence poten-
more likely to return for at least one visit (p < 0.05). tial populations for conduct of clinical trials. It is assumed that their
Conclusions: HIV clinics provide one option for PrEP delivery among remoteness and mobile nature makes it challenging for them to partic-
AGYW, especially but not exclusively for those in HIV serodiscordant ipate in clinical research. We assessed logistical challenges of conduct-
partnerships. ing a clinical trial in fishing communities.
Methods: We conducted a simulated vaccine efficacy trial (SiVET)
using licensed Hepatitis B (Engerix B) among participants from two
PU16.03 FCs along Lake Victoria, one mainland and an island. Study sites were
“I did not support PrEP use because I did not know what it established within the 2 FCs with Staff camped there for 5 days and
was”: lack of information undermines partner support for Fridges powered by gas to store the study products. HIV and preg-
PrEP use by young women in Siaya County, Kenya nancy testing were done on-site and additional testing of Hepatitis B,
K. Agot1; M. Hartmann2; S. Otticha3; A. Minnis2 and S. Roberts2 chemistry, stool, hematology, syphilis done at the central laboratory.
1
Impact Research and Development Organization, Research, Kisumu, Sample carriers wrapped in Bio-hazard bags were used to transport
Kenya, 2RTI International Berkeley, Research Triangle Park, United samples from the FCs. Data collection was via paper CRFs and entry
States, 3Impact Research and Development Organization, Kisumu, Kenya using Microsoft Access.
Results: A total of 643 were screened, 250 participants were
enrolled in the study and a retention of 208 (83%) participants was
Background: Adolescent girls and young women (AGYW) in sub- attained. There were 6 temperature excursions at the island site
Saharan Africa (SSA) are more than twice as likely to acquire HIV as caused by gas running out thus compromising the viability of the vac-
their male peers. Oral pre-exposure prophylaxis (PrEP) is effective in cines. Standard of care health facilities were far from the FCs, causing
reducing the risk of HIV in this population. However, its benefit is lim- 19 (57%) of volunteers not attend referred care. Participants pre-
ited by low uptake and use due to, in large part, lack of support by ferred coming for their visits during out of office hours, leading to late
male partners. We explored with male partners factors contributing to sample collection and delays in result delivery. Increased turnaround
inadequate support for PrEP use. time for some tests performed at the central laboratory, delaying data
Methods: We conducted in-depth interviews (IDIs) with male partners entry and further management of participants. Bad weather interfered
of AGYW who participated in a pilot study to address multi-level effects with sample and vaccine shipment. Maritime travel challenges, unsafe
of gender-based violence on PrEP uptake and adherence among AGYW and poor hygienic conditions in these communities were predominant.
in Siaya County, Kenya. The study designed and piloted an intervention Conclusions: Conducting of clinical trials in FCs poses logistical chal-
comprised of eight support clubs where different PrEP topics were dis- lenges. However, it is possible to mitigate the challenges by use of a
cussed with AGYW, couples’ education events that brought together safe boat, staff being flexible to work in shifts and camp at the site,
AGYW and their male partners for guided discussion on PrEP, and com- use of gas or solar fridges with a pharmacist to monitor temperatures
munity-based male sensitization about PrEP. The IDIs explored knowl- at all times and stock taking to avoid stock depletion. Electronic Data
edge of and support for AGYW’s PrEP use. Data were transcribed and Capture systems like REDCap should be used for data entry.
coded structurally by question using Dedoose software.
206
PU16.06 PU16.09
Delivering PrEP to HIV serodiscordant couples at public Whole-school approaches to promoting adolescent health
health facilities in Kampala, Uganda: early implementation and well-being: lessons from a multilevel HIV-prevention
challenges and solutions intervention through DREAMS in rural KwaZulu-Natal,
D. Thomas1; K. Ortblad1; S. Namanda2; J. Kibuuka2; M. Nakitende2; South Africa
T. Muwonge2; C. Scoville1; D. Izizinga2; F. Nambi2; L. Nakabugo2;
N. Chimbindi1; N. Mthiyane2; I. Birdthistle3; T. Zuma2; L. Sherr4;
A. Mujugira2 and R. Heffron1
1
N. McGrath5; S. Mdluli2; G. Harling4; S. Floyd3; J. Seeley3 and
University of Washington, Global Health, Seattle, United States, M. Shahmanesh4
2
Infectious Disease Institute, Uganda 1
Africa Health Research Institute, Research, Durban, South Africa,
2
Africa Health Research Institute, Durban, South Africa, 3London
Background: In Uganda, there are >50,000 incident HIV cases School of Hygiene and Tropical Medicine, London, United Kingdom,
4
annually and pre-exposure prophylaxis (PrEP) for HIV prevention has University College London, United Kingdom, 5University of
limited availability in public facilities. The Partners PrEP Program Southampton, Southampton, United Kingdom
(PPP) is a stepped-wedge cluster randomized trial that launched
PrEP delivery to HIV-negative members of HIV serodiscordant cou-
Background: South African adolescents are disproportionately bur-
ples by integrating services into antiretroviral therapy (ART) clinics
dened by sexual health-related morbidity, notably teenage pregnancy,
across 12 public health facilities in Kampala, Uganda. This evaluation
HIV and other sexually transmitted infections. The WHO Health
assesses facilitators and barriers of PrEP delivery soon after imple-
Promoting Schools (HPS) framework, an eco-holistic model, uses a
mentation.
whole-school approach to create a positive health environment through:
Methods: Central program staff conducted monthly technical assis-
in-curriculum health education; changes to school ethos and physical
tance (TA) visits to PPP facilities. During these visits, program staff
environment; and family/community involvement to support health pro-
collaborated with health facility staff (e.g., physicians, nurses, HIV
motion. To inform whole-school intervention development, we examined
counsellors) to identify and address PrEP implementation challenges,
the implementation of the school-based component of the DREAMS
which they recorded using standardized reports featuring open and
partnership, a multi-level HIV-prevention intervention in rural KwaZulu-
close-ended questions. We used TA report data collected from Jan-
Natal, South Africa.
uary – December 2019 in 8 PPP facilities and the Consolidated
Methods: In 2017 to 2018 we conducted participatory community-
Framework for Implementation Research (CFIR) to identify themes
mapping of four purposively sampled communities using in-depth
influencing PrEP implementation. Both deductive and inductive
interviews (n = 58), group discussions (n = 13) with adolescents and
approaches were used for codebook development and data analysis.
youth aged 10 to 35, interviews with intervention providers (n = 17)
Results: Among 39 reports from 8 facilities (~5 reports/facility), we
and life orientation teachers (n = 3) and participatory observations. All
identified the following implementation barriers related to CFIR con-
interviews were audio-recorded, transcribed, and analysed using the-
structs cosmopolitanism and executing: ineffective referral networks
matic content analysis.
for recruitment; limited laboratory capacity for sample processing;
Results: The context prior to intervention delivery was one of low
ineffective transport systems for blood samples and viral load results;
reported condom use, high levels of teenage pregnancy rates (major
absent or delayed creatinine results; viral load testing inconsistently
reason for school drop-out among girls), alcohol and drug use, violence,
completed and applied in partners PrEP counselling; limited facility
and transactional sex. However, schools were seen as safe spaces for
staff for troubleshooting PrEP delivery challenges. We identified the
health education, with teachers being perceived as trusted confidants
following implementation facilitators related to CFIR constructs net-
and sources of health information.Most adolescents participated in
works, knowledge and engaging: WhatsApp group to facilitate intra-
DREAMS school-based interventions (16 scripted participatory ses-
facility communication; PrEP champions among facility staff, flexible
sions aimed at changing gender norms; peer and educational support to
testing hours and assisted partner notification to promote client
remain in school) and found them beneficial. However, there were chal-
engagement; job aids to support staff performance; external referral
lenges setting up and delivering these interventions: implementing
networks to enhance couples recruitment; continuing education to
partners were unable to integrate DREAMS health interventions within
improve PrEP knowledge for facility staff.
the existing school curriculum or health programmes, or to provide
Conclusions: PrEP delivery within public health facilities is feasible in
biomedical services such condoms and contraception, due to school
Uganda. Early implementation challenges were primarily related to
management and education policies. Partners were limited to using
identifying new HIV serodiscordant couples and efficiency gaps in lab-
schools as recruitment and delivery venues. Insufficient educational
oratory, sample and results transport/communication systems. Chal-
subsidies and challenges with referrals between DREAMS partners and
lenges can be addressed with additional support, training, and
government departments for further care and other services hindered
improved collaboration within and across facilities. TA reports may
optimal intervention delivery. However, traditional/political leaders buy-
represent a pragmatic data source for improving program delivery and
in, partner home-visits and parental/guardian involvement facilitated
advancing implementation research.
intervention delivery and effectiveness.
Conclusions: As learning-positive spaces with trusted adults, schools
in rural South Africa provide a favourable setting to promote health
and well-being. However, failure to integrate interventions into the
school environment or create school-based/linked biomedical health
services alongside health promotion, limited their effectiveness in
practice.
207
PU16.10 PU16.11
Facilitators and barriers to access and benefiting from the ‘MTV Shuga’: Mass media communication in adolescent
DREAMS initiative among young women who sell sex aged girls and young women in South Africa: Can it increase
18 to 24 in Zimbabwe: A qualitative study awareness and demand for HIV and sexual health
F. Machingura1; G. Jamali1; M. Makamba1; T. Chiyaka1; P. Mushati1; technologies
S. Floyd2; I. Birdthistle3; B. Hensen4; J. Hargreaves4; F.M. Cowan5 and N. Chimbindi1; E. Loha2; T. Zuma2; J. Dreyer2; I. Birdthistle3; S. Floyd3;
J. Busza4 N. Kyegombe3; C. Cawood4; K. Baisley3; J. Seeley3 and
1
Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSH- M. Shahmanesh5
HAR Zimbabwe), Key Populations, Harare, Zimbabwe, 2London School 1
Africa Health Research Institute, Research, Durban, South Africa,
2
of Hygiene and Tropical Medicine, Department of Infectious Disease Africa Health Research Institute, Durban, South Africa, 3London
Epidemiology, London, United Kingdom, 3London School of Hygiene School of Hygiene and Tropical Medicine, London, United Kingdom,
4
and Tropical Medicine, Department of Population Health, London, Uni- Epicentre, South Africa, 5University College London, United Kingdom
ted Kingdom, 4London School of Hygiene and Tropical Medicine, Cen-
tre for Evaluation, London, United Kingdom, 5Liverpool School of
Tropical Medicine, Department of International Public Health, Liver- Background: Mass-media interventions can deliver health promotion
pool, United Kingdom to large numbers of people. We used the national free-to-air TV screen-
ing of MTV-Shuga (the “Down South” series), concurrent with the scale-
up of combination HIV prevention to test the hypothesis that mass-
Background: In Zimbabwe, the DREAMS initiative targeted its combi- media edu-dramas can improve the sexual health of AGYW at high risk
nation prevention package of clinical (including offering pre-exposure of HIV and early pregnancy in KwaZulu-Natal (KZN), South Africa.
prophylaxis (PrEP)) and social interventions to young women who sell Methods: Between August 2017 and July 2018 a stratified cluster-
sex (YWSS). In an impact evaluation of DREAMS, YWSS reported based sampling approach was used to conduct a survey on 18,296
accessing clinical interventions, but few accessed social interventions. AGYW (aged 12 to 24 years) in three high HIV prevalence (>10%) dis-
Using qualitative data collected during a process evaluation nested tricts in KZN. We measured the relationship between exposure to
within the DREAMS impact evaluation, we explored facilitators and MTV-Shuga and condom use at last sex; uptake of HIV-testing and con-
barriers to accessing and benefitting from DREAMS interventions. traception; and awareness of HIV Pre-Exposure Prophylaxis (PrEP). We
Methods: Between 2017 and 2019, we conducted in-depth inter- used a composite score based on 15 questions to assess knowledge of
views with 43 YWSS in the two districts where the DREAMS initiative MTV-Shuga series content, with the median being used as a cut-off to
was being implemented to understand experiences of (not) accessing define level of exposure among those watched the series: None (not
and benefitting from DREAMS. Respondents were purposively watched any MTV-Shuga); Medium (watching MTV-Shuga and being
selected for diversity in age and levels of participation in DREAMS, able to correctly respond to <5 questions); and High (watching MTV-
with 16 YWSS interviewed 2 to 3 times over the study period. Shuga and being able to correctly respond to ≥ 5 questions).
Results: Uptake of DREAMS was motivated by opportunities to Results: 4127 (22.6%) eligible participants were surveyed. 295 (17%)
improve life circumstances and escape poverty or catch-up on missed and 276 (19%) reported medium and high exposure to MTV-Shuga
education (n = 37). Access to health services assured longevity while respectively. Any exposure to MTV-Shuga was associated with older
secondary school and vocational skills training were perceived as a age, education and ever having had sex. After adjustment, exposure to
way out of poverty. Friendships formed through participation in MTV-Shuga watching was associated with greater awareness of PrEP
DREAMS supported YWSS to remain engaged in interventions, helped and lower self-reported HIV testing. There was no association with
improve their self-esteem, and reduced feelings of hopelessness. “My contraception or condom use. (see Figure 1).
friend . . .went to . . . University. . . I‘m now encouraged and will also Conclusions: Less than half of AGYW had exposure to MTV-Shuga.
go to. . . University.” YWSS experienced stigma from non-YWSS peers Whilst those who did had greater awareness of newer sexual health
and intervention providers, and violence from clients and family mem- technologies, there was no relationship with uptake of sexual health
bers, undermining their continuation including of PrEP use (n = 4). and HIV prevention services. Mass-media interventions are important
“When my brother found the pills [PrEP] . . ., he beat me up. . . . I. . . sources of sexual health information but not sufficient to improve
decided to stop taking [PrEP].” Difficulties in affording material (trans- uptake of services in this group.
port, food) or time requirements for participation (beyond subsidised
school fees) and living in disempowering circumstances (n = 30) con-
strained engagement. “They only pay for our school fees, . . . we don’t
go to school . . . don’t have the bus fare.”
Conclusions: DREAMS provided opportunities sought and appreci-
ated by YWSS, however, ‘free’ DREAMS services were not entirely
free of either economic or social costs, and provision of new opportu-
nities does not seem to eradicate existing stigma. In the future, initia-
tives like DREAMS should support facilitators of YWSS’ participation
and reduce the barriers such as material costs they confront, to max-
imise its impact.
208
attribute-levels to understand user preferences for daily and on-

PU16.13 demand oral PrEP use among young people in two South African
Identifying critical attributes and attribute-levels for a cities.
discrete choice experiment on oral pre-exposure Methods: Qualitative data were collected between September-
prophylaxis (PrEP) delivery among young people in Cape November 2018 through 8 group discussions and 20 in-depth inter-
Town and Johannesburg, South Africa views with young people aged 13 to 24 years in Cape Town and
J. Dietrich1; M. Atujuna2; G. Tshabalala3; S. Hornschuh3; M. Mulaudzi3; Johannesburg. Participants were selected based on gender and age
M. Koh4; N. Ahmed2; R. Muhumuza5; A. Ssemata5; K. Otwombe3; L.- stratified convenience sampling. Using a semi-structured interview
G. Bekker2; J. Seeley5; N. Martinson3; F. Terris-Prestholt6 and J. Fox7 guide, interviewers discussed several PrEP attributes (dosing regimen,
1
Perinatal HIV Research Unit, Faculty of Health Sciences, University location, costs, side effects, and protection period), access and use.
of the Witwatersrand, School of Clinical Medicine, Johannesburg, Using a framework analysis approach, transcripts were coded to iden-
South Africa, 2Desmond Tutu HIV Foundation, University of Cape tify context-specific attributes and attribute-levels for delivering oral
Town, Cape Town, South Africa, 3Perinatal HIV Research Unit, Faculty PrEP in South Africa. The adolescent community advisory board,
of Health Sciences, University of the Witwatersrand, Johannesburg, expert and study team opinions were consulted for the final DCE
South Africa, 4Harvard College, Cambridge, MA, Boston, United attributes and levels.
States, 5Medical Research Council/Uganda Virus Research Institute Results: We enrolled 74 participants: 51% (n = 38/74) male, median
and London School of Hygiene & Tropical Medicine Uganda Research age of 18.5 [IQR = 16 to 21.25] years, 91% (n = 67/74) identified as
Unit, Uganda, 6Department of Global Health and Development, Lon- heterosexual and 49% (n = 36/74) had not completed grade 12.
don School of Hygiene and Tropical Medicine, London, United King- Through qualitative data, eight initial candidate attributes with levels
dom, 7King’s College London, London, United Kingdom were identified: (1) Frequency of administration, (2) side effects, (3)
cost, (4) location of PrEP dissemination, (5) person responsible for dis-
pensing, (6) duration of PrEP use, (7) pill intake, and (8) alternative
Background: Globally, pre-exposure prophylaxis (PrEP) shows efficacy routes of administration. Through expert consultations four attributes
in preventing HIV amongst men and women and was approved for and levels remained for the final DCE choice sets: dosing regimen:
use in South Africa in 2016. There is however a lack of awareness and daily, and on-demand PrEP; location: private pharmacy, public clinic,
uptake of PrEP among young South Africans. Discrete choice experi- mobile clinic; cost: free-of-charge, R50 (~2GBP), R200 (~9GBP); and
ments (DCEs) can direct researchers to user needs, and inform how side effects: nausea, headache, rash.
to best implement a health intervention. A Discrete Choice Experi- Conclusions: There is limited methodological literature describing the
ment (DCE) technique was used to identify critical attributes and step-by-step process of developing a DCE for PrEP in adolescents,
209
especially in resource-constrained countries. We provide the process median number of years in PrEP delivery was 2 (IQR: 1 to 3). We also
followed for the DCE technique to understand user preferences for interviewed 16 pharmacy providers: 15 pharmaceutical technologists
daily and on-demand oral PrEP among young people in South Africa. and 1 pharmacist; the median number of years in pharmacy care was
7 (IQR: 4 to 10). Both groups of providers were enthusiastic about a
PU16.14 public-private partnership for pharmacy-based PrEP delivery. Antici-
pated benefits included reduced workload, decongested HIV clinics,
Building public-private partnerships for pharmacy-based
and improved quality of care, while anticipated challenges included
PrEP delivery in Kenya: willingness to collaborate among reaching PrEP providers for consultation and patient confidentiality,
PrEP and pharmacy providers Table 1. Participant recommendations included adequate provider
N. Wairimu1; S. Roche2; K. Ortblad2; P. Mogere3; K. Kamolloh4; training, an online platform for referrals and follow-up, and a toll-free
J. Odoyo4; Z. Kwena4; E. Bukusi4; J. Baeten2 and K. Ngure5 number or WhatsApp group for inter-provider communication.
1
Partners in Health and Research Development, Qualitative Depart- Conclusions: Kenyan PrEP and pharmacy providers are ready and
ment, Nairobi, Kenya, 2University of Washington, Seattle, United willing to work together in a public-private collaboration to support
States, 3Partners in Health and Research Development, Nairobi, pharmacy-based PrEP delivery. Pilot studies are needed to test the
Kenya, 4Kenya Medical Research Institute, Nairobi, Kenya, 5Jomo feasibility and acceptability of this novel PrEP delivery model. Public-
Kenyatta University of Agriculture and Technology, Kenya private collaborations might also facilitate the delivery of other health
interventions, such as testing for sexually transmitted infections, in
pharmacy settings.
Background: The introduction of pharmacy-based PrEP delivery in
Kenya might ease the burden of PrEP delivery for public health facili-
ties and maximize PrEP access for those at HIV risk. We sought to PU16.15
understand PrEP and pharmacy providers’ willingness to engage in a Multilevel barriers to PrEP uptake and adherence among
public-private collaboration for this novel model of PrEP delivery. Black and Hispanic/Latinx transgender women in Southern
Methods: Between October 2019 and March 2020, we conducted California
10 semi-structured in-depth interviews (IDIs) with PrEP providers and A. Ogunbajo1; E. Storholm2; A. Ober2; L. Bogart2; C. Reback3;
16 IDIs with pharmacy providers in Kisumu and Thika, Kenya. Eligible R. Flynn4; P. Lyman4 and S. Morris5
participants were ≥ 18 years and either provided care at a public 1
Harvard T.H. Chan School of Public Health, Epidemiology, Boston,
health facility delivering PrEP or at a private pharmacy registered by United States, 2Rand Corporation, United States, 3Friends Research
Kenya’s Pharmacy and Poisons Board. Data were analyzed themati- Institute, United States, 4LA LGBT Center, United States, 5University
cally using a combination of inductive and deductive approaches. of California San Diego, United States
Results: We interviewed 10 PrEP providers: 2 doctors, 3 clinical offi-
cers, 2 nurses, 2 HIV testing providers, and 1 linkage officer; the
210
Background: Black and Hispanic/Latinx transgender women (TW) in Results: The DHS analysis demonstrated that HIV prevalence among
the United States (U.S.) are disproportionately affected by HIV. Pre- AGYW ages 15–24 can predict HIV incidence with an estimated rela-
exposure prophylaxis (PrEP) reduces risk of HIV infection but uptake tive error not exceeding 20%, and this prediction can be improved to
remains low among Black and Hispanic/Latinx TW. a relative error lower than 9% if HIV prevalence among girls ages
Methods: Between July 2018 and August 2019, we conducted indi- 10–14 is also included in the equation. The Goals-ASM analysis
vidual interviews with 30 Black and Hispanic/Latinx TW who were demonstrated that for every HIV infection directly averted among
prescribed PrEP through a PrEP demonstration project and 10 health- AGYW provided with PrEP for one year, there were an average of 0.4
care providers who provide PrEP services to TW in Los Angeles and infections indirectly averted (95% CI 0.1, 0.7) in the rest of the popu-
San Diego, California. The interviews assessed general attitudes, expe- lation over five years.
riences, and beliefs about PrEP as well as individual-, interpersonal-, Conclusions: These two findings formed the basis of a tool predicting
community-, and structural- level barriers to uptake and adherence. impact and cost-effectiveness of PrEP among AGYW using only HIV
We utilized qualitative content analysis to identify themes from the prevalence, PrEP adherence and continuation rates, PrEP and ART
interviews. costs, and discount rates as inputs.
Results: Findings indicated the presence of individual-level barriers
including cost concerns, mental health issues, substance use, and con-
cerns about PrEP side effects including hormone interaction. Interper-
sonal-level barriers included the influence of intimate/romantic Microbiome & STI: Impact on prevention
partners and the impact of patient-provider communication. Commu-
nity-level barriers consisted of experiencing stigma and negative com-
munity opinions about PrEP use as well as having negative
experiences in healthcare settings. Structural-level barriers included PU19.01
unreliable transportation as well as employment and housing insecu- The impact of vaginal Lactobacillus isolates on host gene
rity. expression involved in inflammation in the female genital
Conclusions: Interventions aiming to increase PrEP uptake and
tract
adherence among Black and Hispanic/Latinx TW in the U.S. should
A. Abrahams1; M.T. Manhanzva2; A. Alisoltani3; R. Froissart4;
employ a multilevel approach to addressing the needs of TW, espe-
H. Gamieldien2; H.B. Jaspan5; S.Z. Jaumdally2; S.L. Barnabas6;
cially the structural barriers that have greatly limited the use of PrEP.
S. Dabee5; J.-A.S. Passmore2 and L. Masson7
1
Institute of Infectious Disease and Molecular Medicine (IDM),
University of Cape Town, Integrative Biomedical Sciences, Cape Town,
South Africa, 2Institute of Infectious Disease and Molecular Medicine
Mathematical modelling: Impact and (IDM), University of Cape Town, Pathology, Cape Town, South Africa,
effectiveness 3
Division of Biomedical Sciences, University of California, Riverside
School of Medicine, Riverside School of Medicine, United States,
4
UMR 5290 MIVEGEC, French National Centre for Scientific
Research (CNRS), University of Montpellier, UMR 5290 MIVEGEC,
PU18.01 French National Centre for Scientific Research (CNRS), France, 5Seat-
Simple tool for geographic prioritization of PrEP for tle Children’s Research Institute, University of Washington, Seattle
adolescent girls and young women based on cost- Children’s Research Institute, Seattle, United States, 6Institute of
effectiveness Infectious Disease and Molecular Medicine (IDM), University of Cape
M. Hamilton1; G. Mahiane1; C. Pretorius1 and K. Kripke2 Town, Department of Clinical Laboratory Sciences, Cape Town, South
1 Africa, 7Disease Elimination Program, Life Sciences Discipline, Burnet
Avenir Health, Takoma Park, United States, 2Avenir Health, Modeling,
Institute, Australia
Planning and Policy Analysis, Takoma Park, United States
Background: An increased abundance of non-optimal, diverse faculta-

Background: Based on cost-effectiveness modeling, the WHO has
tive or strict anaerobic vaginal bacteria is associated with increased
advised that oral PrEP be given to populations at “substantial risk,”
inflammation in the female genital tract (FGT) and resultant heightened
defined as populations with at least 3% incidence. Adolescent girls
HIV-1 acquisition risk. An optimal vaginal microbiome dominated by Lac-
and young women (AGYW) in generalized epidemics are known to be
tobacillus species is associated with reduced inflammation in the FGT
at elevated risk compared with the rest of the population, and control
and dampened immune responses to non-optimal bacteria in vitro. Using
groups of HIV prevention clinical trials among women in these set-
a transcriptomics approach, this research aimed to investigate the
tings have mostly had incidence above 3%. However, surveys powered
immunomodulatory mechanisms of vaginal Lactobacillus species.
to the national or provincial level have failed to identify populations of
Methods: Lactobacillus species were isolated from cervicovaginal fluid
AGYW with incidence above 3%. Behavioral risk scores have not been
samples obtained from young South African women, including two of each
found to be generalizable outside of the settings in which they are
L. mucosae, L. jensenii, L. crispatus and L. vaginalis. The immunomodula-
developed. This suggests that there are highly localized pockets of
tory effects of these lactobacilli on vaginal epithelial (VK2) cells stimulated
high incidence among AGYW that are not captured in surveys. We set
by Gardnerella vaginalis (ATCC 14,018) were tested in vitro. Thereafter,
out to develop a simple tool that uses readily available data to identify
RNA was extracted from VK2 cells for gene expression analysis on the
these hotspots based on cost-effectiveness of PrEP provided to
microarray Affymetrix Clariom S HumanHT platform.
AGYW.
Results: A total of 116 genes were significantly upregulated (FDR
Methods: We analyzed HIV prevalence data from 22 countries where
adjusted p-value ≤ 0.05; log fold change ≥ 1.5) in G. vaginalis-stimu-
Demographic and Health Surveys with had available HIV data, to cre-
lated compared to unstimulated VK2 cells, including genes mapped to
ate a statistical model that predicts HIV incidence from HIV preva-
inflammatory KEGG signaling pathways, cytokine-cytokine receptor
lence. In a separate analysis, we used the Goals Age-Specific Model
interaction, TNF, NFjB, NOD-like receptor, toll-like receptor and
(Goals ASM) calibrated for nine sub-Saharan African countries to esti-
MAPK signaling. Genes commonly upregulated in these pathways
mate the ratio of HIV infections directly averted among AGYW using
included inflammatory cytokines and chemokines: CCL5, CXCL10,
PrEP to HIV infections indirectly averted in the rest of the population.
211
CXCL8, IL1B (adj. p < 0.0001) and IL6 (adj. p = 0.0008). Interestingly, GP in CVM between vaccination groups (Gr1/Gr2 = 23.24/32.64,
27 genes were significantly downregulated (FDR adjusted p- p = 0.556) or between HIV serostatus (HIV-infected/HIV-uninfected;
value ≤ 0.05; log fold change ≤ -1.5) following incubation with G. vagi- Gr1 = 21.91/25.00, p = 0.264; Gr2 = 18.95/45.85, p = 0.743). A cor-
nalis, with several mapping to the longevity pathway. Pre-incubation relation between binding antibody responses in plasma and mucosal
with lactobacilli prior to co-culture with G. vaginalis resulted in several binding antibodies in Gr1 CVM was calculated as 0.3768.
genes involved in inflammation being commonly downregulated in Conclusions: IgG binding antibodies were observed in a substantial
VK2 cells co-cultured with lactobacilli and G. vaginalis in combination percentage of participants who received either Ad26.ZEBOV, MVA-
compared to co-culture with G. vaginalis alone, including TNFSF18 BN-Filo or MVA-BN-Filo, Ad26.ZEBOV in CVM, to lesser extend in
(adj. p = 0.0036), DDX58 (adj. p = 0.0426), IL-7R (adj. p = 0.0007), rectal secretions and saliva. The responses were no longer observed
IFIT2, IFIT3 (adj. p = 0.0005) and CXCL11 (adj. p = 0.0038), while at 6 months post second dose. Specific binding IgA in CVM was
CYP1A1 was upregulated (adj. p = 0.0426). Importantly, host cell gene detected in only few participants at 3 weeks post vaccination. Further
expression differed between Lactobacillus strains, suggesting that investigation of vaccine-induced antibody responses and durability in
immunomodulation occurs via strain-dependent mechanisms and path- mucosal compartments could provide more information regarding the
ways. composition of the Ebola vaccine regimen-elicited immune responses.
Conclusions: This study has identified genes that may be involved in
the immunomodulatory effects of vaginal lactobacilli and provides PU20.02
insight into the inflammatory mechanisms of G. vaginalis, which could
Asymptomatic bacterial STI in young men who have sex
potentially be targeted to improve prevention strategies for HIV-1
and poor reproductive outcomes in women.
with men minimally alters rectal mucosal immune cell
ecosystem
C.G. Ackerley1; S.A. Smith1; P.K. Amancha1; P.M. Murray1; I.R. Pollack1;
R.R. Amara2 and C.F. Kelley1
Mucosal immunity 1
The Hope Clinic of the Emory Vaccine Center, Division of Infectious
Disease, Emory University School of Medicine, Decatur, United States,
2
Yerkes National Primate Research Center, Emory Vaccine Center,
Emory University, Atlanta, United States
PU20.01
Vaccination with Ad26.ZEBOV, MVA-BN-Filo or MVA-BN- Background: Young men who have sex with men (YMSM) are dispro-
Filo, Ad26.ZEBOV induced predominantly IgG binding to portionately affected by sexually transmitted infections (STI) and HIV.
Ebola glycoprotein in cervico-vaginal mucus in HIV-infected Bacterial STI, including asymptomatic gonorrhea, chlamydia, and syphi-
and uninfected participants lis, have been associated with increased risk of HIV acquisition likely
S. Akapirat1; J. Puangkaew1; B. Mwesigwa2; N. Ntinginya3; J. Kosgei4; mediated by increased inflammation. However, the influence of asymp-
S. Rittiroongrad1; H. Kibuuka2; J. Mwakisisile3; F. Sawe4; L.A. Eller5; tomatic STI on the rectal mucosal (RM) immune environment and how
G. Shukarev6; M.V. Alst6; C. Robinson6; V. Bockstal6 and L. Ward7 asymptomatic bacterial STIs could alter mucosal HIV susceptibility are
1
AFRIMS, Retrovirology, Bangkok, Thailand, 2Makerere University Wal- still unclear.
ter Reed Project, Kampala, Uganda, 3Mbeya Medical Research Center, Methods: Innate and adaptive immune cell subsets were assessed in
Tanzania, United Republic of, 4Kenya Medical Research Institute Wal- RM tissue from 24 YMSM (aged 18 to 24 years) with asymptomatic
ter Reed Project, Nairobi, Kenya, 5Military HIV Research Program, rectal STI (gonorrhea, chlamydia, and/or syphilis) and 48 YMSM with-
United States, 6Janssen Vaccines and Prevention, Leiden, Netherlands, out rectal STI by multicolor flow cytometry and subsets were com-
7 pared between the groups with Mann-Whitney U test. To model RM
Joint Project Manager for Chemical, Biological, Radiological, and
Nuclear (CBRN) Medical, United States susceptibility to HIV, rectal explants were challenged ex vivo with HIV-
1 BaL and p24 production was quantified in the supernatant longitudi-
nally from Days 3 through 18 post-infection.
Background: Ebola virus causes severe hemorrhagic fever in humans. Results: Comparing innate immune cell subsets in RM between
The virus can be transmitted by contact with genital, oral or rectal YMSM with and without asymptomatic rectal STI, there were no
secretions of infected patients. Ebola virus is found predominantly in detectable differences in the median proportion of mucosal invariant
Sub-Saharan Africa where HIV co-infection may impact the efficacy of T (MAIT) cells, gd T cells, macrophages, neutrophils, CD1c+ myeloid
vaccines against Ebola. Here, we evaluate mucosal binding antibodies dendritic cells, or plasmacytoid dendritic cells. In addition, we noted
in either HIV-infected or -uninfected RV456/EBL2003 study partici- no differences in the median proportion of adaptive immune cell types
pants who received Ad26.ZEBOV or placebo on Day 1, followed by between the groups including B cells, memory CD4+, CD8+, or regu-
MVA-BN-Filo or placebo on Day 29 (Group (Gr)1), or who received latory T cells (Treg), or in expression of HIV co-receptor (CCR5) or
MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or pla- proliferation markers (Ki67, CD69) on CD4+ T cells. There also were
cebo on Day 15 (Gr2). no differences in pro-inflammatory cytokine production from CD4+ T
Methods: IgG and IgA to EBOV Zaire Glycoprotein (GP) were quanti- cells (IL-17A, IFNg, or TNFa) or CD8+ T cells (IFNg or TNFa) follow-
fied in cervicovaginal mucus (CVM; Gr1/Gr2; N = 48/14), seminal ing PMA/Ionamycin stimulation. Finally, production of p24 in rectal
plasma (N = 15/4), rectal secretions (N = 17/4) and saliva (N = 172/ explant challenge experiments did not differ between YMSM with and
41) at 0, 3 and 24 weeks post second dose by ELISA. without asymptomatic STI.
Results: IgG and IgA binding to EBOV Zaire GP were undetected at Conclusions: While limited to the cell subsets examined here, we did
baseline in all tested specimens. In both groups, IgG binding antibod- not find any appreciable differences in rectal mucosal immune cell
ies were detected in CVM (40%; 25/62), rectal secretions (24%; 5/ composition between YMSM with and without asymptomatic rectal
21) and saliva (1%; 3/213) at 3 weeks post second dose but declined STI. It has been theorized that asymptomatic bacterial STI enhances
to the baseline level at 24 weeks post second dose. IgA binding anti- mucosal susceptibility to HIV infection through promotion of inflam-
bodies were detected in a minority of CVM samples (6%; 4/62). No mation; however, our data do not support marked differences in cellu-
IgG and IgA binding antibody responses were detected in tested semi- lar responses. Additional detailed analyses of the mucosal microbiome
nal plasma. Exploratory post-hoc statistics showed no significant differ- and transcriptome could reveal other inflammatory mechanisms of
ences in geometric mean titers (GMT) of IgG binding to EBOV Zaire enhanced susceptibility.
212
Novel vaccine and other prevention PU21.02

Comparison of HIV incidence in simulated vaccine efficacy
approaches trials and observational cohorts using propensity scores in
key populations in Uganda
A. Abaasa1; Y. Mayanja2; G. Asiki3; M. Price4; P.E. Fast4; P. Kaleebu2
and J. Todd5
PU21.01 1
MRC/UVRI and LSHTM Uganda Research Unit, Statistics, Entebbe,
Willingness of adolescent girls and young women in Uganda, 2MRC/UVRI and LSHTM Uganda Research Unit, Entebbe,
Kampala, Uganda to participate in future efficacy trials of Uganda, 3African Population and Health Research Center, Nairobi,
novel biomedical HIV prevention interventions: the anti- Kenya, 4IAVI, New York, United States, 5London School of Hygiene
retroviral implant and Tropical Medicine, London, United Kingdom
Y. Mayanja1; O. Kamacooko2; W. Senyonga3; V. Muturi-Kioi4;
K.V. Chinyenze5; J. Seeley6; P. Kaleebu7 and M. Price8
1 Background: The design of HIV prevention clinical trials in the con-
MRC/UVRI & LSHTM Uganda Research Unit, HIV Interventions,
text of effective preventive methods is a challenge. Alternate designs,
Entebbe, Uganda, 2MRC/UVRI & LSHTM Uganda Research Unit,
including using non-randomised ‘observational control arms’ have been
Statistics, Entebbe, Uganda, 3MRC/UVRI & LSHTM Uganda Research
proposed. We used HIV simulated vaccine efficacy trials (SiVETs) to
Unit, Clinical Diagnostic & Laboratory Services, Entebbe, Uganda,
4 show pitfalls that may arise from using such observational controls.
IAVI, Medical Affairs, Nairobi, Kenya, 5IAVI, Nairobi, Kenya, 6MRC/
Methods: Two SiVETs were nested within observational cohorts, Jul
UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda, 7MRC/UVRI
2012 – Apr 2014 in fisherfolk (FF), and Aug 2014 – Apr 2017 in
& LSHTM Uganda Research Unit, Basic Science, Entebbe, Uganda,
8 female sex workers (FSW) in Uganda. A licensed Hepatitis B vaccine
IAVI, New York, United States
mimicked a possible HIV vaccine schedule. Both SiVET and non-SiVET
participants were followed-up for 12 months to assess incidence rate
Background: Several novel biomedical HIV prevention interventions ratio (IRR) for HIV. We estimated the effect of trial participation on
will soon be available. Adolescent girls and young women (AGYW) HIV incidence, and used propensity score matching to adjust for dif-
remain at substantial risk of HIV infection and are potential volunteers ferences between SiVET and non-SiVET cohort participant characteris-
for future efficacy trials of novel interventions. We evaluated willing- tics.
ness to participate (WTP) in future trials of biomedical interventions Results: SiVET enrolled 572 participants [282 FF & 290 FSW] and
among AGYW at high-risk of HIV infection in Kampala, Uganda. non-SiVET 953 [283 FF & 670 FSW]. The SiVET cohort had more
Methods: A prospective cohort study recruited HIV-negative AGYW men, age > 25 years, better formal education, and had lived longer in
(14 to 24 years) who received education on 5 biomedical HIV preven- the community (>1 year). Before propensity score matching, HIV inci-
tion interventions that are available (oral pre-exposure prophylaxis dence was much higher in the non-SiVET cohort compared to SiVET:
[PrEP]), likely to be available soon (long acting injectable PrEP and in FF, 8.3/100 person years-at-risk [95% CI 5.6 to 12.4] compared to
anti-retroviral [ARV] vaginal ring), and still hypothetical (ARV implant 3.8 [2.0 to 7.1] giving an incidence rate ratio (IRR) = 0.46 [0.20 to
and HIV vaccine). Information included mode and frequency of deliv- 0.99], p = 0.017. In FSW; the HIV incidence was 4.1 [2.5 to 6.7] in
ery, potential side effects, demonstration of methods, and whether non-SiVET and 3.2 [1.5 to 6.6] in the SiVET giving IRR = 0.78 [0.27 to
interventions are available or hypothetical. We added hypothetical 2.02], p = 0.299. After propensity score matching, non-SiVET and
information of efficacy trials that would evaluate different interven- SiVET participant characteristics were balanced and the IRR was 0.61
tions and included attributes such as randomization, frequent study [0.24 to 1.46], p = 0.121 in the FF, and 0.73 [0.20 to 2.53], p = 0.290
visits and blood draws. We collected baseline socio-demographic and in FSW.
behavioural data. Determinants of WTP in an ARV implant trial were Conclusions: The imbalance in participant characteristics should be
analyzed using logistic regression. taken into account in any comparison using non-randomised cohorts.
Results: Between Jan-Oct 2019, 459 AGYW were invited and 285 With propensity score matching, the trial environment was associated
eligible volunteers enrolled. Mean age was 20y (SD2.2y), 92.6% with 30%-40% reduction in HIV incidence in both FSW and FF popu-
reported paid sex, 31.2% were high-risk alcohol drinkers, 55.4% used lations, which could be due to trial HIV-risk reduction measures. Pro-
contraceptives (commonly injectable and implants). STI prevalence vided data on risk factors are available, propensity scores matching
was:19% chlamydia, 10% gonorrhea (geneXpert) and 2.8% active sero- can allow estimation of trial impact using a non-randomised observa-
logical syphilis (RPR/TPPA).None of the volunteers had heard about tional control arm comparison.
the ARV implant before study screening; 47 were using the contra-
ceptive implant. WTP for the ARV Implant was 46% and the most PU21.03
common reason for WTP was long-term protection (74%). Those who Co-display of hyperstabilized HIV-1 envelope glycoprotein
declined feared painful insertion (48%); five said they already had an
trimers on two-component protein nanoparticles
implant (contraceptive) and would be unwilling to have another
M. Brinkkemper1; P. Brouwer2; K. Sliepen2; R. Ravichandran3; W. Lee4;
inserted. WTP for other methods was HIV vaccine (91%), injectable
G. Ozorowski4; A. Ward4; N. King3 and R. Sanders2
PrEP (70%), ARV vaginal ring (18%). Determinants of WTP for the 1
ARV implant were: using a contraceptive implant (aOR=3.66, 95% CI: Amsterdam UMC, Department of Medical Microbiology, Amsterdam,
1.63 to 8.23), chlamydia diagnosis (aOR=2.63, 95% CI: 1.27 to 5.46), Netherlands, 2Amsterdam UMC, Amsterdam, Netherlands, 3University
frequent travel in the past 3 months (aOR=2.16, 95% CI: 1.21 to of Washington, Seattle, United States, 4The Scripps Research Institute,
3.84). United States
Conclusions: Nearly half of AGYW expressed WTP for an ARV
implant trial. Experience with contraceptive methods with a similar
Background: Most experimental HIV-1 vaccine efforts are aimed at
mode of delivery may increase WTP, frequent travelers may opt for
eliciting broadly neutralizing antibodies (bNAbs) that are capable of
an ARV implant trial.
neutralizing most circulating HIV-1 strains. All bNAbs neutralize the
virus by binding to the envelope glycoprotein (Env) trimer on the viral
membrane. Native-like Env trimers, such as SOSIP trimers, are capable
213
of inducing neutralizing antibodies (NAbs), but neutralization is usually amino-terminal eight residues of the HIV-1-fusion peptide (FP8) -
limited to the sequence-matched virus only. when conjugated to the carrier protein, recombinant tetanus toxoid
Methods: Increasing SOSIP trimer stability, nanoparticle presentation heavy chain fragment (rTTHC) - to be capable of inducing broadly
and vaccines with multiple antigens are approaches that have been neutralizing responses against HIV-1 in animal models. Here we evalu-
successfully applied to improve NAb breadth and potency. Here, we ate the effect of crosslinker of conjugates on the elicitation of FP-
effectively combined these strategies by generating hyperstable SOSIP directed HIV-1 neutralizing responses.
trimers from different env sequences and used a novel nanoparticle Methods: Here we immunized C57BL/6 mice with conjugates of FP
platform to present this cocktail on one nanoparticle to more effec- linked to rTTHC via different crosslinkers followed by boost with
tively engage cross-reactive B cells. We generated hyperstable SOSIP BG505 DS-SOSIP.664 trimer. Serum samples were collected two
designs based on five different clade B env sequences. Our approach weeks after each immunization; anti-FP and anti-trimer immune
utilizes the I53-50 two-component protein nanoparticle platform. The responses were measured after the FP conjugates and Env trimer
intracellular assembly of nanoparticles, e.g. ferritin particles, does not immunization. The neutralization responses against the BG505 D611
allow for the selection of only high quality trimers to be presented on glycan were measured after final trimer immunization.
the particle, which results in a mix of well folded and misfolded Envs. Results: Seven crosslinkers were selected for the FP8v1-rTTHC con-
The two-component nanoparticle system allows for Env purification jugates based on the feature of spacer lengths, flexibility and
prior to particle assembly, which allows for quality control of Env tri- hydrophobicity (Table 1). All peptide conjugates made by variant link-
mers and ensures that only well folded Env trimers are used in ers demonstrate similar antigenicity against FP-specific antibodies,
assembly. VRC34.01, VRC34.05, PGT151 and ACS202 with an apparent affinity
Results: We were able to produce nanoparticles that present the five of tighter than 1 pM. After 3 immunization of FP8v1-rTTHC conju-
clade B SOSIPs that were generated. We immunized rabbits three gates, the mice immunized with crosslinker with spacer great than 5
times with our nanoparticles and the equivalent soluble SOSIP pro- angstroms demonstrate stronger immune responses against fusion
teins. After the first boost binding titers were up by one log in the peptide than those of shorter linker group; While the groups of conju-
rabbits that received the nanoparticles compared to the rabbits that gates using hydrophobic crosslinkers shows significant higher immune
were immunized with the soluble proteins. At this time point, there responses to BG505 DS-SOSIP than the hydrophilic crosslinker.
was no measurable neutralization, but this can be expected for tier-2 Finally, the mice immunized with conjugates coupled by crosslinker
viruses. We currently have all the material from the completed rabbit with 9.4 to 10.6 angstrom spacer length elicited higher neutralizing
study in house, and will continue our analysis as soon as the corona responses and lower trimer base response.
crisis allows us. Conclusions: In summary, based on neutralization and B cell recogni-
Conclusions: Broadening of the immune response is one of the main tion, we found multiple crosslinkers could be used in the FP immuno-
challenges in HIV-1 vaccines. This approach will provide us with new gen prime and trimer boost strategy, with hydrophobic crosslinkers of
insights on how to tackle this problem. 10 angstrom spacer length yielding better results.
PU21.05 PU21.06
Assessment of crosslinker suitability for fusion peptide DNA vs ChAd-vectored vaccines as priming vaccines in
conjugates as priming immunogens for an HIV-1 vaccine heterologous prime-boost regimens to increase HTI
L. Ou1; K. Gulla2; A. Changela2; G.-Y. Chuang2; C. Cheng2; C. Angela2; immunogenicity in mice
O. Sijy2; H. Duang2; E.K. Sarfo1; B. Zhang1; P.P. VRC1; N.A. Doria- A. Olvera; L. Romero-Martın; B. Oriol-Tordera; B. Mothe and
Rose1; W.-P. Kong1; J.R. Mascola1 and P.D. Kwong1 C. Brander
1
NIAID, NIH, Vaccine Research Center, Bethesda, United States, IrsiCaixa - AIDS Research Institute, Host Genetics and Cellular Immu-
2
NIAID, NIH, Bethesda, United States nity, Badalona, Spain
Background: The vaccine elicitation of broadly neutralizing antibodies Background: The HIVACAT T cell immunogen (HTI) was designed
against HIV-1 is a long-sought goal. We previously reported the based on T cell responses to HIV in individuals with controlled/non-
214
controlled HIV infection. The use of heterologous vaccine vectors in glycosylated wild-type BG505. Neutralization breadth in 13 of these
prime-boost strategies has proved to be highly effective in increasing groups included viruses with the second and third most prevalent FP
the levels of vaccine-induced T cells responses. Here, we evaluated sequences. Characterization of twenty-one FP-directed antibodies
the immunogenicity of different prime-boost vaccine regimens using revealed several new classes of FP-directed antibodies capable of
DNA plasmid (D) or Chimpanzee Adenovirus (C) vaccine primes cross-clade neutralization. Structural analysis of three of these
boosted with a Modified Vaccinia Ankara (M) vaccine expressing the revealed diverse conformations of FP, and in one case, a binding
HTI immunogen. Magnitude, breadth and longevity of the HTI induced pocket capable of accommodating diverse FPs.
responses were tested in two different mouse strains. Conclusions: Multiple classes of FP-directed neutralizing antibodies
Methods: Eight groups of 10 C57BL/6 or 12 BALBc mice were used can be elicited in C57BL/6 mice, validating this model for elicitation of
to compare different vaccine regimens including: i) DDD (3 D vaccina- cross-clade-neutralizing FP-directed antibodies. Overall, priming with
tions), ii) DDDM (3 D prime - M boost), iii) C (C vaccination) and iv) Env trimer versus FP-carrier did not impact neutralization breadth in
CM (C prime - M boost). Animals were euthanized three weeks after the murine model whereas factors contributing to breadth and
the last immunization. To measure immune response duration, 4 addi- potency included regimen length, FP length and carrier variation in
tional groups of C57BL/6 mice were vaccinated with each regime and priming immunogens and FP sequence variation in boosting immuno-
euthanized 13 weeks after last vaccination. T cell responses were gens.
measured in spleen cells by INFc-ELISpot, upon stimulation with a set
of 147 overlapping peptides covering the HTI sequence in 17 peptide PU21.09LB
pools.
YkuJ protein as a platform for the presentation of HIV-1
Results: CM vaccination regimen yielded higher magnitude of HTI-
responses compared to DDDM in both mouse strains. The breadth of
MPER
the response in C57BL/6 mice was not statistically different among A. Rudometov1; N. Rudometova1; D. Shcherbakov1; A. Ilyichev1;
vaccination regimes. Greater breadth of responses was observed in A. Bakulina2 and L. Karpenko1
BALBc mice after DDD vaccination. In CM vaccinated C57BL/6 ani-
1
State Research Center of Virology and Biotechnology “Vector”, Kolt-
mals, the magnitude of the response was mainly focused on a pool of sovo, Russian Federation, 2Novosibirsk State University, Novosibirsk,
Pol-derived peptides, but this immunodominance effect was not Russian Federation
observed in BALBc mouse. In C57BL/6 mice, the CM regimen showed
greater longevity since responses maintained significantly higher mag-
Background: One of the fundamental challenges in the development
nitudes 13 weeks after last immunization. Breadth was maintained in
of a vaccine against HIV infection is the design of immunogens and
all vaccination regimens over time, except for the DDD group which
the development of an immunization schedule aimed at the induction
showed a marked reduction in the number of responses at the 13
of bnAbs.
weeks time point.
The aim of this study was to evaluate the properties of the YkuJ pro-
Conclusions: The CM vaccination regimen is a simpler and more
effective vaccination strategy that has the potential to induce broad, tein for the presentation of modified MPER fragments of HIV-1.
In this study, four immunogens were designed to present modified
strong and long-lasting T cell responses to the HTI immunogen com-
MPER sequences with YkuJ protein as a scaffold. We used the data
pared to DDDM.
we obtained earlier using phage display to make substitutions in the
MPER in order to provide the immune system with a possible variety
PU21.08 of epitopes for this region.
Distinct classes of HIV-1 cross-clade neutralizing antibodies Methods: The constructed immunogens were produced in the bac-
targeting fusion peptide elicited in mice by diverse terial system and purified using metal chelate chromatography. Anti-
immunization regimens genicity analysis was performed using dot blot analysis and bnAbs
M. Sastry1; A. Changela1; J. Gorman1; S. O’Dell2; K. Xu1; G.- 10E8, 2F5 and 4E10 obtained from the NIH AIDS Reagent Pro-
Y. Chuang3; H. Geng1; L. Ou1; K. McKee2; A. Nazzari1; C.-H. Shen3; gram. Immunogenicity was tested in a rabbit model. The experi-
G.B. Stewart-Jones1; J. Stuckey1; R. Verardi1 and Y. Wang1 ments were approved at a meeting of the Bioethical Commission of
1
Vaccine Research Center, NIAID, NIH, Structural Biology Section, the FBSI SSC VB “Vector”. Rabbits were primed with MPER-TBI
Bethesda, United States, 2Vaccine Research Center, NIAID, NIH, polypeptide and then boosted with the mixture of YkuJ-based
Bethesda, United States, 3Vaccine Research Center, NIAID, NIH, immunogenes. Immunogenicity was assessed using ELISA. The neu-
Structural Bioinformatics Section, Bethesda, United States tralizing activity of immune sera was determined using env-pseudo-
viruses HIV-1.
Results: As a result, it was shown that all recombinant proteins syn-
Background: The vaccine elicitation of broadly neutralizing antibodies thesized in prokaryotic cells are specifically recognized by bnAbs
against HIV-1 continues to be a challenge. Herein, we report ongoing 10E8, 4E10, and 2F5. Immunization of laboratory animals with a mix-
efforts to investigate the murine model for elicitation of HIV-1 cross- ture of the proteins showed that specific antibodies to the obtained
clade neutralizing antibodies directed against fusion peptide (FP) and immunogens (titer 1: 1000000), including the MPER region (titer 1:
to improve the breadth and potency of FP-directed immune 100000), which show neutralizing activity to the env-pseudovirus
responses. SF162 (IC50 14, 45 lg/mL).
Methods: Seventeen groups of six C57BL/6 mice were immunized in Conclusions: Thus, the engineered chimeric proteins can serve as a
two-week intervals using unique prime-boost regimens. Immunizations basis for the development of immunogens that focus the humoral
incorporated the three most prevalent FP sequences conjugated to immune response to the HIV-1 MPER region. In addition, the scaffold
carriers and HIV-1 envelope (Env) trimers from multiple clades and protein can be used as a platform for the presentation of other HIV-1
with diverse FP sequences. Serum samples were collected throughout antigens, for example, the fusion peptide.
the immunizations and assessed for neutralization. Top neutralizers The study was supported by the grant of the President of the Russian
from each group were selected for hybridoma generation and mono- Federation MK-583.2020.4.
clonal antibody isolation.
Results: Sera from at least two animals in each of the 17 groups
could neutralize BG505 Env-pseudoviruses lacking an N611 glycan,
and in 13 of these groups, neutralization extended to the fully
215
Results: The IM route was more efficient than the SC route to induce
PU21.10LB specific IgG (AUC p =0.041 for MPLA-IM and p =0.015 for SQ-IM)
Innate cell markers that predict anti-HIV neutralizing and autologous nAb (AUC p =0.06). Nevertheless, no significant differ-
antibody titers in vaccinated macaques ence was observed between adjuvants when the IM route was used.
M. Van Tilbeurgh1; P. Maisonnasse1; J.-L. Palgen1; M. Tolazzi2; Unique vaccine signatures were identified and characterized based on
N. Dereuddre-Bosquet1; A.-S. Beignon1; E. Marcos-Lopez1; A.- their HLA-DR, CD39, CD86, CD11b, CD45, CD64, CD14, CD32,
S. Gallouet1; G. Ozorowski3; A.B. Ward3; I. Bontjer4; Y. Aldon5; CD11c, CD1c, FceRI, and CADM1 surface expression. Various combi-
P. McKay5; R. Shattock5; G. Scarlatti2; R.W. Sanders4 and R. Le Grand1 nations of these markers characterized cell families positively associ-
1
Paris-Saclay, Inserm, CEA, Center for Immunology of Viral,
Universite ated with nAb production, whereas CADM1-expressing cells were
Auto-immune, Hematological and Bacterial diseases (IMVA-HB/ negatively associated (p < 0.05).
IDMIT), Fontenay-aux-roses & Le Kremlin-Bice ^tre, France, 2Ospedale Conclusions: We unveiled the association between specific cell signa-
3
San Raffaele, Milan, Italy, Department of Integrative Structural and tures occurring early after immunization and nAb titers. Our results
Computational Biology, The Scripps Research Institute, La Jolla, United demonstrate that monitoring immune signatures during the early vac-
States, 4Academisch Medisch Centrum, Amsterdam, Netherlands, cine development pipeline could assist in predicting outstanding vac-
5
Imperial College London, Department of Medicine, London, United cine candidates, and in optimizing vaccine strategies.
Kingdom
Background: Considering the time and resources invested, innovative Policy and advocacy
early risk prediction methods must be implemented in pre-clinical tri-
als, to decrease late-stage failure of vaccine development especially
for HIV. The objective of this project is to assess the capacity of new
methods to predict the neutralizing antibody responses (nAb) induced PU23.03
by different vaccination regimes. These methods explore both early Being a part of the conversation: capacitating youth to
innate and adaptive responses.
participate in HIV prevention conversations using a digital
Methods: Eighteen cynomolgus macaques were immunized three
times (week 0, 8 and 24) with 20 μg of recombinant HIV Env glyco-
citizen engagement platform in South Africa
protein trimer (SOSIP ConM). Three groups of macaques (n=6) D. Pillay1; K. Plourde2; G. Morales2; E. Briedenhann3; N. Vundamina3;
received either intramuscular injection (IM) of the SOSIP ConM adju- B.-A. Smith4 and S. Mullick3
1
vanted with monophosphoryl lipid A (MPLA) or squalene emulsion Wits RHI, Wits RHI, Johannesburg, South Africa, 2FHI 360, Durham,
(SQ), or subcutaneous injection (SC) of the SOSIP ConM adjuvanted United States, 3Wits RHI, Johannesburg, South Africa, 4UNICEF, South
with MPLA. Innate immune responses were analyzed before and Africa
24 hours after each immunization using a 34-marker mass-cytometry
panel and a SPADE clustering approach to identify innate cell popula-
Background: Oral PrEP has been available to AGYW in South Africa
tions. Linear discriminant analysis of innate cell populations that dis-
from May 2018 and provision is continually being scaled-up. Truly
played similar kinetics, called kinetic families, was done using a three
impactful prevention approaches must be informed by meaningful
steps clustering, to identify cell signatures elicited by immunization. To
youth engagement. Hence, the OPTIONS Consortium, collaborating
identify markers involved in signature differences, Kolmogorov-Smir-
with UNICEF’s U-Report program, developed and implemented a digi-
nov distance was then applied. A generalized linear model was per-
tal citizen engagement approach involving AGYW in HIV prevention
formed on kinetic family abundances and nAb titers with the objective
conversations including those to accelerate access and use of PrEP..
to predict autologous neutralizing responses.
U-Report is a social messaging and data collection tool to improve
Abstract PU21.10LB-Figure 1.
216
citizen engagement. U-Report sends polls and alerts to users, collect- response to HIV, Viral Hepatitis, and other STIs. It also enabled the
ing and publishing real-time responses. expansion of comprehensive access and care for KPs, paving the way
Methods: Information on AGYW’s HIV prevention priorities including for approaches in relation to stigma, discrimination, and its vulnerabili-
oral PrEP information needs, acceptability, policy and program gaps/ ties.
opportunities was collected using three social media polls running for Conclusions: Key Populations’ Strategic Agenda has supported the
2 weeks each from 31 July to 02 September 2019. After polling, a MoH to engage key partners in creating sustainable and long-term
workshop was held with a group of 19 young people to build capacity efforts aimed at the promotion of access and comprehensive care
to use, interpret, disseminate, and advocate for using information to towards KPs. The Agenda has also increased KPs access in public
inform policy contributing to HIV prevention including expediting and health policies in order to promoting equitable access in health ser-
sustaining access to oral PrEP. The workshop included using data for vices.
advocacy, presenting data in an innovative and interactive manner,
including drama skits, role-plays, mock advertisements, and news PU23.05LB
broadcasts.
River State, Nigeria’s non-brothel-based sex wokers prefer
Results: Young people (aged 12 and above) (n = 6000 – 9500) from
all 9 provinces participated in polls including hard-to-reach youth (148
HIV self-testing out of concern for stigma, confidentiality
transgender youth and over half young men). Following polling, work- and rejection
shop participants (aged 21 to 28) used poll results to create personal J. Aseme
action plans, highlighting community goals they wish to achieve. Partic- Greater Women Initiative for Health and Right (GWIHR), Executive
ipants created advocacy plans based on the polls. Mock interviews Director, Port-Harcourt, Nigeria
were performed with participants presenting advocacy plans to work-
shop facilitators acting as a Health Minister. The interviews were then
critiqued by the group. Following the workshop, ambassadors engaged Background: The majority of brothel-based female sex workers
in activities such as awareness raising for 16-days of activism against (BBFSW) know their HIV status and are relatively easy to reach at
gender based violence and setting up of HIV prevention awareness their brothels, unlike their non-brothel-based female sex worker
groups in their community called Community Informed Agents (CIAs). (NBBFSW) counterparts. The latter have low HIV testing rates and do
Conclusions: Utilizing the U-Report platform with an advocacy work- not have an identified hotspot of operation and mostly transact on
shop to train youth, discuss polling results and advocacy plans, has social media and in night hangouts, homes, clubs, and through pimps.
shown to be a useful tool for truly engage young people in the fight A better understanding of the NBBFSW sub-key population and their
against HIV and subsequently for youth to be active agents on change work in diverse locations is central to scaling up HIV-testing services
in their communities. for this group.
Methods: A survey was conducted using a personal interview
approach to ensure a high response of sex workers from each sub-
PU23.04 population, and social media was used to mobilize NBBFSW, in the
Lessons learned from the strategic agenda for key context of COVID-19. Selection of participants was through conve-
populations: Experiences from Brazil nience sampling, whereby any sex worker on site who was willing to
D.A. Calixto1; G. da Silva2; C. Sousa2; A Kruger2; A. de Mello2; participate in the survey was selected. Through sequential personal
M. Colombo2; N. Correia2; C. Alo 2; L. Barreto2; F. Tavares2; T. Pithon2 interviews, a questionnaire was administered to 75 sex workers (50
and G. Pereira2 brothel-based and 25 non-brothel-based) in Rivers State in June
1
Ministry of Health of Brazil, Department of Diseases of Chronic Con- 2020.
ditions and Sexually Transmitted Infections, Brasılia, Brazil, 2Ministry Results: Far fewer number of NBBFSWs know their HIV status com-
of Health of Brazil, Brasılia, Brazil pared to BBFSWs (24% vs. 68%, respectively). While both groups had
similarly low initial levels of knowledge of self-testing (HIVST),
NBBFSW’s preference for HIVST far outweighs that of BBFSW (88%
Background: HIV epidemic in Brazil is concentrated in key popula- vs. 24%, respectively). The survey also showed that more NBBFSWs
tions (KPs) – men who have sex with men, transgender people, drug are concerned about confidentiality, stigmatization and rejection by
users, people deprived of liberty, and female sex workers. Despite the loved ones than the BBFSWs. Because the NBBFSWs involvement in
existence of laws and policies that address KPs specific needs, there is the sex work trade is mostly secretive, these women find it difficult to
evidence of widespread discriminatory attitudes and practices towards openly access HIV testing services and safe sex commodities such as
these populations, addended to stigma and discrimination, which condoms.
remain as thick barriers to accessing services and care related to HIV. Conclusions: Evidence from this survey indicates that there are
In 2018, the Ministry of Health of Brazil (MoH) designed an interven- growing numbers of NBBFSWs whose preference for HIVST outweigh
tion called “Strategic Agenda to Expand Comprehensive Access and those of the BBFSWs. To achieve an increase in the uptake of HIV
Care for Key Populations in HIV, Viral Hepatitis, and Other STIs” as testing services by the NBBFSWs, the introduction of the HIVST
part of a broader initiative known as “Zero Discrimination” launched would be a good point of entry. This is seen as a better way of reach-
by UNAIDS, contributing to the goal of “ending AIDS by 2030”. ing NBBFSW who welcomed the idea of conducting the test by them-
Methods: The MoH developed guidelines and worked along with selves unlike the majority of the BBFSWs who preferred testing with
other Ministries, UN organizations, and civil society in order to health care providers from the community-based organizations.
develop seven lines for strategic actions that are urgent to overcome
the current challenges related to KPs: 1) Health education, 2) Com-
prehensive care, 3) Health Communication, 4) Stigma and discrimina-
tion, 5) Social participation, 6) Management and governance, and 7)
Strategic Information. The MoH provides technical assistance to moni-
toring and sensitization to other partners, such as local AIDS Pro-
grams in Brazil.
Results: The Strategic Agenda for Key Population enabled the MoH
to establish strategic partnerships to implement a set of actions, which
we believe are urgent to overcome current challenges for a better
217
Town, Desmond Tutu HIV Centre, South Africa, 7Makerere Univer-

Preclinical studies for HIV prevention sity-Johns Hopkins University Research Collaboration, Kampala,
Uganda, 8Malawi College of Medicine-John Hopkins University
Research Project, Malawi, 9South African Medical Research Council,
South Africa
PU24.01
Birth microbiota in HIV-exposed-uninfected infants cause Background: Despite significant advances in biomedical HIV preven-
changes in innate and adaptive immune compartments in a tion technologies, little evidence exists regarding their adoption or dif-
murine model fusion of information about these technologies through social
D. Nyangahu1; I. Spacova2; J. Wendoh3; A. Kiravu3; C. Feng4 and networks. We used diffusion of innovation theory to understand if
H. Jaspan4 perceived HIV protection by the dapivirine vaginal ring (DVR), includ-
1 ing changes in knowledge about efficacy of the technology, were asso-
Seattle Children’s Research Institute, Center for Global Infectious
Disease Research, United States, 2University of Antwerp, Bioscience ciated with disclosure to participants’ social network.
Engineering, Belgium, 3University of Cape Town, South Africa, 4Seattle Methods: Women who participated in both the MTN-020/ASPIRE
Children’s Research Institute, United States phase III trial and the open-label extension MTN-025/HOPE trial of
the DVR were included. We examined differences in the number and
type of reported social disclosures between ASPIRE and HOPE, and
Background: Infants who are HIV-exposed but uninfected (iHEU) dis- estimated prevalence ratios or count ratios for associations between
play multiple immune alterations when compared to HIV-unexposed perceived protection in HOPE, and features of these social disclosures
counterparts (iHU). These infants also have altered gut microbiota. (relationship, sex, importance of their opinion and if they were in favor
Given the established importance of the intestinal gut microbiota in of the DVR). Generalized estimating equations with an exchangeable
programming immunity, we hypothesized that inheritance of an altered correlation matrix were used to account for multiple social disclosures
microbiota in iHEU underlies this poor immunity. Here, using a germ- per person.
free mouse model, we investigate possible causal relationship between Results: Of the 1428 participants who enrolled in both trials, almost
stool microbiota and immunity. all reported choosing to participate in HOPE following ASPIRE
Methods: Stool samples at birth from iHU or iHEU were transferred because the DVR was protective against HIV (N = 1431; 98%). Dur-
by oral gavage to germ-free pups at day 5 of life. Control pups was ing ASPIRE, women reported disclosing participation to a median of
gavaged only with PBS. At two weeks of age, pups were sacrificed to five people (Inter-quartile range (IQR) 3 to 10) compared to four in
analyze inherent splenic immunity. Serum cytokine concentrations HOPE (IQR 2 to 5). Other features of social disclosures were similar
were measured by Luminex. by trial. Nevertheless, perceived effectiveness of the DVR in HOPE
Results: At d14 of age, pups gavaged with iHEU stool (Pheu) had (N = 1095; 77% reported a lot of protection) was associated with
significantly lower frequencies and numbers of CD4+ T lymphocytes speaking to a greater number of people about the trial (Count ratio
compared to those gavaged with iHU stool (Phu). Pheu also dis- 0.14; 95% CI 0.09, 0.20), the importance of the person’s opinion of
played reduced numbers of central memory CD8+ T cells (CD8+ the DVR (Prevalence Ratio (PR) 1.12; 95% CI: 1.05, 1.20), and
CD44hiCD62Lhi) versus Phu. Furthermore, Pheu pups had significantly whether the person was also a participant in HOPE (PR 1.52; 95% CI
higher proportions and numbers of Ly6Chi (Ly6ChiCD11b+CD11clo) 1.20, 1.93).
and Ly6Clo monocytes (Ly6CloCD11b+CD11clo) relative to Phu pups. Conclusions: Demonstrated effectiveness of the DVR was a key con-
Analysis of cytokine levels in serum of gavaged pups showed pups sideration in continuing to participate in HOPE but was not related to
gavaged with iHEU stool to have significantly increased concentrations type of social disclosure between trials (sex, relationship etc.). Women
of IFN-gamma and MCP-1 compared to pups gavaged with HU stool. who perceived the DVR to be effective in HOPE were more likely to
Conclusions: Our data shows a direct role of the microbiota in shap- socialize with other trial participants and spread information by talking
ing immunity in iHEU. Furthermore the microbiota of iHEU caused to more people and with people whose opinions they valued about
increased inflammation and monocyte activation as seen in human the DVR.
infants born to mothers living with HIV. To our knowledge, this is the
first report that links the microbiota to immunity in iHEU.
PU25.02
Correlates of adherence to the dapivirine vaginal ring for
HIV-1 prevention
Product acceptability and adherence M. Husnik1; E. Brown2; S. Dadabhai3; Z. Gaffoor4; N. Jeenarain4;
F. Matovu Kiweewa5; E. Livant6; B. Gati Mirembe5; L. Mansoor7;
T. Palanee-Phillips8; D. Singh6; S. Siva4; L. Soto-Torres9; A. van der
Straten10 and J. Baeten11
PU25.01 1
University of Washington, Epidemiology, Seattle, United States, 2Fred
Social disclosures in relation to perceived HIV protection Hutchinson Cancer Research Center, Vaccine and Infectious Disease
provided by the dapivirine vaginal ring Division, Seattle, United States, 3Johns Hopkins Bloomberg School of
Public Health, Lilongwe, Malawi, 4South African Medical Research
M. Stoner1; E. Brown2; L.E. Mansoor3; T. Palanee-Phillips4; T. Tembo5;
Council, South Africa, 5MU-JHU Research Collaboration, Kampala,
G. Nair6; C. Akello7; L. Seyama8; N. Jeenarain9; L. Naidoo9 and A. van
Uganda, 6Magee-Womens Research Institute, Pittsburgh, United
der Straten1
1 States, 7Centre for the AIDS Programme of Research in South Africa
(CAPRISA), Durban, South Africa, 8University of the Witwatersrand,
gle Park, United States, 2Fred Hutchinson Cancer Research Center,
School of Clinical Medicine, Johannesburg, South Africa, 9National
Statistical Center for HIV/AIDS Research and Prevention, Seattle, Uni-
Institutes of Health, Bethesda, United States, 10RTI International,
ted States, 3Center for AIDS Programme of Research in South Africa,
Women’s Global Health Imperative, Research Triangle Park, United
Durban, South Africa, 4University of the Witwatersrand, Wits Repro-
States, 11University of Washington, Medicine, Epidemiology, Global
ductive Health and HIV Institute, Johannesburg, South Africa, 5Univer-
Health, Seattle, United States
sity of North Carolina Project Malawi, Malawi, 6University of Cape
218
Background: Understanding characteristics associated with adher- family planning methods, menstrual bleeding, vaginal practices and
ence to pre-exposure prophylaxis (PrEP) methods for HIV-1 preven- worries associated with ring use.
tion may assist with optimizing implementation efforts for these Results: As in Table 1, longer time on study, later calendar time, pri-
products. The dapivirine vaginal ring is a novel topical PrEP delivery mary partner knowledge that the participant was taking part in the
method. The aim of this study was to discover baseline and time- study, and use of long-acting contraceptive methods were positively
dependent correlates of adherence to ring use. associated with measures of ring adherence. Younger age, ring wor-
Methods: Using data from a randomized, double-blind, placebo-con- ries, condom use, episodes of menstrual bleeding and vaginal washing
trolled, phase III trial of the dapivirine vaginal ring in four African were negatively associated with measures of ring adherence.
countries, we constructed generalized estimating equation models Conclusions: These findings will be useful for recruitment into future
with exchangeable working correlation structure to evaluate correlates clinical studies, real-time adherence monitoring and dapivirine ring
of adherence. Two levels of quarterly dapivirine blood plasma implementation efforts. Evaluating multiple biomarkers of adherence
(>95 pg/mL and >200 pg/mL), and dapivirine released from returned provides a more thorough understanding of correlates of ring adher-
rings (≥0.9 mg and >4.0 mg) defined measures of adherence for ence and could strengthen the design of future adherence marker
recent and cumulative use, respectively. Baseline and time-varying studies.
covariates evaluated in multivariable models included demographics,
sexually transmitted infections, sexual risk, partner characteristics,
Abstract PU25.02-Table 1a.
219
Abstract PU25.02-Table 1b.
palpation or the thin material of the prototypes presented, as they

PU25.03 looked fragile and could kink/break during removal. Participants sup-
Health care providers’ preferences about an MPT implant: ported rods that can be retrieved separately for the contraceptive and
insights from South Africa and Zimbabwe on the HIV prevention indications, in cases of side effects or a desire to con-
Subcutaneous Contraceptive HIV Implant Engineered for ceive. A preloaded trocar system for single rod insertion was favoured
Long-acting Delivery (SCHIELD) Study because it reduces risk of infection and guides insertion depth. HCPs
W. Makoni1; M.K. Shapley-Quinn2; E. Mbatsane3; E. Luecke2; emphasized a need for training on insertion and removals, counselling
S. Nkomo4; K. Ahmed3; L. Johnson5; I. Mahaka4 and A. van der for clients, and adequate product stocks in facilities.
Straten6 Conclusions: An MPT biodegradable implant for prevention of HIV and
1
Pangaea Zimbabwe AIDS Trust, Community Health, Harare, Zim- unintended pregnancy was highly desirable among HCPs. Furthermore,
babwe, 2Women’s Global Health Imperative, RTI International, they emphasized optimizing attributes that ease clinic and HCP burden.
Research Triangle Park, United States, 3Setshaba Research Centre, Product developers should consider a trocar design that simplifies inser-
South Africa, 4Pangaea Zimbabwe AIDS Trust, Harare, Zimbabwe, tion and minimizes risk of infection. Additional operational issues to con-
5
RTI International, Research Triangle Park, United States, 6Centre for sider include adequate training of HCPs to boost their confidence with
AIDS Prevention Studies, United States roll-out of new technologies and health delivery system capacity.
Background: Given the high rates of both HIV and unintended preg- Testing: Technology, coverage, viral load,
nancies in sub-Saharan Africa, the SCHIELD study aims to develop a point of care, CD4 count
Multipurpose Prevention Technology (MPT) for HIV and pregnancy
prevention. Our goal was to provide rapid feedback on implant and
trocar attributes to the product development team from key stake-
holders to improve future adoption and roll-out.
Methods: Mixed methods were employed to determine acceptability
PU26.01
Quality and turnaround times of PMTCT viral load
and preferences among health care providers (HCPs) in Soshanguve,
South Africa and Harare, Zimbabwe. Seventeen in-depth interviews
monitoring under Option B+ in six South African districts
(IDIs) were conducted with purposively sampled participants profes- with high antenatal HIV burden
sionally experienced with contraceptive implants. Topics covered N.K. Ngandu1; T. Mbira2; D. Nsibande2; T. Ramraj2; G. Sherman3 and
implant appearance, duration (6 months – 3 years), size, number of A. Goga2
1
rods inserted at once (1 to 3 rods), flexibility, retrievability, biodegrad- South African Medical Research Council, Health Systems Research
ability and trocar applicator. Pictures and prototype implants were Unit, South Africa, 2South African Medical Research Council, South
handled. Frequencies were run on quantitative data and code reports Africa, 3National Institute of Communicable Diseases, South Africa
from IDI transcripts were analyzed to summarize emerging themes.
Results: Fourteen HCPs favoured a biodegradable implant to lower the
burden associated with implant removals. While preference about the Background: We measured quality of viral load care and turnaround
implant duration varied, most (n = 14) preferred an implant with 1 to 2 times (TAT) for returning viral load results to prevention of mother-
rods lasting <2 years rather than 3 rods lasting 3 years for ease of to-child transmission of HIV (PMTCT) clients in 120 primary health-
insertion. Participants disliked attributes that would complicate remov- care facilities, to understand barriers to monitoring maternal viral load
ability of an implant: e.g. a short rod (~10 mm) as it could complicate and achieving 90% viral suppression.
220
Transmission of HIV
PU28.01
Findings from an HIV risk behavior assessment among
penal and probation population in Ukraine
S. Leontieva1; N. Roman1; T. Gaborets1; K. Gamazina1; S. Vasyliev2;
O. Ianchuk3 and I. Khaniukov4
1
PATH, Ukraine Country Program, Kyiv, Ukraine, 2Ministry of Justice
of Ukraine, Center of Health Care, Kyiv, Ukraine, 3Ministry of Justice
of Ukraine, Center of Probation, Kyiv, Ukraine, 4Ministry of Justice of
Ukraine, Global Fund and Serving Life Projects Implementation Group,
Kyiv, Ukraine
Background: Ukraine’s HIV, tuberculosis, and viral hepatitis (HCV)
rates are among the highest in Europe. HIV prevalence in prisons is
7.6%. The PATH-led, USAID-funded Serving Life project aims to
increase HIV diagnosis and strengthen linkage to integrated HIV, TB,
and viral hepatitis treatment services for detainees, prisoners, and
individuals on probation across 12 PEFAR-supported regions. To
detect risk behaviors for HIV, TB, and HCV and enable early diagnosis
and treatment among these populations, PATH developed a unique,
integrated verbal screening tool that identifies behavioral HIV, TB and
HCV risks and introduced the screening procedure within the Min-
istry of Justice. Health and social service providers now implement
this tool routinely in all penal settings and 24 probation settings.
Methods: With support from the US President’s Emergency Plan for
AIDS Relief, PATH assessed HIV risk behavior using verbal screening
questionnaires implemented in different penal and probation settings.
Serving Life analyzed 598 randomly selected questionnaires (63.9%
Abstract PU26.01-Figure 1. from prisons and 36.1% from probation settings) from the July to
September 2019 period.
Results: The most frequently reported HIV risk behavior was unpro-
tected sex (53% of screened people; 25% of them in the last
Methods: Data were obtained in 2018, from a cross-sectional pro-
3 months), by making tattoos (36%) and sharing needles (20% of
cess evaluation of the PMTCT Option B+ program in six South African
screened people; 30% of them in the last 3 months). Unprotected sex
districts with high antenatal HIV prevalence. Quality of viral load care
within the last 3 months was most often reported in probation cen-
received was measured as the proportion of postnatal clients with
ters (19%). Sharing needles within the last 3 months and having a
viral load results explained to them. Average TATs for viral load results
partner who injects drugs was most often reported in prisons (9.3%).
achieved by facilities were calculated using dates abstracted from 4 to
Conclusions: At ministerial, facility, and individual levels, Serving Life
5 randomly selected facility-based client records. Logistic regression
will focus HIV prevention and testing activities (e.g., HIV counseling,
was used to identify factors associated with each outcome. Logit-
motivational interviewing, informational materials, awareness cam-
based risk difference was used to evaluate whether average facility
paigns, condom usage, syringe exchange, opioid-substitution therapy,
TAT was associated with quality of care.
pre-exposure prophylaxis, etc.) for people who reported HIV risk
Results: Achieving short (≥80% records with TAT ≤ 7 days) overall
behaviors. The assessment findings highlight the necessity to suggest
TAT was uncommon: only 50% of facilities in one rural district, zero
HIV testing to those screened who reported their HIV behavior risks
facilities in one urban-metro and below 40% of facilities in the remain-
during screening. If a person in conflict with the law reports a risk
ing four districts (Figure 1(i)). The significant difference between dis-
within the latest 3 months, repeated HIV testing should be suggested
tricts was influenced by the duration of keeping results in facilities
to this patient in four-six weeks. Serving Life also expects index testing
after receipt from the laboratory and was longest in urban metros
to be more successful among those who reported HIV risk behaviors.
(Figure 1(ii)). Quality of viral load care received ranged between 66%
to 85%. Client-related factors significantly associated with low quality
of care, observed in two urban and one rural district, included pri- PU28.02
mary/lower education achieved, delayed initiation of antiretroviral Factors associated with knowledge of PEP and PrEP among
treatment and experiencing barriers to clinic visits. Experiencing clinic female sex workers in 12 Brazilian cities
visit barriers also showed a negative association with short TATs. A.F. Kolling1 and E. Merchan-Hamann2
Conclusions: We demonstrate average quality of care and delayed 1
Ministry of Health of Brazil, Department of Chronic Disease and Sex-
return of results to PMTCT clients. Future work is needed to under-
ually Infectious, Brasılia, Brazil, 2University of Brasılia, Public Health,
stand reasons for delayed TATs at the PMTCT client population level,
Brazil
in varying settings, and to test interventions for optimizing HIV care.
Background: The HIV epidemic in Brazil is considered to be concen-

trated in some population segments, including female sex workers
(FSW) who have an estimated prevalence rate of 5.3% (95% CI: 4.4%
–6.2%) higher than the general population (0.4%). This study aims to
221
identify the main factors associated with knowledge of PrEP and PEP
among FSW, providing evidence to support the adoption of interven- PU28.03
tions that facilitate FSW access to prevention HIV. Partner age-disparity, sexual risk, and geographic mobility
Methods: This is a cross-sectional epidemiological study, using sam- in rural Kenyan and Ugandan communities
pling based on the Respondent Driven Sampling (RDS) methodology. J. Okiring1; M. Getahun2; S.A. Gutin3; J. Lee2; I. Maeri4; P. Eyul5;
This data was collected from the study carried out in 2016, called E.A. Bukusi4; M.R. Kamya6; M. Gandhi7; C.R. Cohen2; T.B. Neilands8;
“Current Health Project II”, conducted between June and November S. Ssali9; E.D. Charlebois8 and C.S. Camlin2
2016. 1
Infectious Diseases Research Collaboration, Data and Statistics,
Bivariate analyses were performed and tests of corresponding Uganda, 2University of California San Francisco, Department of
hypotheses were applied (Chi-square and when necessary Fisher’s Obstetrics, Gynecology & Reproductive Sciences, United States,
test), the respective 95% confidence intervals, prevalence ratios and 3
University of California San Francisco, 3Department of Medicine,
respective p values were calculated. Subsequently, the Poisson regres- Center for AIDS Prevention Studies, United States, 4Kenya Medical
sion model was used. Research Institute, Nairobi, Kenya, 5Infectious Diseases Research Col-
Results: FSW who had more access to education and those who laboration, Uganda, 6Makerere University, School of Medicine, Kam-
worked in private places were respectively 50% and 25% more likely pala, Uganda, 7University of California San Francisco, Department of
to have knowledge about PEP. FSW not affiliated with NGOs, who Medicine, Division of HIV, Infectious Diseases, and Global Medicine,
have not received informational material on prevention and/or have United States, 8University of California San Francisco, Department of
participated in lectures in the last six months and who do not identify Medicine, Center for AIDS Prevention Studies, United States, 9Maker-
themselves as FSW in health services have less knowledge about PEP ere University, School of Women and Gender Studies, Kampala,
and PrEP. Uganda
Conclusions: We conclude that FSW still does not have enough
knowledge about PrEP and PEP for those who can benefit from these
technologies. Background: Partner age-disparity (a > 5-year difference in the ages
It is necessary to increase knowledge and use, foster partnerships of individuals in sexual relationships) is associated with higher HIV risk
with meaningless NGOs in new models of care, incorporating new among women in sub-Saharan Africa. We investigated sex-specific
strategies to effect combined prevention, which consider the specifici- associations of age-disparate relationships with risk behaviors, sexually
ties of this population. Such strategies should be recognized as individ- transmitted infections (STIs) - chlamydia and gonorrhea, and mobility
ual, social and programmatic vulnerabilities that directly impact access (work/non-work related geographic-movements) among adults in
to and use of HIV and other STI prevention methods. Kenya and Uganda.
Methods: We measured mobility, sexual behavior history, and STIs
(2015 to 2016) in a mobility study nested within an HIV ‘test-and-
treat’ trial (NCT#01,864,603). Participants with no partners/unknown
partner ages were excluded; data for 2179 adults were analyzed.
222
Logistic regression models examined associations between age dispar- government implemented a raft of mitigation measures including a
ity and sexual risk including STIs, serial (non-overlapping), concurrent countywide 1900 to 0500 hours curfew and closure of bars. These
(overlapping), and high-risk (casual and transactional sex) partnerships have significantly affected the normal operations of sex workers and
in the past 6-months, controlling for age, marital-status, occupation, led to low uptake of HIV/sexual and reproductive health (SRH) ser-
household wealth, region, and past 6-month mobility. vices and increased reported cases of gender-based violence.
Results: In the preceding 6-months, 72.7% reported a single partner- Methods: Bar Hostess Empowerment and Support (BHESP) is a key
ship and 27.3% reported multiple partnerships (37.9% men, 16.1% population organization, implementing USAID/PEPFAR-funded EpiC
women). Among those with one partnership (62.1% men, 83.9% project led by FHI 360. BHESP provides services to FSW at drop-in
women), a higher proportion of men (85.1%) than women (76.6%) centers, through outreaches and referral to selected government health
were in an age-disparate partnership (p < 0.001). Age-homogenous facilities. Following the COVID-19 pandemic, BHESP had to stop com-
and disparate relationships were similarly distributed among men and munity outreaches and reduced operating hours at the DIC. The pro-
women reporting multiple relationships. Women reported more serial gram adopted strategies including virtual meetings for HIV positive sex
partnerships (p = 0.052), and fewer concurrent partnerships workers to improve adherence to HIV and multidrug dispensing of
(p < 0.001) as compared to men. Overall, 46.3% reported only age- antiretroviral medications. Social media platforms are used to create
disparate partnership(s), 37.3% mixed age-disparate and homogeneous awareness on HIV/STI prevention as well as COVID 19 information. In
partnerships, and 16.4% only age-homogenous partnership(s). Women addition, home delivery of ART was made possible through peer naviga-
reported higher mobility (p < 0.001), and higher STI prevalence as tors. The program has successfully held all 11 scheduled meetings for
compared to men (p = 0.177). In multivariate analyses, men with both this period from March to Mid May 2020, thus reaching 115 HIV pre-
age-disparate and homogenous partnerships had greater odds of high- vention with positive interventions for FSW despite related constraints.
risk (aOR = 1.61, CI = 1.04 to 2.49, p = 0.031) and/or concurrent Results: Despite negative economic, social and health impact of
(aOR = 3.18, CI = 2.31 to 4.36, p < 0.001) partnerships than men in COVID-19, BHESP has been able to adjust and ensure continuity of
age-disparate partnerships. Women in age-disparate and homogenous services to FSW and especially those living with HIV. Though the pro-
partnerships had greater odds of an STI (aOR = 3.69, CI = 1.48 to gram initially experienced a 75% decrease in the number of FSW
9.18, p = 0.005) and concurrency (aOR = 2.58, CI = 1.32 to 5.05, accessing HIV/SRH services at the DIC, prioritization of HIV positive
p = 0.005) compared to those in only age-disparate partnerships. FSW has ensured that 40% due for refill within the period have at
Conclusions: A higher proportion of men reported multiple, concur- least 3 months’ ART dispensed and 35% of the total clients on ART
rent relationships while women reported more serial relationships. continue to receive adherence support. This has ensured that the
Age-disparate relationships were associated with a greater risk of STIs FSW still get to access health services as usual while at the same time
among women. Age-disparate relationships were also prevalent in staying safe from contracting COVID-19.
high-risk and concurrent partnerships of both men and women. Conclusions: To avoid reversing strides made to eliminate HIV pan-
Women reported more mobility as compared to men. Our findings demic, programs need to ensure that key populations’ specific needs
underscore the importance of interventions that target women in age- are met, especially during the COVID-19 pandemic. Quick adaptation
disparate and concurrent relationships. to adverse environments enriches the program by allowing it to con-
sider more flexible avenues for service provision.
Treatment as prevention
PU29.01
Programming for female sex workers during COVID-19
pandemic: experiences from Bar Hostess Empowerment
and Support Program, Nairobi Kenya
S. Mwangi1; J. Gacheru1; R. Mwendwa1; A. Olawo2; C. Agunga2 and
N. Njuguna2
1
Bar Hostess Empowerment and Support Program (BHESP), HIV Pro-
gram, Nairobi, Kenya, 2FHI 360, Health, Nairobi, Kenya
Background: Kenya’s first confirmed case of Coronavirus Disease

2019 (COVID-19) was on 12th March 2020 following which the
223
Abstract Supplement 4th HIV Research for Prevention conference (HIVR4P // Virtual)
Journal of the International AIDS Society 2021, 24 (Suppl S1)
AUTHOR INDEX
A PE12.01, PU25.01 Andrew, P. OA03.01

Akello, C.A. PE04.01 Angela, C. PU21.05
Abaasa, A. PU21.02 Akolo, C. PE26.01 Angulo, J. OA15.05LB
Abdool Karim, Q. OA02.02, PE20.04 Akolo, M. PE07.08 Anoma, C. PE16.16
Abdool Karim, S. OA08.01, PE02.12, Aktepe, T. OA01.02 Anthony, C. OA08.01, PU14.02
PE20.04, PU02.02 Alain, T. PE01.35 Anyan , J. PE05.10LB
Abel, B. OA14.03 Albri on, T. OA17.04 Anyona, M. PE16.33LB
Abimiku, A. PE19.07 Aldon, Y. PU21.10LB Anzala, O. PE11.12, PE20.08
Aboud, S. OA02.04 Aldous, A. PE20.06 Appenroth, M.N. PE05.12LB
Abrahams, A. PU19.01 Al-Harthi, L. PE07.14LB Araínga, M. OA01.01
Abrahams, A.G. PE19.02 Al Hussein Al Awamlh, O. PE16.41LB Arduino, R.C. PE24.03LB
Abrahams, M.-R. PE27.02, PU14.02 Alisoltani, A. PU19.01 Aribisala, K. PE16.34LB
Abudu, F. PE07.13LB Alisoltanidehkordi, A. PE19.02 Arif, M.S. PE07.05, PE28.09
Abuna, F. PE16.31 Aljedani, S. OA08.05LB Armstrong, E. OA19.01
Accola, M. PE07.13LB Allan, F. OA15.05LB Arnold, F. PE21.05LB
Achieng, M. PE06.03 Allen, J.D. OA15.03 Arnold, K.B. PE20.01
Achilles, S. OA06.01, PE16.32 Allen, M. OA02.05LB, OA18.01, Arrington-Sanders, R. PE01.37
Ackerley, C.G. OA05.04, PU20.02 PE11.11 Arrivillaga, M. PE01.60LB,
Ackerman, M. PE02.11 Allen, S. PU14.03 PU01.24LB
Ackerman, M.E. PE07.12LB Almond, N. PE20.03 Arsenio, J. OA20.04
A. Co rell, C. PE15.02 Aló, C. PU23.04 Arthos, J. PE21.01, PE28.06, PE28.08
Adams, A. PE01.56 Alsaidi, S. PE08.09LB Arts, E. OA12.04LB
Adams, C. OA18.04 Alst, M.V. PU20.01 Aryes, F. PE02.08
Adams, D. PE01.34 Altman, A. OA20.04 Aseme, J. PU23.05LB
Adams, M.L. PE25.01 Alvarado-Llano, B. PE01.60LB, Ash, M. PE07.14LB
Adeagbo, O. OA21.04, PU01.24LB Ashish, A. PE15.02
PE01.41, PE13.01 Alvarenga, A. PE01.37 Asiimwe Biira, F. PE01.15, PU01.09
Adeoye, B. OA08.04 Alvarez, N. PE28.05 Asiimwe Biira, F.A.B. PE01.20
Adesina, M. PE07.13LB Amancha, P.K. OA05.04, PU20.02 Asiki, G. PU21.02
Adeyemo, F. PE07.13LB Amara, R.R. OA05.04, PU20.02 Asio, D. PE01.40
Agaba, P. PE16.34LB Ambiyo, F. PE16.14, PE16.21 Asio, D.J. PE05.09, PE11.07
Aggarwal, D. PE01.61LB Ambrozak, D. PU02.03 Asokan, M. PE02.16LB
Agot, K. PE01.50, PE16.17, Amendola, A. PU07.03 Asowata, O.E. OA05.03
PU16.03 Amole, C.D. OA10.01 Asselin, J. OA16.01
Agrahari, V. PE06.05 Amsterdam PrEP Project team Astemborski, J. PE28.08
Aguilar-Gurrieri, C. PU15.03 in the HIV Transmission Aswani, L. PE16.21
Aguilar Jimenez, W. PE28.05 Elimina on Amsterdam Atujuna, M. OA02.05LB, OA07.04,
Agunga, C. PE26.01, PU29.01 Ini a ve, o.b.o.t. OA11.05LB OA11.02, PE01.49,
Agutu, C. PE26.02 Anand, S.P. PE07.12LB PE01.53, PE01.54,
Agwau Akello, C. OA13.01, PE01.15, Ananworanich, J. PE20.05, PE27.03 PE11.06, PE11.11, PU16.13
PE01.20, PE05.01, Andersen, L. PE01.01 Auchus, I. OA13.04
PU01.09, PU01.12 Andersen-Nissen, E. OA18.01, Ayebare, F. OA04.01
Ah Goo, Y. PE07.14LB OA18.02, OA18.03 Ayele, H. PE20.01
Ahmed, K. PE06.04, PE25.07, Anderson, F. OA05.03 Ayorinde, T. PE07.13LB
PE28.03, PU25.03 Anderson, J. PE11.05 Ayres, F. PE02.01, PE02.07,
Ahmed, N. OA11.02, PE01.54, Anderson, P. OA06.05, OA07.01, PE02.12, PE07.11LB
PU16.13 OA16.04, PE01.38, Ayudhya, R.K. OA16.04
Ahuja, C. PE01.61LB PE25.06 Azizi, H. OA12.04LB
Aid, M. OA05.02 Anderson, P.L. PE08.09LB, PE24.03LB Azoitei, M.L. PE02.14LB
Ajuwon, A. PE01.03 Anderson, S. PE08.01 Azubuike, C. PE08.08LB
Akapirat, S. OA22.02, PU20.01 Andrasik, M. OA02.05LB, OA13.05LB, Åhlberg, A. PE19.05
Ake, J. PE01.25, PE29.02 PE01.13, PE01.29, Ávila-Nieto, C. PU15.03
Akello, C. PE01.26, PE06.01, PE11.06, PE11.11
224
B Bateson, T. OA20.02 Billong, S. PE07.01
Ba ng, J. PE28.03 Bimber, B. OA20.03
Babigumira, J.B. PE26.02 Bauermeister, J. OA16.03, OA16.05, Bimela, J. PU14.04
Babirye O m, M. PU01.12 PE01.11, PE23.01, Binicy, B. PE19.05
Baczenas, J. PE07.10LB PE01.08, PU01.13 Birdthistle, I. PE01.33, PE01.45,
Badal-Faesen, S. OA04.05LB Baum, M.M. PE08.10LB, PE24.04LB PE01.51, PU01.15,
Baernighausen, T. PE16.15 Baumbla , J. OA03.01 PU01.21, PU16.09,
Baeten, J. OA07.01, OA11.04, Beaten, J. OA07.02 PU16.10, PU16.11
PE01.62LB, PE01.59, Beauchamp, G. PE01.30 Birse, K. PE20.01
PE04.01, PE04.02, PE05.04, Beaudoin-Bussières, G. PE07.12LB Björkman Nyqvist, M. PE01.57
PE14.02, PE16.06, Becker, M. PE07.06, PE28.09 Black, L. OA20.05, PE03.01, PU03.01
PE16.14, PE16.18, Beesham, I. PE06.08 Black, S.L. OA14.03
PE19.01, PU01.16, Begg, L. PE09.01 Blackburn, J.M. PE19.02
PU08.02, PU16.14, Béhanzin, L. PE07.01 Blanco, J. OA20.01, PE15.03
PU25.02 Beignon, A.-S. PU21.10LB Blanda, W. PE08.02
Baeten, J.M. PE01.31, PE06.02, Bekker, L.G. OA04.05LB Blandford, A. PE01.41
PE20.01, PE25.03 Bekker, L.-G. OA02.05LB, OA07.04, Blithe, D.L. OA06.01
Baggaley, R. OA10.01 OA07.05LB, OA11.02, Bloom, S. OA19.03, OA19.02
Bagherichimeh, S. OA22.05 OA18.01, OA21.05LB, Blum, C. PE01.43
Bahemana, E. PE01.25, PE29.02 PE01.31, PE01.38, Bock, P. HY01.02LB
Bahl, K. OA12.03 PE01.47, PE01.49, Bockstal, V. PU20.01
Bahram, S. OA01.03 PE01.53, PE01.59, Bock ng, W. PU01.13
Baisley, K. PU16.11 PE11.11, PE16.19, Bodi, C. PE06.10
Bakari, M. OA02.04 PE18.02, PE19.02, Bogart, L. PU16.15
Baker, D. PE07.10LB PE25.06, PU16.13 Boily, M.C. PE18.02
Baker, M. PE22.03 Bekker, V. OA03.05, OA08.01 Boily, M.-C. PE16.04, PE18.01
Baker, P. PE19.09LB Beksinska, M. PE06.04, PE01.58, Bonsignori, M. PE02.14LB
Baker, V. PE01.45 PE06.07, PE06.08, Bontjer, I. PU21.10LB
Bakshi, K. OA04.03, PE22.02 PE16.26, PE28.03 Bordeaux, M. PU01.22
Bakulina, A. PU21.09LB Bell, J PU01.11 Borgia, J. PE07.14LB
Balan, I. PE01.32 Bell, J. PE25.10, PU09.01, PU09.02 Bose, D.L. PE05.08
Balán, I. PE01.10, PE01.36, PU01.13 Bell, L. PE19.02 Bosire, R. PE15.05LB
Balán, I.C. PE01.19 Bello, G. PE11.03 Bosle , B. OA13.04
Balthazar, C. PE11.17 Beloumou, G. PU14.01 Bosque, A. OA14.04
Bam, B. OA13.01 Belovezhets, T. PU02.04LB Bossevot, L. PE21.02
Banda, C.K. PE05.03 Belyaeva, V. PU01.28LB Boswell, M.T. PE07.11LB
Bangsberg, D.R. PE06.02 Benadé, G. PE01.29 Botha, W. PE28.07
Banonya, H. PE01.18 Benhabbour, R. PE08.04 Bourne, A. PE01.22, PE16.01
Bansal, A. OA09.03 Benito, S. PE11.13 Bourrelly, M. PE16.16
Bansal, M. PE02.04 Benjamin, R. PE23.04 Bowring, A. PE07.01
Bantjes, J. PE01.01 Benne , K. PE06.02 Boyd, A. OA11.05LB, PE01.21,
Barabona, G. PU11.02 Bennici, A. PE02.09 PE01.27, PE11.04,
Barker, T. PE16.21 Berdasco, M. OA14.05LB PE16.40LB
Barnabas, R. PE16.06 Bere, T. PE01.54 Boyd, P. PE08.02, PE08.03,
Barnabas, S.L. PE19.02, PU19.01 Berger, A. OA12.04LB PE08.06, PE08.07,
Barnabee, G. PE16.19 Bergström, S. PE19.05 PE24.01, PU08.03
Barnable, P. PE08.09LB Berner Kudrick, L. PE16.07 Brache, V. OA06.03, PE25.01
Barne , R. PE19.06 Berry, N. PE20.03 Bradley, F. PE19.05
Barnighausen, T. PE01.41 Beyrer, C. PE16.04, PE16.36LB, Bramante, J. OA19.03
Barone, M.A. PE16.41LB PE16.39LB Brand, J. PE02.10
Barouch, D. PE02.13 Bezerra, D.R.B. OA13.03 Brand, R. OA16.03, OA16.04
Barreto, L. PU23.04 Bhatasara, T. PE06.10 Brand, R.M. PE08.09LB
Barskiy, K. PU01.19 Bha a, R. PE16.12, PE16.23 Brander, C. OA05.01, OA09.01,
Basalirwa, G. PU16.04 Bha acharya, J. PE02.04, PE15.02, OA14.05LB, OA20.01,
Basappa, M. PE15.06LB PU02.01 PU21.06
Basourakos, S.P. PE16.41LB Bhiman, J. PE02.12, PU02.03 Braun, K. PE07.10LB
Bass, E. OA17.02 Bhushan, N.L. OA10.04 Brenchley, J. PE19.09LB
Basten, M. PE11.04 Biasin, M. PE17.02, PU07.03 Bresenham, D. OA07.04
Bastos, E. OA13.03 Biberfeld, G. OA02.04 Briedenhann, E. PU23.03
225
Brinkkemper, M. PU21.03 Callebaut, C. OA19.05LB Chapman, R. OA18.04, OA15.01,
Broder, G. OA13.05LB Calvo, G. OA21.01 OA12.05
Brodsky, R. PE09.01 Camargo, P. PE01.60LB, PU01.24LB Chapon, C. PE21.02
Brody, C. PE04.05LB Camlin, C.S. PU28.03 Chariyalertsak, S. OA22.02
Broedlow, C. PE01.08 Campbell, E. PE07.14LB Charlebois, E.D. PU28.03
Brooks, K. PU14.03 Campbell, R. PU05.01 Charle , A. PE16.35LB
Brouwer, P. PE21.03 Cañada, J.E. PE11.13 Chatani, M. OA10.03, PE05.12LB,
Brown, B. PE19.07 Capozzi, E. PE20.06, PE20.07 PE23.05
Brown, E. PU25.01, PU25.02, PE22.01 Capparelli, E. OA03.02 Chavanduka, T. PE23.01
Brown, E.R. PE19.01, PE25.03 Caraco, Y. OA04.05LB Chavula, M.P. PE05.13LB
Brown, G. PU01.08 Carapito, R. OA01.03 Chawla, H. PE14.01
Brown, L. PE08.03 Carayon-Lefebvre Cheever, T. OA20.03
Brown, T. PE29.01 d'Hellencourt, F. PE06.04 Chege, G. OA18.04
Browne, E. OA06.04 Carballo-Diéguez, A. PE01.36, PU01.13 Chege, W. OA03.01, PE26.02
Browne, E.N. PE25.03 Cardinaud, S. PE07.03, PE07.09 Chen, B.A. OA06.01
Browne, F. PE07.15LB Carias, A. PE02.13, PE07.05 Chen, C.-W. OA09.01
Bruel, T. PE02.11 Carias, A.M. OA01.01, PE28.09 Chen, J.-L. OA18.05LB
Brumage, L. OA08.05LB Carillon, S. OA17.04 Chen, P.-L. PE06.04
Bruxelle, J.-F. PE21.04LB Carpino, T. OA10.05, PE11.09, Chen, T. OA20.02
Bryndza-Tfaily, E. OA04.04 PE11.14 Chen, X. OA08.02, OA15.04,
Brzezicka, K. OA15.05LB Carrico, A. PE01.08 PE02.10, PE21.05LB
Buchbinder, S. PE11.06, PE16.28 Carrillo, J. OA20.01, PE15.03 Chen, Y. PE07.12LB
Buck, G. PE06.04 Carter, A. OA16.01 Cheng, C. OA08.02, OA15.04,
Buehler, K. PU01.07 Carter, C. PE11.02 PE15.06LB, PE21.05LB,
Bui Thi Minh, H. PE16.23 Car er, A. PE16.35LB PE21.07LB, PU21.05
Bukrinsky, M. OA14.04 Cartwright, A. PE06.07 Cheng, X. PU11.01
Bukusi, D. OA21.02 Carvalheira, E. OA13.03 Chenwi, C. PU14.01
Bukusi, E. OA07.01, OA07.02, Casmir, E. PE16.21 Chernova, O. PE07.02
PE01.31, PE01.59, Casner, R. OA15.04 Cheung, C.S. OA15.04
PE05.04, PE16.06, Castellon, M. PE07.07 Chiavenna, C. PE16.35LB
PE16.18, PE16.19, Cas llo, M. PE11.17 Chikaev, A. PU02.04LB
PE16.21, PU16.14 Castor, D. PE07.07 Chilembo, M. PE05.13LB, PE23.07LB
Bukusi, E.A. PE01.63LB, PU28.03 Ca n, M. PE21.04LB Chilende, C. OA17.03
Bunjun, R. PE20.01 Cawood, C. PE01.45, PU16.11 Chimbindi, N. OA21.04, PE01.42,
Burche , H. PE01.22, PE16.01 Celentano, D. PE01.37 PE06.06, PE13.01,
Burger, D. PE29.01 Celum, C. OA07.04, OA10.01, PU01.15, PU01.21,
Burke, K. OA19.01 OA11.04, OA13.01, PU08.01, PU16.09, PU16.11
Burke, N. OA19.04LB PE01.31, PE01.38, Chinyama, M. PE06.07
Burmen, B. PE23.02 PE01.47, PE01.62LB, Chinyenze, K.V. PE11.07, PU21.01
Burne , N. PE29.01 PE01.59, PE16.19, Chirenje, M. PE01.38, PE25.06
Burns, F. PE04.04LB PE16.28, PE18.02, Chirenje, Z.M. PE19.01
Burns, P. PE01.05 PE25.06 Chiro, O. PE16.20
Busby, L PU01.11 Centlivre, M. PE07.03, PE07.09, Chirwa, E. PE06.05
Bushman, L. OA06.05 PE21.02 Chisenga, T. PE16.24
Bushman, L.R. PE24.03LB Ceru , G. OA15.04 Chitowa, T. PE01.14
Busza, J. PE07.04, PU16.10 Cervera, L. PU15.03 Chitowa, T.H. PE01.26
Buthelezi, M. PE01.19 Chabu, E. PE06.07 Chi enden, L. PE16.34LB
Butheliezi, S. PE01.10 Chacon, J.E. OA04.04 Chitukuta, M. OA17.01
Bwanika, J.M. PE01.18 Chagoma, N. PE05.13LB, PE16.38LB, Chiyaka, T. PU16.10
Byrne, E.H. OA19.03 PE23.07LB Chohan, B. PE19.04
Chakare, T. PE25.09 Choi, K. PE16.05
Chan, K.-W. OA03.03LB Choi, Y. OA22.05, PE20.02
C Chanda, M. PE16.25 Chomont, N. OA14.04
Cabrera, M.V. PE04.01 Chanda, S. PE07.06 Chopera, D. PE27.02, PE28.04
Cáceres, C.F. OA21.01 Chandra, N. OA06.03 Christensen, A. PE25.09
Cáceres Palacios, C.F. PE01.55 Chandran, U. PE14.02 Chu, I.Y.-H. PE01.22, PE16.01
Cai, W. PE28.02 Chang, D. PE29.02 Chua, C.Y.X. PE24.03LB
Caires, P. PE16.27, PE16.30 Chang, J.Y. PE07.07 Chuang, G.-Y. OA08.02, PE02.03,
Calder, B. PE19.02 Chang, L. PE16.24 PU02.03, PU21.08, PU21.05
Cale, E. PE02.09, PU02.03 Chang, X. PE29.01 Chung, A. OA01.04
Calixto, D.A. PE11.16, PU23.04 Changela, A. PE21.05LB, PU21.08, Cianci, G. OA22.03
Callahan, R. PE06.07 PU21.05 Cianci, G.C. PE28.09
Calle, M.L. OA14.05LB Chansakul, A. PE11.09 Cicala, C. PE21.01, PE28.06, PE28.08
226
Claiborne, D. OA20.02 D Desai, M. PE16.35LB
Clark, M. OA06.03, OA06.05, Deshpande, S. PE02.04, PE15.02,
PE08.01, Dabee, S. PE04.02, PE19.02, PU19.01 PU02.01
OA02.01 Dadabhai, S. PE04.01, PU25.02 de Souza, M. PE27.03
Clark, M.R. PE25.01 Dah, T.T.E. PE16.16 de Villiers, T. PE07.11LB
Clayton, A. PE28.08 Dalel, J. OA09.05LB, OA14.03, Devlin, B. OA06.01, OA16.05,
Clerici, M. PE17.02, PU07.03 OA20.05, PE03.01 PE08.02, PE08.03,
Cloete, A. PE01.34 Dallal Bashi, Y. PE08.02, PE08.03, PE08.06, PU08.03
Clotet, B. OA14.05LB, PE15.03, PE08.06, PU08.03 DeVore, H. PE20.06
PU15.03 Dal Santo, J. PE21.07LB de Vos, L. OA07.04
Coates, T. OA07.05LB, OA21.05LB Damian, V. PE22.02 de Vries, H. PE01.27, PE16.10
Cobbing, M. PE04.01 D'Amico, R. OA04.03, PE22.02 de Vries, H.J.C. OA11.05LB
Cohen, C.R. OA19.01, PE01.63LB, Damron, L. PU02.02 De walque, D. PE01.57
PU28.03 Dandekar, S. OA19.04LB Dey, A.K. OA12.03
Cohen, E. OA12.04LB Dangerfield II, D. PE01.30 Dharan, A. PE07.14LB
Cohen, K. PE17.01 Dangi, B. PE08.03, PE08.06 Dhiman, K. PE15.02
Cohen, M. OA02.01, PE16.04 Danields, J. PE20.06 Dhitavat, J. OA22.02
Cohen, M.S. OA03.04LB, HY01.01LB, Daniels, E. PE28.11LB Diabaté, S. PE07.01
OA03.05 Daniels, J. PE20.07, OA07.04 Diaz, J. OA13.02
Cohen, S. PE16.28 Das, D. PU01.13 DiazGranados, C. OA18.01
Colby, D.J. PE27.03 Das, M. PE11.02 DiazGranados, C.A. OA22.02
Colgin, L. OA20.03 da Silva, G. PE11.16, PU23.04 Di Ciaccio, M. PE01.35
Collaco-Moraes, Y. PE04.04LB das Neves, J. PE08.05 Dickson, F. PE11.05
Collier, J. OA18.05LB Daud, J. PE25.09 Dietrich, J. OA11.02, PE01.09, PE01.54,
Collins, C. PE05.05, PU05.01 Davidovich, U. OA11.05LB, PE01.21, PE11.06, PU16.13
Colombo, M. PU23.04 PE01.27, PE01.39, Dietrich, J.J. PE01.29, PE01.13
Combadiere, B. OA14.05LB PE16.10, PE16.40LB Díez, J. PE20.03
Connors, M. PE02.09 Davis, C. OA17.04 Dighera, A. PU07.03
Cooney, E. PE05.11LB Davis, J. OA13.01 Dilernia, D. PE03.04LB, PU14.03
Corbe , E. PE05.07 Davis, K. PE11.17 Dilraj, A. PU01.05
Corbin, L. OA22.03 Davis, S. OA01.04 Dimitrov, D. PE07.01, PE16.04,
Corcoran, M. PE02.17LB De, A. PE07.07 PE18.01, PE18.02
Corey, L. HY01.01LB, OA03.05, Dear, N. PE01.25, PE29.02 Ding, S. OA01.05LB, PE07.12LB,
OA03.04LB, PE28.08 Debnam, S.L. OA10.04 PE11.07
Corley, M.J. PE20.05 Dechasakulpan, P. PE05.05 Dintwe, O. OA18.02, OA18.03
Cornejal, N. PE08.09LB Deese, J. PE06.04, PE28.03, Dirawo, J. PE05.07
Corneli, A. PE01.50, PE16.17, PU01.22 PU01.18, PU06.02 Di mer, J. OA16.01
Corno, L. PE01.57 Dehlendorf, C. PE01.62LB Dixon, D. PE16.25
Correia, N. PE11.16, PU23.04 Delabre, R. PE01.35 Djupsa, S. PU14.01
Corrigan, A. PE15.06LB, PE21.05LB, Delany-Moretlwe, S. HY01.02LB, Dlamini, L.P. PE01.06
PE21.07LB OA11.04, PE01.31, Dobek, G. OA04.04
Corrigan, A.R. OA15.04 PE01.38, PE01.62LB, Dobhal, A. PE14.01
Coulibaly, K.B. OA17.04 PE01.59, PE16.19, Dolezal, C. PE01.10, PE01.19,
Cousens, S. PE01.45 PE18.02, PE25.06 PE01.36, PU01.13
Cowan, F.M. OA21.04, PE05.07, Delgado, E. PE11.13 Dollah, A. OA07.02
PE07.04, PU16.10 Delgado-Diaz, D. PE19.03 Dombrowski, J. PE16.28
Coyer, L. OA11.05LB, PE16.10, del Moral Sánchez, I. OA15.03 Dominguez Islas, C. OA16.05
PE16.40LB Delpech, V. OA16.02, PE04.04LB Dominguez-Islas, C. OA16.03
Crakes, K. OA19.04LB Del Rosario Leon, M. PE05.05 Doncel, G.F. OA06.05, PE08.01,
Cranston, R. OA16.05, PE01.11 Demaria, S. PE24.03LB PE25.01, PU01.14
Creasy, G. PE09.01 Dembélé Keita, B. PE16.16 Donenberg, G. PE01.49, PE01.53
Creasy, G.W. OA16.04 de Mello, A. PU23.04 Dong, K. PE28.04
Cressman, A. OA02.01 DeMouth, M. PE15.06LB Donnell, D. OA16.02, PE01.38,
Crispin, M. OA15.03 den Daas, C. PE11.04 PE01.62LB, PE16.04,
Crooks, E. PE02.09 Deng, W. OA03.04LB PE16.18, PE18.01,
Croucamp, Y. PE09.02, PE09.03, Denisiuk, O. PE16.29 PE18.02, PE25.06, PE28.03
PE25.11 Dennis, M. OA18.05LB, PE24.05LB Donofrio, G. PE02.06
Crowell, T. PE01.25, PE29.02 De Paris, K. PE24.05LB Donovan, B. OA16.01
Crowell, T.A. PE27.03 Dereuddre-Bosquet, N. PE21.02, Doolabh, D. PU14.02
Cunningham, C. OA03.02 PU21.10LB Doolabh, D.S. PE27.02
Curran, K. PE25.09 Derking, R. PE02.10 Doores, K. OA15.05LB
Czarnogorski, M. OA10.01 De Rosa, S. PE17.01 Dopkin, D. OA20.02
Derrick, T. PE08.06 Doria-Rose, N. OA08.02, PE02.06,
227
PE02.16LB, PE15.06LB, Esber, A. PE01.25, PE29.02 Floyd, S. PE01.33, PE01.51,
PE21.05LB, PE21.07LB, Espy, N. PE15.04 PU01.15, PU01.21,
PU02.03 Essat, A. PE15.01 PU16.09, PU16.10, PU16.11
Doria-Rose, N.A. PE02.12, PU21.05 Estcourt, C. PE16.35LB Flynn, J. PE19.09LB
Dorsamy, E. PE25.10, PU09.01, PU09.02 Esteller, M. OA14.05LB Flynn, R. PU16.15
Douglass, N. OA15.01, OA12.05, Esteve-Codina, A. OA14.05LB Fokam, J. PU14.01
OA18.04 E ma, J. OA06.04, PE01.15, Fong, D. OA01.02
Dourado, I. PE16.27, PE16.30 PE01.17, PE05.01, Fonseca, T. PE16.30
Dovel, K. OA21.05LB PE25.02, PU01.09 Forbes, A. OA17.02
Downing, K. OA20.04 E ma Ongom, J. PE01.20 Forbinake, N.A. PE03.03
Dreyer, J. OA21.04, PE06.06, PE13.01, Eto, Y. OA09.01 Ford, S.L. OA04.03, PE22.02, PE22.03
PU08.01, PU16.11 Eubanks, A. PE16.16 Fouda, G. OA18.05LB, PE24.05LB
Driscoll, J. PE02.09 Eudailey, J. OA18.05LB, PE24.05LB Foulds, K. PE15.06LB
D. Tolbert, W. PE07.12LB Eustórgio, M. PE16.27 Fowke, K. OA12.04LB, PE19.05,
Duan, H. OA08.02, PE15.06LB, Eustorgio Filho, M. PE16.30 PU07.01
PE21.07LB Evans, B. OA04.05LB Fowora, M. PE08.08LB
Duang, H. PU21.05 Exposito, J.-Y. OA12.01 Fox, J. OA19.05LB, PE01.54,
Dubrovsky, L. OA14.04 Eyul, P. PU28.03 PU16.13
Dubula-Majola, V. PU01.01 Ezechi, O. PE08.08LB Fram, T. OA09.03
Duerr, R. PE11.18, PU14.04 France, M. OA19.02
Dufloo, J. PE02.11, PE15.01 Franchi , L. OA14.02
Dumchev, K. PE07.02
F Francisco, L.V. PE27.03
Dun, C. PE16.36LB, PE16.39LB Faini, D. OA02.04 Freibo , C. PE07.07
Dunbar, M. OA21.02, PE16.07 Fairbanks, J. PE16.28 Freitas, J. OA13.03
Dunbar, M.S. PE06.10 Fairley, C. OA16.01 Freitas, L. OA13.03
Dunn, D. PE04.04LB Falcone, S. OA12.03 French, A. OA13.02
Dunne, E. OA16.05, PE01.11 Fang, X. OA06.05 Freni Sterran no, A. OA14.03
Dupaty, L. PE07.09 Farcasanu, M. OA19.03 Friedland, B. PE09.01
du Plessis, M. PE19.02 Fardoos, R. OA05.03 Friedland, B.A. OA16.04, PE08.09LB
Duran-Castells, C. OA05.01 Farmer, P. PU14.03 Friedrich, N. OA15.02
Dussupt, V. PE02.06 Farquhar, C. OA21.02, PE15.05LB, Friedrich, T. PE07.10LB
PE26.02 Fries, C. OA18.05LB
Fast, P.E. PU21.02 Froissart, R. PE19.02, PU19.01
E Fromen n, R. OA14.04
Fauci, A. PE21.01
Eakle, R. PE16.22, PE25.09 Fauci, A.S. PE28.06 Frost, S. OA02.01
Ebonwu, J. PE28.10LB Fawzy, M. PE06.07 Frye, V. OA17.04
Ebrahim, S. PE25.10, PU09.01, PU09.02 Fazel, A. OA22.05 Fuchs, E. OA04.03
K.R. Eddy OA13.01 Feinberg, M. OA12.03 Fuchs, E.J. PE22.02
Edfeldt, G. PE19.05 Felber, B. OA12.02 Funsani, P. PE16.24
Edick, S. OA04.03, OA16.03, Fellows, T. OA04.01 Fynn, L. PE01.49, PE01.53
OA16.04, PE08.09LB Fen, Y. PE20.03
Edlefsen, P. OA03.04LB Feng, C. PE04.02, PU24.01 G
Edupugan , S. HY01.01LB, OA03.05 Feng, J. OA08.05LB
Edward, V. PE28.03 Fenizia, C. PU07.03 Gaborets, T. PU28.01
Edwards, J. OA01.02 Fenwick, C. PE07.09 Gacheru, J. PE26.01, PU29.01
Ehrenberg, P. PE02.06 Ferguson, D. PE20.03 Gaffoor, Z. PU25.02
Ekama, S. PE08.08LB Fernandez, N. OA09.05LB, PE03.01, Gaiha, G. OA09.04
Elands, H. OA20.04 PU03.01 Galant, S. OA15.01, OA12.05
El-Hayek, C. OA16.01 Fernández Romero, J.A. PE08.09LB Gale e, P. PE22.02
Eller, L.A. PE02.06, PU20.01 Ferrari, G. OA14.01 Galindo, X. PE01.60LB, PU01.24LB
Eller, M.A. OA22.02 Ferrari, M. PE24.03LB Gallagher, A. PE20.03
Ellner, J. OA08.04 Ferraz, D. PE01.52 Gallouet, A.-S. PU21.10LB
Else, L. OA19.05LB Feuer, C. PE05.12LB, PE23.05 Gama, L. PE05.01
Elsum, I. PU01.08 Fhied, C. PE07.14LB Gamazina, K. PU28.01
Emerson, E. PE01.49, PE01.53 Fielding, K. PE05.07 Gambut, S. PE07.14LB
Emery, A. OA15.05LB Fields, S. PE01.30 Gamieldien, H. PE19.02, PU19.01
Emmanuel-Baker, V. PE20.07 Files, J. OA09.03 Gandhi, M. PU28.03
Engelmann, F. PE02.13 Filipowicz, R. PE23.01 Gangaramany, A. PE09.02, PE09.03,
Enghuus, C. PE25.04 Finzi, A. OA01.05LB, PE07.12LB PE25.11
Engstrom, J. PE04.03LB Fiore-Gartland, A. OA18.03, PE27.01 Gao, X. PE06.04, PU01.18, PU06.02
Erdmann, N. OA09.03 Fischer, M. PE29.01 Garcia, M. OA13.01, OA17.01,
Erikson, D. OA06.02 Fisher, K. PE23.06LB PE01.26, PE12.01
Erikson, D.W. OA06.03 Fitch, L. OA11.01, PE16.33 García-Bodas, E. PE11.13
Eron, J. OA02.01 Fleurs, L. OA18.03 Garcia-Lerma, G. OA22.04
228
Garg, G. PE01.61LB Gomes, F.S. PE16.30 Guthrie, B. OA21.02
Garner, A. OA13.03 Gomez, A. OA10.01, PE09.03, PE25.11 Gu érrez-Granados, S. PU15.03
Garre , N. OA08.01, PU02.03, PU14.02 Gómez, S.A. PE01.60LB, PU01.24LB Gu n, S.A. PU28.03
Garre , N.J. PE02.12 Gomez-Lobo, V. PE20.07 Guy, R. OA16.01
Garrido, C. OA14.01 Gonçalves, E. OA14.05LB Gwande, M. PE01.10
Garrison, L. OA07.01, PE16.06 Gondwe, D. PE01.14, PE05.05 Gwashu-Nyangiwe, A. OA03.04LB
Gasper, M. PE04.02 Gonelli, C. OA01.02, PE15.06LB Gwiazdowski, B. PE11.17
Gasser, R. OA01.05LB Gong, S.Y. OA01.05LB
Ga Mirembe, B. PE01.12, PE04.01, Gonzalez, R. PE05.05
PU01.12, PU01.09, Goodreau, S.M. PE26.02
H
PU25.02 Gooley, P. OA01.02 Haaland, R. OA06.02
Ga Mirembe, B.G.M. PE01.15 Goosen, M. PE28.10LB Haberer, J. OA07.01, PE16.06,
Gaumer, G. PE28.11LB, Gorbach, P. OA07.05LB, OA21.05LB PE16.19
PU01.27LB Gorman, J. OA15.04, PE02.09, Haberer, J.E. PE06.02
Gautam, D. PU01.25LB PE02.16LB, PU02.03, Hachiya, A. PE11.15
Gay, C. OA03.01 PU21.08 Hae-Young, K. PE01.41
Gebrekristos, L. PE01.44 Goss, J. PE24.01 Haigwood, N. OA20.03
Geidelberg, L. PE07.01 Gosselin, A. OA17.04 Hailesilassie, H. PU07.04LB
Gelmon, L. PE11.12, PE07.08 Go umukkala, S. OA01.05LB Hailey-Fair, K. PE01.37
Gendron-Lepage, G. OA01.05LB Gounder, K. PE28.04 Hailu, B. PE23.01
Geng, H. PE15.06LB, PU21.08 Gourlay, A. PE01.51, PU01.15 Haimbe, P. PE05.13LB, PE23.07LB
Geraldo, K. OA13.03 Govind, V. PE01.61LB Halavaty, K.K. PE28.09
Geretz, A. PE02.06 Goyal, K. PE05.08 Halke , M. PE28.09
Getahun, M. PU28.03 Goyal, R. PU02.01 Hall, C. PU01.05
Ghebermichael, M. OA19.02 Grabow, C. PE16.28 Hall, J. PE20.03
Ghosh, M. PE20.06, PE20.07 Graham, B. OA03.02 Ham, C. PE20.03
Giacomet, V. PU07.03 Graham, S. PE11.12, PE16.20 Hamilton, D.T. PE26.02
Giang, L.M. PE16.12 Graham, S.M. PE26.02 Hamilton, M. PU18.01
Gianolio, L. PU07.03 Gramma co, M. PE16.05 Hammer, S. PE28.08
Gibson, W. PE02.05 Grande, K. PE07.10LB Han, K. OA04.03, PE22.02, PE22.03
Gichane, M. PE07.15LB, PE25.02 Grangeiro, A. PE01.52, PE16.27 Han, X. OA03.01
Gichuru, E. PE26.02 Grangeiro, J.R. OA13.03 Handley, S. OA19.03
Giguere, R. PE01.10, PE01.19, PE01.36 Gra oni, A. PE24.03LB Hanif, H. OA06.03, OA06.05, PE08.01,
Gil, H. PE11.13 Gray, B. PE07.07 PE25.01, PU01.14
Gilbert, P.B. HY01.01LB, OA03.04LB Gray, C. PE19.07 Hanke, T. OA09.01, OA12.03,
Giles, E. PE20.03 Gray, G. OA02.05LB, PE19.02 OA14.05LB
Gill, K. PE01.47, PU01.14 Gray, G.E. OA18.01, PE01.13, Hannah, S. OA10.03
Gill, N. OA16.02, PE16.35LB PE28.10LB Hanover, J. PE23.04
Gillmour, J. PE03.04LB Gray, M.D. OA08.05LB Hanscom, B. PE18.01
Gilmour, J. OA09.05LB, PE03.01, Greco, D. PE16.27 Hansen, S. PE29.01
OA20.05, PE20.08, Greene, J. PE29.01 Hanson, C. OA02.04
PU03.01, PU14.03 Greene, R. PE07.07 Hansraj, B. PE08.03
Gilmour, S. OA02.03 Grimley, S. OA01.02 Hao, B.T.M. PE16.12
Giorgi, E. OA03.04LB Grinsztejn, B. OA10.01, PE18.01, Hapgood, J. PE06.09
Gio s, E.S. PE20.03 PE29.03 Happy, M. OA17.02
Giovenco, D. PE01.47 Groff, R. OA20.04 Harding, P. OA03.02
Gitau, E. OA21.02 Grov, C. PE01.08 Hardne , F. OA22.04
Gizaw, A. PU07.04LB Grove, D. OA02.05LB, PE11.11, Hare, J. OA09.05LB, OA14.03,
Glynn, T. PE01.08 PE25.08 PE03.01, PU14.03
G Murugavel, K. PU02.01 Groves, A. PE01.44 Hargreaves, J. PU16.10
G. Murugavel, K. PE15.02 Grunenberg, N. OA02.05LB, OA18.02, Harling, G. OA21.04, PE06.06,
Gòdia, F. PU15.03 OA18.03, PE11.12, PU16.09
Godot, V. PE07.09 PE25.08 Harrison, N. PE16.34LB
Goepfert, P. OA09.03, OA18.02 Grunenburg, N. OA18.01 Harryparsad, R. PE06.04
Goes, L. PE21.01 Gu, Y. OA08.02 Har nger, T. OA15.02
Goetz, B.J. PE14.02 Guanira, J.V. PE01.55 Hartley, O. PE04.03LB
Goga, A. PU26.01 Guédou, F. PE07.01 Hartmann, M. OA06.04, PE16.03,
Gold, D. PE16.35LB Guest, J. PE23.01 PU01.16, PU16.03
Gold, E. PE16.25 Gugasyan, R. PE19.03 Hasan, S. OA03.01
Goldberg, B. PE02.11 Gula , T. PE25.05 Hasen, N. PE25.10, PU09.01, PU09.02
Goldstein, M. PE16.41LB Gulla, K. PU21.05 Hassan, A. PE11.12, PE26.02
Golin, C. OA10.04 Gundacker, H. OA16.05 Hatzold, K. PE05.07
Goliusova, M. PU01.28LB Gunn, J. PU01.08 Haugen, H.S. PE04.02
Gomba, Y. OA21.05LB Gurrion, S. HY01.02LB Hauser, A. OA15.02
229
Havlir, D. PE16.28 Holdsworth, H. PE02.10 Izizinga, D. PU16.06
Havyarimana, E. PE19.07 Homad, L.J. OA08.05LB
Hawkins, T. PE24.03LB Homony, B. OA04.05LB
Hawley, I. OA17.01 Hoornenborg, E. OA11.05LB, PE01.27,
J
Hayes, P. OA09.05LB, OA14.03, PE16.10 Jackson, G PU01.11
PE03.01, OA20.05, Hope, T.J. OA01.01, OA04.04, Jackson, S. OA06.03
PE03.04LB, PU03.01 PE07.05, PE07.06, Jacobs, M.A. PE22.02
Haynes, B.F. OA14.01, PE02.14LB PE28.09, OA22.03 Jacobson, K.R. OA08.04
Hayward, J. PE19.03 Horne, S. PE20.01 Jacot, T. OA06.03, OA06.05
Hayward, M. OA19.02 Hornschuh, S. OA11.02, PE01.09, Jaffer, S. PE16.35LB
Hazra, A. PE16.08 PE01.13, PE01.29, Jaggernath, M. PE06.02
Hazra, R. OA03.02 PU16.13 Jahan, N. OA20.04
He, S. PE28.02 Horvath, K. PE01.12, PE01.18, Jahn, A. PE11.03
Heaps, A. PE14.02, PE16.07 PE23.01 Jain, N. OA17.03
Hearps, A. PE19.03 Horvath, K.J. PE01.29 Jais, M. PE20.06
Hederman, A. PE07.12LB Hosek, S. OA07.04, OA13.02, Jalil, C. OA13.03
Heffron, R. OA06.02, PE16.13, PE01.38, PE11.17, Jamali, G. PE07.04, PU16.10
PE16.19, PU01.18, PE25.06 Jambaya, J. PE12.01
PU06.02, PU16.06 Hosseinipour, M. OA18.01 Janes, H. OA02.05LB, PE11.11,
Heijne, J. PE11.04 Hoxie, J. OA20.02 PE25.08, PE28.08
Hellard, M. OA16.01 Hsu, D. PE20.05 Jani, I. OA18.03
Heller, K. PE20.01 Hu, X. OA12.02 Janiczek, R. PE22.02
Hemmerling, A. OA19.01, PE16.32 Huang, S. PE22.01 Janusziewicz, R. PE08.04
Hendrix, C.W. OA04.05LB, OA04.03, Huang, Y. OA02.05LB, PE17.01, Jaradeh, K. OA13.04
OA06.01, OA16.03, PE25.08 Jarrahian, C. OA04.01
OA16.04, OA16.05, PE08.09LB Hue ner, I. OA22.05LB Jaspan, H. PE19.02, PE19.07, PU01.18,
Heneine, W. PE24.01 Hughes, J. PE16.04, HY01.02LB PU06.02, PU24.01
Hensen, B. PU16.10 Huibner, S. OA19.01, OA22.05 Jaspan, H.B. PU19.01
Herard, K. PU14.03 Hultquist, J. PE07.06 Jaumdally, S.Z. PE19.02, PU19.01
Herbeck, J. OA21.02 Humphrey, N. PU01.11 Jean, J. PE05.06
Herbst, C. OA21.04, PE06.06, PE13.01, Hunidzarira, P. HY01.02LB, PE19.01 Jeenarain, N. PE25.03, PU25.01,
PU08.01 Hunte, R. PE19.06 PU25.02
Hermanus, T. OA12.05, OA15.01, Hunter, E. OA09.05LB, OA14.03, Jelagat Odionyi, J. PE28.01
PE07.11LB PE03.04LB, PU14.03 Jenkins, S. PE05.13LB, PE16.34LB,
Herold, B. PE19.06, PE24.04LB Hural, J. OA03.05, OA03.04LB PE23.07LB
Herrera, C. OA19.04LB, OA19.05LB, Husnik, M. PU25.02 Jenkins, S.Y. OA10.01
PE20.03 Husnik, M.J. PE25.03 Jere, D.L. PE05.03, PU05.02
Hessell, A. OA20.03, PE02.11 Hu enhower, C. OA19.02 Jesaveluk, B. PE19.03
Hewe , P. PE16.26 Hu er, J. OA18.01 Jewanraj, J. PE20.04
Heydarchi, B. OA01.02, PE02.17LB Hwang, P. OA04.05LB Jha, S. OA14.01
Hibbert, M. PE16.35LB Hyrien, O. OA03.01 J.Hope, T. PE20.08
Hickson, F. PE01.22, PE16.01 Jian, N. PE02.06
Hieu, T.T. PE16.12 Jiao, Y. OA16.04, PE08.09LB
Hill, J.E. PE19.08
I
Jin, H. PE16.36LB
Hill, N. PE16.11 Ianchuk, O. PU28.01 Jin Kee, J. PE11.11
Hillier, S. OA04.05LB Idogho, O. PE05.10LB Jiron Sosa, J.P. PE01.55
Hillier, S.L. OA16.03, PE19.01 Igaba, N. PU16.01 Joachim, A. OA02.04
Himansu, S. OA12.03 Igwilo, C. PE08.08LB Jogi, D. PE23.03
Hingankar, N. PE02.04, PE15.02 Ilesanmi, E. PU01.02 John, S.A. PU07.02
Hjorth, A. OA10.05 Ilomuanya, M. PE08.08LB Johnson, A. PE05.05, PE19.03,
Hlongwa, M. PE25.10, PU09.01, Ilyichev, A. PU02.04LB, PU21.09LB OA20.03
PU09.02 Innes, C. OA18.01, PE11.11 Johnson, C. PE05.07
Hlongwane, S. PE01.42, PE06.06, Innocent-Adiele, H. PE11.18 Johnson, L. PE25.07, PU25.03
PU01.21 Inoue, S. PE11.14 Johnson, R. OA11.04, PE01.31, PE01.59
Ho, K. OA16.03, OA16.04, OA16.05, Intasan, J. PE27.03 Johnson, S. OA16.05, PE01.11, PE05.05
PE01.11, PE08.09LB Inves gators, I.P.C. OA09.05LB John-Stewart, G. PE15.05LB, PE16.31
Hoa, V.D. PE16.12 Irby, S. PE01.43 Johnston, B. PE22.01
Hoagland, B. OA13.03 Iroezindu, M. PE01.25, PE29.02 Jones, C. OA02.01
Hobbs, M. PU01.18, PU06.02 Irungu, E. OA07.02, PE16.14, PE16.18 Jongen, V. PE01.27, PE16.10
Hocqueloux, L. PE15.01 Ishii, H. OA09.02 Jongen, V.W. OA11.05LB
Hoesley, C. OA16.04, OA16.05, Ismail, A. OA08.01, PE02.05, OA04.01 Joseph, J. OA09.01
PE01.11, PE08.09LB Isoherranen, N. OA06.02 Joseph, S. OA09.05LB, OA14.01,
Hogarth, P.M. PE15.05LB I mann, M.M. PE24.03LB OA14.03, OA20.05,
Hokke, R. OA15.05LB Izazola-Licea, J.A. PE23.06LB PE20.08, PU14.02
230
Joseph Davey, D. OA07.05LB, Kasaro, M. PE06.07 Kim, J.H. OA22.02
OA21.05LB Kaseke, C. OA09.04 Kimani, J. PE07.08, PE11.12,
Jovaag, A. PE07.10LB Kasiba, R. OA17.05 PE19.05, PU07.01
Joy, C. PE20.06, PE20.07 Kasiita, V. PE16.13 Kimani, M. PE16.20
Joyce, M.G. OA08.02 Kassim, S. OA13.01 Kimata, J.T. PE24.03LB
Ju, S. OA06.03, PE25.01 Kassim, S. PE25.08 Kimsey, C. PE16.28
Jucker, B.M. PE22.02 Katbi, M. PE05.10LB King, D. OA09.05LB, OA14.03,
Julien, J.-P. PE02.01 Kathe, N. PE25.05 PE03.01, PU03.01
Julius, M. PE03.03 Kato, K. OA02.03 King, D.F. OA20.05
Juraska, M. OA03.04LB Katuntu, D. OA04.01 King, N. PE21.03
Justman, J. OA02.02, PE11.03 Katz, A. PE01.19, PE25.02 Kinuthia, J. PE16.31
Katz, A.W.K. PE01.31, PE01.26, Kipkurui, N. PE16.14
PE01.59 Kip nness, C. OA07.01, PE16.06,
K Kaul, R. OA19.01, OA22.05, PE20.02 PE16.14, PE16.21,
Kabarambi, A. PE01.40, PU05.03 Kaushic, C. OA22.01 PE19.04, PU08.02
Kabura, S. OA17.05 Kayange, N. HY01.02LB Kiragga, A. PE01.18
Kacanek, D. PE22.01 Keane, M. OA10.02 Kiravu, A. PU24.01
Kachale, E. PE12.01 Keane, R. PU01.08 Kirby, C. PE28.08
Kagee, A. PE01.01, PE01.29 Kebeya, M.C. PE03.03 Kiriazova, T. PE07.02
Kaimba, M. PE05.13LB Kee, J. OA18.03 Kirilenko, T. PE21.04LB
Kajura-Manyindo, C. PE01.10, PE01.19 Kee, J.J. OA02.05LB, OA18.02 Kirk, G. PE28.08
Kakande, A. OA11.02 Keefer, M. PE05.06 Kirtadze, I. PE07.02
Kaldhusdal, V. PE19.05 Keele, B. PE19.09LB Kiruki, M. PE06.03
Kaldine, H. OA03.05 Kegeles, S.M. OA21.01 Kitajima, T. PU01.25LB
Kaleebu, P. PE01.23, PE01.40, Kelleher, N. PE07.14LB Kitchin, D. OA08.01, PE02.12
PE05.09, PE11.07, PU05.03, Keller, M. PE19.06, PE24.04LB Kitonsa, J. PE01.40, PU05.03
PU21.01, PU21.02 Kelley, C.F. OA05.04, PU20.02 Kiweewa, F.M. PE19.01
Kalinin, A. PU01.19 Kelly, C. OA16.04, PE08.09LB Kla , N. PE01.08
Kali , S. PE06.10 Kelly, C.W. OA06.01 Kleinbeck, K. PE08.03, PE08.06
Kalonji, D. HY01.02LB, OA02.05LB, Kelly, G. PE07.10LB Kløverpris, H.N. OA05.03
PE11.11, PE25.08 Kemigisha, D. OA06.04, OA17.01, Knapp, J. OA12.04LB
Kalua, T. PE11.03 PE01.14, PE05.01, Knight, L. OA21.05LB
Kalule Nabunya, H. PE01.15, PE01.20, PE05.02 Ko, N.-Y. PE01.22, PE16.01
PU01.09 Kemigisha, D.K. PU01.09 Kobie, J. PE17.01
Kamacooko, O. PE01.23, PU21.01 Kempster, S. PE20.03 Kobinger, G. OA12.04LB
Kamau, R. PE06.10 Kemunto, V. PE16.31 Koekkoek, S.M. OA15.03
Kambona, C. PE06.03 Keneema, E. PU16.04 Koh, M. PU16.13
Kamboyi, R. PE16.24, PE23.07LB Kent, S. OA01.04 Kohler, P. PE16.31
Kamboyi, R.L. PE05.13LB Keyser, A. OA18.04 Kohlmeier, A. OA22.04
Kamen, A. OA12.04LB Kgagudi, P. OA03.05, OA08.01, Kolling, A.F. PU28.02
Kamira, B. PE06.01 PE02.08, PE07.11LB Konda, K.A. OA21.01, PE01.55
Kamire, V. PU01.15 Kgositau-Kanza, R. PE05.12LB Kondo, M. PE11.15
Kamolloh, K. PE05.04, PE16.06, Khagayi, S. PE01.33 Kong, W.-P. PU21.05
PU16.14 Khaniukov, I. PU28.01 Kong, X. PE28.06
Kamori, D. PU11.02 Khanyile, D. PE01.45 Kong, X.-P. OA03.03LB
Kamusiime, B. PE16.13 Khawam, J. PE04.04LB Kopf, G. PE16.32
Kamya, M.R. PU28.03 Khoa, T.C.D. PE16.12 Korber, B. OA12.03
Kang, C.-Y. OA12.04LB Khondowe, W. PE16.25 Korczak, B. PE04.03LB
Kanjipite, W. PE16.25 Khoo, S. OA19.05LB Korutaro, V. PE22.01
Kansiime, S. PE01.40 Khosla, A. PU09.01, PU09.02 Kosak, B. PE04.03LB
Kanyemba, B. OA10.03 Khoza, N. PE01.59 Kosgei, J. PU20.01
Kanyenda, T. PE05.13LB, PE16.38LB, Khunwane, M. PE01.13 Kosma, P. PE21.04LB
PE23.07LB Kibalama Ssemambo, P. PE22.01 Kotnik Halavaty, K. PE07.05
Kapito, E. PE06.05 Kibirige, C. OA14.03 Kotze, P. OA02.05LB
Karas, S. PE05.05 Kibuuka, H. PE01.25, PE29.02, Kotzé, P. PE11.11
Karg, C. OA03.01 PU20.01 Koup, R. PE15.06LB
Karim, F. OA05.03 Kibuuka, J. PU16.06 Koutsoukos, M. OA18.01, OA18.02
Karim, S. PU14.02 Kidoguchi, L. OA11.04, PE16.19 Kowatsch, M. PU07.01
Karita, E. PU14.03 Kiggundu, V. PE16.25 Kowo, H. PE16.32
Karlsson Hedestam, G. PE02.17LB Kihara, M. PE08.03 Kozyrina, N. PU01.22LB
Karpenko, L. PU02.04LB, PU21.09LB Kiiza, B. PU01.12 Kramer, P. PE09.03, PE25.11
Karuna, S. OA03.05, OA03.01 Kikuchi, T. PE11.15 Krebs, S. PE20.05
Karunakaran, D. OA04.04 Kilbourne-Brook, M. OA04.01 Kretschmer, S. PE16.24
Kasanda, C. OA17.03 Kilpeläinen, A. OA09.01 Kretzschmar, M. PE11.04
231
Kriel, Y. PE06.02 Landovitz, R. PE18.01 Longwe Mwenda, W. PE22.01
Kripke, K. PU18.01 Langat, R. PE20.08 Lopez, A. OA19.04LB
Kroll, K. OA05.02 Langner, C. PE19.09LB Lopez-Ríos, J. PE01.36, PU01.13
Kroon, E. PE20.05, PE27.03 Larsen, A. PE16.31 Lorenzo Redondo, R. PE20.08
Kruger, A PU23.04 Lassaunière, R. PE28.10LB Lorenzo-Redondo, R. PE28.09
Krumm, S. OA15.05LB Lauder, M.K. PE02.14LB Lorin, V. PE15.01
Krupp, K. OA20.02 Laurent, C. PE16.16 Lou, Y. OA04.03
Ku, S.W.-W. PE01.22, PE16.01 Lawal, I. PE16.34LB Louder, M. OA08.02, PE02.16LB
Kublin, J. PE27.01 Lawrence, J. PE16.11 Loughlin, P. PE07.07
Kuhn, L. PE28.10LB Lazarus, E. PE01.29, PE25.08 Louw, C. PE28.03
Kuimova, U. PU01.28LB Le, P. OA02.03 Lovasi, G.S. OA02.02
Kulpa, D. OA14.02 Lebina, L. OA19.05LB Low, A. OA10.05, PE11.09, PE11.14
Kulzer, J.L. PE01.63LB Lee, E. PE16.34LB Lu, H. OA03.03LB, PE28.02, OA18.01
Kumar, M. PE01.61LB Lee, J. PU28.03 Lu, Z. OA12.02
Kumar, N. PE02.04 Lee, M. PE02.03 Lucas, J. PE05.05
Kumar, R. PE15.02 Lee, R.K. PE16.41LB Ludwig, N. OA21.02
Kumar, S. OA15.03, PE14.01 Lee, S. PE22.02 Luecke, E. PE25.07, PU25.03
Kumbani, L.C. PE05.03, PU05.02 Lee, W. PE21.03 Luetkemeyer, A. PE16.28
Kunjara Na Ayudhya, R.P. OA16.05, Lee, W.H. OA15.03 Lukas, I. PE01.19, PE06.01
PE08.09LB Leggat, D. PE02.06, PE02.10 Lung Bich, N. PE16.23
Kuo, I. PE01.30 Le Grand, R. PE21.02, PU21.10LB Lunika, L. OA11.04
Kuong, U.S. OA20.05 LeMasters, K. OA10.04 Lunkuse, J.F. PE01.23
Kurzman, A. OA10.02 Le Minh, G. PE16.23 Luo, C. OA03.03LB
Kusemererwa, S. PE01.40, PE05.09, Lemos, M.P. PE01.29 Luo, Q. OA21.03, PU11.01
PU05.03 Lentz, C. PE01.10, PE01.19, Lurie, M. PE01.02
Kutner, B. PE01.10, PE01.36 PE01.36 Lusso, P. PE02.12LB
Kutner, B.A. PE01.19 Lenz, C. PE28.01 Luthra, K. PE14.01
Kuwata, T. PU11.02 Leon eva, S. PU28.01 Luthuli, N. OA10.03
Kwach, B. PE16.21 Leslie, A. OA05.03 Lyamuya, E. OA02.04, PU11.02
Kwaro, D. PE01.33, PU01.15 Leslie, G. OA20.02 Lyman, P. PU16.15
Kwena, Z. PU16.14 Lesosky, M. OA07.05LB
Kwon, D. OA19.02 Levy, L. PE16.07
Kwon, D.S. OA19.03 Levy, M. PE16.02, PE25.10,
M
Kwon, Y.D. PE02.16LB PU09.01, PU09.02 Mabvakure, B. OA08.01
Kwong, P. PE02.03, PE02.10, Levy, Y. PE07.03, PE21.02 Macagna, N. OA06.04, OA16.03,
PE02.16LB, PE15.06LB, Lévy, Y. PE07.09 PE01.11, PE01.28
PE21.05LB, PE21.07LB, Lewis, A. OA20.03 Macapagal, K. OA07.03, PU01.07
PU02.03 Lewis, M. PE07.05 MacCamy, A.J. OA08.05LB
Kwong, P.D. PU21.05 Li, C.-W. PE01.22, PE16.01 MacDonald, K.S. PE19.08
Kyambadde, P. OA04.01 Li, P.S. PE16.41LB Machafu, H. PE16.21
Kyegombe, N. PE01.42, PU01.21, Li, S. PE02.17LB Macharia, G. OA14.03, PE03.01
PU16.11 Li, Y. OA12.04LB Macharia, P. OA21.02
Kyomukama, E. PE01.20, PU01.09 Liebenberg, L. PE20.04 Machingura, F. PE07.04, PU16.10
Kyomukama, E.K. PE01.15 Lien Chen, P. PU01.18, PU06.02 Mackenzie, C. OA01.02
Ligh oot, A.F. OA10.04 Macura, K.J. PE22.02
Liljestrom, P. PE07.09 Madden, P. PE07.05
L Lima, F. PE16.30 Madidi, N. OA10.01
LaBoy, R. PE11.17 Lin, B. OA08.02, PE02.16LB Maeri, I. PU28.03
LaBranche, C. OA12.02, OA14.01 Linares Fernandez, S. OA12.01 Mafunda, N. OA19.02
LaBranche, C.C. PE24.05LB Lingenda, G. PE16.25 Magale, H. PE27.01
Lacabaratz, C. PE07.03 Lipscomb, J. PE24.01 Magambo, S. PE01.18
Lafrance, M.-A. OA12.04LB Li le, D. PE24.01 Magaret, C. OA03.04LB
Laher, F. OA02.05LB, OA18.01, Li le, K. PE08.01, PE25.10, Magni, S. OA04.01
OA18.02, OA18.03, PU09.01, PU09.02 Magno, L. PE16.27, PE16.30
PE01.13, PE11.11, PE25.08 Liu, A. PE18.01 Magnus, M. PE01.30, PE20.06
Lai, Y.-T. PE02.10, PU02.03 Liu, D.J. PE28.02 Magnuson, D. PE11.02
Lajoie, J. PE19.05, PU07.01 Liu, L. PE05.03, PE06.05, PU05.02 Magut, F. PE01.33, PU01.15
Lambo e, O. OA01.03 Liu, Q. PE02.16LB Mahaka, I. PE16.07, PE25.07, PU25.03
Lambson, B. OA08.01, PE02.05, Livant, E. PU25.02 Maheu-Giroux, M. PE07.01, PE16.04
PE02.07, PE02.12, PU15.04 LiWang, P. OA19.04LB Mahiane, G. PU18.01
Lambson, B.E. OA03.05 Lodha, R. PE14.01 Mahi , M. PU11.02
Lammert, S. PE01.12, PE01.18 Loha, E. PU16.11 Mahy, M. PE11.10
Lampe, F. PE04.04LB Lombaard, J.H. OA04.05LB Mahyari, E. OA20.03
Landais, E. OA15.05LB Long, J. OA06.01 Maimela, G. PE16.11
232
Maina, G. PE16.14 Markowitz, M. PE28.02 Mayer-Blackwell, K. PE27.01
Maiorana, A. OA21.01 Markt-Maloney, J. OA21.05LB Mayo, A. PE04.01, PE12.01
Maisonnasse, P. PU21.10LB Marlin, R. PE21.02 Mayr, L. OA01.03
Majiwa, M. PE11.12 Marrazzo, J. OA19.02 Mbatsane, E. PE25.07, PU25.03
Makamba, M. PE07.04, PU16.10 Marrazzo, J.M. PE19.01 Mbatsane, T.E. PE05.06
Makanani, B. PE19.01 Marsden, A. PE02.05 Mbira, T. PU26.01
Makhado, Z. PE02.01, PE02.07, PE02.08 Marshall, K. OA18.01, PE28.08 Mbogo, L. OA21.02
Makhale, L.M. PE01.13 Mar n, A. PE28.08 Mbori-Ngacha, D. PE15.05LB
Makhdoomi, M. PE14.01 Mar n, F. PE08.03 Mbuagbaw, L. PU14.01
Makhema, J. HY01.02LB Mar nez, A. PE16.03, PU01.14 McCabe, L. PE04.04LB
Makinde, J. OA09.05LB, OA14.03, Mar nez, D. PE01.08 McCauley, M. PE29.03
OA20.05, PU03.01 Mar nez, E. PE01.60LB, PU01.24LB McClure, T. OA13.01
Makoni, R. PE12.01 Mar nez-Cajas, J.L. PE01.60LB, McCormack, S. PE04.04LB
Makoni, W. PE25.07, PU25.03 PU01.24LB McCormick, T. OA06.03, OA06.05
Malahleha, M. OA02.05LB, PE05.06, Mar nson, N. OA11.02, OA19.05LB, McCorrister, S. PE20.01
PE11.11, PE25.08, PU01.05 PU16.13 McCoy, C. PE08.02, PE08.03,
Malamatsho, R. PE05.06 Maruza, R. PE05.13LB, PE16.38LB, PE08.06, PU08.03
Malaza, A. PE16.11 PE23.07LB McCreary, L. PE06.05
Malcolm, K. PE08.02, PE08.03, PE08.06, Marzan, J. OA13.04 McCreary, L.L. PE05.03, PU05.02
PE08.07, PE24.01, PU08.03 Marzinke, M. OA04.03, OA06.03, McDermo , A. OA03.01, OA03.02,
Malcolm, S. PE20.07 OA16.03, OA16.05 PE02.10, PE15.06LB
Maldini, C. OA20.02 Marzinke, M.A. OA06.01, PE24.03LB McElrath, J. OA03.04LB, OA03.05,
Malhotra, S. OA10.02 Masango, T. PE01.07 PE17.01
Malik, M. PE01.34 Masaulo, P. PE06.03 McFarland, E. OA03.02
Malinski, C. PE16.28 Masawi, S. PU05.03 McGaugh, A. PE01.08
Malone, S. PE09.03, PE25.10, PE25.11, Mascola, J. OA03.02, PE02.06, McGowan, E. OA14.03
PU09.01, PU09.02 PE02.14LB, PE02.16LB, McGowan, I. OA16.04, OA16.05,
Maman, S. PE01.44 PE15.06LB, PE21.05LB, PE04.03LB, PE08.09LB
Mambiya, S. PE22.01 PE21.07LB McGowan, M. PE16.15
Mamede, J. PE07.14LB Mascola, J.R. PE02.12, PU21.05 McGrath, N. OA21.04, PE01.41,
Manabe, Y.C. OA08.04 Mashele, N. OA07.05LB, OA21.05LB PE06.06, PU16.09
Manamela, N. PE02.07, PE02.08, Masika, M. PE11.12 McGuire, A.T. OA08.05LB
PE07.11LB Mason, E. PE16.35LB McIntosh, R. PE01.08
Manavi, K. PE16.35LB Mason, R. PE28.06 McKay, P. PU21.10LB
Månberg, A. PE19.05 Masondo, S. PE20.04 Mckee, K. PE02.16LB
Manchi, P. PE09.02 Massa, P. PE16.27 McKee, K. OA15.04, PU21.08
Mandima, P. HY01.02LB Masson, L. PE06.04, PE19.02, PU19.01 McKellar, M. PU01.22
Mangale, D. PU08.02 Massud, I. OA04.02, OA22.04 McKenna, S. PU01.13
Mangenah, C. PE05.07 Mastro, T. PE28.03 McKinnon, L.R. OA20.04, PE11.12,
Mangwiro, A. PE16.38LB, PE23.07LB Masuku, S.K. PE01.06 PE17.01, PE19.08
Mangxilana, N. OA17.01, PE25.02 Maswai, J. PE01.25, PE29.02 McLaren, P. PE17.01
Manhanzva, M. PE19.02 Masyuko, S. OA21.02 McLellan-Lemal, E. OA06.02, PE04.02
Manhanzva, M.T. PU19.01 Mataboge, P. PE16.11 McMahon-Roessle, S. PE16.15
Mann, J. OA12.04LB Matano, T. OA09.02, PE11.15 McMullen, N. PE08.03
Mansoor, L. PE12.01, PE20.04, PU25.02 Matenga, T.F.L. PE05.13LB McNairy, M.L. PE07.07
Mansoor, L.E. PE04.01, PE01.26, PU25.01 Mateus Duarte, F. PE16.30 McNaughton Reyes, H.L. PE01.44
Manuzak, J. PE01.08 Mathebula, F. OA17.01, PE01.26, McOwan, A. PE16.35LB
Mapengo, R.E. PE02.01, OA03.05 PE01.28, PE16.03, McRaven, M. OA01.01, OA22.03,
Mapetla, K. PU01.05 PU01.16 PE07.05, PE20.08
Maphumulo, B. PE06.07, PE06.08 Mathema, B. OA02.02 MDA, P. PE25.08
Maple, J. PE23.06LB Mathenjwa, M. PE06.02 Mdlalose, G. PU01.01
Maradan, G. PE16.16 Mathenjwa, T. PE01.41 Mdlovu, M. PE01.62LB
Maragh-Bass, A.C. OA10.04 Mathew, C. HY01.02LB Mdluli, S. PU16.09
Marathane, M. PE28.01 Mathur, S. PE09.01 Mdluli, T. PE27.03
Maraventano, I. PE17.02 Matovu Kiweewa, F. PU25.02 Mebane, S. PU08.01
Marcos-Lopez, E. PU21.10LB Matser, A. PE11.04, PE16.40LB Meche na, L. PU02.04LB
Marfil, S. PE15.03, PU15.03 Ma en, D. OA03.04LB, PU14.02 Medina-Colorado, A. PE08.04
Margolin, E. OA12.05, OA15.01 Ma hews, D. OA17.04 Medina-Marino, A. OA07.04
Margolis, D. OA04.03, OA14.01, Ma hews, L.T. PE06.02 Medjahed, H. OA01.05LB
PE22.02, PE22.03, PE28.02 Ma sson, C. PE19.05 Mee, P. OA21.04
Marialuisa, P. OA01.03 Ma ur, D. PE23.06LB Mehou-Loko, C. PE06.04
Maric, D. OA22.03, PE28.09 Mawarire, R. OA07.04 Mehta, S. PE28.08
Marie Carias, A. PE20.08 Mayanja, Y. PE01.23, PU21.01, PU21.02 Mei, X. PE06.05
Markan, R. PE25.05 Mayer, K.H. OA03.01, PE11.06 Meintjes, G. OA02.05LB
233
Melani, R. PE07.14LB Molinos-Albert, L.M. PU15.03, PE15.01 Mtshali, A. PE20.04
Mellors, J.W. PU14.05LB Molitor, A. OA01.03 Mtshali, M. PE01.58
Mellors, MTN-025 Study Team, J. PE14.02 Moll, A. PE16.05 Mudhune, V. OA06.02, PE04.02,
Melo, C. PE08.09LB Moltó, J. OA14.05LB PE11.12
Mendez-Rivera, L. PE02.06 Momin, Z. PE24.03LB Muéses, H.F. PE01.60LB, PU01.24LB
Mensah, E. PE16.16 Mon, S.H.H. PE16.36LB, PE16.39LB Mugambi, M. PE06.10, PE16.18
Mera, R. PE11.02 Monaco, D. PE03.04LB Mugisha, J. PU05.03
Merchan-Hamann, E. PU28.02 Monceaux, V. PE15.01 Mugisha Okello, J. PE05.09
Merill, K. PE01.49 Monroe-Wise, A. OA21.02 Mugo, I.N. PE05.12LB
Merrill, K. PE01.53 Montefiori, D. OA03.04LB, OA14.01 Mugo, N. OA06.02, OA07.01,
Mesa-Frias, M. PE25.05 Montefiori, D.C. OA12.02, PE24.05LB OA07.02, PE04.02, PE05.04,
Messina, M. PE02.09 Monteiro, L. OA13.03 PE16.06, PE16.14, PE16.18,
Meyer, B. PE06.04 Montgomery, E. PU01.16 PE19.04, PU01.14, PU08.02
Meyer, E. PE20.06 Montgomery, E.T. PE01.26, PE16.03 Mugo, P. PE26.02
Meyer, L. PE15.01 Montross, L. PU01.11 Mugurungi, O. PE16.07
Meyers, K. PE07.07, PE28.02 Moodie, Z. OA02.05LB, OA18.02, Mugwanya, K. OA07.02, PE16.13,
Mgodi, N. HY01.02LB, OA03.05, PE11.06, PE25.08 PE16.16
OA06.04, PE01.38, PE04.02, Moodley, D. PE01.44 Muhumuza, R. OA11.02, PE01.54,
PE14.01, PE18.02, PE25.06 Moody, A. OA18.05LB PU16.13
Mgodi, N.M. HY01.01LB Moog, C. OA01.03, OA15.02, PE21.02 Mujugira, A. PE16.13, PU16.06
Mi, G. OA21.03 Moore, J. PE16.04, PE18.01, PE18.02 Mukandavire, C. PE07.01
Michael, N.L. OA22.02 Moore, J.P. PE24.05LB Mukasa Kibengo, F. PE11.07
Michels, D. PE01.35 Moore, P. OA08.03, OA12.05, OA15.01, Mukherjee, J. PE05.08
Micheni, M. PE19.04 OA18.04, PE02.01, PE02.05, Mukoma, W. PE16.22
Mielke, D. OA14.01 PE02.07, PE02.08, PE02.12, Mukui, I. OA10.01, PE16.18
Miles, L. OA17.04 PU02.03, PU15.04 Mukuria, N. PE16.20
Milford, C. PE01.58 Moore, P.L. PE07.11LB Mukwekwerere, P. HY01.02LB
Milinkovic, A. PE16.35LB Moore, S. PE16.32 Mulaudzi, M. OA11.02, PE01.09,
Miller, A. PU01.18, PU06.02 Mora, M. PE16.16 PE01.29, PU16.13
Miller, C. PE01.08 Morales, G. PU23.03 Mulawa, M.J. PE05.13LB
Miller, J. PU01.11 Moreno, G. PE07.10LB Mulhall, F. OA20.04
Miller, S. OA19.01 Moreno, J. OA12.01 Mulhausen, J. PE09.02, PE09.03, PE25.11
Miller, V. OA16.02 Morgan, J. OA19.04LB Mullick, R. PE02.04, PU02.01
Mimi, M. PE16.16 Moriarty, P. PE20.07 Mullick, S. PU23.01
Minalga, B. PU05.01 Moriarty, T. PE20.06 Mullins, J.I. OA03.04LB
Minnis, A. OA06.04, PU16.03 Morris, L. OA03.04LB, OA08.03, Mulumba, E. PE01.15, PE01.20, PU01.09
Mirchandani, K. PE25.05 OA18.04, PE02.01, PE02.04, Mulwa, S. PE01.33, PE01.51, PU01.15
Mirembe, B.G. PE05.01 PE02.05, PE02.07, PE02.08, Mungate, L. PE22.01
Mishra, N. PE14.01 PE02.12, PE07.11LB, PE21.01, Muñoz, A. OA13.02
Mishra, S. PE07.01 PE28.06, PU15.04 Munseri, P. OA02.04
Mitchell, C. OA19.02, OA19.03 Morris, S. OA19.01, PU16.15 Muok, E. PU14.03
Mitchell, J.T. OA10.04 Morrison, C. PE06.04, PE28.03 Mureithi, M. PE20.08
Mitchell, K. PE07.01, PE16.04, Morrison, S. OA06.02, OA07.01 Muresan, P. OA03.02
PE18.01, PE18.02 Morton, J. OA07.02, OA11.04, Muriuki, F. PE07.08
Mi , A. PE06.10 PE01.31, PE01.47, Murphy, D. PE08.02, PE08.03,
Miura, T. OA09.02 PE01.62LB, PE01.59, PE08.06, PE24.01, PU08.03
Miura Zucchi, E. PE01.52 PE16.18, PE16.19 Murray, L. PE01.52
Mkhize, N.N. OA03.05 Moss, J.A. PE08.10LB, PE24.04LB Murray, P.M. OA05.04, PU20.02
Mngadi, K. OA18.01, OA18.03, Motamedi, M. PE08.10LB, PE24.04LB Murrell, B. OA03.04LB
PE27.01, OA18.02 Mothe, B. OA14.05LB, OA20.01, Murungi, L. PE20.08
Moats, C. PE29.01 PU21.06 Murungu, J. PE06.10, PE16.07
Mobley, V. OA02.01 Motsoeneng, B. PE07.11LB Musara, P. OA06.04, PE01.14, PE01.28
Modise, T. OA03.05 Mouquet, H. PE15.01 Musau, A. OA11.03, PE25.09
Moeser, M. OA14.01, PU14.02 Moyo, N.A. OA12.03 Musau, O. PE06.03
Moesers, M. OA02.01 Moyo, T. OA08.01, PE02.01, PE02.08, Musha , P. PU16.10
Mogaka, F. PE01.59, PE16.19 PE02.12, PE07.11LB Musingila, P. PE06.03
Mogere, P. PE05.04, PU08.02, PU16.14 Mpendo, J. HY01.02LB, PU16.04 Musinguzi, D. PE01.18
Moghadassi, M. PE01.63LB Mphili, N. PE06.08 Musinguzi, N. OA07.01
Mohammadi, A. OA22.05 Mposula, H. PE06.01 Musoke, D.K. PE16.15
Mohammed, H. OA16.02 Msafiri, F. OA02.04 Mustanski, B. OA07.03, PE11.01,
Mohan, D. PE25.09 Msane, S. PE06.06 PU01.07
Mohanty, M. PE01.61LB M. Sewall, L. PE15.02 Musukwa, T. PE28.01
Mokgoro, M. HY01.02LB Mthiyane, N. OA21.04, PU01.15, Musyoki, H. OA21.02
Molaudzi, Z. PE02.12, PE07.11LB PU16.09 Mutegi, J. OA11.03, PE25.09
234
Mutero, P. PE01.14 Nanyonga, S. PE01.20, PE05.01 Niles, J.A. PE24.03LB
Mutseta, M. PE05.07 Nanyunja, S. PE22.01 Nilsson, C. OA02.04
Mutua, G. PE11.12 Narpala, S. PE15.06LB Nilsson, P. PE19.05
Muturi-Kioi, V. PU21.01 Nash, S. OA11.02 Nishizawa, M. PE11.15
Muwonge, T. PU16.06 Nasr, M. PE20.07 Nitayaphan, S. OA22.02
Muwonge, T.R. PE16.13 Nasser, M. PE16.28 Njindam, I.M. PE07.01
Mvinjelwa, P. PE01.10 Nathan, A. OA09.04 Njoki, T. OA17.02
Mvududu, R. OA07.05LB Nawaz, F. PE28.06 Njoroge, B. OA06.02, PE04.02
Mwakisisile, J. PU20.01 Nazli, A. OA22.01 Njuguna, N. PE26.01, PU29.01
Mwamba, T. PE05.13LB, PE16.24, Nazzari, A. OA15.04, PU21.08 Njume, D. PU14.01
PE23.07LB Nchabeleng, M. PE25.08 Nkambule, R. OA02.02
Mwangi, J.W. OA17.02 Ncube, B. PE06.10 Nkomo, S. PE25.07, PU25.03
Mwangi, S. PE26.01, PU29.01 Ndadziyira, P. OA13.01 Nkuutu, U. PU16.04
Mwanza, F. OA17.03 Ndhlovu, L. PE29.01 Noble-Campbell, P. PE09.02, PE09.03,
Mwenda, W. PE01.10 Ndhlovu, L.C. PE20.05 PE25.11
Mwendwa, R. PE26.01, PU29.01 Ndirangu, J. PE07.15LB Nomura, T. OA09.02
Mwesigwa, B. PU20.01 Ndjolo, A. PU14.01 Nonyana, N. PE25.09
Mwimali, P. PE06.03 Ndlazi, B. PE01.07 Nonyane, M. OA08.01
Mworeko, L. OA17.02, OA10.03 Ndlovu, M. OA11.04 Norr, K. PE06.05
Myer, L. OA07.05LB, OA21.05LB Ndlovu, N. PE16.07 Norr, K.F. PE05.03, PU05.02
Myers, L. PU01.14 Ndlovu, T. PE01.10 Nsibande, D. PU26.01
Ndossi, G.P.J. PU11.02 N nginya, N. PU20.01
Ndovie, M. PE12.01 Ntuli, A. OA05.03
N Ndua , E.W. OA14.03 Nuhu, F. OA20.04
Nabisere, J. PE06.01 Ndua , R. PE15.05LB Nu all, J. OA16.03, OA16.05,
Nabor, A. OA13.03 Ndungu, G. PU08.02 PE08.02, PE24.01
Nabukenya, S. PE05.09, PU05.03 Ndung'u, T. PE26.02, PE28.04 Nuwagaba-Biribonwoha, H. HY01.02LB
Nagawa, C.V. PU01.12 Nduva, G. PE11.12 Nyagol, B. OA06.02, PE04.02
Nagu, T. OA02.04 Ndwayana, S. PE01.49, PE01.53 Nyambura, K. OA20.04
Nahirya Ntege, P. HY01.02LB Nehete, P.N. PE24.03LB Nyangahu, D. PU24.01
Naicker, N. OA18.03, PE11.11, Neilands, T.B. PU28.03 Nyathi, N. PE16.38LB, PE23.07LB
PE25.08, OA18.02 Nelson, A. PE24.05LB Nyika, H. PE16.38LB, PE23.07LB
Naidoo, A. OA18.03 Nelson, J. OA02.01 Nyitray, A.G. PU07.02
Naidoo, L. PE25.03, PU25.01 Nelson, K. PE01.33
Naidoo, Y. PE05.01, PE06.01, PE12.01 Nelson, L. PE01.30
Nelwamondo, S. PE22.01
O
Naiman, N. PE15.05LB
Nair, G. HY01.02LB, OA04.05LB, Nematadzira, T. OA11.02, PE01.54 Ober, A. PU16.15
OA13.01, PE04.01, Nene, F. OA05.03 Ochieng, C. PE06.03
PE20.01, PE25.03, Neuman, M. OA21.04, PE05.07 Ochieng Ngoje, D. PE01.50
PU25.01, PU01.18, PU06.02 New, F. PU01.27LB Ochsenbauer, C. OA09.05LB
Nakabiito, C. HY01.02LB, OA06.04, Newaz, F. PE28.11LB O'Connell, R.J. OA22.02
PE01.20, PE04.02, Newcomb, M. OA07.03, PU01.07 O'Connor, C. PE16.11
PE05.01, PU01.09, PU01.12 Newman, D. OA14.04 O'Connor, D. PE07.10LB
Nakabiito, C.N. PE01.15 Newmann, S. OA19.01 O'Connor, S. OA06.02, PE07.10LB,
Nakabugo, L. PU16.06 Ngandu, N.K. PU26.01 PE04.02
Nakalega, R. PE01.15, PE01.20, PE05.01, Ngcapu, S. PE20.04 Odawo, P. PE16.24
PE06.01, PU01.09, PU01.12 Ngoc, L.B. PE16.12 Odeagbo, O. PE06.06
Nakamanya, S. PU05.03 Ngoepe, A. OA05.03 O'Dell, S. PE21.05LB, PE21.07LB,
Nakaweesa, T. PU16.04 Ngoje, D. PE16.17 PU21.08
Nakitende, A. PE16.15 Ngugi, C. PE06.10 Odenyo, J. PU16.04
Nakitende, M. PU16.06 Ngure, K. OA07.01, OA07.02, Odhiambo, F. PE01.63LB
Nakiyingi, L. OA08.04 OA13.01, OA17.01, Odhiambo, J. PE25.08
Nakyanzi, T. PE05.01 PE05.04, PE16.06, Odhiambo, J.A. OA02.05LB
Nakyeyune, J. PU01.12 PE16.14, PE16.18, Ododa, E. PE01.63LB
Nalumansi, A. PE16.13 PE16.21, PE19.04, Odoyo, J. OA07.02, PE05.04,
Namanda, S. PE16.13, PU16.06 PE25.02, PU01.14, PE16.18, PU16.14
Nambi, F. PU16.06 PU08.02, PU16.14 Ofotokun, I. OA22.04
Nambusi, M.J. PE05.01 Nguyen, D. PE02.15LB, PE07.12LB Ogbu, O. PE11.18
Nampiira, S. PE01.10, PE01.19 Nguyen, D.N. OA01.05LB Ogello, V. PE16.21
Namukonda, E.S. PE16.09 Nguyen, H. OA02.03 Ogunbajo, A. PU16.15
Nanda, K. PE06.04, PE16.32 Nguyen, P. OA02.03 Okawa, K. OA20.02
Nandakumar, A. PU01.27LB Nguyen Duc, K. PE16.23 Okech, B. PU16.34
Nang, Q. PE16.41LB Nguyen Thi, H. PE16.23 Okeji, N. PE16.34LB
Nanvubya, A. PU16.04 Nhlenyama, M. PE01.42, PU01.21 Okerentugba, P. PU14.04
235
Okesola, N. OA21.04, PE06.06, Oua ara, A.L. OA06.03, OA06.05 Perciani, C. PE19.08
PU08.01 Ouma, E. OA06.02, PE04.02 Pereira, G. PE11.16, PU23.04
Okiring, J. PU28.03 Ouya, D. OA10.03 Perkins, R. PE16.28
Okodan, D. PU16.04 Overbaugh, J. PE15.05LB Perlowski, C. OA03.02
Okoko, N. PE01.63LB Oware, K. OA07.01 Permar, S. OA18.05LB
Okonko, B. PU14.04 Owino, G. PE01.63LB Permar, S.R. PE24.05LB
Okonko, I. PE11.18, PU14.04 Owino, G.V. OA17.05 Perry, B. PE01.50, PE16.17, PU01.22
Okyere-Dede, E.K. PE01.09 Owi , G. PE16.31 Pessoa, C. PE29.01
Oladele, R. PE07.13LB Owuoth, J. PE01.25, PE29.02 Peter, N.F. PE03.03
Oladoye, M. PE07.13LB Oyedeji, D. PE05.10LB Peterhoff, D. OA15.02
Olaleye, O. PE01.03 Oyugi, J. PE19.05, PU07.01 Pe for, A. PE01.47
Olawo, A. PE26.01, PU29.01 Ozorowski, G. OA15.03, PE15.02, Pe for, A.E. OA10.04
Olia, A. PE02.09 PE21.03, PU21.10LB Phanuphak, N. OA22.02, PE20.05,
Olia, A.S. OA15.04 PE27.03
Olivella, M. OA05.01 Phanuphak, P. PE27.03
Olson, A.J. OA08.04
P Phelps, M. OA20.02
Olufadewa, I. PE07.13LB Paiardini, M. OA14.02 Philip, N. PE28.03
Oluoch, J. OA17.05 Paige, M. OA17.04 Philip, N.M. OA02.02
Oluoch, L. PE19.04 Palanee, T. PE16.32 Phillip, J. PU09.02
Olvera, A. PU21.06, OA05.01, OA20.01 Palanee, T.P. PE04.01 Phillips, A.N. PE04.04LB
Olvera, À. OA09.01 Palanee-Phillips, T. OA13.01, PE01.28, Phillips, T.P. PE05.01
O'Malley, G. OA07.02, PE01.31, PE06.01, PE12.01, Phuangngern, Y. OA22.02, PE20.05
PE16.18, PE16.19, PE16.14 PE14.02, PE16.03, Pillay, A.-D.A. OA19.05LB
Ombija, M. PE28.01 PE19.01, PE20.01, Pillay, D. PU23.03
Omollo, V. PE01.31, PE16.19 PE25.03, PE28.03, Pindiwe, B. PE23.07LB, PE16.38LB
Omolo, M. PE23.02 PU01.16, PU01.18, Pintye, J. PE05.04, PE16.31
Omondi, A. PE01.05 PU06.02, PU25.01, PU25.02 Pinyakorn, S. PE27.03
Ongachi, S. PU08.02 Palanee- Phillips, T. PE25.02 Piper, J. OA06.04, OA16.03, OA16.04,
Ongolly, F. OA07.02 Palgen, J.-L. PU21.10LB OA16.05, PE01.11, PE08.09LB
Ongwen, P. OA11.03 Palmer, S. PE07.07 Piper, J.M. OA06.01
Onishi, K. OA02.03 Palupi Rasajan, M. OA19.04LB Pisarski, E. PE16.13
Onono, M. PE20.01, PE28.03, Pan, Y. PE24.01 Pithon, T. PU23.04
PU01.18, PU06.02 Pancera, M. OA08.05LB Pi su hithum, P. OA22.02
Onwe, E. PU01.06 Panchia, R. HY01.02LB Pitsillides, P. PE25.10, PU09.01, PU09.02
Onwuzu, K. OA20.03 Pandey, S. OA20.03 Plank, R. OA04.05LB
Onyango, M. PE01.40 Pankow, A. OA03.04LB Plourde, K. PU23.03
Oosthuysen, B. OA08.01, PE02.07, Pantaleo, G. PE07.09 Plyler, J. PE02.10
PE02.12 Pantophlet, R. PE21.04LB Poignard, P. OA15.05LB
Opaleye, O. PU14.04 Parikh, U. OA06.03, PE14.02 Pokrovskaya, A. PU01.19
Operario, D. PE16.20 Parikh, U.M. PE16.07 Polakowski, L. OA03.01, OA18.01,
Oriol-Tordera, B. OA14.05LB, PU21.06 Parisi, R. PE01.08 OA18.02, OA18.03
O'Rourke, S. PE01.31 Park, C.G. PE05.03 Poliquin, V. OA20.04
Ortblad, K. PE05.04, PE11.10, Passmore, J.-A. PE20.04 Pollack, I.R. OA05.04, PU20.02
PE16.15, PU08.02, Passmore, J.-A.S. PE19.02, PU19.01 Polonis, V. PE02.06
PU16.06, PU16.14 Patel, D. PE06.05 Poloyac, S.M. OA06.01
Or z, A. PE19.09LB Patel, E. PE28.08 Polyak, C. PE01.25, PE29.02
Or z, R. PU15.03 Patel, M. OA04.05LB Pons-Faudoa, F.P. PE24.03LB
Oruka, K. PE16.34LB Patel, P. OA04.03, OA16.01 Poteat, T. PE01.34
Osawe, S. PE19.07 Pa l, C. PE06.05 Po er, E. PE07.05
Oseso, L. OA13.05LB, PE11.06 Pa l, C.L. PE05.03, PU05.02 Pourhassen, N. PE29.01
Osindo, J. PE01.51, PU01.15 Pa l, S. PU02.01 Power, J. PU01.08
Osman, F. PE20.04 Paximadis, M. PE28.10LB Power, K. OA20.02
Ossome, E. PE16.21 Paz-Bailey, G. PE18.01 Prabhakaran, M. PE02.10
Otani-Inoue, M. PE11.15 Pazgier, M. OA01.05LB, PE02.15LB, Pradenas, E. PE15.03, PU15.03
O ashvili, D. PE07.02 PE07.12LB Prasad, R. PE09.03, PE25.11
O eno, F. PE11.12 Peacock, S. OA06.02, PE04.02, PE16.18 Pray, I. PE07.10LB
O eno, M. PE06.10, PU01.15 Pebody, R. PE04.04LB Presley, J. PE16.22
O m, M. PE06.01 Pedersen, J. OA12.04LB Pretorius, C. PU18.01
O ndo, V. PE06.10 Peebles, K. PE16.06 Prévost, J. OA01.05LB
O so, L. PE06.03 Peer, A. OA04.05LB Price, M. OA09.05LB, OA10.02,
O cha, S. PU16.03 Peet, M.M. OA06.03, OA06.05 PE11.07, PE11.12,
Otwombe, K. PU16.13 Pegu, A. PE02.16LB PU14.03, PU16.04,
Ou, L. PE15.06LB, PE21.05LB, Penchala, S.D. OA19.05LB PU21.01, PU21.02
PE21.07LB, PU21.05, PU21.08 Penrose, K. PE14.02 Priestley, C. PE16.35LB
236
Prigmore, B.S. OA02.05LB Rerknimitr, R. PE20.05 Rovirosa, C. PE15.03
Prins, M. OA11.05LB, PE01.27, Resop, R. OA14.04 Rowe, K. PE23.04
PE16.10, PE16.40LB Rey, D. OA01.03 Roxby, A. PE19.04
Psaki, S. PE01.58, PE16.26 Reyes-Umana, L. PE16.28 Rozario, A. PE25.09
Psaros, C. PE06.02 Rhodes, B. PE02.14LB Rozhnova, G. PE11.04
Puangkaew, J. PU20.01 Riaz, F. OA11.01, PE16.33, PE23.06LB Rubinacci, V. PU07.03
Pulerwitz, J. PE01.58, PE16.26 Ribeiro, R. PE08.05 Rudometov, A. PU02.04LB,
Punjani, N. PE16.41LB Rice, J. OA19.02 PU21.09LB
Purcell, D. OA01.02, PE02.17LB Richard, J. OA01.05LB Rudometova, N. PU21.09LB
Purdue, L. OA03.02 Richardson, B. PE15.05LB, PE16.31 Rugeles, M.T. PE28.05
Pyles, R. PE08.04 Richardson, B.A. OA06.01 Ruhweza Katahoire, A. OA04.01
Pyles, R.B. PE08.10LB, PE24.04LB Richardson, S. OA08.01, PE02.07, Ruiz-Riol, M. OA05.01, OA14.05LB,
Pyra, M. OA07.01, PE01.43, PE16.08 PE02.08, PU15.04 OA20.01
Richardson, S.I. PE07.11LB Ruppel, A. PE02.10
Richmond, M. PE19.08 Rushwaya, C. PE01.19, PE12.01
Q Riddler, S. OA04.03, OA16.03 Rusie, L. PE01.43
Qiu, J. OA04.04 Riddler, S.A. OA04.05LB Ruth, S. PU01.08
Qiya, B. PE06.02 Ridgway, J. PE01.43 Ruzagira, E. PE01.40, PE05.09,
Quinn, K.G. PU07.02 Ridzon, R. OA06.02, PE04.02 PU05.03
Riegel, L. PE16.16 Ryan, D. OA07.03
Riggins, L. OA10.04 Ryan, J. PE01.14, PE01.28
R Rigsby, H. OA14.04 Ryan, K. PU01.08
Radakovich, N. PE02.09 Rinehart, A.R. OA10.01 Rybicki, E. OA15.01
Radin, E. PE11.03 Rinke DeWit, T. PE16.20
Ri roongrad, S. PU20.01
Radzey, N. PE06.04
Riva, L. PE07.06
S
Ram, D. OA05.02
Ramos Goes, L. PE28.06 Robb, M.L. OA22.02, PE27.03 Saal, W. PE01.01
Rampyapedi, H. PE05.01 Roberts, A. PE20.06 Sabin, C. PE16.35LB
Ramraj, T. PU26.01 Roberts, S. OA17.01, PE12.01, Sacdalan, C. PE20.05, PE27.03
Randhawa, A. PE17.01 PU01.16, PU16.03 Sacha, J. OA20.03
Raphael, Y. OA10.03, OA17.02 Roberts, S.T. PE16.03 Sadik Shaik, J. OA04.03, PE22.02
Rasmussen, S. OA04.05LB Robertson, M. OA04.05LB Saez-Cirion, A. PE15.01
Ratna, N. OA16.02 Robinson, C. OA20.04, PU20.01 Safina, K. PE01.40
Ratnaratorn, N. PE20.05 Roche, S. PE05.04, PE16.15, PU16.14 Sagaon-Teyssier, L. PE16.16
Ravel, J. OA19.02 Rodger, A. PE04.04LB, PE16.35LB Sagar, M. OA08.04
Ravichandran, R. PE21.03 Rodrigues, J. OA11.01, PE06.10, Saha, P. PE05.08
Rawi, R. PE02.03, PE02.09, PE16.22, PE16.33 Sailer, J. PE09.01
PU02.03 Rodriguez, O. PE02.05 Saintonge Aus n, P. OA17.04
Reast, J. PE25.10, PU09.01, Rodriguez de la Sajadi, M. PE02.15LB
PU09.02 Concepción, M.L. OA20.01 Sajani, A. PE28.06
Reback, C. PU16.15 Rodríguez de la Sakawaki, H. OA09.02
Redd, A. PE28.08 Concepción, M.L. PE15.03, PU15.03 Salami, T. PE01.13
Reddy, K. PE01.14, PE01.28, Rodriguez-Díaz, C. PE11.01 Salazar, A. PE21.02
PE05.01, PE06.01, PE12.01, Roederer, M. PE07.05, PE28.06 Salazar Lostanau, X. OA21.01
PE25.02, PE25.03, Rogers, K. OA01.01 Salazar Quiroz, N. OA01.02, PE02.17LB
PU01.16, PU01.18, PU06.02 Rohan, L. PE24.02 Salfas, B. PE11.01
Reddy, N. OA16.04 Rojas Castro, D. PE01.35, PE16.16 Salihu, A. PE05.10LB
Reed, D. PE11.03 Rolland, M. OA03.04LB, PE02.06 Salit, I. PE20.02
Reed, J. OA11.03, OA20.03, PE16.22, Roman, N. PU28.01 Sallabank, G. PE23.01
PE25.09, PE29.01 Romas, L.N. PE20.01 Salzwedel, J. OA17.03, PE12.02
Reed, S.G. OA12.02 Romero-Mar n, L. OA05.01, OA20.01 Sambai, B. OA21.02
Rees, H. PE28.03 Romero-Mar n, L. PU21.06 Samoff, E. OA02.01
Reeves, R.K. OA05.02 Rönn, M. PE07.01 Samona, A. PE16.24
Rehrauer, W. PE07.10LB Rooney, J.F. PE24.03LB Sanchez, M. PE11.13
Reichardt, N. OA15.05LB Rosas-Umbert, M. OA05.01 Sanchez-Pla, A. OA14.05LB
Reid, J. OA10.01 Rosa , M. OA12.02 Sandberg, B. OA20.04
Rein-Weston, A. OA04.01 Rosen, A. PE05.13LB, PE16.24, Sanders, E. OA09.05LB, PE16.20
Reisner, S. PE05.11LB PE16.38LB, PE23.07LB Sanders, E.j. PE26.02
Reiss, E. OA15.03 Rossin, E. OA09.04 Sanders, R. OA01.02, OA15.02,
Relouzat, F. PE21.02 Rossouw, T. PE07.11LB PE02.10, PE21.03
Rendina, H.J. PE11.01 Rouiller, I. OA01.02 Sanders, R.W. PE24.05LB, PU21.10LB
Rendina, J. PE01.12 Rousseau, E. PE01.31, PE01.59, Sandoval Figueroa, C. PE01.55
Reno, H. OA19.01 PE16.19 Sandstrom, P. PE19.08
Rentas, F. OA13.05LB Rouzioux, C. PE15.01 Sandström, E. OA02.04
237
Sango, A. PE22.01 Sethi, A. OA01.02 Simon, G. PE20.06
Sano, M. PE20.02 Sethi, R. PE14.02 Simpson, J. PE19.09LB
Santos, T. OA13.03 Seyama, L. PU25.01 Simpson, S.M. OA04.04
Sanzone, A. PE02.14LB Seydoux, E. OA08.05LB Simwanza, S.C. PE05.13LB
Saresella, M. PE17.02 Shabalala, F.S. PE01.06 Singh, A. PE25.05, OA05.03
Sarfo, E. PE21.05LB, PE21.07LB Shahmanesh, M. OA21.04, PE01.41, Singh, D. OA06.01, PE01.26,
Sarfo, E.K. OA15.04, PU21.05 PE01.42, PE06.06, PE25.03, PU25.02
Sarmento, B. PE08.05 PE13.01, PU01.15, Singh, N. HY01.02LB, OA02.05LB,
Sarrassat, S. PE01.45 PU01.21, PU08.01, PE11.11
Sastry, K.J. PE24.03LB PU16.09, PU16.11 Singh, O. OA06.05
Sastry, M. OA15.04, PE21.05LB, Shakwelele, H. PE05.13LB, PE23.07LB Singh, P. PE01.61LB
PU21.08 Shakya, P. PU01.25LB Singh Chandrawacar, A. PE15.02
Sa entau, Q. OA15.02 Shalek, A. OA05.03 Sinkele, W. OA21.02
Saubi, N. OA09.01 Shalhav, O. PE01.12, PE11.01 Sirengo, M. PE26.02
Saulle, I. PE17.02 Shan, X. OA20.02 Siskind, R. PU05.01
Saunders, J. OA16.02, PE16.35LB Shang, H. PE28.02 Si ma, E. PE01.19
Saunders, K.O. OA12.02, PE02.14LB Shangase, N. PE07.15LB Siu, G. OA04.01
Sawada, T. PU01.25LB Shapiro, L. OA08.02, PE02.03 Siva, S. PE01.26, PE04.01,
Sawe, F. PU20.01 Shapiro, M. OA20.03 PE12.01, PU25.02
Scarla , G. PU21.10LB Shapley-Quinn, M.K. OA06.04, Sizemore, K.M. PE11.01
Schachtner, M. OA15.02 OA17.01, PU25.03 Sizemore, S. OA02.01
Scheckter, R. OA16.04, PE08.09LB, Shapley-Quinn, M.-K. PE25.07 Sizovs, A. PE24.03LB
PE12.01, PE25.02, PE25.03 Sharma, A. PE01.61LB Skalland, T. OA03.01
Scheepers, C. OA08.01, PE02.01, Sharma, S. PE14.01, OA22.04, Skinner, M.A. PE20.03
PE02.05, PE02.08, PU15.04 PE25.10, PU09.01, PU09.02 Slack, C. PE12.02
Schermer, E.E. OA15.03 Sha ock, R. PU21.10LB Sliepen, K. PE21.03
Schim van der Loeff, M. PE01.27, PE16.10 Shaw, G.M. OA12.02 Slike, B. PE02.06, PE20.05
Schim van der Loeff, M.F. OA11.05LB, Shcherbakov, D. PU21.09LB Slyker, J. PE15.05LB
PE16.40LB Shelton, K.A. PE24.03LB Smedley, J. OA20.03, PE29.01
Schmidt, A.J. PE01.35 Shen, C.-H. OA08.02, PE02.09, Smit, J. PE06.04, PE06.07, PE28.03
Schmidt, S. OA08.02, OA01.03 PE21.07LB, PU21.08 Smit, J.A. PE06.02
Schneider, J. OA01.01, PE02.13, Shen, X. OA12.02 Smit, T. OA21.04
PE07.14LB, PE16.08 Sheng, Z. OA08.01, OA08.02 Smith, A. PE11.12
Scholte, F. OA12.04LB Shenoi, S. PE16.05 Smith, B.-A. PU23.03
Schramm, C. PU02.03 Sherafat-Kazemzadeh, R. PU01.27LB Smith, C. PE25.10, PU09.01, PU09.02
Schuetz, A. OA22.02, PE20.05 Sherburn, R. PE07.12LB Smith, E. OA03.02
Schultz, C.H. PE20.06 Sherman, G. PU26.01 Smith, J. PE24.01
Schwartz, H. OA04.05LB Sherr, L. PE06.06, PU16.09 Smith, P. PE06.02, OA02.05LB
Schwartz, J. PE25.01 Sheth, A. OA22.04 Smith, S.A. OA05.04, PU20.02
Schwartz, J.L. OA06.03 Shiba, V. PE16.11 Soares, F. PE16.27
Schwartz, O. PE02.11, PE15.01 Shiino, T. PE11.15 Soares, M. PE21.01
Sco , H. PE16.28 Shongwe, M.C. PE01.06 Sobieszczyk, M. OA03.01, PE28.08
Scoville, C. PE16.21, PE20.01, PU16.06 Shoptaw, S. PE01.30 Sojane, K. PE28.04
Searle, C. PE25.10, PU09.01, PU09.02 Shorrock, F. PE01.37 Sok, D. PE02.04
Seaton, K. OA18.02, PE17.01 Shrestha, P. PE25.09 Solaiyappan, M. PE22.02
Sebe, M OA18.03 Shrivastava, R. PE08.04 Song, H. PU14.03
Seeley, J. OA21.04, PE01.23, Shu, T. OA09.02 Soni, N. PE07.01
PE01.41, PE01.42, PE01.54, Shukarev, G. PU20.01 Sorren no, I. PE01.52
PE06.06, PU01.21, PU16.09, Shumbullo, E. PU08.01 Soto-Torres, L. OA13.01, OA17.01,
PU16.11, PU16.13, PU21.01 Shvachko, V. PE11.02 PE01.26, PE25.03,
Segal, K. OA11.01, PE06.10, PE16.33 Shvartsman, E. PE19.08 PU25.02
Segura, M.M. PU15.03 Sibanda, E.L. PE05.07 Soto-Torres, L.E. PE04.01
Seidman, D. PE01.62LB Sibeko, S. PE05.01 Sousa, C. PE11.16, PU23.04
Seiphetlo, T.B. OA19.05LB Sicard, T. PE02.01 Sovic, B. PE07.07
Selepe, P. PU14.05LB Sichone, G. PE05.13LB Sozi, C. OA10.01
Selhorst, P. PE27.02 Sidener, H. OA20.03 Spacova, I. PU24.01
Selke, S. PE19.04 Siegel, M. PE16.02 Spanish Group for the Study
Semitala, F. OA04.01 Sijy, O. PU21.05 of New HIV Diagnoses, I PE11.13
Sender, N. OA10.02 Sila, J. PE16.31 Sparks, A. PE16.02
Senyonga, W. PU21.01 Silhol, R. PE07.01 Spence, P. PE08.03, PE08.06
Serebrenik, J. PE19.06 Silondwa, M. PE05.13LB, PE23.07LB Spencer, D. PE02.11
Serna, S. OA15.05LB Silva-San steban, A. OA21.01 Spencer, H. PU15.04
Serrano, M. PE06.04 Silvestri, G. OA14.02 Spire, B. PE16.16
Serrano, P. OA13.02 Simelane, M.S. PE01.06 Spreen, W. OA04.03, PE22.03, PE28.02
238
Springer, S. PE16.05 Tapia, G. PE01.08 Triple , N. PU01.16
Srikrishnan, A.K. PU02.01 Tapia, K. PE19.04 Trkola, A. OA15.02
Srinivasan, P. PE24.01 Taranin, A. PU02.04LB Tsawe, N. OA21.05LB
Ssali, S. PU28.03 Tarhoni, I. PE07.14LB Tshabalala, G. OA11.02, PE01.09,
Ssekasi Miwanda, A. PE22.01 Tarimo, E. OA02.04 PE01.54, PU16.13
Ssemaganda, A. OA20.04 Tarrés-Freixas, F. PU15.03 Tsidya, M. PE01.26
Ssemata, A. OA11.02, PE01.54, PU16.13 Tauya, T. PE25.02 Tsybovsky, Y. PE15.06LB
Ssetaala, A. PU16.04 Tavares, F. PU23.04 Tully, D. PE11.19LB
Stamatatos, L. OA08.05LB, PE02.10 Tavella, N.F. PE11.01 Tumushime, M. PE05.07
Starke, C. PE19.09LB Tayler, V. PE23.03 Tupinambás, U. PE16.27
Statzu, M. OA14.02 Taylor, J.J. OA08.05LB Tuyishime, M. OA14.01
Stein, M. PE20.03 Taylor, O. PE11.19LB Twesige, C. PE16.13
Steiner, M. PU01.18, PU06.02 Teal, V. OA04.05LB Tyers, L. PU14.02
Stephane, O.C. PE03.03 Tehrani, Z. PE02.12LB Tyssen, D. PE19.03
Stephenson, R. PE23.01 Teleshova, N. PE08.09LB
Sterre , S. OA09.03 Tembo, F. PE16.25
Stevenson, M. PE05.11LB Tembo, T. PU25.01
U
Stewart-Jones, G.B. PU21.08 Tenza, S. PE01.28, PE05.05 Ueckermann, V. PE07.11LB
Steytler, J. OA06.01, OA16.03 Terahara, K. OA09.02 Ueno, T. PU11.02
Stoner, M. OA06.04, OA10.04, PU25.01 Terris-Prestholt, F. PE05.07, PU16.13 Ukaere, A. PE05.10LB
Stoové, M. OA16.01, PU01.08 Tevlin, E. OA22.05 ul Hadi, S. PE05.08
Storholm, E. PU16.15 Thabethe, S. PE12.02 Umviligihozo, G. PU14.03
Stracuzzi, M. PU07.03 Thakar, J. PE17.01
Stranix-Chibanda, L. OA11.02, Thakkar, D. PE28.09
OA18.02, OA18.03, Tharao, W. OA22.05
V
PE01.54, PE22.01 Theodore, D.A. PE07.07 Valen n, A. OA12.02
Strauss, J. PE06.04 Thomas, D. PE16.21, PU16.06 Van, H.T.H. PE16.12
Streatfield, C. OA14.03, PE03.01 Thomas, K. OA06.02, OA07.01 van Bilsen, W.P. PE01.21
Strehlau, R. PE28.10LB Thomson, M.M. PE11.13 Vancuren, S. PE19.08
Strong, C. PE01.22, PE16.01 Thurman, A. OA06.03, OA06.05 van den Elshout, M. PE16.10
Stuart, A. PE02.10 Thurman, A.R. PE04.02, PE25.01 van den Elshout, M.A.M. OA11.05LB
Stuckey, J. PU21.08 Tian, M. OA08.02 van der Elst, E. PE26.02
Stuurman, R. PE06.01 Tiemessen, C.T. PE28.10LB Van der Elst, E. PE16.20
Su, J.T. OA04.04 Tieu, H.-V. PE01.13 van der Merwe, L.L.A. PE01.34
Sullivan, A. PE16.35LB Tingler, R. PE01.11 van der Straten, A. OA06.04, OA13.01,
Sullivan, P. PE23.01 Tipsuk, S. PE27.03 PE01.19, PE01.28,
Sung, S. OA04.04 Tlou, T. OA11.04 PE01.31, PE01.47,
Sunguya, B. PU11.02 Todd, J. PE18.01, PU21.02, PE15.06LB PE01.59, PE16.19,
Surenaud, M. PE07.03 Tokusumi, T. OA09.02 PE25.02, PE25.03,
Sutar, J. PE02.04, PU02.01 Tolazzi, M. PU21.10LB PE25.07, PU25.01,
Svensson, J. PE01.57 Tolbert, W. PE02.15LB PU25.02, PU25.03
Svisva, A. PE16.38LB, PE23.07LB Tolbert, W.D. OA01.05LB Van der Straten, A. PE04.01
Swanson, O. PE02.14LB Tolley, E. PE16.03, PE25.01, Van Der Waag, A. PU01.11
Swanstrom, R. OA02.01, PU14.02 PU01.14, PU01.16 van der Walt, Z. PE07.11LB
Szurgot, I. PE07.09 Tomaras, G. OA18.02, PE17.01 Van de Ven, R. PE28.01
Szydlo, D. OA16.03, PE14.02 Tomaras, G.D. OA12.02 van Diepen, A. OA15.05LB
Tomaszewska-Kiecana, M. PE04.03LB van Diepen, M. OA15.01, OA18.04
Torrents de la Peña, A. OA15.03
T Torres, J. PE01.60LB
Van Diepen, M. OA12.05
van Dorsten, R.T. OA08.03, OA03.05
Tachedjian, G. PE19.03 Torres, J.A. PU01.24LB van Duijnhoven, Y.T.H.P. OA11.05LB
Taetgmeyer, M. PE05.07 Torres, T.S. OA13.03 Vane , C. PU07.03
Tagliaferri Rael, C. PE01.36, PU01.13 Tovanabutra, S. PE02.06 van Gils, M. OA01.02, OA15.03,
Tahar, O. OA01.03 Townsley, S. PE02.06 PE15.06LB
Takou, D. PU14.01 Traba oni, D. PE17.02, PU07.03 van Haaren, M.M. OA15.03
Taku, O. PE06.04 Traeger, M. OA16.01 van Harreveld, F. PE01.39
Tala, V. PU14.01 Tragonlugsana, N. PE20.05 van Hougenhouck-
Talan, A. PE01.12, PE11.01 Tran, K. PE16.23 Tulleken, W. PE07.11LB
Tang, A. OA13.04 Tra nig, N. PE21.04LB Vann, N. OA06.05
Tang, J. PE06.07 Travill, D. OA11.04, PE01.31, van Niekerk, N. PU01.05
Tanko, R. PE20.01 PE01.62LB, PE16.19 Van Osch, G PU01.11
Tanno, S. OA20.02 Trevelion, R. PE04.04LB Van Rompay, K.K. PE24.05LB
Tano-Menka, R. OA09.04 Tricot, S. PE21.02 Van Ryk, D. PE21.01, PE28.06
Tanser, F. PE01.41 Trifonova, R. OA20.02 van Schooten, J. PE15.06LB
Tao, L. PE11.02 Trinité, B. PU15.03 Van Tieu, H. PE11.06
239
Van Tilbeurgh, M. PU21.10LB Wamu , B. PE11.10 Williamson, C. OA03.04LB, PE27.02,
van Wees, D. PE11.04 Wan, Y.-H. OA08.05LB PU14.02
Varela, I. PU15.03 Wang, A. PE02.14LB Willy Leroi, T.P. PU14.01
Vargas, G. PE08.10LB, PE24.04LB Wang, H. OA14.02, PE21.07LB, Wilson, K. PE16.31
Varney, J. PU01.11 PE28.02 Wilton, L. PE01.30
Vasan, S. OA22.02, PE20.05 Wang, M. PE19.04, PE28.02 Wines, B. PE15.05LB
Vasyliev, S. PU28.01 Wang, Y. PU21.08 Wirth, K. PE06.02
Veazey, R. OA01.01, PE02.13, Wannamaker, P. PE28.02 Wirtz, A. PE01.34, PE05.11LB,
PE28.09 Wanyoike, I. PU16.02 PE16.36LB
Vega Ramirez, E.H. PE01.55 Ward, A. PE25.08, PE21.03 Wirtz, A.L. PE16.39LB
Velloza, J. PE25.06 Ward, A.B. PE15.02, OA15.03, Witzel, T.C. PE04.04LB
Veloso, V. PE01.55 PU21.10LB Woeber, K. PE25.02
Velter, A. PE01.35 Ward, D. PE04.04LB Wolf, H. PE16.02
Venzon, D.J. OA12.02 Ward, L. PU20.01 Wolfe, J. PE23.01
Verardi, R. PE02.09, PE02.16LB, Ware, C. PE16.02 Wong, A.L. OA12.03
PU21.08 Ware, N. PE16.13 Wooding, D. PE03.04LB
Vermaak, S. PE01.54 Ware, N.C. PE06.02 Wright, E. OA16.01
Verniquet, M. OA01.03 Warren, M. OA10.01, OA10.03, Wu, H. PE29.01
Verrier, B. OA12.01 OA11.01, PE06.10, Wu, H.-J. PE16.01
Vézina, D. OA01.05LB PE16.22, PE16.33, Wu, S. PE28.02
Vezy, R. OA04.03 PE23.06LB Wu, X. OA03.03LB
Vickers, T. OA16.01 Wassenaar, D. PE12.02 Wu, Y. PE07.07
Viegas, E. PE17.01 Watadzaushe, C. PE05.07 Wu, Z. OA21.03
Villani, A.-C. OA19.03 Waters, L. PE16.35LB Wya , M.A. PE16.13
Villes, V. PE01.35 Watrous, D. OA04.04
Villinger, F. OA01.01 Watson, C. PE02.05
Vimonpatranon, S. PE21.01 Weatherburn, P. PE04.04LB
X
Vincent, K. PE08.04 Webb, G. PE29.01 Xaba, S. PE16.38LB, PE23.07LB
Vincent, K.L. PE08.10LB, PE24.04LB Wechsberg, W. PE07.15LB Xavier Hall, C. OA07.03
Vinton, C. PE19.09LB Wee, E. OA12.03 Xiao, S. OA01.01, PE28.09
Vi nghoff, E. PE18.01 Wee, E.G. OA15.03 Xie, D. PE02.09
Voillet, V. OA18.03 Weerasinghe, G. PU01.26LB Ximba, P. OA12.05, OA15.01
von Doussa, H. PU01.08 Wei, D. PE21.01, PE28.06 Xu, J. PE24.03LB, OA19.03,
Vrbanac, V. OA20.02 Weidle, C. OA08.05LB OA19.02, PE19.05
VRC, P.P. PU21.05 Weiner, J.A. OA12.02 Xu, K. OA15.04, PE15.06LB,
Vundamina, N. PU23.03 Weir, B. PE16.36LB PE21.05LB, PE21.07LB,
Vyas, S. PE01.61LB Weir, B.W. PE16.39LB PU21.08
Weiss, D.J. PE01.61LB Xu, R. PU14.03
Weiss, E. PE20.02 Xulu, N. OA19.03
W Weiss, H. PE01.54 Xulu, S. PE06.06
Wachinger, J. PE16.15 Weiss, H.A. OA11.02
Wagner, D. PE16.03, PU01.16 Weiss, S. PE01.52LB
Wagner, R. OA15.02 Weissenhorn, W. OA15.02
Y
Wählby, C. PE19.05 Wejnert, C. PE18.01 Yaffe, Z. PE15.05LB
Wahome, E. PE11.12 Weld, E. OA04.03 Yang, E.S. PE02.16LB
Wairimu, N. PE16.14, PE16.21, Wendoh, J. PU24.01 Yang, Y. PE21.04LB, PE02.09
PU16.14 Were, D. OA11.03, PE25.09 Yao, X. OA12.04LB
Waite, D. OA13.03 Westergaard, R. PE07.10LB Yassin, S. PE16.28
Wakhutu, B. OA11.03, PE25.09 Wes all, D. OA03.04LB Yates, A. PE27.03
Wald, A. PE19.04 Wes n, M. PE16.27 Yaya, I. PE16.16
Wales, B. OA01.02 Westmaco , G. PE20.01 Yin, X. PE07.06
Walker, B. OA09.04 Wheeler, D. PE01.30 Yola, N. OA10.03
Walker, M. OA10.04 Whiteside, Y. PE25.05 Yolitz, J. PE28.06
Wall, A. OA08.05LB Wibmer, C.K. PE21.01 York, T. OA03.04LB
Wallace, S. OA13.05LB, PE11.06 Widanage, W.N. PU01.26LB Young, A. OA17.01
Walsh, A. PE23.01 Wiener, J. PE04.02 Young, I. PE08.04
Walsh, J.L. PU07.02 Wilkinson, A. PE12.02 Young Holt, B. PE16.32
Walsh, S. OA03.01 Williams, W.B. OA12.02 Yousef, A. PE05.05
Wambiya, E.O. PE01.51 Williamson, A.-L. OA12.05, OA15.01, Yousefieh, N. OA06.05
Wamoni, E. PE16.18 OA18.04, PE06.04 Yue, L. PU14.03
240
Z Zheng, R. PE24.02 Zisse e, S. PE25.01, PU01.14
Zhou, K. PU02.03 Zoumenou, I. OA17.04
Zahoor, M.A. OA22.01 Zhou, S. OA02.01, PU14.02 Zucco , G.V. PU07.03
Zewdie, K. OA16.02, PE01.62LB, Zhou, T. OA08.02, OA15.04, PE21.07LB Zucker, J. PE07.07
PE28.03 Zhu, B. PE28.02 Zulu, J. PE23.07LB, PE05.13LB
Zhang, B. OA15.04, PE02.09, Zhu, Y. PE08.10LB Zuma, T. OA21.04, PE01.42, PE06.06,
PE02.16LB, PE21.07LB, Zia, Y. PE16.21 PU01.21, PU16.09, PU16.11
PU21.05 Zieman, B. PE01.58, PE16.26 Zumer, M. PE20.06
Zhang, F. PE28.02 Zimba, C. PE25.02 Zungu, Y. OA05.03
Zhang, H. PU01.25LB Zimmerman, S. OA02.01 Zurawski, G. PE07.03, PE07.09, PE21.02
Zhang, J. PE24.01 Zimmermann, H. PE01.27, PE01.39, Zurawski, S. PE07.09, PE07.03, PE21.02
Zhang, L. PE17.01 PE16.10 Zwolsman, R. OA15.03
Zhang, T. PU05.02 Zimmermann, H.M.L. OA11.05LB Zydowsky, T.M. PE08.09LB
Zhang, Z. OA14.02 Zimmermann, H.M. PE01.21
Zhao, X. PE08.07 Ziraba, A. PE01.33, PE01.51, PU01.15
241
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4th HIV Research For Prevention Conference (HIVR4P Virtual), 27 & 28 January 3 & 4 February 2021

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Abstract Supplement

4th HIV Research for Prevention

Volume 24, Supplement 1, February 2021

Publication only Abstracts

Volume 24, Supplement 1

Author Index 224

Conclusions: HIV-negative serum IgA, and to a lesser extent HIV-

Background: The identification of recent (incident) HIV infections OA02.02

phenotypes, and in some cases, low frequency resistance mutations

Background: CAB LA dosed at 2-month intervals demonstrated viro-

hydrophilic polyether urethane membrane. The membrane was

the context of effective ART and immune reconstitution. It will be crit-

results from a randomized controlled trial of SMS reminders to sup-

PrEP, electronically monitored adherence was 26.9% over 24 months

responses than the corresponding non-adapted epitopes (NAE). A sig-

mild, convalescent COVID-19 patients prior to assessment of CD137

Background: The October 2019 FDA approval of F/TAF (Descovy) as

numbers, geography, and other indicators. This analysis examined data

profound immediately after 15 March 2020, and returned to pre-

at a 1:1 (p = 0.0041; 0.005) or 1:5 (p < 0.0001) target: effector ratio.

summarized the therapy-modulated pathways with eigenvectors of

Conclusions: The TO design is a useful platform for generating Env

Background: Many HIV-1 broadly neutralizing antibodies (bnAbs) iso-

chlamydia (p = 0.116) and urogenital gonorrhoea (p = 0.973) were

Background: Multiple PrEP studies suggest incidence of bacterial OA16.02

more MIV-150 to rectal tissues is likely needed to support further

early in the research process and served as a main form of commu-

OA17.03 Background: HIV prevention research projects often apply “empow-

Background: RV144 demonstrated modest HIV preventive vaccine

Immunization of rabbits indicated that Q11-gp120 also induced higher

Background: While there are methods to prevent HIV infection,

OA21.01 Background: In Peru, considerable gaps remain in achieving the goal

Methods: Immune properties were defined throughout the menstrual OA22.05

targeting this population. Many young Nigerians are ardent social-

Methods: Following ASPIRE, clinicians disseminated results of a 27%

Abstract PE01.26-Table 1. PE01.27

Background: It is feared that pre-exposure prophylaxis (PrEP) will

Support for equitable SRH decision-making was high in both settings:

PE01.38 Background: The impact of biomedical HIV-prevention strategies

Background: While 11% of new HIV infections in the US are in Black

PE01.47 are needed to enhance the prevention toolbox for AGYW. An

a promising strategy to promote positive attitudes and behaviours

Results: Twenty interviews were conducted representing eight HIV

consistent across different regions, the involvement of whole cere-

Broadly neutralizing antibodies PE02.03

Background: Broadly neutralizing antibodies (bnAbs) have shown

mechanism for this is poorly defined. We have previously isolated a

Background: Induction of broadly neutralizing antibodies (bnAbs) as

PE02.17LB Cellular immunity

Abstract PE04.01-Table 1. Results from multivariable logistic regres-

Conclusions: Successful recruitment of AGYW requires a multipronged

condom use. To scale-up, we transferred ownership to communities. PE05.04

the investigator. Proportions were measured for screened and enrolled

PE05.10LB Background: Online recruitment strategies have been implemented

research. However, a combination of traditional and online methods

Conclusions: As the VMMC Program in Zambia strives for sustain-

Conclusions: Use of pre-screening strategies provides valuable insight

al, Canada, 10Harvard T. H. Chan School of Public

Methods: Between April 6 and July 21, 2020, we conducted 42

Background: Female sex workers (FSW) in Zimbabwe have an HIV

Abstract PE07.06-Figure 1. Abstract PE07.06-Figure 2.

(aCD40-RBD). Immunogenicity was tested in humanized NGS mice (hu-

a growing library of converged SARS CoV2 binding peptides. IgG gly-