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CrescentCare Start Initiative: An Intervention to End

the Epidemic

Jason Halperin, MD MPH


I have no financial disclosures.
Objectives

• Brief rationale for immediate initiation of HIV


antiretroviral therapy
• Describe CrescentCare’s procedure to provide
this service
• Review data from immediate start
intervention at CrescentCare
Where is HIV now?
Why Push for Earlier ART?
• Shifting guidelines (DHHS and WHO)
• High attrition rates between time of positive HIV test and ART initiation
• Delays in treatment are associated with
– Increased mortality
– Diminished CD4 recovery
– Avoidable hospitalizations
– Higher costs of treatment for opportunistic
infections
– HIV transmission
• Improved ART tolerability and durability
• Lower risk for viral resistance with current ART regimens
Lessons From Other
International Models
• Same-Day ART (SDART; Haiti)1 • Home-Based Testing (CASCADE;
– Same-day ART vs SOC (RCT; n=280 in Lesotho)2
each group) Positive in-home−based test → same-day
– Inclusion: adult; TN; WHO stage 1 or 2; ART vs SOC (RCT; n=137 in each group]
CD4 ≤500 – Intervention: posttest counseling; pamphlet
– Intervention: ART offered day 1 on ART adherence; POC CD4 and SCr;
– Study stopped due to significance of ART; follow-up at health facility in 14−28
SDART results days
• ART initiation rates – Primary outcome:
• Alive and in care at 12 months (80% vs • Increased rates of linkage to care (69%
72%) vs 43%) by 3 months
• Alive with undetectable VL (53% vs 44%) • VS at 12 months (51% vs 34%)
– Secondary outcome: increased retention at
12 mo
NS, nonsignificant difference; POC, point of care; RCT, randomized control trial; SCr, serum creatinine; SOC, standard of care; WHO, World Health Organization.
1. Koenig S, et al. PLoS Med. 2017. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002357. Accessed May 3, 2018; 2. Labhardt ND, et al.
JAMA. 2018;319(11):1103-1112. Accessed May 3, 2018; 3. Amanyire G, et al. Lancet HIV. 2016;3(11):e539-e548. Accessed May 3, 2018.
San Francisco General Hospital
RAPID Model
HIV+ Diagnosis 1st Clinic Visit 1st PCP Visit ART Start Viral Load
• Disclosure • Registered • Medical evaluation • Pills taken Suppressed
• Referral • Insured • ART criteria met • VL monitoring
• Scheduling • Housing/SU/MH • Adherence
• Counseling • Retention
• Labs

RAPID Visit and ART Start


• Disclosure, counseling, registration
• Insurance
PCP visits
• Housing/SU/MH • VL monitoring
• Labs • ART management
• Counseling • Adherence
• Medical eval • Retention

Pilcher CD, et al. J Acquir Immune Defic Syndr. 2017;74(1):44-51.


RAPID
Uptake of Same-Day ART
Rapid Universal Key Sociodemographics
97.4 100
100 94.9
89.7 RAPID Universal
n=39 n=47
80
Patients on ART, %

63.2 Homelessness 11 (28%) 13 (25%)


60
Uninsured 39 (100%) 47 (100%)
40
26.3
20 14 15.8 Illicit Substance
18 (46%) 18 (38%)
Use
0
0 1 7 30
Days After ART Offer/Clinician Visit

Pilcher CD, et al. J Acquir


Immune Defic Syndr.
2017;74(1):44-51.
Key Facilitators of RAPID Intervention

• Same-day appointments
• Flexible provider scheduling (on-call back-up)
• ART-regimen preapproval prior to genotyping or lab
testing
• Availability of 5-day ART starter packs (Oh, San
Francisco!...)
• Accelerated process for health-insurance initiation
• Observation of first ART dose in clinic (recommended)

Pilcher CD, et al. J Acquir


Immune Defic Syndr.
2017;74(1):44-51.
CrescentCare Start Initiative (CCSI):
Patients diagnosed are seen by a
provider within 72 hours (optimally
same-day) and provided 30 days of ART.

Early Intervention Services (EIS): Same


protocol but patients contacted our
clinic over 72 hours since diagnosis.
Range: 4 days – 22 years
What Is CrescentCare?
• Started as an ASO in 1984.
• FQHC in 2016
• Primary care for adults, adolescents
children
• Specialty care for people living with HIV
• Free HIV and STI testing through our
sexual wellness clinic
• Community-wide/venue based HIV/STI
Testing
• Dentistry
• PrEP clinic
• Transgender clinic
• Psychiatric services
• Addiction Medicine
• Case management, behavioral health,
peer support, insurance enrollment
assistance
Total numbers
• Project started: 12/1/2016
• First CCSI Patient Seen: 12/6/2016
• Expanded to EIS: 12/21/2016

Total numbers: 253


• 153 CCSI
• 100 EIS
Procedure
• Testing:
Courthouse, Healthcare for the Homeless, Venue-
based, Movement, CAN, Brotherhood, STI Clinic
• Internal Referrals:
Client brought down to clinic, linkage navigator
notified for data tracking purposes
• External Referrals:
Planned Parenthood, Tulane Uptown Medical
Care, UMC, Tulane Hospital, Ochsner, local PCP
Procedure/Methods
Medical Provider Visit:
- HIV Lifecycle, importance of adherence, U=U
discussed
- Comorbidities assessed
- Diagnosis verified
- Provider option to not rx, alter medications if
suspected resistance
- 30 day-supply of TAF/FTC/DTG
- DOT
Procedure/Methods
• Meet with Eligibility and enroll in
Medicaid/RW services
• Labs drawn including cbc, cmp, HIV rna, CD4
count, genotype, hla-b5701 etc.
• Referral for case management only if
necessary ie homelessness, significant drug
use
Linkage specialist contacted by Appointment scheduled with
Patient confirmed positive
cellphone. 24 hour phone line provider, labs, eligibility.

Uber transportation DIS called to verify that the


Patient completes
for patient arranged patient is truly treatment
registration form, fqhc form,
if needed. naive/newly dx.
signs consents.

Provider 15-min appointment &


If patient has active Medicaid,
dispenses first dose of ARVs in
send rx to Pharmacy and pick it Intake labs drawn.
office and explains the importance
up same day.
of adherence. DOT

Linkage coordinator verifies that Patient completes Ryan White


the patient attends the follow up paperwork and Medicaid app/ Follow-up appt scheduled for 3-4
provider visit. Then patient is LAHAP app as needed. Future weeks with HIV-RNA repeated at
referred to CHWs for future assessment scheduled with case that time.
follow up. manager.
CCSI/EIS Data Review

• Inclusion Criteria: clients enrolled into CCSI or EIS


program from December 2016 through October 1,
2018

Total included for data review = 235


• 147 CCSI
• 88 EIS
Data Review Presented Today

• 9 possible CCSI Patients • 7 EIS referred but never


diagnosed but not linked linked – (one passed away
within 72 hours. before appointment.)

• 6 of those 9 were not linked • 2 EIS patients refused


at all. medications on day of
diagnosis

• 4 EIS patients were not


started on ARVs due to being
sent to ER at first visit.
Age & Gender
• Median Age (CCSI) = 29
• Median Age (EIS)= 29
EIS
CCSI
Transgender, 4.10% Transgender, Female,
5.68% 10.23%
Female, 21.10%

Male, 84.10%

Male, 74.80%

Male Transgender Female


Female Male Transgender
Demographics
Race HIV Risk Factor
Category Race % Category Risk Factor %

Heterosexual Activity 38.8%


Black/AA 60.5%
CCSI CCSI MSM 61.2%
White 39.5% PWID 3.4%

Latinx/Other 9.5% Heterosexual Activity 27.3%


EIS MSM 72.7%
Black/AA 70.5%
EIS
PWID 6.82%
White 23.9%

Latinx/Other 8.0%
STIs with diagnosis

Category Dx %

Syphilis 23.81%
CCSI Gonorrhea or Chlamydia 26.03%

Hepatitis B or C 4.76%

Syphilis 33%
EIS Gonorrhea or Chlamydia 24.1%

Hepatitis B or C 9.1%
Poverty Level and Insurance

Federal Poverty Level Insurance at Baseline


Category FPL
Insured 48%
CCSI
CCSI Under 100% 39.71%
Uninsured 52%

Insured 44%
EIS Under 100% 36.62% EIS
Uninsured 56%
Linkage time for CCSI (Hours from Knowledge
of Diagnosis to Appointment with a Provider)
Linkage Time (Hours)

15,
11%

20,
14% Under 12 hours
69,
47% 24 hours
48 hours
72 hours
43,
29%
Baseline Data
• Baseline CD4
Category CD4 Median CD4% Median
CCSI 420 cells/mm3 27.65%
EIS 340 cells/mm3 18.4%

• Baseline Viral Load


Category Viral Load Median (copies/ml)
CCSI 41,900
EIS 71,800
Viral Suppression
CCSI Viral Suppression EIS Viral Suppression
Non-
Suppressed Non-Suppressed
1% 9%

Suppressed Suppressed
Non-Suppressed Non-Suppressed
Suppressed Suppressed 91%
99%

145/147 Patients
achieved Viral 80/88 patients
suppression achieved viral
suppression
Results
1. Time from Diagnosis to First Viral Load Suppression: CCSI
2. Time from Linkage to Care to First Viral Load Suppression: EIS

Category Median (days) Mean (days)

CCSI 1 28 40.4

EIS2 27 51.28
CD4 Count, Viral Suppression, Transmitted Resistance

CCSI: EIS:
• All but two patients received TAF/FTC
+ DTG • All but five patients received TAF/FTC +
• 135/146 genotypes were performed DTG
and reviewed. • 87/95 genotypes were performed
• 26/135 (19%) with transmitted • 11/96 (11.4%) with transmitted
resistance resistance.
• 13 with NNRTI resistance • 9 with NNRTI mutations
• 3/26 with M184V/I with two • 2/9 with M184V/I no previous PrEP
previously on PrEP exposure
• 4/26 with multiple PI mutations
including L90M
• All patients with transmitted
resistance achieved viral suppression.
EIS Continuum of Care
70 67
63

60
55 56

50

100%
40 94%

90%
30 89%

20

10

0
Linked Prescribed Same Day ART Retained* Virally Suppressed in last 6
months**
Linked Prescribed Same Day ART Retained* Virally Suppressed in last 6 months**

*Retained at our facility. 4 patients moved out of state, 1 switched clinics in state.
** Viral load obtained from our clinic or the state database. 5 patients moved out of state.
Comparing Published Outcomes
1. CrescentCare Cohort Comparison
29 patients who were diagnosed the year before we initiated CCSI at our testing sites using
the same linkage coordinator and an integrase regimen but not immediate ART.
Mean time from diagnosis to suppression: 89 Days
Difference 43 days (CI: 30 – 55 days) P< 0.0001 (Published in AIDS Patient Care & STDs)

2. Grady Hospital:
90 Patients including new diagnosis, ART naïve and ART experienced immediate start within
72 hours of referral.
Median CD4 count 152 cells/mm
Median time to VS: 41 days
Yet, only 68/90 attended second provider visit

3. San Francisco:
2016: 80/265 patients diagnosed in SF were Rapid Start
Presented at CROI awaiting follow up data

.
NOLA EMA Data
How to Start ART Safely
With Minimal Clinical Data
• DHHS Recommendations, 20181 • Rationale for Recommendations1
– Transmitted mutations conferring
– Recognize International Data and resistance to NNRTI > PI or INSTI
Resource-intensive – Resistance to DRV and DTG emerge
– Avoid NNRTI-based regimens slowly
– Recommended regimensa – Transmitted HIVDR to DRV is rare
• BIC/TAF/FTC (recommended, but not – Single case of transmitted
yet listed
HIVDR to DTG
in DHHS guidelines)
• Subsequently randomized to
• DTG + tenofovirc/FTC
BIC/TAF/FTC and achieved VS
• DRV/r or DRV/cb + tenofovirc/FTC

• IAS Recommendations, July 20182


– Encourage rapid initiation of ART,
including same day initiation
– Recommend unboosted InSTI regimens
as initial therapy (with exception of
ABC/3TC/DTG)
1. US DHHS. Guidelines for Use of Antiretroviral Agents in HIV-1−Infected Adults and Adolescents. 2017. Last updated May 30, 2018.
https://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed May 31, 2018; 2. Saag MS, et al. JAMA.
2018;320(4):379-396. https://jamanetwork.com/journals/jama/fullarticle/2688574.
Issues/Troubleshooting
1. CERV completion and eligibility specialist visit same-day
• CCSI visit becomes, well, not so rapid
2. Documentation of HIV status (community referrals)
3. Discordant rapid HIV testing results & wonky HIV
testing results
4. What if patient cancels or misses their 1st follow-up visit
& is out of medications?
5. People outside of service area (Hammond)
6. Changing the culture of the clinic
7. Medicaid patients have to now access meds on their
own
8. Clinic has to have funds to pay for medications and
then reimbursed
Concluding Comments
What We Know
• Rapid entry/initiation of ART is safe
• Rapid entry/initiation improves
– Time to viral suppression (nationally/internationally)
– Viral suppression at 12 months (my continuum)
– Retention in care at 10−12 months (my continuum)
– Survival at 12 months (international studies)

• Rapid entry/initiation is acceptable to patients


and uptake is good
• Rapid entry/initiation is feasible in a variety of
settings
But…What We Still Need to Learn
• Which populations will benefit most from this approach?
– Difficult-to-retain populations?
– Late-stage vs early-stage disease?
• What is the effect on transmission within communities?
• What are the long-term benefits that rapid approaches
bring
to the HIV care continuum?
– Longitudinal retention and viral suppression?
• What are the best implementation approaches?
– Global vs domestic?
– Ryan White vs FQHC vs Academic vs Private?
Conclusions:
• Our test-and-start strategy at a non-academic federally-
funded health center in a high prevalence city has been
successful in achieving rapid virologic suppression in
almost all clients during the study period.

• There are differences in engagement between newly


diagnosed patients (viral suppression 90%) and those who
deferred immediate linkage (viral suppression 83%) P -
0.0071.

• Immediate ART leading to rapid viral suppression will be a


key component of ending the HIV epidemic.
Thanks
• Our Patients
• Fran Lawless
• New Orleans Regional Planning Council
• Katie Conner
• Pam Holm
• Nicholas Van Sickels
• Isolde Butler
• Jade Zeng
• CrescentCare Staff