HPTN 074

HIV Prevention Trial Network 074

Zubairi Djoerban, Samsuridjal Djauzi, Darma Imran,

Riza Sarasvita, Hepa Susami
 Principal Investigator HPTN 074 Ina Team
 Investigator
 Study Coordinator
 Research Assisstants
 Psychosocial Counselors
 Community Advisor
 Finance
 Outreach Workers
 Screener
 Recruitment Manager
 Lab: Manager, Lab Data Manager, Lab QC Manager,
Phlebotomist
 HPTN = The HIV Prevention Trials Network

HPTN is a worldwide collaborative clinical trials

network that brings together investigators, ethicists,
community and other partners to develop and test the
safety and efficacy of interventions designed to
prevent the acquisition and transmission of HIV

HPTN 052

HPTN 074
 What is HPTN 074?
HPTN 074 aims to determine the feasibility of a future trial
that would assess whether an integrated intervention
combining psychosocial counseling and supported referrals
for antiretroviral therapy (ART) at any CD4 cell count and
substance use treatment for HIV-infected people who inject
drugs (PWID) would reduce HIV transmission to HIV-
uninfected injection partners, as compared to routine care
dictated by national guidelines for HIV-infected PWID.

HPTN 074 is funded by the U.S. National Institute of Allergy and Infectious
Diseases (NIAID), and the U.S. National Institute on Drug Abuse (NIDA), both part
of the U. S. National Institutes of Health (NIH).
 Who participated in the study?
 HPTN 074 was a randomized, controlled trial
conducted among people who inject drugs in
Ukraine, Indonesia and Vietnam.
 Overall, 502 people living with HIV and 806 people
with whom they injected drugs entered the study
over 15 months and were followed for 12 to 24
months after enrollment.
 The median age was 35 years. Eighty-five percent
of participants enrolled were men; most of the
women who participated in the study were enrolled
in Ukraine.
 Why is HPTN 074 important?
 Injection drug use is the predominant risk behavior for
HIV transmission in several parts of the world.
Injection drug use is a major factor underlying the HIV
epidemics in Eastern Europe, the Commonwealth of
Independent States, and manay parts of Asia. A
scalable, integrated intervention to engage people
who inject drugs in HIV care and medication-assisted
treatment (HPTN 074): a randomised, controlled
phase 3 feasibility and efficacy study
 What happened during the study?
 Index participants were randomized to one of two study arms
at a ratio of 1:3 (intervention: standard of care). Index
participants in the intervention arm received (in addition to the
standard harm reduction package) an integrated intervention
that included supported referrals for ART regardless of CD4
cell count and facilitated referral for substance use treatment.
 The psychosocial component of the integrated intervention
was designed to improve engagement and retention in HIV
care and substance use treatment, and included systems
navigation, counseling to encourage engagement in care and
adherence, and social support.
 Index participants in the standard of care arm received
referrals for the in-country standard of care for ART and
substance use treatment and a standardized harm reduction
package. Network injection partners in both arms received a
standardized harm reduction package with referral for
substance use treatment, consistent with national guidelines
 HPTN 074 study sites have completed a one-year study
extension which ended July 6, 2018. Due to the strength of
the preliminary study results, all sites began offering the
integrated intervention to participants who had not initiated
antiretroviral therapy and substance use therapy in the
standard of care arm in late 2017
Publications and
Posters
 The Lancet 392, 747-59, Sept 01, 2018

 A scalable, integrated intervention to engage people

who inject drugs in HIV care and medication-assisted
treatment (HPTN 074): a randomised, controlled
phase 3 feasibility and efficacy study
 Prof William C Miller, MD,
 Prof Irving F Hoffman, MPH
 Brett S Hanscom, PhD,
 Tran V Ha, MD
 Kostyantyn Dumchev, MD,
 Prof Zubairi Djoerban, MD
 Prof Samsuridjal Djauzi, MD
 Hepa Susami et al
 Intervention
Improves Adherence,
Decreases Mortality.

Intervention: psychosocial
counseling and supported
referrals for ARV therapy
substance use treatment
 Publications and Posters
1. A scalable, integrated intervention to engage people who inject
drugs in HIV care and medication-assisted treatment (HPTN
074): a randomised, controlled phase 3 feasibility and efficacy
study  The Lancet, 2018
2. Regional differences between people who inject drugs in an
HIV prevention trial integrating treatment and prevention
(HPTN 074): A baseline Analysis  J Int AIDS Soc, 2018
3. An integrated intervention to increase ART and MAT reduced
mortality among PWID: Results from the HPTN 074
randomized trial  HIV R4P, 2018
 Publications and Posters(2)
4. Benefits Related to Participating in an HIV Prevention Trial
Involving People Who Inject Drugs  HIV R4P, 2018
5. Development and implementation of participant safety plans
for international research with stigmatized populations  The
Lancet HIV, 2018
6. HPTN074: Spatial Accessibility to ART Care among PWID in
Jakarta  NIDA 2017, 2nd best poster
7. Characteristics of HPTN 074 Screened PWID in Jakarta 
NIDA 2017
8. Indonesia Policy Review of People Who Inject Drugs (PWID)
and HIV  NIDA 2017
 Publications and Posters(3)
9. A Geospatial Approach for Participant Recruitment of HPTN
074 Study in Jakarta, Indonesia  NIDA 2016
10. HPTN 074: Density-based Analysis to Identify Spatial
Aggregation of Eligible PWID in Jakarta, NIDA 2016, 2nd best
poster
 Conferences

NIDA Palm Spring 2016

NIDA Montreal Canada 2017

IAS Conference Paris 2017

CROI Conference Boston, 2018

CPDD International Committee Presents Award for
Best Poster at International Research Poster Session
The two semifinalists were
1. Mohammad Muslim of Indonesia for his poster,
“HPTN 074: Spatial Accessibility to ART Care
Among People Who Inject Drugs in Jakarta,” and
2. Bronwyn Myers of South Africa for her
presentation, “HIV Prevalence and Linkage to Care
Among Trauma-Exposed Substance-Using Women
in Cape Town, South Africa.” 2017
CPDD International Committee Presents Award for Best
Poster at International Research Poster Session

The two semifinalists were

1. Juliana Mejia-Trujillo of Colombia for her poster, “An
Experimental Evaluation of a Brief Preventive
Intervention,”
2. Mohammad Muslim of Indonesia for his poster,
“HPTN 074: Density-Based Analysis to Identify
Spatial Aggregation of Eligible PWID in Jakarta. 2016
 Awards for Indonesia Site

Highest Percentage Re-enrolled in Extension

Excellent in Source Documentation
Best Index Retention
Highest Retention
Summary / What’s Next
 KESIMPULAN

 Penggunaan ARV pada kelompok intervensi

hampir dua kali lipat dibandingkan kelompok
layanan standar (SoC).
 Terjadi viral suppression hampir dua kali lipat
pada kelompok intervensi
 Peningkatan akses layanan MAT
 Angka kematian menurun lebih dari 50%
 Tidak ada kasus baru HIV pada kelompok
intervensi
 Intervention
Improves Adherence,
Decreases Mortality.

Intervention: psychosocial
counseling and supported
referrals for ARV therapy
substance use treatment
 CATATAN
 Sekali lagi membuktikan kita bisa ikut penelitian internasional,
publikasi, dan memperoleh penghargaan

 Kendala banyak, bisa diatasi

 Dibantu banyak pihak: Kemenkes, FKUI, RSCM, Badan POM

 Teamwork, Track record

 Implementasi

 Scholarship untuk peneliti muda (www.hptn.org):

- Initial proposal: 8 Februari 2019

- Full applocation: 22 Februari 2019

Terima kasih