Integrated Treatment and Prevention for People Who Inject Drugs: A Vanguard study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care
What is HPTN 074?
HPTN 074 aimed 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 people living with HIV who inject drugs would reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for people living with HIV who inject drugs.
Who participated in the study?
Overall, 502 people living with HIV and 806 people with whom they injected drugs entered the study over 15 months and 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 the study 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 many parts of Asia. The largest estimated populations of people who inject drugs (PWID) are in Russia, China and the U.S. Notably, Ukraine, Vietnam and Indonesia have estimated HIV prevalence among PWID above 30 percent. This persistently high incidence of HIV infection among PWID in many locations with concentrated epidemics necessitates aggressive efforts to prevent HIV transmission.
What happened during the study?
Index participants were randomized to one of two study arms. 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 a referral for substance use treatment, consistent with national guidelines.
What were the key study findings?
At week 26, intervention arm participants were twice as likely to report antiretroviral therapy use compared to the standard of care arm participants and twice as likely to achieve an undetectable viral load. The effects persisted at week 52. Among intervention arm participants at week 52, self-reported substance use treatment uptake was higher compared to the standard of care arm participants. Mortality was significantly lower among intervention arm participants and their partners compared to the standard of care arm participants and their partners. For partners of intervention arm participants, no new HIV infections were observed, while seven were observed among partners in the standard of care arm.
HPTN 074 Version 2.0
HPTN 074 Version 1.0
- HPTN 074 Protocol V1.0 - 26 February 2014
- Letter of Amendment #2 - 28 Sept 2016
- Letter of Amendment #1 - 10 Sept 2015
- Clarification Memo #2 - 20 Apr 2015
- Clarification Memo #1 - 17 Mar 2015
2017 Annual Meeting
- HPTN 074 Ukraine Site Progress
- Indonesia Site: Progress Report
- Vietnam Site: Enrollment and Retention
- HPTN 074 Publications and closeout