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 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.
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 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 many parts of Asia. The largest estimated populations of 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 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.
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