HPTN 037
A Phase III Randomized Study to Evaluate the Efficacy of a Network-oriented Peer Educator Intervention for the Prevention of HIV Transmission Among Injection Drug Users And Their Network Members
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What was HPTN 037?
A Phase III, multi site, two-arm, randomized controlled trial to determine the efficacy of a network-oriented peer educator intervention for prevention of HIV infection among injection drug users and members of their HIV risk network through reduction of HIV risk behaviors.
Who participated in the study?
Approximately 2,610 HIV uninfected injection drug users (index participants) and individuals identified by each index participant as members of their sex and drug-using networks (network members).
What happened during the study?
Index participants and their network members were randomized to one of two groups in a ratio of 1:1. Index participants and network members in both arms received basic HIV counseling and testing enhanced with interactive risk reduction counseling. In addition, index participants randomized to the experimental arm received peer educator training (see protocol for treatment regimen table).
Protocol Status
Concluded
Study Purpose
To determine the efficacy of a network-oriented peer educator intervention for prevention of HIV infection among injection drug users and members of their HIV risk network through reduction of HIV risk behaviors.
Study Design
Phase III, multi site, two-arm, randomized controlled trial.
Study Population
HIV uninfected injection drug users (index participants) and individuals identified by each index participant as members of their sex and drug using networks (network members)
Study Size
Approximately 2610 participants [900 networks = 900 index participants and approximately 1710 network members (an average of 1.9 network members per index participant)]
Study Duration
Approximately 48 months total. Enrollment will require approximately 30 months. Participants will be followed for a minimum of 18 months and a maximum of 30 months
Treatment Regime
Index participants and their network members will be randomized to one of two groups as outlined below in a ratio of 1:1. Index participants and network members in both arms will receive basic HIV counseling and testing enhanced with interactive risk reduction counseling. In addition, index participants randomized to the experimental arm will receive peer educator training (see protocol for treatment regimen table).
Primary Objectives
To determine whether the peer-educator intervention reduces the rate of HIV infection among injection drug users and members of their HIV risk network.
Secondary Objectives
To determine whether the intervention reduces reported injection and sexual HIV risk behaviors in index participants and/or network members.
To determine whether the intervention changes substance use network norms for injection and sexual HIV risk practices.
To determine whether the intervention effects on injection and sexual HIV risk behaviors differ between index and network participants, or by HIV status in each study arm.
To determine whether the intervention effect on behaviors identified as important mediators of the intervention is similar at both sites.