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
What is HPTN 037?Drug abuse and HIV/AIDS are global public health problems. Concurrent epidemics of injection drug use and HIV have been reported in 114 countries. Injection drug use currently is the major mode of transmission of HIV in Eastern Europe and the Newly Independent States, Central Asia, East Asia, parts of South and Southeast Asia, North Africa, the Middle East, Southern Europe, and parts of North and South America. Twenty-six countries report injection drug use as the primary mode of HIV transmission.
Preventing new HIV infections in drug-using populations depends on reaching the target population (coverage) and rapidly making core interventions available, by planning and scaling-up of services for the target population. Specifically, there is an urgent need for approaches to HIV prevention that may affect behavioral norms and impact larger segments of at risk populations. The intervention tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators’ social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks. |
Protocol Status: Participants Off Study & Primary Analysis Complete
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 Regimen: 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.
Protocol Co-Chair: David Celentano get info
Protocol Co-Chair: David Metzger get info
Protocol Chair: Carl Latkin get info
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
Chiang Mai Univ. AIDS Prevention CRS 31458 Chiang Mai, Thailand |
600 index participants and approx. 1170 network participants across Thai sites |
182 indexes and 245 network participants across all Thai sites |
De-Registered |
get more |
|
Chiang Mai, Thailand |
600 index participants and approx. 1170 network participants across Thai sites |
182 indexes and 245 network participants across all Thai sites |
De-Registered |
get more |
|
Sameung, Thailand |
600 index participants and approx. 1170 network participants across Thai sites |
182 indexes and 245 network participants across all Thai sites |
De-Registered |
get more |
|
30310 Philadelphia, United States |
300 index and ~540 network participants across 2 U Penn sites |
232 indexes and 465 network participants across 2 U Penn sites |
De-registered |
get more |
|
Univ. of Pennsylvania, RAP Office 30311 Philadelphia, United States |
300 index and ~540 network participants across 2 U Penn sites |
232 indexes and 465 network participants across 2 U Penn sites |
De-registered |
get more |
