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Study
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Phase Definitions
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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.
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Protocol Status:
Closed to Follow Up
Study Summary
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 DuPuy Celentano
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Protocol Co-Chair:
David Metzger
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Protocol Chair:
Carl Latkin
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Site |
Target
Enrollment |
Cumulative
Enrollment |
Implementation
Status |
More
Info |
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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 |
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PEN House
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 |
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Sameung Recruitment Center
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 |
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University of Pennsylvania Health System, HIV Prevention Research Division
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 |
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University 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 |
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