NCT01159704

Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,304 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug users (IDUs) in three Ukraine oblasts (regions). The investigators propose to compare the effectiveness of a revised and updated manually-driven HIV testing and counseling intervention, the Counseling and Education (C \& E) model developed by NIDA, with the C \& E plus a manualized network intervention. At each site, Odessa, Donetsk and Nikolayev, 250 "index members" and 500 of their network members will be recruited through street outreach over a 32-month period and randomly assigned to C \& E alone or C \& E plus the network intervention. Participants will be tested for drug metabolites, interviewed using ACASI (Audio Computer-Assisted Self-Interviewing), and given a rapid test for HIV at baseline, 6 and 12-months. At six-months, network members will be asked to recruit two others they inject with but who are not in the study. Primary outcomes include knowledge, self-efficacy, injection and sex-related risk behavior reduction and partner disclosure among indexes and primary and secondary network members and intervention diffusion to secondary network members. The investigators hypothesize more positive and significant change, including injection and sex risk reduction, intervention diffusion, and partner disclosure, among indexes as well as first and second network members in the network plus C \& E arm compared to C \& E alone. Specific aims include: 1. To compare the effectiveness of the C \& E alone with the additive effect of a network intervention plus C \& E in increasing knowledge about HIV and increasing self-efficacy to practice safer injection and sex-related behaviors among indexes, primary and secondary network members. 2. To assess the effectiveness of the C \& E alone with the additive effect of a network intervention plus C \& E in reducing drug and sex risk behaviors among indexes, primary and secondary network members. 3. To compare the extent of intervention diffusion to second wave network members in the two arms. 4. To evaluate the extent of disclosure by HIV positive indexes and network members in the two arms

Conditions

• HIV Infection
• HIV Risk Behaviors

Interventions

Type	Name	Description
BEHAVIORAL	Peer Education Model	The peer education intervention will be delivered by trained outreach workers in a group format with 8-10 indexes over five sessions spanning three weeks. The sessions will focus on knowledge of HIV transmission, self-efficacy and skills-building regarding HIV risk reduction, with an emphasis on the dissemination of such information and skills to network members.
BEHAVIORAL	HIV Counseling and Education Model	The C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."

Timeline

• Start date: 2010-07-01
• Primary completion: 2015-11-01
• Completion: 2017-03-01
• First posted: 2010-07-09
• Last updated: 2019-06-19

Locations

3 sites across 1 country: Ukraine