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Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness of HIV 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 (Coyle 1993), with the C & E plus a manualized network intervention based on Latkin's model (Latkin et al. 2003a). 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, 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
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Peer Education Model, HIV Counseling and Education Model
Not yet recruiting
University of Colorado, Denver
Published on BioPortfolio: 2014-08-27T03:12:18-0400
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