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Completed

NCT Number: NCT01159704

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

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • active drug injector
  • 16 years of age or older
  • not too intoxicated to give informed consent
  • not planning to leave the area in the next 6 months and no pending court date that might result in incarceration
  • agree to HIV testing and counseling
  • not involved in prior project research activities in teh previous 24 months
  • Indexes: must be able to recruit two eligible network members into the study
  • Network: agree to participate in five peer educator training sessions

Exclusion criteria

  • being too intoxicated at the time of the interview
  • impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
  • have a known reason why they will not be available for the intervention or the follow-up interview
  • have been involved in prior project research activities in the previous 24 months

Treatment and study plan

Peer Education Model

Behavioral

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.

HIV Counseling and Education Model

Behavioral

The C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."

Primary outcomes

  1. HIV Knowledge

    Time frame: Follow-up interviews at 6 and 12 months

  2. Self-efficacy regarding HIV risk reduction

    Time frame: Follow-up interviews at 6 and 12 months

  3. Injection risk behavior reduction

    Time frame: Follow-up interviews at 6 and 12 months

  4. Sex-related risk behavior reduction

    Time frame: Follow-up interviews at 6 and 12 months

  5. Intervention diffusion to secondary network members

    Time frame: Follow-up interviews at 6 and 12 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Jul 9, 2010
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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