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

This study is currently recruiting participants.
Verified November 2012 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01159704
First received: July 8, 2010
Last updated: November 20, 2012
Last verified: November 2012

July 8, 2010
November 20, 2012
July 2010
July 2014   (final data collection date for primary outcome measure)
  • HIV Knowledge [ Time Frame: Follow-up interviews at 6 and 12 months ] [ Designated as safety issue: No ]
  • Self-efficacy regarding HIV risk reduction [ Time Frame: Follow-up interviews at 6 and 12 months ] [ Designated as safety issue: No ]
  • Injection risk behavior reduction [ Time Frame: Follow-up interviews at 6 and 12 months ] [ Designated as safety issue: No ]
  • Sex-related risk behavior reduction [ Time Frame: Follow-up interviews at 6 and 12 months ] [ Designated as safety issue: No ]
  • Intervention diffusion to secondary network members [ Time Frame: Follow-up interviews at 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01159704 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
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 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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Intervention
  • 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."
  • Experimental: Network plus C&E
    Social network peer education model based on the work of Latkin, plus HIV testing and counseling
    Intervention: Behavioral: Peer Education Model
  • Active Comparator: C&E only
    HIV Testing and Counseling
    Intervention: Behavioral: HIV Counseling and Education Model
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5250
July 2014
July 2014   (final data collection date for primary outcome measure)

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 teh intervention or the follow-up interview
  • have been involved in prior project research activities in the previous 24 months
Both
16 Years and older
Yes
Contact: Sergey Dvoryak, MD, PhD 38 044 521 1668 Dvoryak@uiphp.org.ua
Ukraine
 
NCT01159704
09-0823, R01DA026739-01A1
Yes
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Robert Booth, PhD University of Colorado, Denver
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP