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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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

Condition Intervention
HIV Infections
Intervention
Behavioral: Peer Education Model
Behavioral: HIV Counseling and Education Model

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5250
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Network plus C&E
Social network peer education model based on the work of Latkin, plus HIV testing and counseling
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.
Active Comparator: C&E only
HIV Testing and Counseling
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."

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159704

Contacts
Contact: Sergey Dvoryak, MD, PhD 38 044 521 1668 Dvoryak@uiphp.org.ua

Locations
Ukraine
NGO Recruiting
Donetsk, Ukraine
Contact: Dvoryak       Dvoryak@uiphp.org.ua   
NGO Recruiting
Nikolayev, Ukraine
Contact: Dvoryak       Dvoryak@uiphp.org.ua   
NGO Recruiting
Odessa, Ukraine
Contact: Dvoryak       Dvoryak@uiphp.org.ua   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Robert Booth, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01159704     History of Changes
Other Study ID Numbers: 09-0823, R01DA026739-01A1
Study First Received: July 8, 2010
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
HIV infection
Intervention
Risk-reduction
Injection drug users

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 31, 2014