We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159704
First Posted: July 9, 2010
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Colorado, Denver
July 8, 2010
July 9, 2010
April 14, 2017
July 2010
November 2015   (Final data collection date for primary outcome measure)
  • HIV Knowledge [ Time Frame: Follow-up interviews at 6 and 12 months ]
  • Self-efficacy regarding HIV risk reduction [ Time Frame: Follow-up interviews at 6 and 12 months ]
  • Injection risk behavior reduction [ Time Frame: Follow-up interviews at 6 and 12 months ]
  • Sex-related risk behavior reduction [ Time Frame: Follow-up interviews at 6 and 12 months ]
  • Intervention diffusion to secondary network members [ Time Frame: Follow-up interviews at 6 and 12 months ]
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 (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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HIV Infection
  • HIV Risk Behaviors
  • 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 HIV Counseling&Education
    Social network peer education model plus HIV testing and counseling; the C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."
    Interventions:
    • Behavioral: Peer Education Model
    • Behavioral: HIV Counseling and Education Model
  • Active Comparator: HIV Counseling and Education (C&E) only
    HIV testing and counseling C&E; the C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."
    Intervention: Behavioral: HIV Counseling and Education Model
Booth RE, Davis JM, Dvoryak S, Brewster JT, Lisovska O, Strathdee SA, Latkin CA. HIV incidence among people who inject drugs (PWIDs) in Ukraine: results from a clustered randomised trial. Lancet HIV. 2016 Oct;3(10):e482-9. doi: 10.1016/S2352-3018(16)30040-6. Epub 2016 Jul 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5250
December 2017
November 2015   (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 the intervention or the follow-up interview
  • have been involved in prior project research activities in the previous 24 months
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Ukraine
 
 
NCT01159704
09-0823
R01DA026739-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Institute on Drug Abuse (NIDA)
Principal Investigator: Robert Booth, PhD University of Colorado, Denver
University of Colorado, Denver
April 2017

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