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

Study Overview

• Status: Completed
• Conditions: HIV Infection; HIV Risk Behaviors
• Intervention / Treatment: Behavioral: Peer Education Model; Behavioral: HIV Counseling and Education Model

• Study Type: Interventional
• Enrollment (Actual): 2304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Donetsk, Ukraine
    • NGO
  • Nikolayev, Ukraine
    • NGO
  • Odessa, Ukraine
    • NGO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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."	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."
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."	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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV Knowledge	Follow-up interviews at 6 and 12 months
Self-efficacy regarding HIV risk reduction	Follow-up interviews at 6 and 12 months
Injection risk behavior reduction	Follow-up interviews at 6 and 12 months
Sex-related risk behavior reduction	Follow-up interviews at 6 and 12 months
Intervention diffusion to secondary network members	Follow-up interviews at 6 and 12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Robert Booth, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (Estimate): July 9, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Intervention; HIV infection; Risk-reduction; Injection drug users
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 09-0823; R01DA026739-01A1 (U.S. NIH Grant/Contract)