Clinical trial NCT01159704: Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
Official title: Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
HIV Risk Behaviors
Keywords: HIV infection
Intervention
Risk-reduction
Injection drug users
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-07-09
Enrollment: 2304
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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


Eligibility 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 the intervention or the follow-up interview
* have been involved in prior project research activities in the previous 24 months

Primary outcomes:
measure: HIV Knowledge
timeFrame: Follow-up interviews at 6 and 12 months
measure: Self-efficacy regarding HIV risk reduction
timeFrame: Follow-up interviews at 6 and 12 months
measure: Injection risk behavior reduction
timeFrame: Follow-up interviews at 6 and 12 months
measure: Sex-related risk behavior reduction
timeFrame: Follow-up interviews at 6 and 12 months
measure: Intervention diffusion to secondary network members
timeFrame: Follow-up interviews at 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Donetsk
country: Ukraine
facility: NGO
city: Nikolayev
country: Ukraine
facility: NGO
city: Odessa
country: Ukraine
facility: NGO
Study officials:
affiliation: University of Colorado, Denver
name: Robert Booth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.