Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 2:30 AM
Study NCT ID:
NCT01159704
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2010-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA026739-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |