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

Primary Purpose

HIV Infection, HIV Risk Behaviors

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Peer Education Model
HIV Counseling and Education Model
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV infection, Intervention, Risk-reduction, Injection drug users

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NGO
  • NGO
  • NGO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Network plus HIV Counseling&Education

HIV Counseling and Education (C&E) only

Arm Description

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."

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."

Outcomes

Primary Outcome Measures

HIV Knowledge
Self-efficacy regarding HIV risk reduction
Injection risk behavior reduction
Sex-related risk behavior reduction
Intervention diffusion to secondary network members

Secondary Outcome Measures

Full Information

First Posted
July 8, 2010
Last Updated
June 17, 2019
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01159704
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. To compare the extent of intervention diffusion to second wave network members in the two arms. To evaluate the extent of disclosure by HIV positive indexes and network members in the two arms

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, HIV Risk Behaviors
Keywords
HIV infection, Intervention, Risk-reduction, Injection drug users

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Network plus HIV Counseling&Education
Arm Type
Experimental
Arm Description
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."
Arm Title
HIV Counseling and Education (C&E) only
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Peer Education Model
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIV Counseling and Education Model
Intervention Description
The C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."
Primary Outcome Measure Information:
Title
HIV Knowledge
Time Frame
Follow-up interviews at 6 and 12 months
Title
Self-efficacy regarding HIV risk reduction
Time Frame
Follow-up interviews at 6 and 12 months
Title
Injection risk behavior reduction
Time Frame
Follow-up interviews at 6 and 12 months
Title
Sex-related risk behavior reduction
Time Frame
Follow-up interviews at 6 and 12 months
Title
Intervention diffusion to secondary network members
Time Frame
Follow-up interviews at 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Booth, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
NGO
City
Donetsk
Country
Ukraine
Facility Name
NGO
City
Nikolayev
Country
Ukraine
Facility Name
NGO
City
Odessa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27658879
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.
Results Reference
derived

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

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