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RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Peer mentor intervention
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, injection drug use, social networks

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Of legal age to independently provide written informed consent for research Report having injected drugs at least 12 times in the last three months HIV seronegative (ELISA confirmed) Willing and able to recruit at least three HIV risk network members who are eligible for study participation Exclusion Criteria: Prior or concurrent enrollment in the last 6 months in another HIV behavioral or biomedical prevention study Psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff Any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives

Sites / Locations

  • Biomedical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental

control

Arm Description

social network

testing and counseling

Outcomes

Primary Outcome Measures

Incident number of HIV Infections in social networks

Secondary Outcome Measures

Self reported risk behaviors: entry into drug treatment, cessation of drug use
Self reported risk behaviors: number of sex partners, freq of condom use

Full Information

First Posted
September 16, 2005
Last Updated
May 11, 2016
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00218673
Brief Title
RCT of Russian IDU Peer Network HIV Prevention Intervention - 1
Official Title
Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. We expect that participants who receive the intervention will demonstrate a reduction in the rate of HIV infection and HIV risk behaviors and members of their risk network will also demonstrate reductions in risk behaviors compared to those in the control group.
Detailed Description
Intravenous drug use (IDU) is driving the HIV epidemic in Russia; over 90% of all HIV-1 infections have occurred within communities of IDUs. In St. Petersburg (population 5 million), the prevalence of HIV infection in IDUs (estimated population 100,000) leapt from 4% in 1999 to 12% in 2000. At present there are an estimated 5-7 million IDUs, a four-fold increase since the end of the Soviet Union. In St. Petersburg, there has been a three-fold increase in regular IDUs and a nine-fold increase in teenage IDUs during the past five years. The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators' social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks. Comparison condition: Informed by the Centers for Disease Control model of best practice" standard of care of HIV testing and counseling, participants in the comparison condition will receive risk reduction education and motivational counseling to reduce their risk behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, injection drug use, social networks

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
social network
Arm Title
control
Arm Type
No Intervention
Arm Description
testing and counseling
Intervention Type
Behavioral
Intervention Name(s)
Peer mentor intervention
Intervention Description
groups sessions, 8
Primary Outcome Measure Information:
Title
Incident number of HIV Infections in social networks
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Self reported risk behaviors: entry into drug treatment, cessation of drug use
Time Frame
1 year
Title
Self reported risk behaviors: number of sex partners, freq of condom use
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Of legal age to independently provide written informed consent for research Report having injected drugs at least 12 times in the last three months HIV seronegative (ELISA confirmed) Willing and able to recruit at least three HIV risk network members who are eligible for study participation Exclusion Criteria: Prior or concurrent enrollment in the last 6 months in another HIV behavioral or biomedical prevention study Psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff Any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Latkin, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomedical Center
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
23881187
Citation
Hoffman IF, Latkin CA, Kukhareva PV, Malov SV, Batluk JV, Shaboltas AV, Skochilov RV, Sokolov NV, Verevochkin SV, Hudgens MG, Kozlov AP. A peer-educator network HIV prevention intervention among injection drug users: results of a randomized controlled trial in St. Petersburg, Russia. AIDS Behav. 2013 Sep;17(7):2510-20. doi: 10.1007/s10461-013-0563-4.
Results Reference
derived

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RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

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