RCT of Russian IDU Peer Network HIV Prevention Intervention - 1


Tracking Information

Start Date  ICMJEOctober 2003
Estimated Primary Completion DateOctober 2008   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 23, 2008)
Incident number of HIV Infections in social networks [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 20, 2005)
Incident number of HIV Infections in social networks
Change HistoryComplete list of historical versions of study NCT00218673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 23, 2008)
  • Self reported risk behaviors: entry into drug treatment, cessation of drug use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Self reported risk behaviors: number of sex partners, freq of condom use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: September 20, 2005)
  • Self reported risk behaviors: entry into drug treatment, cessation of drug use
  • Self reported risk behaviors: number of sex partners, freq of condom use

Descriptive Information

Brief Title  ICMJERCT of Russian IDU Peer Network HIV Prevention Intervention - 1
Official Title  ICMJERandomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention
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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Condition  ICMJEHIV Infections
Intervention  ICMJEBehavioral: Peer mentor intervention
groups sessions, 8

Recruitment Information

Estimated Enrollment  ICMJE400
Estimated Completion DateOctober 2008
Estimated Primary Completion DateOctober 2008   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Andrei Koslov, Ph.D.(781)254-2815 ext 1biomed@mailbox.alkor.ru
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00218673
Responsible PartyCarl Latkin, JHU
Study ID Numbers  ICMJEDESPR DA016142, R01-16142-1, NIDA-16142-1
Study Sponsor  ICMJENational Institute on Drug Abuse (NIDA)
Collaborators  ICMJEJohns Hopkins University
Investigators  ICMJE
Principal Investigator:Carl Latkin, Ph.D.Johns Hopkins University
Information Provided ByNational Institute on Drug Abuse (NIDA)