RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00218673
First received: September 16, 2005
Last updated: May 19, 2011
Last verified: November 2008

September 16, 2005
May 19, 2011
October 2003
June 2009   (final data collection date for primary outcome measure)
Incident number of HIV Infections in social networks [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incident number of HIV Infections in social networks
Complete list of historical versions of study NCT00218673 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Self reported risk behaviors: entry into drug treatment, cessation of drug use
  • Self reported risk behaviors: number of sex partners, freq of condom use
Not Provided
Not Provided
 
RCT of Russian IDU Peer Network HIV Prevention Intervention - 1
Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
HIV Infections
Behavioral: Peer mentor intervention
groups sessions, 8
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00218673
DESPR DA016142, 5R01DA016142-05, 5R01DA016142-04, 5R01DA016142-03, 5R01DA016142-02, 1R01DA016142-01, R01-16142-1, NIDA-16142-1
Not Provided
Carl Latkin, JHU
Johns Hopkins Bloomberg School of Public Health
  • National Institute on Drug Abuse (NIDA)
  • Johns Hopkins University
Principal Investigator: Carl Latkin, Ph.D. Johns Hopkins University
Johns Hopkins Bloomberg School of Public Health
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP