RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

HIV Infections Clinical Trial

Official title:

Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218673
• Other study ID #: DESPR DA016142
• Secondary ID: 5R01DA016142R01-
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: May 11, 2016
• Start date: October 2003
• Est. completion date: June 2009

Study information

• Verified date: May 2016
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Peer mentor intervention
groups sessions, 8

Locations

Country	Name	City	State
Russian Federation	Biomedical Center	St. Petersburg

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Johns Hopkins University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident number of HIV Infections in social networks		1 year	No
Secondary	Self reported risk behaviors: entry into drug treatment, cessation of drug use		1 year	No
Secondary	Self reported risk behaviors: number of sex partners, freq of condom use		3 months	No