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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Peer mentor intervention

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • St. Petersburg, Russian Federation, 197110
    • Biomedical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 96 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; social network	Behavioral: Peer mentor intervention; groups sessions, 8
No Intervention: control; testing and counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incident number of HIV Infections in social networks	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Self reported risk behaviors: entry into drug treatment, cessation of drug use	1 year
Self reported risk behaviors: number of sex partners, freq of condom use	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA); Johns Hopkins University
• Investigators: Principal Investigator: Carl Latkin, Ph.D., Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: HIV; social networks; injection drug use
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: DESPR DA016142; 5R01DA016142 (U.S. NIH Grant/Contract); R01-16142-1; NIDA-16142-1