RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

NCT ID: NCT00218673

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-06-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

experimental

social network

Group Type: EXPERIMENTAL

Peer mentor intervention

Intervention Type: BEHAVIORAL

groups sessions, 8

control

testing and counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer mentor intervention

groups sessions, 8

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Carl Latkin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl Latkin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Biomedical Center

Saint Petersburg, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 23881187 (View on PubMed)

Other Identifiers

5R01DA016142

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-16142-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-16142-1

Identifier Type: -

Identifier Source: secondary_id

DESPR DA016142

Identifier Type: -

Identifier Source: org_study_id