RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

This study has been completed.

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Information provided by (Responsible Party):

Carl Latkin, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT00218673

First received: September 16, 2005

Last updated: May 11, 2016

Last verified: May 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Behavioral: Peer mentor intervention	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Incident number of HIV Infections in social networks [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	400
Study Start Date:	October 2003
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: experimental social network	Behavioral: Peer mentor intervention groups sessions, 8
No Intervention: control testing and counseling

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.

Eligibility


Ages Eligible for Study:	16 Years to 100 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218673

Locations


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

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators


Principal Investigator:	Carl Latkin, Ph.D.	Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Carl Latkin, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00218673 History of Changes
Other Study ID Numbers:	DESPR DA016142 5R01DA016142 R01-16142-1 NIDA-16142-1
Study First Received:	September 16, 2005
Last Updated:	May 11, 2016
Health Authority:	United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:


HIV injection drug use social networks

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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