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
  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:


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)
Intervention Details:
    Behavioral: Peer mentor intervention
    groups sessions, 8
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 and older
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
Johns Hopkins University
Investigators
Principal Investigator: Carl Latkin, Ph.D. Johns Hopkins University
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carl Latkin, JHU
ClinicalTrials.gov Identifier: NCT00218673     History of Changes
Other Study ID Numbers: DESPR DA016142, 5R01DA016142-05, 5R01DA016142-04, 5R01DA016142-03, 5R01DA016142-02, 1R01DA016142-01, R01-16142-1, NIDA-16142-1
Study First Received: September 16, 2005
Last Updated: May 19, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 22, 2014