ClinicalTrials.gov
ClinicalTrials.gov Menu

RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00218673
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 13, 2016
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

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Peer mentor intervention Phase 3

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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention
Study Start Date : October 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incident number of HIV Infections in social networks [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Self reported risk behaviors: entry into drug treatment, cessation of drug use [ Time Frame: 1 year ]
  2. Self reported risk behaviors: number of sex partners, freq of condom use [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 ( U.S. NIH Grant/Contract )
R01-16142-1
NIDA-16142-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Carl Latkin, 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