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Clinical Trials/NCT00838773
NCT00838773
Completed
Phase 2

HIV Prevention Within High-Risk Social Networks

Medical College of Wisconsin3 sites in 3 countries1,292 target enrollmentMay 2007
ConditionsBehavior

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Behavior
Sponsor
Medical College of Wisconsin
Enrollment
1292
Locations
3
Primary Endpoint
Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This grant involves 24 social networks of young men who have sex with men, Roma, and young high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.

Detailed Description

For over 4 years, our international collaborative research team has carried out a social network HIV prevention intervention trial with community populations of young men who have sex with men (YMSM), disadvantaged ethnic minority Roma (Gypsies), and high-risk heterosexual adult (YHA) women and men in Hungary, Bulgaria and Russia. Eastern Europe has seen a sharp increase in HIV incidence, and social network interventions are high in cultural relevance because post-communist populations have a long history of trusting and relying upon their personal networks more than their governments. Across the three countries represented in our research during the past funding period, we enrolled social networks of YMSM, Roma, and YHAs. This study will renew our international collaboration to extend this network intervention approach. Our study, to date, has worked with very small independent friendship groups (usually composed of 5-6 people) as "egocentric" social networks.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Kelly

Professor of Psychiatry and Behavioral Medicine

Medical College of Wisconsin

Eligibility Criteria

Inclusion Criteria

  • Members of a friendship group will be eligible for enrollment if they are of legal age to independently consent to participate in this study. In its review and approval of this protocol, the IRB at BotkinHospital, St. Petersburg, Russia verified and confirmed in writing to us that the age of research participation consent is
  • In its review and approval of this protocol, the IRB at the Health and Social Development Foundation determined that the age of research participation consent in Bulgaria is
  • In Hungary, the IRB at the Institute of Sociology at the Hungarian Academy of Sciences determined that the age of independent consent to participate in this study is

Exclusion Criteria

  • Individuals will be excluded from enrollment into the study if they are below the age for providing independent consent or are not capable of providing informed consent based on impairment due to the presence of sever psychopatology, substance use, or similar conditions observed at the time of informed consent. Social networks will be excluded from the study if: (1) more than 33% of named network members do not agree to participate; (2) fewer than 50% of members report occurrence of unprotected intercourse during the past 3 months at baseline; or (3) more than 10% of a network's members are also members of another network enrolled in the study.

Outcomes

Primary Outcomes

Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.

Time Frame: August 2015

Secondary Outcomes

  • 15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group.(August 2015)

Study Sites (3)

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