International Social Network Intervention

Phase 2

Completed

• Conditions: Behavior
• Interventions: Behavioral: YHA; Behavioral: YMSM; Behavioral: ROMA

• Registration Number: NCT00838773
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2012-04
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1292

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 15. 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 16. 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 14.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHA	YHA	Young Heterosexual Adults
YMSM	YMSM	Young Men Who Have Sex with Men
ROMA	ROMA	Gypsies (Bulgarian)

Primary Outcome Measures

Name	Time	Method
Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.	August 2015

Secondary Outcome Measures

Name	Time	Method
15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group.	August 2015

Trial Locations

Locations (3)

Health and Social Development Foundation; 🇧🇬 Sofia, Bulgaria

Botkin Hospital for Infectious Diseases #30; 🇷🇺 St. Petersburg, Russian Federation

Hungarian Academy of Sciences; 🇭🇺 Budapest, Hungary