HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00310973
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

This study will evaluate the effectiveness of peer-led HIV/sexually transmitted disease (STD)risk reduction educational counseling in reducing HIV risk behavior among the social networks of young men who have sex with men and Roma men and women in Bulgaria and Hungary.

Detailed Description

HIV is spreading more rapidly in Eastern Europe than anywhere else in the world. Bulgaria and Hungary are still in the early stages of the crisis. However, without efforts to prevent the spread of HIV and AIDS, both countries are likely to fall victim to the HIV/AIDS growth curve that has already affected the rest of Eastern Europe. Bulgarian and Hungarian young men who have sex with men (YMSM) and Roma men and women are at the greatest risk for HIV infection. In both countries, HIV is spread primarily through sexual transmission. Prevention efforts that are undertaken now could help these countries avoid an explosive HIV/AIDS epidemic. YMSM and Roma men in Bulgaria and Hungary are more likely to trust HIV/AIDS information received from someone they know than from an official statement. Therefore, entire social networks will be recruited for this study and the leader of each network will be responsible for delivering the prevention information to his or her peers. This study will evaluate the effectiveness of peer-led HIV/STD risk reduction educational counseling in reducing HIV risk behavior among the social networks of YMSM and Roma men and women in Bulgaria and Hungary.

This study will recruit 40 YMSM and 40 Roma high-risk social networks. Each network will be randomly assigned to receive either standard HIV/AIDS risk reduction or the intervention. Networks assigned to receive the intervention will be assessed sociometrically to determine the 'social influence' leaders of each group. The leaders will then attend a 9-session program over the course of 3 months that will train them to deliver theory-based risk-reduction messages and peer-counseling to their respective social networks. The messages will focus on promoting safer sex knowledge, attitudes, intentions, perceived norms, and self-efficacy. All participants will be offered STD testing and their HIV-risk behavior will be assessed at Months 3 and 12. Participants assigned to receive the standard HIV/AIDS risk reduction will then receive the network intervention for an additional 12 months.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• At least 50% of social network members complete baseline assessments
• At least 50% of assessed members of a social network report unprotected vaginal or anal intercourse outside of a mutually monogamous relationship in the 6 months prior to study entry

Exclusion Criteria

• Does not meet inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse	Months 3 and 12 post intervention

Secondary Outcome Measures

Name	Time	Method
Lower incidence of sexually transmitted diseases	Months 3 and 12 post intervention
Change in AIDS-related scales	Months 3 and 12 post intervention

Trial Locations

Locations (3)

Health and Social Development Foundation; 🇧🇬 Sofia, Bulgaria

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

Institute of Sociology, Hungarian Academy of Sciences; 🇭🇺 Budapest, Hungary