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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00310973 |
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 young men who have sex with men and Roma men and women in Bulgaria and Hungary.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Behavioral: Social Network Intervention |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | HIV Prevention Within High-Risk Social Networks |
Estimated Enrollment: | 320 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | November 2005 |
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Health and Social Development Foundation | |
Sofia, Bulgaria | |
Hungary | |
Institute of Sociology, Hungarian Academy of Sciences | |
Budapest, Hungary | |
Russian Federation | |
Botkin Hospital for Infectious Diseases | |
St. Petersburg, Russian Federation |
Principal Investigator: | Jeffrey A. Kelly, PhD | Medical College of Wisconsin |
Study Director: | Yuri A. Amirkhanian, PhD | Medical College of Wisconsin |
Study ID Numbers: | R01 MH64410, DAHBR 9A-ASPG |
Study First Received: | April 3, 2006 |
Last Updated: | July 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00310973 History of Changes |
Health Authority: | United States: Federal Government |
HIV Prevention Risk Behavior Reduction |
Roma Bulgaria HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |