HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00310973
First received: April 3, 2006
Last updated: July 21, 2006
Last verified: April 2006

April 3, 2006
July 21, 2006
February 2003
Not Provided
Measured at Months 3 and 12: Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse
Same as current
Complete list of historical versions of study NCT00310973 on ClinicalTrials.gov Archive Site
  • Measured at Months 3 and 12: Lower incidence of sexually transmitted diseases
  • Change in AIDS-related scales
Same as current
Not Provided
Not Provided
 
HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks
HIV Prevention Within High-Risk Social Networks

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
HIV Infections
Behavioral: Social Network Intervention
Not Provided
Kelly JA, Amirkhanian YA, Kabakchieva E, Vassileva S, Vassilev B, McAuliffe TL, DiFranceisco WJ, Antonova R, Petrova E, Khoursine RA, Dimitrov B. Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma (Gypsy) men in Bulgaria: randomised controlled trial. BMJ. 2006 Nov 25;333(7578):1098. Epub 2006 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
November 2005
Not Provided

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
Both
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Hungary,   Russian Federation
 
NCT00310973
R01 MH64410, DAHBR 9A-ASPG
Not Provided
Not Provided
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
Study Director: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
National Institute of Mental Health (NIMH)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP