HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Kelly, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00310973
First received: April 3, 2006
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: Social Network Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: HIV Prevention Within High-Risk Social Networks

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse [ Time Frame: Months 3 and 12 post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lower incidence of sexually transmitted diseases [ Time Frame: Months 3 and 12 post intervention ] [ Designated as safety issue: No ]
  • Change in AIDS-related scales [ Time Frame: Months 3 and 12 post intervention ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: February 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310973

Locations
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
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
Study Director: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Kelly, Professor and Director, Center for AIDS Intervention Research, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00310973     History of Changes
Other Study ID Numbers: R01 MH64410, R01MH064410, DAHBR 9A-ASPG
Study First Received: April 3, 2006
Last Updated: April 20, 2015
Health Authority: United States: Federal Government

Keywords provided by Medical College of Wisconsin:
HIV
Prevention
Risk Behavior Reduction
Roma
Bulgaria
HIV seronegativity

ClinicalTrials.gov processed this record on May 25, 2015