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Completed

NCT Number: NCT00310973

HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Health and Social Development Foundation, Sofia, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social network intervention

Behavioral

Primary outcomes

  1. Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse

    Time frame: Months 3 and 12 post intervention

Secondary outcomes

  1. Lower incidence of sexually transmitted diseases

    Time frame: Months 3 and 12 post intervention

  2. Change in AIDS-related scales

    Time frame: Months 3 and 12 post intervention

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

HIV Prevention Within High-Risk Social Networks

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 5, 2006
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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