HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

HIV Infections Clinical Trial

Official title:

HIV Prevention Within High-Risk Social Networks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310973
• Other study ID #: R01MH064410
• Secondary ID: R01MH064410DAHBR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 3, 2006
• Last updated: April 20, 2015
• Start date: February 2003
• Est. completion date: November 2005

Study information

• Verified date: April 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Social Network Intervention

Locations

Country	Name	City	State
Bulgaria	Health and Social Development Foundation	Sofia
Hungary	Institute of Sociology, Hungarian Academy of Sciences	Budapest
Russian Federation	Botkin Hospital for Infectious Diseases	St. Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Russian Federation, 

References & Publications (7)

Amirkhanian YA, Kelly JA, Kabakchieva E, Kirsanova AV, Vassileva S, Takacs J, DiFranceisco WJ, McAuliffe TL, Khoursine RA, Mocsonaki L. A randomized social network HIV prevention trial with young men who have sex with men in Russia and Bulgaria. AIDS. 200 — View Citation

Amirkhanian YA, Kelly JA, Kabakchieva E, McAuliffe TL, Vassileva S. Evaluation of a social network HIV prevention intervention program for young men who have sex with men in Russia and Bulgaria. AIDS Educ Prev. 2003 Jun;15(3):205-20. — View Citation

Amirkhanian YA, Kelly JA, Kirsanova AV, DiFranceisco W, Khoursine RA, Semenov AV, Rozmanova VN. HIV risk behaviour patterns, predictors, and sexually transmitted disease prevalence in the social networks of young men who have sex with men in St Petersburg — View Citation

Amirkhanian YA, Kelly JA, McAuliffe TL. Identifying, recruiting, and assessing social networks at high risk for HIV/AIDS: methodology, practice, and a case study in St Petersburg, Russia. AIDS Care. 2005 Jan;17(1):58-75. — View Citation

Kabakchieva E, Vassileva S, Kelly JA, Amirkhanian YA, DiFranceisco WJ, McAuliffe TL, Antonova R, Mihaylova M, Vassilev B, Khoursine R, Petrova E. HIV risk behavior patterns, predictors, and sexually transmitted disease prevalence in the social networks of — View Citation

Kelly JA, Amirkhanian YA, Kabakchieva E, Csepe P, Seal DW, Antonova R, Mihaylov A, Gyukits G. Gender roles and HIV sexual risk vulnerability of Roma (Gypsies) men and women in Bulgaria and Hungary: an ethnographic study. AIDS Care. 2004 Feb;16(2):231-45. — View Citation

Takács J, Amirkhanian YA, Kelly JA, Kirsanova AV, Khoursine RA, Mocsonaki L. "Condoms are reliable but I am not": A qualitative analysis of AIDS-related beliefs and attitudes of young heterosexual adults in Budapest, Hungary, and St. Petersburg, Russia. C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse		Months 3 and 12 post intervention	No
Secondary	Lower incidence of sexually transmitted diseases		Months 3 and 12 post intervention	No
Secondary	Change in AIDS-related scales		Months 3 and 12 post intervention	No