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HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Social Network Intervention
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Prevention, Risk Behavior Reduction, Roma, Bulgaria, HIV seronegativity

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health and Social Development Foundation
  • Institute of Sociology, Hungarian Academy of Sciences
  • Botkin Hospital for Infectious Diseases

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lower incidence of sexually transmitted diseases
Change in AIDS-related scales

Full Information

First Posted
April 3, 2006
Last Updated
April 20, 2015
Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00310973
Brief Title
HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks
Official Title
HIV Prevention Within High-Risk Social Networks
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Prevention, Risk Behavior Reduction, Roma, Bulgaria, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Social Network Intervention
Primary Outcome Measure Information:
Title
Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse
Time Frame
Months 3 and 12 post intervention
Secondary Outcome Measure Information:
Title
Lower incidence of sexually transmitted diseases
Time Frame
Months 3 and 12 post intervention
Title
Change in AIDS-related scales
Time Frame
Months 3 and 12 post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Kelly, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuri A. Amirkhanian, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
Facility Information:
Facility Name
Health and Social Development Foundation
City
Sofia
Country
Bulgaria
Facility Name
Institute of Sociology, Hungarian Academy of Sciences
City
Budapest
Country
Hungary
Facility Name
Botkin Hospital for Infectious Diseases
City
St. Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
16641823
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 young Roma (Gypsy) men in Sofia, Bulgaria. Sex Transm Dis. 2006 Aug;33(8):485-90. doi: 10.1097/01.olq.0000204533.20324.56.
Results Reference
result
PubMed Identifier
16227798
Citation
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. 2005 Nov 4;19(16):1897-905. doi: 10.1097/01.aids.0000189867.74806.fb.
Results Reference
result
PubMed Identifier
16830606
Citation
Takacs 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. Cent Eur J Public Health. 2006 Jun;14(2):59-66. doi: 10.21101/cejph.a3373.
Results Reference
result
PubMed Identifier
16409680
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, Russia. Int J STD AIDS. 2006 Jan;17(1):50-6. doi: 10.1258/095646206775220504.
Results Reference
result
PubMed Identifier
12866833
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. doi: 10.1521/aeap.15.4.205.23832.
Results Reference
result
PubMed Identifier
14676028
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. doi: 10.1080/09540120410001641075.
Results Reference
result
PubMed Identifier
15832834
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. doi: 10.1080/09540120412331305133.
Results Reference
result
PubMed Identifier
17040924
Citation
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. doi: 10.1136/bmj.38992.478299.55. Epub 2006 Oct 13.
Results Reference
derived

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HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

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