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Trial record 51 of 1934 for:    Sexually Transmitted Diseases | NIH

HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00310973
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeffrey Kelly, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE April 3, 2006
First Posted Date  ICMJE April 5, 2006
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE February 2003
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse [ Time Frame: Months 3 and 12 post intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2006)
Measured at Months 3 and 12: Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse
Change History Complete list of historical versions of study NCT00310973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Lower incidence of sexually transmitted diseases [ Time Frame: Months 3 and 12 post intervention ]
  • Change in AIDS-related scales [ Time Frame: Months 3 and 12 post intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2006)
  • Measured at Months 3 and 12: Lower incidence of sexually transmitted diseases
  • Change in AIDS-related scales
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks
Official Title  ICMJE HIV Prevention Within High-Risk Social Networks
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE Behavioral: Social Network Intervention
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2006)
320
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Hungary,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00310973
Other Study ID Numbers  ICMJE R01MH064410( U.S. NIH Grant/Contract )
R01MH064410 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASPG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Kelly, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
Study Director: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date April 2015

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