International Social Network Intervention - Full Text View

Purpose

This grant involves 24 social networks of young men who have sex with men, Roma, and young high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.

Condition	Intervention	Phase
Behavior	Behavioral: YMSM Behavioral: YHA Behavioral: ROMA	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup. [ Time Frame: August 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group. [ Time Frame: August 2015 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1640
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2013
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: YMSM Young Men Who Have Sex with Men	Behavioral: YMSM Leaders of networks in the experimental condition will participate in a 9-session intervention training program that will inspire and assist leaders to communicate HIV prevention risk reduction messages with their immediate friends. The first five sessions will focus on HIV risk predictors including HIV/AIDS knowledge, safer sex peer norms, condom attitudes, condom use intentions, and self-efficacy in remaining safe. The remaining four sessions will reinforce the leaders for continuing their HIV prevention communications and remind them of the topics during the main sessions.
Experimental: YHA Young Heterosexual Adults	Behavioral: YHA Leaders of networks in the experimental condition will participate in a 9-session intervention training program that will inspire and assist leaders to communicate HIV prevention risk reduction messages with their immediate friends. The first five sessions will focus on HIV risk predictors including HIV/AIDS knowledge, safer sex peer norms, condom attitudes, condom use intentions, and self-efficacy in remaining safe. The remaining four sessions will reinforce the leaders for continuing their HIV prevention communications and remind them of the topics during the main sessions.
Experimental: ROMA Gypsies (Bulgarian)	Behavioral: ROMA Leaders of networks in the experimental condition will participate in a 9-session intervention training program that will inspire and assist leaders to communicate HIV prevention risk reduction messages with their immediate friends. The first five sessions will focus on HIV risk predictors including HIV/AIDS knowledge, safer sex peer norms, condom attitudes, condom use intentions, and self-efficacy in remaining safe. The remaining four sessions will reinforce the leaders for continuing their HIV prevention communications and remind them of the topics during the main sessions.
No Intervention: Control All study participants (including those in control condition networks) receive HIV/AIDS/STD risk reduction counseling at baseline, as well as testing and treatment or treatment referral for STDs and HIV infection. STD/HIV testing and treatment or treatment referral are provided at each followup point. This constitutes the control intervention.

Detailed Description:

For over 4 years, our international collaborative research team has carried out a social network HIV prevention intervention trial with community populations of young men who have sex with men (YMSM), disadvantaged ethnic minority Roma (Gypsies), and high-risk heterosexual adult (YHA) women and men in Hungary, Bulgaria and Russia. Eastern Europe has seen a sharp increase in HIV incidence, and social network interventions are high in cultural relevance because post-communist populations have a long history of trusting and relying upon their personal networks more than their governments. Across the three countries represented in our research during the past funding period, we enrolled social networks of YMSM, Roma, and YHAs. This study will renew our international collaboration to extend this network intervention approach. Our study, to date, has worked with very small independent friendship groups (usually composed of 5-6 people) as "egocentric" social networks.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:Members of a friendship group will be eligible for enrollment if they are of legal age to independently consent to participate in this study. In its review and approval of this protocol, the IRB at BotkinHospital, St. Petersburg, Russia verified and confirmed in writing to us that the age of research participation consent is 15. In its review and approval of this protocol, the IRB at the Health and Social Development Foundation determined that the age of research participation consent in Bulgaria is 16. In Hungary, the IRB at the Institute of Sociology at the Hungarian Academy of Sciences determined that the age of independent consent to participate in this study is 14.

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Exclusion Criteria:Individuals will be excluded from enrollment into the study if they are below the age for providing independent consent or are not capable of providing informed consent based on impairment due to the presence of sever psychopatology, substance use, or similar conditions observed at the time of informed consent. Social networks will be excluded from the study if: (1) more than 33% of named network members do not agree to participate; (2) fewer than 50% of members report occurrence of unprotected intercourse during the past 3 months at baseline; or (3) more than 10% of a network's members are also members of another network enrolled in the study.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838773

Locations

Bulgaria
Health and Social Development Foundation
Sofia, Bulgaria
Hungary
Hungarian Academy of Sciences
Budapest, Hungary
Russian Federation
Botkin Hospital for Infectious Diseases #30
St. Petersburg, Russian Federation

Sponsors and Collaborators

Medical College of Wisconsin

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Jeffrey A, Kelly, PhD	Medical College of Wisconsin
Study Director:	Yuri A. Amirkhanian, Ph.D.	Medical College of Wisconsin
Study Director:	Judit Takacs, Ph.D.	Institute of Sociology of Hungarian Academy of Sciences
Study Director:	Elena Kabakchieva, MD	Health and Social Development Foundation

More Information

No publications provided

Responsible Party:	Jeffrey Kelly, Professor of Psychiatry and Behavioral Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00838773 History of Changes
Other Study ID Numbers:	DESPR R01 DA023854, 9R01DA023854, 9 R01 DA023854
Study First Received:	February 5, 2009
Last Updated:	March 18, 2013
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on May 21, 2013