International Social Network Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Kelly, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00838773
First received: February 5, 2009
Last updated: March 18, 2013
Last verified: March 2013

February 5, 2009
March 18, 2013
May 2007
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00838773 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
International Social Network Intervention
HIV Prevention Within High-Risk Social Networks

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Behavior
  • 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.
  • 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.
  • 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.
  • Experimental: YMSM
    Young Men Who Have Sex with Men
    Intervention: Behavioral: YMSM
  • Experimental: YHA
    Young Heterosexual Adults
    Intervention: Behavioral: YHA
  • Experimental: ROMA
    Gypsies (Bulgarian)
    Intervention: Behavioral: ROMA
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1640
December 2013
April 2012   (final data collection date for primary outcome measure)

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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Both
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Hungary,   Russian Federation
 
NCT00838773
DESPR R01 DA023854, 9R01DA023854, 9 R01 DA023854
Yes
Jeffrey Kelly, Medical College of Wisconsin
Medical College of Wisconsin
National Institute on Drug Abuse (NIDA)
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
Medical College of Wisconsin
March 2013

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