Tracking Information
Start Date ICMJE | May 2007 |
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Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 5, 2009) | 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 ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE (submitted: February 5, 2009) | 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 ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | International Social Network Intervention |
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Official Title ICMJE | HIV Prevention Within High-Risk Social Networks |
Brief Summary | 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. |
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. |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Condition ICMJE | Behavior |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1640 | ||||||||
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Estimated Completion Date | August 2009 | ||||||||
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | 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. - 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. - | ||||||||
Gender | Both | ||||||||
Ages | 14 Years and older | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Bulgaria, Hungary, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00838773 | ||||||||||||||||
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Responsible Party | Jeffrey A. Kelly, Ph.D., Medical College of Wisconsin | ||||||||||||||||
Study ID Numbers ICMJE | DESPR R01 DA023854, 9 R01 DA023854 | ||||||||||||||||
Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||||||||||
Collaborators ICMJE | |||||||||||||||||
Investigators ICMJE |
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Information Provided By | National Institute on Drug Abuse (NIDA) |