Clinical trial NCT00838773: International Social Network Intervention
Official title: HIV Prevention Within High-Risk Social Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Behavior
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-02-06
Enrollment: 1292
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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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Primary outcomes:
measure: Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.
timeFrame: August 2015
Secondary outcomes:
measure: 15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group.
timeFrame: August 2015
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Health and Social Development Foundation
city: Budapest
country: Hungary
facility: Hungarian Academy of Sciences
city: St. Petersburg
country: Russian Federation
facility: Botkin Hospital for Infectious Diseases #30
Study officials:
affiliation: Medical College of Wisconsin
name: Jeffrey A, Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Yuri A. Amirkhanian, Ph.D.
role: STUDY_DIRECTOR
affiliation: Institute of Sociology of Hungarian Academy of Sciences
name: Judit Takacs, Ph.D.
role: STUDY_DIRECTOR
affiliation: Health and Social Development Foundation
name: Elena Kabakchieva, MD
role: STUDY_DIRECTOR
References:
citation: Takacs J, Kelly JA, P Toth T, Mocsonaki L, Amirkhanian YA. Effects of Stigmatization on Gay Men Living with HIV/AIDS in a Central-Eastern European Context: A Qualitative Analysis from Hungary. Sex Res Social Policy. 2013 Mar 1;10(1):24-34. doi: 10.1007/s13178-012-0102-5. Epub 2012 Oct 25.
citation: Amirkhanian YA. Social networks, sexual networks and HIV risk in men who have sex with men. Curr HIV/AIDS Rep. 2014 Mar;11(1):81-92. doi: 10.1007/s11904-013-0194-4.
citation: Amirkhanian YA, Kelly JA, Takacs J, McAuliffe TL, Kuznetsova AV, Toth TP, Mocsonaki L, DiFranceisco WJ, Meylakhs A. Effects of a social network HIV/STD prevention intervention for MSM in Russia and Hungary: a randomized controlled trial. AIDS. 2015 Mar 13;29(5):583-93. doi: 10.1097/QAD.0000000000000558.
citation: Amirkhanian YA, Kelly JA, Kabakchieva E, Antonova R, Vassileva S, Difranceisco WJ, McAuliffe TL, Vassilev B, Petrova E, Khoursine RA. High-risk sexual behavior, HIV/STD prevalence, and risk predictors in the social networks of young Roma (Gypsy) men in Bulgaria. J Immigr Minor Health. 2013 Feb;15(1):172-81. doi: 10.1007/s10903-012-9596-4.