International Social Network Intervention

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ClinicalTrials.gov Identifier: NCT00838773

Recruitment Status : Completed

First Posted : February 6, 2009

Last Update Posted : April 25, 2016

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Jeffrey Kelly, Medical College of Wisconsin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Behavior	Behavioral: YMSM Behavioral: YHA Behavioral: ROMA	Phase 2

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1292 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	HIV Prevention Within High-Risk Social Networks
Study Start Date :	May 2007
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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 ]

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	14 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:

Takács J, Kelly JA, P Tóth 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. Epub 2012 Oct 25.

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. Review.

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.

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.


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:	R01DA023854 ( U.S. NIH Grant/Contract ) 9R01DA023854 ( U.S. NIH Grant/Contract )
First Posted:	February 6, 2009 Key Record Dates
Last Update Posted:	April 25, 2016
Last Verified:	April 2016

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