International Social Network Intervention

NCT ID: NCT00838773

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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YMSM

Young Men Who Have Sex with Men

Group Type EXPERIMENTAL

YMSM

Intervention Type BEHAVIORAL

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.

YHA

Young Heterosexual Adults

Group Type EXPERIMENTAL

YHA

Intervention Type BEHAVIORAL

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.

ROMA

Gypsies (Bulgarian)

Group Type EXPERIMENTAL

ROMA

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Kelly

Professor of Psychiatry and Behavioral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey A, Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Yuri A. Amirkhanian, Ph.D.

Role: STUDY_DIRECTOR

Medical College of Wisconsin

Judit Takacs, Ph.D.

Role: STUDY_DIRECTOR

Institute of Sociology of Hungarian Academy of Sciences

Elena Kabakchieva, MD

Role: STUDY_DIRECTOR

Health and Social Development Foundation

Locations

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Health and Social Development Foundation

Sofia, , Bulgaria

Site Status

Hungarian Academy of Sciences

Budapest, , Hungary

Site Status

Botkin Hospital for Infectious Diseases #30

Saint Petersburg, , Russia

Site Status

Countries

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Bulgaria Hungary Russia

References

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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.

Reference Type RESULT
PMID: 23439743 (View on PubMed)

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.

Reference Type RESULT
PMID: 24384832 (View on PubMed)

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.

Reference Type RESULT
PMID: 25565495 (View on PubMed)

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.

Reference Type RESULT
PMID: 22370730 (View on PubMed)

Other Identifiers

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9R01DA023854

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA023854

Identifier Type: NIH

Identifier Source: org_study_id

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