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

Arm | Intervention/treatment |
---|---|
Experimental: YMSM
Young Men Who Have Sex with Men
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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.
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Experimental: YHA
Young Heterosexual Adults
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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.
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Experimental: ROMA
Gypsies (Bulgarian)
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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.
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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.
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- Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup. [ Time Frame: August 2015 ]
- 15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group. [ Time Frame: August 2015 ]

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
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 |
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 |
Publications of Results:
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 |