NCT00838773

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,292

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

4.9 years

First QC Date

February 5, 2009

Last Update Submit

April 21, 2016

Conditions

Behavior

Outcome Measures

Primary Outcomes (1)

  • Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.

    August 2015

Secondary Outcomes (1)

  • 15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group.

    August 2015

Study Arms (4)

YMSM

EXPERIMENTAL

Young Men Who Have Sex with Men

Behavioral: YMSM

YHA

EXPERIMENTAL

Young Heterosexual Adults

Behavioral: YHA

ROMA

EXPERIMENTAL

Gypsies (Bulgarian)

Behavioral: ROMA

Control

NO INTERVENTION

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.

Interventions

YMSMBEHAVIORAL

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.

YMSM
YHABEHAVIORAL

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
ROMABEHAVIORAL

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

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Health and Social Development Foundation

Sofia, Bulgaria

Location

Hungarian Academy of Sciences

Budapest, Hungary

Location

Botkin Hospital for Infectious Diseases #30

Saint Petersburg, Russia

Location

Related Publications (4)

  • 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.

    PMID: 23439743RESULT

  • 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.

    PMID: 24384832RESULT

  • 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.

    PMID: 25565495RESULT

  • 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.

    PMID: 22370730RESULT

MeSH Terms

Conditions

Behavior

Study Officials

  • Jeffrey A, Kelly, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Medicine

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

May 1, 2007

Primary Completion

April 1, 2012

Study Completion

March 1, 2016

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

BU(1)HU(1)RU(1)