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Russian Labor Migrant HIV Prevention Trial

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ClinicalTrials.gov Identifier: NCT01177995
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 23, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study is a randomized outcome trial of a social network HIV prevention intervention for at-risk labor migrants who have arrived in St. Petersburg, Russia, to seek work. Most come to St. Petersburg from Moldova, Tajikistan, Uzbekistan, Ukraine, and other poor post-Soviet republics. While living in Russia, labor migrants are also living in a city and country with high HIV prevalence. Many labor migrants have limited awareness of AIDS, and most are living in a location far from their spouses, family members, and others. For that reason, labor migrants are vulnerable to risk behavior for contracting HIV.

This study hypothesizes that members of labor migrant social networks whose network leaders are trained to deliver HIV prevention messages will exhibit greater reductions in sexual risk behavior (unprotected intercourse with nonspousal partners) from baseline to 3- and 12-month followup assessments than will members of social networks whose members receive standard, individual HIV risk reduction counseling alone.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Social Network Intervention Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Fostering an AIDS Research and Training Center Infrastructure in Russia (Labor Migrant HIV Prevention Trial)
Study Start Date : October 2008
Primary Completion Date : September 2011
Study Completion Date : August 2013

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: Social Network
Leaders of labor migrant social networks will be trained to disseminate HIV prevention messages to the members of their social networks. The training will sequentially target ways to increase network members' HIV-related knowledge and norms, attitudes, intentions, and confidence in how to avoid risk. Leaders will be encouraged to have these discussions with network members between and after training sessions.
Behavioral: Social Network Intervention
Social network leaders will communicate HIV prevention messages to members of their social networks.

Outcome Measures

Primary Outcome Measures :
  1. Unprotected sexual intercourse events with a nonspousal partner [ Time Frame: up to 12 months post intervention ]

Secondary Outcome Measures :
  1. AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy [ Time Frame: up to 12 months post intervention ]
    Factors reflecting HIV risk

  2. Substance use related to sexual behavior [ Time Frame: up to 12 months post intervention ]
    use of alcohol or other drugs in relation to sexual behavior

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • being a labor migrant intending to temporarily work and reside in St. Petersburg, Russia, or being named as a member of the social network of a labor migrant;
  • being at least 16 years old (the age at which persons can be legal labor migrants and are also legally considered to be able to provide informed consent);
  • being able to complete written consent forms and questionnaire measures in Russian, Moldovan, Tajik, or Uzbek language
  • providing written informed consent

Exclusion Criteria:

  • being younger than age 16;
  • not being able to complete written materials in the Russian, Moldovan, Tajik, or Uzbek language;
  • planning to reside in St. Petersburg, Russia, for less than four months;
  • having a severe mental or developmental disorder apparent by mental status during the study or consent explanation that, in the opinion of a trained interviewer, would preclude ability to understand informed consent or complete study measures
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): NCT01177995

Sponsors and Collaborators
Medical College of Wisconsin
National Institute of Mental Health (NIMH)
Principal Investigator: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
More Information

Responsible Party: Yuri A. Amirkhanian, PhD, Associate Professor of Psychiatry and Behavioral Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01177995     History of Changes
Other Study ID Numbers: R24MH082471 ( U.S. NIH Grant/Contract )
PRO9948 ( Other Identifier: Medical College of Wisconsin )
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013