Russian Labor Migrant HIV Prevention Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yuri A. Amirkhanian, PhD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01177995
First received: August 6, 2010
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
HIV
Behavioral: Social Network Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Fostering an AIDS Research and Training Center Infrastructure in Russia (Labor Migrant HIV Prevention Trial)

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Unprotected sexual intercourse events with a nonspousal partner [ Time Frame: up to 12 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy [ Time Frame: up to 12 months post intervention ] [ Designated as safety issue: No ]
    Factors reflecting HIV risk

  • Substance use related to sexual behavior [ Time Frame: up to 12 months post intervention ] [ Designated as safety issue: No ]
    use of alcohol or other drugs in relation to sexual behavior


Enrollment: 207
Study Start Date: October 2008
Study Completion Date: August 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177995

Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
  More Information

No publications provided

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: R24-MH082471, R24MH082471, PRO9948
Study First Received: August 6, 2010
Last Updated: August 21, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 16, 2014