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

August 6, 2010
August 21, 2013
October 2008
September 2011   (final data collection date for primary outcome measure)
Unprotected sexual intercourse events with a nonspousal partner [ Time Frame: up to 12 months post intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01177995 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Russian Labor Migrant HIV Prevention Trial
Fostering an AIDS Research and Training Center Infrastructure in Russia (Labor Migrant HIV Prevention Trial)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Behavioral: Social Network Intervention
Social network leaders will communicate HIV prevention messages to members of their social networks.
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.
Intervention: Behavioral: Social Network Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
August 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01177995
R24-MH082471, R24MH082471, PRO9948
No
Yuri A. Amirkhanian, PhD, Medical College of Wisconsin
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
Medical College of Wisconsin
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP