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Clinical Trials/NCT01177995
NCT01177995CompletedPhase 2

Fostering an AIDS Research and Training Center Infrastructure in Russia (Labor Migrant HIV Prevention Trial)

Medical College of Wisconsin0 sites207 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
207
Primary Endpoint
Unprotected sexual intercourse events with a nonspousal partner

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
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

Arms & Interventions

Social Network

Experimental

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: Social Network Intervention (Behavioral)

Outcomes

Primary Outcomes

Unprotected sexual intercourse events with a nonspousal partner

Time Frame: up to 12 months post intervention

Secondary Outcomes

  • AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy(up to 12 months post intervention)
  • Substance use related to sexual behavior(up to 12 months post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yuri A. Amirkhanian, PhD

Associate Professor of Psychiatry and Behavioral Medicine

Medical College of Wisconsin

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