Russian Labor Migrant HIV Prevention Trial

NCT ID: NCT01177995

Last Updated: 2013-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-08-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Social Network Intervention

Intervention Type: BEHAVIORAL

Social network leaders will communicate HIV prevention messages to members of their social networks.

Interventions

Social Network Intervention

Social network leaders will communicate HIV prevention messages to members of their social networks.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Yuri A. Amirkhanian, PhD

Associate Professor of Psychiatry and Behavioral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuri A. Amirkhanian, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Jeffrey A. Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Other Identifiers

R24MH082471

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO9948

Identifier Type: OTHER

Identifier Source: secondary_id

R24MH082471

Identifier Type: NIH

Identifier Source: org_study_id

View Link