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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Social Network Intervention

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Unprotected sexual intercourse events with a nonspousal partner	up to 12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy	Factors reflecting HIV risk	up to 12 months post intervention
Substance use related to sexual behavior	use of alcohol or other drugs in relation to sexual behavior	up to 12 months post intervention

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: August 6, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (ESTIMATE): August 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 21, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: R24MH082471 (NIH); PRO9948 (OTHER: Medical College of Wisconsin)