Russian Labor Migrant HIV Prevention Trial

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177995
• Other study ID #: R24MH082471
• Secondary ID: R24MH082471PRO99
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2010
• Last updated: August 21, 2013
• Start date: October 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: August 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Social Network Intervention
Social network leaders will communicate HIV prevention messages to members of their social networks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected sexual intercourse events with a nonspousal partner		up to 12 months post intervention	No
Secondary	AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy	Factors reflecting HIV risk	up to 12 months post intervention	No
Secondary	Substance use related to sexual behavior	use of alcohol or other drugs in relation to sexual behavior	up to 12 months post intervention	No