Clinical trial NCT01177995: Russian Labor Migrant HIV Prevention Trial
Official title: Fostering an AIDS Research and Training Center Infrastructure in Russia (Labor Migrant HIV Prevention Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-08-09
Enrollment: 207
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Unprotected sexual intercourse events with a nonspousal partner
timeFrame: up to 12 months post intervention
Secondary outcomes:
measure: AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy
timeFrame: up to 12 months post intervention
measure: Substance use related to sexual behavior
timeFrame: up to 12 months post intervention
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wisconsin
name: Yuri A. Amirkhanian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Jeffrey A. Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: