HIV Clinical Trial
Official title:
Fostering an AIDS Research and Training Center Infrastructure in Russia (Labor Migrant HIV Prevention Trial)
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | National Institute of Mental Health (NIMH) |
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 |
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