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Completed

NCT Number: NCT01177995

Russian 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.

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Key information

Conditions

HIV

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social network intervention

Behavioral

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

Primary outcomes

  1. Unprotected sexual intercourse events with a nonspousal partner

    Time frame: up to 12 months post intervention

Secondary outcomes

  1. AIDS-related knowledge, attitudes, intentions, perceived norms, and self-efficacy

    Time frame: up to 12 months post intervention

    Factors reflecting HIV risk

  2. Substance use related to sexual behavior

    Time frame: up to 12 months post intervention

    use of alcohol or other drugs in relation to sexual behavior

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Aug 9, 2010
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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