HIV Infection Clinical Trial
Official title:
Evaluating a Microfinance Intervention for High Risk Women in Mongolia
The proposed study aims to test the feasibility and preliminary efficacy of a combined
4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34
training session and matched savings) to reduce unprotected sex and to increase proportion
of income from sex work among women engaged in high risk sexual activity in Ulaanbaatar,
Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical
trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility
screening, eligible women will complete informed consent, a baseline assessment, and be
randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus
microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.
The study design will permit us to:
1. Examine and enhance the feasibility (i.e. recruitment, engagement, attendance,
retention data collection) of a combination HIV sexual risk reduction and MF
intervention with high risk women in Ulaanbaatar, Mongolia;
2. Examine the preliminary outcomes of the interventions on decreasing unprotected acts of
vaginal and anal intercourse; increasing the proportion of protected vaginal and/or
anal acts using barrier protection and decreasing number of sexual partners with
repeated measures at baseline, immediately post-intervention, and 3 and 6 month
follow-up assessments.
3. Use the results of the pilot study to inform the design of a future R01 application.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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