Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Study Overview
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Brief Summary
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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: 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; 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. Use the results of the pilot study to inform the design of a future R01 application.

Official Title
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Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Conditions
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HIV Infection

Intervention / Treatment
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* Behavioral: HIV Sexual Risk reduction
* Behavioral: HIV Sexual Risk reduction plus Microfinance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: She is at least 18 years of age; She reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol or other goods; She reports having engaged in unprotected vaginal or anal sexual intercourse in the past 90 days with a paying sexual partner; and She reports being interested in learning about and developing her own small business. Exclusion Criteria: assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIVSRR<br>4 sessions of HIV sexual risk reduction | Behavioral: HIV Sexual Risk reduction<br>* 4 sessions of HIV sexual risk reduction<br>|
| Experimental: HIVSRR + Microfinance<br>4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of intervention | Behavioral: HIV Sexual Risk reduction plus Microfinance<br>* 4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unprotected acts of vaginal and anal intercourse; | The primary outcomes include: 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of protected vaginal and/or anal acts using barrier protection; |  | 6 months | 
| number of sexual partners |  | 6 months | 
| Proportion of income from sex work |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, prevention, microfinance, sex work, Mongolia