Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Not Applicable

Completed

• Conditions: HIV Infection
• Interventions: Behavioral: HIV Sexual Risk reduction; Behavioral: HIV Sexual Risk reduction plus Microfinance

• Registration Number: NCT01861431
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Status Verified: 2013-07
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIVSRR	HIV Sexual Risk reduction	4 sessions of HIV sexual risk reduction
HIVSRR + Microfinance	HIV Sexual Risk reduction plus Microfinance	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

Primary Outcome Measures

Name	Time	Method
unprotected acts of vaginal and anal intercourse;	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of income from sex work	6 months
number of sexual partners	6 months
proportion of protected vaginal and/or anal acts using barrier protection;	6 months

Trial Locations

Locations (1)

Aira Toivgoo, co-PI; 🇲🇳 Ulaanbaatar,, Mongolia