Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Columbia University

Status: Completed

Conditions: HIV Infection

Treatments: Behavioral: HIV Sexual Risk reduction plus Microfinance; Behavioral: HIV Sexual Risk reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01861431

R34MH093227 (U.S. NIH Grant/Contract)

AAAF4402

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

HIVSRR

Active Comparator group

Description:

4 sessions of HIV sexual risk reduction

Treatment:

Behavioral: HIV Sexual Risk reduction

HIVSRR + Microfinance

Experimental group

Description:

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

Treatment:

Behavioral: HIV Sexual Risk reduction plus Microfinance