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Evaluating a Microfinance Intervention for High Risk Women in Mongolia

NCT01861431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

BEHAVIORAL

HIV Sexual Risk reduction

4 sessions of HIV sexual risk reduction

BEHAVIORAL

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

Sponsors & Collaborators

Principal Investigators

  • Susan S Witte, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • Mongolia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861431 on ClinicalTrials.gov