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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Behavioral: HIV Sexual Risk reduction; Behavioral: HIV Sexual Risk reduction plus Microfinance

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mongolia
  • Ulaanbaatar,, Mongolia
    • Aira Toivgoo, co-PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIVSRR; 4 sessions of HIV sexual risk reduction	Behavioral: HIV Sexual Risk reduction; 4 sessions of HIV sexual risk reduction
Experimental: HIVSRR + 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	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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Susan S Witte, PhD, Columbia University

Publications and helpful links

General Publications

• Tsai LC, Carlson CE, Aira T, Norcini Pala A, Riedel M, Witte SS. The impact of a microsavings intervention on reducing violence against women engaged in sex work: a randomized controlled study. BMC Int Health Hum Rights. 2016 Oct 28;16(1):27. doi: 10.1186/s12914-016-0101-3.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: HIV, prevention, microfinance, sex work, Mongolia
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: AAAF4402; R34MH093227 (U.S. NIH Grant/Contract)