Evaluating a Microfinance Intervention for High Risk Women in Mongolia
Primary Purpose
HIV Infection
Status
Completed
Phase
Not Applicable
Locations
Mongolia
Study Type
Interventional
Intervention
HIV Sexual Risk reduction
HIV Sexual Risk reduction plus Microfinance
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infection focused on measuring HIV, prevention, microfinance, sex work, Mongolia
Eligibility Criteria
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
Sites / Locations
- Aira Toivgoo, co-PI
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
HIVSRR
HIVSRR + Microfinance
Arm Description
4 sessions of HIV sexual risk reduction
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
proportion of protected vaginal and/or anal acts using barrier protection;
number of sexual partners
Proportion of income from sex work
Full Information
NCT ID
NCT01861431
First Posted
May 20, 2013
Last Updated
March 17, 2015
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01861431
Brief Title
Evaluating a Microfinance Intervention for High Risk Women in Mongolia
Official Title
Evaluating a Microfinance Intervention for High Risk Women in Mongolia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, prevention, microfinance, sex work, Mongolia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIVSRR
Arm Type
Active Comparator
Arm Description
4 sessions of HIV sexual risk reduction
Arm Title
HIVSRR + Microfinance
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
HIV Sexual Risk reduction
Intervention Description
4 sessions of HIV sexual risk reduction
Intervention Type
Behavioral
Intervention Name(s)
HIV Sexual Risk reduction plus Microfinance
Intervention 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
Primary Outcome Measure Information:
Title
unprotected acts of vaginal and anal intercourse;
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
proportion of protected vaginal and/or anal acts using barrier protection;
Time Frame
6 months
Title
number of sexual partners
Time Frame
6 months
Title
Proportion of income from sex work
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan S Witte, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aira Toivgoo, co-PI
City
Ulaanbaatar,
Country
Mongolia
12. IPD Sharing Statement
Citations:
PubMed Identifier
27793147
Citation
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.
Results Reference
derived
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Evaluating a Microfinance Intervention for High Risk Women in Mongolia
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