Evaluating a Microfinance Intervention for High Risk Women in Mongolia

HIV Infection Clinical Trial

Official title:

Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861431
• Other study ID #: AAAF4402
• Secondary ID: R34MH093227
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: March 17, 2015
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection

Intervention

Behavioral:
• HIV Sexual Risk reduction
4 sessions of HIV sexual risk reduction
• 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

Locations

Country	Name	City	State
Mongolia	Aira Toivgoo, co-PI	Ulaanbaatar,

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	proportion of protected vaginal and/or anal acts using barrier protection;		6 months	No
Secondary	number of sexual partners		6 months	No
Secondary	Proportion of income from sex work		6 months	No