Evaluating a Microfinance Intervention for High Risk Women in Mongolia

NCT ID: NCT01861431

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-12-31

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:

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

HIVSRR

4 sessions of HIV sexual risk reduction

Group Type: ACTIVE_COMPARATOR

HIV Sexual Risk reduction

Intervention Type: BEHAVIORAL

4 sessions of HIV sexual risk reduction

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

Group Type: EXPERIMENTAL

HIV Sexual Risk reduction plus Microfinance

Intervention Type: BEHAVIORAL

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

Interventions

HIV Sexual Risk reduction

4 sessions of HIV sexual risk reduction

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Susan Witte

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan S Witte, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Aira Toivgoo, co-PI

Ulaanbaatar, , Mongolia

Countries

Mongolia

References

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.

Reference Type: DERIVED

PMID: 27793147 (View on PubMed)

Other Identifiers

R34MH093227

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAF4402

Identifier Type: -

Identifier Source: org_study_id