Evaluating a Microfinance Intervention for High Risk Women in Mongolia

NCT01861431 | Completed

• 2 other identifiers: AAAF4402R34MH093227
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Use the results of the pilot study to inform the design of a future R01 application.

Conditions

HIV Infection

Keywords

HIV, prevention, microfinance, sex work, Mongolia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

HIVSRR

ACTIVE COMPARATOR

4 sessions of HIV sexual risk reduction

Behavioral: HIV Sexual Risk reduction

HIVSRR + Microfinance

EXPERIMENTAL

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

Interventions

HIV Sexual Risk reduction BEHAVIORAL

4 sessions of HIV sexual risk reduction

HIVSRR

HIV Sexual Risk reduction plus Microfinance 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

HIVSRR + Microfinance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Aira Toivgoo, co-PI

Ulaanbaatar, Mongolia

Location

Related Publications (1)

• 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.

  PMID: 27793147 DERIVED

MeSH Terms

Conditions

HIV Infections; Sex Work

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexual Behavior; Behavior

Study Officials

• Susan S Witte, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 18, 2015

Record last verified: 2013-07

Locations

MO (1)