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Evaluating a Microfinance Intervention for High Risk Women in Mongolia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Witte, Columbia University
ClinicalTrials.gov Identifier:
NCT01861431
First received: May 20, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.

Condition Intervention
HIV Infection
Behavioral: HIV Sexual Risk reduction
Behavioral: HIV Sexual Risk reduction plus Microfinance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • unprotected acts of vaginal and anal intercourse; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • number of sexual partners [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of income from sex work [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861431

Locations
Mongolia
Aira Toivgoo, co-PI
Ulaanbaatar,, Mongolia
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Susan S Witte, PhD Columbia University
  More Information

No publications provided

Responsible Party: Susan Witte, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01861431     History of Changes
Other Study ID Numbers: AAAF4402, R34MH093227
Study First Received: May 20, 2013
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
HIV, prevention, microfinance, sex work, Mongolia

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014