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

May 20, 2013
July 29, 2013
April 2010
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01861431 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluating a Microfinance Intervention for High Risk Women in Mongolia
Evaluating a Microfinance Intervention for High Risk Women in Mongolia

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infection
  • Behavioral: HIV Sexual Risk reduction
    4 sessions of HIV sexual risk reduction
  • 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
  • Active Comparator: HIVSRR
    4 sessions of HIV sexual risk reduction
    Intervention: Behavioral: 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
    Intervention: Behavioral: HIV Sexual Risk reduction plus Microfinance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
107
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Mongolia
 
NCT01861431
AAAF4402, R34MH093227
No
Susan Witte, Columbia University
Columbia University
National Institute of Mental Health (NIMH)
Principal Investigator: Susan S Witte, PhD Columbia University
Columbia University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP