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Evaluating a Microfinance Intervention for Vulnerable Women in Kazakhstan (MFKZ)

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ClinicalTrials.gov Identifier: NCT02406482
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Susan Witte, Columbia University

Brief Summary:
This study will examine the efficacy of a combined HIV and microfinance intervention to reduce biologically confirmed sexually transmitted infections (STIs), and new incidence of HIV and HCV, as well as reported sexual and drug risk behaviors among 520 women who have injected drugs in the past year and who engage in sex trading in Temirtau and Pavlodar, Kazakhstan. The proposed study builds on findings from an R34 by the investigative team testing a combination HIV prevention and microfinance intervention. Building on successful protocols and significant results, we will randomly assign 520 women who inject drugs and engage in sex trading from Temirtau and Pavlodar, Kazakhstan to either (1) a 4 session HIV prevention intervention combined with a 6 session financial literacy intervention, enrollment in an existing vocational training program and receipt of matched savings (HIVRR+MF); or to the 4 session HIV prevention intervention alone. The HIVRR intervention is guided by social cognitive theory. The HIVRR+MF intervention integrates asset theory with social cognitive theory. The MF includes: 1) financial literacy; 2) vocational training; and 3) micro-savings to support transition to a more permanent employment status. We hypothesize that increasing financial literacy, enhancing vocational skills required to fill marketable positions in the local economy, and beginning a personal savings program, combined with HIV risk reduction, will lead to significant reductions in study outcomes compared to an HIVRR intervention without a microfinance intervention.

Condition or disease Intervention/treatment Phase
HIV/AIDS and Infections Behavioral: Microfinance intervention (MF) Behavioral: HIV risk reduction (HIVRR) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating a Microfinance Intervention for Vulnerable Women in Kazakhstan
Study Start Date : April 2015
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIVRR + MF
Four sessions of education and intervention (Behavioral: HIV risk reduction (HIVRR)) followed by financial literacy, micro-savings and vocational training (Behavioral: Microfinance intervention (MF)).
Behavioral: Microfinance intervention (MF)
Six sessions provided three times per week over two weeks by a study team facilitator. The sessions focus on banking services, savings (including how to open an account), budgeting (including development of a household budget), debt management, and financial negotiations, 1:1 matched savings account for women, followed by vocational training: Women assigned to the HIVRR+MF arm decide during their financial literacy sessions which vocational training program in which they would like to be enrolled (24 sessions).

Behavioral: HIV risk reduction (HIVRR)
Four sessions delivered twice a week for the first two weeks. Sessions derive from three evidence-based interventions with demonstrated efficacy to reduce drug and sexual HIV-risk behaviors in vulnerable women. Content focuses on basic transmission risk; educating about the risks of alcohol and drug use and how sexual behavior increases HIV risk; male and female condom use; examining the context for sexual risk including male partner sexual risk behavior (e.g. multiple partners) and violence against women; reducing other sexual risks (e.g., mutual masturbation, correct use of lubricants).

Active Comparator: HIVRR only
Four sessions of education and intervention (Behavioral: HIV risk reduction (HIVRR)).
Behavioral: HIV risk reduction (HIVRR)
Four sessions delivered twice a week for the first two weeks. Sessions derive from three evidence-based interventions with demonstrated efficacy to reduce drug and sexual HIV-risk behaviors in vulnerable women. Content focuses on basic transmission risk; educating about the risks of alcohol and drug use and how sexual behavior increases HIV risk; male and female condom use; examining the context for sexual risk including male partner sexual risk behavior (e.g. multiple partners) and violence against women; reducing other sexual risks (e.g., mutual masturbation, correct use of lubricants).




Primary Outcome Measures :
  1. Incidence of biologically confirmed STIs [ Time Frame: 12 months ]
    To examine whether women assigned to the combined HIVRR+MF intervention have: (1) a lower cumulative incidence of biologically confirmed STIs syphilis, gonorrhea, chlamydia trichomoniasis and mycoplasma)

  2. Rate of new HIV and HCV cases [ Time Frame: 12 months ]
    To examine if the rate of new HIV and HCV cases is lower compared to those assigned to the HIVRR arm over the 12 month follow-up

  3. Number of unprotected vaginal and anal sexual acts with both regular and paying partners [ Time Frame: 12 months ]
  4. Proportion of unprotected vaginal and anal sexual acts with both regular and paying partners [ Time Frame: 12 months ]
  5. Number of unsafe injection acts [ Time Frame: 12 months ]
  6. Proportion of unsafe injection acts [ Time Frame: 12 months ]
  7. Proportion of monthly income from sex work [ Time Frame: 12 months ]
    To examine whether there is a lower proportion of monthly income from sex work at 3, 6, and 12 months, compared to women assigned to HIVRR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. at least 18 years old;
  2. reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol, drugs, or other goods;
  3. reports having injected drugs in the past year;
  4. reports having engaged in unprotected sexual intercourse in the past 90 days with either a paying, casual, or intimate (main) sexual partner;
  5. reports being interested in learning a marketable vocation, specifically hairdressing or cooking/baking.

Exclusion Criteria:

  1. assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments. (As in prior SIG and GHRCCA studies, a standardized diagnostic tool will not be used. Rather, as part of informed consent, a potential participant is asked to state her understanding regarding three areas covered earlier during the informed consent protocol: (a) the nature and extent of participation in the study; (b) the risks involved with participation; and (c) the potential benefits of participation in the study. If a participant is unable to respond to any of the three items by reiterating the information presented earlier, she will be excluded from the study.)
  2. does not speak and understand Russian at a conversational level;
  3. unwilling or unable to commit to completing the study;
  4. has plans to move two or more hours away from the study site during the study follow up period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406482


Locations
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Kazakhstan
GHRCCA office
Almaty, Kazakhstan
GHRCCA office
Pavlodar, Kazakhstan
GHRCCA office
Temirtau, Kazakhstan
Sponsors and Collaborators
Columbia University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Susan Witte, Ph.D. Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susan Witte, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT02406482     History of Changes
Other Study ID Numbers: AAAN8855
5R01DA036514-03 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Susan Witte, Columbia University:
sex work, Kazakhstan, microfinance, drug use