NCT02406482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3.3 years

First QC Date

March 30, 2015

Last Update Submit

February 11, 2019

Conditions

HIV/AIDS and Infections

Keywords

sex work, Kazakhstan, microfinance, drug use

Outcome Measures

Primary Outcomes (7)

  • Incidence of biologically confirmed STIs

    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)

    12 months

  • Rate of new HIV and HCV cases

    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

    12 months

  • Number of unprotected vaginal and anal sexual acts with both regular and paying partners

    12 months

  • Proportion of unprotected vaginal and anal sexual acts with both regular and paying partners

    12 months

  • Number of unsafe injection acts

    12 months

  • Proportion of unsafe injection acts

    12 months

  • Proportion of monthly income from sex work

    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

    12 months

Study Arms (2)

HIVRR + MF

EXPERIMENTAL

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)Behavioral: HIV risk reduction (HIVRR)

HIVRR only

ACTIVE COMPARATOR

Four sessions of education and intervention (Behavioral: HIV risk reduction (HIVRR)).

Behavioral: HIV risk reduction (HIVRR)

Interventions

Microfinance intervention (MF)BEHAVIORAL

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).

HIVRR + MF
HIV risk reduction (HIVRR)BEHAVIORAL

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).

HIVRR + MFHIVRR only

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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. (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.)
  • does not speak and understand Russian at a conversational level;
  • unwilling or unable to commit to completing the study;
  • has plans to move two or more hours away from the study site during the study follow up period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GHRCCA office

Almaty, Kazakhstan

Location

GHRCCA office

Pavlodar, Kazakhstan

Location

GHRCCA office

Temirtau, Kazakhstan

Location

Related Publications (3)

  • Mukherjee TI, Terlikbayeva A, McCrimmon T, Primbetova S, Mergenova G, Benjamin S, Witte S, El-Bassel N. Association of gender-based violence with sexual and drug-related HIV risk among female sex workers who use drugs in Kazakhstan. Int J STD AIDS. 2023 Sep;34(10):666-676. doi: 10.1177/09564624231170902. Epub 2023 Apr 21.

    PMID: 37083464DERIVED

  • El-Bassel N, McCrimmon T, Mergenova G, Chang M, Terlikbayeva A, Primbetova S, Kuskulov A, Baiserkin B, Denebayeva A, Kurmetova K, Witte SS. A cluster-randomized controlled trial of a combination HIV risk reduction and microfinance intervention for female sex workers who use drugs in Kazakhstan. J Int AIDS Soc. 2021 May;24(5):e25682. doi: 10.1002/jia2.25682.

    PMID: 33955170DERIVED

  • McCrimmon T, Witte S, Mergenova G, Terlikbayeva A, Primbetova S, Kuskulov A, Bellamy SL, El-Bassel N. Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial. Trials. 2018 Mar 20;19(1):187. doi: 10.1186/s13063-018-2566-y.

    PMID: 29558982DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeInfectionsSex Work

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehavior

Study Officials

  • Susan Witte, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

KA(3)