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. 2018 Mar 20;19(1):187.
doi: 10.1186/s13063-018-2566-y.

Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial

Affiliations

Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial

Tara McCrimmon et al. Trials. .

Abstract

Background: Among women at high risk for HIV and other sexually transmitted diseases (STIs), gender and economic issues limit the impact of behavioral prevention strategies. Women in Kazakhstan with dual risks of sex trading and drug use face elevated risk for HIV and STIs and may benefit from an economic empowerment intervention which combines HIV-risk reduction (HIVRR) education with financial skills-building and asset-building to promote reduced reliance on sex trading for income.

Methods/design: The study employs a two-arm, cluster-randomized controlled trial (c-RCT) design. We will use cluster randomization to assign 350 women in approximately 50 cohorts to a traditional four-session HIV-risk-reduction intervention combined with a six-session financial literacy intervention, enrollment in a 24-session vocational training program and receipt of matched savings (HIVRR+MF); or to the four-session HIV-risk-reduction intervention alone (HIVRR). Repeated behavioral and biological assessments will be conducted at baseline, then at 6, 9, and 15 months post randomization/session 1.

Discussion: This study responds to an identified need in the academic literature for rigorous testing of structural interventions, including combination microfinance and HIV-prevention interventions.

Trial registration: ClinicalTrials.gov, ID: NCT02406482 . Registered on 30 March 2015.

Keywords: Drug use; HIV; Microfinance; STI; Women.

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Conflict of interest statement

Ethics approval and consent to participate

This trial was approved by Columbia University’s Institutional Review Board (IRB), and by the Ethics Committee of the Kazakhstan School of Public Health (KSPH).

Informed consent was conducted verbally with all study participants before taking part in screening for study eligibility. A written consent form was reviewed with all eligible participants before they completed the initial assessments.

This study was funded to Drs. El-Bassel (PI) and Susan Witte (PI). The grant number is: R01 DA036514. The funder was not involved in study design or analysis.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Theoretical framework
Fig. 2
Fig. 2
Consolidated Standards of Reporting Trials (CONSORT) flow diagram
Fig. 3
Fig. 3
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule

References

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