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Clinical Trial Summary

-Purpose: To develop and evaluate an intervention designed to improve consistent contraceptive use and dual method use in particular, among female sex workers (FSWs) in Rift Valley Province in Kenya.

Design: A qualitative descriptive study will be conducted to develop the intervention. A quasi-experimental, non-randomized, two-group, pre-/post-intervention design will be used to evaluate the intervention.

Study Population: FSWs living in Naivasha, Gilgil, and Nanyuki, Rift Valley Province.

Study Duration: Phase I - 3 months Phase II - 12 months Objectives: Develop an intervention designed to increase contraceptive use among FSWs by incorporating formative data and behavioral theory and by involving the target audience and service providers in the development of the intervention.

Examine the effectiveness of the intervention at increasing non-barrier modern contraceptive use and dual method use among FSWs.

Assess the feasibility and acceptability of the intervention, on the parts of both the clients (FSW) and service providers.

Estimate the unit cost to provide these services to one client. Study Site: Rift Valley Province, Kenya


Clinical Trial Description

The goal of this study is to develop and evaluate a theory-based intervention that could be incorporated into routine health services to improve the sexual and reproductive health of women who engage in sex work if demonstrated to be effective. To accomplish this goal, the study will be conducted in two phases. During the first phase of the study, FSWs and service providers in the study sites will assist in the design of the intervention, in an effort to increase the likelihood that it will be accepted, feasible, and effective. Brief formative research will be conducted with FSWs and service providers, followed by working group meetings with self-selected FSWs, service providers, and GSKenya representatives who will review data and work with study investigators and/or their designees to design the intervention. During the second phase of this study, the intervention will be implemented and evaluated.

The study is planned for two sites within Rift Valley Province, Kenya. The first "site" is comprised of two adjacent towns, Naivasha and Gilgil. The town of Nanyuki will serve as the second site.

Based on findings from the formative phase of this study, and on observations and feedback from providers, a package of enhancements to the current package of services delivered to FSW will be implemented and evaluated.

- Family Planning (FP) Messaging for peer educators and informational materials material - Peer educators will be trained using existing materials to deliver accurate messaging on FP/dual method use, during individual encounters and in group sessions.

- Screening for unmet FP need in drop-in centers - Integration of FP needs screening in the service delivery points will increase the number of FSW accessing FP. This will be done through sensitization of service providers and provision of a brief job aid that can be used to screening clients for unmet need, including unmet need for dual method use.

- Providers FP counseling job aid - The AIDS, Population and Health Integrated Assistance (APHIA) Plus project will adapt the existing Balanced Counseling Strategy Plus: A Toolkit for Family Planning Service Providers Working in High HIV/Sexually Transmitted Infection (STI) Prevalence Settings for providers to use within the context of the DICs and in referral sites in the catchment area.

- Commodities - increasing method mix - The methods that will be available to all women attending services at the DIC will be expanded. In addition to the current oral contraceptive pills, DMPA, male and female condoms, both the intra-uterine contraceptive devices (IUCD) and implants will be added to the mix of methods available.

Hours of DIC operation - Based on findings from the formative phase of the study, the hours of operation for DICs will be extended into the late evening hours to accommodate the schedules of FSW. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01957813
Study type Interventional
Source FHI 360
Contact
Status Completed
Phase N/A
Start date June 20, 2013
Completion date May 30, 2014

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