Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01957813
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2013-09-04
Brief Title:
Evaluation of a Peer Education Program to Promote Family Planning Among Female Sex Workers in Kenya
Sponsor:
FHI 360
Organization:
FHI 360
Study Overview
Official Title:
Development and Evaluation of an Intervention to Increase Family Planning Use Among Female Sex Workers in Kenya
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 andor 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 FPdual 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 HIVSexually 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
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 FPdual 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 HIVSexually 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None