Evaluation of a Peer Education Program to Promote Family Planning Among Female Sex Workers in Kenya

NCT ID: NCT01957813

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 719 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-20
• Study Completion Date: 2014-05-30

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

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 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.

Conditions

Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard Health Services

Service currently being provided to FSW in Naivasha include peer education and health services delivered through a drop-in center (DIC) staff by a counselor and a nurse. For peer education, there are six modules that the peer educators walk all peers through with sessions being held once a week.

Group Type: OTHER

Standard Health Services

Intervention Type: OTHER

Peer education and health services

LifeStyle Counseling

A package of enhancements to the current package of services delivered to FSW will be implemented and evaluated.

Group Type: EXPERIMENTAL

Lifestyle Counseling

Intervention Type: BEHAVIORAL

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 DICs Providing job aids to FP counselors Expanding FP methods with intra-uterine contraceptive devices (IUCD) and implants Time change in DIC hours of operation

Interventions

Lifestyle Counseling

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 DICs Providing job aids to FP counselors Expanding FP methods with intra-uterine contraceptive devices (IUCD) and implants Time change in DIC hours of operation

Intervention Type: BEHAVIORAL

Standard Health Services

Peer education and health services

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Self-identifies as a FSW. For the purposes of this study, a FSW is defined as a woman who is sexually active and reports receiving money or goods in exchange for sex in the last 6 months as part of her source of income/livelihood.
• Is between the ages of 16 and 49 years
• Provides oral informed consent

Exclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gold Star Kenya (GSKenya)

UNKNOWN

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Dulli, PhD, MHS

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

APHIA Plus HIV Prevention Drop-in Centers

Naivasha, Rift Valley Province, Kenya

APHIA Plus HIV Prevention Drop-in Centers

Nanyuki, Rift Valley, Kenya

Countries

Kenya

References

Dulli L, Field S, Masaba R, Ndiritu J. Addressing broader reproductive health needs of female sex workers through integrated family planning/ HIV prevention services: A non-randomized trial of a health-services intervention designed to improve uptake of family planning services in Kenya. PLoS One. 2019 Jul 24;14(7):e0219813. doi: 10.1371/journal.pone.0219813. eCollection 2019.

Reference Type: DERIVED

PMID: 31339919 (View on PubMed)

Other Identifiers

10285

Identifier Type: -

Identifier Source: org_study_id