Clinical trial NCT01957813: Evaluation of a Peer Education Program to Promote Family Planning Among Female Sex Workers in Kenya
Official title: Development and Evaluation of an Intervention to Increase Family Planning Use Among Female Sex Workers in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: APHIA AIDS, Population and Health Integrated Assistance
DIC Drop-in center
DMPA depot medroxyprogesterone acetate
DRH Division of Reproductive Health
FAIR Family AIDS Initiative Response
FHOK Family Health Options Kenya
FP Family planning
FGD Focus group discussion
FSW Female sex worker
GSKenya Gold Star Kenya
HTC HIV testing and counseling
HIV Human Immunodeficiency Virus
KNASP Kenya National AIDS Strategic Plan
MARPS Most at-risk populations
MoPHS Ministry of Public Health and Sanitation
MMS Ministry of Medical Services
NASCOP National AIDS and STI Control Program
RH Reproductive health
SRH Sexual and reproductive health
STI Sexually transmitted infection
USAID United States Agency for International Development
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Gold Star Kenya (GSKenya)
First posted: 2013-10-08
Enrollment: 719
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

-

Primary outcomes:
measure: Dual Method Contraceptive Use
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability and Feasibility among providers
timeFrame: 6 months
measure: Acceptability and feasibility of intervention among Clients
timeFrame: 6 months
measure: Acceptability and feasibility of Intervention among Peer Educators (PE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Naivasha
country: Kenya
facility: APHIA Plus HIV Prevention Drop-in Centers
state: Rift Valley Province
city: Nanyuki
country: Kenya
facility: APHIA Plus HIV Prevention Drop-in Centers
state: Rift Valley
Study officials:
affiliation: FHI 360
name: Lisa Dulli, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.