Evaluating a longitudinal cohort of clinics engaging in the Family Planning Elevated Contraceptive Access Program (FPE CAP): study protocol of a comparative interrupted time series analysis (Preprint)

BACKGROUND Access to high quality, comprehensive contraceptive care is an inherent component of reproductive human rights. Yet hindrances to specific aspects of contraceptive provision, including availability, accessibility, acceptability and quality continue to perpetuate unmet need. The state of Utah has recently passed a series of contraceptive policies intended to improve contraceptive access. Despite these positive changes to theoretical access, fiscal appropriations to support implementation of these policies have been minimal and many individuals still struggle to access contraception. OBJECTIVE The Family Planning Elevated Contraceptive Access program (FPE CAP), part of a larger statewide contraceptive initiative, specifically aims to improve contraceptive access within health clinics. This paper describes the study protocol for evaluating the success of FPE CAP. METHODS Health clinics apply for membership in the FPE CAP. Upon acceptance in the program, they receive: 1) a cash grant for clinical supplies, equipment, and personnel expenses; 2) reimbursement for contraceptive services and methods for eligible clients; 3) technical support, training, and proctoring on counseling and providing all methods of contraception; 4) method stocking of intrauterine devices and implants; 5) demand generation activities, including local media campaigns, to inform community members about the FPE CAP program and possible eligibility. FPE collects monthly service delivery reports from participating clinics for evaluation purposes. The primary outcomes of FPE CAP are: 1) level and trend changes in contraceptive service delivery among individuals earning ≤138% FPL following membership in FPE CAP compared to historical data and control clinics; and 2) level and trend changes in contraceptive service delivery among FPE CAP clients earning between 139-250% FPL (including those ineligible for Medicaid) compared to historical data and control clinics. To assess this, we will conduct comparative interrupted time series analyses assessing level and trend changes in intervention and control clinics 12-months prior to the intervention, for the 2-year duration of the intervention, and for the subsequent 12-months following the intervention. RESULTS We found that the study is adequately powered (>80% power) with our planned number of clinics and the number of months of data available in the study. To date, we have successfully completed recruitment and enrollment of 8 of the expected 9 health organizations and four of the control clinics. Completed health organization enrollment for both intervention and control organizations is expected finish in December of 2020. CONCLUSIONS The study aims to provide insight into a new approach to contraceptive initiatives, through addressing comprehensive aspects of contraceptive care at the health system level. Ongoing state policy changes and implementation components may affect evaluation outcomes. CLINICALTRIAL ClinicalTrials.gov: NCT03877757 Open Science Framework: DOI 10.17605/OSF.IO/QJC9K.