Evaluating a Longitudinal Cohort of Clinics Engaging in the Family Planning Elevated Contraceptive Access Program: Study Protocol for a Comparative Interrupted Time Series Analysis
Authors: Simmons Rebecca Grace , Myers Kyl , Gero Alexandra , Sanders Jessica N , Quade Caitlin , Mullholand Madeline , Turok David K 
Published: August 2020

Background
Access to high-quality, comprehensive contraceptive care is an inherent component of reproductive human rights. However, hindrances to specific aspects of contraceptive provision, including availability, accessibility, acceptability, and quality, continue to perpetuate unmet needs. 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 the 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. On acceptance in the program, they receive a cash grant for clinical supplies, equipment, and personnel expenses; reimbursement for contraceptive services and methods for eligible clients; technical support, training, and proctoring on counseling and providing all methods of contraception; method stocking of intrauterine devices and implants; and demand generation activities, including local media campaigns, to inform community members about the FPE CAP and possible eligibility. FPE collects monthly service delivery reports from participating clinics for evaluation purposes. The primary outcomes of FPE CAP are level and trend changes in contraceptive service delivery among individuals earning ≤138% federal poverty level (FPL) following membership in FPE CAP and among FPE CAP clients earning between 139% and 250% FPL (including those ineligible for Medicaid) compared with historical data and control clinics. To assess this, we will conduct comparative interrupted time series analyses assessing the level and trend changes in intervention and control clinics 12 months before 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 the recruitment and enrollment of 8 of the expected 9 health organizations and 4 of the control clinics. Completed health organization enrollment for both intervention and control organizations is expected to be completed in December 2020.

Conclusions
The study aims to provide insight into a new approach to contraceptive initiatives by addressing comprehensive aspects of contraceptive care at the health system level. Ongoing state policy changes and implementation components may affect the evaluation outcomes.

International Registered Report Identifier (IRRID)
DERR1-10.2196/18308