Strengthening Primary Care With a Minimal Digital Ecosystem in Burkina Faso: Protocol for a Pragmatic Mixed Methods Implementation Study.

Background: In Burkina Faso, the Minimal Digital Ecosystem (MDE)-a suite of 9 integrated digital tools-was introduced to support key health system functions, including care delivery, financial management, medication oversight, governance, and data use. However, evidence regarding the maturity of its real-world implementation and the determinants influencing its adoption remains scarce. Objective: This pragmatic mixed methods study aims to (1) measure MDE implementation maturity across 4 dimensions (adoption, fidelity, penetration, sustainability), (2) identify multilevel determinants using the Consolidated Framework for Implementation Research (CFIR 2.0) and Normalization Process Theory (NPT), and (3) examine associations between implementation degree and primary health care (Centre de Santé et de Promotion Sociale [CSPS]) performance. Methods: We use a sequential explanatory design (quantitative → qualitative) in 4 districts covering 72 CSPSs. Phase 1 involves a cross-sectional survey of all eligible health workers, facility managers, and community health workers (estimated 612 respondents nested within facilities) using CFIR- and NPT-informed questionnaires. Following psychometric validation (exploratory/confirmatory factor analysis; reliability assessment via Cronbach α and McDonald ω), we will fit multilevel models with CSPS random intercepts and district fixed effects to (1) quantify between-facility implementation variance, (2) test associations with CFIR and NPT determinants, and (3) examine relationships with CSPS performance indicators. Phase 2 involves purposive sampling of facilities with varying implementation profiles for interviews, focus groups, and observations, analyzed using reflexive thematic analysis to explain quantitative patterns. Results: Ethics approval was obtained from Burkina Faso's National Ethics Committee (number 2023-06-136). The study was funded in June 2022 (Gates Foundation, Grant INV-056021) and is being conducted across 72 primary health care facilities in 4 districts (Manga, Sapouy, Ténado, and Ziniaré) in Burkina Faso. Qualitative data collection commenced in November 2025 and was completed in January 2026. Quantitative data collection took place from January 2023 to October 2025. As of May 2026, qualitative data collection was completed, and quantitative analyses had commenced. Psychometric analyses are underway. Conclusions: By addressing key evidence and measurement gaps in digital health implementation, this protocol will (1) generate context-specific guidance on implementing and institutionalizing a complex digital health ecosystem and (2) provide validated, ready-to-use instruments to quantify implementation at the CSPS level. Together, these outputs will help policymakers and program managers define and track "implementation success," informing-and accelerating-the scale-up and optimization of the MDE in resource-constrained settings.