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Background Implementing an evidence-based hypertension program in primary healthcare centers (PHCs) in the Federal Capital Territory, Nigeria is an opportunity to improve hypertension diagnosis, treatment, and control and reduce deaths from cardiovascular diseases. This qualitative research study was conducted in Nigerian PHCs with patients, non-physician health workers, administrators and primary care physicians to inform contextual adaptations of Kaiser Permanente Northern California's hypertension model and the World Health Organization’s HEARTS technical package for the system-level, Hypertension Treatment in Nigeria (HTN) Program. Methods Purposive sampling in 8 PHCs identified patients (n = 8), non-physician health workers (n = 12), administrators (n = 3), and primary care physicians (n = 6) for focus group discussions and interviews. The Primary Health Care Performance Initiative (PHCPI) conceptual framework and Consolidated Framework for Implementation Research (CFIR) domains were used to develop semi-structured interviews (Appendix 1, Supplemental Materials) and coding guides. Content analysis identified multilevel factors that would influence program implementation. Results Participants perceived the need to strengthen four major health system inputs across CFIR domains for successful adaptation of the HTN Program components: (1) reliable drug supply and blood pressure measurement equipment, (2) enable and empower community healthcare workers to participate in team-based care through training and education, (3) information systems to track patients and medication supply chain, and (4) a primary healthcare system that could offer a broader package of health services to meet patient needs. Specific features of the PHCPI framework considered important included: accessible and person-centered care, provider availability and competence, coordination of care, and proactive community outreach. Participants also identified patient-level factors, such as knowledge and beliefs about hypertension, and financial and transportation barriers that could be addressed with better communication, home visits, and drug financing. Participants recommended using existing community structures, such as village health committees and popular opinion leaders, to improve knowledge and demand for the HTN Program. Conclusions These results provide information on specific primary care and community contextual factors that can support or hinder implementation and sustainability of an evidence-based, system-level hypertension program in the Federal Capital Territory, Nigeria, with the ultimate aim of scaling it to other parts of the country.

Background Hypertension is the most common cardiovascular disease in Nigeria and contributes to a large non-communicable disease burden. Our aim was to implement and evaluate a large-scale hypertension treatment and control program, adapted from the Kaiser Permanent Northern California and World Health Organization HEARTS models, within public primary healthcare centers in the Federal Capital Territory, Nigeria. Methods A type 2 hybrid, interrupted time series design was used to generate novel information on large-scale implementation and effectiveness of a multi-level hypertension control program within 60 primary healthcare centers in the Federal Capital Territory, Nigeria. During the formative phase, baseline qualitative assessments were held with patients, health workers, and administrators to inform implementation package adaptation. The package includes a hypertension patient registry with empanelment, performance and quality reporting, simplified treatment guideline emphasizing fixed-dose combination therapy, reliable access to quality essential medicines and technology, team-based care, and health coaching and home blood pressure monitoring. Strategies to implement and adapt the package were identified based on barriers and facilitators mapped in the formative phase, previous implementation experience, mid-term qualitative evaluation, and ongoing stakeholder and site feedback. The control phase included 11 months of sequential registration of hypertensive patients at participating primary healthcare centers, followed by implementation of the remainder of the package components and evaluation over 37 subsequent, consecutive months of the intervention phase. The formative phase was completed between April 2019 and August 2019, followed by initiation of the control phase in January 2020. The control phase included 11 months (January 2020 to November 2020) of sequential registration and empanelment of hypertensive patients at participating primary healthcare centers. After completion of the control phase in November 2020, the intervention phase commenced in December 2020 and will be completed in December 2023. Discussion This trial will provide robust evidence for implementation and effectiveness of a multi-level implementation package more broadly throughout the Federal Capital Territory, which may inform hypertension systems of care throughout Nigeria and in other low- and middle-income countries. Implementation outcome results will be important to understand what system-, site-, personnel-, and patient-level factors are necessary for successful implementation of this intervention. Trial registration ClinicalTrials.gov NCT04158154. The trial was prospectively registered on November 8, 2019.

Background Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization’s Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions. Methods BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program’s development to illustrate how it could be applied to future studies. Results We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components’ implementation intensities could have been used to identify effective intervention components. Conclusion These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation. Trial registration ClinicalTrials.gov, NCT02148952; registered on May 29, 2014