BackgroundAcross sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services.The Systems Analysis and Improvement Approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-Hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation.MethodsWe will deploy a Hybrid Type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN.Discussion:SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up.

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BACKGROUND Optimal delivery of prevention of mother to child transmission of HIV (PMTCT) programs is challenging, including in Mozambique. The Systems Analysis and Improvement Approach (SAIA) is a multi-component, systems engineering strategy that has demonstrated PMTCT cascade improvement in a previous cluster randomized trial. To facilitate scale-up and improve integration into routine management systems, the SAIA-SCALE trial (NCT03425136) evaluates delivery of SAIA to health facilities by maternal and child health district supervisors, with minimal external support. SAIA-SCALE uses the RE-AIM framework to evaluate essential ingredients for public health impact that are infrequently reported. In this article we report intervention reach, adoption, implementation, and maintenance.METHODS SAIA-SCALE is a stepped-wedge trial in 36 facilities covering all 12 districts of Manica province, central Mozambique, from 2018—2021. Each district received a one-year intensive phase with external research staff support and financial support, followed by a maintenance phase with only limited financial support. We used data from health management information systems and implementation tracking to assess reach, adoption, implementation, and maintenance of the SAIA strategy using descriptive statistics.RESULTS SAIA-SCALE reached 36 facilities covering over 146,000 institutional births and 206,000 first antenatal care visits during the study period. Mean scores on two organizational readiness predictors of adoption were 4.82/5 for change commitment and 4.78/5 for change efficacy. Program adoption was 100%—all 12 targeted districts attended initial training, and all targeted 36 facilities initiated the SAIA strategy. Intensive and maintenance phases comprised equal facility-months. Each facility received an average of 1.1 and 1.0 mentorship visits per month from district supervisors during the intensive and maintenance phases, respectively. Across all facilities, 429 workplans were developed during the intensive and 432 during the maintenance phase. Facility staff reported implementing 91.8% of intensive phase workplans, and 85.9% of maintenance phase workplans. Facilities reported adopting into routine practice 70% and 62% of micro-interventions tested during the intensive and maintenance phases, respectively.CONCLUSIONS Assessment of reach, adoption, implementation, and maintenance revealed the successful integration of a systems engineering strategy for PMTCT into routine healthcare management systems in Mozambique. R-AIM should more frequently be reported alongside effectiveness for a deeper understanding of sustained public health impact of HIV prevention programs.Trial registration:ClinicalTrials.gov NCT03425136 (registered 02/06/2018).