Implementation of a Combination Intervention for Sustainable Blood Pressure Control in Rural KwaZulu-Natal, South Africa (IMPACT-BP)

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ABSTRACT Uncontrolled hypertension is the primary risk factor for stroke and hypertensive heart disease, which are the leading causes of NCD deaths in South Africa, and of disability adjusted-life years lost globally. Clinical trials have demonstrated sizeable reductions in morbidity and mortality with modest reductions in blood pressure. Yet, there is a large knowledge-implementation gap between efficacy literature on hypertension control and effectiveness of health systems to provide hypertension care. This is particularly true in resource- limited settings, where the constrained public health infrastructure will require innovative scalable and cost- effective interventions. In South Africa, 25% of the population over 15 years have elevated blood pressure, yet only 33% of those with hypertension are on treatment. In rural KwaZulu-Natal, we recently found that 16% of adults > 18 years old have hypertension, and fewer than 25% of them are controlled. The scientific goals of this project are to inform best practices for implementation of interventions to promote hypertension care in rural sub-Saharan Africa. We have undertaken mixed-methods formative work to identify significant structural barriers to engagement in hypertension care. Qualitative interviews with patients and healthcare professionals also revealed that lack of patient self-efficacy, structural barriers, and nursing training deficiencies were additional health systems barriers. Finally, we reviewed best practices for hypertension care and engaged local stakeholders to propose a package of interventions relevant to the rural South African setting, and potentially applicable to other low-medium resource settings. We will conduct an implementation evaluation of a two-level intervention package: 1) an enhanced clinic-level intervention, through stepped-wedge cluster randomization, and 2) an individually randomized home blood pressure monitoring system to promote self-efficacy. We will evaluate the implementation using the Consolidated Framework for Implementation Research and the Proctor Implementation outcomes framework, with a focus on Acceptability & Fidelity (Aim 1), Effectiveness (Aim 2) and Cost-effectiveness and Sustainability (Aim 3). To do so, we will leverage a multidisciplinary team of experts, and an externally-funded hypertension screening and referral program for 30,000 individuals in the catchment area during 2018-2019. This proposal is responsive to multiple priorities stated in PAR-18-007, including 1) implementation of evidence-based practices within clinical settings, 2) partnership with existing care systems, 3) longitudinal observation to assess sustainability, and 4) focus on reduction of health disparities. Perhaps most importantly, due to our partnership with the Department of Health, we are well-poised to advance the implementation science to elucidate best practices for hypertension care in resource-limited settings, with global implications. !