Application of Implementation Science approaches to assess the effectiveness of Task-shifted WHO-PEN to address cardio metabolic complications in people living with HIV in Zambia

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TITLE: Administrative Supplement for “Application of implementation science approaches to assess the effectiveness of task-shifted WHO PEN to address cardiometabolic complications in people living with HIV in Zambia” ABSTRACT This project focuses on integrating the evidence-based WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach to managing cardiovascular disease risk factors and cardiometabolic complications of HIV into routine care settings for persons living with HIV in Lusaka, Zambia. During the formative UG3 phase of the project, we successfully adapted WHO-PEN for the national HIV program in Zambia using local data and implementation science theory and created a multi-component, evidence-based intervention that we have coined “TASKPEN”. TASKPEN addresses challenges faced by HIV patients who have cardiometabolic comorbidities or complications related to HIV or its treatment, and aims to improve detection and management of cardiometabolic non-communicable diseases (NCDs) that disproportionately affect people living with HIV in Zambia. TASKPEN evidence-based components include: a “one-stop shop” for HIV and cardiometabolic disease care; guidelines, training materials, and treatment algorithms for health workers based on WHO PEN; laboratory services for screening and diagnostic testing of cardiometabolic NCDs; and a strengthened NCD medication supply chain. TASKPEN delivers these components by employing an overarching implementation strategy of clinical service integration and sub-component strategies of task-shifting, practice facilitation, and changing of physical infrastructure and equipment to accommodate screening and treatment of hypertension, diabetes mellitus, and dyslipidemia. Our overarching and sub-component strategies will enable nurses and community health workers to deliver integrated, evidence-based care for these conditions in routine HIV clinical settings with support provided by practice facilitators and NCD decision support tools imbedded in the national electronic medical record. As the individual components of TASKPEN are already recommended by Zambia national guidelines, the TASKPEN package will be delivered under the auspices of routine HIV care. We hypothesize that TASKPEN will result in dual control of both HIV and cardiometabolic NCDs of interest, and improve secondary clinical endpoints, including cardiovascular disease risk (as determined by the Atherosclerotic Cardiovascular Disease, ASCVD, risk score) and HIV viral suppression for persons living with HIV attending 12 HIV clinics serving as our study sites in Lusaka, Zambia. To test this hypothesis, we plan to conduct a type 2- hybrid effectiveness-implementation stepped-wedge trial, which is a quasi-experimental design that allows for measurement of clinical effectiveness alongside assessment of implementation outcomes and strategies. The trial incorporates several clinical and methodological innovations, including the first use of point-of-care diagnostics for NCDs in Zambia, a total clinic sampling approach to make generalizable insights into the impact of TASKPEN on the entire HIV care population, and cost-effectiveness modeling. In addition, the trial serves as a hands-on training platform for five pre-doctoral, doctoral, and post-doctoral implementation science fellows from the University of Zambia, including a recipient of a small research program grant from NHLBI. The funding requested via this supplement will support strategic investment in the following areas critical to UH3 success and where unexpected expenses were incurred: 1) putting in place basic health system building blocks required for TASKPEN introduction; 2) ensuring quality data collection by retaining existing, trained study staff; and 3) sustaining funding for five pre/post/doctoral fellows mentored through the project. Our hope is that by the end of the project, the Ministry of Health will consider wider scale-up of the TASKPEN intervention in the Zambian health system, and that our fellows will be well-positioned to apply for independent NIH D43 or K43 funding.