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

Centre For Infectious Disease Research, Lusaka

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Abstract

PROJECT SUMMARY This project focuses on task shifting and integrating the evidence-based WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach to managing cardiovascular disease risk factors and cardiometabolic complication of HIV into routine care settings for persons living with HIV in Lusaka, Zambia. Using local data and implementation science theories, we will adapt WHO-PEN for the national HIV program in Zambia, and create a streamlined, task-shifted evidence-based intervention that we have coined ?TASKPEN?. TASKPEN will focus on addressing challenges faced by HIV patients who have cardio-metabolic complications related to HIV or its treatment, but in the future could be expanded to address other noncommunicable diseases. TASKPEN aims to improve detection and management of these complications. We hypothesize that the TASKPEN intervention will result in reduced cardiovascular disease risk as determined by the Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) risk score, as well as clinical improvement in a number of secondary end-points, including HIV viral suppression, for HIV- positive patients attending PEPFAR-supported HIV clinics in the urban Lusaka district of Zambia. The implementation strategies used will enable productive interactions between activated, informed patients and proactive, prepared health care professionals by task shifting most of the care to nurses and community health workers who will be supported by the training and adapted screening and treatment algorithms based on WHO-PEN protocols. TASKPEN will be integrated into routine primary care HIV services where nurses and community health workers lead the intervention. As the individual components of TASKPEN are already recommended by Zambia national HIV guidelines, screening of participants to take part in the study will be done as part of routine HIV care. For those eligible, the screening for metabolic complications will be done at baseline, and 6, 12, and 24 months. Those found with any cardiometabolic complications will receive an individualized management plan, which will combine usual HIV care plus the adapted protocol for management of cardiovascular disease risk factors and cardiometabolic complications. To advocate for scale-up of TASKPEN in Zambia, we plan to evaluate its clinical impact using a cross- sectional type 2-hybrid effectiveness-implementation stepped-wedge design, which is a quasi-experimental design that allows for measurement of clinical effectiveness alongside assessment of implementation outcomes and strategies. Our hope is that by the end of the study, the Zambian Ministry of Health will maintain TASKPEN at all study facilities and would consider wider scale-up in the Zambian health system.