Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

Introduction: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions.
Methods and Analysis: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (T _P ), initiation of implementation (T ₀ ) and 1-year postinitiation (T ₁ ). We will extract project-related data from secondary documents at T _P and conduct multistakeholder qualitative interviews to gather data at T ₀ and T _1. We will undertake descriptive statistical analysis of T _P data and analyse T ₀ and T ₁ data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks.
Ethics and Dissemination: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.
Competing Interests: Competing interests: JvO reports Horizon2020 grants (643 692 and 825432) outside the submitted work. AGT declares funding from the National Health & Medical Research Council (NHMRC, Australia: GNT1042600, GNT1122455, GNT1171966, GNT1143155, GNT1182017), Stroke Foundation Australia (SG1807), and Heart Foundation Australia (VG102282) outside the submitted work. ML-P declares support from Fogarty International Centre, National Institutes of Health [R21TW009982], under the Global Alliance for Chronic Diseases (GACD) Diabetes ProgramProgramme. MEE reports grant funding from the Argentinian Ministry of Health (MoH) under the GACD program. AS declares funding from the Japan Agency for Medical Research & Development, as part of the GACD, outside the submitted work. FJH is partially funded by the National Institute for Health Research (NIHR) and the Medical Research Council (MRC), and is a member of the Action on Salt, and World Action on Salt, Sugar and Health (WASSH). AB declares grants from the MoH Argentina, National Institutes of Health, and World Diabetes Foundation, outside the submitted work. AP declares grant and fellowship support from the NHMRC outside the submitted work, Member of the Board of Directors, The George Institute India, and past Member of the Board of Directors, Heart Health Research Center, Beijing, PRC. RJ declares grant, outside the submitted work, from WHO Geneva, WHO South-East Asia Region (SEARO), Elrha Research for Health in Humanitarian Crises (R2HC), (Wellcome Trust, UK AID and NHS), DBT/ Wellcome Trust India Alliance and Gates Foundation. In the past 3 years, MDH has received research funding from American Heart Association, Verily, and AstraZeneca for research unrelated to this manuscript and has patents pending for heart failure polypills. The George Institute for Global Health has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. None of the others authors has any conflict of interest to declare.
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