COmmunity-Pharmacies managing hypertension: intervention development and Evaluation in Bangladesh and Pakistan (COPE-BP).

Introduction Bangladesh and Pakistan experience very substantial health and economic impacts of cardiovascular disease (CVD) related morbidity and mortality. Epidemiological research suggests that reducing blood pressure (BP) by 10mmHg systolic or 5mmHg diastolic significantly reduces CVD risk. However, in both countries, 60-70% of individuals with hypertension remain undiagnosed and untreated, with over 60% of diagnosed cases having uncontrolled hypertension. This situation is exacerbated by limited healthcare access, which particularly affects low-income urban residents (LIURs) forming over 50% of both countries inhabitants. Addressing the burden of uncontrolled hypertension and associated CVDs requires integrated community-based approaches that are more effective than the current, fragmented standard care. A community pharmacy, defined as a retail outlet with qualified staff dispensing medicines located within the community it serves, is one such resource relied upon by LIURs in lower middle-income countries (LMICs) for a variety of health needs. While community pharmacists are willing to expand services beyond drug dispensing, they often operate independently from formal health systems. Given the challenges of increasing CVDs, rapid urbanisation, and unmet need for primary healthcare, their role in reducing the burden of hypertension and CVDs in resource-constrained settings is potentially transformative. We therefore propose developing and testing a multicomponent intervention (COPE-BP) to deliver hypertension care via community pharmacies to vulnerable LIURs in Bangladesh and Pakistan. Research Plan The research programme, comprising six work-packages, will develop and test the effectiveness and cost-effectiveness of the COPE-BP intervention, with embedded process evaluation: 1. Developing the intervention using geo-mapping of existing community pharmacies and surrounding health facilities, a survey and interviews incorporating stakeholders perspectives, and co-creation stakeholder workshops. 2. Feasibility cluster Randomised Controlled Trial (cRCT) to assess the feasibility of and refine intervention and trial methods before the definitive trial. 3. A pragmatic cRCT, with a 3-month internal pilot, to evaluate effectiveness of COPE-BP compared to usual care. The primary outcome will be systolic BP at 24 months. 4. Process evaluation to understand fidelity, the process of COPE-BP implementation, mechanism of (how the intervention may produce) change, and influence of context on implementation and outcomes. 5. Developing a cost-effectiveness model for hypertension care to assess the long-term value for money and population health impact of COPE-BP, the costs of scale up and the value of investment in strategies to improve uptake. 6. Capacity building, at individual and institutional levels, will be an integral part of all work- packages. Underpinned by Essence guidance, this will focus on developing capacity in community-based research and academic leadership; upskilling community pharmacists and augmenting the primary healthcare system while promoting gender equity. Expected Outcomes If COPE-BP improves BP control among 50% of LIURs with hypertension in Bangladesh and Pakistan, it could address the needs of approximately 35 million people in both countries and potentially save around 62,000 lives annually[1]. As hypertension and CVDs impose significant financial burdens on underserved populations[2], this approach may additionally improve economic outcomes. COPE-BP will also enhance research and hypertension management capacity in LMICs.