A Low-Cost, Scalable Treatment Strategy for Improving Hypertension Control in Low- and Middle-Income Settings

Research Question How effective, tolerable, implementable, and cost-effective is a new treatment strategy compared to usual care for hypertension control in primary care settings in Nigeria and Sri Lanka? Background Of the many strategies evaluated for improving hypertension control in low- and middle-income countries (LMICs), very few resource-intensive strategies achieved >70% hypertension control. The strategy based on initial/early use of low-dose combination therapy has the potential to achieve greater than 80% hypertension control at scale. Our previous randomised clinical trials in Sri Lanka and Nigeria in tertiary care settings, along with a recently reported study in rural Rwanda, suggest that a new treatment strategy (involving low-dose triple single-pill combinations based standard treatment protocol) can achieve more than 80% hypertension control quickly, durably, and cost-effectively with no increase in adverse effects. Aims and objectives We aim to evaluate, among adults with uncontrolled hypertension, a new treatment strategy compared to usual care for effectiveness, implementation, budget impact, and cost-effectiveness for the treatment and control of hypertension in primary care settings in Nigeria and Sri Lanka. Methods First, we plan to further understand the context and refine and adapt the treatment strategy through conducting literature review and formative parallel convergent mixed-methods research guided by the Implementation Research Logic Model, involving stakeholders, and extending our previous work in Nigeria and Sri Lanka. Second, we plan to conduct a pragmatic, randomised, open-label, parallel-group trial to evaluate, among adults with uncontrolled hypertension, the new treatment strategy compared to usual care (hypertension management based on local guidelines/county specific treatment protocol) for effectiveness and safety for hypertension control in primary care settings. The primary outcome will be the percentage of participants with hypertension control (clinic blood pressure <140/90 mmHg) at 6 months. Third, we will assess the reach, effectiveness, adoption, implementation, and maintenance of the new treatment strategy using explanatory sequential mixed-methods research guided by the RE-AIM framework. Finally, we will evaluate the budget impact, cost effectiveness, and budget needed for the national scale up of the new treatment strategy compared to usual care for improving hypertension control. We will train primary healthcare providers on the management of hypertension, and researchers on undertaking hypertension research. We will collaborate closely with stakeholders and partners to co-design, conduct, and disseminate our research. Timelines for Delivery The project will be delivered over 45 months. Anticipated impact and dissemination The key impact of this research will be improved knowledge related to hypertension control – assessing whether new strategy can reliably achieve over 80% hypertension control in primary care settings. Additional impacts will be increased awareness of hypertension, enhanced skills and confidence among healthcare staff in LMICs; more efficient hypertension management protocols in primary care settings; reduced health inequities by improving access to quality care among the poorest and most vulnerable population; changes to local guidelines; and influence on policy and decision-making processes to integrate the intervention into national health policies and programs, ensuring sustainability and scalability. We plan to disseminate our findings mainly through medical journals, conference presentations, and meetings with stakeholders.