Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka

Cardiovascular diseases (CVD) have become the leading cause of mortality globally. In South Asia, high rates of CVD are
observed at a younger age than in other countries causing a reduction in productive life years with severe economic consequences. High blood pressure (BP) confers the greatest attributable risk to death and disability associated with CVD.

Our Wellcome Trust funded Control of Blood Pressure and Risk Attenuation (COBRA) trial (2004 to 2007) in Karachi, Pakistan, suggested the combined strategy of family based home health education (HHE) delivered by trained community health workers (CHW) plus care of individuals by trained private general practitioners (GP) to optimally manage hypertension had the most marked beneficial impact on BP compared to usual care, or single interventions. However, the COBRA intervention was designed for an urban South Asian setting, where private GPs cater to over 75% of the patients seeking care. Most of South Asia is still rural (73% Bangladesh, 64% Pakistan, 71% India, 85% Sri Lanka) where prevalence of hypertension is high and healthcare infrastructure and provider characteristics are very different compared to the urban setting. The COBRA trial did not evaluate effectiveness of strategies delivered using the public health infrastructure, or generalizability to the rural population in Pakistan. It is also not clear whether any benefit would extend to rural communities in other South Asian countries.

In our ongoing COBRA-BPS feasibility study in Bangladesh, Pakistan, and Sri Lanka, we modified COBRA by developing a comprehensive "multicomponent intervention (MCI)" for effective delivery of hypertension care using the rural predominantly public primary care infrastructure. We also conducted extensive stakeholder consultation and received very favourable response for a full scale trial to evaluate MCI in 3 countries.

We now propose a cluster randomised controlled trial (RCT) on 2550 adults with hypertension in 30 rural communities in Bangladesh, Pakistan and Sri Lanka, to evaluate a comprehensive MCI comprised of specifically comprised 1) home health education (HHE) by government community health workers (CHWs), 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, 3) trained public and private providers in management of hypertension and using a checklist, 4) designated hypertension triage counter and hypertension care coordinators in government clinics, 5) a financing model to compensate for additional health services including targeted subsidies.


A total of 15 communities (5 in each country) will be randomised to MCI and 15 (5 in each country) to usual care in 3
countries. Individuals with hypertension will be followed for 2 years to assess whether MCI compared to usual care is more
effective at lowering BP, and cost effective in terms of preventing CVD related disability and death. We will also interview
stakeholders and conduct serial focus group discussions of patients on their experience with the strategy in relation to
various components of MCI.

If shown to be successful, our findings will be helpful in securing political commitment from stakeholders for up-scaling MCI
strategies at the national level in these South Asian countries. The South-South collaboration and shared experiences will
be very valuable in co-ordinating a regional action plan on NCDs with a focus on hypertension as an entry point. Our trial
will provide direct evidence of the value of using comparable models and platforms for non-communicable disease
management which would extend to other Asian countries with similar ethnic population and healthcare infrastructure.

We propose a two-year stratified cluster randomised controlled trial (RCT) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka aimed at lowering BP levels of individuals with hypertension (systolic BP >=140 mm Hg or diastolic BP >=90 mm Hg, or on antihypertensive therapy). The RCT will enrol 2550 individuals with hypertension in these communities to evaluate the effectiveness of a "multi-component strategy (MCI)" that includes intervention components 1 through 5 below vs. usual care, which does not include any of these components. The MCI components are:

1. Home health education (HHE) by government community health workers (CHWs), plus
2. blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus
3. Trained public and private providers in management of hypertension and using a checklist, plus
4. designated hypertension care coordinators and hypertension triage counter in government clinics, plus
5. compensation for additional services including targeted subsidies.

Primary effectiveness outcome will be change in systolic BP from baseline to follow-up at 24 months.

We will also quantify the incremental cost-effectiveness of MCI in terms of incremental cost per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted based on well-defined relationships between blood pressure reductions and CVD events averted. We will also interview stakeholders and conduct serial focus group discussions of patients on their experience with the strategy in relation to various components of MCI.

1. Address major public health challenge in South Asia: Hypertension is a major contributor to death and disability from cardiovascular disease (CVD) in South Asia. About 1 in 4 adults suffers from hypertension in Bangladesh, Pakistan, and Sri Lanka. However, there are no specific public health programs at the federal, provincial or district level with the expertise in designing and managing programs for prevention and control of hypertension. The 3 South Asian countries have recently prioritised non-communicable diseases (NCDs) on their national and provincial health agenda. However, operational plan is lacking. Our trial aims to evaluate potentially effective and sustainable comprehensive strategies through the primary care system for managing hypertension in rural Bangladesh, Pakistan and Sri Lanka. If successful, scaling up the interventions would be immensely beneficial to the South Asian region and possibly other low-and middle- income countries (LMICs) in terms of reducing mortality and building human capital.

2. Health Systems Strengthening and Capacity Building for Hypertension (and NCD) care: Our trial is capable of reconfiguring and strengthening the capacity of the health system by establishing a team based approach and referral links with documentation of standardised care to enhance hypertension management. The trial uses hypertension as an entry point into developing rural NCD health services and the HHE component of our intervention is the first-line approach for management of diabetes and other common NCDs. The use of statins among high CVD risk individuals follows an up-to-date comprehensive CVD risk reduction strategy. Models of coordinated care are recommended by the World Health Organisation for communicable disease programs, such as Directly Observed Treatment (DOTS) for tuberculosis, HIV, and management of malaria. However, evidence on using comparable models and platforms for NCD management is scarce. Contrasting the experiences from these 3 countries should provide valuable lessons to implement an action plan, and also validate the usefulness of our approach for other countries in the region and
beyond.

3. Detailed Policy Relevant Economic Evaluation: We plan to conduct both a budgetary impact analysis and a cost-effectiveness analysis (CEA) for Bangladesh, Pakistan and Sri Lanka. The detailed CEA will be performed from the societal, government and participants perspectives. Country specific estimates from government and patients' perspectives will be computed for local applicability. In addition, the analysis from the societal perspective would be performed for 3 countries together to provide estimates with implications for other South Asian countries and other LMICs. This information would be very valuable for seeking political commitment from key stakeholders and is likely to enhance uptake of findings as sustainable provincial/national/regional public health programs.

4. Knowledge Translation and Policy Impact: The trial will provide an opportunity to establish governance structures, mechanisms, and strategies to ensure prompt dissemination and uptake of research findings locally, nationally and regionally. The trial evaluates delivery of hypertension management strategies using the public health infrastructure. If successful, this will serve as a platform for up-scaling other model programs into public health interventions. The engagement of governments in 3 countries with investigators would bring hypertension management agenda into national and regional health focus and also facilitate implementation of NCD control programmes in other LMICs. We will further catalyse the process of research to policy translation in Asia Pacific region and supporting organisations and government contacts, and by involving the key stakeholders from national governments and medical research councils, NGOs, international agencies, and media partners.