METHODS: HOPE 4 was an open, community-based, cluster-randomised controlled trial involving 1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia. 16 communities were randomly assigned to control (usual care, n=727), and 14 (n=644) to the intervention. After community screening, the intervention included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter) to improve adherence to medications and healthy behaviours. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. The HOPE 4 trial is registered at ClinicalTrials.gov, NCT01826019.

FINDINGS: All communities completed 12-month follow-up (data on 97% of living participants, n=1299). The reduction in Framingham Risk Score for 10-year cardiovascular disease risk was -6·40% (95% CI 8·00 to -4·80) in the control group and -11·17% (-12·88 to -9·47) in the intervention group, with a difference of change of -4·78% (95% CI -7·11 to -2·44, p<0·0001). There was an absolute 11·45 mm Hg (95% CI -14·94 to -7·97) greater reduction in systolic blood pressure, and a 0·41 mmol/L (95% CI -0·60 to -0·23) reduction in LDL with the intervention group (both p<0·0001). Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001). There were no safety concerns with the intervention.

INTERPRETATION: A comprehensive model of care led by NPHWs, involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based.

OBJECTIVES: Based on the growing evidence that many elements of chronic disease management can be shifted to nonphysician health care workers (NPHW), the HOPE-4 (Heart Outcomes Prevention and Evaluation Program) aimed to develop, test, and implement a training curriculum on CVD prevention and control in Colombia, Malaysia, and low-resource settings in Canada.

METHODS: Curriculum development followed an iterative and phased approach where evidence-based guidelines, revised blood pressure treatment algorithms, and culturally relevant risk factor counseling were incorporated. Through a pilot-training process with high school students in Canada, the curriculum was further refined. Implementation of the curriculum in Colombia, Malaysia, and Canada occurred through partner organizations as the HOPE-4 team coordinated the program from Hamilton, Ontario, Canada. In addition to content on the burden of disease, cardiovascular system pathophysiology, and CVD risk factors, the curriculum also included evaluations such as module tests, in-class exercises, and observed structured clinical examinations, which were administered by the local partner organizations. These evaluations served as indicators of adequate uptake of curriculum content as well as readiness to work as an NPHW in the field.

RESULTS: Overall, 51 NPHW successfully completed the training curriculum with an average score of 93.19% on module tests and 84.76% on the observed structured clinical examinations. Since implementation, the curriculum has also been adapted to the World Health Organization's HEARTS Technical Package, which was launched in 2016 to improve management of CVD in primary health care.