Implementing integrated hypertension and diabetes management using the World Health Organization's HEARTS model: protocol for a pilot study in the Guatemalan national primary care system.

BACKGROUND: The HEARTS technical package was developed by the World Health Organization to address the implementation gap in cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities in Guatemala are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala. METHODS: A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n = 45), hypertension (n = 45), or both (n = 10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on healthy-lifestyle counseling and evidence-based treatment protocols, strengthening access to medications and diagnostics, training on risk-based cardiovascular disease management, team-based care and task sharing, and systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed-methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control), key implementation outcomes (adoption, fidelity, usability, and sustainability), and patient-reported outcome measures (diabetes distress, disability, and treatment burden). Using an implementation mapping approach, a Technical Advisory Committee will develop implementation strategies for subsequent scale-up planning. DISCUSSION: This trial will produce evidence on implementing HEARTS-aligned hypertension and diabetes care in the MOH primary care system in Guatemala. Results also will inform future HEARTS projects in Guatemala and other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT06080451. The trial was prospectively registered on October 12, 2023.

Assessing costs of a hypertension management program: An application of the HEARTS costing tool in a program planning workshop in Thailand.

The HEARTS technical package, a part of the Global Hearts Initiative to improve cardiovascular health globally, is a strategic approach for cardiovascular disease prevention and control at the primary care level. To support the evaluation of costs associated with HEARTS program components, a costing tool was developed to evaluate the incremental cost of program implementation. This report documents an application of the HEARTS costing tool during a costing workshop prior to the initiation of a HEARTS pilot program in Thailand's Phothong District, 2019-2020. During the workshop, a mock exercise was conducted to estimate the expected costs of the pilot study. The workshop application of the tool underscored its applicability to the HEARTS program planning process by identifying cost drivers associated with individual program elements. It further illustrated that by supporting disaggregation of costs into fixed and variable categories, the tool can inform the scalability of pilot projects to larger populations. Lessons learned during the initial development and application of the costing tool can inform future HEARTS evaluation efforts.