Evaluating implementation of the hearts hypertension and diabetes primary care model in guatemala - improving care for people with hypertension and diabetes in low- and middle-income countries (LMICS)…

The National Heart, Lung, and Blood Institute awarded the Regents of the University of Michigan $942,143 on September 25, 2025, to evaluate implementation of the World Health Organization's HEARTS hypertension and diabetes primary care model in Guatemala's Ministry of Health system under Assistance Listing 93.837 (Cardiovascular Diseases Research).

The University of Michigan study team will conduct a mixed-methods evaluation spanning a 30-month implementation period followed by a 30-month maintenance period, assessing quantitative measures across RE-AIM domains with qualitative data collection and analysis to explain quantitative findings. Co-primary outcomes focus on reach metrics in the target population. The evaluation leverages Guatemala's September 2024 launch of a fully-financed HEARTS implementation project covering 27 health districts with more than 100 primary health facilities, addressing the implementation gap between HEARTS pilot feasibility and population-level impact in low- and middle-income countries.

Place of performance is Ann Arbor, Michigan, with period of performance through June 30, 2030. Sub-recipients deliver integrated research components: Baylor College of Medicine (qualitative study preparation, subject recruitment, qualitative data collection and analysis, and dissemination to patient advisory council and academic venues); Instituto de Nutrición de Centro América y Panamá (salary support for research team and resources for research and training activities in Guatemala); Wuqu' Kawoq, S.A. / Maya Health Alliance (semi-structured interview guide development, stakeholder interviews at three time points, qualitative data transcription and coding, mixed-methods analysis contribution, patient advisory panel formation, and dissemination within Maya Indigenous communities); and University of Washington (economic evaluation methods development, primary data analysis, and cost-effectiveness modeling).

Evaluating implementation of the hearts hypertension and diabetes primary care model in guatemala - improving care for people with hypertension and diabetes in low- and middle-income countries (LMICS) is one of the most critical health challenges worldwide. Approximately 80% of people with these two diseases live in LMICS. Pharmacological management of hypertension and diabetes in primary care is one of the most highly effective and cost-effective interventions available. Yet, limited implementation of hypertension and diabetes primary care in LMICS contributes to markedly worse health outcomes than in high-income countries. The overall goal of this proposal is to evaluate the implementation of the world health organization's (who) hearts technical package ("hearts") in the ministry of health (MOH) primary care system in guatemala. The hearts model is who's recommended approach to closing the "implementation GAP" of hypertension and diabetes primary care in LMICS. While pilot testing in many countries shows that hearts is feasible, several implementation challenges have limited its population benefits. To investigate and overcome these implementation challenges, this proposal leverages a unique and time-sensitive scientific opportunity in guatemala. In september 2024, the guatemalan MOH is launching a fully-financed hearts hypertension and diabetes implementation project in 27 health districts covering >100 primary health facilities. Yet, while the implementation of hearts in guatemala is fully financed, there are limited resources to evaluate its implementation. In aim 1, the study team will conduct a mixed methods evaluation over a 30-month implementation period followed by a 30-month maintenance period. Quantitative measures will be assessed in each RE-aim domain. Informed by quantitative results, qualitative data will be collected and analyzed to explain quantitative results. The CO-primary outcomes will be in the reach domain, defined as the count of people treated per person-month during the implementation period ("treatment rate"). The treatment rate will be calculated separately for hypertension and diabetes using a difference-in-differences approach with patient-level ministry of health administrative data. During the maintenance phase, RE-aim quantitative measures will continue to be iteratively assessed, and the RE-aim sustainability extension will be used to qualitatively explore the dynamic nature of sustainability, sustainability determinants, and the evolution of implementation strategies. In aim 2, the study team will evaluate the cost-effectiveness and budget impact of hearts by integrating costs and clinical data into a mathematical modeling tool. This proposal leverages prior nhlbi investments in guatemala to produce knowledge to close the implementation GAP of hypertension and diabetes treatment in LMICS. The proposal is responsive to the goals of PAR-22-105 to promote implementation of evidence-based interventions into public health practice and aligns with the nhlbi's strategic vision 6.CC.11: "multidisciplinary, multinational partnerships are needed to develop effective and sustainable strategies for combating chronic hlbs disorders in developing nations." protection of human subjects 1. Risks to human subjects 1.a human subjects involvement, characteristics, and design 1.a.1 overall study design this study is not an NIH-defined intervention study or clinical trial. Rather, the study is a prospective, observational evaluation of the implementation of the world health organization's hearts technical package ("hearts") in guatemala. Hearts functions as a quality improvement project that the guatemalan ministry of health (MOH) is funding and implementing. The proposal includes no implementation or intervention activities, only evaluation activities. In aim 1, we will conduct a mixed methods evaluation of hearts implementation in guatemala using the RE-aim (reach, effectiveness, adoption, implementation, maintenance) framework. The evaluation will occur over a 30-month implementation period followed by a 3