Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation (MULTI-HEARTS)

Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation (MULTI-HEARTS)

The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Hypertension (HTN)
• Intervention / Treatment: Other: HEARTS implementation strategies; Other: Supply chain strengthening

Detailed Description

Hypertension and diabetes frequently co-occur and together are a leading cause of death and disability. Despite the availability of effective treatments, many patients remain untreated or uncontrolled. HEARTS is a package of implementation strategies recommended by the World Health Organization and Pan American Health Organization to improve cardiovascular disease management in primary care. To date, most HEARTS projects have focused on hypertension alone, and rigorous evaluations of HEARTS for integrated hypertension and diabetes care are lacking.

This cluster-randomized trial will be conducted in 36 Ministry of Health primary care facilities (Health Centers) in Guatemala. Health Centers will be randomized 1:1 to HEARTS or enhanced usual care. The HEARTS intervention consists of five implementation strategies adapted to Guatemala: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols; (3) strengthening supply chains of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The comparator arm receives enhanced usual care, which includes standard Ministry of Health clinical care plus supply chain strengthening to ensure between-arm differences are not attributable to medication availability.

Approximately 1,440 patients with hypertension-diabetes multimorbidity (40 per facility) will be enrolled and assessed at baseline and 12 months. Co-primary outcomes are change in systolic blood pressure and hemoglobin A1c. Secondary outcomes include diastolic blood pressure, and proportions achieving blood pressure control (<130/<80 mmHg), hemoglobin A1c control (<7.0%), and combined control. A cost-effectiveness and budget impact analysis will be conducted from the health care sector perspective. The implementation period is 30 months, followed by a 12-month maintenance period.

• Study Type: Interventional
• Enrollment (Estimated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Flood, MD; Phone Number: 734-647-2892; Email: dcflood@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Systolic blood pressure ≥130 mmHg on ≥2 occasions, defined as the mean of 6 measurements at 2 study visits scheduled at least 1 day apart but within 7 days
• Hemoglobin A1c ≥6.5%
• Able and willing to provide informed consent

Exclusion Criteria:

• Does not live in Health Center's catchment area or is unwilling to receive care at the Health Center
• Currently pregnant or planning pregnancy in the next 2 years
• Has been diagnosed with type 1 diabetes, or there is high suspicion of this diagnosis by study physicians
• Has severe chronic or terminal illness such that primary care management of hypertension and/or diabetes would be clinically inappropriate, including end-stage kidney disease
• Confined to bed
• Planning to leave the study area in the next 2 years
• Unwilling to comply with protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEARTS Integrated Hypertension-Diabetes Care; Health Centers in the experimental arm receive a package of five multilevel HEARTS implementation strategies adapted to Guatemala for integrated hypertension-diabetes multimorbidity care: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols for hypertension and diabetes; (3) strengthening supply chains of a core set of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The implementation period is 30 months, followed by a 12-month maintenance period.	Other: HEARTS implementation strategies; A package of five multilevel implementation strategies based on the WHO/PAHO Hearts Technical Package, adapted to Guatemala: (1) Training and supportive supervision for health workers on evidence-based hypertension and diabetes treatment protocols; (2) Simplifying treatment protocols; (3) Strengthening supply chains of a core set of medications and supplies; (4) Task sharing with non-physician health workers; (5) Implementing quality monitoring systems using standardized registries and indicators.; Other: Supply chain strengthening; Strengthening supply chains of a core set of medications and supplies for hypertension and diabetes care. This strategy is provided to both arms to ensure that observed between-arm differences are attributable to the other HEARTS implementation strategies rather than to variations in medication and supply availability.
Active Comparator: Enhanced Usual Care; Health Centers in the comparator arm receive enhanced usual care consisting of standard clinical care and medications for hypertension and diabetes available through the Ministry of Health system, aligned with national clinical guidelines. As an enhancement to usual care, comparator Health Centers also receive the strategy to strengthen supply chains of medications and supplies. This enhancement ensures that between-arm differences are not due to variations in clinical resource availability and minimizes the risk of contamination, as supply chain management in the MOH system occurs at multiple levels.	Other: Supply chain strengthening; Strengthening supply chains of a core set of medications and supplies for hypertension and diabetes care. This strategy is provided to both arms to ensure that observed between-arm differences are attributable to the other HEARTS implementation strategies rather than to variations in medication and supply availability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	Between-arm mean difference in change in systolic blood pressure (mmHg)	Enrollment to 12 months
Change in hemoglobin A1c	Between-arm mean difference in change in hemoglobin A1c (%)	Enrollment to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diastolic blood pressure	Between-arm mean difference in change in diastolic blood pressure (mmHg)	Enrollment to 12 months
Proportion with blood pressure control	Between-arm difference in proportion achieving blood pressure <130/<80 mmHg	Enrollment to 12 months
Proportion with hemoglobin A1c control	Between-arm difference in proportion achieving HbA1c <7.0%	12 months
Proportion with combined blood pressure and hemoglobin A1c control	Between-arm difference in proportion achieving blood pressure <130/<80 mmHg and HbA1c <7.0%	12 months

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HL183254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data from the clinical trial will be shared via the NHLBI BioLINCC repository. Data will include sociodemographics, anthropometrics, medical history, blood pressure, hemoglobin A1c, and self-reported outcomes.
• IPD Sharing Time Frame: Data will be made accessible no later than the time of publication of the primary results or the end of the grant period, whichever comes first. Data will be available for a minimum of 10 years.
• IPD Sharing Access Criteria: Controlled access through the NHLBI BioLINCC platform. Researchers must submit a data access request and sign a Data Use Agreement. Access and reuse will comply with NIH, institutional, and Guatemalan policies on data sharing and ethical guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No