Implementation Support for HEARTS-Based Hypertension and Diabetes Care in Guatemala (MULTI-HEARTS)

November 8, 2026 updated by: David Flood, University of Michigan

Cluster-Randomized Trial of Implementation Support for HEARTS-Based Care Among Adults With Hypertension and Diabetes in Guatemala (MULTI-HEARTS)

The purpose of this study is to find out whether extra support for 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 health centers deliver better treatment. It is the official model for high blood pressure and diabetes care in Guatemala's Ministry of Health. In this study, 36 Ministry of Health health centers in Guatemala will be randomly assigned to 1 of 2 groups. Health centers in both groups will use HEARTS through the Ministry of Health's routine training, treatment guides, and digital tools. Health centers in 1 group will also receive 36 months of extra support from the Institute of Nutrition of Central America and Panama (INCAP). This support includes refresher training for health workers every 6 months, monthly supportive supervision visits, and coaching of a health center quality committee to use data to improve 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, at 6 months, and at 12 months. The main measure is systolic blood pressure at 12 months. The most important other measure is hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months) at 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

MULTI-HEARTS is a cluster-randomized, hybrid type 2 effectiveness-implementation trial of implementation support for HEARTS, the official model for hypertension and diabetes primary care in Guatemala's Ministry of Health. Health centers in both arms will implement HEARTS through the Ministry of Health's routine strategies. In the implementation support arm, health centers also will receive additional implementation support strategies directed at health workers, managers, and support staff.

The primary objective is to evaluate whether HEARTS implementation support leads to better hypertension and diabetes control than routine HEARTS implementation among adults with hypertension and diabetes. We hypothesize that implementation support will lead to lower mean systolic blood pressure at 12 months (primary outcome) compared to routine HEARTS implementation. The key secondary outcome is mean hemoglobin A1c (HbA1c) at 12 months. Other secondary outcomes are mean diastolic blood pressure and the proportions of participants with blood pressure control, HbA1c control, and combined blood pressure and HbA1c control at 12 months. The primary implementation outcome is Reach, which is defined in the study to be the monthly number of patients treated with both antihypertensive and glucose-lowering medications at participating health centers. In an economic evaluation, we will also estimate costs, cost-effectiveness, and budget impact.

We will randomize 36 Ministry of Health health centers in a 1:1 ratio, with stratification by health area. We will enroll 1,440 adults aged 18 years or older with systolic blood pressure ≥130 mmHg and HbA1c ≥6.5%. There will be approximately 40 participants per health center and a total of 720 per arm. Allowing for 15% attrition, the trial will have at least 80% power to detect a between-arm difference of 5.0 mmHg in mean systolic blood pressure at 12 months. The health centers serve urban and rural communities, and many participants will live in poverty and have limited literacy. Some trial participants are expected to be Indigenous Maya and will primarily speak a Mayan language rather than Spanish.

After a 1-year trial planning period, health centers will be randomized before the start of the 36-month implementation period. Each participant will be followed for 12 months. Ministry of Health administrative data will also be collected for a 6-month post-trial period. In addition to the trial data, the study includes additional data collection for implementation and economic evaluations.

Study Type

Interventional

Enrollment (Estimated)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Peter Rohloff, MD, PhD
  • Phone Number: 617-732-5500
  • Email: prohloff@mgb.org

Study Locations

  • Guatemala
      • Guatemala City, Guatemala
        • Ministry of Health health centers
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Blood pressure criteria, defined as mean systolic blood pressure of ≥130 mmHg at the screening visit and again at the enrollment visit, held 1 to 14 days apart.
  • Glycemic criteria, defined as one of the following: (a) for individuals with a prior diagnosis of diabetes or currently taking a glucose-lowering drug, HbA1c of ≥6.5% at the screening visit; (b) for individuals without a prior diagnosis of diabetes and not taking a glucose-lowering drug, HbA1c of ≥6.5% at both the screening and enrollment visits.
  • Living in a community served by one of the health centers included in the study and willing to receive health care at the corresponding health center.
  • Provides informed consent in Spanish or the main Mayan language in the municipality where they live.

Exclusion Criteria:

  • Pregnant or planning pregnancy during the 12-month follow-up period, based on self-report.
  • Type 1 diabetes, based on self-reported medical history or the judgment of the study physician.
  • Illness that, in the judgment of the study physician, limits life expectancy to less than 12 months or would prevent completion of study follow-up, including but not limited to end-stage kidney disease requiring or awaiting dialysis, advanced heart failure, liver failure, or cancer under active treatment.
  • Currently participating in another research study involving an intervention.
  • Planning to leave the community served by the health center during the 12-month follow-up period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation support arm

Routine HEARTS implementation with additional implementation support from INCAP for 36 months.
Other: HEARTS implementation support

Group refresher training every 6 months, monthly supportive supervision visits, and data-driven coaching of a health center quality committee, delivered by INCAP implementation support physicians to health workers, managers, and support staff.

Other: Routine HEARTS implementation

An initial training-of-trainers workshop, Clinical Pathways for hypertension and type 2 diabetes, and digital tools, delivered by the Ministry of Health under its National Strategy for Cardio-Reno-Metabolic Risk Management based on HEARTS.
Active Comparator: Routine implementation arm

Routine HEARTS implementation alone.
Other: Routine HEARTS implementation

An initial training-of-trainers workshop, Clinical Pathways for hypertension and type 2 diabetes, and digital tools, delivered by the Ministry of Health under its National Strategy for Cardio-Reno-Metabolic Risk Management based on HEARTS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 12 months after the enrollment visit

Between-arm mean difference in systolic blood pressure, using the mean of 3 automated readings.
12 months after the enrollment visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 12 months after the enrollment visit

Key secondary outcome. Between-arm mean difference in hemoglobin A1c, measured with a point-of-care device.
12 months after the enrollment visit
Diastolic blood pressure
Time Frame: 12 months after the enrollment visit

Between-arm mean difference in diastolic blood pressure, using the mean of 3 automated readings.
12 months after the enrollment visit
Proportion of participants with blood pressure control
Time Frame: 12 months after the enrollment visit

Between-arm difference in the proportion of participants with blood pressure control of <130/<80 mmHg, as defined in national guidelines.
12 months after the enrollment visit
Proportion of participants with hemoglobin A1c control
Time Frame: 12 months after the enrollment visit

Between-arm difference in the proportion of participants with hemoglobin A1c control of <7.0%, as defined in national guidelines.
12 months after the enrollment visit
Proportion of participants with combined blood pressure control and hemoglobin A1c control
Time Frame: 12 months after the enrollment visit

Between-arm difference in the proportion of participants with combined blood pressure control (<130/<80 mmHg) and hemoglobin A1c control (<7.0%), as defined in national guidelines.
12 months after the enrollment visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
University of Washington
Institute of Nutrition of Central America and Panama
Ministry of Health, Guatemala
Wuqu' Kawoq, Maya Health Alliance

Investigators

  • Principal Investigator: David Flood, MD, MSc, University of Michigan
  • Principal Investigator: Peter Rohloff, MD, PhD, Brigham and Women's Hospital
  • Principal Investigator: Manuel Ramírez-Zea, MD, PhD, Institute of Nutrition of Central America and Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 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)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 8, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00301585
  • R61HL183254 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will deposit de-identified participant-level data collected at study visits in a data repository selected in accordance with NHLBI policy.

IPD Sharing Time Frame

No later than the time of an associated publication or the end of the performance period, whichever comes first.

IPD Sharing Access Criteria

The repository will control access to the data in accordance with NHLBI policy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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