Implementing WHO HEARTS-D Guidelines in Bangladesh for Diabetes Control and Prevention

NCT07155902 | Not Yet Recruiting

• 2 other identifiers: 1152321R01HL175636-01
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type-2 diabetes (T2D) is rising at an alarming rate in the low- and middle-income countries (LMIC). This rapid increase in the T2D burden has a particular impact on cities, where more than half the LMIC populations currently live and where 3 out of 4 people with T2D reside. In response to this growing global challenge, the World Health Organization (WHO) has emphasized (a) the need for an equitable and sustained improvement in the detection, treatment, and control of T2D, and (b) a rapid implementation of the WHO's evidence-based HEARTS-D module. However, currently, in most LMICs (such as Bangladesh), effective adoption of the WHO HEARTS-D module into routine urban primary care has been limited. These include suboptimal delivery mechanisms, poor uptake, weak monitoring system, and inadequate capacities. To address this, the investigators will evaluate a community-to-facility integrated strategy to implement WHO HEARTS-D module in the existing urban service delivery system in Bangladesh. First, the investigators will develop and optimize a community-to-facility integrated strategy for adopting the WHO HEARTS-D module using Implementation Mapping. Guided by this approach, the investigators will conduct mixed methods assessments to: (a) identify contextual factors, and (b) assess the implementation behavior of providers that may influence T2D care in cities. The investigators will then develop and optimize a suitable implementation strategy that can achieve high coverage, access and utilization of T2D care, specifically for urban poor populations, through iterative cycles of mixed methods qualitative assessments, implementation, and outcome measurements. For this aim, study staff will select the key stakeholders, primary care providers and CHWs as participants, based in 3 wards in Sylhet city of Bangladesh. Second, the investigators will evaluate the impacts of the optimized community-to-facility integrated strategy on implementation outcomes. The investigators will conduct a 2-arm, type 2, hybrid implementation-effectiveness randomized trial. The study will involve 20 municipal wards as clusters from Sylhet city (10 in each arm). This study compare the following strategies: (a) a community-to-facility integrated strategy for implementing the WHO HEARTS-D module and (b) a facility-only usual service delivery. The investigators will evaluate the implementation process by relevant outcomes based on the RE-AIM framework components: reach, effectiveness, implementation, and maintenance. Third, the investigators will compare the effectiveness of this strategy on T2D status. In a study sample of 10,000 randomly selected participants, the investigators will compare improvements in the prevalence of controlled T2D, treatment uptake and adherence to glucose-lowering therapy, T2D complications and awareness among participants in both study arms from baseline to end-line. Our study should guide the policymakers into effective implementation and sustainment of WHO HEARTS-D module that can be: (a) embedded within local organizational structures, and (b) adapted to similar contexts globally.

Conditions

Type 2 Diabetes (T2DM)

Keywords

T2D IR; HEARTS-D; Type 2 Diabetes; Implementation Research; Non-communicable disease (NCD)

Outcome Measures

Primary Outcomes (2)

• Implementation of the Community-to-Facility Integrated Care Intervention

  This outcome will measure the extent to which the integrated community-to-facility care intervention has been successfully implemented, based on the RE-AIM framework.

  Baseline; and through study completion, an average of 1 year.

• Effectiveness of the Community-to-Facility Integrated Care Intervention on Health Outcome

  This outcome will evaluate the effectiveness of the intervention by measuring the percentage of study participants with uncontrolled T2D

  Baseline; and through study completion, an average of 1 year

Study Arms (2)

The community-to-facility integrated strategy

EXPERIMENTAL

The community-to-facility integrated strategy arm will focus on a joined-up T2D care delivery across the primary, secondary, and healthcare facilities, and urban communities. The intervention arm includes community-based care where Community Health Workers (CHWs) visit households to identify eligible individuals and refer them to relevant facilities. This arm will involve (i) 10 randomly chosen ward clusters, and (ii) primary health care centers and Community Health Workers (CHWs) serving these wards.

Other: The community-to-facility integrated strategy

Existing services with no additional involvement of the PHCC-based CHWs

NO INTERVENTION

The remaining 10 ward clusters not included in the intervention arm will be considered as the comparison arm. The participants in this arm will receive the existing conventional services for diabetes in the PHCC and other clinical facilities. However, unlike the experimental arm, there will be no additional involvement of the PHCC-based CHWs in community-based screening and referral.

Interventions

The community-to-facility integrated strategy OTHER

The community-to-facility integrated strategy will focus on a joined-up T2D care delivery across the primary, secondary, and healthcare facilities, and urban communities.

The community-to-facility integrated strategy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult individuals, ≥35 years of age,
• Of either sex,
• Long-term residents in the study area (defined by being a homeowner or a resident for at least the past three years), and
• Willing to provide informed consent for study procedures and follow-up.

You may not qualify if:

• Individuals planning to migrate from the study area before completing the first 12-month follow-up period, and

Sponsors & Collaborators

• Florida International University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Projahnmo Research Foundation: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• The University of Texas Health Science Center, Houston: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdullah H Baqui, DrPH

  Johns Hopkins Bloomberg School of Public Health

  STUDY CHAIR

Central Study Contacts

Rajiv Chowdhury, PhD

CONTACT

(305) 348-5265; rajiv.chowdhury@fiu.edu

Salahuddin Ahmed, PhD

CONTACT

+880-1714-079499; sahmed@prfbd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized, type-2 hybrid effectiveness-implementation study

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: September 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share