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

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)

Interventions

OTHER

The community-to-facility integrated strategy

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Projahnmo Research Foundation

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Florida International University

  lead OTHER

Principal Investigators

• Abdullah H Baqui, DrPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2029-09-30

Completion

2029-09-30