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Digitally Facilitated, Integrated Community and Facility-Based Interventions: The HEART-TB Trial Protocol

NCT07440160 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2026-02-27

No results posted yet for this study

Summary

Effective tuberculosis treatment outcome relies on adherence. However, many TB patients struggle to adequately adhere to their prescribed regimen due to various social, economic, personal, and healthcare system barriers. However, previous interventions did not adequately consider combined strategies in a way that addressed social, personal, economic, and health system barriers to case detection, treatment adherence, and outcomes. As a result, the investigator developed novel holistic interventions, which include community-based TB patient support, family and patient adherence support strategies, digital adherence support strategies, and structured training for health care providers. Investigators are now conducting a type II hybrid effectiveness-implementation study to evaluate the effectiveness and implementation of digitally facilitated integrated community- and facility-based interventions on case detection and medication adherence and treatment outcomes among patients on TB treatment in South Ethiopia using the RE-AIM framework.

Conditions

Interventions

OTHER

HEART-TB

Several previous interventional studies did not adequately consider combined strategies in a way that addressed social, personal, economic, and health system barriers to case detection, treatment adherence, and outcomes. As a result, the investigator developed novel holistic interventions, which include community-based TB patient support, family and patient adherence support strategies, digital adherence support strategies, and structured training for health care providers.

Sponsors & Collaborators

  • Arba Minch University

    lead OTHER

Principal Investigators

  • Degu J Dare, MD, PhD · KNCV Tuberculosis Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-15
Completion
2026-12-30

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440160 on ClinicalTrials.gov