Clinical Trial

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

Study acronym: HEART-TB
Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07440160
Lead Sponsor Arba Minch University
Conditions Tuberculosis
Enrollment 278 participants
Start Date 2025-07-01
Primary Completion 2026-12-15 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-27