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ACTIVE NOT RECRUITING
NCT07440160
NA

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

Sponsor: Arba Minch University

View on ClinicalTrials.gov

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.

Official title: Digitally Facilitated, Integrated Community and Facility-Based Interventions to Improve Tuberculosis Case Detection and Treatment Adherence in South Ethiopia: A Type II Hybrid Effectiveness-Implementation Study: The HEART-TB Trial Protocol

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

278

Start Date

2025-07-01

Completion Date

2026-12-30

Last Updated

2026-02-27

Healthy Volunteers

No

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.

Locations (1)

Arba Minch University

Arba Minch, South Ethiopia Region, Ethiopia