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NCT07440160Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
278 (estimated)
First submitted
13 Feb 2026
Start date
Jul 2025
Primary completion date
Dec 2026
Lead sponsor
Arba Minch University
Diseases
Tuberculosis
NCT number
NCT07440160

What you commit to

  • Study type: Interventional
  • Planned participants: 278
  • From Jul 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • All patients with pulmonary TB will be including in the study.
  • All health workers who are working in TB clinic for at least 1 year
  • All family member of pulmonary TB patient
  • Health facilities with TB diagnostic facility Exclusion criteria
  • Patients with comorbidities other than HIV
  • Patients planning to transfer to other facility
  • Severely ill, and /or mentally incapable of giving consent will be excluded.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Arba Minch University
Coordinator of this site? Confirm its status
Arba MinchEthiopiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.