Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:39 AM
Study NCT ID:
NCT07440160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digitally Facilitated, Integrated Community and Facility-Based Interventions: The HEART-TB Trial Protocol
Sponsor:
Arba Minch University
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEART-TB
Brief 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.
Detailed Description:
The specific aims of this study include (1) to explore barriers, facilitators, and needs influencing patients' adherence to TB medication; (2) to explore providers', patients', community members', and program managers' perspectives on the acceptability, feasibility, and sustainability of the designed interventions using the RE-AIM framework and the theoretical framework of acceptability and feasibility; (3) to explore barriers and facilitators of integrated intervention implementation using the Consolidated Framework for Implementation Research; and (4) to determine the effect of the designed intervention on TB detection rate, medication adherence, and treatment outcomes. The investigators will answer the following research questions: (1) What are the barriers and facilitators for the implementation of digitally facilitated, integrated community- and facility-based (HEART) interventions for tuberculosis case detection, treatment adherence, and treatment outcomes? (2) How acceptable, feasible, and sustainable are implementing digitally facilitated, integrated community and facility (HEART)-based interventions? (3) Do digitally facilitated, integrated community- and facility-based interventions (HEART) improve tuberculosis case detection, treatment adherence, and treatment outcomes among TB patients in comparison with the standard of care? It is a two-arm study where the intervention group receives the digitally facilitated, integrated community and facility-based interventions (HEART), and the control group receives the standard facility-based care.
The following intervention will be provided:
* Structured training: Health extension and health care workers received training on special adherence counseling and active case detection.
* Special adherence counseling: TB patients and their adherence supporters will receive special adherence counseling.
* Medication adherence support: Adherence supporters, selected by TB patients who received special adherence counseling, will provide ongoing daily home-based TB medication adherence support.
* Short message service (SMS): To reinforce daily TB medication intake, TB patients and their adherence supporters will receive daily short mobile message service.
* Self-adherence support: In the absence of external adherence support, TB patients will monitor their adherence and come to drug refills every month.
A pragmatic type-2 hybrid effectiveness-implementation study will be conducted in the five zones of South Ethiopia between 2025 and 2026. First, the investigator will explore the barriers and facilitators of TB medication adherence, as well as the acceptability and feasibility of the integrated intervention using a qualitative research design. Finally, a quasi-experimental study will be conducted to evaluate the effectiveness of interventions on case detection, medication adherence, and treatment outcomes. A comprehensive data quality control and management plan will be implemented throughout the study to ensure the reliability, validity, and integrity of the data. Data collectors will undergo thorough training on ethical research practices, interview techniques, and the study's objectives to maintain consistency in data collection. This training will include practical exercises to ensure the team is familiar with the interview guide and can effectively engage participants. Additionally, the data collection tool will undergo a pretest with a small sample from a similar population, allowing for necessary revisions to ensure clarity and effectiveness. Informed consent will be obtained from all participants, ensuring they understand the study's purpose, procedures, and their rights. All interviews and focus group discussions will be audio-recorded with participants' consent, and the recordings will be transcribed verbatim for accuracy. Qualitative data will be analyzed using thematic content analysis using Atlas. Ti (Version 7.5.5 Difference-in-differences, mixed-effects linear and logistic regression, and Generalized Estimating Equation (GEE) will be employed to evaluate the intervention's effect using STATA version 19.0.
The following intervention will be provided:
* Structured training: Health extension and health care workers received training on special adherence counseling and active case detection.
* Special adherence counseling: TB patients and their adherence supporters will receive special adherence counseling.
* Medication adherence support: Adherence supporters, selected by TB patients who received special adherence counseling, will provide ongoing daily home-based TB medication adherence support.
* Short message service (SMS): To reinforce daily TB medication intake, TB patients and their adherence supporters will receive daily short mobile message service.
* Self-adherence support: In the absence of external adherence support, TB patients will monitor their adherence and come to drug refills every month.
A pragmatic type-2 hybrid effectiveness-implementation study will be conducted in the five zones of South Ethiopia between 2025 and 2026. First, the investigator will explore the barriers and facilitators of TB medication adherence, as well as the acceptability and feasibility of the integrated intervention using a qualitative research design. Finally, a quasi-experimental study will be conducted to evaluate the effectiveness of interventions on case detection, medication adherence, and treatment outcomes. A comprehensive data quality control and management plan will be implemented throughout the study to ensure the reliability, validity, and integrity of the data. Data collectors will undergo thorough training on ethical research practices, interview techniques, and the study's objectives to maintain consistency in data collection. This training will include practical exercises to ensure the team is familiar with the interview guide and can effectively engage participants. Additionally, the data collection tool will undergo a pretest with a small sample from a similar population, allowing for necessary revisions to ensure clarity and effectiveness. Informed consent will be obtained from all participants, ensuring they understand the study's purpose, procedures, and their rights. All interviews and focus group discussions will be audio-recorded with participants' consent, and the recordings will be transcribed verbatim for accuracy. Qualitative data will be analyzed using thematic content analysis using Atlas. Ti (Version 7.5.5 Difference-in-differences, mixed-effects linear and logistic regression, and Generalized Estimating Equation (GEE) will be employed to evaluate the intervention's effect using STATA version 19.0.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: