TuberculosisHEART-TBNCT07440160
Digitally Facilitated, Integrated Community and Facility-Based Interventions: The HEART-TB Trial Protocol
A study testing HEART-TB in people with Tuberculosis, run by Arba Minch University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- HEART-TB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Jul 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- HEART-TB
- Keywords
- Tuberculosis, Digital health intervention, Medication adherence support intervention, Case detection, Ethiopia, Holistic intervention
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEART-TBOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Holistic engagement on TB case detection, adherence reinforcement , and treatment | Experimental | The following intervention will be provided:
1. Structured training: Health extension and health care workers received training on special adherence counseling and active case detection.
2. Special adherence counseling: TB patients and their adherence supporters will receive special adherence counseling.
3. Medication adherence support: Adherence supporters, selected by TB patients who received special adherence counseling, will provide ongoing daily home-based TB medication adherence support.
4. Short message service (SMS): To reinforce daily TB medication intake, TB patients and their adherence supporters will receive daily short mobile message service.
5. Self-adherence support: In the absence of external adherence support, TB patients will let their adherence support be monitored by themselves and come to drug refills on a monthly basis. Receives: Other: HEART-TB |
| Patients proceed with the standard care/ control group | Active comparator | The national TB treatment program recommends a total of six months of daily treatment for drug-sensitive TB in two phases. Intensive Phase: For the first two months, the patient takes a combination of four drugs: rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E). At the end of this phase, a sputum test is conducted. If the test is negative or positive but shows drug sensitivity, the patient is moved to the continuation phase. If the sputum test remains positive and indicates drug resistance, the TB is classified as drug-resistant, treatment is discontinued, and the patient is switched to second-line treatment. In this case, patients take their medication directly.
Continuation Phase: This phase lasts for the next four months, during which the patients take a combination of two drugs, ethambutol (E) and isoniazid (H), with a monthly follow-up schedule to evaluate adherence. In the fifth month, a second sputum conversion test takes place. If the results remain positive Receives: Other: HEART-TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB case detection
TB case detection rate (CDR) is the percentage of people detected with TB using rapid molecular tests like GeneXpert and sputum smear microscopy as recommended by the World Health Organization (WHO). It will be calculated as the proportion of TB cases notified by the facility divided by the estimated number of TB cases in the facility catchment area, expressed as a percentage. The estimated number of TB cases will be computed using the Ethiopian TB incidence rate of 146 per 100,000 population by multiplying the incidence rate by the total catchment population for that year and dividing by 100,000. The case detection rate will then be calculated by dividing the number of notified TB cases by the estimated number of TB cases and multiplying the result by 100.
Measured: The case detection rate will be measured after six months of intevention
TB medication adherance
TB medication adherence will be evaluated using an 11-item Adherence to Refills and Medications Scale. The tool consists of two subscales: an 8-item medication-taking subscale and a 3-item refill subscale. Participants will respond to the items using a Likert scale, where 1="none of the time," 2="some of the time," 3="most of the time," and 4="all of the time." The total score ranges from 11 to 44. The lower scores indicate better adherence, and the higher scores represent a higher level of non-adherence. A score of 11 is classified as "adhered," and a score above 11 indicates "non-adhered." An interviewer-administered structured questionnaire will be used to collect adherence to TB treatment.
Measured: The data for adherence will be measured at the 2nd, 4th, and 6th months of TB treatment.
Tuberculosis treatment cure rate
The cure rate is the percentage of bacteriologically confirmed TB patients at the beginning of treatment who completed treatment as recommended by the Ethiopian guideline for Clinical and Programmatic Management of TB and Leprosy and were smear- or culture-negative in the 5th month of treatment and on at least one previous occasion. This will be computed by dividing the number of TB patients declared cured by the total number of bacteriologically confirmed pulmonary TB patients during the six months of treatment follow-up. The date will be collected from the facility-based TB registration logbook and laboratory registers.
Measured: After six months of tuberculosis treatment
Tuberculosis treatment completion rate
Treatment completion rate is the percentage of TB patients who completed treatment without evidence of failure but with no record to show that sputum or culture results in the 5th month of treatment were negative, either because tests were not done or because results are unavailable. This will be computed by dividing the number of TB patients who complete TB treatment by the total TB patients registered during the six months of treatment follow-up. Both the TB registration logbook at the TB clinic and the laboratory registers will be used to collect the data.
Measured: After six months of tuberculosis treatment follow-up.
Tuberculosis Treatment Success rate
Treatment success rate: the percentage of TB patients who were declared cured and completed TB treatment during the six months of treatment follow-up. This will be calculated by dividing the sum of patients who were declared as cured and complete by the total number of TB patients registered during the six months of TB treatment follow-up. The date will be collected from the facility-based TB registration logbook and laboratory registers.
Measured: At the six-month tuberculosis treatment
Loss to follow-up rate
Loss to follow-up rate: the percentage of tuberculosis patients whose treatment was interrupted for eight or more consecutive weeks after getting registered at a TB treatment center or who did not start anti-tuberculosis treatment for eight or more consecutive weeks. This will be calculated by dividing the number of tuberculosis patients lost to follow-up by the total number of tuberculosis patients registered during the six months of tuberculosis treatment follow-up. The date will be collected from the facility-based tuberculosis registration logbook and laboratory registers.
Measured: After the six months of tuberculosis treatment follow-up
Percenatge of acceptability of the intervention
The acceptability of the intervention will be determined using a standardized questionnaire based on the acceptability theoretical framework. The tool comprises eight constructs and will be assessed on a 5-point Likert scale, with a total score ranging from 8 to 40. The overall mean score will be used to determine the acceptable level. Patients who score higher than the mean accept the intervention, whereas those who score lower do not. The investigator will determine the percentage of subjects who accepted and did not accept the intervention. Additionally, the investigator will assess the acceptability of the intervention using in-depth interviews and group discussion guides based on the acceptability theoretical framework.
Measured: This will be measured after three months of the intervention.
Feasibility of the intervention
Feasibility of the intervention will be assessed qualitatively using an in-depth interview guide adopted from the construct of Bowen et al feasibility theoretical framework.
Measured: Feasibility of the intervention will be evaluated after the three months of the intervention.
Secondary outcomes (3)
Weight of participants
Weight of participants: A calibrated digital standing weight scale will be used to measure the weight of tuberculosis patients, which will be measured to the nearest 0.1 kilogram. During weight measurement, patients will be ordered to put on light clothing and take off their shoes.
Measured: Weight will be measured at initiation and the 3rd and 6th months of tuberculosis treatment.
Height of participants
Height of participants: A wall-mounted stadiometer will be used to measure the standing height of the patients, and it will be taken to the nearest 0.1 centimeter. The Frankfurt plane procedure will be applied when measuring height and the posture of the head, shoulders, and thoracic spine in comfortable erect standing.
Measured: Height will be measured at initiation and at the 3rd and 6th months of TB treatment.
Body mass index of participants
Body mass index: this will be computed by dividing weight in kilograms (kg) by height in meters squared (m²). Then the result will be designated as underweight when the body mass index is less than 18.5 kg/m², normal (18.5 kg/m² and 24.9 kg/m²), overweight (25 kg/m² and 29.9 kg/m²), and obese (≥ 30 kg/m²), respectively.
Measured: The investigator will compute the body mass index at the initiation and 3rd and 6th months of tuberculosis treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jul 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- At the TB center, patients who are newly diagnosed with drug-sensitive TB and completing their first month of TB treatment will be approached to provide consent for participation. Those in the intervention facilities will be given the Holistic engagement on case detection, adherence reinformed and TB treatment intervention, whereas those in the comparison facilities will be put under standard care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arba Minch University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mulugeta Dalbo Datamo, Arba Minch University
- Investigators
- Degu J Dare, MD, PhD, Study chair, KNCV Tuberculosis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440160
- Sponsor's protocol ID
- MD23334
- Acronym
- HEART-TB
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To keep the confidentiality of participants individual participant identification is not planned to share with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07440160
- Acronym / sponsor ID
- HEART-TB / MD23334
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Digital health intervention, Medication adherence support intervention, Case detection, Ethiopia, Holistic intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Arba Minch UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- At the TB center, patients who are newly diagnosed with drug-sensitive TB and completing their first month of TB treatment will be approached to provide consent for participation. Those in the intervention facilities will be given the Holistic engagement on case detection, adherence reinformed and TB treatment intervention, whereas those in the comparison facilities will be put under standard care.
| Arm | Type | Receives |
|---|---|---|
| Holistic engagement on TB case detection, adherence reinforcement , and treatment | Experimental | Other: HEART-TBThe following intervention will be provided: 1. Structured training: Health extension and health care workers received training on special adherence counseling and active case detection. 2. Special adherence counseling: TB patients and their adherence supporters will receive special adherence counseling. 3. Medication adherence support: Adherence supporters, selected by TB patients who received special adherence counseling, will provide ongoing daily home-based TB medication adherence support. 4. Short message service (SMS): To reinforce daily TB medication intake, TB patients and their adherence supporters will receive daily short mobile message service. 5. Self-adherence support: In the absence of external adherence support, TB patients will let their adherence support be monitored by themselves and come to drug refills on a monthly basis. |
| Patients proceed with the standard care/ control group | Active comparator | Other: HEART-TBThe national TB treatment program recommends a total of six months of daily treatment for drug-sensitive TB in two phases. Intensive Phase: For the first two months, the patient takes a combination of four drugs: rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E). At the end of this phase, a sputum test is conducted. If the test is negative or positive but shows drug sensitivity, the patient is moved to the continuation phase. If the sputum test remains positive and indicates drug resistance, the TB is classified as drug-resistant, treatment is discontinued, and the patient is switched to second-line treatment. In this case, patients take their medication directly. Continuation Phase: This phase lasts for the next four months, during which the patients take a combination of two drugs, ethambutol (E) and isoniazid (H), with a monthly follow-up schedule to evaluate adherence. In the fifth month, a second sputum conversion test takes place. If the results remain positive |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEART-TBSeveral 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. | Other | Holistic engagement on TB case detection, adherence reinforcement , and treatment, Patients proceed with the standard care/ control group |
Primary outcome
TB case detection
Time frame: The case detection rate will be measured after six months of intevention
TB case detection rate (CDR) is the percentage of people detected with TB using rapid molecular tests like GeneXpert and sputum smear microscopy as recommended by the World Health Organization (WHO). It will be calculated as the proportion of TB cases notified by the facility divided by the estimated number of TB cases in the facility catchment area, expressed as a percentage. The estimated number of TB cases will be computed using the Ethiopian TB incidence rate of 146 per 100,000 population by multiplying the incidence rate by the total catchment population for that year and dividing by 100,000. The case detection rate will then be calculated by dividing the number of notified TB cases by the estimated number of TB cases and multiplying the result by 100.
TB medication adherance
Time frame: The data for adherence will be measured at the 2nd, 4th, and 6th months of TB treatment.
TB medication adherence will be evaluated using an 11-item Adherence to Refills and Medications Scale. The tool consists of two subscales: an 8-item medication-taking subscale and a 3-item refill subscale. Participants will respond to the items using a Likert scale, where 1="none of the time," 2="some of the time," 3="most of the time," and 4="all of the time." The total score ranges from 11 to 44. The lower scores indicate better adherence, and the higher scores represent a higher level of non-adherence. A score of 11 is classified as "adhered," and a score above 11 indicates "non-adhered." An interviewer-administered structured questionnaire will be used to collect adherence to TB treatment.
Tuberculosis treatment cure rate
Time frame: After six months of tuberculosis treatment
The cure rate is the percentage of bacteriologically confirmed TB patients at the beginning of treatment who completed treatment as recommended by the Ethiopian guideline for Clinical and Programmatic Management of TB and Leprosy and were smear- or culture-negative in the 5th month of treatment and on at least one previous occasion. This will be computed by dividing the number of TB patients declared cured by the total number of bacteriologically confirmed pulmonary TB patients during the six months of treatment follow-up. The date will be collected from the facility-based TB registration logbook and laboratory registers.
Tuberculosis treatment completion rate
Time frame: After six months of tuberculosis treatment follow-up.
Treatment completion rate is the percentage of TB patients who completed treatment without evidence of failure but with no record to show that sputum or culture results in the 5th month of treatment were negative, either because tests were not done or because results are unavailable. This will be computed by dividing the number of TB patients who complete TB treatment by the total TB patients registered during the six months of treatment follow-up. Both the TB registration logbook at the TB clinic and the laboratory registers will be used to collect the data.
Tuberculosis Treatment Success rate
Time frame: At the six-month tuberculosis treatment
Treatment success rate: the percentage of TB patients who were declared cured and completed TB treatment during the six months of treatment follow-up. This will be calculated by dividing the sum of patients who were declared as cured and complete by the total number of TB patients registered during the six months of TB treatment follow-up. The date will be collected from the facility-based TB registration logbook and laboratory registers.
Loss to follow-up rate
Time frame: After the six months of tuberculosis treatment follow-up
Loss to follow-up rate: the percentage of tuberculosis patients whose treatment was interrupted for eight or more consecutive weeks after getting registered at a TB treatment center or who did not start anti-tuberculosis treatment for eight or more consecutive weeks. This will be calculated by dividing the number of tuberculosis patients lost to follow-up by the total number of tuberculosis patients registered during the six months of tuberculosis treatment follow-up. The date will be collected from the facility-based tuberculosis registration logbook and laboratory registers.
Percenatge of acceptability of the intervention
Time frame: This will be measured after three months of the intervention.
The acceptability of the intervention will be determined using a standardized questionnaire based on the acceptability theoretical framework. The tool comprises eight constructs and will be assessed on a 5-point Likert scale, with a total score ranging from 8 to 40. The overall mean score will be used to determine the acceptable level. Patients who score higher than the mean accept the intervention, whereas those who score lower do not. The investigator will determine the percentage of subjects who accepted and did not accept the intervention. Additionally, the investigator will assess the acceptability of the intervention using in-depth interviews and group discussion guides based on the acceptability theoretical framework.
Feasibility of the intervention
Time frame: Feasibility of the intervention will be evaluated after the three months of the intervention.
Feasibility of the intervention will be assessed qualitatively using an in-depth interview guide adopted from the construct of Bowen et al feasibility theoretical framework.
3 secondary outcomes
Weight of participants
Time frame: Weight will be measured at initiation and the 3rd and 6th months of tuberculosis treatment.
Height of participants
Time frame: Height will be measured at initiation and at the 3rd and 6th months of TB treatment.
Body mass index of participants
Time frame: The investigator will compute the body mass index at the initiation and 3rd and 6th months of tuberculosis treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. To keep the confidentiality of participants individual participant identification is not planned to share with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Degu J Dare, MD, PhD study chair
KNCV Tuberculosis Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEART-TB in people with Tuberculosis, run by Arba Minch University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB case detection (time frame: The case detection rate will be measured after six months of intevention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.