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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TB case detection', 'timeFrame': 'The case detection rate will be measured after six months of intevention', 'description': '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.'}, {'measure': 'TB medication adherance', 'timeFrame': 'The data for adherence will be measured at the 2nd, 4th, and 6th months of TB treatment.', 'description': '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.'}, {'measure': 'Tuberculosis treatment cure rate', 'timeFrame': 'After six months of tuberculosis treatment', 'description': '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.'}, {'measure': 'Tuberculosis treatment completion rate', 'timeFrame': 'After six months of tuberculosis treatment follow-up.', 'description': '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.'}, {'measure': 'Tuberculosis Treatment Success rate', 'timeFrame': 'At the six-month tuberculosis treatment', 'description': '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.'}, {'measure': 'Loss to follow-up rate', 'timeFrame': 'After the six months of tuberculosis treatment follow-up', 'description': '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.'}, {'measure': 'Percenatge of acceptability of the intervention', 'timeFrame': 'This will be measured after three months of the intervention.', 'description': '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.'}, {'measure': 'Feasibility of the intervention', 'timeFrame': 'Feasibility of the intervention will be evaluated after the three months of the intervention.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Weight of participants', 'timeFrame': 'Weight will be measured at initiation and the 3rd and 6th months of tuberculosis treatment.', 'description': '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.'}, {'measure': 'Height of participants', 'timeFrame': 'Height will be measured at initiation and at the 3rd and 6th months of TB treatment.', 'description': '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.'}, {'measure': 'Body mass index of participants', 'timeFrame': 'The investigator will compute the body mass index at the initiation and 3rd and 6th months of tuberculosis treatment.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Digital health intervention', 'Medication adherence support intervention', 'Case detection', 'Ethiopia', 'Holistic intervention'], 'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe following intervention will be provided:\n\n* Structured training: Health extension and health care workers received training on special adherence counseling and active case detection.\n* Special adherence counseling: TB patients and their adherence supporters will receive special adherence counseling.\n* Medication adherence support: Adherence supporters, selected by TB patients who received special adherence counseling, will provide ongoing daily home-based TB medication adherence support.\n* Short message service (SMS): To reinforce daily TB medication intake, TB patients and their adherence supporters will receive daily short mobile message service.\n* Self-adherence support: In the absence of external adherence support, TB patients will monitor their adherence and come to drug refills every month.\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* All patients with pulmonary TB will be including in the study.\n* All health workers who are working in TB clinic for at least 1 year\n* All family member of pulmonary TB patient\n* Health facilities with TB diagnostic facility Exclusion criteria\n* Patients with comorbidities other than HIV\n* Patients planning to transfer to other facility\n* Severely ill, and /or mentally incapable of giving consent will be excluded.'}, 'identificationModule': {'nctId': 'NCT07440160', 'acronym': 'HEART-TB', 'briefTitle': 'Digitally Facilitated, Integrated Community and Facility-Based Interventions: The HEART-TB Trial Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Arba Minch University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MD23334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Holistic engagement on TB case detection, adherence reinforcement , and treatment', 'description': 'The following intervention will be provided:\n\n1. Structured training: Health extension and health care workers received training on special adherence counseling and active case detection.\n2. Special adherence counseling: TB patients and their adherence supporters will receive special adherence counseling.\n3. Medication adherence support: Adherence supporters, selected by TB patients who received special adherence counseling, will provide ongoing daily home-based TB medication adherence support.\n4. Short message service (SMS): To reinforce daily TB medication intake, TB patients and their adherence supporters will receive daily short mobile message service.\n5. 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.', 'interventionNames': ['Other: HEART-TB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients proceed with the standard care/ control group', 'description': '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.\n\nContinuation 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', 'interventionNames': ['Other: HEART-TB']}], 'interventions': [{'name': 'HEART-TB', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Holistic engagement on TB case detection, adherence reinforcement , and treatment', 'Patients proceed with the standard care/ control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4400', 'city': 'Arba Minch', 'state': 'South Ethiopia Region', 'country': 'Ethiopia', 'facility': 'Arba Minch University', 'geoPoint': {'lat': 6.03333, 'lon': 37.55}}], 'overallOfficials': [{'name': 'Degu J Dare, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'KNCV Tuberculosis Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To keep the confidentiality of participants individual participant identification is not planned to share with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arba Minch University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mulugeta Dalbo Datamo', 'investigatorAffiliation': 'Arba Minch University'}}}}