Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:19 AM
Study NCT ID:
NCT07313995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Health Intervention to Improve TPT Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment: digital health intervention Control: standard care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TB preventive therapy initiation', 'timeFrame': 'It will be up to 3 months.', 'description': 'The primary outcome of this study will be the number of close contacts to index TB patients who initiated TPT (mean change of TPT initiation from the baseline)'}, {'measure': 'TB preventive therapy completion', 'timeFrame': 'It will be up to 4 months.', 'description': 'The second primary outcome of this study will be the number of close contacts to index TB patients who completed TPT (the mean change of TPT completion in relation to baseline data)'}], 'secondaryOutcomes': [{'measure': 'Contact investigations', 'timeFrame': '12 weeks.', 'description': 'Close contacts of index drug-sensitive pulmonary TB patients who were identified and screened for TB (the mean change of contact investigation in relation to baseline data)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Health', 'TB preventive therapy', 'TPT initiation'], 'conditions': ['Tuberculosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '40278775', 'type': 'BACKGROUND', 'citation': 'Abelti E, Dememew Z, Gebreyohannes A, Alemayehu Y, Terfassa T, Janfa T, Jerene D, Suarez P, Datiko D. Community-Based Tuberculosis Preventive Treatment Among Child and Adolescent Household Contacts in Ethiopia. Trop Med Infect Dis. 2025 Apr 9;10(4):102. doi: 10.3390/tropicalmed10040102.'}, {'pmid': '36425906', 'type': 'BACKGROUND', 'citation': 'Seid G, Alemu A, Dagne B, Sinshaw W, Gumi B. Tuberculosis in household contacts of tuberculosis patients in sub-Saharan African countries: A systematic review and meta-analysis. J Clin Tuberc Other Mycobact Dis. 2022 Nov 12;29:100337. doi: 10.1016/j.jctube.2022.100337. eCollection 2022 Dec.'}, {'pmid': '29767733', 'type': 'BACKGROUND', 'citation': 'Reichler MR, Khan A, Sterling TR, Zhao H, Moran J, McAuley J, Bessler P, Mangura B; Tuberculosis Epidemiologic Studies Consortium Task Order 2 Team. Risk and Timing of Tuberculosis Among Close Contacts of Persons with Infectious Tuberculosis. J Infect Dis. 2018 Aug 14;218(6):1000-1008. doi: 10.1093/infdis/jiy265.'}, {'pmid': '37164625', 'type': 'BACKGROUND', 'citation': 'Alene KA, Python A, Weiss DJ, Elagali A, Wagaw ZA, Kumsa A, Gething PW, Clements ACA. Mapping tuberculosis prevalence in Ethiopia using geospatial meta-analysis. Int J Epidemiol. 2023 Aug 2;52(4):1124-1136. doi: 10.1093/ije/dyad052.'}, {'pmid': '36405995', 'type': 'BACKGROUND', 'citation': 'Shegaze M, Boda B, Ayele G, Gebremeskel F, Tariku B, Gultie T. Why people die of active tuberculosis in the era of effective chemotherapy in Southern Ethiopia: A qualitative study. J Clin Tuberc Other Mycobact Dis. 2022 Nov 13;29:100338. doi: 10.1016/j.jctube.2022.100338. eCollection 2022 Dec.'}, {'pmid': '30939169', 'type': 'BACKGROUND', 'citation': 'Shimeles E, Enquselassie F, Aseffa A, Tilahun M, Mekonen A, Wondimagegn G, Hailu T. Risk factors for tuberculosis: A case-control study in Addis Ababa, Ethiopia. PLoS One. 2019 Apr 2;14(4):e0214235. doi: 10.1371/journal.pone.0214235. eCollection 2019.'}, {'pmid': '26112265', 'type': 'BACKGROUND', 'citation': 'Neiderud CJ. How urbanization affects the epidemiology of emerging infectious diseases. Infect Ecol Epidemiol. 2015 Jun 24;5:27060. doi: 10.3402/iee.v5.27060. eCollection 2015.'}, {'pmid': '19394122', 'type': 'BACKGROUND', 'citation': 'Lonnroth K, Jaramillo E, Williams BG, Dye C, Raviglione M. Drivers of tuberculosis epidemics: the role of risk factors and social determinants. Soc Sci Med. 2009 Jun;68(12):2240-6. doi: 10.1016/j.socscimed.2009.03.041. Epub 2009 Apr 23.'}, {'type': 'BACKGROUND', 'citation': 'WHO. Global tuberculosis report 2024 [Internet] Geneva:; 2024. Available from: https://iris.who.int/bitstream/handle/10665/379339/9789240101531-eng.pdf?sequence=1'}]}, 'descriptionModule': {'briefSummary': "Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population. Specifically, tuberculosis in children and newly diagnosed TB cases show there is current transmission of TB; to reduce this transmission and to attain the end TB strategy, preventing household TB transmission plays a great role. However, initiation and completion of TB preventive therapy (TPT) among close contacts of index TB patients are suboptimal. Some of the identified factors of low TPT initiation and completion are insufficient patient education, inadequate understanding of TPT, health professionals' perception, parental knowledge, and belief. The digital health intervention is currently being studied as a suggested health intervention that improves the utilization of health care services, including treatment adherence. A systematic review shows that TB treatment outcomes improved with the use of patient education, counseling, text reminders, and digital health technologies. However, other literature indicates controversial results, including our systematic review result, which identified that video directly observed therapy and text message (digital intervention) have no significant effect on TPT completion. In addition, the studies are scarce; therefore, this study aims to assess the effect of video-based education intervention combined with text message reminder (digital health intervention) in improving the initiation and completion of TPT among close contacts of drug-sensitive pulmonary TB patients in South Ethiopia.\n\nThe study hypothesizes that digital health intervention for close contacts of index drug-sensitive pulmonary TB patients will lead to higher TPT initiation and completion rates than standard care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All household and close contacts of drug-sensitive pulmonary TB patients\n* Living in the catchment area of the selected health facility\n* Willing to stay for at least 4 months in the catchment area\n\nExclusion Criteria:\n\n* Individuals with a known allergy to TPT drugs or those contraindicated for TPT drugs\n* Close contacts screened as symptomatic for TB\n* Close contacts with drug-resistant TB\n* Temporary residents staying for less than 4 months'}, 'identificationModule': {'nctId': 'NCT07313995', 'acronym': 'DHiTPT', 'briefTitle': 'Digital Health Intervention to Improve TPT Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Arba Minch University'}, 'officialTitle': 'Digital Health Intervention in Improving Preventive Treatment Initiation and Completion Among Close Contacts of Tuberculosis Patients in South Ethiopia', 'orgStudyIdInfo': {'id': 'IRB/23333/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital health intervention', 'description': 'In this arm, the participants will receive standard care and a digital health intervention that includes video-based health education and text reminders.', 'interventionNames': ['Behavioral: Digital health intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In this arm, the participants will receive standard care based on the national guidelines.'}], 'interventions': [{'name': 'Digital health intervention', 'type': 'BEHAVIORAL', 'description': 'The treatment arm will provide a digital health intervention (video-based health education combined with text messaging) in addition to standard care. Video-based education will be provided for 5-7 minutes every month for three months, and a text message will be sent for less than 1 minute every month for three months.', 'armGroupLabels': ['Digital health intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gistane Ayele', 'role': 'CONTACT', 'email': 'ayelegistane@yahoo.com', 'phone': '_251925347903'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arba Minch University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gistane Ayele', 'investigatorAffiliation': 'Arba Minch University'}}}}