Digital Health Intervention to Improve TPT Uptake

Official title

Digital Health Intervention in Improving Preventive Treatment Initiation and Completion Among Close Contacts of Tuberculosis Patients in South Ethiopia

Overview

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. The 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.

Interventions

• Behavioral Digital health intervention
  The treatment arm will provide a digital health intervention (video-based health education) in addition to standard care. Video-based education will be provided for 5-7 minutes every week for three weeks.

Primary outcome measures

• TB preventive therapy initiation [Time frame: It will be up to 3 months.]
• TB preventive therapy completion [Time frame: It will be up to 4 months.]

Secondary outcome measures (2)

• Contact investigations [Time frame: 12 weeks.]
• TB prevalence [Time frame: within 4 months]

Eligibility criteria

Inclusion criteria

• All household and close contacts of drug-sensitive pulmonary TB patients
• Living in the catchment area of the selected health facility
• Willing to stay for at least 4 months in the catchment area

Exclusion criteria

• Individuals with a known allergy to TPT drugs or those contraindicated for TPT drugs
• Close contacts screened as symptomatic for TB
• Close contacts with drug-resistant TB
• Temporary residents staying for less than 4 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Ethiopia · 2 centers

• Arba Minch General Hospital and Dilfana Primary Hospital — Arba Minch
• Sawula General Hospital and Sawula Health Center — Sawula, Goffa Zone

Publications

• 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 40278775
• 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 36425906
• 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 29767733
• 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 37164625
• 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 36405995
• 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 30939169
• Neiderud CJ. How urbanization affects the epidemiology of emerging infectious diseases. Infect Ecol Epidemiol. 2015 Jun 24;5(1):27060. doi: 10.3402/iee.v5.27060. eCollection 2015. PMID 26112265
• 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. PMID 19394122

Identifiers

NCT: NCT07313995 · IRB/23333/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗