Digital Health Intervention to Improve TPT Uptake

NCT07313995 | Not Yet Recruiting

• 1 other identifier: IRB/23333/2025
• Study Type: interventional
• Target: 304
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tuberculosis, Pulmonary

Keywords

Digital Health; TB preventive therapy; TPT initiation

Outcome Measures

Primary Outcomes (2)

• TB preventive therapy initiation

  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)

  It will be up to 3 months.

• TB preventive therapy completion

  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)

  It will be up to 4 months.

Secondary Outcomes (1)

• Contact investigations

  12 weeks.

Study Arms (2)

Digital health intervention

EXPERIMENTAL

In this arm, the participants will receive standard care and a digital health intervention that includes video-based health education and text reminders.

Behavioral: Digital health intervention

Control

NO INTERVENTION

In this arm, the participants will receive standard care based on the national guidelines.

Interventions

Digital health intervention BEHAVIORAL

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.

Digital health intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arba Minch University: lead

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 26112265 BACKGROUND

• 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 BACKGROUND

• WHO. Global tuberculosis report 2024 [Internet] Geneva:; 2024. Available from: https://iris.who.int/bitstream/handle/10665/379339/9789240101531-eng.pdf?sequence=1

  BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Gistane Ayele

CONTACT

_251925347903; ayelegistane@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Treatment: digital health intervention Control: standard care

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 2, 2026
• Study Start: January 15, 2026
• Primary Completion: February 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12