Digital Health Intervention to Improve TPT Uptake

NCT ID: NCT07313995

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-06-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Digital health intervention

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

Group Type: EXPERIMENTAL

Digital health intervention

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital health intervention

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.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arba Minch University

OTHER

Sponsor Role: lead

Responsible Party

Gistane Ayele

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Gistane Ayele

Role: CONTACT

ayelegistane@yahoo.com

_251925347903

References

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.

Reference Type: BACKGROUND

PMID: 40278775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36425906 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29767733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37164625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36405995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30939169 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26112265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19394122 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

IRB/23333/2025

Identifier Type: -

Identifier Source: org_study_id