Tuberculosis, PulmonaryDHiTPTNCT07313995
Digital Health Intervention to Improve TPT Uptake
A study testing Digital health intervention in people with Tuberculosis, Pulmonary, run by Arba Minch University at 14 sites in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Digital health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 14 sitesEthiopia
- Study dates
- 22 May 2026to 22 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Ethiopia14 sites, 8 recruiting
- Completed
Arba Minch General Hospital and Dilfana Primary Hospital
Arba Minch, South Ethiopia, 0021
- Completed
Chano Health center
Arba Minch, South Ethiopia, 0021
- Completed
Gerese Primary Hospital
Arba Minch, South Ethiopia, 0021
- Completed
Shelle Health center
Arba Minch, South Ethiopia, 0021
- Completed
Birbir Primary Hospital
Birbir, South Ethiopia, 0021
- Recruiting
Chencha Generl Hospital
Chencha, South Ethiopia, 0021
Ermias Desalegn, BSC, +25126570327, ayelegistane@yahoo.com
- Recruiting
Zadha Health center
Chencha, South Ethiopia, 0021
Abebech Asseffa, +251916880288, ayelegistane@yahoo.com
- Recruiting
Bulki Health center
Felege Neway, South Ethiopia, 0021
Solomon Nigussie, +251968463804, ayelegistane@yahoo.com
- Recruiting
Dombe Health center
Felege Neway, South Ethiopia, 0021
Mekdes Lencha, +251969340002, ayelegistane@yahoo.com
- Recruiting
Galma Health center
Felege Neway, South Ethiopia, 0021
Kalose Kama, +251910081405, ayelegistane@yahoo.com
- Recruiting
Lotte Health center
Felege Neway, South Ethiopia, 0021
Abebe Gelaye, +251938987922, ayelegistane@yahoo.com
- Recruiting
Shefite Health center
Felege Neway, South Ethiopia, 0021
Andinet Andu, +251993585052, ayelegistane@yahoo.com
- Recruiting
Sawla General Hospital and Sawla Health Center
Felege Neway, South Ethiopia
Tinsae E Tinsu, MSC, 0967981826, tinsae@gmail.com
ayelegistane@yahoo.com
- Completed
Laha Primary Hospital
Laha, South Ethiopia, 0021
About this study
Official title: Digital Health Intervention in Improving Preventive Treatment Initiation and Completion Among Close Contacts of Tuberculosis Patients in South Ethiopia
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
- Being tested
- Digital health intervention
- Keywords
- Digital Health, TB preventive therapy, TPT initiation
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital health intervention | Experimental | In this arm, the participants will receive standard care and a digital health intervention, which is video-based health education through a mobile phone. Receives: Behavioral: Digital health intervention |
| Control | No intervention | In this arm, the participants will receive standard of care based on the national TB and TB/HIV guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: It will be up to 4 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)
Measured: It will be up to 4 months.
Secondary outcomes (2)
Contact investigations
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)
Measured: 16 weeks.
TB prevalence
Assess TB prevalence among household/close contacts during the study period.
Measured: within 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start22 May 2026
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment: digital health intervention Control: standard care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arba Minch University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gistane Ayele, Arba Minch University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313995
- Sponsor's protocol ID
- IRB/23333/2025
- Acronym
- DHiTPT
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided
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.
PubMed 40278775Seid 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.
PubMed 36425906Reichler 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.
PubMed 29767733Alene 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.
PubMed 37164625Shegaze 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.
PubMed 36405995Shimeles 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.
PubMed 30939169Neiderud 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.
PubMed 26112265Lonnroth 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.
PubMed 19394122WHO. Global tuberculosis report 2024 [Internet] Geneva:; 2024. Available from: https://iris.who.int/bitstream/handle/10665/379339/9789240101531-eng.pdf?sequence=1