Data for: "Cluster-randomised trial of digital adherence technology interventions to reduce poor end-of-treatment outcomes and recurrence among adults with drug-sensitive tuberculosis in Ethiopia"
The data are from a pragmatic cluster-randomised trial in Ethiopia. Seventy-eight health facilities (clusters) were randomised to three arms (1:1:1): smart pillbox, medication labels, or standard of care. Adults (≥18 years) with drug-sensitive pulmonary tuberculosis on a fixed-dose combination tuberculosis treatment regimen were enrolled and followed-up for 12 months after treatment initiation. Those in the pillbox arm received a pillbox with customisable audio-visual reminders, while participants in the label arm received their TB medication with a weekly unique code label. Opening the box or texting the code prompted real-time dose logging on the adherence platform, facilitating differentiated response to individual’s adherence by a healthcare worker. The primary outcome comprised death, loss to follow-up, treatment failure, switch to drug-resistant tuberculosis treatment, or recurrence; secondary outcomes included loss to follow-up. Analysis accounted for clustered design with multiple imputation for the primary outcome. The trial is registered with PACTR202008776694999.
Additional Information
Data access is embargoed until 1 October 2025.
Keywords
tuberculosis treatment, Adherence, digital health, digital adherence technologyItem Type | Dataset |
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Capture method | Interview: Face-to-face, Interview: Telephone-delivery, Lab observation: Participant, Computer-based observation, Other |
Date | 10 June 2024 |
Language(s) of written materials | English |
Creator(s) |
Fielding, K |
LSHTM Faculty/Department | Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology & International Health (2023-) |
Research Centre |
International Statistics and Epidemiology Group TB Centre |
Participating Institutions | London School of Hygiene & Tropical Medicine, London, United Kingdom, KNCV Tuberculosis Plus, Ethiopia, KNCV Tuberculosis Plus, The Hague, Netherlands, Aurum Institute, Johannesburg, South Africa, National Tuberculosis Control Program, Ethiopian Ministry of Health, Addis Ababa, Ethiopia |
Funders |
Project Funder Grant Number Funder URI Adherence Support Coalition to End TB: evaluation of digital adherence technologies for TB treatment in Ethiopia 2019–33-ASCENT https://unitaid.org/ |
Date Deposited | 23 Jun 2025 09:24 |
Last Modified | 23 Jun 2025 09:25 |
Publisher | London School of Hygiene & Tropical Medicine |
Explore Further
- Cluster-randomized trial of digital adherence technologies and differentiated care to reduce poor end-of-treatment outcomes and recurrence among adults with drug-sensitive pulmonary TB in Ethiopia (Paper)
- Pan African Clinical Trials Registry (Other)
- Equity, cost and disability adjusted life years (DALYs) of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis (Paper)
- 10.17037/DATA.00004639 (DOI)
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subject - Data
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lock - Restricted to Request access for all
- Data Sharing Agreement
- Available under Data Sharing Agreement
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info - ASCENT Ethiopia CRT data
description - text/plain
- folder_info
- 105B
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subject - Documentation
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- Available under Creative Commons: Attribution 4.0
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info - Codebook for ASCENT Ethiopia CRT data
html - text/html
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