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 |
---|---|
Resource Type |
Resource Type Resource Description Dataset Quantitative |
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
- Evaluation of implementation and effectiveness of digital adherence technology with differentiated care to support tuberculosis treatment adherence and improve treatment outcomes in Ethiopia: a study protocol for a cluster randomised trial.
- Modelling the epidemiological and economic impact of digital adherence technologies with differentiated care for tuberculosis treatment in Ethiopia
- 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)
Data / Code
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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
Documentation
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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
- folder_info
- 16kB