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Data · dataset · 2024

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"

Listed in LSHTM Data Compass

The data are from a pragmatic cluster-randomised trial in Ethiopia.

Description

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.

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Analysis accounted for clustered design with multiple imputation for the primary outcome. The trial is registered with PACTR202008776694999.

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Provenance · 1 source records, 11 field assertions
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