Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Oct 5, 2023
Date Accepted: May 8, 2024
Tuberculosis Treatment Compliance under Smartphone-based Video-observed Therapy versus Community-based Directly Observed Therapy: A Cluster Randomized Controlled Trial
ABSTRACT
Background:
There are no recent studies comparing the compliance rates of both patients and observers in tuberculosis (TB) treatment between the video observed therapy (VOT) and directly observed therapy (DOT) programs.
Objective:
We aimed to compare the average number of days that patients with pulmonary tuberculosis (TB) and their observers were compliant under VOT and DOT.
Methods:
Patient and observer compliance with TB treatment between VOT and DOT programs were compared as the average number of VOT and DOT compliance days and sputum-conversion rate in a 60-day cluster randomized controlled trial with pulmonary TB patients (VOT=63, DOT=65) with positive sputum acid-fast bacilli smears and 38 observers, equally randomized into the VOT and DOT groups (each, n=1–5 patients). The VOT group submitted videos to observers via smartphones; the DOT group followed standard procedures. An intention-to-treat analysis assessed compliance of both patients and observers.
Results:
The VOT group had higher average compliance than the DOT group (patients, mean difference [95% confidence interval, CI]: 15.2 [4.8–25.6] days; observers: 21.2 [13.5–28.9] days). The sputum-conversion rates in the VOT and DOT groups were 73.0% and 61.5%, respectively (P=0.167).
Conclusions:
Smartphone-based VOT significantly outperformed community-based DOT in ensuring compliance with TB treatment among observers. However, the study was underpowered to confirm improved compliance among patients with pulmonary TB and to detect differences in sputum conversion rates. Clinical Trial: thaiclinicaltrials.org TCTR20210624002; https://www.thaiclinicaltrials.org/show/TCTR20210624002
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