@Article{info:doi/10.2196/24510,
author="Ragan, Elizabeth J
and Gill, Christopher J
and Banos, Matthew
and Bouton, Tara C
and Rooney, Jennifer
and Horsburgh, Charles R
and Warren, Robin M
and Myers, Bronwyn
and Jacobson, Karen R",
title="Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study",
journal="JMIR Res Protoc",
year="2021",
month="Jun",
day="16",
volume="10",
number="6",
pages="e24510",
keywords="tuberculosis; directly observed therapy; treatment adherence and compliance; medication adherence; mobile applications",
abstract="Background: A major challenge for prospective, clinical tuberculosis (TB) research is accurately defining a metric for measuring medication adherence. Objective: We aimed to design a method to capture directly observed therapy (DOT) via mobile health carried out by community workers. The program was created specifically to measure TB medication adherence for a prospective TB cohort in Western Cape Province, South Africa. Methods: Community workers collect daily adherence data on mobile smartphones. Participant-level adherence, program-level adherence, and program function are systematically monitored to assess DOT program implementation. A data dashboard allows for regular visualization of indicators. Numerous design elements aim to prevent or limit data falsification and ensure study data integrity. Results: The cohort study is ongoing and data collection is in progress. Enrollment began on May 16, 2017, and as of January 12, 2021, a total of 236 participants were enrolled. Adherence data will be used to analyze the study's primary aims and to investigate adherence as a primary outcome. Conclusions: The DOT program includes a mobile health application for data collection as well as a monitoring framework and dashboard. This approach has potential to be adapted for other settings to improve the capture of medication adherence in clinical TB research. Trial Registration: Clinicaltrials.gov NCT02840877; https://clinicaltrials.gov/ct2/show/NCT02840877 ",
issn="1929-0748",
doi="10.2196/24510",
url="https://www.researchprotocols.org/2021/6/e24510",
url="https://doi.org/10.2196/24510",
url="http://www.ncbi.nlm.nih.gov/pubmed/34132642"
}