%0 Journal Article
%@ 1929-0748
%I JMIR Publications
%V 10
%N 6
%P e24510
%T Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study
%A Ragan,Elizabeth J
%A Gill,Christopher J
%A Banos,Matthew
%A Bouton,Tara C
%A Rooney,Jennifer
%A Horsburgh,Charles R
%A Warren,Robin M
%A Myers,Bronwyn
%A Jacobson,Karen R
%+ Section of Infectious Diseases, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, United States, 1 617 414 5213, kjacobso@bu.edu
%K tuberculosis
%K directly observed therapy
%K treatment adherence and compliance
%K medication adherence
%K mobile applications
%D 2021
%7 16.6.2021
%9 Protocol
%J JMIR Res Protoc
%G English
%X 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 
%M 34132642
%R 10.2196/24510
%U https://www.researchprotocols.org/2021/6/e24510
%U https://doi.org/10.2196/24510
%U http://www.ncbi.nlm.nih.gov/pubmed/34132642