TY  - JOUR
AU  - Ragan, Elizabeth J
AU  - Gill, Christopher J
AU  - Banos, Matthew
AU  - Bouton, Tara C
AU  - Rooney, Jennifer
AU  - Horsburgh, Charles R
AU  - Warren, Robin M
AU  - Myers, Bronwyn
AU  - Jacobson, Karen R
PY  - 2021
DA  - 2021/6/16
TI  - Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study
JO  - JMIR Res Protoc
SP  - e24510
VL  - 10
IS  - 6
KW  - tuberculosis
KW  - directly observed therapy
KW  - treatment adherence and compliance
KW  - medication adherence
KW  - mobile applications
AB  - 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 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2021/6/e24510
UR  - https://doi.org/10.2196/24510
UR  - http://www.ncbi.nlm.nih.gov/pubmed/34132642
DO  - 10.2196/24510
ID  - info:doi/10.2196/24510
ER  -