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Published on: May 19, 2020
Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a
Elizabeth J Ragan1, Christopher J Gill2, Matthew Banos2
1Section of Infectious Diseases, Boston Medical Center, Boston, MA, United States.
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.
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