Measuring adherence to TB medication in observational research: a DOT program designed for a prospective cohort study (Preprint)

UNSTRUCTURED A major challenge for prospective, clinical tuberculosis (TB) research is accurately defining a metric for measuring medication adherence. We present the design and methodology of a mobile health (mHealth)-based directly observed therapy (DOT) program developed for the purpose of measuring anti-TB medication adherence for a prospective TB cohort in Western Cape Province, South Africa. DOT workers collect daily adherence data on mobile smartphones. Both participant-level adherence as well as program-level adherence and program function are systematically and regularly monitored to assess implementation of the DOT program. A data dashboard allows for regular visualization of indicators. Numerous mechanisms were designed to prevent or limit data falsification and ensure study data integrity. This approach can be adapted in other settings to improve the capture of anti-TB medication adherence outside of a hospitalized setting.