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. 2021 Jun 16;10(6):e24510.
doi: 10.2196/24510.

Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study

Elizabeth J Ragan  1 , Christopher J Gill  2 , Matthew Banos  2 , Tara C Bouton  1 , Jennifer Rooney  1 , Charles R Horsburgh  1   2   3 , Robin M Warren  4 , Bronwyn Myers  5   6 , Karen R Jacobson  1
Affiliations

Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study

Elizabeth J Ragan et al. JMIR Res Protoc. .

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.

Keywords: directly observed therapy; medication adherence; mobile applications; treatment adherence and compliance; tuberculosis.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Flow diagram of data collection app for directly observed therapy days (Monday through Friday). Small dashed lines denote pathways to observed therapy. Large dashed lines denote pathways to self-reported therapy. Dotted lines denote pathways to a missed dose classification.
See this image and copyright information in PMC

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