Digital adherence technology for tuberculosis treatment supervision: a stepped-wedge cluster randomized trial
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Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
PLoS medicine
Abstract
Adherence to and completion of tuberculosis (TB) treatment remain problematic in many
high-burden countries. 99DOTS is a low-cost digital adherence technology that could
increase TB treatment completion.
Methods and findings
We conducted a pragmatic stepped-wedge cluster-randomized trial including all adults
treated for drug-susceptible pulmonary TB at 18 health facilities across Uganda over 8
months (1 December 2018–31 July 2019). Facilities were randomized to switch from routine
(control period) to 99DOTS-based (intervention period) TB treatment supervision in consecutive
months. Patients were allocated to the control or intervention period based on which
facility they attended and their treatment start date. AU : IchangedPatientswereallocatedtothecontrolorinterventionperiodbasedontheirtreatmentstartdatetoPatientswereallocatedtothecontroloHealth facility staff and patients were not blinded to the intervention. The primary outcome was TB treatment completion. Due to the
pragmatic nature of the trial, the primary analysis was done according to intention-to-treat
(ITT) and per protocol (PP) principles. This trial is registered with the Pan African Clinical Trials
Registry (PACTR201808609844917). Of 1,913 eligible patients at the 18 health facilities
(1,022 and 891 during the control and intervention periods, respectively), 38.0% were
women, mean (SD) age was 39.4 (14.4) years, 46.8% were HIV-infected, and most (91.4%)
had newly diagnosed TB. In total, 463 (52.0%) patients were enrolled on 99DOTS during the intervention period. In the ITT analysis, the odds of treatment success were similar in
the intervention and control periods (adjusted odds ratio [aOR] 1.04, 95% CI 0.68–1.58, p =
0.87). The odds of treatment success did not increase in the intervention period for either
men (aOR 1.24, 95% CI 0.73–2.10) or women (aOR 0.67, 95% CI 0.35–1.29), or for either
patients with HIV infection (aOR 1.51, 95% CI 0.81–2.85) or without HIV infection (aOR
0.78, 95% CI 0.46–1.32). In the PP analysis, the 99DOTS-based intervention increased the
odds of treatment success (aOR 2.89, 95% CI 1.57–5.33, p = 0.001). The odds of completing
the intensive phase of treatment and the odds of not being lost to follow-up were similarly
improved in PP but not ITT analyses. Study limitations include the likelihood of selection
bias in the PP analysis, inability to verify medication dosing in either arm, and incomplete
implementation of some components of the intervention.
Conclusions
99DOTS-based treatment supervision did not improve treatment outcomes in the overall
study population. However, similar treatment outcomes were achieved during the control
and intervention periods, and those patients enrolled on 99DOTS achieved high treatment
completion. 99DOTS-based treatment supervision could be a viable alternative to directly
observed therapy for a substantial proportion of patients with TB.
Description
Keywords
Digital adherence, Technology, Tuberculosis treatment, Stepped-wedge cluster-randomized trial
Citation
Cattamanchi A, Crowder R, Kityamuwesi A, Kiwanuka N, Lamunu M, Namale C, et al. (2021) Digital adherence technology for tuberculosis treatment supervision: A stepped-wedge clusterrandomized trial in Uganda. PLoS Med 18(5): e1003628. https://doi.org/10.1371/journal. pmed.1003628