Digital adherence technology for tuberculosis treatment supervision: a stepped-wedge cluster randomized trial

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dc.contributor.authorCattamanchi, Adithya
dc.contributor.authorCrowder, Rebecca
dc.contributor.authorKityamuwesi, Alex
dc.contributor.authorKiwanuka, Noah
dc.contributor.authorLamunu, Maureen
dc.contributor.authorNamale, Catherine
dc.contributor.authorKunihira Tinka, Lynn
dc.contributor.authorSanyu Nakate, Agnes
dc.contributor.authorGgita, Joseph
dc.contributor.authorTurimumahoro, Patricia
dc.contributor.authorBabirye2, Diana
dc.contributor.authorOyuku, Denis
dc.contributor.authorBerger, Christopher
dc.contributor.authorTucker, Austin
dc.contributor.authorPatel, Devika
dc.contributor.authorSammann, Amanda
dc.contributor.authorStavia, Turyahabwe
dc.contributor.authorDowdy, David
dc.contributor.authorKatamba, Achilles
dc.date.accessioned2023-01-18T15:19:08Z
dc.date.available2023-01-18T15:19:08Z
dc.date.issued2021
dc.description.abstractAdherence 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.en_US
dc.identifier.citationCattamanchi 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.1003628en_US
dc.identifier.urihttps://doi.org/10.1371/journal. pmed.1003628
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/7021
dc.language.isoenen_US
dc.publisherPLoS medicineen_US
dc.subjectDigital adherenceen_US
dc.subjectTechnologyen_US
dc.subjectTuberculosis treatmenten_US
dc.subjectStepped-wedge cluster-randomized trialen_US
dc.titleDigital adherence technology for tuberculosis treatment supervision: a stepped-wedge cluster randomized trialen_US
dc.typeArticleen_US
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