In:
PLOS Medicine, Public Library of Science (PLoS), Vol. 18, No. 5 ( 2021-5-6), p. e1003628-
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. Health 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. Trial registration Pan-African Clinical Trials Registry ( PACTR201808609844917 ).
Type of Medium:
Online Resource
ISSN:
1549-1676
DOI:
10.1371/journal.pmed.1003628
DOI:
10.1371/journal.pmed.1003628.g001
DOI:
10.1371/journal.pmed.1003628.g002
DOI:
10.1371/journal.pmed.1003628.g003
DOI:
10.1371/journal.pmed.1003628.t001
DOI:
10.1371/journal.pmed.1003628.t002
DOI:
10.1371/journal.pmed.1003628.s001
DOI:
10.1371/journal.pmed.1003628.s002
DOI:
10.1371/journal.pmed.1003628.s003
DOI:
10.1371/journal.pmed.1003628.s004
DOI:
10.1371/journal.pmed.1003628.s005
DOI:
10.1371/journal.pmed.1003628.s006
DOI:
10.1371/journal.pmed.1003628.s007
DOI:
10.1371/journal.pmed.1003628.s008
DOI:
10.1371/journal.pmed.1003628.s009
DOI:
10.1371/journal.pmed.1003628.s010
DOI:
10.1371/journal.pmed.1003628.s011
DOI:
10.1371/journal.pmed.1003628.s012
DOI:
10.1371/journal.pmed.1003628.r001
DOI:
10.1371/journal.pmed.1003628.r002
DOI:
10.1371/journal.pmed.1003628.r003
DOI:
10.1371/journal.pmed.1003628.r004
DOI:
10.1371/journal.pmed.1003628.r005
DOI:
10.1371/journal.pmed.1003628.r006
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2164823-2
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