Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion

Crowder, Rebecca; Kityamuwesi, Alex; Kiwanuka, Noah; Lamunu, Maureen; Namale, Catherine; Tinka, Lynn Kunihira; Nakate, Agnes Sanyu; Ggita, Joseph; Turimumahoro, Patricia; Babirye, Diana; Oyuku, Denis; Berger, Christopher; Tucker, Austin; Patel, Devika; Sammann, Amanda; Dowdy, David W.; Turyahabwe, Stavia; Cattamanchi, Adithya; Katamba, Achilles

doi:10.1136/bmjopen-2020-039895

Cited by 12 publications

(28 citation statements)

References 19 publications

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“…Power and sample size. With 18 clusters (health facilities), an anticipated harmonic mean of 15 eligible patients per month at each health facility, 6 steps (3 health facilities randomized to the intervention each month), and a type 1 error (alpha) of 0.05, the trial had 89% power to detect a 10% increase in the treatment success proportion, comparing the intervention relative to the control period [8]. The power calculation assumed a pre-implementation treatment success rate of 51% and an intraclass correlation coefficient of 0.001 (both determined using 2017 Uganda NTLP data from participating health facilities).…”

Section: Methodsmentioning

confidence: 99%

“…A waiver of informed consent was granted to access patient demographic and clinical information recorded in TB treatment registers. The trial protocol has been published previously [ 8 ], and copies of the trial protocol, statistical analysis plan, and CONSORT checklist are available as S1 Trial Protocol , S1 Statistical Analysis Plan , and S1 CONSORT Checklist , respectively.…”

Section: Methodsmentioning

confidence: 99%

“…The stepped-wedge design increased acceptability among the participating health facilities and feasibility of training sites on the intervention. 99DOTS implementation AU : Pleasecheckthattheeditstothesentence99DOTimplementatio and health economic outcomes are described in the trial protocol [8]; implementation and health economic outcomes will be reported later. Previous publications have described the trial protocol [8], baseline TB treatment outcomes at the trial sites [9], and the human-centered design process used to adapt the 99DOTS platform to better meet the needs of patients and health workers [10,11].…”

Section: Plos Medicinementioning

confidence: 99%

“…The randomization AU : PleasecheckthattheeditstothesentenceTherandomization:::captureyourmeaning process was carried out at a ceremony attended by stakeholders from all participating health facilities in which facility representatives participated in the randomization by pulling labeled balls out of a bag, determining their allocation [8]. Blinding of the intervention time period to health facility staff and patients was not feasible as they were the targets of the intervention.…”

Section: Randomization and Maskingmentioning

confidence: 99%

“…Each row corresponds to a patient. The dataset includes 13 columns: intervention group-randomization block (1)(2)(3)(4)(5)(6); health facility-health facility where the patient initiated treatment (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18); health center-type of facility (health center, hospital); trial month-month during which the patient initiated treatment (0-7); study period (control, buffer, intervention); sex; age; HIV status; disease class (bacteriologically confirmed pulmonary TB, clinically diagnosed pulmonary TB); retreatment -patient type (new, retreatment); treated successfully-primary outcome; persisting on treatment-secondary outcome; not lost to follow-up-secondary outcome.…”

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confidence: 99%

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Digital adherence technology for tuberculosis treatment supervision: A stepped-wedge cluster-randomized trial in Uganda

Cattamanchi

Crowder

Kityamuwesi³

et al. 2021

PLoS Med

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Background 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).

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%