Opportunities to improve digital adherence technologies and TB care using human-centered design

Berger, Christopher; Patel, Devika; Kityamuwesi, Alex; Ggita, Joseph; Tinka, Lynn Kunihira; Turimumahoro, Patricia; Neville, Kathleen; Chehab, Lara; Chen, A Z; Gupta, Nakull; Turyahabwe, Stavia; Katamba, Achilles; Cattamanchi, Adithya; Sammann, Amanda

doi:10.5588/ijtld.20.0184

Cited by 8 publications

(9 citation statements)

References 6 publications

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“…During the intervention period, the decision to offer and accept 99DOTS-based supervision was left to treating providers and patients, respectively. The standard 99DOTS platform was adapted using human-centered design methods in collaboration with local stakeholders and end-users prior to the start of the trial, with further adaptation of the envelope design during the first 2 months of the trial ( S3 Fig ) [ 10 , 11 ]. If enrolled on 99DOTS, patients were given TB medication blister packs placed inside the adapted 99DOTS envelope, received daily automated SMS dosing reminders, and were asked to confirm dosing by making daily toll-free phone calls to the 99DOTS system.…”

Section: Methodsmentioning

confidence: 99%

“…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%

“…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: Plos Medicinementioning

confidence: 99%

mentioning

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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“…( 5) A minority of people with TB expressed similar concerns in our study, and the overall high scores across COM-B categories among people with TB may in part be due to our extensive customization of the 99DOTS platform using human centered design methods. (9,10) We did not find evidence that 99DOTS weakens the relationship between people with TB and health workers; all people with TB agreed that 99DOTS helps them feel more connected to their health workers, with 82% strongly agreeing. Key strengths of our study include that it was nested within a highly pragmatic trial making interpretation of its findings more broadly applicable to people with TB in Uganda and sub-Saharan Africa.…”

Section: S2 Figure)mentioning

confidence: 76%

Implementation, feasibility, and acceptability of 99DOTS-based supervision of treatment for drug-susceptible TB in Uganda

Kiwanuka

Kityamuwesi

Crowder

et al. 2022

Preprint

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99DOTS is a low-cost digital adherence technology that allows people with tuberculosis (TB) to self-report treatment adherence. There are limited data on its implementation, feasibility, and acceptability from sub-Saharan Africa. We conducted a longitudinal analysis and cross-sectional surveys nested within a stepped-wedge randomized trial at 18 health facilities in Uganda between December 2018 and January 2020. The longitudinal analysis assessed implementation of key components of a 99DOTS-based intervention, including self-reporting of TB medication adherence via toll-free phone calls, automated text message reminders and support actions by health workers monitoring adherence data. Cross-sectional surveys administered to a subset of people with TB and health workers assessed 99DOTS feasibility and acceptability. Composite scores for capability, opportunity, and motivation to use 99DOTS were estimated as mean Likert scale responses. Among 462 people with pulmonary TB enrolled on 99DOTS, median adherence was 58.4% (inter-quartile range [IQR] 38.7-75.6) as confirmed by self-reporting dosing via phone calls and 99.4% (IQR 96.4-100) when also including doses confirmed by health workers. Phone call-confirmed adherence declined over the treatment period and was lower among people with HIV (median 50.6% vs. 63.7%, p<0.001). People with TB received SMS dosing reminders on 90.5% of treatment days. Health worker support actions were documented for 261/409 (63.8%) people with TB who missed >3 consecutive doses. Surveys were completed by 83 people with TB and 22 health workers. Composite scores for capability, opportunity, and motivation were high; among people with TB, composite scores did not differ by gender or HIV status. Barriers to using 99DOTS included technical issues (phone access, charging, and network connection) and concerns regarding disclosure. 99DOTS was feasible to implement and highly acceptable to people with TB and their health workers. National TB Programs should offer 99DOTS as an option for TB treatment supervision.

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“…A systematic review in 2022 of 16 RCTs evaluating DATs, including 10 that assessed impact on treatment completion, found that 4/10 reported a positive impact on treatment completion, 1/10 reported a significantly negative impact, and 5/10 reported no significant impact on treatment completion (14). The version of 99DOTS implemented in this study was enhanced using human-centered design methods, which offer benefits over SMS or phone reminders alone (15, 16). Despite these improvements and further refinement from the previous version of 99DOTS implemented in Uganda (9), our study found that treatment success rates were similar before and after the implementation of enhanced 99DOTS and remained below the WHO target of 90%.…”

Section: Discussionmentioning

confidence: 99%

Implementation of enhanced 99DOTS for TB treatment supervision in Uganda: An interrupted time series analysis

Crowder,

Nakasendwa,

Kityamuwesi

et al. 2024

Preprint

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Rationale: Digital adherence technologies are being scaled-up for tuberculosis treatment despite limited evidence of their effectiveness and concerns about accessibility. Objectives: To determine whether an enhanced 99DOTS-based treatment supervision improves uptake of 99DOTS and tuberculosis treatment outcomes. Methods: We included all adults initiated on treatment for drug-suceptible pulmonary tuberculosis between August 2019 and June 2021 at 18 99DOTS-experienced health (n=6,382) facilities and 12 99DOTS-naive health facilities (n=4,253) in Uganda. Using an interrupted time series design, we compared the proportions with treatment success (primary outcome) and enrolled on 99DOTS in the 9 months before and the 12 months after implementing an 'enhanced 99DOTS' intervention that included components to increase uptake (providing low-cost phones to people with TB when needed) and enhance treatment monitoring and support (task shifting to community health workers and automated task lists). Data on treatment initiation and outcomes were derived from routine TB treatment registers. Measurements and Main Results: At 99DOTS-experienced facilities, the proportion enrolled on 99DOTS increased from 49.2% to 86.4%. The proportion completing treatment remained similar across periods (78.3% vs. 78.6%). There was no immediate level change in treatment success following the intervention but there was a significant change in monthly slope (proportion ratio 1.01, 95% CI 1.00-1.02), reflecting an improved treatment success trend following the intervention. Results were similar at 99DOTS-naive facilities, except there was no significant change in treatment success slope. Conclusions: Enhanced 99DOTS had high uptake and did not negatively affect treatment outcomes. Equity in access should be prioritized during implementation.

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Opportunities to improve digital adherence technologies and TB care using human-centered design

Cited by 8 publications

References 6 publications

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

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

Implementation, feasibility, and acceptability of 99DOTS-based supervision of treatment for drug-susceptible TB in Uganda

Implementation of enhanced 99DOTS for TB treatment supervision in Uganda: An interrupted time series analysis

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