Cluster-randomized trial of digital adherence technologies and differentiated care to reduce poor end-of-treatment outcomes and recurrence among adults with drug-sensitive pulmonary TB in Ethiopia

Tadesse, Amare W; Sahile, Mamush; Foster, Nicola; McQuaid, Christopher Finn; Weldemichael, Gedion Teferra; Abdurhman, Tofik; Mohammed, Zemedu; Belachew, Mahilet; Shiferaw, Amanuel; Assefa, Demelash; Gadissa, Demekech; Yazew, Hiwot; Yakob, Nuria; Shewamene, Zewdneh; Goscé, Lara; van Rest, Job; Madden, Norma; Charalambous, Salome; van Kalmthout, Kristian; Bedru, Ahmed; Letta, Taye; Jerene, Degu; Fielding, Katherine L

doi:10.1101/2024.05.09.24307117

Cited by 3 publications

(1 citation statement)

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“…or pillbox study arms (aOR=1.04; 95%CI:0.74-1.45; p=0.95) when compared against the standard of care (SOC) [13]. We conducted a trial-based distributional cost-effectiveness analysis to assess the equity impact, costs and cost-effectiveness of digital adherence technologies with differentiated care compared to the SOC in Ethiopia.…”

Section: Introductionmentioning

confidence: 99%

Equity, cost and disability adjusted life years of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis

Foster,

Tadesse,

Belachew

et al. 2024

Preprint

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SummaryBackgroundEvidence of the cost-effectiveness of digital adherence technologies (DATs) for supporting tuberculosis treatment has been inconclusive and primarily omitted patient-incurred costs. We aimed to assess the societal costs, equity impact and cost-effectiveness of DATs and differentiated care compared to routine care in Ethiopia.MethodsWe conducted a distributional cost-effectiveness analysis using data from the cluster randomised trial that evaluated the implementation of labels and pillbox followed by differentiated care to support tuberculosis treatment adherence in 78 health facilities in Ethiopia. We estimated the costs, cost per disability-adjusted life year (DALYs) averted and equity impact of the implementation of the DATs interventions. Costs and DALYs were estimated at a participant level based on patient events collected during the trial and the trial endpoints for intention-to-treat population. Uncertainty in cost-effectiveness estimates were assessed by plotting cost-effectiveness acceptability frontiers. The trial is registered with Pan African Clinical Trial Registry (PACTR) PACTR202008776694999, registered on 11 August 2020 athttps://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241and has been completed.FindingsThe mean total societal treatment cost per trial participant was US$507 (95%CI: 458; 555) in the SOC, US$196 (95%CI: 190; 218) in the labels and US$206 (95%CI: 167; 213) in the pillbox study arms. We estimated that there was a 49-56% probability that the implementation of the DAT interventions, would improve the cost-effectiveness of tuberculosis treatment at a cost-effectiveness threshold of US$100. There was no difference in DALYs between socio-economic position groups (p=0.920), however, patient costs were less concentrated among those relatively poor in the intervention arms – labels (illness concentration index [ICI]=0.03 (95%CI: 0.01; 0.05)) and pillbox (ICI=0.01 (95%CI:-0.01; 0.02)); compared to the SOC (ICI=-0.05 (95%CI: -0.07; -0.02). Between group comparison (p<0.001).InterpretationDAT interventions were cost-saving and reduced the inequitable distribution of patient costs compared to the SOC. This highlights the potential value of interventions that reduce health service visits in improving the equitable distribution of health services.FundingUnitaid (Grant Agreement Number: 2019-33-ASCENT).Research in contextEvidence before this studyIn November 2022, we searched PubMed and MedRxiv for English-language studies published between January 2000 and current, using the terms “tuberculosis” AND “cost” AND (“Digital Adherence Technologies” OR “DATS” OR “99DOTS” OR “Pillbox”). This search was repeated as part of a systematic review in April 2023 followed by an update in May 2024. Twenty-nine relevant studies have been identified, estimating the costs of DATS, though many did not assess the full economic costs of implementation. Only two studies included an assessment of patient-incurred costs, and none considering the equity distribution of costs or outcomes using an asset-based index.Added value of this studyThe ASCENT study provides robust evidence using a comprehensive economic evaluation framework, that DATs decreased the cost of tuberculosis treatment in Ethiopia for a cohort of adults with pulmonary tuberculosis. There was a 49-56% probability of DATs improving the cost-effectiveness of tuberculosis treatment and there was no significant difference in disability adjusted life years (DALYs) between study arms. The implementation of DATs did not change the distribution of costs or DALYs between people with tuberculosis (PWTB) of different household socio-economic position, however it did reduce the magnitude of patient costs among PWTB in the lower socio-economic position (SEP) quintile.Implications of all the available evidenceWhile there is limited evidence of the effectiveness of Digital Adherence Technologies (DATs), this study is the first to show what impact the DATs may have on the costs of treatment, by reducing the number of healthcare visits leading to cost savings. There is further evidence that DATs may reduce the burden of patient costs on those who are least wealthy. We recommend that future investments in DATs for tuberculosis treatment support consider how healthcare providers integrate DATs for tuberculosis treatment support in the health facility workflow and how this translates to cost savings.

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Section: Introductionmentioning

confidence: 99%

Equity, cost and disability adjusted life years of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis

Foster,

Tadesse,

Belachew

et al. 2024

Preprint

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Process evaluation of pragmatic cluster randomized trials of digital adherence technologies for tuberculosis treatment support: a mixed methods study in five countries

Madden,

Tadesse,

Leung

et al. 2024

Preprint

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BackgroundDigital adherence technologies (DATs) could improve the person-centredness of TB treatment. Acceptability of DATs is high, though evidence of their effectiveness is varied. Our objective was to understand the fidelity of DAT interventions within five cluster-randomized trials.MethodsTwo DATs (smart pill box, medication labels) were assessed, with real-time adherence data made available to healthcare providers (HCPs) on a digital platform in Ethiopia, the Philippines, South Africa, Tanzania, and Ukraine. The process evaluation framework assessed four components: inputs, processes, outputs, and outcomes. Fidelity of the most important intervention components was evaluated by quantitative indicators, with analysis conducted by country and DAT type. Content analysis of qualitative sub-studies supplemented some indicators.ResultsEngagement with DATs was high among persons with TB (PwTB). Pillbox users showed high levels of sustained engagement, with digitally recorded doses ranging from 82% to 91%. Sole ownership of a mobile phone was highest in South Africa (90%) and lowest in the Philippines (63%). Differences were also observed in the frequency of logins by HCPs to the adherence platform and the type of device used. In the Philippines and Ukraine, >50% of logins were from mobile phones. In Ethiopia, Tanzania, and Ukraine there was at least one login to the platform on 71% of weekdays per facility, compared with the Philippines and South Africa at 42% and 52%, respectively. A feeling of connection between PwTB and their HCP was reported by over 95% of participants surveyed in Ethiopia and Tanzania, this was 84% in South Africa and 76% Philippines, a finding underpinned by qualitative data.ConclusionWe observed varying levels of intervention fidelity between countries. Timeliness and intensity of utilization of real-time data, and taking required actions are impacted by staff and health system capacity. Acceptance of DATs is high; therefore, future work should focus on identifying optimal intervention strategies.

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Modelling the epidemiological and economic impact of digital adherence technologies with differentiated care for tuberculosis treatment in Ethiopia

Goscé,

Tadesse,

Foster

et al. 2024

BMJ Glob Health

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BackgroundDigital adherence technologies (DATs) with associated differentiated care are potential tools to improve tuberculosis (TB) treatment outcomes and reduce associated costs for both patients and healthcare providers. However, the balance between epidemiological and economic benefits remains unclear. Here, we used data from the ASCENT trial to estimate the potential long-term epidemiological and economic impact of DAT interventions in Ethiopia.MethodsWe developed a compartmental transmission model for TB, calibrated to Ethiopia and parameterised with patient and provider costs. We compared the epidemiological and economic impact of two DAT interventions, a digital pillbox and medication labels, to the current standard of care, assuming each was introduced at scale in 2023. We projected long-term TB incidence, mortality and costs to 2035 and conducted a threshold analysis to identify the maximum possible epidemiological impact of a DAT intervention by assuming 100% treatment completion for patients on DAT.FindingsWe estimated small and uncertain epidemiological benefits of the pillbox intervention compared with the standard of care in Ethiopia, with a difference of −0.4% (95% uncertainty interval (UI) −1.1%; +2.0%) incident TB episodes and −0.7% (95% UI −2.2%; +3.6%) TB deaths. However, our analysis also found large total provider and patient cost savings (US$163 (95% UI US$118; US$211) and US$3 (95%UI: US$1; US$5), respectively, over 2023–2035), translating to a 50.2% (95% UI 35.9%; 65.2%) reduction in total cost of treatment. Results were similar for the medication label intervention. The maximum possible epidemiological impact a theoretical DAT intervention could achieve over the same timescale would be a 3% (95% UI 1.4%; 5.5%) reduction in incident TB and an 8.2% (95% UI 4.4%; 12.8%) reduction in TB deaths.InterpretationDAT interventions, while showing limited epidemiological impact, could substantially reduce TB treatment costs for both patients and the healthcare provider.

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Cluster-randomized trial of digital adherence technologies and differentiated care to reduce poor end-of-treatment outcomes and recurrence among adults with drug-sensitive pulmonary TB in Ethiopia

Cited by 3 publications

References 27 publications

Equity, cost and disability adjusted life years of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis

Equity, cost and disability adjusted life years of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis

Process evaluation of pragmatic cluster randomized trials of digital adherence technologies for tuberculosis treatment support: a mixed methods study in five countries

Modelling the epidemiological and economic impact of digital adherence technologies with differentiated care for tuberculosis treatment in Ethiopia

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