Abstract
BackgroundDigital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited. We aim to implement and evaluate the effectiveness of smart pillboxes and medication labels linked to an adherence data platform, to create a differentiated care response to patient adherence and improve TB care among adult pulmonary TB participants. Our study is part of the Adherence Support Coalition to End TB (ASCENT) project in Ethiopia.Methods/DesignWe will conduct a pragmatic three-arm cluster-randomised trial with 78 health facilities in two regions in Ethiopia. Facilities are randomised (1:1:1) to either of the two intervention arms or standard of care. Adults aged ≥ 18 years with drug-sensitive (DS) pulmonary TB are enrolled over 12 months and followed-up for 12 months after treatment initiation. Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses. Participants at standard of care facilities receive routine care. For those that had bacteriologically confirmed TB at treatment initiation and can produce sputum without induction, sputum culture will be performed approximately 6 months after the end of treatment to measure disease recurrence. The primary endpoint is a composite unfavourable outcome measured over 12 months from TB treatment initiation defined as either poor end of treatment outcome (lost to follow-up, death, or treatment failure) or treatment recurrence measured 6 months after the scheduled end of treatment. This study will also evaluate the effectiveness, feasibility, and cost-effectiveness of DAT systems for DS-TB patients.DiscussionThis trial will evaluate the impact and contextual factors of medication label and smart pillbox with a differentiated response to patient care, among adult pulmonary DS-TB participants in Ethiopia. If successful, this evaluation will generate valuable evidence via a shared evaluation framework for optimal use and scale-up.Trial registration: Pan African Clinical Trials Registry PACTR202008776694999, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241, registered on August 11, 2020.
Highlights
Digital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited
Over 1250 TB patients were screened for eligibility across all study arms and 586 enrolled, of which 40% are females, median age 30 years and 67% had smear confirmed TB. This trial is a pragmatic cluster-randomised trial and the first of its kind to evaluate effectiveness of smart-pill box and medication labels linked to a web-based adherence platform with differentiated response to patient adherence in Ethiopia
The aim of this trial extends beyond reducing the proportion of poor end of TB treatment outcomes to include evaluating the 6-month disease free survival, process evaluation, and the wider epidemiological impact and cost-effectiveness of DAT systems for DS-TB patients
Summary
Digital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited. The World Health Organization (WHO) End TB Strategy, in alignment with the Sustainable Development Goals (SDG), has set ambitious goals to end the global TB epidemic by 2035 [3]. This strategy requires high-impact interventions to ensure equitable access to high-quality diagnosis, treatment, care, and prevention, without imposing catastrophic costs, to people with TB. While significant improvements in TB treatment outcomes have been observed after the introduction of DOT, global treatment success rates for both drug-sensitive (DS)-TB and drugresistant (DR)-TB remain below the 90% target for 2025 set out in WHO’s End TB strategy [1, 3]. The traditional DOT approach assumes that all TB patients require the same level of monitoring and support, rather than focusing care on patients that are at higher risk for non-adherence and poor outcomes, and in need of intensified support [8]
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