Evaluation of implementation and effectiveness of digital adherence technology with differentiated care to support tuberculosis treatment adherence and improve treatment outcomes in Ethiopia: a study protocol for a cluster randomised trial

BMC Infectious Diseases

Demekech G. Umeta¹  Gedion T. Weldemichael¹  Hiwot Yazew¹  Demelash Assefa¹  Ahmed Bedru¹  Tofik Abdurhman¹  Zemedu Mohammed¹  Kristian van Kalmthout²  Degu Jerene²  Jens Levy²  Job van Rest²  Taye Letta³  Amare W. Tadesse⁴  Katherine L. Fielding⁵  Nicola Foster⁶  Matthew Quaife⁶  Christopher Finn McQuaid⁶ 

[1] KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia;KNCV Tuberculosis Foundation, The Hague, the Netherlands;National Tuberculosis Control Program, Ethiopian Ministry of Health, Addis Ababa, Ethiopia;TB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK;TB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK;School of Public Health, University of the Witwatersrand, Johannesburg, South Africa;TB Modelling Group, TB Centre, and Centre for Mathematical Modelling of Infectious Diseases, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK;

关键词: Tuberculosis;    Smart pillbox;    Medication label;    Trial;    Cluster randomised;    Pragmatic;    Ethiopia;   

DOI  :  10.1186/s12879-021-06833-x

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY