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

Abstract Background 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. We aim to implement and evaluate the effectiveness of smart pil...

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Autores principales:	Amare W. Tadesse, Zemedu Mohammed, Nicola Foster, Matthew Quaife, Christopher Finn McQuaid, Jens Levy, Kristian van Kalmthout, Job van Rest, Degu Jerene, Tofik Abdurhman, Hiwot Yazew, Demekech G. Umeta, Demelash Assefa, Gedion T. Weldemichael, Ahmed Bedru, Taye Letta, Katherine L. Fielding
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Tuberculosis Smart pillbox Medication label Trial Cluster randomised Pragmatic Infectious and parasitic diseases RC109-216
Acceso en línea:	https://doaj.org/article/120aeeaf4d3c48d7b9cf0a2941115cf7
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spelling	oai:doaj.org-article:120aeeaf4d3c48d7b9cf0a2941115cf72021-11-14T12:44:25ZEvaluation 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 trial10.1186/s12879-021-06833-x1471-2334https://doaj.org/article/120aeeaf4d3c48d7b9cf0a2941115cf72021-11-01T00:00:00Zhttps://doi.org/10.1186/s12879-021-06833-xhttps://doaj.org/toc/1471-2334Abstract Background 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. 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/Design We 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. Discussion This 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.Amare W. TadesseZemedu MohammedNicola FosterMatthew QuaifeChristopher Finn McQuaidJens LevyKristian van KalmthoutJob van RestDegu JereneTofik AbdurhmanHiwot YazewDemekech G. UmetaDemelash AssefaGedion T. WeldemichaelAhmed BedruTaye LettaKatherine L. FieldingBMCarticleTuberculosisSmart pillboxMedication labelTrialCluster randomisedPragmaticInfectious and parasitic diseasesRC109-216ENBMC Infectious Diseases, Vol 21, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Tuberculosis Smart pillbox Medication label Trial Cluster randomised Pragmatic Infectious and parasitic diseases RC109-216
spellingShingle	Tuberculosis Smart pillbox Medication label Trial Cluster randomised Pragmatic Infectious and parasitic diseases RC109-216 Amare W. Tadesse Zemedu Mohammed Nicola Foster Matthew Quaife Christopher Finn McQuaid Jens Levy Kristian van Kalmthout Job van Rest Degu Jerene Tofik Abdurhman Hiwot Yazew Demekech G. Umeta Demelash Assefa Gedion T. Weldemichael Ahmed Bedru Taye Letta Katherine L. Fielding 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
description	Abstract Background 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. 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/Design We 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. Discussion This 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.
format	article
author	Amare W. Tadesse Zemedu Mohammed Nicola Foster Matthew Quaife Christopher Finn McQuaid Jens Levy Kristian van Kalmthout Job van Rest Degu Jerene Tofik Abdurhman Hiwot Yazew Demekech G. Umeta Demelash Assefa Gedion T. Weldemichael Ahmed Bedru Taye Letta Katherine L. Fielding
author_facet	Amare W. Tadesse Zemedu Mohammed Nicola Foster Matthew Quaife Christopher Finn McQuaid Jens Levy Kristian van Kalmthout Job van Rest Degu Jerene Tofik Abdurhman Hiwot Yazew Demekech G. Umeta Demelash Assefa Gedion T. Weldemichael Ahmed Bedru Taye Letta Katherine L. Fielding
author_sort	Amare W. Tadesse
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/120aeeaf4d3c48d7b9cf0a2941115cf7
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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

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