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...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-11-01
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| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-021-06833-x |
| _version_ | 1818837057626177536 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-19T03:16:27Z |
| format | Article |
| id | doaj.art-120aeeaf4d3c48d7b9cf0a2941115cf7 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-19T03:16:27Z |
| publishDate | 2021-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-120aeeaf4d3c48d7b9cf0a2941115cf72022-12-21T20:37:52ZengBMCBMC Infectious Diseases1471-23342021-11-0121111110.1186/s12879-021-06833-xEvaluation 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 trialAmare W. Tadesse0Zemedu Mohammed1Nicola Foster2Matthew Quaife3Christopher Finn McQuaid4Jens Levy5Kristian van Kalmthout6Job van Rest7Degu Jerene8Tofik Abdurhman9Hiwot Yazew10Demekech G. Umeta11Demelash Assefa12Gedion T. Weldemichael13Ahmed Bedru14Taye Letta15Katherine L. Fielding16TB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM)KNCV Tuberculosis FoundationTB Modelling Group, TB Centre, and Centre for Mathematical Modelling of Infectious Diseases, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM)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)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)KNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationKNCV Tuberculosis FoundationNational Tuberculosis Control Program, Ethiopian Ministry of HealthTB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM)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.https://doi.org/10.1186/s12879-021-06833-xTuberculosisSmart pillboxMedication labelTrialCluster randomisedPragmatic |
| spellingShingle | 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 BMC Infectious Diseases Tuberculosis Smart pillbox Medication label Trial Cluster randomised Pragmatic |
| 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_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_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_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 |
| topic | Tuberculosis Smart pillbox Medication label Trial Cluster randomised Pragmatic |
| url | https://doi.org/10.1186/s12879-021-06833-x |
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