Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes (SELFTB)
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ClinicalTrials.gov Identifier: NCT04216420 |
Recruitment Status :
Recruiting
First Posted : January 2, 2020
Last Update Posted : December 2, 2020
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Sponsor:
Addis Ababa University
Collaborators:
Addis Ababa University, College of Health Sciences, CDT-Africa, Ethiopia
Emory University School of Medicine, US
Armauer Hansen Research Institute, Ethiopia
John E. Fogarty International Center, US
Information provided by (Responsible Party):
Dr. Tsegahun Manyazewal, Addis Ababa University
Tracking Information | |||||||||
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First Submitted Date ICMJE | December 27, 2019 | ||||||||
First Posted Date ICMJE | January 2, 2020 | ||||||||
Last Update Posted Date | December 2, 2020 | ||||||||
Actual Study Start Date ICMJE | June 1, 2020 | ||||||||
Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes | ||||||||
Official Title ICMJE | Electronic Pillbox-enabled Self-administered Therapy Versus Standard Directly Observed Therapy for Tuberculosis Medication Adherence and Treatment Outcomes in Ethiopia: a Multicenter Randomized Controlled Trial | ||||||||
Brief Summary | To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended countries maximize the use of digital adherence technologies. Sub-Saharan Africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered TB care. This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness of the intervention from the patient and provider perspectives. It is designed as a multicenter, randomized, controlled, open-label, non-inferiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Tuberculosis | ||||||||
Intervention ICMJE | Device: Electronic pillbox-enabled SAT
It is a digital device manufactured by Wisepill Technologies, South Africa. Every time a pill dispenser is opened, the evriMED500 stores the date and time of the opening. Adherence data and reports can be viewed on the Wisepill Cloud Server and on the mobile-friendly browser application.
Other Name: EvriMed500 medication monitoring and reminder system
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Study Arms ICMJE |
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Publications * | Manyazewal T, Woldeamanuel Y, Holland DP, Fekadu A, Blumberg HM, Marconi VC. Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial. Trials. 2020 May 5;21(1):383. doi: 10.1186/s13063-020-04324-z. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
144 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 31, 2021 | ||||||||
Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Ethiopia | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04216420 | ||||||||
Other Study ID Numbers ICMJE | 077/19/CDT D43TW009127 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dr. Tsegahun Manyazewal, Addis Ababa University | ||||||||
Study Sponsor ICMJE | Addis Ababa University | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Addis Ababa University | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |