Electronic Pillbox-enabled Self-administered Therapy Versus Standard DOT for TB Treatment Adherence and Outcomes
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|ClinicalTrials.gov Identifier: NCT04216420|
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Device: Electronic pillbox-enabled SAT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, multicenter, open-label, randomized, controlled, superiority, mixed-methods trial, supplemented with Multiphase Optimization Strategy (MOST) for interventions on behavioral and social determinants of adherence.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Electronic pillbox-enabled self-administered therapy (SAT)
TB patients in the experimental arm will be dispensed with TB medication supply (HRZE fixed-dose combination therapy) for every 15 days in medication event reminder monitor (MERM) pillbox device (evriMed500 digital medication monitoring and reminder device manufactured by Wisepill Technologies, South Africa) to self-administer throughout the intensive phase
Device: Electronic pillbox-enabled SAT
It is a 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
No Intervention: Standard directly observed therapy (DOT)
TB patients in the standard DOT arm will visit the healthcare facility each business day in the intensive (2 months) phase to swallow their daily dose of HRZE with direct observation of the healthcare provider per the standard currently practicing DOT procedure.
- Level of adherence [ Time Frame: Two months ]Proportion of patients who missed doses in intervention (pill count) versus DOT (direct observation) arms, confirmed further by urine isoniazid test (IsoScreen test, GFC Diagnostics Ltd, Bicester, England) and a self-report on Morisky Medication Adherence Scale (MMAS-8, an 8-item structured, valid tool to measure self-reported medication adherence).
- Sputum conversion [ Time Frame: Before and after the two-month intensive phase ]Proportion of patients with smear conversion following the intensive phase in intervention versus DOT arms, confirmed further by pre-post intensive phase TB liquid culture and drug susceptibility testing (BD BACTEC MGIT 960 TB system, BD Diagnostics, Maryland, US).
- Poor treatment outcomes [ Time Frame: Two months ]Proportion of patients with poor treatment outcomes (treatment not completed, death, or loss to follow-up) in intervention versus DOT arms.
- Cost-effectiveness: value of health effects [ Time Frame: Two months ]Quality-adjusted life years (QALY) of patients in intervention versus DOT arms under EuroQol's EQ-5D-5L quality of life questionnaire, with discount rates of 3% and a score out of 100, where 100 means the best health a patient imagines.
- Cost-effectiveness: individual and societal costs of treatment [ Time Frame: Two months ]Proportion of individual and societal costs of treatment when management of adherence followed pillbox-enabled SAT versus DOT.
- Acceptability [ Time Frame: Two months ]Proportion of patients in intervention versus DOT arms who perceived satisfaction with their TB treatment when measured on Treatment Satisfaction Questionnaire for Medication scale (TSQM v 1.4, a 14-item valid tool to assess patients' satisfaction with medication across four domains - effectiveness, side effects, convenience, and global satisfaction).
- Usability [ Time Frame: End of two months ]Proportion of patients in the intervention arm who perceived the pillbox-enabled SAT as usable (easy to use, benefiting, adherence motivator, reputable) in an interviewer-administered, close-ended questionnaire.
- Behavioral determinants [ Time Frame: Two months ]Proportion of patients with behavioral factors (use cigarettes, alcohol, chat, cocaine/marijuana) that had adherence problems in the first month of their treatment but improved following additional interventions using Multiphase Optimization Strategy (MOST): i) behavioral intervention, ii) behavioral plus reducing refill schedules to one week (from two weeks), and iii) reassigning to DOT.
- Social determinants [ Time Frame: Two months ]Proportion of patients with social determinants (homeless, unemployed, illiterate) that had adherence problems in the first month of treatment but improved following further interventions using MOST i) behavioral intervention, ii) behavioral plus reducing refill schedules to one week (from two weeks), and iii) reassigning to DOT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216420
|Contact: Tsegahun Manyazewal, PhD||118961396 ext +firstname.lastname@example.org|
|Contact: Yimtubezinash Woldeamanuel, MD, PhD||118961396 ext +email@example.com|
|Addis Ababa University, College of Health Sciences|
|Addis Ababa, Ethiopia, 9086|
|Contact: Tsegahun Manyazewal, PhD 118787311 ext +251 firstname.lastname@example.org|