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Electronic Pillbox-enabled Self-administered Therapy Versus Standard DOT for TB Treatment Adherence and Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216420
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
Addis Ababa University, College of Health Sciences
Emory University
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Dr. Tsegahun Manyazewal, Addis Ababa University

Brief Summary:
To address the multifaceted problems associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization has recently recommended countries to maximize the use of digital adherence technologies. Sub-Saharan Africa needs to early 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) over standard DOT on TB medication adherence and treatment outcomes in Ethiopia. It also aims to assess the usability, cost-effectiveness, and acceptability by patients and healthcare providers of the pillbox-enabled SAT. It is designed as a 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Device: Electronic pillbox-enabled SAT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with new or previously treated bacteriologically confirmed drug-sensitive pulmonary TB
  • Eligible to start the standard 6-month first-line anti-TB medication
  • Outpatient
  • Men or women age 18 to 75 years
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Patients with known drug-resistant TB
  • Any condition that causes cognitive impairment such as severe acute illness or injury, developmental retardation, or severe psychiatric illness and thus precludes informed consent or safely participating in the study procedures
  • Inpatients
  • Expected to move away from the study site before the final study follow up at month two
  • Concurrent extrapulmonary TB
  • Contraindicated medications
  • Active liver disease that requires a TB regimen other than HREZ

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216420


Contacts
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Contact: Tsegahun Manyazewal, PhD 118961396 ext +251 tsegahunm@gmail.com
Contact: Yimtubezinash Woldeamanuel, MD, PhD 118961396 ext +251 yimtubezenash.wamanuel@aau.edu.et

Locations
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Ethiopia
Addis Ababa University, College of Health Sciences
Addis Ababa, Ethiopia, 9086
Contact: Tsegahun Manyazewal, PhD    118787311 ext +251    tsegahunm@gmail.com   
Sponsors and Collaborators
Addis Ababa University
Addis Ababa University, College of Health Sciences
Emory University
Armauer Hansen Research Institute, Ethiopia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Tsegahun Manyazewal, Principal Investigator, Addis Ababa University
ClinicalTrials.gov Identifier: NCT04216420    
Other Study ID Numbers: 077/19/CDT
D43TW009127 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Tsegahun Manyazewal, Addis Ababa University:
Tuberculosis
Pillbox
Self-administered therapy
Directly observed therapy (DOT)
Adherence
Treatement outcome
Multiphase optimization strategy (MOST)
Ethiopia
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections