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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04216420
Other study ID # 077/19/CDT
Secondary ID D43TW009127
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date August 31, 2021

Study information

Verified date July 2022
Source Addis Ababa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (health-related quality of life and catastrophic costs) 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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date August 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 years and above - 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 - Concurrent extrapulmonary TB - Contraindicated medications - Active liver disease that requires a TB regimen other than HREZ

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MERM-observed self-administered therapy
The MERM device has an electronic module and a medication container that records adherence, stores medication, emits audible and visual on-board alarms to remind patients to take their medications on time and refill, and enables providers to download the data and monitor adherence. It is manufactured by Wisepill Technologies, South Africa.

Locations

Country Name City State
Ethiopia Addis Ababa University, College of Health Sciences Addis Ababa

Sponsors (5)

Lead Sponsor Collaborator
Addis Ababa University Addis Ababa University, College of Health Sciences, CDT-Africa, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Emory University School of Medicine, US, Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of adherence Individual-level percentage adherence over the two-month intensive phase measured by adherence records compiled from MERM device vs. DOT records. Two months
Primary Sputum conversion Participant with sputum smear converted following the standard two-month intensive phase treatment Before and after the two-month intensive phase
Secondary Negative IsoScreen urine isoniazid test Number of participants with negative IsoScreen urine isoniazid test Two months
Secondary Adverse treatment outcome Participants having at least one of the three events: treatment not completed; death; or loss to follow-up. Two months
Secondary Self-reported adherence Participants who self-reported to have forgotten to take their medication Two months
Secondary Health-related quality of life (HRQoL) The association between MERM-observed therapy and HRQoL, with the HRQoL measured and calculated for each participant by arm using the EuroQoL 5-dimension 5-level (EQ-5D-5L) score ranging from 0 to 1, with a higher score designating better HRQoL. Two months
Secondary Catastrophic costs Participants with overall TB treatment cost exceeding or equivalent to 20% of their income. Two months
Secondary Post-diagnostic cost from an individual patient's perspective Participant's cumulative direct costs (out-of-pocket costs related to anti-TB drug pick-up) and indirect costs (guardian and coping costs) over the two-month intensive phase. Two months
Secondary Patient-reported treatment satisfaction Participant's treatment satisfaction measured using the treatment satisfaction questionnaire for medication version 1.4 (TSQM v1.4) tool on a scale 0 to 100, with higher score indicating better satisfaction. Two months
Secondary Patient-reported usability of the MERM device Participant's experience using the MERM device measured by an 18-item questionnaire and the score transformed in to a scale from 0 to 100, with higher score indicating better usability (Intervention arm only). Two months
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