Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Device: MERM-observed self-administered therapy

• Registration Number: NCT04216420
• Lead Sponsor: Addis Ababa University

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 (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-06-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-08-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MERM-observed self-administered therapy (SAT)	MERM-observed self-administered therapy	A participant in the intervention arm (n = 57) will receive a 15-day TB medication supply in the evriMED500 MERM device to self-administer. The participant returns every 15 days, where the healthcare provider counts any remaining tablets in the pillbox device, connects the MERM module with a computer and downloads the pill-taking data, reviews the event reports together with the participant and captures the data, underwent IsoScreen urine isoniazid test and refills the participant with a 15-day medication supply in the MERM device.

Primary Outcome Measures

Name	Time	Method
Level of adherence	Two months	Individual-level percentage adherence over the two-month intensive phase measured by adherence records compiled from MERM device vs. DOT records.
Sputum conversion	Before and after the two-month intensive phase	Participant with sputum smear converted following the standard two-month intensive phase treatment

Secondary Outcome Measures

Name	Time	Method
Catastrophic costs	Two months	Participants with overall TB treatment cost exceeding or equivalent to 20% of their income.
Patient-reported treatment satisfaction	Two months	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.
Post-diagnostic cost from an individual patient's perspective	Two months	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.
Negative IsoScreen urine isoniazid test	Two months	Number of participants with negative IsoScreen urine isoniazid test
Self-reported adherence	Two months	Participants who self-reported to have forgotten to take their medication
Health-related quality of life (HRQoL)	Two months	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.
Patient-reported usability of the MERM device	Two months	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).
Adverse treatment outcome	Two months	Participants having at least one of the three events: treatment not completed; death; or loss to follow-up.

Trial Locations

Locations (1)

Addis Ababa University, College of Health Sciences; 🇪🇹 Addis Ababa, Ethiopia