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

Tuberculosis Clinical Trial

— SELFTB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216420
• Other study ID #: 077/19/CDT
• Secondary ID: D43TW009127
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tuberculosis

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