An interventional study of MERM-observed self-administered therapy in Tuberculosis, sponsored by Addis Ababa University. Completed at 1 site in Ethiopia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by Addis Ababa University · Not applicable, Interventional, and Treatment
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.
1,417 studies on the registry are indexed under Tuberculosis; 207 are open to participants now.
This study's enrollment of 114 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Addis Ababa University is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Device: MERM-observed self-administered therapy
The provider handles a participant in the control arm (n = 57) according to the standard DOT, where the participant visits the healthcare facility each day throughout the intensive phase to swallow the daily dose with direct observation by the healthcare provider. The participant will undergo the urine isoniazid test every 15 days. Both arms will be treated based on the WHO-recommended two-month fixed-dose-combination of first-line anti-TB drug (2RHZE) delivered as a single daily dose and followed throughout the intensive phase that lasts two months. In the end, participants will undergo a microbiological test to assess sputum smear conversion and trained study staff will complete several data tools, including a treatment outcome monitoring tool, adherence self-report, HRQoL, cost, treatment satisfaction, and MERM usability tools.
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.
Also known as: EvriMed500 medication event reminder monitor
Level of adherence
Individual-level percentage adherence over the two-month intensive phase measured by adherence records compiled from MERM device vs. DOT records.
Time frame: Two months
Sputum conversion
Participant with sputum smear converted following the standard two-month intensive phase treatment
Time frame: Before and after the two-month intensive phase
Negative IsoScreen urine isoniazid test
Number of participants with negative IsoScreen urine isoniazid test
Time frame: Two months
Adverse treatment outcome
Participants having at least one of the three events: treatment not completed; death; or loss to follow-up.
Time frame: Two months
Self-reported adherence
Participants who self-reported to have forgotten to take their medication
Time frame: Two months
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.
Time frame: Two months
Catastrophic costs
Participants with overall TB treatment cost exceeding or equivalent to 20% of their income.
Time frame: Two months
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.
Time frame: Two months
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.
Time frame: Two months
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).
Time frame: Two months
Plan to share: Yes
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Addis Ababa University