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TuberculosisSELFTBNCT04216420

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

A study testing MERM-observed self-administered therapy in people with Tuberculosis, run by Addis Ababa University at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis
What is being tested?
MERM-observed self-administered therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteEthiopia
Study dates
1 Jun 2020to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

  • Addis Ababa University, College of Health Sciences

    Addis Ababa, 9086

Other trials in Ethiopia

About this study

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

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.

Conditions
Tuberculosis
Being tested
MERM-observed self-administered therapy
Keywords
Tuberculosis, Medication event reminder monitor, Self-administered therapy, Directly observed therapy (DOT), Adherence, Treatement outcome, Digital health, Ethiopia
Medical subject headings
Tuberculosis, Directly Observed Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MERM-observed self-administered therapyDevice

    Also called EvriMed500 medication event reminder monitor

    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.

Study groups in NCT04216420
Study groupRoleWhat they receive
MERM-observed self-administered therapy (SAT)ExperimentalA 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.
Receives: Device: MERM-observed self-administered therapy
Standard directly observed therapy (DOT)No interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of adherence

    Individual-level percentage adherence over the two-month intensive phase measured by adherence records compiled from MERM device vs. DOT records.

    Measured: Two months

  2. Sputum conversion

    Participant with sputum smear converted following the standard two-month intensive phase treatment

    Measured: Before and after the two-month intensive phase

Secondary outcomes (8)

  1. Negative IsoScreen urine isoniazid test

    Number of participants with negative IsoScreen urine isoniazid test

    Measured: Two months

  2. Adverse treatment outcome

    Participants having at least one of the three events: treatment not completed; death; or loss to follow-up.

    Measured: Two months

  3. Self-reported adherence

    Participants who self-reported to have forgotten to take their medication

    Measured: Two months

  4. 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.

    Measured: Two months

  5. Catastrophic costs

    Participants with overall TB treatment cost exceeding or equivalent to 20% of their income.

    Measured: Two months

  6. 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.

    Measured: Two months

  7. 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.

    Measured: Two months

  8. 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).

    Measured: Two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start1 Jun 2020
  3. Primary completion31 Jul 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multicenter, randomized, controlled, open-label, non-inferiority, effectiveness-implementation type 2 hybrid trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04216420
Sponsor's protocol ID
077/19/CDT
Other IDs
D43TW009127
Acronym
SELFTB
Status last verified
Jul 2022
First submitted
27 Dec 2019
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Manyazewal T, Woldeamanuel Y, Getinet T, Hoover A, Bobosha K, Fuad O, Getahun B, Fekadu A, Holland DP, Marconi VC. Patient-reported usability and satisfaction with electronic medication event reminder and monitor device for tuberculosis: a multicentre, randomised controlled trial. EClinicalMedicine. 2023 Jan 17;56:101820. doi: 10.1016/j.eclinm.2022.101820. eCollection 2023 Feb.

    PubMed 36684395

  • Manyazewal T, Woldeamanuel Y, Holland DP, Fekadu A, Marconi VC. Effectiveness of a digital medication event reminder and monitor device for patients with tuberculosis (SELFTB): a multicenter randomized controlled trial. BMC Med. 2022 Sep 28;20(1):310. doi: 10.1186/s12916-022-02521-y.

    PubMed 36167528

  • Manyazewal T, Woldeamanuel Y, Fekadu A, Holland DP, Marconi VC. Effect of Digital Medication Event Reminder and Monitor-Observed Therapy vs Standard Directly Observed Therapy on Health-Related Quality of Life and Catastrophic Costs in Patients With Tuberculosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 15;5(9):e2230509. doi: 10.1001/jamanetworkopen.2022.30509.

    PubMed 36107429

  • Manyazewal T, Woldeamanuel Y, Blumberg HM, Fekadu A, Marconi VC. The potential use of digital health technologies in the African context: a systematic review of evidence from Ethiopia. NPJ Digit Med. 2021 Aug 17;4(1):125. doi: 10.1038/s41746-021-00487-4.

    PubMed 34404895

  • Manyazewal T, Woldeamanuel Y, Holland DP, Fekadu A, Blumberg HM, Marconi VC. Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial. Trials. 2020 May 5;21(1):383. doi: 10.1186/s13063-020-04324-z.

    PubMed 32370774

Questions about this trial

What is this clinical trial studying?

A study testing MERM-observed self-administered therapy in people with Tuberculosis, run by Addis Ababa University at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of adherence (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04216420, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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