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Completed

NCT Number: NCT04216420

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Directly Observed Therapy Gram-Positive Bacterial Infections Health Behavior Infections Medication Adherence Mycobacterium Infections Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addis Ababa University, College of Health Sciences

Addis Ababa, 9086, Ethiopia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MERM-observed self-administered therapy

Device

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.

Other names: EvriMed500 medication event reminder monitor

Primary outcomes

  1. Level of adherence

    Time frame: Two months

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

  2. Sputum conversion

    Time frame: Before and after the two-month intensive phase

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

Secondary outcomes

  1. Negative IsoScreen urine isoniazid test

    Time frame: Two months

    Number of participants with negative IsoScreen urine isoniazid test

  2. Adverse treatment outcome

    Time frame: Two months

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

  3. Self-reported adherence

    Time frame: Two months

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

  4. Health-related quality of life (HRQoL)

    Time frame: 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.

  5. Catastrophic costs

    Time frame: Two months

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

  6. Post-diagnostic cost from an individual patient's perspective

    Time frame: 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.

  7. Patient-reported treatment satisfaction

    Time frame: 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.

  8. Patient-reported usability of the MERM device

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Addis Ababa University

Other

Collaborators

  • Armauer Hansen Research Institute, Ethiopia
  • Emory University School of Medicine, US
  • Fogarty International Center of the National Institute of Health

Registry information

Official study 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

Acronym: SELFTB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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