Tuberculosis
Conditions
Keywords
Tuberculosis, Medication event reminder monitor, Self-administered therapy, Directly observed therapy (DOT), Adherence, Treatement outcome, Digital health, Ethiopia
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.
Interventions
DEVICEMERM-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.
Sponsors
Emory University School of Medicine, US
Armauer Hansen Research Institute, Ethiopia
Fogarty International Center of the National Institute of Health
Addis Ababa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Permuted block randomization method was used to randomly allocate participants and maintain a balance of the number of participants assigned to each arm. The study investigators who were responsible for assessing study outcomes and writing the report were blinded to group allocation until the manuscript was completed. A statistician masked to group allocation performed the analyses.
Intervention model description
A multicenter, randomized, controlled, open-label, non-inferiority, effectiveness-implementation type 2 hybrid trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Catastrophic costs | Two months | Participants with overall TB treatment cost exceeding or equivalent to 20% of their income. |
| Negative IsoScreen urine isoniazid test | Two months | Number of participants with negative IsoScreen urine isoniazid test |
| 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. |
| 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). |
| 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. |
| Adverse treatment outcome | Two months | Participants having at least one of the three events: treatment not completed; death; or loss to follow-up. |
Countries
Ethiopia
Outcome results
None listed