Trials / Completed
CompletedNCT04216420
Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Addis Ababa University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-07-31
- Completion
- 2021-08-31
- First posted
- 2020-01-02
- Last updated
- 2022-07-12
Locations
1 site across 1 country: Ethiopia
Source: ClinicalTrials.gov record NCT04216420. Inclusion in this directory is not an endorsement.