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

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.

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