Clinical trial NCT04216420: Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
Medication event reminder monitor
Self-administered therapy
Directly observed therapy (DOT)
Adherence
Treatement outcome
Digital health
Ethiopia
Lead sponsor: Addis Ababa University
Sponsor class: OTHER
Collaborators: name: Emory University School of Medicine, US
name: Armauer Hansen Research Institute, Ethiopia
name: Fogarty International Center of the National Institute of Health
First posted: 2020-01-02
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, randomized, controlled, open-label, non-inferiority, effectiveness-implementation type 2 hybrid trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of adherence
timeFrame: Two months
measure: Sputum conversion
timeFrame: Before and after the two-month intensive phase
Secondary outcomes:
measure: Negative IsoScreen urine isoniazid test
timeFrame: Two months
measure: Adverse treatment outcome
timeFrame: Two months
measure: Self-reported adherence
timeFrame: Two months
measure: Health-related quality of life (HRQoL)
timeFrame: Two months
measure: Catastrophic costs
timeFrame: Two months
measure: Post-diagnostic cost from an individual patient's perspective
timeFrame: Two months
measure: Patient-reported treatment satisfaction
timeFrame: Two months
measure: Patient-reported usability of the MERM device
timeFrame: Two months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Ababa University, College of Health Sciences
Study officials:
affiliation: Emory University School of Medicine and Rollins School of Public Health
name: Henry M Blumberg, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.