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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Level of adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard directly observed therapy (DOT)
The provider handles a participant in the control arm (n = 57) according to the standard DOT, where the participant visits the healthcare facility each day throughout the intensive phase to swallow the daily dose with direct observation by the healthcare provider. The participant will undergo the urine isoniazid test every 15 days.
Both arms will be treated based on the WHO-recommended two-month fixed-dose-combination of first-line anti-TB drug (2RHZE) delivered as a single daily dose and followed throughout the intensive phase that lasts two months. In the end, participants will undergo a microbiological test to assess sputum smear conversion and trained study staff will complete several data tools, including a treatment outcome monitoring tool, adherence self-report, HRQoL, cost, treatment satisfaction, and MERM usability tools.
MERM-observed self-administered therapy (SAT)
A participant in the intervention arm (n = 57) will receive a 15-day TB medication supply in the evriMED500 MERM device to self-administer. The participant returns every 15 days, where the healthcare provider counts any remaining tablets in the pillbox device, connects the MERM module with a computer and downloads the pill-taking data, reviews the event reports together with the participant and captures the data, underwent IsoScreen urine isoniazid test and refills the participant with a 15-day medication supply in the MERM device.
干预措施: MERM-observed self-administered therapy (Device)
结局指标
主要结局
Level of adherence
时间窗: 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
时间窗: Before and after the two-month intensive phase
Participant with sputum smear converted following the standard two-month intensive phase treatment
次要结局
- Post-diagnostic cost from an individual patient's perspective(Two months)
- Catastrophic costs(Two months)
- Patient-reported treatment satisfaction(Two months)
- Negative IsoScreen urine isoniazid test(Two months)
- Self-reported adherence(Two months)
- Health-related quality of life (HRQoL)(Two months)
- Patient-reported usability of the MERM device(Two months)
- Adverse treatment outcome(Two months)
研究者
Dr. Tsegahun Manyazewal
Principal Investigator
Addis Ababa University