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首页> 外文期刊>Trials >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
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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

机译：启用电子药丸的自我管理治疗与标准直接观察到埃塞俄比亚的结核药物药物粘附和治疗结果（SelftB）：用于多中心随机对照试验的议定书

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BACKGROUND:To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended that 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 of the intervention from the patient and provider perspectives.METHODS:This is a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. The study is designed to enroll 144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to start the standard 6-month first-line anti-TB regimen. Participants in the intervention arm (n?=?72) will receive 15 days of HRZE-isoniazid, rifampicin, pyrazinamide, and ethambutol-fixed-dose combination therapy in the evriMED500 medication event reminder monitor device for self-administration. When returned, providers will count any remaining tablets in the device, download the pill-taking data, and refill based on preset criteria. Participants can consult the provider in cases of illness or adverse events outside of scheduled visits. Providers will handle participants in the control arm (n?=?72) according to the standard in-person DOT. Both arms will be followed up throughout the 2-month intensive phase. The primary outcomes will be medication adherence and sputum conversion. Adherence to medication will be calculated as the proportion of patients who missed doses in the intervention (pill count) versus DOT (direct observation) arms, confirmed further by IsoScreen urine isoniazid test and a self-report of adherence on eight-item Morisky Medication Adherence Scale. Sputum conversion is defined as the proportion of patients with smear conversion following the intensive phase in intervention versus DOT arms, confirmed further by pre-post intensive phase BACTEC MGIT TB liquid culture. Pre-post treatment MGIT drug susceptibility testing will determine whether resistance to anti-TB drugs could have impacted culture conversion. Secondary outcomes will include other clinical outcomes (treatment not completed, death, or loss to follow-up), cost-effectiveness-individual and societal costs with quality-adjusted life years-and acceptability and usability of the intervention by patients and providers.DISCUSSION:This study will be the first in Ethiopia, and of the first three in sub-Saharan Africa, to determine whether electronic pillbox-enabled SAT improves adherence to TB medication and treatment outcomes, all without affecting the inherent dignity and economic wellbeing of patients with TB.TRIAL REGISTRATION:ClinicalTrials.gov, NCT04216420. Registered on 2 January 2020.
机译：背景：为了满足与结核病（TB）相关的多方面挑战直接观察治疗（DOT），世界卫生组织最近建议各国最大限度地利用数字依据技术。撒哈拉以南非洲需要调查这些技术在当地背景下的效力，并积极促进患者以患者为中心的TB护理的全球决策。本研究旨在评估与埃塞俄比亚在埃塞俄比亚中的结核病药物和治疗结果上的标准点相比，评估了能够的自我施用治疗（SAT）的有效性。它还旨在评估患者和提供者观点的干预的可用性，可接受性和成本效益。方法：这是一种多中心，随机，控制，开放标签，优势，有效性 - 实施混合，混合方法，双臂试验。该研究旨在注册144名患有新的或先前治疗的细菌学证实的药物敏感的肺结核，有资格启动标准的6个月一线抗TB方案。干预臂中的参与者（n？=α72）将在Evrimed500药物事件提醒监测装置中获得15天的Hrze-Isoniazid，利福平，吡嗪酰胺和乙胺醛固定剂量联合治疗，用于自我管理。返回后，提供商将在设备中计算任何剩余的片剂，下载丸丸数据，并根据预设标准重新填充。参与者可以在预定访问之外的疾病或不良事件的情况下咨询提供商。提供商将根据标准的亲自点处理控制臂（n？=Δ72）的参与者。在整个2个月的密集阶段，双臂都会随访。主要结果将是药物依从性和痰液转换。将依从药物治疗将被计算为错过干预（丸计数）与点（直接观察）武器中的剂量的患者的比例，通过IsoScreen尿体Isoniazid测试进一步确认，并对八件疗法用药依从性的依从性的自我报告规模。痰液转化被定义为干预相对于点臂的强化阶段后涂片型患者的比例，通过预先密集的相Bactec Mgit TB液体培养来进一步证实。后处理前治疗前的MgIT药物易感性测试将确定对抗结核病药物的耐药可能是否有影响培养转化。二次结果将包括其他临床结果（治疗未完成，死亡或丧失的损失），成本效益 - 个人和社会成本，具有质量调整的生命年份 - 患者和提供者的干预的可接受性和可用性。探讨：这项研究将是埃塞俄比亚的第一个，并在撒哈拉以南非洲的前三名，确定是否能够改善依赖于结核病药物和治疗结果的依赖，而不是影响患者的固有尊严和经济福祉TB.Trial注册：ClinicalTrials.gov，NCT04216420。在2020年1月2日注册。

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