背景:为了解决与结核病(TB)直接观察治疗(DOT)相关的多方面挑战,世界卫生组织最近建议各国最大限度地利用数字遵守技术。撒哈拉以南非洲需要在当地背景下调查此类技术的有效性,并为围绕以患者为中心的结核病护理的全球决策做出积极贡献。这项研究旨在评估与标准DOT相比,Pillbox自给药疗法(SAT)对埃塞俄比亚结核病药物依从性和治疗结果的有效性。它还旨在评估可用性,可接受性,以及从患者和提供者角度进行干预的成本效益。
方法:这是一个多中心,随机化,控制,开放标签,优越性,有效性-实施混合,混合方法,双臂审判。该研究旨在招募144名新的或以前接受过治疗的门诊患者,细菌学证实,有资格开始标准6个月一线抗结核方案的药物敏感性肺结核。干预组(n=72)的参与者将接受15天的HRZE-异烟肼,利福平,吡嗪酰胺,和乙胺丁醇固定剂量联合治疗在evriMED500药物事件提醒监测装置自我给药。返回时,提供商将计算设备中剩余的平板电脑,下载服药数据,和根据预设的标准重新填充。参与者可以在计划访问之外的疾病或不良事件的情况下咨询提供者。提供商将根据标准的亲自DOT处理控制臂(n=72)中的参与者。双方将在整个2个月的密集阶段进行跟进。主要结果将是药物依从性和痰液转换。对药物的坚持将计算为在干预(药丸计数)与DOT(直接观察)臂中错过剂量的患者比例,通过IsoScreen尿液异烟肼测试和8项Morisky药物依从性量表的依从性自我报告进一步证实。痰转换定义为干预与DOT组的强化期后涂片转换患者的比例,强化期BACTECMGITTB液体培养进一步证实。治疗前的MGIT药物敏感性测试将确定抗结核药物的抗性是否可能影响培养物转化。次要结果将包括其他临床结果(治疗未完成,死亡,或后续损失),成本-效果-具有质量调整生命年的个人和社会成本-以及患者和提供者对干预措施的可接受性和可用性。
结论:这项研究将是埃塞俄比亚的第一项研究,在撒哈拉以南非洲的前三个国家中,为了确定启用电子药丸盒的SAT是否提高了对结核病药物的依从性和治疗结果,所有这些都不会影响结核病患者的固有尊严和经济福祉。
背景:ClinicalTrials.gov,NCT04216420。于2020年1月2日注册。
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov, NCT04216420. Registered on 2 January 2020.