在南非，与标准治疗相比，采用药物监测和差异化护理方法对药物敏感型肺结核患者进行治疗依从性和临床结局的研究：一项整群随机试验。
Treatment adherence and clinical outcomes amongst in people with drug-susceptible tuberculosis using medication monitor and differentiated care approach compared with standard of care in South Africa: a cluster randomized trial.
作者信息
Charalambous Salome, Maraba Noriah, Jennings Lauren, Rabothata Israel, Cogill Dolphina, Mukora Rachel, Hippner Piotr, Naidoo Pren, Xaba Nokhanyo, Mchunu Lihle, Velen Kavindhran, Orrell Catherine, Fielding Katherine L
机构信息
The Aurum Institute, Aurum House, Parktown, Johannesburg 2193, South Africa.
University of Witwatersrand, School of Public Health, Johannesburg 2193, South Africa.
出版信息
EClinicalMedicine. 2024 Jul 27;75:102745. doi: 10.1016/j.eclinm.2024.102745. eCollection 2024 Sep.
BACKGROUND
Poor treatment adherence contributes to lower treatment completion and higher loss to follow-up among people with tuberculosis (PWTB). Medication monitors have shown some evidence of improved adherence.
METHODS
We conducted a cluster randomised trial in 18 primary health clinics in South Africa between May 2019-February 2022. Persons (aged ≥ 2 years) with drug-sensitive tuberculosis (DS-TB) were enrolled. All participants were provided with monitors which were silent in the standard of care (SoC) arm. In the intevention arm, weekly adherence reports were reviewed and participants received intensified support as appropriate (text, phone call, home visit, motivational counselling). The primary outcome was adherence, which was calculated as days box was opened (proxy for drug taken)/total expected treatment days as a binary variable (<80% versus ≥80%). Analysis took into account clustered design. The trial was registered with the Pan African Trial Registry PACTR20190268115772.
FINDINGS
We enrolled 2727 participants (38% women, median age 36 (IQR 27-45 years), of whom 2584 had available adherence data. The primary outcome (measured as ≥80% adherence) was higher in intervention versus SoC arm (81.0% versus 50.8%, adjusted risk ratio (ARR) 1.51 (1.36-1.66). Similarly, overall percentage adherence was higher in intervention versus SoC arm (88.5% versus 69.7%, adjusted risk difference 16.8% (13.3%-20.4%)).
INTERPRETATION
People with DS-TB had improved treatment adherence in the intervention arm. We believe the effect on adherence is important and warrants continued use and evaluation of these technologies.
FUNDING
The study is funded by Bill & Melinda Gates Foundation, Uinted States, the Stop TB Partnership, Switzerland, and the South African Medical Research Council, South Africa.
背景
治疗依从性差导致结核病患者的治疗完成率降低和失访率升高。药物监测器已显示出一些改善依从性的证据。
方法
2019年5月至2022年2月期间，我们在南非的18家初级卫生保健诊所进行了一项整群随机试验。纳入了年龄≥2岁的药物敏感结核病（DS-TB）患者。所有参与者均获得了监测器，在标准治疗（SoC）组中监测器处于静音状态。在干预组中，每周审查依从性报告，并根据情况为参与者提供强化支持（短信、电话、家访、动机咨询）。主要结局是依从性，以药盒打开天数（代表服药情况）/总预期治疗天数计算，作为二元变量（<80% 与≥80%）。分析考虑了整群设计。该试验已在泛非试验注册中心注册，注册号为PACTR20190268115772。
结果
我们纳入了2727名参与者（38%为女性，中位年龄36岁（四分位间距27 - 45岁）），其中2584名有可用的依从性数据。干预组的主要结局（以≥80%依从性衡量）高于SoC组（81.0%对50.8%，调整风险比（ARR）为1.51（1.36 - 1.66））。同样，干预组的总体依从率百分比高于SoC组（88.5%对69.7%，调整风险差异为16.8%（13.3% - 20.4%））。
解读
DS-TB患者在干预组中的治疗依从性得到改善。我们认为对依从性的影响很重要，值得继续使用和评估这些技术。
资金来源
该研究由美国比尔及梅琳达·盖茨基金会、瑞士终止结核病伙伴关系和南非医学研究理事会资助。
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