Algorithm-guided empirical tuberculosis treatment for people with advanced HIV (TB Fast Track): an open-label, cluster-randomised trial
Algorithm-guided empirical tuberculosis treatment for people with advanced HIV (TB Fast Track): an open-label, cluster-randomised trial
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DOI：
10.1016/s2352-3018(19)30266-8
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发表时间：
2020-01-01
期刊：
影响因子：
16.1
通讯作者：
Fielding, Katherine L.
中科院分区：
文献类型：
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作者：
Grant, Alison D.;Charalambous, Salome;Fielding, Katherine L.
背景 结核病常常未被诊断，是艾滋病毒阳性人群死亡的主要原因。我们的目的是测试使用临床算法，使初级卫生保健诊所的护士能够开始经验性结核病治疗，与晚期艾滋病毒成人的护理标准相比，是否会降低死亡率。方法在这项开放标签整群随机对照试验中，我们从南非 24 个初级卫生保健诊所招募了个体。使用计算机生成的随机数将诊所随机分配（1:1）以提供干预或常规护理（对照）。符合资格的参与者是HIV阳性成年人（年龄≥18岁），CD4计数为150个细胞/μL或更低，在过去6个月内未接受过抗逆转录病毒治疗（ART）或在过去3个月内未接受过结核病治疗，并且不需要紧急转诊医院。在干预诊所中，研究护士根据结核病症状、体重指数、护理点血红蛋白浓度和尿液阿拉伯脂甘露聚糖测定结果对参与者进行评估。根据研究算法分类为患有结核病的可能性较高的参与者（尿脂阿拉伯甘露聚糖检测呈阳性、体重指数
Background Tuberculosis, which is often undiagnosed, is the major cause of death among HIV-positive people. We aimed to test whether the use of a clinical algorithm enabling the initiation of empirical tuberculosis treatment by nurses in primary health-care clinics would reduce mortality compared with standard of care for adults with advanced HIV disease.Methods In this open-label cluster-randomised controlled trial, we recruited individuals from 24 primary health-care clinics in South Africa. The clinics were randomly assigned (1:1) to either deliver an intervention or routine care (control) using computer-generated random numbers. Eligible participants were HIV-positive adults (aged >= 18 years) with CD4 counts of 150 cells per mu L or less, who had not had antiretroviral therapy (ART) in the past 6 months or tuberculosis treatment in the past 3 months, and did not require urgent hospital referral. In intervention clinics, study nurses assessed participants on the basis of tuberculosis symptoms, body-mass index, point-of-care haemoglobin concentrations, and urine lipoarabinomannan assay results. Participants classified by a study algorithm as having high probability of tuberculosis (positive urine lipoarabinomannan assay, body-mass index