Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in Brazil

描述（由申请人提供）：结核病（TB）是艾滋病毒感染者最常见的死亡原因。在HIV感染患者中诊断潜伏性结核感染（LTBI）是具有挑战性的，因为最常用的测试，结核菌素皮肤测试（TST），是过时的，在HIV感染和BCG接种人群中的敏感性差，并且操作上难以管理。世界卫生组织目前建议，在可以实施TST检测LTBI的地区，建议仅为TST阳性的HIV感染患者提供预防性治疗。一种新的血液检测试剂盒Quantiferon TB Gold In-Tube（QGIT）检测试剂盒最近已被美国FDA批准用于检测LTBI，但相对较少的已发表研究在HIV感染患者中评价了该检测试剂盒，并且关于QGIT常规使用的信息很少，即在常规临床护理条件下的检测性能和该血液检测的最佳操作。我们提出了一个集群随机试验（CRT），比较QGIT性能在艾滋病毒感染者参加公共艾滋病毒诊所在里约热内卢，巴西与常规TST，并确定QGIT是否更快地识别艾滋病毒感染者谁是潜伏感染，并导致更快地启动结核病预防治疗。我们将把QGIT检测与常规CD 4监测联系起来，这将消除常规诊所工作人员的负担，并最大限度地减少对常规抽血的干扰。在里约热内卢，TST和异烟肼预防治疗的延迟时间非常长，等待TST的艾滋病毒感染者患结核病的风险相当高，因此需要更好的战略。该研究的具体目的是：1）比较将QGIT与CD 4血液采集和巴西里约热内卢HIV诊所TST护理流程的现行标准联系起来对操作指标的影响，2）比较实施QGIT与TST标准实践的成本效益，3）探索影响QGIT成功实施的态度和操作因素。我们的主要重点是将QGIT与常规CD 4抽血联系起来，这是创新和合乎逻辑的测试参数。除了对干预措施的实施进行结构化过程评价和确定QGIT与TST相比的成本效益外，这些发现还将提供迄今为止在发展中国家的操作环境中比较这两种测试的最佳证据，并指导在巴西和TST无法有效诊断艾滋病毒潜伏感染的其他地区传播和实施这一战略，感染的病人。

DESCRIPTION (provided by applicant): Tuberculosis (TB) is the most common cause of death among people living with HIV. Diagnosing latent tuberculosis infection (LTBI) among HIV-infected patients is challenging, as the most commonly used test, the tuberculin skin test (TST), is out-dated, has poor sensitivity in HIV-infected and BCG vaccinated populations, and is operationally difficult to administer. The World Health Organization currently recommends that in regions where the TST can be implemented to detect LTBI, provision of preventive therapy is recommended only for HIV-infected patients with a positive TST. A new blood assay, Quantiferon TB Gold In-Tube (QGIT) test, has been recently approved by the US FDA for detecting LTBI, however relatively few published studies have evaluated this assay in HIV-infected patients and little information exists about the routine use of QGIT, i.e. test performance under routine clinical care conditions and optimal operationalization of this blood test. We propose a cluster randomized trial (CRT) to compare QGIT performance in HIV-infected persons attending public HIV clinics in Rio de Janeiro, Brazil with routine TST, and to determine if QGIT more quickly identifies HIV-infected patients who are latently infected and leads to faster initiation of TB preventive therapy. We will link QGIT testing with routine CD4 monitoring which will eliminate the burden of the routine clinic staff and minimally interfere with routine blood draws. Delays in TST and provision of isoniazid preventive therapy in Rio de Janeiro are extremely long, and risk of TB disease is quite high among HIV-infected patients waiting for a TST, thus a better strategy is needed. The specific aims of the study are 1) to compare the impact of linking QGIT with CD4 blood collection and the current standard of care process of TST in HIV clinics in Rio de Janeiro, Brazil on operational metrics, 2) to compare cost-effectiveness of implementing QGIT versus standard practice of TST, and 3) to explore attitudinal and operational factors influencing successful implementation of QGIT. Our primary focus on linking QGIT with routine CD4 blood draws is innovative and logical given the parameters of the test. These findings, in addition to conducting a structured process evaluation of the implementation of the intervention and determining the cost effectiveness of QGIT compared to TST will provide the best evidence to date comparing these two tests in an operational setting in a developing country, and guide dissemination and implementation of this strategy throughout Brazil and other regions where TST is ineffective at diagnosing latent infection in HIV- infected patients.