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

用于检测巴西艾滋病毒/艾滋病患者结核感染的 Quantiferon Gold 检测

• 批准号: 8843075
• 负责人: JONATHAN E. GOLUB
• 金额: $ 33.94万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-25 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8843075
• 关键词: AIDS/HIV problem; Accounting; Adherence; Biological Assay; Blood; Blood Tests; Brazil; Caring; Cause of Death; Clinic; Collection; Conceptions; Consensus; Developing Countries; Diagnosis; Diagnostic; Dimensions; Disease; Ensure; Epidemic; Evaluation; Goals; Gold; Guidelines; HIV; Health; Health Knowledge, Attitudes, Practice; Human Resources; Incidence; Infection; Interferon Type II; Intervention; Latin America; Life; Link; Metric; Monitor; Outcome; Outcome Study; Patients; Performance; Persons; Population; Preventive; Procedures; Process; Provider; Publishing; Quality-Adjusted Life Years; Relative (related person); Risk; Services; Structure; Testing; Time; Tube; Tuberculin Test; Tuberculosis; Viral load measurement; Work; World Health Organization; arm; base; clinical care; cost effective; cost effectiveness; experience; high risk; improved; innovation; isoniazid; latent infection; new technology; performance tests; prevent; programs; randomized trial; screening; standard of care; uptake; vaccination against tuberculosis

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.

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。诊断 HIV 感染者中的潜伏性结核感染 (LTBI) 具有挑战性，因为最常用的测试结核菌素皮试 (TST) 已经过时，在 HIV 感染者和接种 BCG 的人群中敏感性较差，且不可行。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，仅建议对TST阳性的HIV感染者提供预防性治疗。美国 FDA 最近批准了一种新的血液检测方法 Quantiferon TB Gold In-Tube (QGIT) 检测用于检测 LTBI，但是相对较少的已发表研究在 HIV 感染者中评估了这种检测方法，并且关于常规使用的信息也很少QGIT，即常规临床护理条件下的测试性能以及该血液测试的最佳操作。我们提出一项整群随机试验 (CRT)，以比较在巴西里约热内卢公共 HIV 诊所就诊的 HIV 感染者与常规 TST 的 QGIT 表现，并确定 QGIT 是否可以更快地识别潜伏感染的 HIV 感染者并导致感染更快地开始结核病预防治疗。我们将把 QGIT 检测与常规 CD4 监测结合起来，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。里约热内卢的 TST 和异烟肼预防性治疗的延迟时间极长，等待 TST 的 HIV 感染者患结核病的风险相当高，因此需要更好的策略。该研究的具体目的是 1) 比较将 QGIT 与 CD4 血液采集联系起来以及巴西里约热内卢 HIV 诊所当前 TST 护理流程标准对操作指标的影响，2) 比较实施 QGIT 与 TST 标准实践的对比，以及 3) 探索影响 QGIT 成功实施的态度和操作因素。考虑到测试参数，我们主要关注将 QGIT 与常规 CD4 抽血联系起来，这是创新且合乎逻辑的。这些发现，除了对干预措施的实施进行结构化流程评估并确定 QGIT 与 TST 相比的成本效益之外，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，并指导传播并在巴西和其他 TST 无法有效诊断 HIV 感染者潜伏感染的地区实施这一战略。