The STOP Study

停止研究

• 批准号: 8472365
• 负责人: Tracey Packer
• 金额: $ 32.51万
• 依托单位: SAN FRANCISCO DEPARTMENT OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-15 至 2015-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8472365
• 关键词: STOP; Study

DESCRIPTION (provided by applicant): Detection of acute HIV infection (AHI), defined as the time between HIV acquisition and seroconversion, is of high public health importance. Studies indicate that transmissions during acute infection account for a disproportionate number of new HIV infections. Supporting the prevention importance of AHI detection, persons newly diagnosed with HIV dramatically reduce their risk behavior, and testing partners of AHI index cases results in a high percentage of newly diagnosed HIV cases. Attempts to detect AHI have mostly involved RNA-detection algorithms using pooled HIV antibody-negative specimens, commonly known as pooled nucleic acid amplification testing (NAAT). But pooling can be expensive, laborious, and operationally daunting. An alternative for AHI detection is to use antigen-antibody combination tests, so called "fourth- generation" immunoassays. Although such tests are not yet approved by the FDA in the United States, they are easy to perform, relatively inexpensive, and easily automated. However, there is a paucity of data available on the performance of fourth-generation assays relative to HIV RNA detection algorithms in the public health setting. Whether the potential increased efficiency of fourth-generation testing, and possible lower cost of such tests, compensate for missing infections otherwise detectable by NAAT pooling remains to be determined. In addition, the overall public health effect and cost-effectiveness of sexual partner and social network partner notification and testing in the setting of routine AHI screening requires further study. Therefore, as required in the RFA "Screening Targeted Populations to Interrupt On-going Chains of Transmission with Enhanced Partner Notification" the specific aims of this project are: 1. To evaluate the yield, cost-effectiveness, and feasibility of screening for AHI with a fourth-generation enzyme immunoassay (EIA) in high-risk/high-incidence settings compared to pooled NAAT. 2. To evaluate the yield, cost-effectiveness, and feasibility of enhanced partner notification/contact tracing techniques linked to AHI screening. The San Francisco Department of Public Health's (SFDPH) HIV Prevention Section is uniquely qualified to respond to this RFA. Expanding upon our well-coordinated HIV testing programs, we will collect and test 22,000 specimens for this project at sites with high HIV incidence, including among men who have sex with men (MSM) and MSM of color. All four proposed collaborating clinical sites have a long history collaborating with us on testing and partner notification interventions; three have experience with NAAT pooling. Our SFDPH Microbiology Lab has experience with fourth-generation EIA and a history of leadership, research and collaboration on cutting-edge public health initiatives. Finally, we have a twenty-five year history of successful collaboration with the Centers for Disease Control and Prevention, ensuring that scientific and operational goals will be met.

描述（由申请人提供）：急性艾滋病毒感染（AHI）的检测，定义为艾滋病毒获取和血清转化之间的时间，具有很高的公共健康重要性。 研究表明，急性感染期间的传播是新的HIV感染数量不成比例的。支持AHI检测的预防重要性，新诊断为HIV的人会大大降低其风险行为，并测试AHI指数案件的伴侣，导致新诊断的已诊断出的HIV病例的比例很高。 试图检测AHI的尝试主要涉及使用合并的HIV抗体阴性标本（通常称为合并的核酸扩增测试（NAAT））的RNA检测算法。 但是合并可能是昂贵，费力且在操作上令人生畏的。 AHI检测的一种替代方法是使用抗原抗体组合测试，即称为“第四代”免疫测定。尽管此类测试尚未在美国的FDA批准，但它们易于执行，相对便宜且易于自动化。 但是，相对于公共卫生环境中的HIV RNA检测算法，关于第四代测定的性能的数据很少。 是否有可能提高第四代测试的效率，以及此类测试的可能较低的成本，以补偿NAAT POLING可检测到的缺失感染。 此外，在常规AHI筛查中，性伴侣和社交网络合作伙伴通知和测试的总体公共卫生效应以及成本效益需要进一步研究。 因此，按照RFA的“筛选目标人群的筛查，以中断伴侣通知的持续传播链”。 2。评估与AHI筛查相关的增强合作伙伴通知/接触跟踪技术的产量，成本效益和可行性。 旧金山公共卫生部（SFDPH）的艾滋病毒预防部门具有独特的资格来应对此RFA。 扩展了我们协调的HIV测试计划，我们将在艾滋病毒发病率高的网站（包括与男性发生性关系（MSM）和MSM有色人种的男性中为此项目收集和测试22,000个标本。 所有四个提议的合作临床站点都在与我们进行测试和合作伙伴通知干预措施方面的历史悠久。三个具有Naat Poling的经验。 我们的SFDPH微生物学实验室具有第四代EIA的经验以及领导力，研究和合作的历史，在尖端公共卫生计划中。 最后，我们与疾病控制和预防中心成功合作有25年的历史，以确保实现科学和运营目标。