Monitoring Atypical HIV Strains among Persons Newly Dia*

监测新发感染者中的非典型艾滋病病毒毒株*

• 批准号: 7282578
• 负责人: CAROL A CIESIELSKI
• 金额: $ 8.16万
• 依托单位: CITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7282578
• 关键词: AIDS /HIV diagnosis; antiAIDS agent; blood tests; clinical research; cooperative study; data collection methodology /evaluation; diagnosis design /evaluation; diagnosis quality /standard; drug resistance; genotype; human immunodeficiency virus 1; human subject; mathematics; nucleic acid purification; nucleic acid sequence; patient oriented research; polymerase chain reaction; sample collection; serology /serodiagnosis; virus genetics

DESCRIPTION (provided by applicant): The purpose of the program is to expand the ability of the Chicago Department of Public Health (CDPH) to perform surveillance of the prevalence of atypical strains of HIV, including drug resistant strains and non-B subtypes, by piloting the use of dried blood spots. CDPH is conducting a CDC-funded study to conduct studies of atypical and resistant HIV strains in persons newly diagnosed with HIV using remnant serum from the diagnostic specimen. This study, "Variant, Atypical and Resistant HIV Surveillance (VARHS)," is currently being implemented at eight sites in Chicago. However, some diagnostic sites and clinical centers in Chicago cannot be included in that surveillance effort due to logistical problems with specimen availability, specimen processing time, or staff acceptance. The sites selected for this project represent a diverse range of testing settings and encompass a wide geographic area of Chicago. Location types include hospitals, neighborhood clinics, community centers, late-night street corners, needle exchange programs, outreach sites, and drug rehabilitation centers. This diversity will provide a unique opportunity to conduct atypical HIV surveillance activities in non-health care settings, and may more accurately represent all persons newly diagnosed with HIV in Chicago. Moreover, data from this project will enhance the ability of CDPH to conduct surveillance for resistant and atypical HIV strains. Because of Chicago's very large immigrant population, the ability to monitor atypical strains is especially valuable. Our objectives are to: (1) monitor the prevalence of HIV drug resistant strains and non-B HIV-1 subtypes in persons newly diagnosed with HIV in public and private settings in Chicago, including those in which sera are not available for HIV genotyping and those in which sera are used.; (2) compare the results of HIV genotyping for atypical strain surveillance purposes from both a serum specimen and a dried blood spot collected not more than three months after HIV diagnosis; (3) compare the prevalence of atypical strains of HIV among persons diagnosed at sites where remnant sera from HIV diagnostic specimens are used for HIV drug resistance and subtype surveillance, and sites where remnant sera cannot be used, such as sites where sera is not used for HIV diagnosis, sites where phlebotomy volumes for HIV testing specimens are consistently below the 1 ml minimum of remnant serum for HIV genotyping for the purpose of atypical strain surveillance, sites where the use of sera from the diagnostic blood draw for HIV genotyping is not practical because the time between blood draw and processing is consistently greater than 96 hours rendering the amplification of virus for HIV drug resistance genotyping problematic, and sites where the use of dried blood spots (DBS) for atypical HIV strain surveillance is more acceptable than the use of sera to staff or participants, or where fewer resources may be required to collect DBS than sera; and (4) evaluate the resources needed and the logistics involved in collecting and transporting specimens and amplifying HIV for genotyping from DBS, compared with using HIV diagnostic sera, for routine atypical HIV strain surveillance.

描述（由申请人提供）： 该方案的目的是扩大芝加哥公共卫生部（CDPH）的能力，通过试点使用干血斑，监测非典型艾滋病毒株的流行情况，包括耐药株和非B亚型。CDPH正在进行一项由CDC资助的研究，利用诊断标本中的残留血清，对新诊断为艾滋病毒感染者的非典型和耐药艾滋病毒株进行研究。 这项名为“变异、非典型和耐药艾滋病毒监测（VARHS）”的研究目前正在芝加哥的八个地点实施。 然而，由于标本可用性、标本处理时间或工作人员接受方面的后勤问题，芝加哥的一些诊断中心和临床中心无法纳入该监测工作。 为该项目选择的研究中心代表了各种各样的测试设置，并涵盖了芝加哥的广泛地理区域。 地点类型包括医院、社区诊所、社区中心、深夜街角、针头交换项目、外展站点和戒毒中心。 这种多样性将提供一个独特的机会，进行非典型的艾滋病毒监测活动，在非卫生保健设置，并可能更准确地代表所有人新诊断为艾滋病毒在芝加哥。 此外，来自该项目的数据将提高该委员会监测抗药性和非典型艾滋病毒菌株的能力。 由于芝加哥的移民人口非常多，监测非典型菌株的能力特别有价值。 我们的目标是：（1）监测芝加哥公共和私人环境中新诊断出的艾滋病毒感染者中艾滋病毒耐药株和非B类艾滋病毒1亚型的流行情况，包括那些无法获得血清进行艾滋病毒基因分型的人和那些使用血清的人; (2)比较诊断后不超过三个月内收集的血清样本和干血斑的HIV基因分型结果，以进行非典型菌株监测;（3）比较在使用来自HIV诊断标本的残余血清进行HIV耐药性和亚型监测的地点和不能使用残余血清的地点诊断的人中HIV非典型毒株的流行率，例如血清不用于HIV诊断的场所，HIV检测样本的采血体积始终低于用于HIV基因分型的最小残留血清1 ml以进行非典型菌株监测的场所，使用来自诊断性抽血的血清进行HIV基因分型是不切实际的，因为抽血和处理之间的时间始终大于96小时，使得用于HIV耐药性基因分型的病毒扩增存在问题，以及使用干血点（DBS）进行非典型HIV毒株监测比使用血清更可接受的工作人员或参与者，或者收集DBS所需资源比收集血清所需资源少的研究中心;和（4）与使用HIV诊断血清相比，评估收集和运输标本以及扩增HIV用于DBS基因分型所需的资源和后勤，进行常规非典型HIV病毒株监测。