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: 7115931
• 负责人: CAROL A CIESIELSKI
• 金额: $ 8.41万
• 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/7115931
• 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）： 该计划的目的是通过试点使用干血斑，扩大芝加哥公共卫生部 (CDPH) 对非​​典型 HIV 病毒株（包括耐药病毒株和非 B 亚型）流行情况进行监测的能力。 CDPH 正在开展一项由 CDC 资助的研究，利用诊断样本中的残余血清对新诊断出的 HIV 患者的非典型和耐药 HIV 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，由于样本可用性、样本处理时间或工作人员接受程度等后勤问题，芝加哥的一些诊断站点和临床中心无法纳入该监测工作。 该项目选择的地点代表了各种测试环境，涵盖了芝加哥广阔的地理区域。 地点类型包括医院、邻里诊所、社区中心、深夜街角、针具交换项目、外展场所和戒毒康复中心。 这种多样性将为在非医疗机构中开展非典型艾滋病毒监测活动提供独特的机会，并可能更准确地代表芝加哥所有新诊断出的艾滋病毒感染者。 此外，该项目的数据将增强 CDPH 监测耐药性和非典型 HIV 毒株的能力。 由于芝加哥有大量移民人口，监测非典型菌株的能力尤其有价值。 我们的目标是：(1) 监测芝加哥公共和私人场所新诊断出的 HIV 患者中 HIV 耐药菌株和非 B HIV-1 亚型的流行情况，包括那些无法使用血清进行 HIV 基因分型的患者和使用血清的患者。 (2) 比较 HIV 诊断后三个月内采集的血清样本和干血点的 HIV 基因分型结果，以用于非典型毒株监测； (3) 比较在使用 HIV 诊断标本的残余血清用于 HIV 耐药性和亚型监测的场所和不能使用残余血清的场所（例如不使用血清进行 HIV 诊断的场所、HIV 检测标本的抽血量始终低于 1 ml 最低限度的场所）诊断的人群中，非典型 HIV 毒株的患病率。 用于非典型毒株监测目的的 HIV 基因分型剩余血清、使用诊断抽血血清进行 HIV 基因分型不切实际的场所，因为抽血和处理之间的时间始终大于 96 小时，导致 HIV 耐药基因分型的病毒扩增出现问题，以及使用干血斑 (DBS) 进行非典型 HIV 毒株监测的场所 比使用血清更容易被工作人员或参与者接受，或者收集 DBS 所需的资源可能比血清少； (4) 与使用 HIV 诊断血清进行常规非典型 HIV 毒株监测相比，评估收集和运输标本以及扩增 HIV 进行基因分型所需的资源和后勤工作，以进行 DBS 基因分型。