Comparisons of Public Health Screening Methods for Acute and Early HIV Infection

急性和早期艾滋病毒感染的公共卫生筛查方法比较

• 批准号: 8312718
• 负责人: Joanne Donna Stekler
• 金额: $ 51.67万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8312718
• 关键词: AIDS prevention; Acute; Address; Adult; Advocate; Antibodies; Anus; Biological Assay; Blood; Caring; Centers for Disease Control and Prevention (U.S.); Chi-Square Tests; Clinic; Clinical Trials Design; Collaborations; Counseling; County; Data; Detection; Developing Countries; Diagnosis; Enrollment; Fingers; Frequencies; Funding; Goals; HIV; HIV Antibodies; HIV Infections; HIV Seropositivity; HIV antibody positive; HIV-1; Health Policy; Home environment; Human immunodeficiency virus test; Incidence; Individual; Infection; International; Intervention; Liquid substance; Location; Methods; Nucleic Acid Amplification Tests; Oral; Partner Notification; Penetrance; Performance; Persons; Population; Prevalence; Prevention; Prevention program; Prospective Studies; Public Health; RNA; Randomized; Randomized Clinical Trials; Recommendation; Recruitment Activity; Relative (related person); Reporting; Research; Risk; Risk Reduction; Sampling; Screening procedure; Sensitivity and Specificity; Sex Behavior; Site; Specimen; Spottings; Swab; Test Result; Testing; Time; Training; Translational Research; United States; Universities; Variant; Venipunctures; Washington; arm; base; cost; cost effectiveness; diaries; disorder prevention; high risk; men; men who have sex with men; prevent; programs; time interval; tool; transmission process

This is a critical time for HIV prevention programs. Recent recommendations advocate universal HIV antibody testing in order to identify the estimated 25% of HIV-infected individuals who are unaware of their HIV status. In the United States, men who have sex with men (MSM) still represent the group with the greatest risk for HIV acquisition despite a high penetrance of testing. Efforts to prevent HIV transmission must therefore increase the frequency of HIV testing among MSM and thereby decrease the time interval that infected individuals are unaware of their status and their potential for transmission. However, strategies that increase the frequency of HIV testing in a population with high incidence will paradoxically increase the rate of false-negative test results in the "window period" following HIV acquisition, requiring the use of antibody tests with the highest sensitivity in early infection or concurrent nucleic acid amplification testing (NAAT) to shorten the window period further. Of 14005 specimens from MSM tested by Public Health - Seattle & King County (PHSKC) from September 2003 to June 2008, 328 (2.3%) MSM were HIV antibody-positive, and 36 (0.3%) antibody-negative MSM had acute infection. The OraQuickADVANCE Rapid HIV-1/2 Antibody Test (OraQuick) detected only 153 (80%) of the 192 HIV-infected MSM screened by the rapid test. The proposed studies will increase our understanding of the interactions between the frequency of HIV testing, test sensitivity, and the diagnosis of acute and early HIV infection. In Aim #1, we will evaluate an intervention to increase the frequency of HIV testing by randomizing HIV-negative MSM to either home self-testing with OraQuick or to testing in clinic settings that include NAAT. In Aim #2 we will compare the real-time performance of three rapid HIV antibody tests in order to determine their relative capabilities to detect persons immediately after HIV acquisition. In Aim #3, we will generate data to evaluate the performance of NAAT on specimens (oral fluids and dried blood spots) that could be collected as part of home testing or in other settings without immediate access to NAAT. Cost-effectiveness analyses will be performed to evaluate the costs of different HIV testing strategies per case of HIV infection identified. This application addresses several topics that had been sought to advance prevention opportunities to reduce HIV transmission. These research topics include methods to increase the detection of acute and early HIV infection, including the combination of rapid assays and NAAT, and ways to diagnose acute and early infection in developing countries. The expansion of HIV testing with antibody testing alone may have undesired effects if highly-infectious persons with recent HIV infection receive false-negative test results and are inappropriately reassured. The cross-disciplinary collaboration between PHSKC and the University of Washington will support this translational research to inform local, national, and international public health policy.

这是艾滋病毒预防计划的关键时刻。最近的建议提倡普遍的艾滋病毒抗体 检测，以确定估计25%的艾滋病毒感染者谁不知道他们的艾滋病毒状况。 在美国，男男性行为者（MSM）仍然是感染艾滋病毒风险最高的群体 尽管测试的成功率很高。因此，必须加强预防艾滋病毒传播的努力 艾滋病毒检测的频率在男男性行为者，从而减少感染者的时间间隔 不知道他们的状态和传播的可能性。然而，增加频率的策略 在发病率高的人群中进行艾滋病毒检测反而会增加假阴性检测结果的发生率 在感染艾滋病毒后的“窗口期”，需要使用灵敏度最高的抗体检测 在感染早期或同时进行核酸扩增检测（NAAT），以进一步缩短窗口期。 从2010年9月开始，公共卫生部-西雅图和金郡（PHSKC）对14005份MSM样本进行了检测， 2003年至2008年6月，328名（2.3%）MSM为HIV抗体阳性，36名（0.3%）抗体阴性MSM为HIV抗体阳性。 急性感染OraQuickADVANCE快速HIV-1/2抗体测试（OraQuick）仅检测出153例（80%） 用快速检测法筛查出192例HIV感染的MSM。建议的研究将增加我们对以下问题的了解： HIV检测频率、检测灵敏度和急性和早期HIV诊断之间的相互作用 感染在目标1中，我们将评估一种干预措施，通过随机分配 HIV阴性的男男性接触者可以在家里用OraQuick进行自我检测，也可以在包括NAAT在内的诊所进行检测。 在目标#2中，我们将比较三种快速HIV抗体检测的实时性能，以确定 他们在感染艾滋病毒后立即检测出感染者的相对能力。在目标#3中，我们将生成数据 评价NAAT在可采集标本（口腔液和干血斑）上的性能 作为家庭测试的一部分或在其他环境中，而不能立即访问NAAT。成本-效果分析 将进行评估的成本，不同的艾滋病毒检测策略，每例艾滋病毒感染的确定。 该应用程序涉及几个主题，这些主题旨在促进预防机会，以减少 艾滋病毒传播。这些研究课题包括增加急性和早期艾滋病毒检测的方法 感染，包括快速检测和NAAT的组合，以及诊断急性和早期感染的方法 在发展中国家扩大艾滋病毒检测，仅进行抗体检测可能会产生不良影响， 最近感染艾滋病毒高度传染者得到假阴性检测结果， 放心PHSKC和华盛顿大学之间的跨学科合作将支持 这项转化研究为地方，国家和国际公共卫生政策提供信息。