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.

这是预防艾滋病毒计划的关键时刻。最新建议提倡通用艾滋病毒抗体 进行测试以确定估计不知道其HIV状况的艾滋病毒感染者中估计的25％。 在美国，与男人发生性关系的男人（MSM）仍然代表艾滋病毒风险最大的群体 尽管测试的渗透性很高，但采集。因此，预防艾滋病毒传播的努力必须增加 MSM之间的HIV检测频率，从而减少感染个体的时间间隔是 不知道其状态和传播潜力。但是，增加了增加频率的策略 较高发病率的人群中的艾滋病毒测试将矛盾地提高假阴性测试结果的速率 在获取HIV后的“窗口”中，需要使用具有最高灵敏度的抗体测试 在早期感染或并发核酸扩增测试（NAAT）中，以进一步缩短窗户周期。 9月，由公共卫生和金县（PHSKC）测试的MSM的14005个标本 2003年至2008年6月，328（2.3％）MSM为HIV抗体阳性，36（0.3％）抗体阴性MSM具有 急性感染。 Oraquickadvance快速HIV-1/2抗体测试（Oraquick）仅检测到153（80％） 通过快速测试筛选的192 HIV感染的MSM。拟议的研究将增加我们对 HIV检测频率，测试灵敏度以及急性和早期HIV的诊断之间的相互作用 感染。在AIM＃1中，我们将评估一种干预措施，以通过随机化来增加HIV测试的频率 HIV阴性MSM可以通过Oraquick进行自我测试或在包括NAAT在内的诊所环境中进行测试。 在AIM＃2中，我们将比较三种快速HIV抗体测试的实时性能，以确定 他们在获取艾滋病毒后立即检测人员的相对能力。在AIM＃3中，我们将生成数据 评估可以收集的标本（口腔液和干血点）上NAAT的性能 作为家庭测试或其他设置的一部分，无需立即访问NAAT。成本效益分析 将执行每例发现的HIV感染病例的不同HIV测试策略的成本。 该申请涉及试图促进预防机会减少预防机会的几个主题 艾滋病毒传播。这些研究主题包括增加急性和早期HIV检测的方法 感染，包括快速测定和NAAT的组合，以及诊断急性和早期感染的方法 在发展中国家。单独使用抗体测试的HIV测试扩展可能会产生不希望的影响。 近期HIV感染的高度感染者会获得虚假测试结果，并且不适当 放心。 PHSKC与华盛顿大学之间的跨学科合作将支持 这项转化研究旨在为当地，国家和国际公共卫生政策提供信息。