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: 8118947
• 负责人: Joanne Donna Stekler
• 金额: $ 51.79万
• 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/8118947
• 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; 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

DESCRIPTION (provided by applicant): 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 OraQuick ADVANCE 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. PUBLIC HEALTH RELEVANCE: Recent CDC recommendations advocate universal HIV antibody testing for all adults 13-64 years old and more frequent HIV testing for individuals at risk for HIV acquisition. However, strategies that increase the frequency of HIV testing in a population with high HIV incidence will paradoxically increase the rate of false-negative test results in the "window period" following HIV acquisition, requiring the use of HIV antibody tests with the highest sensitivity in early infection or concurrent nucleic acid amplification testing (NAAT) to shorten the window period further. The studies described in this proposal will evaluate different HIV testing strategies to increase the diagnosis of highly infectious individuals with acute and early HIV infection while increasing the frequency of HIV testing among a population at high risk for HIV acquisition and transmission.

描述（由申请人提供）：这是预防HIV计划的关键时机。最近的建议主张普遍的HIV抗体测试，以确定估计不知道其HIV状况的HIV感染者中估计的25％。在美国，尽管测试很高，但与男性发生性关系（MSM）的男性仍然代表着艾滋病毒收购风险最大的群体。因此，预防艾滋病毒传播的努力必须增加MSM之间的艾滋病毒测试频率，从而减少感染个体的时间间隔不了解其状态和传播的潜力。但是，增加发病率较高的人群中HIV检测频率的策略将在艾滋病毒获取后的“窗口期”中矛盾地提高假阴性测试的速率，需要在早期感染中使用具有最高敏感性的抗体测试或同时感染的核酸酸扩增测试（NAAT），以便更缩短窗口周期。从2003年9月至2008年6月，由公共卫生和金县（PHSKC）测试的14005个标本中，有328（2.3％）MSM为HIV抗体阳性，36（0.3％）抗体（0.3％）抗体（0.3％）抗体 - 阴性MSM患有急性感染。 Oraquick Advance快速HIV-1/2抗体测试（ORAQUICK）仅检测到通过快速测试筛选的192个HIV感染的MSM中的153（80％）。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感染的诊断之间的相互作用的理解。在AIM＃1中，我们将通过将HIV阴性MSM随机化为与Oraquick的家庭进行自我测试或在包括NAAT在内的临床环境中进行测试，以评估一种干预措施，以增加HIV检测的频率。在AIM＃2中，我们将比较三种快速HIV抗体测试的实时性能，以确定其在获取HIV后立即检测人员的相对能力。在AIM＃3中，我们将生成数据，以评估可以作为家庭测试的一部分或在其他情况下收集的，而无需立即访问NAAT。将进行成本效益分析，以评估发现鉴定出艾滋病毒感染病例的不同艾滋病毒测试策略的成本。该申请介绍了一些试图促进预防机会减少艾滋病毒传播的主题。这些研究主题包括增加急性和早期艾滋病毒感染检测的方法，包括快速测定和NAAT的结合，以及诊断发展中国家急性和早期感染的方法。如果近期艾滋病毒感染的高度感染者获得假阴性测试结果，并且不适当地放心，则单独使用抗体测试的HIV检测可能会产生不希望的影响。 PHSKC与华盛顿大学之间的跨学科合作将支持这项转化研究，以告知本地，国家和国际公共卫生政策。公共卫生相关性：最近的CDC建议提倡对所有13-64岁成年人的普遍HIV抗体测试，并且针对患有艾滋病毒风险的人的艾滋病毒测试和更频繁的艾滋病毒测试。但是，增加HIV发病率的人群中HIV测试频率的策略将在艾滋病毒获取后的“窗口期”中矛盾地提高假阴性测试的速率，需要在早期感染或同时感染中使用具有最高敏感性的HIV抗体测试或同时核酸扩增测试（NAAT）以进一步处理窗口时期。该提案中描述的研究将评估不同的HIV测试策略，以增加对急性和早期HIV感染的高度感染性个体的诊断，同时增加了艾滋病毒收购和传播高风险的人群中HIV测试的频率。