Behavioral Science Aspects of Rapid Test Acceptance

描述（由申请人提供）：本申请涉及PA-07-307艾滋病毒/艾滋病药物滥用方面的“改善获取和利用艾滋病毒咨询和检测的研究”，用于“艾滋病毒/艾滋病和与艾滋病相关的合并感染”，如“丙型肝炎病毒（HCV），其他性传播感染（STIs）”。目前在美国唯一被批准使用的快速检测是针对HIV感染的。其他国家也在使用丙型肝炎（HCV）和梅毒等其他疾病的检测。为响应美国疾病控制与预防中心在《联邦公报》上发表的机会，现在美国有候选的丙型肝炎病毒和梅毒快速检测试剂盒可供实验使用。该项目将进行两部分研究，以评估实验性快速测试的准确性和可接受性。在第一部分中，行为研究和服务中心（CBRS）将从现有的血清库中运送血清到疾病预防控制中心，在那里，血清样本将用HCV、梅毒和HIV的快速检测试剂盒进行检测。结果将被发送回CBRS，在CBRS中，之前的标准实验室检测结果将被解盲，CDC实验检测结果将与标准检测结果进行敏感性和特异性评估。在第2部分中，在四组试验中，将向参与者提供快速和标准测试的不同组合，以评估参与者接受哪些测试。在CBRS，只有少数接受了艾滋病快速检测的客户接受了这项服务。选择快速艾滋病毒检测的人更有可能是受过教育的男性、同性恋者、年轻人和白人。他们不太可能是黑人或注射吸毒者。这项拟议的研究有可能对HIV、梅毒和HCV的筛查产生重大影响。快速检测有可能增加检测结果的接收，特别是在不太可能返回使用传统检测来获取检测结果的群体中。拟议研究的数据将有助于fda批准实验性筛选测试。候选测试是为护理点设计的（口服液和/或全血），因此需要在血清样本上进行验证后进行实时测试，因此试验将能够评估测试在预期使用环境中的准确性以及它们在实际情况下对潜在客户的可接受性。

DESCRIPTION (provided by applicant): This application addresses "Studies to improve access and utilization of HIV counseling and testing" for "HIV/AIDS and AIDS-related co-infections" such as "hepatitis C virus (HCV), other sexually transmitted infections (STIs)" that are part of PA-07-307 Drug Abuse Aspects of HIV/AIDS. The only rapid tests that are approved for use in the US currently are for HIV infection. Tests for other conditions such as hepatitis C (HCV) and syphilis are in use in other countries. In response to an Opportunity that the CDC published in the Federal Register, there are now candidate rapid test kits for HCV and syphilis available for experimental use in the US. This project will conduct a two-part study to assess the experimental rapid tests for accuracy and acceptability. In part 1, the Center for Behavioral Research and Services (CBRS) will ship serum from an existing serum bank to CDC where the serum samples will be tested with the rapid test kits for HCV, syphilis, and HIV. The results will be sent back to CBRS where the previous standard laboratory test results will be unblinded and the CDC experimental test results will be assessed for sensitivity and specificity as compared to the standard test results. In part 2, different combinations of rapid and standard tests will be offered to participants in a four-arm trial to assess which tests are accepted by the participants. Only a minority of clients at CBRS who have been offered the rapid test for HIV have accepted it. Those who chose rapid HIV tests were more likely to be male, educated, gay, young and White. They were less likely to be Black, or injection drug users. The proposed study has the potential to have a significant impact upon screening for HIV, syphilis, and HCV. Rapid tests have the potential to increase the receipt of test results, particularly among groups that are less likely to return for their results using traditional testing. The data from the proposed study will contribute to FDA-approval for the experimental screening tests. The candidate tests are designed for Point of Care (either oral fluid and/or whole blood), and thus will require real-time testing after they have been validated on the serum samples, so the trial will be able to evaluate both the accuracy of the tests in settings of intended use and their acceptability to potential clients in real-world situations. PUBLIC HEALTH RELEVANCE: The relevance of this research to public health is to make it possible to test for hepatitis C and syphilis at point of care so that people will receive their results immediately instead of requiring people to wait for at least a week to get their test results. This research will make rapid tests for HIV available that can detect HIV infection earlier and are more accurate than current tests available in the United States.