Behavioral Science Aspects of Rapid Test Acceptance

描述(由申请人提供)：本申请针对“艾滋病毒/艾滋病和艾滋病相关的混合感染”，如“丙型肝炎病毒(丙型肝炎病毒)、其他性传播感染(STI)”，这是PA-07-307艾滋病毒/艾滋病药物滥用方面的一部分，旨在“研究改善艾滋病毒咨询和检测的可及性和利用率”。目前，美国唯一被批准使用的快速检测方法是艾滋病毒感染。其他国家也在使用丙型肝炎和梅毒等其他疾病的检测。美国疾病控制与预防中心在《联邦公报》上公布了一个机会，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。该项目将进行一项两部分的研究，以评估实验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)将从现有的血清库将血清运往疾控中心，在那里血清样本将用丙型肝炎病毒、梅毒和艾滋病毒的快速检测试剂盒进行检测。结果将被送回CBRS，在那里以前的标准实验室测试结果将是非盲目的，CDC实验测试结果将与标准测试结果相比进行敏感性和特异性评估。在第二部分中，将在四臂试验中向参与者提供快速测试和标准测试的不同组合，以评估参与者接受哪些测试。在CBRS接受艾滋病毒快速检测的客户中，只有一小部分人接受了这种方法。那些选择快速艾滋病毒检测的人更有可能是男性、受过教育、同性恋、年轻和白人。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艾滋病毒、梅毒和丙型肝炎病毒的筛查产生重大影响。快速检测有可能增加对检测结果的接收，特别是在那些使用传统检测不太可能返回结果的群体中。这项拟议研究的数据将有助于FDA批准实验性筛查测试。候选测试是为关注点(口服液和/或全血)设计的，因此在血清样本上验证后需要进行实时测试，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现实世界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.