The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)

项目概要/摘要 这是推进艾滋病毒预防和护理的关键时刻。在美国，测试已经成为 艾滋病毒/艾滋病传播广泛，大多数艾滋病毒感染者都知道自己的状况。抗逆转录病毒疗法 (ART)已经变得如此简单和可容忍，大多数PLWH可以达到“检测不到”的艾滋病毒水平， 对他们自己的健康有益，并且变得“不可传染”给他们的伴侣。暴露前预防（PrEP） 是一种安全有效的减少艾滋病毒感染的方法。然而，护理点（POC）艾滋病毒检测， 是FDA批准的仍然未能识别高传染性的人与急性感染，并实时遵守 艾滋病毒治疗和PrEP的咨询选择有限。艾滋病毒继续产生不成比例的影响 在男性和男男性行为者中， 甲基苯丙胺使用者的风险尤其高。POC核酸的成功实施 检测（NAT）有可能解决艾滋病毒预防和护理方面的一些剩余挑战。 为本合作协议（U 01）提出的项目将开发、实施和评估以下模型： 在寻求艾滋病毒检测、PEP和PrEP的艾滋病毒阴性者和艾滋病毒阳性者中使用POC NAT 在社区和临床环境中。经过一段时间的形成性工作，以建立方案、标准操作程序、数据 收集工具和数据分析计划，目标#1和#2将评估 定性POC NAT的人不知道是艾滋病毒阳性，并将确定其使用的影响PrEP 艾滋病毒检测呈阴性者的接受率和持久性以及及时获得艾滋病毒连续护理成果 在新检测出艾滋病毒呈阳性的人中。目标3将实施POC NAT定制的行为干预 评价接受ART治疗的PLWH对病毒学抑制时间的影响。目标#4将量化 在社区和临床环境中实施POC NAT的可接受性和可行性，并收集成本 和相关数据进行成本效益分析。最后，在目标5中，一项独特但相关的研究将比较 多种POC NAT在一系列HIV RNA水平上的敏感性、特异性和一致性。 本项目将收集有关POC NAT性能和相关临床结局、患者和 提供者关于可接受性和可行性的观点，以及实施科学成果，包括 成本效益。雇用一个在艾滋病毒检测（包括POC NAT）方面具有实质性专业知识的研究团队， PrEP和HIV临床护理和规划，社区和公共卫生专业知识，药物依从性 干预措施和成本效益分析，这种合作将致力于实施POC NAT， 记录真实的世界的测试性能和开发模型，以改善艾滋病毒的护理和预防 在美国的成果。

Project Summary/Abstract This is a critical time for the advancement of HIV prevention and care. In the U.S., testing has become widespread, and most persons who are living with HIV (PLWH) are aware of their status. Antiretroviral therapy (ART) has become so simple and tolerable that most PLWH can achieve “undetectable” HIV levels, reaping benefits for their own health and becoming “untransmittable” to their partners. Pre-exposure prophylaxis (PrEP) is a safe and efficacious method of reducing HIV acquisition. However, the point-of-care (POC) HIV tests that are FDA-approved still fail to recognize highly infectious persons with acute infection, and real-time adherence counseling options for HIV treatment and PrEP are limited. HIV continues to have disproportionate impact among men and transgender persons who have sex with men, with subpopulations like racial/ethnic minorities and methamphetamine-users being at particularly high risk. Thoughtful implementation of POC nucleic acid tests (NAT) has potential to address some of the remaining challenges in HIV prevention and care. The project proposed for this Cooperative Agreement (U01) will develop, implement, and evaluate models for use of POC NAT among HIV-negative persons seeking HIV testing, PEP, and PrEP and HIV-positive persons in community and clinical settings. Following a period of formative work to establish protocols, SOPs, data collection instruments, and data analysis plans, Aims #1 and #2 will evaluate the sensitivity and specificity of a qualitative POC NAT in persons not known to be HIV-positive and will determine the impact of its use on PrEP uptake and persistence among persons testing HIV-negative and on time to HIV continuum of care outcomes among persons testing newly HIV-positive. Aim #3 will implement a POC NAT-tailored behavioral intervention to evaluate impact on time to virologic suppression among PLWH receiving ART. Aim #4 will quantify the acceptability and feasibility of implementation of POC NAT in community and clinical settings and collect cost and related data for cost-effectiveness analyses. Finally, in Aim #5, a distinct but related study will compare the sensitivity, specificity, and agreement of multiple POC NATs over a range of HIV RNA levels. This project will collect data on the performance of POC NAT and associated clinical outcomes, patient and provider perspectives regarding acceptability and feasibility, and implementation science outcomes including cost effectiveness. Employing a research team with substantive expertise in HIV testing including POC NAT, PrEP and HIV clinical care and programming, community and public health expertise, medication adherence interventions, and cost-effectiveness analysis, this collaboration will work to implement POC NAT with the goal of documenting real world test performance and developing models to improve HIV care and prevention outcomes in the U.S.