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)

项目摘要/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 大多数艾滋病毒携带者(PLWH)知道自己的状况。抗逆转录病毒治疗 (抗逆转录病毒疗法)已经变得如此简单和可容忍，以至于大多数PLWH可以达到“无法检测到”的艾滋病毒水平，从而收获 对自己的健康有益，并变得“无法传递”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，医疗点(POC)艾滋病毒检测表明 FDA批准的仍不能识别高感染性急性感染的人，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 在与男性发生性关系的男性和变性人中，有像种族/少数民族这样的亚群 甲基苯丙胺使用者的风险特别高。深思熟虑的POC核酸实施 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(U01)提出的项目将开发、实施和评估 在寻求HIV检测、PEP和PrEP的HIV阴性者和HIV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，以建立协议、SOP、数据 收集工具和数据分析计划，目标#1和#2将评估 未知HIV阳性人群中的定性POC NAT，并将确定其使用对PrEP的影响 艾滋病毒阴性和及时检测到艾滋病毒连续护理结果的人的接受度和持久性 在检测新的艾滋病毒阳性的人中。目标3将实施PoC NAT量身定制的行为干预 评价接受抗逆转录病毒治疗对PLWH患者的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取费用 以及用于成本效益分析的相关数据。最后，在目标5中，一项不同但相关的研究将比较 在一系列HIV RNA水平上检测多个POC NAT的敏感性、特异性和一致性。 该项目将收集关于PoC NAT性能和相关临床结果、患者和 提供商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。聘用在艾滋病毒检测方面具有实质性专业知识的研究团队，包括POC NAT， 预科和艾滋病毒临床护理和规划、社区和公共卫生专业知识、用药依从性 干预和成本效益分析，此协作将致力于实施PoC NAT，目标是 记录真实世界的检测表现并开发模型来改善艾滋病毒的护理和预防 在美国取得的成果

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.