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)

GAIN（NAT 的更大准入和影响）研究：通过 HIV 护理点核酸检测 (NAT) 改善 HIV 诊断、护理联系和预防服务

• 批准号: 10013096
• 负责人: Joanne Donna Stekler
• 金额: $ 87.77万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10013096
• 关键词: GAIN; Greater; Access; Impact; NAT

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.

项目摘要/摘要 这是促进艾滋病毒预防和护理的关键时刻。在美国，测试已成为 宽度，大多数患有艾滋病毒（PLWH）的人都知道自己的地位。抗逆转录病毒疗法 （艺术）变得如此简单和容忍，以至于大多数PLWH都能达到“无法检测到的”艾滋病毒水平，从而收获 对自己的健康的好处，并对伴侣变得“不可转移”。暴露前预防（PREP） 是减少艾滋病毒收购的一种安全有效的方法。但是，护理点（POC）HIV测试 FDA批准是否仍然无法识别具有急性感染和实时依从性的高度感染者 HIV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 在与男人发生性关系的男人和跨性别者中 甲基苯丙胺 - 使用者的风险特别高。周到的POC核酸实施 测试（NAT）有潜力解决艾滋病毒预防和护理中剩余的一些挑战。 该合作协议（U01）提出的项目将开发，实施和评估模型 在寻求HIV测试，PEP和PREP和HIV阳性人的HIV阴性人员中使用POC NAT 在社区和临床环境中。经过一段时间的形成工作，以建立协议，SOP，数据 收集工具和数据分析计划的目标＃1和＃2将评估A的灵敏度和特异性 定性的POC NAT是不知道HIV阳性的人，并将确定其使用对PREP的影响 测试HIV阴性的人的吸收和持久性，并准时到达艾滋病毒连续性的护理结果 在测试新近艾滋病毒阳性的人们中。 AIM＃3将实施POC NAT的行为干预 评估对接收艺术的PLWH抑制时间的影响。 AIM＃4将量化 在社区和临床环境中实施POC NAT并收集成本的可接受性和可行性 和相关数据进行成本效益分析。最后，在AIM＃5中，一项独特但相关的研究将比较 多个POC NAT在一系列HIV RNA水平上的敏感性，特异性和一致性。 该项目将收集有关POC NAT和相关临床结果的数据，患者和 提供者有关可接受性和可行性以及实施科学成果的观点 成本效益。雇用具有艾滋病毒测试实质性专业知识的研究团队，包括POC NAT， 预备和艾滋病毒临床护理和编程，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，这项合作将有助于实施POC NAT 记录现实世界的测试绩效和开发模型以改善艾滋病毒护理和预防 美国的结果