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，测试已成为 普遍存在，并且大多数艾滋病毒感染者 (PLWH) 都了解自己的状况。抗逆转录病毒治疗 （ART）已经变得如此简单和可以忍受，以至于大多数艾滋病病毒感染者可以达到“无法检测到”的艾滋病毒水平，收获 对他们自己的健康有利，并且变得“无法传染”给他们的伴侣。暴露前预防 (PrEP) 是减少艾滋病毒感染的安全有效的方法。然而，即时护理 (POC) HIV 检测 已获得 FDA 批准，但仍无法识别急性感染的高传染性人群，且实时依从性 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 在男性和男男性行为者中，以及少数民族等亚人群中 甲基苯丙胺使用者的风险尤其高。周到实施POC核酸 检测（NAT）有可能解决艾滋病毒预防和护理中剩余的一些挑战。 本合作协议 (U01) 拟议的项目将开发、实施和评估模型 在寻求 HIV 检测、PEP 和 PrEP 的 HIV 阴性者以及 HIV 阳性者中使用 POC NAT 在社区和临床环境中。经过一段时间的建立协议、SOP、数据的形成性工作 目标 #1 和 #2 将评估收集仪器和数据分析计划的敏感性和特异性 对未知 HIV 阳性人群进行定性 POC NAT，并将确定其使用对 PrEP 的影响 HIV 阴性检测者的接受度和持续性以及按时获得 HIV 连续护理结果的情况 新检测出的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 评估对接受 ART 的 PLWH 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 以及成本效益分析的相关数据。最后，在目标#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 性能和相关临床结果、患者和患者的数据 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。聘请在 HIV 检测（包括 POC NAT）方面拥有丰富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，此次合作将致力于实施 POC NAT，其目标是 记录真实世界的测试表现并开发模型以改善艾滋病毒护理和预防 在美国的结果