Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials Unit

哥伦比亚艾滋病预防和控制伙伴关系临床试验单位

• 批准号: 10169016
• 负责人: WAFAA M. EL-SADR
• 金额: $ 90万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-10 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10169016
• 关键词: 2019-nCoV; AIDS/HIV problem; Administrative Supplement; Area; COVID-19; Clinical; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communicable Diseases; Communities; Disease; Educational Materials; Grant; Health Priorities; Infrastructure; Laboratories; Location; Methods; Molecular; Population; Positioning Attribute; Prevention; Preventive Intervention; Protocols documentation; Research; Research Personnel; Serological; Testing; Therapeutic Intervention; clinical center; clinical research site; disorder risk; global health; innovation; pandemic disease; parent grant; research clinical testing; response; scale up; therapeutic evaluation

Project Summary The SARS-CoV-2 pandemic has presented the field of infectious diseases and the clinical trials networks with a number of challenges and opportunities. This Administrative Supplement request is being submitted for the parent grant, the Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials Unit (Columbia Partnership Clinical Trials Unit, grant # 5UM1AI069470). The Columbia Partnership CTU encompasses four Clinical Research Sites (CRSs) and one protocol-specific CRS aligned with three DAIDS-sponsored networks, but this request is focused exclusively to support a crucial activity, the efficient and rapid expansion of SARS- CoV-2 serological and molecular testing in diverse communities served by three of the four CRSs: The Columbia P&S CRS, Harlem Prevention Center CRS and Bronx Prevention Center CRS. Each of the CRSs, by virtue of their location in areas highly impacted by COVID-19 disease, relationships with local communities, clinical and scientific expertise of investigators is in a unique position to not only expand testing, but do so by using innovative strategies and among populations at greatest risk of the disease. The specific aims of this supplement request are: (1) To leverage the existing clinical, laboratory and administrative infrastructure of the Columbia Partnership CTU to efficiently and rapidly scale-up for SARS-CoV-2 testing activities; specifically to help scale up testing in response to the growing need to provide clinical testing to diverse communities heavily and disproportionately impacted by COVDI-19; and to prepare for upcoming clinical trials investigating therapeutic and preventive interventions for COVID-19 disease. (2) To build on the existing community engagement infrastructure to implement innovative methods to engage local communities and stakeholders around SARS-CoV-2 testing and research efforts and to develop a suite of educational materials in support of COVID-19 studies.

项目概要 SARS-CoV-2 大流行给传染病领域和临床试验网络带来了新的挑战。 一些挑战和机遇。本行政补充请求的提交目的是 家长资助，哥伦比亚预防和控制艾滋病毒/艾滋病临床试验单位伙伴关系（哥伦比亚 合作临床试验单位，拨款#5UM1AI069470）。哥伦比亚合作伙伴 CTU 包括四个 临床研究站点 (CRS) 和一个与三个 DAIDS 赞助的网络相一致的特定于协议的 CRS， 但这一请求专门用于支持一项重要活动，即 SARS 的有效和快速扩张 在四个 CRS 中的三个服务的不同社区中进行 CoV-2 血清学和分子检测： 哥伦比亚 P&S CRS、哈莱姆预防中心 CRS 和布朗克斯预防中心 CRS。每个 CRS 由 由于其位于受 COVID-19 疾病严重影响的地区、与当地社区的关系、 研究人员的临床和科学专业知识处于独特的地位，不仅可以扩大测试，而且可以通过 使用创新策略并针对疾病风险最大的人群。本次活动的具体目标 补充要求是： (1) 利用现有的临床、实验室和行政基础设施 哥伦比亚合作伙伴 CTU 高效、快速地扩大 SARS-CoV-2 检测活动；专门针对 帮助扩大检测规模，以满足向不同社区提供临床检测的日益增长的需求 并且受到 COVDI-19 的影响尤为严重；并为即将进行的临床试验做准备 COVID-19 疾病的治疗和预防干预措施。 (2) 以现有社区为基础 实施创新方法以吸引当地社区和利益相关者参与的参与基础设施 围绕 SARS-CoV-2 测试和研究工作，并开发一套教育材料来支持 COVID-19 研究。