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.

项目摘要 SARS-CoV-2大流行给传染病领域和临床试验网络带来了 一些挑战和机遇。本行政补充申请提交给 哥伦比亚预防和控制艾滋病毒/艾滋病临床试验合作单位（哥伦比亚 Partnership Clinical Trials Unit，grant#5UM1AI069470）。哥伦比亚合作反恐组包括四个 临床研究中心（CRS）和一个方案特定CRS与三个DAIDS申办的网络一致， 但这一请求只集中于支持一项关键活动，即SARS的有效和快速扩展- 在四个CRS中的三个CRS所服务的不同社区进行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，通过 凭借其位于受COVID-19疾病严重影响的地区，与当地社区的关系， 研究者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 利用创新战略，在疾病风险最高的人群中开展工作。具体目标是 补充要求是：（1）利用现有的临床、实验室和行政基础设施 哥伦比亚伙伴CTU有效和快速地扩大SARS-CoV-2检测活动;特别是 帮助扩大测试规模，以应对日益增长的向不同社区提供临床测试的需求， 并受到CO2 -19的不成比例的影响;并为即将进行的临床试验做准备， 针对COVID-19疾病的治疗和预防干预措施。(2)在现有社区的基础上 参与基础设施，以实施创新方法，使当地社区和利益攸关方参与其中 围绕SARS-CoV-2测试和研究工作，并开发一套教育材料， COVID-19研究。