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

项目摘要 SARS-CoV-2大流行为传染病领域和临床试验网络提供了 挑战和机遇并存。此行政补充申请是为 父母赠款，哥伦比亚预防和控制艾滋病毒/艾滋病临床试验伙伴关系单位(哥伦比亚 伙伴关系临床试验单位，赠款#5UM1AI069470)。哥伦比亚伙伴关系CTU包括四个 临床研究网站(CRS)和一个特定于方案的CRS与三个由DAIDS赞助的网络结盟， 但这一请求完全是为了支持一项至关重要的活动，即有效和快速地传播SARS-- 四个CRSS中的三个在不同社区进行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。每一个CRSS，由 由于他们位于受新冠肺炎疾病影响严重的地区，与当地社区的关系， 研究人员的临床和科学专长处于独特的地位，不仅可以扩大检测，而且可以通过 使用创新战略，并在疾病风险最高的人群中开展这一活动。这样做的具体目的是 补充要求是：(1)利用现有的临床、实验室和行政基础设施 哥伦比亚合作伙伴CTU高效、快速地扩大SARS-CoV-2检测活动；具体地说， 帮助扩大测试规模，以应对在很大程度上向不同社区提供临床测试的日益增长的需求 并受到COVDI-19的不成比例的影响；并为即将到来的临床试验做准备 新冠肺炎病的治疗和预防干预措施。(2)在现有社区基础上继续发展 参与基础设施，实施创新方法，让当地社区和利益相关者参与进来 围绕SARS-CoV-2测试和研究工作，并开发一套教育材料，以支持 新冠肺炎研究。

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.