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.
Access to SARS-CoV-2 testing is one of the highest global health priorities. This project seeks to build on the expertise of the Columbia Partnership CTU to expand SARS-CoV-2 testing in diverse communities most impacted by COVID-19.
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