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

Project SummaryThe SARS-CoV-2 pandemic has presented the field of infectious diseases and the clinical trials networks witha number of challenges and opportunities. This Administrative Supplement request is being submitted for theparent grant, the Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials Unit (ColumbiaPartnership Clinical Trials Unit, grant # 5UM1AI069470). The Columbia Partnership CTU encompasses fourClinical 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: TheColumbia P&S CRS, Harlem Prevention Center CRS and Bronx Prevention Center CRS. Each of the CRSs, byvirtue 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 byusing innovative strategies and among populations at greatest risk of the disease. The specific aims of thissupplement request are: (1) To leverage the existing clinical, laboratory and administrative infrastructure of theColumbia Partnership CTU to efficiently and rapidly scale-up for SARS-CoV-2 testing activities; specifically tohelp scale up testing in response to the growing need to provide clinical testing to diverse communities heavilyand disproportionately impacted by COVDI-19; and to prepare for upcoming clinical trials investigatingtherapeutic and preventive interventions for COVID-19 disease. (2) To build on the existing communityengagement infrastructure to implement innovative methods to engage local communities and stakeholdersaround SARS-CoV-2 testing and research efforts and to develop a suite of educational materials in support ofCOVID-19 studies.