CoVPN 5002: SARS-CoV-2 Prevalence Study

Abstract: The proposed research, CoVPN 5002, will directly contribute to preparedness for SARS-CoV-2vaccine and other COVID-19 prevention and treatment studies by determining the prevalence ofSARS-CoV-2 infection and seroprevalence among samples of individuals at elevated risk as well asthe general population. This research will determine the extent to which children and adults in thestudy communities have SARS-CoV-2 infection or evidence of prior SARS-CoV-2 infection (based onantibody tests, self-report, and medical records). Additionally, about participants' household memberswith COVID-like illness and deaths, combined with serologic data from participants, may also provideinformation about transmission dynamics within households. Questionnaire data will inform estimatesof the percent of individuals of different age groups, including children, who may have had anasymptomatic COVID-19 infection. The frequency of infection among children and whether childrenplay an important role in community transmission is poorly understood. The study will also estimatethe association of SARS-CoV-2 seroprevalence with medical co-morbidities associated with moresevere disease outcomes and identify demographic and social risk factors associated with infection.Finally, this research will provide important information about SARS-CoV-2 transmission, COVID-19disease, attitudes about and uptake of containment and mitigation measures, racial and ethnic healthdisparities, varied access to testing and public health resources by key demographicindicators, prospects for new prevention and treatment strategies, and inform mathematical models ofdisease progression and projection of future COVID-19 risk.The HPTN SDMC, housed at the Fred Hutchinson Cancer Research Center in Seattle, takesadvantage of the strengths of the institution, which also includes the HVTN SDMC. The HPTN SDMChas faculty biostatisticians experienced in the design, conduct and analysis of global clinical trials andsurveillance studies, who support research through leadership in statistical design, trial conduct andanalysis, and development and implementation of innovative statistical methods as needed andmotivated by the scientific goals. The SDMC provides regulatory compliant data managementfunctions for all trials it implements, including electronic data capture directly from research sites orthe field, integration of laboratory specimens and assay results, and electronic participant reportedoutcomes.