COVID-19 Infection, Reinfection, and Vaccine Effectiveness in a Prospective Cohort of Arizona Frontline/Essential Workers: The AZ HEROES Research Protocol.

backgroundThe Arizona Healthcare, Emergency Response, and Other Essential workers Study (AZ HEROES) aims to examine the epidemiology of SARS-CoV-2 infection and COVID-19 illness among adults with high occupational exposure risk.

objectiveStudy objectives include estimating incidence of SARS-CoV-2 infection in essential workers by symptom presentation and demographic factors, determining independent effects of occupational and community exposures on incidence of SARS-CoV-2 infection, establishing molecular and immunologic characteristics of SARS-CoV-2 infection in essential workers, describing the duration and patterns of rRT-PCR-positivity, and examining post-vaccine immunologic response.

methodsEligible participants include Arizona residents aged 18-85 years who work at least 20 hours per week in an occupation involving regular direct contact (within three feet) with others. Recruitment goals are stratified by demographic characteristics (50% aged 40 or older, 50% women, and 50% Hispanic or American Indian), by occupation (40% healthcare personnel, 30% first responders, and 30% other essential workers), and by prior SARS-CoV-2 infection (with up to 50% seropositive at baseline). Information on sociodemographics, health and medical history, vaccination status, exposures to individuals with suspected or confirmed SARS-CoV-2 infection, use of personal protective equipment, and perceived risks are collected at enrollment and updated through quarterly surveys. Every week, participants complete active surveillance for COVID-19-like illness (CLI) and self-collect nasal swabs. Additional self-collected nasal swab and saliva specimens are collected in the event of CLI onset. Respiratory specimens are sent to Marshfield Laboratories and tested for SARS-CoV-2 by real-time reverse transcription polymerase chain reaction (rRT-PCR) assay. CLI symptoms and impact on work and productivity are followed through illness resolution. Serum specimens are collected every 3 months and additional sera are collected following incident rRT-PCR positivity and after each COVID-19 vaccine dose. Incidence of SARS-CoV-2 infections will be calculated by person-weeks at risk and compared by occupation and demographic characteristics and by seropositivity status and infection and vaccination history.

resultsThe AZ HEROES study was funded by the Centers for Disease Control and Prevention. Enrollment began July 27, 2020 and as of May 1, 2021 a total of 3,165 participants have been enrolled in the study.

conclusionsAZ HEROES is unique in aiming to recruit a diverse sample of essential workers and prospectively following strata of SARS-CoV-2 seronegative and seropositive adults. Survey results combined with active surveillance data on exposure, CLI, weekly molecular diagnostic testing, and periodic serology will be used to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, assess the intensity and durability of immune responses to natural infection and COVID-19 vaccination, and contribute to the evaluation of COVID-19 vaccine effectiveness. CLINICALTRIAL: INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/28925.