MURDOCK Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study

Method:

Questionnaire The investigators will use RedCap to introduce the study, obtain online
informed consent, and administer an electronic questionnaire to MURDOCK Study participants
currently residing in North Carolina who have a valid email address on file (N~7200). The
question bank for the questionnaire is attached to the application. It includes demographics,
education and employment, and questions about symptoms, contacts and exposures, the
participant's household, behaviors, and practice of mitigation strategies. The opportunity to
enroll and complete the baseline questionnaire will remain open for 1 month. Follow up
surveys will be made available to consented participants on the same day for each week they
are administered. The investigators anticipate a 20% response rate to the survey (N~1500).
Recruitment materials, consent and questionnaires, materials related to return of results to
participants, and verbal study communications will be available in both English and Spanish.

COVID-19 PCR testing A randomly selected subset of individuals who consent to participate
(N~300-500 initially, with the potential to expand testing to more survey participants as
additional funding becomes available), weighted to ensure representation by race/ethnicity,
age, and sex, will be invited to participate in COVID-19 polymerase chain reaction (PCR)
viral testing by at-home collection and return of self-administered nasal swabs. Saliva
specimens may replace the nasal swab specimen. Specimens will be collected at baseline and
every 2 weeks in conjunction with questionnaire administration. Participants will have the
opportunity to opt out of participation in this component at the time of consent and
enrollment. Those who do not opt out will be eligible for the random selection for COVID-19
testing. The investigators will provide specimen collection materials and instructions for
collection, along with return shipping instructions to participants in pre-prepared kits.
COVID-19 PCR testing will be conducted at the North Carolina State Laboratory of Public
Health. This is a CLIA-certified laboratory. Samples for COVID-19 PCR testing will be
identified only by a unique study identification number for each participant. Results of
COVID-19 testing will be returned from the State Lab to the MURDOCK Study investigative team
as results are available from testing (expected turnaround time ~4 days from receipt at State
Lab) by secure transfer for incorporation into the RedCap study database.

COVID-19 serology testing The same randomly selected subset of individuals who collect
at-home samples for COVID-19 PCR testing (N~300-500 initially, with the potential expand to
more survey participants as additional resources become available), will also provide a blood
sample for serologic testing for SARS-CoV-2 IgG antibodies. Specimens will be collected by
routine venipuncture at the MURDOCK Study office in Kannapolis, NC and potentially 2-3
additional locations in Cabarrus County. Study visits for venipuncture will be deferred for 2
weeks in participants whose nasal swab PCR testing for COVID-19 is positive. Participants
will be screened for COVID-19 symptoms at the time of scheduling the visit for venipuncture
and at arrival for the visit. Participants who screen positive for COVID-19 symptoms will be
referred for clinical COVID-19 testing and will have their initial serology testing deferred
until a negative clinical test is documented or for 2 weeks if clinical testing is not
performed.

Specimens for serology will be collected at baseline approximately 1 month after the first
questionnaire and 2 weeks after the first nasal swab collection and COVID-19 PCR testing.
Specimens for serology will be collected at least bi-monthly and up to monthly thereafter
through a total study duration of 6, and up to 12, months. SARS-CoV-2 serologic testing for
IgG antibodies will be conducted in the laboratory of Thomas Denny, MSc, MPhil in the Duke
Human Vaccine Institute on the campus of Duke University Medical Center using a commercial
IgG assay (Perkin-Elmer). Samples for serology will be identified only by a unique study
identification number for each participant. Results of serological testing will be returned
from the Denny laboratory to the MURDOCK Study investigative team at regular, prespecified
intervals by secure transfer for incorporation into the RedCap study database. The Denny
laboratory is CLIA-certified. Any residual serum after SARS-CoV-2 serologic testing will be
frozen at -80°C and stored for future use in the Duke COVID-19 Biorepository (Pro00105316).

Return of Results to Participants:

The investigators will share aggregate results from questionnaires and testing with all
participants and the public through multiple routes, including email, social media and the
press and with the scientific community through presentations at scientific meetings and
publications. The investigators will also provide regular reports on accruing study data to
NCDHHS. Participants will not be identified individually in these aggregate reports. The
investigators also will return the results of both COVID-19 PCR testing and serologic testing
for SARS-CoV-2 antibodies to individual study participants. Individual return of results will
follow the following principles:

COVID-19 test results. A standard template for return of negative COVID-19 test results will
be IRB approved and used to notify participants of their results. If a participant tests
positive for COVID-19, the participant will be contacted by phone by the study PI or a
designate to convey the result. General recommendations for participants who test positive
will be IRB approved. The investigators will also offer these participants a link through
which they can consider participation in the Duke COVID Community Watch support program
(Pro00105189). Positive COVID-19 test results will also be reported to the local/state health
department.

SARS-CoV-2 serology results. An IRB approved standard template will be used to convey the
results of SARS-CoV-2 serology to participants. Care will be taken to ensure that
participants understand what information the results of their SARS-CoV-2 serology conveys
(and does not convey) in order to avoid any risk of misinterpretation, particularly of
positive results.

Selection of Subjects

List inclusion/exclusion criteria and how subjects will be identified. The MURDOCK NCDHHS
COVID-19 Prevalence Study will examine COVID-19 prevalence and SARS-CoV-2 antibody prevalence
in Cabarrus County, NC by leveraging the community-based cohort enrolled in the MURDOCK Study
Community Registry and Biorepository (MURDOCK Study). The MURDOCK Study is an ongoing
longitudinal health study operated by the Translational Population Health Research Center in
the Duke Clinical & Translational Science Institute and approved by the Duke University
Institutional Review Board (Duke IRB Pro00011196). The MURDOCK Study recruited 12,526
residents from 20 Zip Codes in the Cabarrus County/Kannapolis region, and currently follows
10,407 active participants. As part of the MURDOCK Study, all participants provided
demographic, clinical, and behavioral data via an enrollment questionnaire, were geospatially
mapped at the street address level, and consented to a yearly follow up questionnaire. They
also provided consent to be contacted by MURDOCK Study staff up to four times per year to
consider participation in future research opportunities. A recent protocol communication to
the IRB was approved to allow additional contacts for high priority COVID-19 research studies
(Pro00011196-SE-45.0). Our study population for this protocol will include approximately 7200
active MURDOCK Study participants who currently reside in North Carolina and have a valid
email address on file. The active study participants who receive a recruitment email and
consent to participate (estimated 20%) will have the opportunity to declare their interest in
testing and from among those 300-500 will be randomly selected to participate in the testing.
The anticipated number to enroll is set at 1,000 but may be adjusted up based on response
rate.