To Duke School Students, Parents, Staff and Faculty:
Duke University School of Medicine is doing an observational study to assess the utility of classroom environmental testing for COVID as a way to conduct surveillance for SARS-CoV-2 among students and/or faculty and staff.
Though widespread COVID screening has been proposed as a tool to monitor for transmission among college students, there are numerous practical barriers to routine interval screening in younger children. The most sensitive tests (PCR from a nasopharyngeal swab) are costly, require a trained provider to collect the sample, and are not well tolerated by children. Though a range of more tolerable tests (e.g., saliva, oropharyngeal swabs, anterior nasal swabs) have gained recent attention, most still rely on costly PCR methods. Regardless of method, repeatedly testing individuals with currently available tests is unlikely to be sustainable at sufficiently large scale for active surveillance in schools.
Observational Study Proposal
This study proposes to collect twice weekly swabs of the environment in and around the classrooms: doorknobs, chairs, desk and tabletops, floors, and bathrooms. In addition, saliva samples will be self-collected by the students/teachers/staff of the classroom twice weekly, on the same days as environmental testing. Self-collection of saliva samples will occur at home prior to coming to school and returned to the study team in designated collection containers at school that morning. Not all classrooms will have environmental testing, but saliva samples will be collected and stored for all students, faculty and staff from participating classrooms who choose not to opt-out of the study.
Environmental swabs will be tested for SARS-CoV-2. If the environmental swab is positive, the saliva samples from the same day from the relevant classroom pod will be tested. If the environmental swab is negative, the saliva samples will not be tested. In addition, if a student, faculty or staff is reported to the school as having COVID, the most recent saliva samples from the relevant pod will be pulled for testing and environmental swabs of the class will be collected immediately to assess for detection of SARS-CoV-2 in the environment. All stored samples will be destroyed at the end of the study.
The study will also use the symptom and COVID exposure/testing data collected from the Ascend Assessment Application. The study will only track the number of individuals with symptoms or a positive COVID test per pod. Study personnel will not have access to individual or identifying information from participants.
Protocol in the Event of a Positive Saliva Test
While the study does not collect individual identifying information, we believe it is important for participating families and school administrators to be aware of any positive results detected from saliva tests collected for study purposes. School administrators will have a list linking saliva samples to individuals. In the event that a saliva sample tests positive for COVID, school officials will be notified of the positive result such that the participant and family with the positive sample can be informed of their result. Because saliva testing is only a screening test at present, we will recommend that any subject with a positive saliva sample be evaluated by their personal physician for testing by one of the approved tests (generally a nasopharyngeal swab PCR test). We will recommend that any subject with a positive saliva test remain out of school until they have been evaluated and cleared by their physician.
Summary of Risks and Benefits
This study is purely observational and does not involve any treatment or interventions. Since the only samples collected will be environmental swabs and saliva (spit), this is considered a minimal risk study.
Participants should be aware that any positive result from saliva testing will be shared with the participant (or parent in the case of a student) via school administrators. Any participant with a positive saliva test will be advised to undergo clinical testing with one of the approved tests (generally a nasopharyngeal swab PCR test) through their primary medical provider, and will be advised to stay home from school until cleared by their physician to return. Consequently, this may be disruptive to the participant and could result in missed days of in-person school attendance.
There is the potential for loss of confidentiality, though outside of notification of positive saliva testing results as above, every precaution will be taken to preserve the anonymity and data security of participants. As noted, study personnel will not receive individual identifying data and only school administrators will have access to the list of participants for the sole purpose of notifying families of positive saliva results as above.
Lastly, in addition to the study as proposed above, the Duke research team is partnering with the eighth grade faculty and students to engage them in this research project. The eighth grade students will learn about research design, protocol writing, human subjects research ethics, and data collection and analysis. Eighth grade students may participate in classroom environmental swab collection, distribution of sterile collection cups for saliva testing, and analysis of de-identified summary data.
Choice to Participate
Students, teachers, or parents may opt-out of participating in the study by simply notifying school administration using the forms below. Similarly, eighth grade students and parents can opt-out of student involvement in research engagement in the research project. Students and parents may change their mind about participation at any time.
Where can I learn more about this study?
If you have any questions or concerns you can contact the study team by email:
Nicholas Turner MD MHSc, email: firstname.lastname@example.org
Susanna Naggie MD MHS, email: email@example.com
If you have additional questions or concerns about this study at Duke School, emails are also welcome by Lisa Nagel, Head of School, and Kathy Bartelmay, Director of Curriculum and Professional Development, Project Liaison.
Lisa Nagel email: firstname.lastname@example.org
Kathy Bartelmay email: email@example.com
Nicholas Turner, MD MHSc
Medical Instructor - Division of Infectious Diseases
Duke University Medical Center