Clinical trial NCT05607147: Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing
Official title: Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Keywords: Dental Healthcare Worker
Testing
Seroprevalence
Perception of Safety
Adoption of risk mitigation practice
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study to assess feasibility of testing dental healthcare workers for seropositivity and antigen positivity for SARS-CoV-2 (Rapid Antigen point-of-care testing).
Primary purpose: OTHER

Brief summary: 10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.

Detailed description: 10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..

Eligibility criteria: Inclusion Criteria:

* Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine

Exclusion Criteria:

* Previous participation

Primary outcomes:
measure: Dental Health Care Worker (DHCW) Willingness to Participate in the Study
timeFrame: Day 1
measure: DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing
timeFrame: Day 28
measure: DHCW Test Completion
timeFrame: Day 28
measure: DHCW Ease of Complying With Protocol
timeFrame: Day 28
measure: Number of DHCW With Complete Surveys
timeFrame: Through study completion (3 months)
Secondary outcomes:
measure: SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
timeFrame: 28 days
measure: Positive Antibody Testing
timeFrame: 28 days
measure: Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
timeFrame: 28 days
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Cecile A Feldman, DMD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. American Dental Association COVID-19 Toolkit - Update to Office Procedures During COVID-19. https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/coronavirus/update_to_office_procedures_during_covid19.pdf accessed on November 11, 2021.
citation: Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.
citation: Shirazi S, Stanford CM, Cooper LF. Testing for COVID-19 in dental offices: Mechanism of action, application, and interpretation of laboratory and point-of-care screening tests. J Am Dent Assoc. 2021 Jul;152(7):514-525.e8. doi: 10.1016/j.adaj.2021.04.019. Epub 2021 May 4.