Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing
PREDICT-DHCW
Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2021
CompletedFirst Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 7, 2022
CompletedResults Posted
Study results publicly available
March 20, 2023
CompletedAugust 24, 2023
August 1, 2023
16 days
October 31, 2022
December 12, 2022
August 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Dental Health Care Worker (DHCW) Willingness to Participate in the Study
Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study
Day 1
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing
Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing
Day 28
DHCW Test Completion
Percentage of DHCWs with completed SARS-CoV-2 test completed
Day 28
DHCW Ease of Complying With Protocol
Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study
Day 28
Number of DHCW With Complete Surveys
Number of participants with complete Start-of-study, Triage and End-of-Study surveys
Through study completion (3 months)
Secondary Outcomes (3)
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
28 days
Positive Antibody Testing
28 days
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
28 days
Study Arms (1)
SARS-CoV-2 testing
OTHERThere is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral Antigen and antibody to the virus as described.
Interventions
Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for adoption of risk mitigation practices and for perceptions of safety
Eligibility Criteria
You may qualify if:
- Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine
You may not qualify if:
- Previous participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers School of Dental Medicine
Newark, New Jersey, 07103, United States
Related Publications (3)
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.
BACKGROUNDEstrich 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.
PMID: 33071007BACKGROUNDShirazi 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.
PMID: 34176567BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gayathri Subramanian, PhD, DMD
- Organization
- Rutgers School of Dental Medicine, Newark, New Jersey, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Cecile A Feldman, DMD, MBA
Rutgers School of Dental Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 7, 2022
Study Start
January 26, 2021
Primary Completion
February 11, 2021
Study Completion
February 11, 2021
Last Updated
August 24, 2023
Results First Posted
March 20, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
If the COVID test results show that a participant is positive for COVID-19, the study staff will tell the participant the results. The study staff will be required to give the participant's name to the state's Department of Public Health if the participant tests positive because this is the law. At the end of the study, de-identified data will be provided to the National Coordinating Center.