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Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing (PREDICT-DHCW)

Primary Purpose

SARS-CoV2 Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing for SARS CoV2 Antigen and Antibody
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS-CoV2 Infection focused on measuring Dental Healthcare Worker, Testing, Seroprevalence, Perception of Safety, Adoption of risk mitigation practice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine Exclusion Criteria: Previous participation

Sites / Locations

  • Rutgers School of Dental Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SARS-CoV-2 testing

Arm Description

There 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.

Outcomes

Primary Outcome Measures

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
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
DHCW Test Completion
Percentage of DHCWs with completed SARS-CoV-2 test completed
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
Number of DHCW With Complete Surveys
Number of participants with complete Start-of-study, Triage and End-of-Study surveys

Secondary Outcome Measures

SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing
Positive Antibody Testing
Number of participants who tested positive for antibody to SARS-CoV2
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study

Full Information

First Posted
October 31, 2022
Last Updated
August 10, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05607147
Brief Title
Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing
Acronym
PREDICT-DHCW
Official Title
Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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)..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
Keywords
Dental Healthcare Worker, Testing, Seroprevalence, Perception of Safety, Adoption of risk mitigation practice

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SARS-CoV-2 testing
Arm Type
Other
Arm Description
There 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.
Intervention Type
Device
Intervention Name(s)
Testing for SARS CoV2 Antigen and Antibody
Intervention Description
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
Primary Outcome Measure Information:
Title
Dental Health Care Worker (DHCW) Willingness to Participate in the Study
Description
Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study
Time Frame
Day 1
Title
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing
Description
Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing
Time Frame
Day 28
Title
DHCW Test Completion
Description
Percentage of DHCWs with completed SARS-CoV-2 test completed
Time Frame
Day 28
Title
DHCW Ease of Complying With Protocol
Description
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
Time Frame
Day 28
Title
Number of DHCW With Complete Surveys
Description
Number of participants with complete Start-of-study, Triage and End-of-Study surveys
Time Frame
Through study completion (3 months)
Secondary Outcome Measure Information:
Title
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
Description
Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing
Time Frame
28 days
Title
Positive Antibody Testing
Description
Number of participants who tested positive for antibody to SARS-CoV2
Time Frame
28 days
Title
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
Description
Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine Exclusion Criteria: Previous participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile A Feldman, DMD, MBA
Organizational Affiliation
Rutgers School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers School of Dental Medicine
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
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.
Results Reference
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PubMed Identifier
33071007
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.
Results Reference
background
PubMed Identifier
34176567
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. Erratum In: J Am Dent Assoc. 2021 Sep;152(9):719.
Results Reference
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Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing

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