New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations

March 8, 2023 updated by: Shawna V. Hudson, PhD, Rutgers, The State University of New Jersey

NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations)

This mixed methods study evaluates the effectiveness and cost of a healthcare worker focused outreach intervention strategy versus community organization led outreach to explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability.

Study Overview

Detailed Description

In Aim 2, the investigators conduct a mixed methods study to evaluate the effectiveness and cost of: (1) the healthcare worker focused outreach intervention strategy versus (2) community organization led outreach working with community based organizations. The investigators explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability. The primary outcome is uptake of COVID-19 testing using the novel Rutgers Clinical Genomics Laboratory/RUCDR saliva test, the first FDA authorized diagnostic test using saliva to detect SARS-CoV-2 for non-invasive, home based self-testing. To compare participation rates in the two arms, our primary outcome, the investigators will use data on the number of tests performed per month up to a 12 month study period. For each intervention, the start time is the date of first attempted contact with potential participants and the end date is either the end of the study period, or the date at which the 1000th individual was tested (whichever comes first).

Study Type

Interventional

Enrollment (Actual)

2017

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Community Members and Healthcare Workers

  • Self-identification as Black or Hispanic/Latino.
  • Resident of Union, Passaic, Middlesex, or Essex County, NJ.
  • Parent/legal guardian able to provide permission to participate for those under 18

Exclusion Criteria:

  • Under 4 years of age.
  • Unable to speak, understand, and/or read English or Spanish.
  • Unable to provide informed consent/assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthcare Worker Focused Outreach Intervention Strategy
This a focused outreach intervention strategy specifically designed for healthcare workers.
Other Names:
  • Informational intervention
Active Comparator: Community Organization Led Outreach
This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.
Other Names:
  • Informational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Complete COVID-19 Testing
Time Frame: 1 year
Number of participants who return their saliva testing kit.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020002549
  • 3UL1TR003017-02S2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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