Clincosm LogoSign in Get a demo

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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT04766333
Collaborator
(none)
2,017
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
253.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthcare Worker Focused Outreach
  • Behavioral: Community Organization Led Outreach
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2017 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations)
Actual Study Start Date :
May 3, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Healthcare Worker Focused Outreach Intervention Strategy

Healthcare Worker Focused Outreach Intervention Strategy

Behavioral: Healthcare Worker Focused Outreach
This a focused outreach intervention strategy specifically designed for healthcare workers.
Other Names:
  • Informational intervention

    		•
    Active Comparator: Community Organization Led Outreach

    Community Organization Led Outreach

    Behavioral: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants who complete COVID-19 testing [1 year]

      Number of participants who return their saliva testing kit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers University New Brunswick New Jersey United States 08901

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shawna V. Hudson, PhD, Professor and Research Division Chief Department of Family Medicine and Community Health, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT04766333
    Other Study ID Numbers:
    • 2020002549
    First Posted:
    Feb 23, 2021
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 12, 2022