- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766333
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
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:
|
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.
General Publications
- Jimenez ME, Rivera-Nunez Z, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Martinez Alcaraz E, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines. JAMA Netw Open. 2021 Jul 1;4(7):e2117074. doi: 10.1001/jamanetworkopen.2021.17074.
- Barrett ES, Andrews TR, Roy J, Greenberg P, Ferrante JM, Horton DB, Gordon M, Rivera-Nunez Z, Pellerano MB, Tallia AF, Budolfson M, Georgopoulos P, Reed D, Lynn B, Rosati R, Castaneda M, Dixon F, Pernell C, Hill D, Jimenez ME, Blaser MJ, Panettieri R Jr, Hudson SV. Community- Versus Health Care Organization-Based Approaches to Expanding At-Home COVID-19 Testing in Black and Latino Communities, New Jersey, 2021. Am J Public Health. 2022 Nov;112(S9):S918-S922. doi: 10.2105/AJPH.2022.306989. Epub 2022 Oct 20.
- Rivera-Nunez Z, Jimenez ME, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Gordon M, Sullivan B, Rosati RJ, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Experiences of Black and Latinx health care workers in support roles during the COVID-19 pandemic: A qualitative study. PLoS One. 2022 Jan 18;17(1):e0262606. doi: 10.1371/journal.pone.0262606. eCollection 2022.
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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