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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766333
• Other study ID #: 2020002549
• Secondary ID: 3UL1TR003017-02S
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2017
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Health Behavior
• Health Care Seeking Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Complete COVID-19 Testing	Number of participants who return their saliva testing kit.	1 year