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

NCT ID: NCT04766333

Last Updated: 2023-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2017 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Covid19 Health Care Seeking Behavior Health Behavior

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Healthcare Worker Focused Outreach Intervention Strategy

Healthcare Worker Focused Outreach Intervention Strategy

Group Type ACTIVE_COMPARATOR

Healthcare Worker Focused Outreach

Intervention Type BEHAVIORAL

This a focused outreach intervention strategy specifically designed for healthcare workers.

Community Organization Led Outreach

Community Organization Led Outreach

Group Type ACTIVE_COMPARATOR

Community Organization Led Outreach

Intervention Type BEHAVIORAL

This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.

Interventions

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Healthcare Worker Focused Outreach

This a focused outreach intervention strategy specifically designed for healthcare workers.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Informational intervention Informational intervention

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Shawna V. Hudson, PhD

Professor and Research Division Chief Department of Family Medicine and Community Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rutgers University

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34264327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36265092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35041702 (View on PubMed)

Juarez R, Phankitnirundorn K, Ramirez A, Peres R, Maunakea AK, Okihiro M. Vaccine-Associated Shifts in SARS-CoV-2 Infectivity Among the Native Hawaiian and Other Pacific Islander Population in Hawaii. Am J Public Health. 2022 Nov;112(S9):S896-S899. doi: 10.2105/AJPH.2022.306973. Epub 2022 Sep 15.

Reference Type DERIVED
PMID: 36108254 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3UL1TR003017-02S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020002549

Identifier Type: -

Identifier Source: org_study_id

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