dbGaP Study Accession: phs002567

NIH Institute/Center: NCATS

RADx Data Program: RADx-UP

Release Date: 08/29/2023

DOI: 10.60773/ddc6-ar41

Study Description: The COVID-19 pandemic disproportionately impacts members of under-represented minority (URM) communities. Unfortunately, URM and other vulnerable communities remain profoundly under-tested. As such, new approaches are needed to disseminate and accomplish testing that could be generalized across the US. New Jersey can serve as a unique, virtual testing laboratory, ranking 11th in the US in population, 2nd in the US (after NY) in the per capita rate of COVID-19 deaths, and 5th in total cases, while representing a highly diverse state with substantial Black and Latinx minority populations. Rutgers has assembled cohorts of healthcare workers (HCWs) to monitor the spread of COVID-19 and to enroll subjects for clinical and vaccine trials. While building these cohorts, it was recognized that many URMs serve as HCWs or personal care aides often in lower-income roles, and these workers were more often infected compared with those with higher income occupations. Given these observations, it is posited that HCWs in occupations at lower incomes would facilitate testing among their households and their communities. In a sense, these HCWs served as ambassadors to catalyze community-based COVID-19 testing. NJ HEROES TOO (New Jersey Healthcare Essential WoRker Outreach and Education Study - Testing Overlooked Occupations) proposed to approach URM HCWs who have been identified as index individuals who will act as ambassadors to help expand testing in their households and extended networks. In Aim 1, an innovative, HCW-centric outreach intervention strategy was (co-)designed, developed, and implemented to engage Black and Latinx minority communities. Community perceptions about COVID-19 testing, treatment, and vaccination were explored to design COVID-19 testing materials and messages that were culturally tailored to address concerns of Black and Latinx minority communities. In Aim 2, a mixed methods study was conducted to evaluate the effectiveness and cost of: (1) the HCW-focused outreach intervention strategy versus (2) standard community engaged outreach, working with community based organizations (CBOs). Contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability were explored. The primary outcome was uptake of COVID-19 testing in the targeted populations. 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 was used. The hypothesis was that a participatory outreach strategy approach focused on identified index HCWs would mobilize quicker uptake of testing within community settings than best-practice CBO recruitment approaches. It was also hypothesized that recruitment through index HCWs would be more successful for hard to reach participants compared to a traditional CBO approach. The strategy focusing on HCWs could easily be expanded to other front-line and essential workers, making the strategy generalizable and sustainable.

Updated Date: 04/17/2024

Principal Investigator: Hudson, Shawna

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Community Outreach Programs; Pandemic Perceptions or Decision-Making; Social Determinants of Health; Testing Rate or Uptake

Data Collection Method: Antigen Testing Device; Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: Healthcare Workers; Testing Disparities

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Questionnaire or Survey

Study Start Date: 09/25/2020

Study End Date: 02/29/2024

Species: Human

Estimated Cohort Size: 2000

Study Population Focus: Adults; African Americans; Children; Essential Workers; Hispanics or Latinos; Lower Socioeconomic Status (SES) Populations; Racial or Ethnic Minorities

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04766333

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7699516/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8283554/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436370/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8765643/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9707722/

Acknowledgement Statement: This study was supported through funding, 7UL1TR003017-05, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-UP program. We thank each of the participants, without whom this study would not be possible. We are grateful to our community partners, healthcare partners and Rutgers colleagues who comprise the NJ HEROES TOO team. Approved users should acknowledge the provision of data access by dbGaP for accession phs002567.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PAR-18-464

NIH Grant or Contract Number(s): 7UL1TR003017-05

Consent/Data Use Limitations: General Research Use