Study Information

dbGaP Study Accession: phs002708

NIH Institute/Center: NIEHS

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/nvkn-xv26

Updated Date: 04/10/2024

Study Description: UC San Diego's Superfund Research Center (SRC), supported by the NIEHS Superfund Research Program since 2000, was engaged in research and Public Health initiatives that examined the cumulative impacts of poor nutrition and other health disparities on the etiology of a variety of diseases. The ethnically diverse low-income communities in San Diego SRC engages are predominantly populated by people of color where poverty, pollution, inadequate infrastructure, and structural racism create unhealthy living conditions. These same communities are being ravaged by COVID-19, which is caused by infection by the SARS-CoV-2 virus. With California becoming one of the global pandemic epicenters in the US, coupled with the growing need for rapid COVID-19 testing, SRC partnered with expertise at UC San Diego to develop simple, rapid and inexpensive FDA-authorized COVID-19 testing that were offered using community-driven, contextually relevant strategies to accelerate broad testing uptake among underserved communities in San Diego. While all areas of San Diego County are seeing rising cases of COVID-19 infections, southern San Diego communities along the US-Mexico border, including Chula Vista, Otay Mesa and San Ysidro, are experiencing disproportionate increases in infections. Among these communities, San Ysidro stands out for several reasons. First, it represents one of the poorest communities in San Diego, a condition that drives health disparities. Second, San Ysidro has the highest incidence of COVID-19 cases in San Diego County, even with current (inadequate) levels of testing. Third, San Ysidro is located a significant distance from the major health centers in San Diego, such as UC San Diego Health, and access to adequate testing is problematic. Fourth, San Ysidro is home to San Ysidro Health (SYH), a federally qualified health center that is the largest healthcare delivery system serving San Ysidro residents, and which has a long-standing relationship with UC San Diego. This local health facility has struggled to access COVID-19 testing. Taken together, these factors make San Ysidro a good place to create a prototype two-year community-engaged testing research project. Further, regular prenatal and pediatric care visits were still being conducted to sustain their known positive impacts on pregnancy and child health outcomes; this creates an excellent opportunity to engage families in COVID-19 testing in an otherwise hard-to-reach population. The SYH Maternal and Child Health Center (MCHC) was a busy prenatal and pediatric care site located less than 2 miles from the US-Mexico border, and was the focus of this project. Through a multi-level community-engaged approach and in partnership with a diverse Community and Scientific Advisory Board (CSAB), a set of contextually relevant strategies were developed, implemented, and evaluated. These strategies accelerated the broad delivery and uptake of COVID-19 testing among pregnant women and children and support scaling across the entire San Ysidro community of 27,000 residents. It was hypothesized that the implementation of an extensive and rapid COVID-19 testing program would markedly decrease the disparities experienced by underserved communities in testing access and ultimately in morbidity and mortality from COVID-19.

Principal Investigator: Laurent, Louise

Has Data Files: Yes

Study Domain: Community Outreach Programs; Social Determinants of Health; Rapid Diagnostic Test (RDT); Medical Device/Tool Development

Data Collection Method: Survey

Keywords: Individual-Level Data; Remnant Samples from COVID-19 Testing; Nutrition

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys

Study Start Date: 06/23/2022

Study End Date: 03/31/2023

Species: Human Data

Estimated Cohort Size: 10000

Study Population Focus: Children; Pregnant (or Nursing) Women; Underserved/Vulnerable Population; African American; Lower Socioeconomic Status (SES) Population; Adults; Older Adults or Elderly

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9974043/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9574473/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108217/

Acknowledgement Statement: This study was supported through funding, 3P42ES010337-20S1, for the National Institute of Environmental Health Sciences (NIEHS) as part of the RADx-UP program. The CO-CREATE projects has established partnerships with San Ysidro Health and The Global ARC to help guide recruitment methods as well as providing community feedback to ensure these methods of participant engagement and enrollment are tailored to the unique demographic of the San Ysidro community. UC San Diego Clinical Research Coordinators and San Ysidro Health Research Assistants have been on-site at the San Ysidro Maternal and Child Health Clinic in San Ysdiro on a weekly basis conducting COVID-19 testing and conducting participant surveys. CO-CREATE staff engage in weekly team meetings to support efforts and provide collaborative feedback to build upon weekly on-site learnings and adaptations. Approved users should acknowledge the provision of data access by dbGaP for accession phs002708.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: PA-20-135

NIH Grant or Contract Number(s): 3P42ES010337-20S1

Consent/Data Use Limitations: General Research Use

Study Documents
Study Documents Table
Document
Document Name
File Size
Download
READMEproject7_README.html281.65 KB
Study Documentationphs002708_Project 7_Protocol_27MAR2023.pdf885.02 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project7_DATA_transformcopy.csvTabular Data - Harmonizedcsv9394
project7_DATA_origcopy.csvTabular Data - Non-harmonizedcsv9394