dbGaP Study Accession: phs002648

NIH Institute/Center: NIGMS

RADx Data Program: RADx-UP

Release Date: 08/31/2023

DOI: 10.60773/wx0n-5518

Study Description: There are limited studies on the spread of SARS-CoV-2 infection in rural essential workers. This gap-in-knowledge were addressed to develop and implement novel pandemic strategies to keep open rural essential workplaces, such as coal mines. The long-term goal of the study was to mitigate the spread of the pandemic in miners, a population of high-risk, rural essential workers who are susceptible and vulnerable to COVID-19, and who are predominantly racial/ethnic minorities in New Mexico (NM). The study objective was to provide proof-of-principle for frequent point-of-care molecular testing as a workplace surveillance tool to monitor and prevent the spread of SARS-CoV-2 infection in this unique population. The central hypothesis was that frequent workplace molecular surveillance is an effective method to reduce SARS-CoV-2 infection and discover novel host risk factors. The site of molecular surveillance (intervention site) was a surface mine in McKinley County, NM, located just outside the Navajo Nation, comprised of 66% minority miners. Miners at the intervention site will provide nasal swabs every alternate work shift, which were analyzed with the Abbott ID Now, COVID-19 test, i.e., the 'index' test. The control mine located at Campbell County, Wyoming, has similar mine characteristics as the intervention mine. The rationale for this study was to establish the suitability of longitudinal molecular surveillance to prevent and control SARS-CoV-2 infection in this unique population by completing the following aims. Specific Aim 1: To determine the acceptance rate to frequent point-of-care molecular workplace surveillance among miners. Hypothesis 1: Miners will have a cumulative acceptance rate of frequent testing at 85%, with the added objective of exploring difference in acceptance by miner characteristics. Specific Aim 2: To determine the ability to detect the presence of SARS-CoV-2 by point-of-care molecular workplace surveillance in a real-world setting of miners. Hypothesis 2: The sensitivity of the index test in a real-world study setting is a) comparable to that described by others in controlled settings, and b) positively associated with viral load in upper respiratory specimens. Specific Aim 3: To determine the effectiveness and implementation costs of frequent point-of-care molecular workplace surveillance on reducing incident infection rates of SARS-CoV-2. Hypothesis 3A: Frequent point-of-care molecular testing over six months in the intervention mine will result in lower incident seropositivity rates compared to the control mine. Hypothesis 3B: Frequent point-of-care molecular surveillance in the intervention mine is cost-effective compared to the control mine. Specific Aim 4: To determine novel predictive host factors associated with incident SARS-CoV-2 infection in miners. Hypothesis 4: Miners with incident infection demonstrate less frequent use of cloth face coverings outside the workplace, greater mine dust exposure intensity, presence of dust-related lung disease, and racial/ethnic minority status than those not infected. Successful completion of the study established the acceptability and effectiveness of the proposed surveillance in work settings where common occupational mitigation strategies were not possible. Findings from this study provided broad-reaching implications for novel pandemic strategies to keep rural essential workplaces open. By working with the NIH RADx-UP Coordinating and Data Collection Center, this study provided crucial data for subsequent studies of vaccine interventions in rural minority essential workers.

Updated Date: 04/17/2024

Principal Investigator: Sood, Akshay

Has Data Files: Yes

Study Domain: Point-of-Care (POC) Testing; Rapid Diagnostic Test (RDT)

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

Keywords: COVID Transmission; Near Patient Testing

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Clinical; Questionnaire or Survey

Study Start Date: 11/01/2020

Study End Date: 07/13/2023

Species: Human

Sample Size: 280

Study Population Focus: Adults; Essential Workers; Older Adults or Elderly; Racial or Ethnic Minorities; Rural Communities

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04977050

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014565/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8328374/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452235/

Acknowledgement Statement: This study was supported through funding, 3U01GM132175-03S1, for the National Institute of General Medical Sciences (NIGMS) as part of the RADx-UP program. The project acknowledges the contributions by our community partners William Cotton Jarrell and Kelly Zimmerscheid from New Mexico and Wyoming respectively. Approved users should acknowledge the provision of data access by dbGaP for accession phs002648.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): 3U01GM132175-03S1

Consent/Data Use Limitations: General Research Use