The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners

NCT04977050 | Completed Results DMC

• 2 other identifiers: HRPO 20-6803U01GM132175-03S1
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of the study is 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, partly based on exposure to particulate air pollution, and who are predominantly racial/ethnic minorities in New Mexico (NM) (3, 11). The study objective is 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 is that frequent workplace molecular surveillance is an effective method to reduce SARS-CoV-2 infection and discover novel host risk factors for the virus. The site of molecular surveillance (intervention site) will be a surface coal mine in McKinley County, NM, located just outside the Eastern Agency of the Navajo Nation, comprised of 66% minority miners. This site offers a unique opportunity for a community-based study of SARS-CoV-2 infection in this population. Miners at the intervention site will provide nasal swabs before beginning their work shift on alternate days that will be analyzed with a 'screening' molecular test (12). This test is ideal because it is low cost, simple, portable, point-of-care, rapid, and can be performed by minimally trained professionals in low-infrastructure settings. The control site is a similar coal mine in Campbell County, Wyoming (WY). Both mines, operated by the same company, have similar engineering, administrative, and personal protective measures in place. The rationale for this study is to establish the suitability of longitudinal molecular surveillance to prevent and control SARS-CoV-2 infection in this unique population by completing the following specific aims.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of Participants Screened (Molecular)

  Rapid antigen test for COVID-19

  12 months

Study Arms (2)

Intervention Site

EXPERIMENTAL

All miners in the New Mexico intervention mine site who will be administered nasal swabs for antigen testing every other work shift, and serological testing 3 months.

Diagnostic Test: Quidel quickvue antigen test for COVID-19

Controled site

NO INTERVENTION

All miners in the Wyoming Control mine site who will be administered serological testing 3 months.

Interventions

Quidel quickvue antigen test for COVID-19 DIAGNOSTIC_TEST

rapid antigen test on nasal swab specimen for COVID-19

Intervention Site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female Miner employed at intervention mine or the control mine.
• \> 18 years of age.
• Willing and able to provide and sign Informed Consent Form.
• Willing and able to comply with study procedures.

You may not qualify if:

• Unable or unwilling to provide and sign Informed Consent Form
• \< 18 years of age.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (2)

• Sood A, Pollard C, Suer KL, Vlahovich K, Walker J. Caring for Miners During the Coronavirus Disease-2019 (COVID-19) Pandemic. J Rural Health. 2021 Jan;37(1):165-168. doi: 10.1111/jrh.12444. Epub 2020 Jun 2. No abstract available.

  PMID: 32277775 BACKGROUND

• Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

  PMID: 38597249 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Akshay Sood
• Organization: University of New Mexico

ASood@salud.unm.edu

505-272-4751

Study Officials

• Aksay Sood, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 26, 2021
• Study Start: February 22, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 3, 2024
• Results First Posted: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from current to Infinite
• Access Criteria: request to Duke Clinical Research Institute

Locations

US (1)