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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quidel quickvue antigen test for COVID-19
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Site

Controled site

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Screening test (molecular)
Rapid antigen test for COVID-19

Secondary Outcome Measures

Diagnostic test (RT-PCR)
Confirmatory COVID-19 test on nasopharyngeal swab
Serologic antibody test
Antibody for COVID-19

Full Information

First Posted
July 14, 2021
Last Updated
June 21, 2023
Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04977050
Brief Title
The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners
Official Title
Keeping Rural Minority 'Essential' Workplaces Open Safely During the COVID-19 Pandemic: The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners (Short Title: The Miners' Pandemic Project)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 screening 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 (latter measured in nose and nasopharynx using quantitative reverse transcriptase-polymerase chain reaction or RT-PCR). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Site
Arm Type
Experimental
Arm Description
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.
Arm Title
Controled site
Arm Type
No Intervention
Arm Description
All miners in the Wyoming Control mine site who will be administered serological testing 3 months.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quidel quickvue antigen test for COVID-19
Intervention Description
rapid antigen test on nasal swab specimen for COVID-19
Primary Outcome Measure Information:
Title
Screening test (molecular)
Description
Rapid antigen test for COVID-19
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diagnostic test (RT-PCR)
Description
Confirmatory COVID-19 test on nasopharyngeal swab
Time Frame
12 months
Title
Serologic antibody test
Description
Antibody for COVID-19
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Unable or unwilling to provide and sign Informed Consent Form < 18 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aksay Sood, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share with Duke Clinical Research Institute. As per NIH requirements.
IPD Sharing Time Frame
from current to Infinite
IPD Sharing Access Criteria
request to Duke Clinical Research Institute
Citations:
PubMed Identifier
32277775
Citation
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.
Results Reference
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The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners

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