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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04977050
Enrollment
230
Registered
2021-07-26
Start date
2021-02-22
Completion date
2022-10-31
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DIAGNOSTIC_TESTQuidel quickvue antigen test for COVID-19

rapid antigen test on nasal swab specimen for COVID-19

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Screened (Molecular)12 monthsRapid antigen test for COVID-19

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Site
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. Quidel quickvue antigen test for COVID-19: rapid antigen test on nasal swab specimen for COVID-19
169
Controled Site
All miners in the Wyoming Control mine site who will be administered serological testing 3 months.
61
Total230

Baseline characteristics

CharacteristicIntervention SiteControled SiteTotal
Age, Categorical
<=18 years
13 Participants0 Participants13 Participants
Age, Categorical
>=65 years
2 Participants1 Participants3 Participants
Age, Categorical
Between 18 and 65 years
154 Participants60 Participants214 Participants
Age, Continuous44 years
STANDARD_DEVIATION 11.2
45.2 years
STANDARD_DEVIATION 11.9
44.6 years
STANDARD_DEVIATION 11.3
Ethnicity (NIH/OMB)
Hispanic or Latino
97 Participants4 Participants101 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants54 Participants117 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants3 Participants12 Participants
Race (NIH/OMB)
American Indian or Alaska Native
27 Participants2 Participants29 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
31 Participants3 Participants34 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants0 Participants14 Participants
Race (NIH/OMB)
White
96 Participants56 Participants152 Participants
Region of Enrollment
United States
169 Participants61 Participants230 Participants
Sex: Female, Male
Female
14 Participants11 Participants25 Participants
Sex: Female, Male
Male
154 Participants48 Participants202 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1690 / 61
other
Total, other adverse events
0 / 1690 / 61
serious
Total, serious adverse events
0 / 1690 / 61

Outcome results

Primary

Number of Participants Screened (Molecular)

Rapid antigen test for COVID-19

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention SiteNumber of Participants Screened (Molecular)169 Participants
Controled SiteNumber of Participants Screened (Molecular)61 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026