Clinical trial NCT04977050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-07-26
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants Screened (Molecular)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Aksay Sood, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.