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临床试验/NCT04977050
NCT04977050已完成不适用

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)

University of New Mexico2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
2
主要终点
Number of Participants Screened (Molecular)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Number of Participants Screened (Molecular)

时间窗: 12 months

Rapid antigen test for COVID-19

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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