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Study Information

dbGaP Study Accession: phs002648

NIH Institute/Center: NIGMS

RADx Data Program: RADx-UP

Release Date: 08/31/2023

DOI: 10.60773/wx0n-5518

Study Description: There are limited studies on the spread of SARS-CoV-2 infection in rural essential workers. This gap-in-knowledge were addressed to develop and implement novel pandemic strategies to keep open rural essential workplaces, such as coal mines. The long-term goal of the study was 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, and who are predominantly racial/ethnic minorities in New Mexico (NM). The study objective was 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 was that frequent workplace molecular surveillance is an effective method to reduce SARS-CoV-2 infection and discover novel host risk factors. The site of molecular surveillance (intervention site) was a surface mine in McKinley County, NM, located just outside the Navajo Nation, comprised of 66% minority miners. Miners at the intervention site will provide nasal swabs every alternate work shift, which were analyzed with the Abbott ID Now, COVID-19 test, i.e., the 'index' test. The control mine located at Campbell County, Wyoming, has similar mine characteristics as the intervention mine. The rationale for this study was to establish the suitability of longitudinal molecular surveillance to prevent and control SARS-CoV-2 infection in this unique population by completing the following aims. 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 index 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. 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. Successful completion of the study established the acceptability and effectiveness of the proposed surveillance in work settings where common occupational mitigation strategies were not possible. Findings from this study provided broad-reaching implications for novel pandemic strategies to keep rural essential workplaces open. By working with the NIH RADx-UP Coordinating and Data Collection Center, this study provided crucial data for subsequent studies of vaccine interventions in rural minority essential workers.

Updated Date: 04/17/2024

Principal Investigator: Sood, Akshay

Has Data Files: Yes

Study Domain: Point-of-Care (POC) Testing; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device; Interview or Focus Group; Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: COVID Transmission; Near Patient Testing

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Clinical; Questionnaire or Survey

Study Start Date: 11/01/2020

Study End Date: 07/13/2023

Species: Human

Estimated Cohort Size: 227

Study Population Focus: Adults; Essential Workers; Older Adults or Elderly; Racial or Ethnic Minorities; Rural Communities

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04977050

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014565/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8328374/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452235/

Acknowledgement Statement: This study was supported through funding, 3U01GM132175-03S1, for the National Institute of General Medical Sciences (NIGMS) as part of the RADx-UP program. The project acknowledges the contributions by our community partners William Cotton Jarrell and Kelly Zimmerscheid from New Mexico and Wyoming respectively. Approved users should acknowledge the provision of data access by dbGaP for accession phs002648.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3U01GM132175-03S1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 214
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_educationWhat is the highest level of education you have achieved outside or in the United States?
nih_zipWhat is your zip code?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
nih_vape_freqVaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all?
nih_cig_smoke_freqNicotine Frequency: Do you now smoke cigarettes?
nih_smoking_ynDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
nih_history_smokingHistory of Smoking
nih_alcohol_ynAlcohol use (Yes or No)
nih_lifetime_use_alcoholIn your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips? (Yes or No)
nih_alcohol_frequencyHow often did you have a drink containing alcohol ?
nih_asthmaAsthma
nih_cancer_past_yrCancer diagnosis and/or treatment within the past 12 months
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_immunocompromisedImmunocompromised condition
nih_autoimmAutoimmune disease
nih_copdChronic obstructive pulmonary disease (COPD)
nih_chronic_lungOther chronic lung disease
nih_depressionDepression
nih_alc_sub_abuseAlcohol or substance use disorder
nih_iv_drug_useIntravenous drug use
nih_other_chronic_condOther chronic condition
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_throat_congestion_noseSore throat, congestion or runny nose
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
age_yrsAge For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years)
bio_sex_birth_2What was your sex assigned at birth on your birth certificate?
cc_asthma_2Asthma
cc_asud_2Alcohol or substance use disorder
cc_autoimm_2Autoimmune disease
cc_cancer_2Cancer diagnosis and/or treatment within the past 12 months
cc_chronickd_2Chronic kidney disease (CKD)
cc_clung_2Other chronic lung disease
cc_copd_2Chronic obstructive pulmonary disease (COPD)
cc_cvd_2Cardiovascular disease (CVD or heart disease)
cc_depression_2Depression
cc_diabetes_2Diabetes
cc_hypertension_2Hypertension (HTN, high blood pressure)
cc_imm_2Immunocompromised condition
cc_intrav_2Intravenous drug use
cc_otherchroniccond_2Other chronic condition
cc_othermh_2Other mental health disorder
cc_sickle_2Sickle Cell Anemia
covid_abpain_2Abdominal Pain
covid_cough_2Cough
covid_diffbreath_2Shortness of breath or difficulty breathing
covid_fever_2Fever or chills
covid_headache_2Headache
covid_myalgia_2Muscle or body aches
covid_nausea_2Feeling sick to your stomach or vomiting, diarrhea
covid_olfactory_2New loss of taste or smell
covid_runnynose_2Sore throat, congestion or runny nose
covid_skinrash_2Skin Rash
lifetime_use_alcoholIn your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips?
pregnancy_statusAre you currently pregnant?
race_ethn_hispanicAre you of Hispanic, Latino, or Spanish origin?
self_reported_disabilityDo you have a disability that interferes with your ability to carry out daily activities? Examples of daily activities include walking, climbing stairs, shopping, balancing a checkbook, bathing or dressing.
self_reported_height_feetFeet
self_reported_height_inchesInches
self_reported_weight_lbsHow much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy?
smoker_cur_stat_2Do you now smoke cigarettes?
vaper_cur_statDo you now use electronic cigarettes every day, some days, rarely, or not at all?
zip_codeZip Code
alcohol_date_mdy-
alcohol_daysperweek-
consentdt_mdy-
consent_given-
consent_ident-
consent_recontact-
consent_rule-
consent_zip_2-
covid_fatique_2-
covid_pandemic_challenges_abod_2-
covid_pandemic_challenges_food_2-
covid_pandemic_challenges_wate_2-
covid_test_approval-
covid_test_collection_setting-
covid_test_date_mdy-
covid_test_performed_location-
covid_test_result-
covid_test_specimen_collector-
covid_test_specimen_type-
covid_test_study_setting-
covid_test_tar_dis_stat_2___1-
covid_test_tar_dis_stat_2___2-
covid_test_tar_dis_stat_2___3-
covid_test_tar_dis_stat_2___4-
covid_test_tar_dis_stat_2___5-
covid_test_tar_dis_stat_2___6-
covid_test_tar_dis_stat_2___9-
covid_test_type-
covid_vaccine-
cov_pan_chal_hlth_2-
cov_pan_chal_med_2-
cov_pan_chlng_trans_2-
cov_tst_mthd_2-
edu_years_of_school-
family_income-
flu_vaccine_season_3-
gender_identity_term_2-
hlthstat_date_mdy-
household_famgen_3-
housing_date_mdy-
iden_date_mdy-
index-
jobloss_covid19_2-
language_english-
language_home___1-
language_home___2-
language_home___3-
language_home___4-
language_home___5-
language_home___6-
language_home___7-
language_home___8-
language_home___9-
language_home___90-
language_home___99-
med_date_mdy-
med_hx_date_mdy-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
preferred_contact_method_2-
race_ethn_asian_detail_3___1-
race_ethn_asian_detail_3___2-
race_ethn_asian_detail_3___3-
race_ethn_asian_detail_3___4-
race_ethn_asian_detail_3___5-
race_ethn_hispanic_detail_2___1-
race_ethn_hispanic_detail_2___2-
race_ethn_hispanic_detail_2___3-
race_ethn_hispanic_detail_2___4-
race_ethn_islander_detail_2___1-
race_ethn_islander_detail_2___10-
race_ethn_islander_detail_2___11-
race_ethn_islander_detail_2___12-
race_ethn_islander_detail_2___13-
race_ethn_islander_detail_2___14-
race_ethn_islander_detail_2___2-
race_ethn_islander_detail_2___3-
race_ethn_islander_detail_2___4-
race_ethn_islander_detail_2___5-
race_ethn_islander_detail_2___6-
race_ethn_islander_detail_2___7-
race_ethn_islander_detail_2___8-
race_ethn_islander_detail_2___9-
race_ethn_race___1-
race_ethn_race___15-
race_ethn_race___2-
race_ethn_race___3-
race_ethn_race___4-
race_ethn_race___5-
race_ethn_race___99-
recentmonth_covidtest_2-
recentresult_covidtest-
recentyear_covidtest_3-
redcap_event_name-
redcap_repeat_instance-
redcap_repeat_instrument-
sex_orient_id-
smoker_number-
smoke_years-
sociodem_date_mdy-
sym_date_mdy-
take_presc_meds-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_positive_for_covid-
vacc_date_mdy-
vaccine_concerns_3___1-
vaccine_concerns_3___10-
vaccine_concerns_3___2-
vaccine_concerns_3___3-
vaccine_concerns_3___4-
vaccine_concerns_3___5-
vaccine_concerns_3___6-
vaccine_concerns_3___7-
vaccine_concerns_3___8-
vaccine_concerns_3___9-
vaccine_reasons_3___1-
vaccine_reasons_3___2-
vaccine_reasons_3___3-
vaccine_reasons_3___4-
vaccine_reasons_3___5-
vaccine_reasons_3___6-
vaccine_reasons_3___7-
vaccine_reasons_3___8-
vaccine_reasons_3___9-
withdrawal-
work_closecont_2-
work_ppe_2-
work_ppe_date_mdy-
work_wash_2-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationproject65_DDE_dictionary_origcopy.xlsx23.35 KB
Study Documentationphs002648_Project 65_Protocol_15OCT2021.pdf847.30 KB
READMEproject65_README.html274.87 KB
Data Files
Total Files: 8
Data Files: 3
Metadata Files: 3
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project65_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv15518

project65_DATA_transformcopy.csvTabular Data - Harmonizedcsv15518
project65_DATA_origcopy.csvTabular Data - Non-harmonizedcsv15518