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 Name | Label |
---|---|
nih_record_id | User ID |
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_education | What is the highest level of education you have achieved outside or in the United States? |
nih_zip | What is your zip code? |
nih_disability | Do you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities? |
nih_vape_freq | Vaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
nih_cig_smoke_freq | Nicotine Frequency: Do you now smoke cigarettes? |
nih_smoking_yn | Do you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)? |
nih_history_smoking | History of Smoking |
nih_alcohol_yn | Alcohol use (Yes or No) |
nih_lifetime_use_alcohol | In 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_frequency | How often did you have a drink containing alcohol ? |
nih_asthma | Asthma |
nih_cancer_past_yr | Cancer diagnosis and/or treatment within the past 12 months |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_mental_health_disorder | Mental health disorder |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_immunocompromised | Immunocompromised condition |
nih_autoimm | Autoimmune disease |
nih_copd | Chronic obstructive pulmonary disease (COPD) |
nih_chronic_lung | Other chronic lung disease |
nih_depression | Depression |
nih_alc_sub_abuse | Alcohol or substance use disorder |
nih_iv_drug_use | Intravenous drug use |
nih_other_chronic_cond | Other chronic condition |
nih_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_fatigue | Excessive fatigue |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_skin_rash | Skin rash |
nih_throat_congestion_nose | Sore throat, congestion or runny nose |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
age_yrs | Age For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years) |
bio_sex_birth_2 | What was your sex assigned at birth on your birth certificate? |
cc_asthma_2 | Asthma |
cc_asud_2 | Alcohol or substance use disorder |
cc_autoimm_2 | Autoimmune disease |
cc_cancer_2 | Cancer diagnosis and/or treatment within the past 12 months |
cc_chronickd_2 | Chronic kidney disease (CKD) |
cc_clung_2 | Other chronic lung disease |
cc_copd_2 | Chronic obstructive pulmonary disease (COPD) |
cc_cvd_2 | Cardiovascular disease (CVD or heart disease) |
cc_depression_2 | Depression |
cc_diabetes_2 | Diabetes |
cc_hypertension_2 | Hypertension (HTN, high blood pressure) |
cc_imm_2 | Immunocompromised condition |
cc_intrav_2 | Intravenous drug use |
cc_otherchroniccond_2 | Other chronic condition |
cc_othermh_2 | Other mental health disorder |
cc_sickle_2 | Sickle Cell Anemia |
covid_abpain_2 | Abdominal Pain |
covid_cough_2 | Cough |
covid_diffbreath_2 | Shortness of breath or difficulty breathing |
covid_fever_2 | Fever or chills |
covid_headache_2 | Headache |
covid_myalgia_2 | Muscle or body aches |
covid_nausea_2 | Feeling sick to your stomach or vomiting, diarrhea |
covid_olfactory_2 | New loss of taste or smell |
covid_runnynose_2 | Sore throat, congestion or runny nose |
covid_skinrash_2 | Skin Rash |
lifetime_use_alcohol | In your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips? |
pregnancy_status | Are you currently pregnant? |
race_ethn_hispanic | Are you of Hispanic, Latino, or Spanish origin? |
self_reported_disability | Do 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_feet | Feet |
self_reported_height_inches | Inches |
self_reported_weight_lbs | How much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy? |
smoker_cur_stat_2 | Do you now smoke cigarettes? |
vaper_cur_stat | Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
zip_code | Zip 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 | - |