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Study Information

dbGaP Study Accession: phs003027

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

DOI: 10.60773/cghr-4117

Release Date: 08/29/2022

Study Description: This biorepository was established to obtain, store, and share body fluid samples for SARS-CoV-2 research. Samples were obtained at the study sites. The overall study duration was open ended to allow ongoing enrollment and indefinite storage of samples. There was no limit to the number of volunteers who could consent to participate in the study. The time frame for enrollment of volunteers and endpoints of the study were open ended, and duration of participation was only limited by withdrawal of consent to store data or samples. Participants were asked to complete a survey through the Eureka digital study platform. The survey collected demographic information, delineated the types of samples provided, and collected information about experience with COVID-19 (e.g., symptoms or exposures). Samples were collected in a location equipped for safely obtaining specimens from potentially SARS-CoV-2-infected participants, e.g., ED or inpatient units, ambulatory clinics, or COVID-19 community screening events.

Updated Date: 04/17/2024

Principal Investigator: Broach, John

Has Data Files: Yes

Study Domain: Virological Testing

Data Collection Method: Smartphone; Survey

Keywords: Near Patient Testing

Study Design: Open Cohort

Multi-Center Study: Yes

Study Sites: UMass Chan Medical School; UMass Lowell; Oregon Health & Science University; Northwestern University; University of Iowa; University of Kansas Medical Center; Morehouse School of Medicine; John Hopkins University;

Data Types: Behavioral; Questionnaire or Survey

Study Start Date: 05/21/2021

Study End Date: 03/31/2022

Species: Human

Estimated Cohort Size: 1721

Study Population Focus: Adults; Children; Older Adults or Elderly

Acknowledgement Statement: This study was supported through funding, 5U54HL143541-05, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx Tech program. National Institutes of Health (NIH) program support came from NHLBI (Erin Iturriaga and Jue Chen), NIBIB (Bill Heetderks and Andrew Weitz), and NIH Presidential Innovation Fellow Krishna Juluru. Operations support and data management occurred primarily through the UMass Chan Medical School’s Center for Clinical and Translational Science, Clinical Studies Core, and the Department of Population and Quantitative Health Sciences. Additional recruitment of participants occurred at UMass Lowell; Oregon Health & Science University; Northwestern University; University of Iowa; University of Kansas Medical Center; Morehouse School of Medicine; John Hopkins University. Data collection occurred through the Eureka Platform managed by the UCSF team. Quest Diagnostics ran the standard comparators (Roche 6800 Cobas PCR for SARS-CoV-2 assays). Approved users should acknowledge the provision of data access by dbGaP for accession phs003027.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: PAR-17-453

NIH Grant or Contract Number(s): 5U54HL143541-05

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 299
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_education_yrsHow many years of education have you completed?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
nih_deafAre you deaf or do you have serious difficulty hearing?
nih_blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
nih_memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
nih_walk_climbDo you have serious difficulty walking or climbing stairs?
nih_dress_batheDo you have difficulty dressing or bathing?
nih_errandBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
nih_vaping_ynVaping use (Yes or No)
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_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_yrsHow often did you have a drink containing alcohol in the past year?
nih_alcohol_frequencyHow often did you have a drink containing alcohol ?
nih_asthmaAsthma
nih_cancerCancer
nih_cancer_active_treatmentCancer (including leukemia or lymphoma) undergoing active treatment?
nih_cancer_past_yrCancer diagnosis and/or treatment within the past 12 months
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_heart_attackA heart attack (myocardial infarction)?
nih_chfCongestive Heart failure (CHF, Heart Failure)?
nih_strokeStroke or TIA (Transient Ischemic Attack or Mini-Stroke)?
nih_immunodeficiencyImmunodeficiency (NOT including HIV)?
nih_hivChronic HIV infection?
nih_anemiaAnemia or other blood disorder (do not include leukemia or lymphoma)?
nih_premature_birthHistory of premature birth (being born before 37 weeks of pregnancy)
nih_chdChronic Heart Disease
nih_cfCystic Fibrosis
nih_cld_bpdCLD BPD (Chronic Lung Disease Bronchopulmonary Dysplasia)
nih_copd_plusChronic obstructive pulmonary disease (COPD) including emphysema, chronic bronchitis, obstructive pulmonary disease?
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_throat_congestion_noseSore throat, congestion or runny nose
nih_red_eyesRed or painful eyes
nih_high_tempA temperature greater than 100.4 °F
nih_no_symptNone of the above
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
nih_height_categoryApproximately what is your height?
nih_weight_categoryApproximately what is your weight?
age_at_registrationAge
alcoholHow often did you have a drink containing alcohol in the past year?
anemiaAnemia or other blood disorder (do not include leukemia or lymphoma)?
asthmaAsthma, to the point that you use inhalers daily or have been to the hospital for your asthma?
cancerCancer (including leukemia or lymphoma) undergoing active treatment?
cfCF
chdCHD
chfCongestive Heart failure (CHF, Heart Failure)?
ckdDecreased kidney (renal) function or kidney (renal) failure?
cld_bpdCLD BPD
cond_prev_activityDo you have any serious physical or mental condition(s) that limit your ability to perform daily activities?
copdCOPD (emphysema, chronic bronchitis, obstructive pulmonary disease)?
coronary_artery_diseaseCoronary artery disease (blockages in your heart vessels) or angina (chest pain)?
coughA cough (worse than usual)
diabetesDiabetes? Do not include pre-diabetes.
doctor_shoppingBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping? (15 years old or older)
dressing_bathingDo you have difficulty dressing or bathing? (5 years or older)
ethnicityAre you of Hispanic or Latino origin?
fever_chillsSymptoms of fever or chills
hbpHigh blood pressure or hypertension (except that occurred during pregnancy and did not last after pregnancy)?
hearingAre you deaf or do you have serious difficulty hearing?
heart_attackA heart attack (myocardial infarction)?
high_tempA temperature greater than 100.4 °F
hivChronic HIV infection?
immunodeficiencyImmunodeficiency (NOT including HIV)?
memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? (5 years or older)
mental_illnessHave you ever been told by a physician, psychologist, or healthcare provider that you have any mental illness (for example depression, anxiety, bipolar, schizophrenia, or other)?
muscle_achesMuscle aches (worse than usual)
nausea_vomiting_diarrheaNausea, vomiting or diarrhea
no_symptomsNone of the above
prematureHistory of premature birth (being born before 37 weeks of pregnancy)
race_amindAmerican Indian
race_asianAsian
race_blackBlack
race_dkDon't know
race_otherOther
race_pacislPacific Islander
race_whiteWhite
red_eyesRed or painful eyes
sc_anemiaHave you ever been told by a physician or healthcare provider that you have sickle cell anemia?
sexGender
shortness_of_breathShortness of breath
smokingDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
strokeStroke or TIA (Transient Ischemic Attack or Mini-Stroke)?
unable_to_taste_or_smellUnable to taste or smell
user_idUser ID
visionAre you blind or do you have serious difficulty seeing, even when wearing glasses?
walk_stairsDo you have serious difficulty walking or climbing stairs? (5 years or older)
workingWe would like to know about what you do-are you working now, looking for work, retired, keeping house, a student, or what?
zipZipcode
abc_concern-
abc_location-
abc_performed-
abc_time-
action_taken_1-
action_taken_2-
action_taken_3-
action_taken_4-
adverse_what_1-
adverse_what_2-
adverse_what_3-
adverse_what_4-
alcohol_how_many-
alcohol_often-
alcohol_six_or_more-
an_concern-
an_location-
an_medium-
an_performed-
an_time-
ASSAY-
attribution_1-
attribution_2-
attribution_3-
attribution_4-
complex-
confident-
congestion-
covid_tx_curr-
covid_tx_prev-
covid_vax-
covid_vax_co-
covid_vax_co2-
covid_vax_co3-
covid_vax_date_dose1-
covid_vax_date_dose2-
covid_vax_date_dose3-
covid_vax_doses-
cumbersome-
date_end_1-
date_end_2-
date_end_3-
date_end_4-
date_start_1-
date_start_2-
date_start_3-
date_start_4-
days_since_symptom_start-
dbs_concern-
dbs_location-
dbs_performed-
dbs_sample_success-
dbs_time-
dev_date_noted_1-
dev_date_noted_2-
dev_date_noted_3-
dev_date_noted_4-
dev_date_occured_1-
dev_date_occured_2-
dev_date_occured_3-
dev_date_occured_4-
dev_risk_1-
dev_risk_2-
dev_risk_3-
dev_risk_4-
difficult_breathing-
easy-
education-
education_additional-
expected_1-
expected_2-
expected_3-
expected_4-
fatigue-
frequent-
gender_additional-
headache-
height_ft-
height_in-
household_sx_past_48_hrs-
inconsistency-
indian_health-
insurance_any-
insurance_direct-
insurance_not_covered-
insurance_work-
int_cont_result-
integrated-
internal_cont_res-
internal_flags-
internal_flags_desc-
known_exposure-
known_exposure_days-
learn-
medicaid-
medicare-
mt_concern-
mt_location-
mt_medium-
mt_medium_oth-
mt_performed-
mt_sample_success-
mt_time-
muscle_body_aches-
nih_chronic_kidney_disease_trt-
nih_coronary_artery_dis_angina-
np_concern-
np_location-
np_medium-
np_medium_oth-
np_performed-
np_sample_success-
np_time-
outcome_1-
outcome_2-
outcome_3-
outcome_4-
performed_lab-
pregnancy-
promoter-
quick-
research_datetime-
research_test-
runny_nose-
sal_concern-
sal_performed-
sal_sample_success-
sal_time-
scratchy_throat-
serious_1-
serious_2-
serious_3-
serious_4-
severity_1-
severity_2-
severity_3-
severity_4-
site-
smoking_amount-
smoking_ecig-
sore_throat-
sore_throat_2-
stand_adverse_attrib-
stand_adverse_event-
stand_adverse_what__1-
stand_adverse_what__2-
stand_adverse_what__3-
stand_adverse_what__4-
stand_adverse_what__5-
stand_adverse_what__99-
standard_datetime-
standard_form_dt-
standard_result-
standard_test-
stand_concerns-
stand_cycle_time-
stand_cycle_time_1-
stand_cycle_time_2-
stand_cycle_time_ind-
stand_cycle_time_tar-
stand_d_result-
stand_location-
stand_method-
stand_performed-
stand_qs_result-
stand_result_time-
stand_tar1-
stand_tar2-
sus_score-
technical-
tricare-
vb_concern-
vb_count_tube_gold-
vb_count_tube_green-
vb_count_tube_oth-
vb_count_tube_red-
vb_location-
vb_sample_success-
vb_time-
vb_type_tube_gold-
vb_type_tube_green-
vb_type_tube_oth-
vb_type_tube_oth_specify-
vb_type_tube_red-
vb_volume-
weight-
why_dbs_samp_not_collec-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs003027_MASTER Pediatric-Specific Research Center Staff Survey_17SEP2021.pdf809.89 KB
Study Documentationphs003027_MASTER POCT Usability Questionnaire_Adult_03MAY2021.pdf577.33 KB
Study Documentationphs003027_MASTER POCT Usability Questionnaire_Pediatric_17SEP2021.pdf606.79 KB
Study Documentationphs003027_Protocol_02FEB2022.pdf620.32 KB
Study Documentationphs003027_Test Us Bank Eureka Survey_11NOV2021.pdf555.83 KB
Study Documentationphs003027_Test Us Bank Kids Eureka Survey_11NOV2021.pdf750.88 KB
Data Files
Total Files: 5
Data Files: 3
Metadata Files: 0
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
phs003027_transformcopy_2024-03-18.csvTabular Data - Harmonizedcsv1721

phs003027_tier2_3_2024-04-09.csvTabular Data - Non-harmonizedcsv1721

phs003027_origincopy_2024-03-18.csvTabular Data - Non-harmonizedcsv1721