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Study Information

dbGaP Study Accession: phs002871

NIH Institute/Center: NIAID

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/1tqv-dv25

Study Description: This study sought to understand the factors associated with COVID-19 morbidity and mortality disparities and to lay the foundation to reduce disparities for those underserved and vulnerable populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from the COVID-19 pandemic. This implementation study assessed the modality and venue preferences for COVID 19 testing in rural, incarcerated, and other underserved populations in the state of Alabama. The objective of the study was to evaluate the implementation of a rapid scale-up SARS CoV-2 testing strategy. The original goal of the study was to conduct 30,000 tests in rural counties statewide. In Aim 1, the study defined higher case burden as counties with more than 25 daily cases of COVID-19 per 100,000 total population and lower case burden as less than 10 daily cases per 100,000, both using a 7-day average. In order to identify communities particularly vulnerable to morbidity and disease spread, age, race, income and education were mapped based on census data; and the COVID vulnerability index which included social determinants of health as well as data regarding healthcare access, and COVID-19 disease risk factors. The study also mapped areas where mitigation efforts are particularly poor via cell phone movement and a surrogate measure of belief in COVID-19 science and public policy recommendations. These data were used to work with community partners to prioritize rural counties for testing delivery. All analyses used publicly available aggregate data and did not enroll individuals. As such, these Aim 1 data were not transmitted to the CDCC. For Aim 2, the study partnered with a third-party survey vendor to collect the full battery of Tier 1 Common Data Elements (CDEs) required for the project. The survey sample (n~300) was a representative sample of the rural populations from various counties in which the tests were administered. This data was uploaded to the CDCC including all required CDEs. For Aim 3, in collaboration with community partners, specifically the Alabama Area Health Education Centers (AHEC), the study administered COVID-19 tests within underserved rural populations statewide. All told from 10/01/20 until 02/28/22, the study administered over 23,000 PCR tests, which resulted in a 12% positivity rate. This included testing with the Visby point-of-care PCR test developed via RADx-TECH, which had particular uptake in rural jails across Alabama. In accordance with DHHS reporting requirements, this study collected basic demographic data from all those who were tested, including race, gender, and age. As approved by NIH, this limited dataset was provided for all persons tested via this project, but not all CDEs, as testing was done as standard of care and not for research purposes. Aim 4 of the study evaluated the effectiveness of the testing initiative’s implementation strategy, which was completed by June 2022. This study wanted to know how appropriate and feasible the testing initiative has been for those involved. The target population for this aim of the study were researchers, administrators, and testing staff who have been involved in the project, and did not include the general population and communities offered testing services. As such, there was no individual-level data capture aligned with the CDCC CDE model. This study collected over 100 surveys and conducted 50 in-depth interviews for this aim.

Updated Date: 04/17/2024

Principal Investigator: Saag, Michael S

Has Data Files: Yes

Study Domain: Social Determinants of Health

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

Keywords: COVID-19 Morbidity Rates; COVID-19 Mortality Rates; Individual-Level Data; Testing Effectiveness

Study Design: Cross-Sectional

Multi-Center Study: No

Data Types: Behavioral; Clinical; Questionnaire or Survey

Study Start Date: 09/23/2020

Study End Date: 08/31/2022

Species: Human

Estimated Cohort Size: 35000

Study Population Focus: Adults; Children; Incarcerated or Institutionalized Populations; Older Adults or Elderly; Rural Communities; Underserved or Vulnerable Populations

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35952331/

Acknowledgement Statement: This study was supported through funding, 3P30AI027767-33S1, for the National Institute of Allergy and Infectious Diseases (NIAID) as part of the RADx-UP program. We would like to acknowledge support from the Center for AIDS Research. The University of Alabama at Birmingham's Research and Informatics Services Center (RISC) within the Division of Infectious Diseases at the Heersink School of Medicine managed this project, including its research components. RISC partnered with many local organizations, including ConnectionHealth, Acclinate Genetics, the Alabama Quality Management Group, and the Alabama Area Health Education Centers to plan and implement a robust testing strategy in many rural, incarcerated, and other underserved populations in the state. Approved users should acknowledge the provision of data access by dbGaP for accession phs002871.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): 3P30AI027767-33S1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 222
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_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_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_health_statusWould you say that (your) health in general is excellent, very good, good, fair, or poor?
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
current_employment_statusWe would like to know about what you do -- are you working now, looking for work, retired, keeping house, a student, or something else?
hi_coverage_typeWhat is the primary kind of health insurance or health care plan that you have now? (Exclude plans that pay for only one type of Service (such as, nursing home care, accidents, family planning, or dental care) and plans that only provide extra cash when hospitalized. )
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_centimetersCentimeters
self_reported_height_feetFeet
self_reported_height_inchesInches
self_reported_height_metersMeters
self_reported_weight_kgsHow much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy?
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_zip_2-
covid_pandemic_challenges_abod_2-
covid_pandemic_challenges_food_2-
covid_pandemic_challenges_wate_2-
covid_test_result-
covid_test_result_datetime-
covid_test_type-
covid_vaccine-
cov_pan_chal_hlth_2-
cov_pan_chal_med_2-
cov_pan_chlng_trans_2-
cov_tst_mthd_2-
disability_date_mdy-
edu_years_of_school-
employed_ew-
employed_healthcare_2-
family_income-
flu_vaccinehistind_2-
flu_vaccine_season_3-
gender_identity_term_2-
hi_loss_covid-
hlthstat_date_mdy-
household_congregate_3-
household_famgen_3-
household_homeless-
housing_date_mdy-
iden_date_mdy-
index-
isolate_maintain_job-
jobloss_covid19_2-
language_home___1-
language_home___10-
language_home___11-
language_home___12-
language_home___13-
language_home___14-
language_home___15-
language_home___16-
language_home___17-
language_home___18-
language_home___19-
language_home___2-
language_home___20-
language_home___21-
language_home___22-
language_home___23-
language_home___24-
language_home___25-
language_home___26-
language_home___27-
language_home___28-
language_home___29-
language_home___3-
language_home___30-
language_home___31-
language_home___32-
language_home___33-
language_home___34-
language_home___35-
language_home___36-
language_home___37-
language_home___38-
language_home___39-
language_home___4-
language_home___40-
language_home___41-
language_home___42-
language_home___43-
language_home___44-
language_home___45-
language_home___46-
language_home___5-
language_home___6-
language_home___7-
language_home___8-
language_home___9-
language_home___90-
language_home___99-
language_pref-
med_hx_date_mdy-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
preferred_contact_method_2-
quarantine_maintain_job-
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_hispanic_detail_2___5-
race_ethn_hispanic_detail_2___6-
race_ethn_hispanic_detail_2___7-
race_ethn_hispanic_detail_2___99-
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-
self_reported_health_status_assessment-
self_reported_height_coded-
self_reported_weight_units_2-
sex_orient_id-
smoker_number-
sociodem_date_mdy-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
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_concerns_3___96-
vaccine_concerns_3___99-
vaccine_reasons_3___1-
vaccine_reasons_3___10-
vaccine_reasons_3___11-
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-
vaccine_reasons_3___96-
vaccine_reasons_3___99-
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 Documentationphs002871_Project 2_Protocol.pdf101.77 KB
READMEproject2_README.html274.70 KB
Study Documentationphs002871_Project 2_Participant Information Sheet.pdf117.45 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project2_DATA_transformcopy.csvTabular Data - Harmonizedcsv24082
project2_DATA_origcopy.csvTabular Data - Non-harmonizedcsv24082