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 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_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
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_health_status | Would you say that (your) health in general is excellent, very good, good, fair, or poor? |
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 |
current_employment_status | We 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_type | What 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_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_centimeters | Centimeters |
self_reported_height_feet | Feet |
self_reported_height_inches | Inches |
self_reported_height_meters | Meters |
self_reported_weight_kgs | How much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy? |
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_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 | - |