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Study Information

dbGaP Study Accession: phs002741

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/q2xk-0f98

Study Description: SARS-CoV-2, the virus that causes COVID-19, has ravaged underserved and vulnerable populations in the United States (US), including in the US territories of Puerto Rico (PR) and the US Virgin Islands (USVI). Pre-pandemic data from the Eastern Caribbean Health Outcomes Research Network (ECHORN) Cohort Study (ECS) (NIH/NIMHD U24MD006938; Pl: Nunez-Smith) indicate nearly 61% of the population-based representative sample (n=3000) has at least one chronic condition making them high risk for severe complications from COVID-19. Nearly 30% of ECS participants report food insecurity. These ECS data were recently requested by the Congressional Ways and Means Committee to scope the threat of the COV1D-19 pandemic to the Caribbean US territories. This competitive revision leverages the Yale Transdisciplinary Collaborative Center for Health Disparities Research focused on Precision Medicine (Yale-TCC; NIH/NIMHD U54MD010711; MPI: Nunez-Smith), which supports broader scientific engagement across ECHORN members. ECHORN was founded in 2011 as a consortium of researchers and non-academic stakeholder partners, using a participatory action research approach, to address the epidemic of non-communicable diseases in the region. The Yale-TCC is a community-engaged and stakeholder-driven network with a consortium comprised of 60 individuals representing 35 organizations spanning academia, research, health policy, faith-based organizations, community-based organizations, and civic societies. The Yale-TCC Governing Board guides prioritization. The goal of the proposed community-engaged research was to, in concert with the RADx-UP consortium, understand factors that have led to the disproportionate disease burden and deploy interventions that improve the reach, access, uptake and impact of COVID-19 testing technologies and strategies across FQHCs, local CBOs, and clinical laboratories in the USVl and PR. Rigorous quasi-experimental designs were used to evaluate the proposed testing intervention projects. This was achieved through the following specific aims: Aim 1: Enhance testing implementation strategies in the USVI and PR utilizing community-based assets and cultural responsiveness to address barriers to full participation in the testing continuum from diagnosis through to seif-isolation. An initial partnership with 3 FQHCs (two in USVI and one in PR) and 2 CBOs (one in USVI and one in PR) was leveraged to refine and implement a multi-component intervention to increase testing, contact tracing, and safe and effective quarantine and isolation, with a focus on the most vulnerable populations. An interrupted time series study design was used to analyze the effect of the intervention on the primary implementation outcome of reach. Secondary Implementation outcomes of adoption, fidelity, acceptability, and sustainability were assessed, as is the secondary effectiveness outcome of ER utilization. Community partners were engaged throughout the intervention refinement, implementation, and evaluation process. Aim 2: Assess the diffusion and uptake of FDA authorized and approved testing technologies across existing and emerging testing models. Through stakeholder and community engagement meetings, intervention components that provide the necessary education/health promotion information, training, and resources that were needed to address barriers at the FQHC, CBO, and community-level to adopt, implement, and disseminate new testing technologies were determined. Sustainability of this model for integration of future technologies or vaccines was addressed and assessed.

Updated Date: 04/17/2024

Principal Investigator: Nunez-Smith, Marcella

Has Data Files: Yes

Study Domain: Diagnostic Testing; Testing Rate or Uptake; Virological Testing

Data Collection Method: Contact Tracing; Survey

Keywords: Caribbean US Populations; Emergency Room (ER) Utilization

Study Design: Interventional or Clinical Trial

Multi-Center Study: Yes

Study Sites: Frederiksted Health Care (St. Croix; USVI); St. Thomas East End Medical Center (St. Thomas; USVI); Health ProMed (San Juan; Puerto Rico); Puerto Rico Science; Technology and Research Trust (San Juan; Puerto Rico)

Data Types: Behavioral; Clinical; Electronic Medical Records; Questionnaire or Survey

Study Start Date: 09/22/2020

Study End Date: 08/31/2022

Species: Human

Sample Size: 24068

Study Population Focus: Adults; Children; Older Adults or Elderly; Underserved or Vulnerable Populations

Acknowledgement Statement: This study was supported through funding, 3U54MD010711-05S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. MPI: Nunez-Smith. We would like to thank each of our site teams for their invaluable collaboration and leadership on this project: Frederiksted Health Care (St. Croix, USVI), St. Thomas East End Medical Center (St. Thomas, USVI), Health ProMed (Puerto Rico) and Puerto Rico Science, Technology, and Research Trust. Approved users should acknowledge the provision of data access by dbGaP for accession phs002741.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): 3U54MD010711-05S1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 266
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_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_other_sympOther
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
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_other_2Other
covid_runnynose_2Sore throat, congestion or runny nose
covid_skinrash_2Skin Rash
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_fatique_2-
covid_pandemic_challenges_abod_2-
covid_pandemic_challenges_food_2-
covid_pandemic_challenges_wate_2-
covid_test_approval-
covid_test_collect_datetime-
covid_test_collection_setting-
covid_test_date_mdy-
covid_test_performed_location-
covid_test_result-
covid_test_result_datetime-
covid_test_result_sent_datetime-
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-
crowding_since_last-
data_source-
edu_years_of_school-
employed_ew-
employed_healthcare_2-
employment_status_since_last-
eviction_since_last-
family_income-
fi_afford_balanced_meals-
fi_change_diet-
fi_change_diet_frequency-
fi_eat_less-
fi_food_money_frequency-
fi_high_quality_2-
fi_hungry-
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_concerns-
housing_crowding-
housing_date_mdy-
housing_eviction-
iden_date_mdy-
income_change_since_last-
isolate_child-
isolate_maintain_job-
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_hx_date_mdy-
moved_since_last-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
preferred_contact_method_2-
quarantine_child-
quarantine_maintain_job-
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_asian_detail___99-
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_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_islander_detail___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-
stable_housing-
survey_language-
sym_date_mdy-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
tested_positive_for_covid-
two_of_two_doses-
vacc_date_mdy-
vaccine_avail-
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_dose-
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-
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 Documentationphs002741_Project 27_Protocol_04NOV2020.pdf586.11 KB
READMEproject27_README.html274.92 KB
Study Documentationproject27_DDE_dictionary_origcopy.csv120.55 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
project27_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv43275

project27_DATA_transformcopy.csvTabular Data - Harmonizedcsv43275
project27_DATA_origcopy.csvTabular Data - Non-harmonizedcsv43275