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Study Information

dbGaP Study Accession: phs002825

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

Release Date: 12/07/2023

DOI: 10.60773/v97k-6w36

Study Description: Racial/ethnic minority and low socioeconomic status (SES) populations suffer profound health inequities across a wide variety of conditions as well as a disproportionate burden of the negative health consequences of the COVID-19 pandemic. Latinos make up ~14% of the Utah population vs. ~21% of Utah's COVID-19 cases (50% higher) and the case rate is over 3-fold higher in neighborhoods characterized by high vs. low deprivation. In the Utah 2020-2021 school year, there have been 36,484 school-associated cases of COVID-19. The ongoing partnerships with the Utah Department of Health (UDOH) allowed access to real-time information on "hotspot schools" across the state. One of the Utah school district partners, Granite School District (n=85 schools), had the 3rd highest number of cases of COVID-19 and 45% of its schools have a student population with >50% eligible to receive free/reduced lunch and 60% have a student population that is >50% ethnic minority. Schools bear a large part of the burden of managing COVID-19 testing and communicating with parents about testing their children. Few schools in Utah have information technology systems in place to support systematic communication with parents about student COVID-19 testing and tracking testing outcomes. Through the existing RADx-UP grant (UL1TR002538-03S4), the team developed a text messaging and health navigator infrastructure that was deployed in federally-qualified health centers across Utah. The study chose to use text messaging because it is widely available in underserved communities, with 97% of individuals with an annual income <$30,000 and 96% with educational attainment of high school or less having a phone that can text. This project addressed key testing challenges in schools by building on existing collaborations with school districts and with UDOH on COVID-19 testing and existing infrastructure. This study worked closely with schools and the Utah public health system to implement and test a shovel-ready and scalable health information technology approach that delivers automated text messages (TMs) to staff and students' parents around COVID-19 testing. In addition, students in some schools received a health navigator (HN) follow-up to ensure that tests are completed. HN were community members who have been trained in case management. Families were offered the recently FDA-approved in-home serial testing approach if accessing in-person testing was a challenge. Within the context of a cluster-randomized trial, this study employed a rapid cycle design to test interventions on a small scale, using short time frames (<1month) and iterative evaluation cycles. This approach was extremely successful in the current RADx-UP project, SCALE-UP Utah. The proposed trial compared the efficacy of TM versus TM+HN. This project had several potential impacts on COVID-19 testing for elementary and middle school students in disadvantaged school settings: 1] SCALE-UP Counts provided critical data on the impact of pragmatic and scalable approaches to increasing COVID-19 testing and reducing COVID-19-related health inequities among students and their families. 2] The rapid cycle research approach utilized in this project allowed the team to quickly disseminate effective interventions to other schools and adapt interventions to changing testing policies and local outbreaks and rates. 3] The use of HNs who are members of the students' communities maximized the team's ability to integrate communities' cultural factors and strengths and to promote the acceptability of the testing support provided. 4] SCALE-UP Counts hold a significant impact on community transmission of COVID-19 due to the provision of testing to students' immediate household members. Rates of household transmission were 50-75% and thus, ensuring testing for households is essential towards decreasing community spread. 5] The interventions were made readily available for adoption by other disadvantaged school settings and the data will advance population health and implementation science.

Updated Date: 04/17/2024

Principal Investigator: Wu, Yelena

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; COVID Hotspots; COVID in School Settings; Diagnostic Testing; Social Determinants of Health

Data Collection Method: Antigen Testing Device; Survey

Keywords: COVID Communication via Text Messaging; COVID Hotspot Communities; Families/Legal Guardians of School-aged Children/Young Adults; In-person Testing; School Staff/Stakeholders; School-aged Children/Young Adults

Study Design: Interventional or Clinical Trial

Multi-Center Study: Yes

Study Sites: Granite School District

Data Types: Behavioral; Questionnaire or Survey; Social

Study Start Date: 11/20/2022

Study End Date: 11/20/2023

Species: Human

Estimated Cohort Size: 5600

Study Population Focus: Adults; Children; Hispanics or Latinos; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Racial or Ethnic Minorities; School Communities; Underserved or Vulnerable Populations

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05112900

Publication URL: https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394508/; https://pubmed.ncbi.nlm.nih.gov/37394512/

Acknowledgement Statement: This study was supported through funding, 3OT2HD108097-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We are thankful to our collaborators, the Huntsman Cancer Institute and the University of Utah, the Utah Department of Health, and the participating school districts. Additionally, we want to thank the participants that made this study possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002825.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.

NIH Grant or Contract Number(s): 3OT2HD108097-01S1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 341
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_ssn-
consent_zip_2-
covid_barrier___1-
covid_barrier___2-
covid_barrier___3-
covid_barrier___4-
covid_barrier___5-
covid_barrier___6-
covid_barrier___7-
covid_barrier___8-
covid_barrier___9-
covid_barrier___98-
covid_barrier___99-
covid_fatique_2-
covid_had-
covid_iso_chal___1-
covid_iso_chal___2-
covid_iso_chal___3-
covid_iso_chal___4-
covid_iso_chal___5-
covid_iso_chal___6-
covid_iso_chal___7-
covid_iso_chal___8-
covid_iso_chal___9-
covid_iso_chal___98-
covid_iso_chal___99-
covid_pandemic_challenges_abod_2-
covid_pandemic_challenges_food_2-
covid_pandemic_challenges_wate_2-
covid_pto-
covid_risk-
covid_tested_30-
covid_tst_reas-
covid_vaccine-
cov_pan_chal_hlth_2-
cov_pan_chal_med_2-
cov_pan_chlng_trans_2-
cov_tst_mthd_2-
education-
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_famgen_3-
household_homeless-
household_size-
household_test-
housing_date_mdy-
iden_date_mdy-
index-
info_concern-
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-
other_positive-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
preferred_contact_method_2-
preoccupied-
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_3___99-
race_ethn_asian_detail___99-
race_ethn_hispanic_detail___1-
race_ethn_hispanic_detail___2-
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_hispanic_detail___3-
race_ethn_hispanic_detail___4-
race_ethn_hispanic_detail___5-
race_ethn_hispanic_detail___6-
race_ethn_hispanic_detail___7-
race_ethn_hispanic_detail___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_2___99-
race_ethn_islander_specify-
race_ethn_other-
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-
race_other-
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-
sex_orient_id-
sex_orient_specify-
sociodem_date_mdy-
sym_date_mdy-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
tested_negative-
tested_positive-
tested_positive_for_covid-
testing_activities-
testing_comm_2___1-
testing_comm_2___2-
testing_comm_2___3-
testing_comm_2___4-
testing_comm___5-
testing_comm_other-
testing_died-
testing_hosp-
testing_missingwork-
testing_sick-
testing_wait_2-
test_intent_2-
test_pbenearound_2-
test_pbeneexposed_2-
test_pbenepos_2-
test_pbenepositive-
test_pbenesafe_2-
test_pbenework_2-
test_pbeneworry_2-
test_percvaccuneg_2-
test_percvaccupos_2-
test_positive-
test_priskcontact_2-
test_priskhlthcare_2-
test_priskknow_2-
test_prisklater_2-
test_prisknohelp_2-
test_prisknosymp_2-
test_priskouch_2-
test_resneg_2___1-
test_resneg_2___2-
test_resneg_2___3-
test_resneg_2___4-
test_respos_2___1-
test_respos_2___2-
test_respos_2___3-
trust_coll_2-
trust_cortf_2-
trust_doc_2-
trust_fam_2-
trust_flead_2-
trust_news_2-
trust_social_2-
trust_usgov_2-
vacc_date_mdy-
vaccine_avail-
vaccine_booster-
vaccine_concerns_2___99-
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___96-
vaccine_concerns___99-
vaccine_conven_2-
vaccine_dose-
vaccine_edu_post-
vaccine_edu_pre-
vaccine_effective_2-
vaccine_free_2-
vaccine_last_dte-
vaccine_literacy-
vaccine_manufac_2-
vaccine_no_pain_2-
vaccine_options-
vaccine_prev_expos-
vaccine_reasons_2___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___96-
vaccine_reasons___99-
vaccine_rec1_dte-
vaccine_requirement-
vaccine_safe_2-
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 Documentationphs002825_Project 85_Protocol.pdf361.31 KB
READMEproject85_README.html274.78 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
project85_DATA_transformcopy.csvTabular Data - Harmonizedcsv4901
project85_DATA_origcopy.csvTabular Data - Non-harmonizedcsv4901
project85_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv4901