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Study Information

dbGaP Study Accession: phs002759

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/y7xk-ma85

Release Date: 08/30/2023

Study Description: This proposal tested the hypothesis that frequent screening testing would provide additional benefit, beyond current school-based mitigation strategies, to prevent SARS-CoV-2 transmission. This study completed a cluster randomized trial to compare the incidence of school-based SARS-CoV-2 transmission between weekly surveillance testing of students and school staff versus testing only symptomatic students and staff. In this proposal, 12 middle and high schools from five predominantly African-American school districts in the St. Louis metropolitan area were cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. This study performed qualitative listening sessions and interviews with members of the school community including parents, teachers, administrators, and students to understand the facilitators and barriers to testing, the concerns regarding in-person school, and potential issues involving vaccine hesitancy evident in all populations and groups. This study provided critically needed, rigorous data to inform the utility of screening testing in schools and if it is important in aiding schools in the African-American community to return to in-person instruction. Additionally, the measurements of school-based transmission rates helped participating schools in the African-American community assess the impact of their mitigation strategies, demonstrated potential risk points for transmission that can be targeted for further intervention, and reassured the community on the safety of their schools. Finally, the study results aided participating researchers, school districts and communities in understanding how to mitigate concerns about in-person schooling and the reliability of the mitigation strategies (with or without screening testing) in preventing COVID-19 transmission.

Updated Date: 04/17/2024

Principal Investigator: Newland, Jason

Has Data Files: Yes

Study Domain: COVID in School Settings; Pandemic Perceptions or Decision-Making; Screening Testing; Social Determinants of Health

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

Keywords: COVID Transmission Rates; Families/Legal Guardians of School-aged Children/Young Adults; Return to In-person Learning; School Staff/Stakeholders; School-aged Children/Young Adults; School-based Testing; Vaccine Hesistancy

Study Design: Case-Control

Multi-Center Study: No

Data Types: Questionnaire or Survey

Study Start Date: 04/01/2021

Study End Date: 03/31/2023

Species: Human

Estimated Cohort Size: 5000

Study Population Focus: Adults; African Americans; Children; Children; Older Adults or Elderly; School Communities; Underserved or Vulnerable Populations

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04875520

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737177/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737179/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737181/; https://pubmed.ncbi.nlm.nih.gov/35260896/; https://pubmed.ncbi.nlm.nih.gov/35698094/; https://pubmed.ncbi.nlm.nih.gov/36992895/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10040557/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9189793/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647737/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647738/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647774/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647777/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647778/

Acknowledgement Statement: This study was supported through funding, 3OT2HD107557-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We want to acknowledge the community who has partnered with us on this work through engagement in so many different ways. We also want to acknowledge the team working to implement and execute this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002759.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): 3OT2HD107557-01S1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 315
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_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_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_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?
disability_blind_2Are you blind, or do you have serious difficulty seeing, even when wearing glasses?
disability_deaf_2Are you deaf, or do you have serious difficulty hearing?
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?
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-
caregiver-
caregiverhelp-
coachsport-
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-
disability_date_mdy-
discord-
discordchange-
edu_years_of_school-
employed_ew-
employed_healthcare_2-
eviction-
family_income-
familystress-
fi_afford_balanced_meals-
fi_change_diet-
fi_change_diet_frequency-
fi_food_money_frequency-
fi_high_quality_2-
flu_vaccinehistind_2-
flu_vaccine_season_3-
gender_identity_term_2-
grade_level___1-
grade_level___10-
grade_level___11-
grade_level___12-
grade_level___13-
grade_level___14-
grade_level___15-
grade_level___2-
grade_level___3-
grade_level___4-
grade_level___5-
grade_level___6-
grade_level___7-
grade_level___8-
grade_level___9-
grade_level___98-
helpneighbor-
hi_loss_covid-
hlthstat_date_mdy-
household_famgen_3-
household_homeless-
housing_concerns-
housing_date_mdy-
ieppeds-
intellect-
int_other-
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-
neighborhood-
noschoolreason___1-
noschoolreason___2-
noschoolreason___3-
noschoolreason___4-
noschoolreason___5-
noschoolreason___98-
otherchronic-
pedsvaccine-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
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_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_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-
respondantother-
respondanttype-
role_other-
school_2-
schoollink-
schoolparticipant-
school_role___1-
school_role___10-
school_role___11-
school_role___12-
school_role___2-
school_role___3-
school_role___4-
school_role___5-
school_role___6-
school_role___7-
school_role___8-
school_role___9-
self_reported_health_status_assessment-
self_reported_height_coded-
self_reported_weight_units_2-
sex_orient_id-
smoker_number-
smoke_years-
sociodem_date_mdy-
stable_housing-
sym_date_mdy-
symptom_begin-
symptom_overview-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
tested_positive_for_covid-
test_intent_2-
test_pbenearound_2-
test_pbeneexposed_2-
test_pbenepos_2-
test_pbenesafe_2-
test_pbenework_2-
test_pbeneworry_2-
test_percvaccuneg_2-
test_percvaccupos_2-
test_priskcontact_2-
test_priskhlthcare_2-
test_priskknow_2-
test_prisklater_2-
test_prisknohelp_2-
test_prisknosymp_2-
test_priskouch_2-
test_type-
trust_coll_2-
trust_cortf_2-
trust_doc_2-
trust_fam_2-
trust_flead_2-
trustneighbor-
trust_news_2-
trust_usgov_2-
type_learn-
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_other-
vaccine_reasons_3___1-
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-
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 Documentationproject72_DDE_dictionary_origcopy.csv108.89 KB
Study Documentationphs002759_Project 72_Protocol.pdf279.97 KB
READMEproject72_README.html274.77 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
project72_DATA_transformcopy.csvTabular Data - Harmonizedcsv19152
project72_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv19152

project72_DATA_origcopy.csvTabular Data - Non-harmonizedcsv19152