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 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_deaf | Are you deaf or do you have serious difficulty hearing? |
nih_blind | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
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_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_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_fatigue | Excessive fatigue |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_skin_rash | Skin rash |
nih_throat_congestion_nose | Sore throat, congestion or runny nose |
nih_other_symp | Other |
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 |
covid_abpain_2 | Abdominal Pain |
covid_cough_2 | Cough |
covid_diffbreath_2 | Shortness of breath or difficulty breathing |
covid_fever_2 | Fever or chills |
covid_headache_2 | Headache |
covid_myalgia_2 | Muscle or body aches |
covid_nausea_2 | Feeling sick to your stomach or vomiting, diarrhea |
covid_olfactory_2 | New loss of taste or smell |
covid_other_2 | Other |
covid_runnynose_2 | Sore throat, congestion or runny nose |
covid_skinrash_2 | Skin Rash |
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? |
disability_blind_2 | Are you blind, or do you have serious difficulty seeing, even when wearing glasses? |
disability_deaf_2 | Are you deaf, or do you have serious difficulty hearing? |
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? |
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 | - |
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 | - |