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Study Information

dbGaP Study Accession: phs003507

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/w561-ag09

Release Date: 03/04/2024

Study Description: Low-Income Asian Americans (AA) with limited English proficiency (LEP) represent a meaningful proportion of low-wage frontline workers in essential service industries. Many also live in multigenerational households with crowded conditions and with their elderly relatives in ethnic neighborhoods, areas that have experienced high rates of COVID-19 infection. Unfortunately, AAs have encountered numerous barriers to COVID-19 testing across individual, provider/health system and community/societal levels, including anti-Asian racism and discrimination, fear of safety at test sites and on public transportation, lack of health insurance, lack of culturally and language-appropriate COVID-19 information and navigation, and limited access to COVID-19 testing sites. As a result, AAs have the lowest COVID-19 testing rate across all racial/ethnic groups. This is particularly concerning in light of the recent surge in cases due to the BA.2 variant and lifting of COVID restrictions, which has led to increases in COVID-19 infections and hospitalizations especially among vulnerable populations. FDA-approved over-the-counter (OTC) COVID-19 diagnostic tests offer a valuable evidence-based strategy for empowering vulnerable AAs (who are hesitant or otherwise unable to obtain in-person PCR testing) to complete self-testing. Although prior studies have demonstrated the feasibility of COVID-19 self-testing in communities with access barriers, no intervention study has focused on vulnerable low-income frontline workers and seniors with LEP across diverse AA ethnic groups (Chinese, Vietnamese, Korean, Filipino, Indian, and other South Asian Americans), the fastest growing US population. Thus, the overall goal of this application was to implement a community-engaged multifaceted intervention (IMPROVE intervention) to increase access to and uptake of rapid COVID-19 self-testing across diverse AA populations. Guided by the NIMHD Research Framework and Social Cognitive Theory to address sociocultural/environmental and individual/interpersonal influences for COVID self-testing, the central hypothesis was that trusted messengers (community health navigators, heath providers, and peer advocates) were essential to reducing testing barriers and increasing uptake of COVID-19 self-testing. The Specific Aims were to: (1) Engage community partners to implement a pragmatic cluster-randomized trial in 12 CBO sites to evaluate the effectiveness of the community-engaged and evidence-based IMPROVE intervention in increasing access to and uptake of COVID-19 self-testing (primary outcome) and changes in mitigation behaviors including adherence to mask wearing and COVID-19 vaccination (secondary outcomes) in underserved and vulnerable ethnic AAs (N=1200 AAs); and (2) Evaluate Intervention Reach, Effectiveness, Adoption, Implementation and Maintenance using the RE-AIM framework to facilitate IMPROVE intervention dissemination to more CBOs and enhance its sustainability over time. The primary outcomes included COVID-19 self-testing uptake (number of tests done and locations) and access to COVID-19 self-testing (difficulties of getting tested in the community, and access to at-home self-test kits, difficulties in using self-test kits). The secondary outcomes included changes in COVID-19 mitigation behaviors, including COVID-19 testing, COVID-19 testing intention if testing not performed, COVID-19 vaccine uptake (dosage and brands of vaccine received, to be verified via self-report or vaccine card upload), and intention/hesitancy; mask-wearing and other mitigation strategies, and treatment received and difficulties if positive. The project was one of the first to evaluate an evidence-based community-engaged approach to reducing systemic barriers and filled gaps in research on COVID-19 self-testing and mitigation adherence in above-stated ethnic AA vulnerable populations.

Updated Date: 03/04/2024

Principal Investigator: Ma, Grace X

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Community Outreach Programs; Rapid Diagnostic Test (RDT); Social Determinants of Health; Testing Rate or Uptake; Vaccination Rate or Uptake

Data Collection Method: Antigen Testing Device; Survey

Keywords: Improving Access to COVID Information and Interventions; Individual-Level Data; Mitigation Strategies; Populations with Limited English Proficiency

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Behavioral; Clinical; Family History; Questionnaire or Survey; Social

Study Start Date: 11/01/2022

Study End Date: 10/31/2024

Species: Human

Estimated Cohort Size: 1200

Study Population Focus: Adults; Asians; Children; Essential Workers; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Racial or Ethnic Minorities; Underserved or Vulnerable Populations

Acknowledgement Statement: This study was supported through funding, 3U01MD018320-01S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. The study team wanted to acknowledge RADx-UP program from NIH, collaborating community-based organizations, and the study participants for their support and contribution in study design and implementation. Approved users should acknowledge the provision of data access by dbGaP for accession phs003507.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: RFA-OD-22-006

NIH Grant or Contract Number(s): 3U01MD018320-01S1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 278
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_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_memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
nih_walk_climbDo you have serious difficulty walking or climbing stairs?
nih_dress_batheDo you have difficulty dressing or bathing?
nih_errandBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
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?
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?
disability_decisions_2Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? (5 years of age or older)
disability_dress_2Do you have difficulty dressing or bathing? (5 years of age or older)
disability_errands_2Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping? (15 years of age or older)
disability_walking_2Do you have serious difficulty walking or climbing stairs? (5 years of age or older)
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?
alcohol_daysperweek-
consent_given-
consent_recontact-
covid_fatique_2-
covid_pandemic_challenges_abod_2-
covid_pandemic_challenges_food_2-
covid_pandemic_challenges_wate_2-
covid_test_result-
covid_vaccine-
cov_pan_chal_hlth_2-
cov_pan_chal_med_2-
cov_pan_chlng_trans_2-
cov_tst_mthd_2-
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-
household_congregate_3-
household_famgen_3-
household_homeless-
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-
positiveyear_covidtest_3-
preferred_contact_method_2-
quarantine_maintain_job-
race_ethn_asian_detail_3___1-
race_ethn_asian_detail_3___10-
race_ethn_asian_detail_3___11-
race_ethn_asian_detail_3___12-
race_ethn_asian_detail_3___13-
race_ethn_asian_detail_3___14-
race_ethn_asian_detail_3___15-
race_ethn_asian_detail_3___16-
race_ethn_asian_detail_3___17-
race_ethn_asian_detail_3___18-
race_ethn_asian_detail_3___19-
race_ethn_asian_detail_3___2-
race_ethn_asian_detail_3___20-
race_ethn_asian_detail_3___21-
race_ethn_asian_detail_3___22-
race_ethn_asian_detail_3___3-
race_ethn_asian_detail_3___4-
race_ethn_asian_detail_3___5-
race_ethn_asian_detail_3___6-
race_ethn_asian_detail_3___7-
race_ethn_asian_detail_3___8-
race_ethn_asian_detail_3___9-
race_ethn_asian_detail_3___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_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-
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-
test_accesseasy_2-
test_accesswhere_2-
tested_for_covid-
tested_positive_for_covid-
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_wash_2-
zip_code_3digit-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
READMEproject116_README.html275.15 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project116_DATA_origcopy.csvTabular Data - Non-harmonizedcsv3709
project116_DATA_transformcopy.csvTabular Data - Harmonizedcsv3709