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 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_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_memory | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? |
nih_walk_climb | Do you have serious difficulty walking or climbing stairs? |
nih_dress_bathe | Do you have difficulty dressing or bathing? |
nih_errand | Because 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_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_pregnancy | Pregnancy status |
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? |
disability_decisions_2 | Because 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_2 | Do you have difficulty dressing or bathing? (5 years of age or older) |
disability_errands_2 | Because 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_2 | Do you have serious difficulty walking or climbing stairs? (5 years of age or older) |
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? |
pregnancy_status | Are you currently pregnant? |
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? |
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 | - |