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Study Information

dbGaP Study Accession: phs002720

NIH Institute/Center: NIDA

RADx Data Program: RADx-UP

DOI: 10.60773/pkzs-t351

Release Date: 08/30/2023

Study Description: In the U.S., women who use illicit drugs (WWUD) have disproportionately high rates of infectious (e.g., HIV, HCV), chronic, and pulmonary diseases that elevate their risk for COVID-19. Their health and disease profile is driven by enduring social conditions (e.g., scarcity of income, food insecurity, access to health services, housing, discrimination). These prevailing social conditions can also undermine WWUDs' ability to protect themselves from COVID-19 (e.g., washing hands, social distancing). Drug procurement and use, which are largely social processes, further challenge these self-protection measures. Testing and future vaccination is vital to reducing COVID-19 among this high-risk population, necessitating accessible testing schemes. Here, a mixed methods study was conducted that draws upon the Andersen Behavioral Model10 and is grounded in eco-social theory. Specifically, the Baltimore-based study aimed to: 1) explore predisposing social factors (e.g., housing, food security), individual-level factors (e.g., drug use, mental health), and beliefs (e.g., medical mistrust) that are facilitators and barriers of COVID-19 testing and perceived risks (e.g., income generation, violence) resulting from a diagnosis through in-depth interviews among WWUD (N=15) and a cultural domain analysis (N=45); 2) gain an understanding of the enabling community-level environment (e.g., medical and social service agencies that currently serve WWUD, existing city-wide COVID-19 testing sites) that could facilitate or hinder WWUDs' COVID-testing uptake through observations (N=8-10) and key informant interviews (N=10); and examine predisposing social factors, individual-level factors, and beliefs that are associated with COVID-19 testing and retesting among a cohort (N=250) of WWUD at baseline and 3-month follow-up. Optional testing offered at both study visits were a self-administered, rapid antigen test. The role of medical mistrust in shaping women's' use of healthcare services were examined, as well as experiences of stigma and discrimination in healthcare settings, particularly among Black participants. In Baltimore, this mistrust was particularly pronounced, with Johns Hopkins Hospital having a long history of mistrust in the Black community owing to experimentation and deception of research engagement. The study was guided by a community advisory board (CAB) who informed its design and implementation as well as engaged in disseminating the results at community meetings to inform COVID-testing scale up.

Updated Date: 04/17/2024

Principal Investigator: Sherman, Susan G

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Mental Health; Rapid Diagnostic Test (RDT); Social Determinants of Health; Substance Use; Testing Rate or Uptake

Data Collection Method: Antigen Testing Device; Interview or Focus Group; Survey

Keywords: Medical Mistrust

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Behavioral; Questionnaire or Survey; Social

Study Start Date: 11/01/2020

Study End Date: 10/31/2022

Species: Human

Estimated Cohort Size: 250

Study Population Focus: Adults; African Americans; Older Adults or Elderly; People Living with HIV/AIDS; Racial or Ethnic Minorities; Underserved or Vulnerable Populations

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9770432/

Acknowledgement Statement: This study was supported through funding, 3R01DA041243-05S4, for the National Institute on Drug Abuse (NIDA) as part of the RADx-UP program. Dr. Sherman is supported by an endowment from the Bloomberg American Health Initiative. We would like to thank CARE study participants who trusted us with their stories and experiences. Approved users should acknowledge the provision of data access by dbGaP for accession phs002720.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: PA-12-281

NIH Grant or Contract Number(s): 3R01DA041243-05S4

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 209
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_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_feetFeet
self_reported_height_inchesInches
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_date_mdy-
alcohol_daysperweek-
consentdt_mdy-
consent_given-
consent_ident-
consent_recontact-
consent_ssn-
consent_zip_2-
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-
edu_years_of_school-
employed_ew-
flu_vaccinehistind_2-
flu_vaccine_season_3-
gender_identity_term_2-
hi_loss_covid-
hlthstat_date_mdy-
household_congregate_3-
household_famgen_3-
household_homeless-
hous_emp_and_insur_com-
housing_date_mdy-
iden_date_mdy-
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-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
quarantine_maintain_job-
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_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-
redcap_repeat_instrument-
self_reported_health_status_assessment-
self_reported_height_coded-
self_reported_weight_units_2-
sex_orient_id-
smoker_number-
sociodem_date_mdy-
sym_date_mdy-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
tested_positive_for_covid-
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_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 Documentationphs002720_Project 64_Protocol_04APR2022.pdf680.34 KB
READMEproject64_README.html274.68 KB
Study Documentationproject64_DDE_dictionary_origcopy.docx126.00 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
project64_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv226

project64_DATA_transformcopy.csvTabular Data - Harmonizedcsv226
project64_DATA_origcopy.csvTabular Data - Non-harmonizedcsv226