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Study Information

dbGaP Study Accession: phs003123

NIH Institute/Center: NIDA

RADx Data Program: RADx-UP

Release Date: 08/29/2023

DOI: 10.60773/eg9v-8e46

Study Description: Through the RADx-UP Phase I study, correlates of point-of-care COVID-19 testing (POCT) uptake at baseline and reuptake at a 3-month follow-up visit among WWUD (N=250) in Baltimore, MD were examined. In this Phase II, C2SPARC study, this study examined POCT uptake in both research and service delivery contexts. Specifically, the study proposed adding a 6-month visit (C2SPARC visit) among the CARE cohort in order to examine trends in POCT uptake over time. Secondly, in partnership with the SPARC Center, a leading harm reduction organization that serves WWUD, the study proposed designing and implementing POCT on their nighttime mobile outreach van that provides harm reduction supplies (e.g., condoms, naloxone, syringes), basic necessities (e.g., food, clothing), and trauma informed micro-counseling. C2SPARC leveraged long-term community partnerships (see letters of support), an existing Community Advisory Board (CAB), and a well-established research infrastructure. The study employed Andersen's Behavioral Model10 (Aim 1), PRISM (Practical, Robust, Implementation, and Sustainability Model)11 (Aim 2), and the Theoretical Framework of Acceptability (TFA)12 (Aim 3) to meet the following aims. 1. To examine predisposing (e.g., social - homelessness, food insecurity; individual - drug use, race/ ethnicity, health beliefs) and enabling (prior COVID-19 testing, vaccine uptake) factors that predict uptake of POCT over a six-month period in WWUD (N=250) in Baltimore, Maryland. 2. To collaborate with the SPARC Center to develop and implement POCT on their mobile outreach van that primarily serves WWUD in Baltimore City, Maryland. 3. To examine the feasibility (e.g., testing uptake) and acceptability (e.g., participant burden, testing self-efficacy) of mobile POCT among WWUD (N=250) who are clients of SPARC outreach. Through Aim 1, the study examined a range of predisposing (social and individual) and enabling factors that predict POCT uptake over a six-month period. By leveraging Phase I's existing cohort and data collection, the C2SPARC visit doubles the follow-up length, allowing for longitudinal data analysis. Predictors of POCT uptake are shaped by Andersen's Behavioral framework and informed by the extensive prior research with the study population. The C2SPARC visit leveraged the existing Phase I CARE research infrastructure, which is built on 15 years of community-engaged field research among WWUD and female sex workers (FSW) who use drugs. This additional data collection wave deepened the understanding of the drivers of COVID-19 testing uptake among this highly marginalized population in the context of a rapidly evolving testing and vaccine landscape. Through Aim 2, the study investigators partnered with the SPARC Center to develop, pilot, and implement a POCT service two nights per week on their outreach van (see Preliminary Studies). This implementation process was informed by Aim 1 findings and by formative qualitative data collection including key informant interviews with outreach staff (N=5) and systematic observations (N=6) of the SPARC outreach van, guided by the PRISM framework. Through Aim 3, the study investigators assessed the program feasibility (i.e., testing uptake) of POCT on SPARC outreach through analyzing SPARC outreach administrative data. The study employed the TFA framework to measure acceptability of COVID-19 testing via a brief anonymous survey administered to SPARC clients (N=250) when POCT is offered. C2SPARC was innovative in leveraging the Phase I cohort in examining drivers of POCT uptake longitudinally, which then informed the implementation of POCT on a highly subscribed mobile outreach van. Further, situating POCT in the context of existing relationships with trusted service providers was urgently needed. The study's impact and sustainability was further enhanced by the engagement of a seasoned CAB. C2SPARC was responsive to NOT-OD-21-103 in that it expanded the RADx-UP Phase I study to build enhanced point-of-care infrastructures that can be sustained beyond the current pandemic. Study results were quickly disseminated to the target population, service providers, and policy makers through products (i.e., fact sheets, manuscripts) and events (i.e., community forums) to inform community-based testing and eventual vaccination programs targeting WWUD and similarly marginalized populations.

Updated Date: 04/17/2024

Principal Investigator: Sherman, Susan G

Has Data Files: Yes

Study Domain: Mobile Unit Testing; Point-of-Care (POC) Testing; 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: Marginalized Populations; Near Patient Testing

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Behavioral; Questionnaire or Survey; Social

Study Start Date: 09/15/2021

Study End Date: 08/31/2023

Species: Human

Estimated Cohort Size: 500

Study Population Focus: Adults; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Underserved or Vulnerable Populations

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 phs003123.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: 560
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_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_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_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-
cl_condom-
clientcov-
clientn-
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-
covmyth_1-
covmyth_2-
covmyth_3-
covmyth_4-
covmyth_5-
covmyth_6-
covmyth_7-
cov_pan_chal_hlth_2-
cov_pan_chal_med_2-
cov_pan_chlng_trans_2-
covposnotif-
covsx_withdraw-
covtestloc-
cov_tst_mthd_2-
depyou-
depyou_n-
depyou_who_1-
depyou_who_2-
depyou_who_3-
depyou_who_4-
depyou_who_5-
depyou_who_5_text-
distributionchannel-
docref-
docworry-
drguse1_1-
drguse1_2-
drguse1_3-
drguse1_4-
drguse1_5-
drguse1_6-
drguse1_7-
drguse1_8-
durationinseconds-
edu_years_of_school-
employed_ew-
fatalod6-
finished-
flu_vaccinehistind_2-
flu_vaccine_season_3-
fluvax_wh-
foundcl3_1-
foundcl3_11-
foundcl3_13-
foundcl3_13_text-
foundcl3_4-
foundcl3_5-
foundcl3_6-
foundcl3_7-
foundcl3_9-
gender_identity_term_2-
hi_loss_covid-
hlthstat_date_mdy-
household_famgen_3-
household_homeless-
hous_emp_and_insur_com-
housing_date_mdy-
hungry-
inctype_1-
inctype_10-
inctype_11-
inctype_12-
inctype_13-
inctype_14-
inctype_14_text-
inctype_4-
inctype_5-
inctype_6-
inctype_7-
inctype_8-
inctype_9-
injdrg31_1-
injdrg31_2-
injdrg31_3-
injdrg31_4-
injdrg31_5-
injdrg31_6-
injdrg31_7-
injdrg31_8-
isolate_maintain_job-
jobloss_covid19_2-
k6_1-
k6_2-
k6_3-
k6_4-
k6_5-
k6_6-
k6fx-
k6_phys-
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-
lasted-
livech_curr-
livech_curr_12_text-
liven-
locationlatitude-
locationlongitude-
med_hx_date_mdy-
_merge-
narcan-
nep3-
neploc_1-
neploc_3-
neploc_3_text-
neploc_4-
nonfod6-
odlast-
odnalox-
odnalox_who-
odnalox_who_12_text-
pipes3_1-
pipes3_10-
pipes3_6-
pipes3_7-
pipes3_8-
pipes3_9-
progress-
q289-
q290_size-
q290_type-
q291_size-
q291_type-
q359_1-
q359_2-
q359_3-
q359_4-
q359_5-
q421-
q422-
q423-
q424_4-
q424_8-
q424_8_text-
q424_9-
q425-
q427_1-
q427_10-
q427_11-
q427_2-
q427_3-
q427_4-
q427_5-
q427_6-
q427_7-
q427_8-
q427_9-
q429-
q430-
q435-
q436-
q437_5-
q437_6-
q439-
q440_1-
q440_10-
q440_11-
q440_5-
q440_6-
q440_7-
q440_8-
q440_9-
q441-
q442-
q4431_1-
q4431_2-
q4431_3-
q4431_4-
q4431_5-
q4431_6-
q4431_7-
q4431_8-
q456-
q464-
q466_1-
q466_12-
q466_13-
q466_14-
q466_16-
q466_17-
q466_17_text-
q468_1-
q468_2-
q468_3-
q468_4-
q468_6-
q468_7-
q468_7_text-
q471-
q472-
q4731_1-
q4731_2-
q4731_3-
q4731_4-
q4731_5-
q4731_6-
q474-
q476_1-
q476_2-
q476_3-
q476_4-
q476_6-
q476_7-
q476_7_text-
q4771_1-
q4771_2-
q4771_3-
q4771_4-
q4771_5-
q4771_6-
q4771_7-
q4791_1-
q4791_2-
q4791_3-
q4791_5-
q4791_6-
q4791_7-
q4791_8-
q481_1-
q481_2-
q481_3-
q481_4-
q481_5-
q481_6-
q481_7-
q482-
q483-
q484-
q486-
q487-
q488_1-
q488_2-
q488_3-
q488_4-
q488_5-
q488_6-
q5-
q507-
q508_1-
q508_10-
q508_4-
q508_5-
q508_6-
q508_7-
q508_8-
q508_9-
q513_1-
q513_2-
q513_3-
q513_4-
q513_5-
q513_6-
q513_7-
q513_8-
q514_1-
q514_10-
q514_11-
q514_2-
q514_3-
q514_4-
q514_5-
q514_6-
q514_7-
q514_8-
q514_9-
q515-
q516-
q518-
q519-
q529-
q571-
q597-
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-
regclin-
regdoc-
reuse3_1-
reuse3_4-
reuse3_5-
reuse3_6-
rp_condom-
rp_fem-
rp_male-
rp_n-
safecov-
safehome-
safesw-
safesw_cov-
self_reported_health_status_assessment-
self_reported_height_coded-
self_reported_weight_units_2-
sex_orient_id-
smkdrg31_1-
smkdrg31_2-
smkdrg31_3-
smkdrg31_4-
smkdrg31_5-
smkdrg31_6-
smkdrg31_7-
smoker_number-
sociodem_date_mdy-
srtdrg31_1-
srtdrg31_2-
srtdrg31_3-
srtdrg31_4-
srtdrg31_5-
srtdrg31_6-
srtdrg31_7-
srtdrg31_8-
srtfxcov31_1-
srtfxcov31_2-
srtfxcov31_3-
srtfxcov31_4-
srtfxcov31_5-
srtfxcov31_6-
srtfxcov31_7-
srtfxcov31_8-
status-
sterile3-
swcovfx-
swever-
swfx3-
swldrg31_1-
swldrg31_2-
swldrg31_3-
swldrg31_4-
swldrg31_5-
swldrg31_6-
swldrg31_7-
swldrg31_8-
sym_date_mdy-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
tested_positive_for_covid-
topconcern_1-
topconcern_10-
topconcern_11-
topconcern_12-
topconcern_13-
topconcern_14-
topconcern_14_text-
topconcern_15-
topconcern_16-
topconcern_17-
topconcern_18-
topconcern_2-
topconcern_3-
topconcern_4-
topconcern_5-
topconcern_6-
topconcern_7-
topconcern_8-
topconcern_9-
unmetdoc-
useppl-
userlanguage-
usewhere_1-
usewhere_10-
usewhere_11-
usewhere_12-
usewhere_13-
usewhere_14-
usewhere_16-
usewhere_16_text-
usewhere_7-
usewhere_8-
usewhere_9-
v421-
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-
vaxdose-
vaxhes_1-
vaxhes_10-
vaxhes_11-
vaxhes_2-
vaxhes_3-
vaxhes_4-
vaxhes_5-
vaxhes_6-
vaxhes_7-
vaxhes_8-
vaxhes_9-
wantdoc-
work_closecont_2-
work_ppe_2-
work_ppe_date_mdy-
work_wash_2-
youdep-
youdep_who_1-
youdep_who_10-
youdep_who_11-
youdep_who_13-
youdep_who_13_text-
youdep_who_8-
youdep_who_9-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs003123_Project S17_Protocol.pdf737.78 KB
READMEprojectS17_README.html274.67 KB
Study DocumentationprojectS17_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
projectS17_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv145

projectS17_DATA_origcopy.csvTabular Data - Non-harmonizedcsv145
projectS17_DATA_transformcopy.csvTabular Data - Harmonizedcsv145