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Study Information

dbGaP Study Accession: phs002634

NIH Institute/Center: NIAID; NIMHD

RADx Data Program: RADx-UP

Release Date: 08/31/2023

DOI: 10.60773/ad5b-vx98

Study Description: This study tested an adaptation of the HIV Continuum of Prevention, Care, and Treatment Framework (CoPCT) for use in tracking COVID-19 testing and follow-up in a medically and socially vulnerable population. Utilizing the integrated research collaborative framework that facilitates dialogue among researchers, community members, and service providers as a tool for optimizing the adaptive intervention, this study took place at the North Jersey Community Research Initiative (NJCRI). The Multiphase Optimization Strategy (MOST) was used to optimize an adaptive intervention that successfully navigates COVID-19 medically or socially vulnerable people through a continuum of prevention, care and treatment (CoPCT) modeled on the HIV CoPCT. The COVID-19 CoPCT starts with testing and continues with successful adherence to prevention or treatment guidelines to help prevent and/or treat COVID-19. The study assessed the effectiveness of Navigation Services compared to referrals in increasing COVID-19 testing and Brief Counseling in increasing adherence to the State of NJ recommendations for COVID-19 prevention and treatment. The effect of Critical Dialogue on testing behavior among people who decline to be tested for COVID-19 was also examined. The investigators developed decision rules about what evidence-based-interventions work best for what types of people (e.g., those who test right away, versus decliners) and in what period of the COVID-19 continuum. This study shed light on factors associated with testing and adherence to NJ recommendations. Investigators followed Community Based Participatory Research principles in implementing a sequential, multiple assignment randomized trial (SMART) design.

Updated Date: 04/17/2024

Principal Investigator: Windsor, Liliane Cambraia

Has Data Files: Yes

Study Domain: Health Behaviors; Testing Rate or Uptake; Virological Testing

Data Collection Method: Interview or Focus Group; Survey

Keywords: CBPR; Community Based Participatory Research; Counseling; Critical Dialogue Intervention; MOST; Multiphase Optimization Strategy; Navigation Services; SMART; Sequential Multiple Assignment Randomized Trial

Study Design: Interventional or Clinical Trial

Multi-Center Study: Yes

Study Sites: University of Illinois Urbana Champaign; North Jersey Community Research Initiative; University of Michigan

Data Types: Behavioral; Clinical; Cognitive; Family History; Psychological; Questionnaire or Survey; Social; Supporting Documents

Study Start Date: 01/12/2022

Study End Date: 12/31/2023

Species: Human

Estimated Cohort Size: 670

Study Population Focus: Adults; Older Adults or Elderly; Underserved or Vulnerable Populations

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04757298

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35421999/

Acknowledgement Statement: This study was supported through funding, 3R01MD010629-04S2 and 5U01AI169469-02, for the National Institute on Minority Health and Health Disparities (NIMHD) and the National Institute of Allergy and Infectious Diseases (NIAID) as part of the RADx-UP program. The research team thanks the participants and community members who have contributed to the development, implementation, analyses, and evaluation of this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002634.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-21-008

NIH Grant or Contract Number(s): 3R01MD010629-04S2; 5U01AI169469-02

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 201
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_zipWhat is your zip code?
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_smoking_ynDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
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_autoimmAutoimmune disease
nih_copdChronic obstructive pulmonary disease (COPD)
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_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_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_intrav_2Intravenous drug use
cc_otherchroniccond_2Other chronic condition
cc_othermh_2Other mental health disorder
cc_sickle_2Sickle Cell Anemia
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
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?
vaper_cur_statDo you now use electronic cigarettes every day, some days, rarely, or not at all?
zip_codeZip Code
alcohol_date_mdy-
alcohol_daysperweek-
consentdt_mdy-
consent_given-
consent_ident-
consent_recontact-
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_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-
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-
hlthstat_date_mdy-
household_congregate_3-
household_famgen_3-
household_homeless-
housing_date_mdy-
iden_date_mdy-
jobloss_covid19_2-
language_home___1-
language_home___17-
language_home___2-
language_home___3-
language_home___36-
language_home___4-
language_home___5-
language_home___6-
language_home___7-
language_home___8-
language_home___90-
med_hx_date_mdy-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
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___6-
race_ethn_race___1-
race_ethn_race___15-
race_ethn_race___2-
race_ethn_race___3-
race_ethn_race___4-
race_ethn_race___5-
recentresult_covidtest-
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-
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___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 Documentationphs002634_Project 106_Protocol.pdf484.20 KB
Study Documentationphs002634_Project 70_Protocol.pdf440.11 KB
READMEproject70_README.html274.77 KB
READMEproject106_README.html274.97 KB
Data Files
Total Files: 12
Data Files: 4
Metadata Files: 4
Dictionary Files: 4
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project106_DATA_transformcopy.csvTabular Data - Harmonizedcsv2770
project106_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2770
project70_DATA_transformcopy.csvTabular Data - Harmonizedcsv849
project70_DATA_origcopy.csvTabular Data - Non-harmonizedcsv849