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 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_zip | What is your zip code? |
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_smoking_yn | Do you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)? |
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_autoimm | Autoimmune disease |
nih_copd | Chronic obstructive pulmonary disease (COPD) |
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_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_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_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_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 |
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? |
vaper_cur_stat | Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
zip_code | Zip 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 | - |