dbGaP Study Accession: phs002872
NIH Institute/Center: NCI
RADx Data Program: RADx-UP
DOI: 10.60773/02m0-qe56
Release Date: 08/30/2023
Study Description: This competitive revision submitted to the RADx-UP Initiative (NOT-20-121) aimed to extend the infrastructure of P50 Implementation Science Center for Cancer Control Equity (ISCCCE) to accelerate COVID testing in 9 hotspot communities in MA. ISCCCE is a strong partnership with the Massachusetts League of Community Health Centers, in which the team co-designed studies to increase implementation of evidence-based practices focused on equity. Together, this study was extremely well-positioned to extend the community-engaged efforts to COVID-19 testing, and to build an infrastructure that would support future COVID-related mitigation and prevention efforts in the vulnerable communities that the community health centers (CHCs) serve. This project included 6 community health center- community partnerships in nine vulnerable communities that continue to be COVID hot spots. These communities collectively had 1.3 million residents. Partner CHCs focused on COVID-19 testing for diagnostic purposes in symptomatic individuals, with limited outreach testing in high-risk communities. This project expanded the scope of testing to include prospective surveillance activities using dedicated testing and outreach teams. Accelerated testing efforts focused on CHC patients and community members who had significant social and medical vulnerabilities to COVID, per the NOSI, including those living in congregate housing, people experiencing homelessness, those with substance use disorders, low wage essential workers, and those with limited English proficiency. The partnership was well-integrated into the State's testing and contact tracing strategy, and well-positioned to leverage those resources. The study drew on a strongly community-engaged, equity-focused approach to implementation, and on Mass League's extensive experience in HIV testing and contact tracing. This study used an interrupted time series design to evaluate the impact of the enhanced outreach efforts on testing rates overall and on priority populations in the context of different phases of re-opening and restrictions. This study also used an exploratory sequential mixed methods approach to conduct a series of community-engaged pilot studies to address key barriers to testing and different approaches to return of results. The Human Participant Research Unit, co-led by academic and community-based investigators, guided the partnership's work through an ethics and equity lens. The study supported the CHC-community partnerships through the Testing Capacity and Innovation Team, which provided infectious disease expertise and technical guidance on COVID testing. The Community Communications Team used educational and communication design strategies to develop culturally and linguistically appropriate materials to support the testing activities.
Updated Date: 04/17/2024
Principal Investigator: Emmons, Karen M
Has Data Files: Yes
Study Domain: COVID Hotspots; Community Outreach Programs; Diagnostic Testing; Substance Use; Testing Rate or Uptake
Data Collection Method: Contact Tracing; Survey
Keywords: COVID Hotspot Communities; Congregate Settings; Diagnostic Testing; Individual-Level Data; Limited English Proficiency Populations
Study Design: Longitudinal Cohort
Multi-Center Study: No
Data Types: Behavioral; Clinical; Electronic Medical Records; Questionnaire or Survey
Study Start Date: 09/01/2020
Study End Date: 08/31/2022
Species: Human
Estimated Cohort Size: 125000
Study Population Focus: Adults; Children; Essential Workers; Homeless or Unhoused Populations; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Racial or Ethnic Minorities; Underserved or Vulnerable Populations
ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04802187
Publication URL: https://pubmed.ncbi.nlm.nih.gov/36404728/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8525052/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8987278/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8987278/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9076025/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9404072/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9558183/
Acknowledgement Statement: This study was supported through funding, 5P50CA244433-04, for the National Cancer Institute (NCI) as part of the RADx-UP program. This data was collected as part of a partnership between the Implementation Science Center for Cancer Control Equity, the Massachusetts League of Community Health Centers, and participating community health centers. Approved users should acknowledge the provision of data access by dbGaP for accession phs002872.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-CA-19-006
NIH Grant or Contract Number(s): 5P50CA244433-04
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_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_diabetes | Diabetes |
nih_sickle_cell_disease | Sickle cell disease |
nih_chronic_lung | Other chronic lung disease |
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_skin_rash | Skin rash |
nih_throat_congestion_nose | Sore throat, congestion or runny nose |
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_chronickd_2 | Chronic kidney disease (CKD) |
cc_clung_2 | Other chronic lung disease |
cc_cvd_2 | Cardiovascular disease (CVD or heart disease) |
cc_diabetes_2 | Diabetes |
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_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? |
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. ) |
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_feet | Feet |
self_reported_height_inches | Inches |
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? |
covid_fatique_2 | - |
covid_test_collection_setting | - |
covid_test_performed_location | - |
covid_test_specimen_collector | - |
covid_test_specimen_type | - |
covid_test_study_setting | - |
covid_test_type | - |
data_source | - |
edu_years_of_school | - |
employed_ew | - |
household_homeless | - |
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___90 | - |
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 | - |
redcap_event_name | - |
redcap_repeat_instance | - |
redcap_repeat_instrument | - |
self_reported_height_coded | - |
self_reported_weight_units_2 | - |
test_accesseasy_2 | - |
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 | - |