Increasing COVID-19 Testing in Chicago's African American Testing Desserts
Primary Purpose
COVID-19 Pandemic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 Testing
Sponsored by

About this trial
This is an interventional prevention trial for COVID-19 Pandemic
Eligibility Criteria
Inclusion Criteria:
• All individuals who request a COVID-19 test, including pregnant women and children of all ages
Exclusion Criteria:
• Individuals who have tested positive for Covid-19 in the prior 3 months
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COVID-19 Testing
Arm Description
COVID-19 antigen and PCR Testing
Outcomes
Primary Outcome Measures
COVID-19 Testing Uptake
The number of neighborhood residents tested for COVID-19
Secondary Outcome Measures
Full Information
NCT ID
NCT05197452
First Posted
January 13, 2022
Last Updated
December 27, 2022
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05197452
Brief Title
Increasing COVID-19 Testing in Chicago's African American Testing Desserts
Official Title
Alive Church Network: Increasing COVID-19 Testing in Chicago's African American Testing Deserts
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study uses a population-based approach to increase uptake of COVID-19 testing within a highly segregated and underserved African American community in Chicago.
Detailed Description
The epidemic of novel coronavirus disease 2019 (COVID-19) has caused an unprecedented public health crisis in the United States. African Americans (AA) have been disproportionately impacted, as systemic inequities have contributed to increased exposure and vulnerability to COVID-19. Evidence suggests that AAs are delaying testing and care for COVID-19, which increases risk of transmission and poor outcomes. In Chicago, segregated AA neighborhoods have experienced some of the highest COVID-19 mortality rates in the city, yet large portions of these neighborhoods remain testing deserts. Providing trusted, accessible, community-based testing in underserved AA communities is critical to ensuring that AAs receive an early diagnosis, thereby reducing the risk of further transmission and improving clinical outcomes. This study leverages the Alive Church Network (ACN), a long-standing, community-driven coalition of African American pastors and public health researchers that was developed as a sustainable infrastructure to address health inequities in chronic disease in segregated AA neighborhoods in Chicago. The ACN was designed to address lack of access to health care, cultural insensitivity, and lack of trust, which are the root cause of disparities in chronic disease as well as infectious disease, including COVID-19. This project utilizes the ACN infrastructure to create a network of church-based testing sites in a segregated and underserved AA neighborhood in Chicago that will provide COVID-19 testing and education as well as linkage to healthcare and social resources. Pastors who serve predominantly AA congregations on the South Side of Chicago will form a coalition to promote community-wide COVID-19 testing in local churches and church-based events where residents are congregating, such as Sunday church services, food pantries, and other gatherings. Residents of all ages will receive COVID-19 education and free severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) testing with rapid turn-around of results from an on-site clinical team, as well as connection to local resources to address social needs, including food, housing, and medical care. At-home COVID-19 tests will also be provided to residents for their personal use and to distribute to others in their social network. The primary aim of the study is to evaluate the impact of the ACN COVID-19 testing intervention on uptake of testing among residents of target high poverty AA neighborhoods in Chicago. The primary analysis uses an interrupted time series framework, which is a quasi-experimental approach, to test whether the ACN testing intervention is successful at increasing uptake of testing by at least 20% among residents in the target neighborhoods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This testing intervention is being conducted to increase uptake of COVID-19 testing among residents of the target neighborhoods. The investigators hypothesize that the testing intervention will increase uptake of testing by at least 20%. To assess the impact of the intervention, the investigators will use an interrupted time series (ITS) framework to test the null hypothesis that the addition of the COVID-19 testing intervention would result in no significant change in the level or trend of weekly COVID-19 testing for neighborhood residents. ITS analysis is a quasi-experimental approach to establish causal inference in situations where randomized controlled trials are not feasible, and uses segmented regression to measure changes in the level and slope of the outcome in a post-intervention period compared to a pre-intervention period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 Testing
Arm Type
Experimental
Arm Description
COVID-19 antigen and PCR Testing
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 Testing
Intervention Description
For in-person PCR testing, a nasal swab will be inserted shallowly into the participant's nose and rotated in each nostril. The swab will be broken off into a designated test tube and placed into a specimen bag along with a label. All specimens will be stored in a cooler until they are transported the Rush Laboratory for COVID-19 analysis.
For at home antigen testing, participants will download an app to their mobile phone and watch an informational video. The test will be self-administered by inserting a nasal swab into the nostril until a cap containing the swab touches the nose; rubbing the swab tip around the nose cavity 3 times; removing the swab and repeating in the other nostril. The nasal swab, a dropper, processing fluid, and a blue tooth connected analyzer are provided with the testing kit to analyze the sample for COVID-19. COVID-19 home test results are displayed on the participants smart phone after 15 minutes.
Primary Outcome Measure Information:
Title
COVID-19 Testing Uptake
Description
The number of neighborhood residents tested for COVID-19
Time Frame
31 weeks
Other Pre-specified Outcome Measures:
Title
Re-AIM Framework
Description
Use the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the ACN COVID-19 testing intervention.
Time Frame
Up to 6 months after end of study
Title
Needs Assessment
Description
Conduct a rapid needs assessment to identify barriers to and facilitators of COVID-19 testing to inform a tailored outreach and intervention strategy to increase Covid-19 testing among high-risk African Americans. The John Hopkins Covid 19 Community Response survey will used to assess perceptions, knowledge, attitudes, barriers and access to Covid-19 testing.
Time Frame
First 2 months of the study
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• All individuals who request a COVID-19 test, including pregnant women and children of all ages
Exclusion Criteria:
• Individuals who have tested positive for Covid-19 in the prior 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lynch, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Increasing COVID-19 Testing in Chicago's African American Testing Desserts
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