Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05197452 |
Other study ID # |
20110407 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 23, 2021 |
Est. completion date |
November 18, 2022 |
Study information
Verified date |
December 2022 |
Source |
Rush University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.