Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention 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.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
COVID-19 Testing
COVID-19 antigen and PCR Testing
  • Behavioral: COVID-19 Testing
    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.

Recruiting Locations

More Details

NCT ID
NCT05197452
Status
Completed
Sponsor
Rush University Medical Center

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.