Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NR018463 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Testing | Experimental | COVID-19 antigen and PCR Testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Testing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Testing Uptake | Covid testing uptake was measured as the number of neighborhood residents (i.e., count of unique participants) tested for COVID-19 at any timepoint during the study which occurred between December 2020 and August 2022. The were 397 testing events at churches or community site where participants could be tested during this time period. Individuals may have been tested more than once but were only counted once. Testing uptake was assessed as the number of participants tested at least once (n=2167). Pre and post evaluations were not performed. The measure was based a single count of participants tested. | Up to 20 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Re-AIM Framework | Use the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the ACN COVID-19 testing intervention. | Up to 6 months after end of study |
| Needs Assessment |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Lynch, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60422 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm Only | We only had a single arm in this trial because there were not sufficient data points to test our original hypothesis. The intervention arm consisted of individuals who received a Covid PCR test. Enrollment is closed and all collected data is currently reported. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Testing | COVID-19 antigen and PCR Testing 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. At home testing was performed by inserting a nasal swab into the nostril until the cap containing the swab touched 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 were 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | COVID-19 Testing Uptake | Covid testing uptake was measured as the number of neighborhood residents (i.e., count of unique participants) tested for COVID-19 at any timepoint during the study which occurred between December 2020 and August 2022. The were 397 testing events at churches or community site where participants could be tested during this time period. Individuals may have been tested more than once but were only counted once. Testing uptake was assessed as the number of participants tested at least once (n=2167). Pre and post evaluations were not performed. The measure was based a single count of participants tested. | The analysis population included unique individuals tested for Covid-19 | Posted | Count of Participants | Participants | Up to 20 months |
|
Up to 20 months
Staff members recorded any adverse events that occurred during testing. We did not monitor adverse events after testing since this not was not a part of our intervention (i.e., there was no designated follow-up period). There were no adverse or serious adverse events reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm Only | We only had a single arm in this trial because there were not sufficient data points to test our original hypothesis. The intervention arm consisted of individuals who received a Covid PCR test. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yolanda Cartwright | Research Manager | 224-420-0323 | yolanda_cartwright@rush.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2021 | Apr 16, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
We established a network of testing sites in African American churches and community sites located in testing deserts in Chicago. Individuals of all ages were eligible for testing. Individuals with a confirmed COVID-19 infection within the past 3 months were ineligible. Testing was open to the public and no appointments were necessary. Testing was offered 5 days per week (at 1 or 2 locations each day) with varying hours of operation to accommodate community member's work and school schedules. There was no limit to the number of times an individual could be tested.
Testing was administered by experienced mobile clinical teams of community health workers and registered nurses from Rush University Medical Center. Participants received COVID-19 education, social determinants of health screening, and free SARS-CoV-2 polymerase chain reaction (PCR) testing.
Not provided
Not provided
Not provided
Not provided
|
Evaluate COVID-19 testing history, attitudes towards COVID-19 testing, and perceived risk of COVID-19 via survey.
| First 2 months of the study prior to the start of the testing intervention |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Re-AIM Framework | Use the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the ACN COVID-19 testing intervention. | We did not have enough enrolled participants to assess this outcome. | Posted | Up to 6 months after end of study |
|
|
| Other Pre-specified | Needs Assessment | Evaluate COVID-19 testing history, attitudes towards COVID-19 testing, and perceived risk of COVID-19 via survey. | 215 participants who completed the needs assessment survey | Posted | Number | participants | First 2 months of the study prior to the start of the testing intervention |
|
|
|
| 0 |
| 2,167 |
| 0 |
| 2,167 |
| 0 |
| 2,167 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| Had a family member, friend, or colleague who died from Covid 19 |
|
| Thought a family member, friend or colleague would get Covid 19 in the future |
|
| Thought that they themselves would get Covid 19 in the future |
|
| Would get tested at a church in their neighborhood if availble |
|