Alive Church Network: Increasing COVID-19 Testing in Chicago's African American Testing Deserts
Phase: NA
Conditions: COVID-19 Pandemic
Sponsor: Rush University Medical Center

09/09/2021 
Research Study Protocol 
Protocol Title: Alive Church Network: Increasing COVID-19 Testing in Chicago’s 
African American Testing Deserts 
Protocol Number: 20110407 
National Clinical Trial (NCT) Identified Number:  05197452 
 
Principal Investigator: Elizabeth Lynch, PhD 
Sponsor: Rush University Medical Center 
1700 W Van Buren, Suite 470 
Chicago, IL 60612 
 
Funded by: National Institutes of Health 
Version Number:  1.2 
Version Date: 09 September 2021 
 

09/09/2021 
OBJECTIVE 
This study takes a population-based approach which aims to increase uptake of COVID-19 testing 
within a highly segregated and underserved African American (AA) community in Chicago. The 
proposed project utilizes the Alive Church Network (ACN) infrastructure to create a network of 
church-based testing sites in our target area 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. Residents of all ages will receive COVID-19 education and free SARS-CoV-2 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. Our church network will also 
provide infrastructure for scientists to conduct future studies related to COVID-19 and other diseases 
that disproportionately impact AAs. 
 
Our team plans to perform 10,000 SARS-CoV-2 PCR tests within 31 weeks at churches located in 
testing deserts in South Side neighborhoods. A clinical team comprising registered nurses and 
community health workers will be deployed to the sites and will perform tests in designated areas of 
the churches that meet CDPH community-based testing standards. Testing will be available up to five 
days per week. To maximize efficiency of testing, residents will be encouraged to call ahead and 
schedule a test, however we will also provide testing to walk-ins. In addition to scheduled testing in 
churches, testing will be also be performed at church-based events where residents are 
congregating, such as Sunday church services, food pantries, and other gatherings. In order to 
increase testing in children, testing will be performed at youth activities such as camps and sports 
league practices and games. Covid-19 home tests will also be distributed at churches, church-based 
events and youth activities to provide a convenient at home testing option for residents. Residents will 
be provided with at home tests for their own use and to distribute to others in their social network. 
During the testing process, study staff will educate participants about COVID-19, including providing 
advice about infection control and guidelines for what to do in the event of a positive test result. 
 
BACKGROUND/RATIONALE 
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 COVID-19 testing intervention is to 
place COVID-19 testing sites in AA churches on the South Side of Chicago. 
 
TESTING INTERVENTION 
 
Study Subjects/Method 
 
Recruitment 
Recruitment efforts will be guided by a Pastor Advisory Board (PAB), which will recommend 
strategies for recruiting and engaging members of their churches and the surrounding communities. 

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The Pastors will distribute flyers to their church members and potentially use a multi-pronged 
approach to publicize their Coalition. The communication strategy may include: news releases in 
community newspapers, local media outlets (radio, TV and editorial) and social media on the church’s 
platforms.  
 
Study Inclusion Criteria 
All individuals who request a COVID-19 test will be included in the study, including pregnant women 
and children of all ages. However, only adults will complete the survey portion of the study. Children 
will only be eligible to participate in the COVID-19 testing. Individuals who have tested positive for 
COVID-19 in the prior 3 months will not be eligible for the study. 
 
Registration and Consent Process 
For scheduled church testing and church-based event testing, participants will register by phone or in 
person at the testing site. In both cases, we will perform the informed consent process verbally rather 
than using written consent forms. For youth testing, written registration and consent forms will be 
completed by parents prior to testing. 
 
For scheduled church testing and church-based event testing, we will be conducting the consent 
process in multiple stages. When people register for a test (either in person or on the phone) we tell 
them basic details about the study and request consent to put their information into Epic. Participants 
have the option of doing the Covid-19 test and the Resource survey, doing the Covid-19 test only, 
doing the resource survey only (if they are not eligible for the Covid-19 test), or doing nothing at all 
and not registering. (see Registration Information sheet in portal section 5.5). 
 
If a parent wants a child to be tested we will read the section of the Registration Information Sheet 
about children and ask for consent for the child. Children between age 7 and 17 will be read a 
separate information sheet for their assent when they are onsite, before testing. Children will not 
complete the survey but will only receive a COVID-19 test. Research staff will document participants’ 
consent and children’s assent on a separate document that will be maintained separately from the 
survey responses. If the participant chooses not to consent they will be provided other locations 
where they can be tested. 
 
Participants who complete the Resource survey will be given a longer information sheet describing 
the test and the survey. They are asked to consent at this point for the test and survey. (see Survey 
information sheet in portal section 5.5.) 
 
Participants who complete the test only and not the resource survey will be given a separate 
information sheet describing only the test.  (see Test only Information sheet in portal section 5.5.) 
 
If the participant chooses not to consent they will be provided other locations where they can be 
tested.  
 
For youth testing, a written registration form and a written consent form will be given to parents or 
legal guardians to provide general consent to regular COVID-19 testing for the duration of the camp 
or sports season for their children. Children will be read a separate information sheet for their assent 
during the camp or sports activity, before testing. 
 
Survey 
Adults will complete a short survey prior to receiving their COVID-19 test. The survey will take 
approximately 15 minutes. If participants enroll over the phone, they will be sent an email with a link 

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to the questionnaire in SNAP (HIPPAA compliant software). If the participant enrolls on site, they will 
complete a paper survey or complete the survey on a tablet.  
 
If the participant has already been tested with the ACN, they will not complete the survey if they have 
already completed it.  
 
If a social need is identified on the study questionnaire, which includes screening for social 
determinants of health, study staff will phone participants and use NOWPOW database to connect 
them to resources to address their needs. If the participant has two or more social needs, or housing 
needs beyond rental assistance they will be referred to a social worker or senior community health 
worker. If someone needs help finding a PCP or health insurance they are referred to a navigator with 
that type of expertise. 
 
No participant will be identified individually. Rather, all data will be reported in aggregate and 
confidentiality will be protected. All participant information will be maintained and kept confidential as 
required by law. 
 
 
TESTING PROTOCOL 
 
Once the participant is consented and completes the survey, study staff will register participants in 
Rush’s Electronic Medical Record (EMR) System, Epic, if they are not already registered. Study staff 
will help participants enroll in the Rush patient portal, MyChart, if they are not already enrolled. Then 
participants will receive the COVID-19 test.  
 
COVID-19 testing 
For scheduled church testing and church-based event testing, security staff of churches, testing site 
staff and volunteers will assure that visitors to the testing site wear masks and follow social distancing 
guidelines. Testing staff include a Community Health RN, two Community Health Workers and a 
research assistant. The RN will oversee clinical operations at the sites. The Community Health 
Workers (CHWs) will assist the RNs at the sites, including registering participants, consenting, data 
collection, and distributing educational materials.  
 
Prior to the testing event, labels for specimens for participants who preregistered will be printed at 
Rush by study personnel. If a person does not preregister, they will be enrolled on site by study. 
Samples taken from participants who were enrolled onsite will be given a handwritten label. All staff 
doing on-site SARS-CoV-2 testing will wear proper PPE, including a gown, disposable gloves, an N95 
mask, a face shield and goggles. 
 
Participants will be tested via the nasal swab by the CHW. For the nasal swab, the CHW will first brief 
the patient on what the testing procedure will be and instructions to follow during the exam. In 
addition, an estimated time period to expect the results will also be explained to participants. The 
swab will be broken off into a designated test tube. This tube will be placed into a specimen bag 
along with a label. 
 
For youth testing, a rapid antigen or PCR test will be performed using a nasal swab. The nasal swab 
will be inserted shallowly into the participant’s nose (less than one inch into the nostril). The swab will 
be broken off into a designated test tube. The tube will be placed into a specimen bag along with a 
label. Some children, depending on their age, will be allowed to self-collect their COVID-19 nasal 
swab depending on the manufacturer’s instructions. The parent or legal guardian will be allowed to 

09/09/2021 
authorize another guardian (≥ 18 years of age) to assist their child with collecting the self-collected 
nasal swab on the consent form. A Rush staff member may also assist the child with collection of the 
self-collected swab. 
 
All specimens will be stored in a cooler until they are transported the Rush University Medical Center 
Clinical Microbiology Laboratory, which is accredited by CLIA (CLIA Certificate Number 14D0696069) 
and by the College of American Pathologists (CAP) (CAP Accreditation Number 1872203). 
Specimens will be transported to the lab daily. 
 
Communication of Results and Follow-up 
Test results will be entered into Epic. If a participant is enrolled in MyChart they will receive an email 
informing them that their results are available. For participants with negative results, they will receive 
their results via MyChart and will receive an email or text informing them that their results are 
available. If the participant does not have access to MyChart they will be informed at the time of 
testing that if they have not received a phone call within 3 days indicating that their result is positive 
(see communication procedure for positive participants below) then their result is negative. They will 
be provided with the toll free phone number for Rush Access to call for their results. 
 
In the case of a positive result, participants will receive a phone call from a nurse or community health 
worker within 24 hours. The nurse or CHW will provide instructions for how to quarantine and care for 
themselves during this period, screen the participant for social needs that may influence ability to 
quarantine safely or access care in the future, collect information about potentially exposed contacts 
to assure that they are contacted and receive testing, and connect the participant with resources to 
address identified needs using the NowPow referral platform. In the event the patient has more 
complicated issues, the CHW will refer the participant to a nurse or social worker for further 
assistance. 
 
All positive participants will receive a  follow-up call from the community health worker at 2 weeks and 
4 weeks after the positive test to assist with any initial and emerging concerns they may have, assess 
COVID-19 symptoms, healthcare utilization due to COVID-19, and connection to referred resources. 
 
At Home Testing Protocol 
 
For at home testing, a distribution tracking form will be completed at the time of registration and will 
be used to record the name, cell phone number, and email address of the person who will be 
distributing the test(s). Both the at home test box and tracking sheet will contain an identical label 
showing the individual test ID numbers for each test distributed to the participant for tracking 
purposes. The individual distributing the tests will be provided with a test for personal use as well as 
tests to distribute to others in their social network. The registration and consent process for at home 
testing will be completed electronically using QR code technology. A QR code will be affixed to each 
at home test box and will provide access to the study information sheet using the participants smart 
phone. Participants will provide electronic consent before performing the test. 
 
Participants using the at home tests will also complete a short survey electronically with their smart 
phone using the QR code. The brief survey will assess basic demographic information, history of 
Covid-19, and vaccination status and is to be completed before performing the test. 
 
The individuals distributing the at home tests to their social network will receive a $20 gift card 
electronically for completing the survey, performing a test, and distributing the tests. They will receive 
a follow-up text message or phone call after 7 days to assess whether or not they have used and/or 

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distributed their tests. Individuals who receive a test will be invited to become a test distributor and 
receive tests to distribute to their social network. 
 
To perform at home testing, participants will download an app to their mobile phone and they will be 
instructed to watch an informational video. The test is designed for use without the aid of a healthcare 
professional. The test will be performed 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. Results 
are saved within the app and the time and date of the test and test result will be provided to Rush 
staff by secure download from the product manufacturer.