COVID-19 Testing BehaviorsPhase 2FRIINCT07450209
COVID-19 Rapid Test-to-Treat With African American Churches (Faithful Response II)
A Phase 2 study testing COVID-19 rapid test-to-treat in people with COVID-19 Testing Behaviors, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
This 2-arm clustered, randomized community trial will test a multilevel, religiously-tailored COVID-19 rapid, self-testing and treatment intervention against a nontailored, education condition on uptake of COVID-19 rapid testing with 900 adult African American church members and community members using outreach… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Testing Behaviors
- What is being tested?
- COVID-19 rapid test-to-treat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a) self-identify as African American, b) aged 18 or older; c) willing to participate in 2 surveys after church services, electronically, by phone, or in the study's office space; d) willing to provide contact information (i.e., two phone numbers, mailing/email address, phone numbers for two persons with whom they have ongoing contact; and e) regularly attend church (>once a month) or use church outreach services (e.g., daycare services, food programs) >4 times/year.
Who cannot join
- persons with plans to move from KC metro area over the next 12 months and non-English speaking/reading persons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Testing and Linkage to Care With African American Church and Health Agency Partners
This 2-arm clustered, randomized community trial will test a multilevel, religiously-tailored COVID-19 rapid, self-testing and treatment intervention against a nontailored, education condition on uptake of COVID-19 rapid testing with 900 adult African American church members and community members using outreach ministry services from 12 churches at 6 months. Rapid COVID-19 self-testing and contact tracing (beliefs and practices), and use of linkage to care services (e.g., referrals to treatment, health insurance, medical home/appointments, community resources) will also be examined. Findings from this study could provide a scalable model for feasible, accessible and acceptable COVID-19 rapid, self-testing (with rapid linkage to treatment and health/community resources) in public (churches and their affiliate settings and organizations), home, and health provider spaces by equipping African American churches with culturally-appropriate, easy-to-use rapid test kits, health department support, and tailored COVID-19 test-to-treat education and promotion tools.
Read the detailed description
Many multilayered barriers increase risk for COVID-19 among AA including poverty, essential jobs with increased virus exposure, cultural norms (eg, risk denial, medical/contact tracing mistrust), chronic health conditions, and limited access to healthcare and other services/resources. These barriers highlight the need for accessible, trusted COVID-19 testing and linkage to antiviral treatment and care services (LTC; e.g., health, prevention programs, community resources, contact tracing) and to community resources (e.g., food, rent assistance) to help slow COVID-19 spread in AA communities. The AA church is an institution with extensive influence in AA communities and may be an ideal setting for increasing reach of COVID-19 test-to-treat (TTT) interventions with LTC in hard hit AA communities. Yet, no controlled AA church-based studies exist on COVID-19 TTT interventions. The primary aim of this study is to fully test a culturally/religiously-tailored, church-based COVID-19 TTT with LTC intervention condition against a non-tailored education condition on COVID-19 rapid testing rates at 6 months with adult AA church members and the community members they serve. Churches will be matched on membership size, denomination and past participation in church health intervention studies, then randomized to treatment condition. Twelve churches (6 churches per arm; 55 church and 20 community members/church; N=900 total) will participate in the study. Antiviral and contact tracing intentions and use will also be examined at 6 months as secondary outcomes. Other types of COVID-19 testing and linkage to care use will also be assessed. Guided by the Theory of Planned Behavior and Socioecological Model, our community-engaged approach includes trained church leaders delivering a culturally, church-appropriate COVID-19 TTT Toolkit inclusive of digital tools: a) individual self-help materials and automated/tailored text messages; b) ministry group educational information; c) virtual/in-person church services with COVID-19 related materials/activities (e.g., sermons, pastors modeling rapid-self testing, testimonials, bulletins); and d) church-community level linkage to care (LTC) services (e.g., contact tracing, treatment, healthcare, community resources) provided by contact tracers serving as community health workers (CHW). Intervention churches will host 2 COVID-19 TTT events and will also provide members with take-home COVID-19 rapid self-test kits. Potential mediators/moderators related to receipt of COVID-19 testing will be evaluated, and a process evaluation to determine implementation facilitators, barriers, and fidelity related to increasing COVID19 testing rates. Our ongoing meetings with our long-term faith and health partners is enabling us to quickly adapt our AA church-based COVID-19 testing, HIV testing and diabetes prevention interventions for the proposed study. This novel study is the first to fully test a COVID-19 TTT intervention in AA churches. It could provide a theory-based, multilevel scalable model for equipping AA churches to deliver wide-reaching COVID-19 rapid testing and promote treatment with health agency partners.
- Conditions
- COVID-19 Testing Behaviors
- Being tested
- COVID-19 rapid test-to-treat, Standard COVID19 education control arm
- Keywords
- COVID-19 testing, faith-based organizations, COVID-19 treatment, community engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 rapid test-to-treatBehavioural
This community-engaged approach includes trained church leaders delivering a culturally, church-appropriate COVID-19 test-to-treat toolkit materials/activities via multilevel church outlets: a) self-help materials and tailored text messages; b) ministry group educational information; c) church services with COVID-19 related materials/activities (e.g., sermons, pastors modeling rapid-self testing, testimonials, bulletins); and d) church-community level linkage to care services (e.g., healthcare, community resources) provided by health department testers cross-trained as community health workers. Intervention churches will host 2 COVID-19 TTT events in coordination with the local health department, which provide rapid testing onsite at participating churches, provide members with take-home COVID-19 rapid self-test kits, and support an option for members to use a proctored telehealth rapid test that will be able to qualify persons for a anti-viral treatment prescription (e.g., Paxlovid).
Standard COVID19 education control armBehavioural
Multilevel delivery of standard COVID-19 education by church leaders and 2 COVID-19 testing events.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 rapid test-to-treat | Experimental | Church-based COVID19 rapid testing (2 testing events) promoted with a COVID19 Toolkit delivered by church health workers and linkage to treatment/care delivered by contact tracer community health workers. Receives: Behavioral: COVID-19 rapid test-to-treat; Behavioral: Standard COVID19 education control arm |
| Standard COVID-19 education control arm | Active comparator | Standard COVID-19 information inclusive of test-to-treat information that has not been tailored will be delivered by church health workers Receives: Behavioral: Standard COVID19 education control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of COVID-19 testing
COVID19 rapid testing will be assessed via self-report (ever, last 6 months, month/day/year) and objectively assessed with data reports provided by the Kansas City MO Health Department
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 May 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Testing BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Jannette Berkley-Patton, PhD, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450209
- Sponsor's protocol ID
- 2038603KC-387550
- Other IDs
- U01MD018310
- Acronym
- FRII
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Testing and Linkage to Care With African American Church and Health Agency Partners
- ClinicalTrials.gov ID
- NCT07450209
- Acronym / sponsor ID
- FRII / 2038603KC-387550
- Conditions
- COVID-19 Testing Behaviors
- Keywords
- COVID-19 testing, faith-based organizations, COVID-19 treatment, community engagement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2-arm clustered, randomized community trial will test a multilevel, religiously-tailored COVID-19 rapid, self-testing and treatment intervention against a nontailored, education condition on uptake of COVID-19 rapid testing with 900 adult African American church members and community members using outreach ministry services from 12 churches at 6 months. Rapid COVID-19 self-testing and contact tracing (beliefs and practices), and use of linkage to care services (e.g., referrals to treatment, health insurance, medical home/appointments, community resources) will also be examined. Findings from this study could provide a scalable model for feasible, accessible and acceptable COVID-19 rapid, self-testing (with rapid linkage to treatment and health/community resources) in public (churches and their affiliate settings and organizations), home, and health provider spaces by equipping African American churches with culturally-appropriate, easy-to-use rapid test kits, health department support, and tailored COVID-19 test-to-treat education and promotion tools.
Detailed description
Many multilayered barriers increase risk for COVID-19 among AA including poverty, essential jobs with increased virus exposure, cultural norms (eg, risk denial, medical/contact tracing mistrust), chronic health conditions, and limited access to healthcare and other services/resources. These barriers highlight the need for accessible, trusted COVID-19 testing and linkage to antiviral treatment and care services (LTC; e.g., health, prevention programs, community resources, contact tracing) and to community resources (e.g., food, rent assistance) to help slow COVID-19 spread in AA communities. The AA church is an institution with extensive influence in AA communities and may be an ideal setting for increasing reach of COVID-19 test-to-treat (TTT) interventions with LTC in hard hit AA communities. Yet, no controlled AA church-based studies exist on COVID-19 TTT interventions. The primary aim of this study is to fully test a culturally/religiously-tailored, church-based COVID-19 TTT with LTC intervention condition against a non-tailored education condition on COVID-19 rapid testing rates at 6 months with adult AA church members and the community members they serve. Churches will be matched on membership size, denomination and past participation in church health intervention studies, then randomized to treatment condition. Twelve churches (6 churches per arm; 55 church and 20 community members/church; N=900 total) will participate in the study. Antiviral and contact tracing intentions and use will also be examined at 6 months as secondary outcomes. Other types of COVID-19 testing and linkage to care use will also be assessed. Guided by the Theory of Planned Behavior and Socioecological Model, our community-engaged approach includes trained church leaders delivering a culturally, church-appropriate COVID-19 TTT Toolkit inclusive of digital tools: a) individual self-help materials and automated/tailored text messages; b) ministry group educational information; c) virtual/in-person church services with COVID-19 related materials/activities (e.g., sermons, pastors modeling rapid-self testing, testimonials, bulletins); and d) church-community level linkage to care (LTC) services (e.g., contact tracing, treatment, healthcare, community resources) provided by contact tracers serving as community health workers (CHW). Intervention churches will host 2 COVID-19 TTT events and will also provide members with take-home COVID-19 rapid self-test kits. Potential mediators/moderators related to receipt of COVID-19 testing will be evaluated, and a process evaluation to determine implementation facilitators, barriers, and fidelity related to increasing COVID19 testing rates. Our ongoing meetings with our long-term faith and health partners is enabling us to quickly adapt our AA church-based COVID-19 testing, HIV testing and diabetes prevention interventions for the proposed study. This novel study is the first to fully test a COVID-19 TTT intervention in AA churches. It could provide a theory-based, multilevel scalable model for equipping AA churches to deliver wide-reaching COVID-19 rapid testing and promote treatment with health agency partners.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 rapid test-to-treat | Experimental | Behavioral: COVID-19 rapid test-to-treat, Behavioral: Standard COVID19 education control armChurch-based COVID19 rapid testing (2 testing events) promoted with a COVID19 Toolkit delivered by church health workers and linkage to treatment/care delivered by contact tracer community health workers. |
| Standard COVID-19 education control arm | Active comparator | Behavioral: Standard COVID19 education control armStandard COVID-19 information inclusive of test-to-treat information that has not been tailored will be delivered by church health workers |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a) self-identify as African American, b) aged 18 or older; c) willing to participate in 2 surveys after church services, electronically, by phone, or in the study's office space; d) willing to provide contact information (i.e., two phone numbers, mailing/email address, phone numbers for two persons with whom they have ongoing contact; and e) regularly attend church (>once a month) or use church outreach services (e.g., daycare services, food programs) >4 times/year.
Key exclusion criteria (1 listed)
- persons with plans to move from KC metro area over the next 12 months and non-English speaking/reading persons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 rapid test-to-treatThis community-engaged approach includes trained church leaders delivering a culturally, church-appropriate COVID-19 test-to-treat toolkit materials/activities via multilevel church outlets: a) self-help materials and tailored text messages; b) ministry group educational information; c) church services with COVID-19 related materials/activities (e.g., sermons, pastors modeling rapid-self testing, testimonials, bulletins); and d) church-community level linkage to care services (e.g., healthcare, community resources) provided by health department testers cross-trained as community health workers. Intervention churches will host 2 COVID-19 TTT events in coordination with the local health department, which provide rapid testing onsite at participating churches, provide members with take-home COVID-19 rapid self-test kits, and support an option for members to use a proctored telehealth rapid test that will be able to qualify persons for a anti-viral treatment prescription (e.g., Paxlovid). | Behavioural | COVID-19 rapid test-to-treat |
| Standard COVID19 education control armMultilevel delivery of standard COVID-19 education by church leaders and 2 COVID-19 testing events. | Behavioural | COVID-19 rapid test-to-treat, Standard COVID-19 education control arm |
Primary outcome
Uptake of COVID-19 testing
Time frame: Baseline, 6 months
COVID19 rapid testing will be assessed via self-report (ever, last 6 months, month/day/year) and objectively assessed with data reports provided by the Kansas City MO Health Department
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannette Berkley-Patton, PhD principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVID-19 rapid test-to-treat in people with COVID-19 Testing Behaviors, run by University of Missouri, Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of COVID-19 testing (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.