COVID-19 Rapid Test-to-Treat With African American Churches (Faithful Response II) (FRII)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Testing Behaviors
• Intervention / Treatment: Behavioral: COVID-19 rapid test-to-treat; Behavioral: Standard COVID19 education control arm

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 Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• persons with plans to move from KC metro area over the next 12 months and non-English speaking/reading persons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19 rapid test-to-treat; 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.	Behavioral: COVID-19 rapid test-to-treat; 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).; Behavioral: Standard COVID19 education control arm; Multilevel delivery of standard COVID-19 education by church leaders and 2 COVID-19 testing events.
Active Comparator: Standard COVID-19 education control arm; Standard COVID-19 information inclusive of test-to-treat information that has not been tailored will be delivered by church health workers	Behavioral: Standard COVID19 education control arm; Multilevel delivery of standard COVID-19 education by church leaders and 2 COVID-19 testing events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Missouri, Kansas City
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Jannette Berkley-Patton, PhD, University of Missouri, Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: COVID-19 testing, faith-based organizations, COVID-19 treatment, community engagement
• Other Study ID Numbers: 2038603KC-387550; U01MD018310 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No