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

NCT07450209 | Active Not Recruiting Phase 2

• 2 other identifiers: 2038603KC-387550U01MD018310
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COVID-19 Testing Behaviors

Keywords

COVID-19 testing, faith-based organizations, COVID-19 treatment, community engagement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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

Behavioral: Standard COVID19 education control arm

Interventions

COVID-19 rapid test-to-treat BEHAVIORAL

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).

COVID-19 rapid test-to-treat

Standard COVID19 education control arm BEHAVIORAL

Multilevel delivery of standard COVID-19 education by church leaders and 2 COVID-19 testing events.

COVID-19 rapid test-to-treat; Standard COVID-19 education control arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

School of Medicine

Kansas City, Missouri, 64108, United States

Location

Study Officials

• Jannette Berkley-Patton, PhD

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 4, 2026
• Study Start: May 15, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)