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NCT Number: NCT07450209

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

School of Medicine

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Standard COVID19 education control arm

Behavioral

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

COVID-19 Testing and Linkage to Care With African American Church and Health Agency Partners

Acronym: FRII

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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