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Clinical Trials/NCT07450209
NCT07450209Active, not recruitingPhase 2

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

University of Missouri, Kansas City1 site in 1 country900 target enrollmentStarted: May 15, 2024Last updated:
Interventions

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
900
Locations
1
Primary Endpoint
Uptake of COVID-19 testing

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: COVID-19 rapid test-to-treat (Behavioral)

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.

Intervention: Standard COVID19 education control arm (Behavioral)

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

Intervention: Standard COVID19 education control arm (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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