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

Conditions

• COVID-19 Testing Behaviors

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Accepted

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).
• Standard COVID19 education control arm — BEHAVIORAL
  Multilevel delivery of standard COVID-19 education by church leaders and 2 COVID-19 testing events.

Study Details

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.

Key Dates

Start date

May 15, 2024

Status verified

Feb 2026

Primary completion

Mar 1, 2026

Completion

Mar 1, 2026

Study Design

Enrollment

900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• 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.
• 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

Primary Outcome Measure

Uptake of COVID-19 testing [ Time Frame: Baseline, 6 months ]

Locations (1)

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