Clinical trial NCT04978207: A Faithful Response to COVID-19 Project
Official title: COVID-19 Testing and Linkage to Care With Faith-based and Health Agency Partners: A Faithful Response to COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: A Multilevel, Tailored COVID-19 Testing Condition
A Nontailored COVID-19 Testing Control Condition
Keywords: African American
Faith-based
COVID-19 testing
Cultural tailoring
Linkage to care
Contact tracing
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A culturally-religiously tailored COVID-19 testing and linkage to care arm versus a standard COVID-19 education arm in African American churches
Primary purpose: DIAGNOSTIC

Brief summary: This 2-arm clustered, randomized community trial will test a multilevel, COVID-19 testing and linkage to care (eg, health insurance, medical appointments, community resources, contact tracing) intervention against a nontailored, attention-control condition on uptake of COVID-19 testing with adult African American church-affiliated members at 6 months. Contact tracing approval (beliefs and participation contact tracing) and COVID19 prevention behaviors will also be examined. Findings from this study could provide a theory-based, multilevel model for delivering scalable, wide-reaching COVID-19 testing and linkage to care services, including contact tracing, by supporting African American faith leaders with culturally-appropriate, easy-to-use tools and health agency partnerships.

Detailed description: The primary aim of this study is to conduct a two-arm clustered randomized controlled trial to fully test a multilevel, religiously-tailored African American church-based COVID19 testing and linkage to care (LTC) intervention (Tx) vs a nontailored multilevel, attention-control (AC) condition on COVID19 testing uptake (primary outcome) at 6 mos. LTC, contact tracing approval (CTA) and prevention behaviors (exploratory secondary outcomes) will also be examined with participants, adult African American church and community members. Churches will be matched on attendance size and denomination, and randomly assigned to Tx or AC. Previous HIV testing and diabetes prevention studies conducted in African American churches, whereby the Theory of Planned Behavior (TPB) and Socioecological Model will guide intervention design and delivery, will be adapted for this project. Using a community engaged approach, these models provide a theoretically-based, ecologically-expanded TBP framework for intervention delivery through multilevel church outlets to increase reach, dose, and impact. Sixteen churches (45 church members and 15 community members using outreach services per church; N= 960 total) have been project to be required to detect significant increases in testing.

Trained church health workers will deliver the Tx intervention during existing, multilevel church activities using a culturally-tailored COVID19 Tool Kit inclusive of digital tools consisting of: a) individual self-help materials and automated/tailored text messages; b) virtual supportive group seminars about COVID19; c) virtual/in-person church services with COVID19 related materials/activities (e.g., sermons, pastors modeling testing, testimonials, bulletins); and d) church-community level COVID19 testing and LTC services (e.g., healthcare, prevention programs, community resources, contact tracing) provided virtually by community health workers. All churches will host COVID19 testing events. First, a pilot study site will be used to test project feasibility followed by the 16 RCT faith-based study sites. Social, ethical, behavioral implications (SEBI) data will also be collected. All data will be made available to the Rapid Acceleration of Diagnostics Underserved Populations (RADxUP) Data Consortium.

Specific Aims (SA):

SA 1. Test a tailored TPB-guided multilevel, COVID19 intervention against a nontailored AC arm on uptake of COVID19 testing, and LTC/CTA \& prevention behaviors with African American church-populations at 6 months.

Hypothesis: The tailored, TPB testing/LTC intervention will attain higher testing rates than AC at 6 months.

SA 2. Evaluate roles of potential mediators and moderators related to COVID19 testing among church-affiliated African Americans at 6 months to determine modifiable facilitators/barriers.

SA 3. Conduct a process evaluation to understand study implementation facilitators, barriers, and fidelity; and examine relationships between implementation, intervention dose and exposure, and intervention outcomes to identify and improve essential intervention components.

Significance: This novel study is the first to fully test a COVID19 testing and LTC intervention in African American churches. It could provide a theory-based, multilevel model for delivering scalable, wide-reaching COVID19 testing and LTC by supporting African American faith leaders with culturally-appropriate, easy-to-use tools and health agency partnerships. It could have a major impact on uptake of COVID19 testing, inform on LTC and contact tracing, and streamline future vaccine delivery in African American communities hard hit by COVID19.

Eligibility criteria: Inclusion Criteria:

* Participants will be eligible to participate if they are: a) self-identified as African American/Black; 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 include: persons with plans to move from KC metro area over the next 12 months and non-English speaking/reading persons.

Exclusion Criteria:

* Living outside of the Kansas or Missouri geographical areas

Primary outcomes:
measure: COVID-19 testing uptake
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Linkage to care
timeFrame: Change from baseline at 6 months
measure: COVID-19 prevention behaviors
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: Independence
country: United States
facility: Rhema Church
state: Missouri
city: Kansas City
country: United States
facility: Boone Tabernacle
state: Missouri
city: Kansas City
country: United States
facility: Centennial United Methodist Church
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Health Department
state: Missouri
city: Kansas City
country: United States
facility: University of Missouri-Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Sunlight Missionary Baptist Church
state: Missouri
city: Kansas City
country: United States
facility: Apostolic Church of God
state: Missouri
city: Kansas City
country: United States
facility: Jameson Memorial Temple
state: Missouri
city: Kansas City
country: United States
facility: Kingdom Word Ministries
state: Missouri
city: Kansas City
country: United States
facility: Memorial Church International
state: Missouri
Study officials:
affiliation: UMKC School of Medicine
name: Jannette Berkley-Patton, PhD
role: PRINCIPAL_INVESTIGATOR
References: