Official Title
COVID-19 Testing and Linkage to Care With Faith-based and Health Agency Partners: A Faithful Response to COVID-19
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.

Recruiting
A Multilevel, Tailored COVID-19 Testing Condition
A Nontailored COVID-19 Testing Control Condition

Behavioral: A Faithful Response to COVID-19
See previous description
Multilevel, religiously-culturally tailored COVID-19 testing and linkage to care
Standard COVID19 information (non-tailored) attention control arm

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Rhema Church
Independence, Missouri, 64052

Recruiting

Investigator: Michael Jones

Boone Tabernacle
Kansas City, Missouri, 64106

Recruiting

Investigator: Lemuel Thuston

Centennial United Methodist Church
Kansas City, Missouri, 64108

Recruiting

Investigator: Jason Bryles

Kansas City Health Department
Kansas City, Missouri, 64108

Active, not recruiting

University of Missouri-Kansas City
Kansas City, Missouri, 64108

Recruiting

Investigator: Jannette Berkley-Patton, PhD
Contact: 816-235-6362

Sunlight Missionary Baptist Church
Kansas City, Missouri, 64110

Recruiting

Investigator: Rickey Rambo

Apostolic Church of God
Kansas City, Missouri, 64127

Recruiting

Investigator: Morris Brown

Jameson Memorial Temple
Kansas City, Missouri, 64128

Recruiting

Investigator: Faith Allen, PhD

Kingdom Word Ministries
Kansas City, Missouri, 64128

Recruiting

Investigator: Eric Morrison

Memorial Church International
Kansas City, Missouri, 64134

Recruiting

Investigator: Larry Aiken

Contacts

Carole Bowe Thompson
816-235-6062
bowethompsonc@umkc.edu

Jenifer Y Allsworth, PhD
816-235-1781
allsworthj@umkc.edu

Jannette Berkley-Patton, PhD
Principal Investigator
UMKC School of Medicine

University of Missouri, Kansas City
NCT Number
Keywords
African American
Faith-based
COVID-19 testing
Cultural tailoring
Linkage to care
contact tracing
MeSH Terms
Disease