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Completed

NCT Number: NCT04978207

A Faithful Response to COVID-19 Project

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhema Church, Independence, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

A Faithful Response to COVID-19

Behavioral

See previous description

Primary outcomes

  1. COVID-19 testing uptake

    Time frame: Change from baseline at 6 months

    COVID19 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

  1. Linkage to care

    Time frame: Change from baseline at 6 months

    Utilization of linkage to care services via self-report (types of services received, number of contacts, engagement in contact tracing) and objectively assessed with data reports provided by the Kansas City MO Health Department

  2. COVID-19 prevention behaviors

    Time frame: Change from baseline at 6 months

    Engagement in COVID19 prevention/mitigation behaviors (eg, mask wearing, 6 ft social distancing, hand washing, sheltering in place/quarantine)

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Registry information

Official study title

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

Acronym: FR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2021
Registry last updated
Mar 24, 2023

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.