A Multilevel, Tailored COVID-19 Testing ConditionFRNCT04978207
A Faithful Response to COVID-19 Project
A study testing A Faithful Response to COVID-19 in people with A Multilevel, Tailored COVID-19 Testing Condition and A Nontailored COVID-19 Testing Control Condition, run by University of Missouri, Kansas City at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- A Multilevel, Tailored COVID-19 Testing Condition, A Nontailored COVID-19 Testing Control Condition
- What is being tested?
- A Faithful Response to COVID-19
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,013 participants
- Where
- 10 sitesUnited States
- Study dates
- 6 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Living outside of the Kansas or Missouri geographical areas
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Rhema Church
Independence, Missouri, 64052
Boone Tabernacle
Kansas City, Missouri, 64106
Centennial United Methodist Church
Kansas City, Missouri, 64108
Kansas City Health Department
Kansas City, Missouri, 64108
University of Missouri-Kansas City
Kansas City, Missouri, 64108
Sunlight Missionary Baptist Church
Kansas City, Missouri, 64110
Apostolic Church of God
Kansas City, Missouri, 64127
Jameson Memorial Temple
Kansas City, Missouri, 64128
Kingdom Word Ministries
Kansas City, Missouri, 64128
Memorial Church International
Kansas City, Missouri, 64134
About this study
Official title: COVID-19 Testing and Linkage to Care With Faith-based and Health Agency Partners: A Faithful Response to COVID-19
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.
Read the 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.
- Conditions
- A Multilevel, Tailored COVID-19 Testing Condition, A Nontailored COVID-19 Testing Control Condition
- Being tested
- A Faithful Response to COVID-19
- Keywords
- African American, Faith-based, COVID-19 testing, Cultural tailoring, Linkage to care, Contact tracing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Faithful Response to COVID-19Behavioural
See previous description
| Study group | Role | What they receive |
|---|---|---|
| Multilevel, religiously-culturally tailored COVID-19 testing and linkage to care | Experimental | Church-based COVID19 promoted with a religiously-culturally tailored Faithful Response COVID19 Toolkit delivered by church health workers (trained in an enhanced communication style) through multilevel church outlets (e.g., sermon guide, responsive reading, church bulletin inserts, automated text messages) and linkage to care delivered by community health workers who also conduct contact tracing; inclusive of 2 church-based COVID-19 testing events at each participating site. Receives: Behavioral: A Faithful Response to COVID-19 |
| Standard COVID19 information (non-tailored) attention control arm | Active comparator | Standard COVID-19 information that has not been tailored delivered by trained church health workers via a toolkit; inclusive of 2 church-based COVID19 testing evens at each participating site. Receives: Behavioral: A Faithful Response to COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 testing uptake
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
Measured: Change from baseline at 6 months
Secondary outcomes (2)
Linkage to care
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
Measured: Change from baseline at 6 months
COVID-19 prevention behaviors
Engagement in COVID19 prevention/mitigation behaviors (eg, mask wearing, 6 ft social distancing, hand washing, sheltering in place/quarantine)
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start6 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A Multilevel, Tailored COVID-19 Testing ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jannette Berkley-Patton, University of Missouri, Kansas City
- Investigators
- Jannette Berkley-Patton, PhD, Principal investigator, UMKC School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978207
- Sponsor's protocol ID
- IRB #2038603 KC
- Acronym
- FR
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared per a data agreement plan with NIH and with Duke University as part of the Rapid Acceleration of Diagnostics Underserved Populations initiative. Additionally de-identified data can be requested directly from the primary and secondary contacts. We will make the de-identified data and associated documentation available to potential requesters only under a data sharing agreement (based on the requester's proposed use of the data and under the guidance of our Institutional Review Board) that provides for: (1) a commitment to using the data only for research purposes and to not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Testing and Linkage to Care With Faith-based and Health Agency Partners: A Faithful Response to COVID-19
- ClinicalTrials.gov ID
- NCT04978207
- Acronym / sponsor ID
- FR / IRB #2038603 KC
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Multilevel, religiously-culturally tailored COVID-19 testing and linkage to care | Experimental | Behavioral: A Faithful Response to COVID-19Church-based COVID19 promoted with a religiously-culturally tailored Faithful Response COVID19 Toolkit delivered by church health workers (trained in an enhanced communication style) through multilevel church outlets (e.g., sermon guide, responsive reading, church bulletin inserts, automated text messages) and linkage to care delivered by community health workers who also conduct contact tracing; inclusive of 2 church-based COVID-19 testing events at each participating site. |
| Standard COVID19 information (non-tailored) attention control arm | Active comparator | Behavioral: A Faithful Response to COVID-19Standard COVID-19 information that has not been tailored delivered by trained church health workers via a toolkit; inclusive of 2 church-based COVID19 testing evens at each participating site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Living outside of the Kansas or Missouri geographical areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Faithful Response to COVID-19See previous description | Behavioural | Multilevel, religiously-culturally tailored COVID-19 testing and linkage to care, Standard COVID19 information (non-tailored) attention control arm |
Primary outcome
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
2 secondary outcomes
Linkage to care
Time frame: Change from baseline at 6 months
COVID-19 prevention behaviors
Time frame: Change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Yes. De-identified data will be shared per a data agreement plan with NIH and with Duke University as part of the Rapid Acceleration of Diagnostics Underserved Populations initiative. Additionally de-identified data can be requested directly from the primary and secondary contacts. We will make the de-identified data and associated documentation available to potential requesters only under a data sharing agreement (based on the requester's proposed use of the data and under the guidance of our Institutional Review Board) that provides for: (1) a commitment to using the data only for research purposes and to not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannette Berkley-Patton, PhD principal investigator
UMKC School of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Faithful Response to COVID-19 in people with A Multilevel, Tailored COVID-19 Testing Condition and A Nontailored COVID-19 Testing Control Condition, run by University of Missouri, Kansas City at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 testing uptake (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.