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COVID-19NCT05918952

RADx-UP CDCC Rapid Research Pilot Program "Culturally-relevant Community Connections (C3) to Increase COVID-19 Testing

An observational study of COVID-19, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to identify barriers and facilitators to COVID testing among members of the Black/African American community. The expected outcome of this project is to increase COVID testing among Black/African American community. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Covid-19 Antibody Test and Short Clip videos
How many people
327 participants
Where
1 siteUnited States
Study dates
21 Aug 2023to 13 Jun 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Study population: Black/African American adults

Who may be able to join

  • Identify as Black/African American
  • 18 Years and older
  • visit the beauty salon or barber shop to enroll in the study

Who cannot join

  • under the age of 18
  • non Black/African American identifying

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hair Designs By Tasha

    Greensboro, North Carolina, 27408

Other trials in United States

About this study

Official title: RADx-UP CDCC Rapid Research Pilot Program: "Culturally-relevant Community Connections (C3) to Increase COVID-19 Testing in the Black/African American Community".

The purpose of this study is to identify barriers and facilitators to COVID testing among members of the Black/African American community. The expected outcome of this project is to increase COVID testing among Black/African American community. The secondary aim is to examine the use of culturally relevant edutainment video messaging combined with trusted opinion leaders in the community as a strategy to increase COVID testing.

Read the detailed description

The pandemics of COVID-19 and racial discrimination in America have joined forces to illuminate inequalities in healthcare delivery and health outcomes of Black Americans. These pandemics have increased attention to the medical distrust, racism, discrimination, implicit bias, and unequal treatment that has occurred in this country for centuries.

Trusted venues such as barber shops and beauty salons are gatekeepers and facilitators of trusted information in the Black community. The investigators are addressing Health disparities through Engagement, Equity, Advocacy, and Trust (HEEAT) Research Lab partners with barbers and stylists for health promotion in communities of color. The investigators co-founded North Carolina Barbers and Stylists for Health Equity (NCBSHE), a network of barber shops and beauty salons serving primarily Black clientele throughout NC. NCBSHE is led by barbers and stylists, with academic partners serving the organization in non-leadership roles.

Due to barriers including access to care, discrimination, and medical distrust, engaging the Black community in health research and improvement activities requires a community-based approach. The investigators' novel approach integrates evidence-based strategies that will address these barriers to engagement. The success of this project in increasing the uptake of COVID-19 testing in the Black community will serve as a model for other health-related activities beyond COVID.

Research Approach

The investigators' current and prior work addressing HIV prevention among Black women successfully trained stylists in the community to bring awareness and knowledge of pre-exposure prophylaxis (PrEP). The first three months of this COVID-19 project will focus on training stylists and barbers as Opinion Leaders (OLs), development of edutainment videos, and training of research staff. An NP will provide telehealth support to customers who test positive, and the Community Coordinator will facilitate the OL workshop. The workshop will include updates on COVID-19 in the designated testing areas, CDC guidelines for COVID-19, clinical presentation, prevention strategies, testing, and telehealth policies and procedures, and roles and responsibilities of an OL. An OL serves as a community liaison between the researcher and the community. They do not serve as interventionists but are informed of research practices and current studies taking place in their community.

Investigators will partner with an established communication strategist team we have previously worked with to co-develop culturally and socially relevant short clip edutainment videos.

OLs training as an evidence-based model to promote health. Without ready and convenient access to credible, peer-reviewed information, people in search of information about health and well-being appear to turn to trusted local information sources such as personal connections and trusted healthcare professionals. Kim and colleagues note the importance of social networks and local information sources among underserved communities. Training of beauty industry professionals as OLs has been promising. There is evidence that customer confidence is increased when stylists undertake workshops in preparation for sharing information.

Edutainment videos are an evidence-based intervention strategy for health promotion and prevention among communities of color. Grounded in transportation theory, edutainment videos are designed to entertain and improve literacy while communicating prosocial norms and behaviors. These short clip videos will be accessible by scanning a QR code in the barber shop or beauty salon. A trained beauty professional will offer each client the opportunity to view the video. A $5 off coupon for hair services with the designated salon/shop will be offered if the client watches the video. At the end of the video, the client will be asked if they would like to be tested that day. If they respond no, the client will be asked a set of questions that explain the reason (e.g., I was tested in the past 2 weeks, I prefer to get tested at my doctor's office, I don't think I have COVID, I don't trust the COVID test). If the customer says yes, the client will be asked a set of questions about the reason for the decision (facilitators) (e.g., I feel comfortable testing in this space, the video encouraged me to be tested today, I have been wanting to get tested, but did not have easy access to testing).

A nurse-led model of care: the role of the advanced practice nurse and telehealth. NPs are positioned to advance health equity and support efforts to improve testing in the community. In prior work by the team and others, the nursing workforce is increasingly being recognized as being uniquely positioned to drive healthcare innovation to advance health equity. A recent National Academies of Sciences, Engineering, and Medicine (NASEM) report outlined a comprehensive vision for nurse-led innovation as a driving force in overhauling conventional models of health service delivery. Specifically, the NASEM report endorses the scale-up of nurse-led interdisciplinary care delivered directly in community settings. The NP will be a liaison for OLs and salons/shops and will contact customers who test positive for COVID to educate them of next steps. Since COVID, telehealth has been used to improve access to care and address barriers such as transportation, childcare limitations, and needing time off for appointments. Telehealth addresses traditional barriers to and disparities in access to care while also improving efficiency.

Conditions
COVID-19
Being tested
Covid-19 Antibody Test, Short Clip videos
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Covid-19 Antibody TestDiagnostic test

    The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.

    Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.

  • Short Clip videosOther

    Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.

Study groups in NCT05918952
Study groupRoleWhat they receive
Culturally-relevant Community Connections (C3)1-health COVID-19 test and Video
Receives: Diagnostic Test: Covid-19 Antibody Test; Other: Short Clip videos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Completed COVID-19 Tests

    Measured: 24-48 hours

  2. COVID-19 Testing Decision-Making Scale (CTDMS) General Sentiment (GS) Subscale

    The CTDMS is an 8-item measure with 2 subscales: General Sentiment (4 items) and Practical Support (4 items). The GS subscale score is calculated as a mean with a range of 1 to 5. Higher scores indicate stronger agreement with positive general attitudes and experiences toward COVID-19.

    Measured: Baseline

  3. COVID-19 Testing Decision-Making Scale (CTDMS) Practical Support (PS) Subscale

    The CTDMS is an 8-item measure with 2 subscales: General Sentiment (4 items) and Practical Support (4 items). The PS subscale score is calculated as a mean with a range of 1 to 5. Higher scores reflect greater perceived practical support for testing (e.g., importance, accessibility).

    Measured: Baseline

Secondary outcomes (1)
  1. Video Feedback Scale (VFS)

    The VFS contains 9 items, each with a response scale of 1 to 5. The VFS total score is calculated as a mean with a range of 1 to 5. Higher scores indicate greater perceived impact, cultural resonance, and acceptability of the intervention videos for health behavior change.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start21 Aug 2023
  3. Primary completion13 Jun 2024
  4. Study completion13 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05918952
Sponsor's protocol ID
Pro00112394
Other IDs
R0606A
Status last verified
Dec 2025
First submitted
21 Jun 2023
Last updated
2 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Duke University at 1 site 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 3 inclusion and 2 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 2 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Completed COVID-19 Tests (time frame: 24-48 hours). The study lists 3 primary outcomes in all. 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 2 Jan 2026.

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