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

NCT ID: NCT05918952

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 327 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2024-06-13

Brief 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. 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Culturally-relevant Community Connections (C3)

1-health COVID-19 test and Video

Covid-19 Antibody Test

Intervention Type: DIAGNOSTIC_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 videos

Intervention Type: OTHER

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.

Interventions

Covid-19 Antibody 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.

Intervention Type: DIAGNOSTIC_TEST

Short Clip videos

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Schenita Randolph, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Locations

Hair Designs By Tasha

Greensboro, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R0606A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00112394

Identifier Type: -

Identifier Source: org_study_id