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| ID | Type | Description | Link |
|---|---|---|---|
| R0606A | Other Grant/Funding Number | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally-relevant Community Connections (C3) | 1-health COVID-19 test and Video |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 Antibody Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Completed COVID-19 Tests | 24-48 hours | |
| 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. | Baseline |
| 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). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Black/African American adults
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| Name | Affiliation | Role |
|---|---|---|
| Schenita Randolph, PhD | Duke University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hair Designs By Tasha | Greensboro | North Carolina | 27408 | United States |
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Two beauty salons and three barbershops agreed to partner to implement this project. Recruitment of customers in these shops took place through word of mouth, an IRB-approved recruitment flyer, and through the co-developed edutainment videos.
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| ID | Title | Description |
|---|---|---|
| FG000 | Culturally-relevant Community Connections (C3) | 1-health COVID-19 test and Video 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Culturally-relevant Community Connections (C3) | 1-health COVID-19 test and Video 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Completed COVID-19 Tests | Posted | Count of Participants | Participants | 24-48 hours |
|
Up to 48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testing Group | 1-health COVID-19 test and Video 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Schenita Randolph | Duke University School of Nursing | 919-684-3786 | schenita.randolph@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2024 | Dec 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2023 | Aug 9, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087124 | COVID-19 Serological Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Covid-19 antibody test
|
| Short Clip videos | 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. |
|
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
|
| 0 |
| 327 |
| 0 |
| 327 |
| 0 |
| 327 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| Regression, Logistic |
| 0.029 |
Low sample size and power. Model considered unstable and potentially overfit. Results not reliable. |
| Odds Ratio (OR) |
| 11.01 |
| 2-Sided |
| 95 |
| 1.27 |
| 95.17 |
| Other |