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

NCT05918952 | Completed Results DMC

• 2 other identifiers: Pro00112394R0606A
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Video Feedback Scale (VFS)

  24 hours

Study Arms (1)

Culturally-relevant Community Connections (C3)

1-health COVID-19 test and Video

Diagnostic Test: Covid-19 Antibody Test; Other: Short Clip videos

Interventions

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.

Culturally-relevant Community Connections (C3)

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.

Culturally-relevant Community Connections (C3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Black/African American adults

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Hair Designs By Tasha

Greensboro, North Carolina, 27408, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Covid-19 antibody test

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Results Point of Contact

• Title: Dr. Schenita Randolph
• Organization: Duke University School of Nursing

schenita.randolph@duke.edu

919-684-3786

Study Officials

• Schenita Randolph, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 26, 2023
• Study Start: August 21, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)