A Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans

NCT05903885 | Recruiting

• 1 other identifier: 0115-23-EP
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.

Conditions

Colorectal Cancer; Prevention

Keywords

Prevention; Department of motor vehicles; Cross-sectoral partnership; African Americans; Screening

Outcome Measures

Primary Outcomes (1)

• Fecal Immunochemical Test Kit Return Rate

  The fecal immunochemical test kit (FIT) return rate is the proportion of participants who have completed the screening by returning the FIT kits.

  6 months from date of FIT distribution

Secondary Outcomes (2)

• Fecal Immunochemical Test (FIT) Kit Positive Rate

  6 months from date of FIT distribution

• Follow-up Colonoscopy Completion Rate

  6 months from date of positive FIT result notification

Study Arms (2)

On-site Group

EXPERIMENTAL

The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Participants in the on-site group will be guided through the kit process by trained research staff present. They will be given instructions on collecting the stool sample and using the FIT kit properly. They will also be given a culturally tailored educational brochure, a prepaid return envelope, and receive reminder text messages and phone calls within 3 weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

Other: On-site Fecal Immunochemical Test (FIT) Kit Distribution

On-site Group With Social Media Advertising

ACTIVE COMPARATOR

The onsite group with social media advertising participants will receive FIT kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Additionally, they will be exposed to targeted social media advertisements on Facebook, Instagram, and YouTube. These participants will encounter ads featuring video content with community member testimonials, emphasizing the importance of colorectal cancer screening for African Americans aged 45-75. The campaign will run from August 19 to October 29, 2024. Participants in this group will receive the FIT kits at the DMV along with detailed instructions on how to collect the stool sample and use the kit. They will also receive a culturally tailored educational brochure, prepaid return envelope, reminder text messages, and phone calls within three weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

Other: On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution

Interventions

On-site Fecal Immunochemical Test (FIT) Kit Distribution OTHER

Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104, by research staff.

Also known as: Face-to-face distribution

On-site Group

On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution OTHER

Participants will receive home-based Fecal Immunochemical Test (FIT) kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104, by research staff supplemented by exposure to targeted social media advertisements.

On-site Group With Social Media Advertising

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identification as Black or African American
• Between 45 and 75 years old
• Not up-to-date with colorectal cancer (CRC) screening per guidelines
• Willingness to provide contact information for follow-up
• Ability to speak, read, and write English
• Current residency in Douglas County, NE.

You may not qualify if:

• History of colorectal cancer (CRC)
• History of adenomas (precancerous polyps) or inflammatory bowel disease
• Family history of colorectal cancer (CRC)

Sponsors & Collaborators

• University of Nebraska: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (2)

Department of Motor Vehicles (DMV)

Omaha, Nebraska, 68104, United States

RECRUITING

Douglas County Treasurer's Office

Omaha, Nebraska, 68104, United States

RECRUITING

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jungyoon Kim, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jungyoon Kim, PhD

CONTACT

(402) 552-7235; jungyoon.kim@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study aims to enroll 600 participants to each of two groups to evaluate strategies in improving colorectal cancer screening rates among African Americans. The groups are the on-site group and the on-site group with social media advertising. The latter group will have exposure to targeted ads on Facebook, Instagram, and YouTube which will run from August 19 to October 29, 2024. The social media campaign will target African American residents of Omaha, aged 45-75. Both groups will be given fecal immunochemical test (FIT) kits, a prepaid return envelope, and an educational brochure when visiting the Department of Motor Vehicles (DMV), 4606 N 56th St Suite 100, Omaha, NE 68104. Both groups will also be given reminder messages and post-FIT navigation support, if needed. Participants' information and perceptions will be collected via surveys. FIT return rate, positive screening rate, and follow-up colonoscopy completion rate will be compared between groups, controlling for covariates.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)