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

University of Nebraska

Status: Enrolling

Conditions: Prevention; Colorectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05903885

0115-23-EP

Details and patient eligibility

About

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.

Full description

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. The American Cancer Society reported that African Americans are about 20% more likely to have CRC and 40% more likely to die from it compared to other racial groups. The main reasons for high CRC incidence and mortality for African Americans are structural barriers in access to quality healthcare and timely screening that can be attributed in large part to historical and persistent structural racism in the U.S. To address this gap and improve CRC screening rates among African Americans, this study will partner with the Department of Motor Vehicles (DMV) to recruit African Americans eligible for CRC screening during their regular visits to the DMV. Investigators will recruit 1,200 participants aged 45-75 for CRC screening.

Upon consent, participants' demographic and screening-related information will be collected via a paper-based registration survey (e.g., name, age, gender, race/ethnicity, address, healthcare access, recent CRC screening history, smoking status, and personal/family history of CRC). 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. 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 from August 19, 2024, to October 29, 2024, to increase awareness and potentially improve participation rates.

Kits are returned to a designated Nebraska Medicine lab, and test results will be mailed to participants within 14-21 days. Follow-up services, including assistance with scheduling colonoscopies and applying for financial support programs, will be provided by a health navigator at Charles Drew Health Center for participants with positive results or those without health insurance or a primary care provider. Outcomes (screening completion rate and positive results) will be compared between the onsite and onsite with social media advertising groups, controlling for other covariates (age, gender, income, previous screening, smoking status, healthcare access, and health beliefs). The study will also assess the cost-effectiveness of each strategy and the completion rate of follow-up colonoscopies after receiving positive FIT results. Participants' perceptions and beliefs about screening will be collected via an online survey.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

On-site Group

Experimental group

Description:

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.

Treatment:

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

On-site Group With Social Media Advertising

Active Comparator group

Description:

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.

Treatment:

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