Clinical trial NCT05903885: A Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans
Official title: Using a Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Prevention
Keywords: Prevention
Department of motor vehicles
Cross-sectoral partnership
African Americans
Screening
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2023-06-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fecal Immunochemical Test Kit Return Rate
timeFrame: 6 months from date of FIT distribution
Secondary outcomes:
measure: Fecal Immunochemical Test (FIT) Kit Positive Rate
timeFrame: 6 months from date of FIT distribution
measure: Follow-up Colonoscopy Completion Rate
timeFrame: 6 months from date of positive FIT result notification
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Department of Motor Vehicles (DMV)
state: Nebraska
city: Omaha
country: United States
facility: Douglas County Treasurer's Office
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jungyoon Kim, PhD
role: PRINCIPAL_INVESTIGATOR
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