A Cross-sectional Partnership to Improve Prevention

Study Overview
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Brief Summary
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This study is a non-randomized, 2-arm clinical trial comparing the effectiveness of two strategies for distributing FIT (fecal immunochemical test) kits in a community-based colorectal cancer screening program targeting African Americans (AAs). The main questions this study aims to answer are: Does the on-site distribution of FIT kits result in higher return rates compared to direct mailing? Which distribution strategy (onsite vs. direct mailing) is a more cost-effective approach for increasing colorectal cancer screening rates among underserved populations? Participants in the study will be African Americans who are eligible for colorectal cancer screening. Participants will be assigned to one of two groups: the on-site distribution group or the direct mailing group. In the on-site distribution group, participants will be given FIT kits at a designated Department of Motor Vehicle (DMV) service location. In the direct mailing group, participants will receive the FIT kits through the mail using the DMV database.

Detailed Description
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African Americans (AAs) face racial disparities in colorectal cancer (CRC), with higher incidence and mortality rates, as well as lower screening rates. To address this gap and improve CRC screening rates among AAs, this study will use an evidence-based, community-based intervention program partnering with multiple cross-sectoral organizations, such as DMV, to recruit AAs who are eligible for CRC screening. This study will test different 'distribution' strategies (onsite vs. mailing) using the resources from the partner organizations. For the onsite strategy, the investigators will set up a health promotion booth at a selected DMV location to recruit participants face-to-face, and the investigator's research staff will distribute screening kits on-site (n=600). For the mailing strategy, the investigators will collaborate with the Nebraska Department of Health and Human Services (DHHS) to mail out screening kits to eligible participants using DMV Driver's License Database (n=600). All participants will receive 1) a free screening kit with a prepaid return envelope, 2) a tailored educational brochure, 3) reminder text/calls, and 4) post-navigation services in case of positive results. Fecal Immunochemical Test (FIT) will be used. Kits are returned to a designated lab location for testing, and test results will be mailed to participants within 14-21 days. Upon consent, participants' demographic and screening-related information will be collected via the registration form (e.g., name, contact information, race, gender, previous screening history, etc.). Participants' perceptions and beliefs about screening will be collected via an online survey through text message 3 days after participants receive the screening kit. Kit return status and results will be collected via the participant tracking log shared by the key personnel in the partnership. Outcomes (screening completion rate and positive results) will be compared between the onsite and mailing groups, controlling for other covariates (age, gender, race, healthcare access, income, previous screening history, and health beliefs).

Official Title
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Using a Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans

Conditions
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Colorectal Cancer, Prevention

Intervention / Treatment
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* Other: On-site Fecal Immunochemical Test (FIT) Kit Distribution
* Other: Mailed Fecal Immunochemical Test (FIT) Kit Distribution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identification as Black or African American. Age between 45 and 75 years. 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: Individuals with a personal history of colorectal cancer (CRC). Individuals with a personal history of adenomas (precancerous polyps) or inflammatory bowel disease. Individuals with a family history of colorectal cancer (CRC).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The on-site distribution (face-to-face) group will receive FIT kits at a designated location (DMV) distributed by a research staff , while the direct mailing group will receive FIT kits through the mail (no physical contact) using the DMV database. All the other conditions are the same for both group except the distribution strategy. FIT return rate will be compared between onsite group and mailing group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onsite group<br>The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (DMV) location. Participants in the on-site group will be guided through the process of receiving the FIT kits by trained staff present at the designated location. They will be given instructions on collecting the stool sample and using the FIT kit properly. They will also be given a tailored educational brochure, reminder text messages, and phone calls within 3 weeks of the receipt of the FIT kit and post-navigation services for positive results. | Other: On-site Fecal Immunochemical Test (FIT) Kit Distribution<br>* Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the DMV site by the research staff.<br>* Other names: Face-to-face distribution;|
| Active Comparator: Mailing group<br>The mailing group participants will receive an initial letter from the the Nebraska Department of Health and Human Services (NE DHHS) asking whether they are interested in receiving Fecal Immunochemical Test (FIT) packets. For those who responded yes, NE DHHS will send FIT kits on behalf of the research team. These participants will receive the FIT kits mailed to their provided addresses using the DMV database. Participants in the mailing group will receive the FIT kits by mail along with detailed instructions on how to collect the stool sample and use the kit. The mailing group will also receive a tailored educational brochure, reminder text messages, and phone calls within three weeks of receipt of the FIT kit and post-navigation services in case of positive results. | Other: Mailed Fecal Immunochemical Test (FIT) Kit Distribution<br>* Participants will receive home based Fecal Immunochemical Test (FIT) kit directly by mailing without any personal (face-to-face) contact.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Immunochemical Test (FIT) kite return rate | Proportion of participants who have completed the screening by returning Fecal Immunochemical Test (FIT) kits | 6 months from the date of FIT distribution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Immunochemical Test (FIT) kit positive rate | Proportion of participants who have positive Fecal Immunochemical Test (FIT) kit results | 6 months from the date of FIT distribution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Department of motor vehicles, Cross-sectoral partnership, African Americans, Screening