Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity (PRIME)

University of Arizona

Status: Not yet enrolling

Conditions: Colorectal Cancer

Treatments: Behavioral: Video text message; Behavioral: Mailed FIT; Behavioral: Reminders; Behavioral: Social needs navigation; Behavioral: In-clinic CRC screening promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT06542835

STUDY00004612

Details and patient eligibility

About

Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

Full description

The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 45 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 45-64
• Eligible for colorectal cancer (CRC) screening
• Current patients (seen in the clinic in the last 6 months)
• Primary speaker of English or Spanish
• Cell phone listed in Electronic Health Record (EHR)
• No recent history of CRC screening
• Resides in one of the neighborhoods included in the main trial

Exclusion criteria

• Colorectal disease (e.g., ulcerative colitis or colectomy)
• Personal history of colorectal cancer
• End-stage or life-threatening diseases
• Known to be under hospice care
• Living in a skilled nursing facility
• Patients who decline research participation will be removed from the patient contact list

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

Video text message, mailed FIT, and social needs navigation

Experimental group

Description:

Tailored video text message, mailed FIT, and navigation to address patients' social needs.

Treatment:

Behavioral: Social needs navigation

Behavioral: Mailed FIT

Behavioral: Video text message

Usual care

Active Comparator group

Description:

Colorectal cancer (CRC) screening offers during in-person clinic visits.

Treatment:

Behavioral: In-clinic CRC screening promotion

Behavioral: Reminders