Community Partnership for Telehealth Solutions to Convey Information and Enhance Care (PRIME)

Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Video text message; Behavioral: Mailed FIT; Behavioral: Social needs navigation; Behavioral: In-clinic CRC screening promotion; Behavioral: Reminders

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gloria Coronado, PhD; Phone Number: 5039147100; Email: gdcoronado@arizona.edu
• Study Contact Backup: Name: Katherine Mendoza, MPH; Phone Number: 8477672847; Email: katherinemendoza@arizona.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90040
      • Recruiting
      • AltaMed Health Services Corporation
      • Contact: Anne Escaron, PhD; Phone Number: 323-695-3601; Email: aescaron@AltaMed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video text message, mailed FIT, and social needs navigation; Tailored video text message, mailed FIT, and navigation to address patients' social needs.	Behavioral: Video text message; Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.; Behavioral: Mailed FIT; Mailed FIT kits.; Behavioral: Social needs navigation; Patient navigation to address social needs.
Active Comparator: Usual care; Colorectal cancer (CRC) screening offers during in-person clinic visits.	Behavioral: In-clinic CRC screening promotion; Stool-test orders, colonoscopy referrals.; Behavioral: Reminders; Centralized text and/or telephone reminders for ordered tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC Screening Completion at the Individual Level	Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIT completion	Measure the completion rate of fecal immunochemical tests (FIT) within 6 months of receiving the intervention. This will compare the proportion of participants who complete FIT in the post-intervention group versus the pre-intervention group.	6 months
Rate of Follow-Up Colonoscopy Completion	Track the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups.	12 months
Time to follow-up colonoscopy	Measure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups.	Within 12 months post abnormal FIT result

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: San Diego State University; Kaiser Permanente; AltaMed Health Services Corporation
• Investigators: Principal Investigator: Anne Escaron, PhD, AltaMed Health Services Corporation

Publications and helpful links

General Publications

• Rivelli JS, Schneider JL, Vaughn KA, Locher BW, Shaw MC, Martinez LS, Ruiz E, Thompson JH, Escaron AL, Coronado GD. Improving animated instructional videos for colorectal cancer screening: An application of learner verification and revision. Transl Behav Med. 2025 Jan 16;15(1):ibaf020. doi: 10.1093/tbm/ibaf020.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: video; text messaging; telehealth; cancer screening; patient navigation; stool testing; fecal testing; Latinx health disparities
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STUDY00004612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No