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

March 24, 2026 updated by: Gloria Coronado, University of Arizona

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90040
        • Recruiting
        • AltaMed Health Services Corporation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: Within 12 months post abnormal FIT result
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe