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Recruiting

NCT Number: NCT06542835

Community Partnership for Telehealth Solutions to Convey Information and Enhance Care

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

Recruiting

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AltaMed Health Services Corporation

Los Angeles, California, 90040, United States

Location status: Recruiting

Location contact

Anne Escaron, PhD

CONTACT

[email protected]

323-695-3601

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video text message

Behavioral

Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.

In-clinic CRC screening promotion

Behavioral

Stool-test orders, colonoscopy referrals.

Mailed FIT

Behavioral

Mailed FIT kits.

Social needs navigation

Behavioral

Patient navigation to address social needs.

Reminders

Behavioral

Centralized text and/or telephone reminders for ordered tests.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gloria Coronado, PhD

CONTACT

[email protected]

5039147100

Katherine Mendoza, MPH

CONTACT

[email protected]

8477672847

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • AltaMed Health Services Corporation
  • Kaiser Permanente
  • San Diego State University

Registry information

Official study title

Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

Acronym: PRIME

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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