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Community Partnership for Telehealth Solutions to Convey Information and Enhance Care

Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06542835
Acronym
PRIME
Enrollment
6000
Registered
2024-08-07
Start date
2024-07-31
Completion date
2027-01-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

cancer screening, telehealth, video, text messaging, patient navigation, stool testing, fecal testing, Latinx health disparities

Brief summary

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

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.

Interventions

BEHAVIORALVideo text message

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

BEHAVIORALIn-clinic CRC screening promotion

Stool-test orders, colonoscopy referrals.

BEHAVIORALMailed FIT

Mailed FIT kits.

BEHAVIORALSocial needs navigation

Patient navigation to address social needs.

BEHAVIORALReminders

Centralized text and/or telephone reminders for ordered tests.

Sponsors

University of Arizona
Lead SponsorOTHER
San Diego State University
CollaboratorOTHER
AltaMed Health Services Corporation
CollaboratorOTHER
Kaiser Permanente
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CRC Screening Completion at the Individual Level6 monthsMeasure 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

MeasureTime frameDescription
FIT completion6 monthsMeasure 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.
Rate of Follow-Up Colonoscopy Completion12 monthsTrack the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups.
Time to follow-up colonoscopyWithin 12 months post abnormal FIT resultMeasure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups.

Countries

United States

Contacts

CONTACTGloria Coronado, PhD
gdcoronado@arizona.edu5039147100
CONTACTKatherine Mendoza, MPH
katherinemendoza@arizona.edu8477672847
PRINCIPAL_INVESTIGATORAnne Escaron, PhD

AltaMed Health Services Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026