Primary Care–GI Connect to improve colonoscopy follow-up after an abnormal FIT
Official title: Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
Run by Jonsson Comprehensive Cancer Center · NCT06568016 · Data updated 2026-11-12
This trial tests whether a clinic-wide Primary Care–GI Connect program helps patients at community health centers get colonoscopies within six months after an abnormal fecal immunochemical test (FIT).
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | February 28, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT06568016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults receiving care at the participating NEVHC FQHC clinics who have an abnormal FIT result are the intended participants for this program.
✕Probably not a fit
Patients who are not screened with FIT, who already completed a timely follow-up colonoscopy, or who decline coordination services are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pragmatic, cluster-randomized trial in six Federally Qualified Health Center (FQHC) clinics (about 1,500 patients) comparing usual care to a multilevel care-coordination program called Primary Care–GI Connect. Clinics are randomized 3 versus 3; usual care includes monthly EHR FIT tracking and standardized result communication, while the intervention adds GI liaisons who provide enhanced coordination and navigation. The trial measures colonoscopy receipt within six months of an abnormal FIT and also systematically examines implementation quality using a multilevel framework. Investigators will measure incremental cost-effectiveness to inform feasibility and potential for broader dissemination.
Why it matters
Potential benefit: If successful, the program could increase timely colonoscopy completion after abnormal FITs and reduce missed or late-detected colorectal cancers in underserved populations.
How similar studies have gone: Prior multicomponent care-coordination and navigation interventions in safety-net settings have shown improved follow-up colonoscopy rates in some studies, though effects vary by context and intensity.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6 adult care NEVHC clinic sites
Where it's running
-
University of California at Los Angeles
Los Angeles, California, United States Recruiting -
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States Not yet recruiting
Study contacts
- Principal investigator: Folasade P May, MD, PhD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Jessica Tuan
- Email: JTuan@mednet.ucla.edu
- Phone: 310-825-3181
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.