Personalized risk-based follow-up for cervical cancer screening in practice
Official title: Personalized Risk-based Follow-up of Cervical Cancer Screening in Practice (PREDICT), Randomized Control Trial
Run by Massachusetts General Hospital · NCT06872346 · Data updated 2026-11-12
This trial tests a personalized cervical cancer screening approach in primary care patients to see if reminders and outreach can improve how people are followed after a Pap/HPV test.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 70 Years |
| Sex | Women only |
| Enrollment | 7500 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 22, 2026 |
| Main results expected | July 22, 2028 |
| Study ends | January 22, 2029 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT06872346 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 21-70 with a cervix who receive care at participating Mass General Brigham primary care practices and have had a Pap and/or HPV test within the past 3.5 years with a CCSM-derived 5-year risk warranting follow-up.
✕Probably not a fit
Patients who have had cervical cancer or CIN3+ diagnoses before the most recent screening, those without a cervix, or those who cannot communicate in English or Spanish may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this study, primary care patients in the Mass General Brigham system who are due for follow-up cervical cancer screening are randomized at the clinic level to three arms: standard care, visit-based reminders, or visit-based reminders with population outreach. The goal is to use a validated, open-source CDS tool to deliver risk-based recommendations aligned with ASCCP guidelines and to support care delivery through an integrated health IT platform. The intervention emphasizes a stepped, tailored approach that engages both patients and primary care teams to optimize surveillance or diagnostic steps when risk warrants it. The trial is designed to test whether this personalized, risk-driven management can improve appropriate follow-up while reducing unnecessary interventions. The study will assess feasibility, adherence to recommendations, and potential benefits of the CDS-supported workflow in real-world clinics.
Why it matters
Potential benefit: If successful, patients may receive more timely and appropriate follow-up care, potentially reducing missed high-risk cases and over-testing.
How similar studies have gone: Prior work suggests risk-based, CDS-supported screening can streamline follow-up and improve guideline-concordant care, though this exact setup with population outreach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria, Individuals who: * have a cervix and are 21-70 years old * receive care at a participating primary care practice (i.e. PCP team visit within past 3 years) * have had a Pap and/ or HPV test within the past 3.5 years * has a CCSM result that suggest a 5-year risk of developing CIN3+ that warrants surveillance at 1 or 3 years, diagnostic colposcopy, or treatment (i.e., above average risk). Inclusion of those up to age 70 is intended to identify individuals whose prior history does not meet screening exit criteria, and warrants surveillance or diagnostic care even though women with adequate prior screening can stop at age 65 Exclusion Criteria Individuals who: * were diagnosed with cervical cancer/ CIN3+ prior to the most recent screening Pap or HPV test * have had their cervix removed * are not English or Spanish-speaking.
Where it's running
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Massachusetts General Brigham
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Jennifer S Hass, MD
- Email: Jennifer.Haas@mgh.harvard.edu
- Phone: 617-724-1832
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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.