NCT06872346 · Massachusetts General Hospital
Personalized Risk-based Follow-up of Cervical Cancer Screening in Practice, RCT
(PREDICT)
What this study is about
The goal of this PREDICT is to assess a personalize approach to screening and management of cervical cancer testing. The investigators will evaluate patients who are due for a follow up cervical cancer screening in the primary care clinics in the Massachusetts General Brigham system.
View original scientific description
The goal of this PREDICT is to assess a personalize approach to screening and management of cervical cancer testing. The investigators will evaluate patients who are due for a follow up cervical cancer screening in the primary care clinics in the Massachusetts General Brigham system.
Interventions
OTHER
Visit-based IT reminders to patients and practitioners
To identify patients due for CCSM, simplify test ordering/referral, and track follow-up, PREDICT will include: 1) automated updating of a patient's problem list with the current cervical screening finding, 2) automated updating of cervical cancer health maintenance topics to the appropriate time interval and follow-up test/ procedure through the use of modifiers, 3) "SmartSets" to standardize ordering of procedures/ specialty referrals.
OTHER
Population outreach
Patients will be sent a reminder letter 90 days prior to the due date via the patient portal or mailed if no portal account (Outreach 1). If needed, four weeks later a phone call from the outreach coordinator reminds patients of the follow-up date if scheduled or helps establish follow-up (Outreach 2). The coordinator could also place an order for a referral and send a reminder to the practitioner to sign it if appropriate. The coordinator will review and document any "alternative care plans" discussed by the PCP and patient.
Primary outcome measures
Primary effectiveness outcome
Time frame: 120 days
The primary effectiveness outcome, measured at the patient level, is receipt of follow-up within 120 days of the due date, extracted from EHR/ associated claims documentation, for individuals with a 5-year risk of developing CIN3+ of 0.6% or more. This time interval was selected to allow patients sufficient time to move through the stepped care intervention with enough time to schedule recommended follow-up given practitioner availability
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations