Recruiting

Cervical CancerPersonalized Risk-based Follow-up of Cervical Cancer Screening in Practice, RCT

Sponsor:

Massachusetts General Hospital

Code:

NCT06872346

Conditions

Cervical Cancer Screening

Eligibility Criteria

Sex: Female

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Visit-based IT reminders to patients and practitioners

Population outreach

Study Details

Brief summary:

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. Patients will be randomized by clinic into three different arms (Arm 1: standard care, Arm 2: visit based reminders, Arm 3: visit based reminders and population health outreach)

Conditions

Cervical Cancer Screening

Study ID

NCT06872346

Start date

Jul 22, 2026

Status verified date

Nov, 2025

Completion date

Jan 22, 2029

Anticipated

Primary completion date

Jul 22, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 21 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

7500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Arm 1: Standard Care

Patients will receive the usual care provided by their PCP, practice, and/or specialist.

active comparator: Arm 2: Visit Based Reminder

Visit based reminders for physicians and patients that will be seen in Epic and Patient Gateway

active comparator: Arm 3: Population Health Outreach

Visit based reminders for physicians and patients that will be seen in Epic and Patient Gateway. Patients will received outreach from a population health coordinator. Patients will be sent educational materials, a reminder letter, and if needed, additional help scheduling their follow up appointment.

Interventions

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.

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 measure

Primary effectiveness outcome [ Time Frame: 120 days ]

Central Contacts and Locations

Central contacts

Jennifer S Hass, MD

617-724-1832 Jennifer.Haas@mgh.harvard.edu

Amy J Wint, MSc

awint@mgh.harvard.edu

Locations

Massachusetts General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 7, 2026

Last verified

Nov, 2025

Keywords

Cervical Cancer
Screening
Clinical Decision Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-07.