NCT07351110

Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.

Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.

Detailed description

We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer. We will use the six steps of the Intervention Mapping approach to guide the process of testing the intervention. This project aligns with the current efforts at the University of Florida Health Cancer Institute (UFHCI) and UF Health Internal Medicine to improve cervical cancer screening rates among under-screened women. We will partner with these efforts to test the PINPOINT intervention. Project CONTINUITY (Connecting You to Care in the Community) at UFHCI, Office of Community Outreach and Engagement (COE), is working to increase adherence to cervical screening and follow-up by; (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method, community clinical navigators (CCN) and community health workers (CHWs), customized messages and support for patient portal access for test results, and (2) implementing strategies to address non-medical drivers that may influence an individual's ability to adhere to the screening, with an initial focus on removing transportation barriers through the use of a mobile outreach clinic (MOC). Currently, a patient navigator supervised by Dr. Dianne Goede identifies patients who have an upcoming office visit and are due for cervical cancer screening at UF Health Internal Medicine. The patient navigator outreaches the patient, reminds them of their overdue status for cervical cancer screening and the importance of cervical cancer screening, and inquires if they are agreeable to complete screening at the scheduled office visit. We will reach out to patients who remain unscreened for cervical cancer 2 months after their scheduled visit with UF Health Internal Medicine. We will obtain a list of patients from the UF Health Consent2Share database. Patients who agree to participate in our study will be randomized to either receive the PINPOINT intervention (self-collection test with patient navigation) or standard of care (reminder to screen from UF Health Internal Medicine). We will use the sealed envelope randomization method to assign participants to either treatment or control groups right after intake. We will pilot the PINPOINT intervention at UF Internal Medicine clinics and use Proctor's Framework for Implementation Outcomes to evaluate the intervention. Changes will be made to the intervention protocol and tested in a future randomized trial with a larger sample. Hypothesis: PINPOINT will meet the needs of women living with socioeconomic challenges, T2D, and obesity, and will align with the clinical workflow. PINPOINT will be appropriate, feasible and acceptable.27 Outcome: The PINPOINT intervention will have positive outcomes in terms of feasibility and acceptability among patients.

Conditions

• Diabetes
• Cervical Cancer (Early Detection)
• Obesity & Overweight

Interventions

Type	Name	Description
BEHAVIORAL	patient navigation and self-collection	Patients will receive a combination of patient navigation, education, and cervical cancer self-collection sampling as part of the intervention to support cervical cancer screening.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-09-15
• Completion: 2026-12-24
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

2 sites across 1 country: United States