Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. (PINPOINT)

January 16, 2026 updated by: University of Florida

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rahma Mkuu, PhD
  • Phone Number: (352) 294-8419
  • Email: rmkuu@ufl.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Gainesville, Florida, United States, 32611
        • UF Health Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The following eligibility criteria will be used to determine inclusion into the study:

  1. Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible
  2. Active UF Internal Medicine patient and has had an appointment in the last 2 months.
  3. Assigned sex at birth is female
  4. Have Obesity or Type 2 Diabetes
  5. Not currently pregnant (self-report)
  6. Have not given birth in the prior 12 weeks
  7. No previous history of cervical cancer
  8. No previous history of a hysterectomy
  9. Have not undergone cancer screening in the past 3 years or more
  10. Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).
  11. Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.
  12. Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).

Exclusion Criteria:

  • Previous history of cervical cancer
  • Total hysterectomy
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
PINPOINT intervention arm will entail assigning patients to a patient navigator to assist them with screening reminders and address any barriers they have to screening, education on cervical cancer screening, and patients will also be offered the opportunity to self-collect their sample for cervical cancer screening.
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.
Other Names:
  • patient navigation
  • self-collection
  • self-sampling
No Intervention: Control Arm
No intervention arm, patients will receive reminders for screening according to current clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical cancer screening
Time Frame: within 6 months
receiving cervical cancer screening either via self-collection, pap smear, or hpv testing
within 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: from enrollment until they complete screening or at the end of the trial at 6 months
How agreeable or satisfactory participants find the intervention or implementation strategy. Questions include, HPV Self-Collection meets my approval, HPV Self-Collection is appealing to me, I like HPV Self-Collection, and I welcome HPV Self-Collection. Participants will fill a 4 point likert scale for each, (completely disagree, disagree, neither agree not disagree, agree, completely agree).
from enrollment until they complete screening or at the end of the trial at 6 months
Appropriateness
Time Frame: from enrollment until they complete screening or at the end of the trial at 6 months
The perceived fit or compatibility of the intervention for a specific setting, provider, or consumer, or to address a problem. Questions include, HPV Self-Collection seems fitting, HPV Self-Collection seems suitable, HPV Self-Collection seems applicable., and HPV Self-Collection seems like a good match. Participants will fill a 4 point likert scale for each, (completely disagree, disagree, neither agree not disagree, agree, completely agree).
from enrollment until they complete screening or at the end of the trial at 6 months
Feasibility measure
Time Frame: from enrollment until they complete screening or at the end of the trial at 6 months
- The extent to which an intervention can be successfully used in a given setting. Questions include, HPV Self-Collection seems implementable, HPV Self-Collection seems possible, HPV Self-Collection seems doable, and HPV Self-Collection seems easy to use. Participants will fill a 4 point likert scale for each, (completely disagree, disagree, neither agree not disagree, agree, completely agree).
from enrollment until they complete screening or at the end of the trial at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 24, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202500780
  • 1K01CA292583-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Deidentified data will be available after the results of the study are published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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