Recruiting

PINPOINT Intervention

Sponsor:

University of Florida

Code:

NCT07351110

Conditions

Diabetes

Cervical Cancer (Early Detection)

Obesity & Overweight

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

patient navigation and self-collection

Study Details

Brief 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.

Conditions

Diabetes

Cervical Cancer (Early Detection)

Obesity & Overweight

Study ID

NCT07351110

Start date

Aug 30, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

no intervention: Control Arm

No intervention arm, patients will receive reminders for screening according to current clinical practice

Interventions

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.

Primary outcome measure

  • Cervical cancer screening [ Time Frame: within 6 months ]

Central Contacts and Locations

Central contacts

Rahma Mkuu, PhD

(352) 294-8419rmkuu@ufl.edu

Daniela Rivero-Mendoza, MS.

crivero@ufl.edu

Locations

UF Health Internal Medicine

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Dianne G Goede, MD

352-265-0140diannelroberts@ufl.edu

Principal Investigator:

Dianne L Goede, MD

More Information

Sponsor

University of Florida

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • cervical cancer screening
  • self-collection
  • self-sampling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-10.