NCT07351110

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

January 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

cervical cancer screeningself-collectionself-sampling

Outcome Measures

Primary Outcomes (1)

  • Cervical cancer screening

    receiving cervical cancer screening either via self-collection, pap smear, or hpv testing

    within 6 months

Secondary Outcomes (3)

  • Acceptability

    from enrollment until they complete screening or at the end of the trial at 6 months

  • Appropriateness

    from enrollment until they complete screening or at the end of the trial at 6 months

  • Feasibility measure

    from enrollment until they complete screening or at the end of the trial at 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

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.

Also known as: self-collection, self-sampling, patient navigation
Intervention

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible
  • Active UF Internal Medicine patient and has had an appointment in the last 2 months.
  • Assigned sex at birth is female
  • Have Obesity or Type 2 Diabetes
  • Not currently pregnant (self-report)
  • Have not given birth in the prior 12 weeks
  • No previous history of cervical cancer
  • No previous history of a hysterectomy
  • Have not undergone cancer screening in the past 3 years or more
  • 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).
  • Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.
  • Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).

You may not qualify if:

  • Previous history of cervical cancer
  • Total hysterectomy
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health Internal Medicine

Gainesville, Florida, 32611, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (3)

  • Mkuu RS, Staras SA, Szurek SM, D'Ingeo D, Gerend MA, Goede DL, Shenkman EA. Clinicians' perceptions of barriers to cervical cancer screening for women living with behavioral health conditions: a focus group study. BMC Cancer. 2022 Mar 9;22(1):252. doi: 10.1186/s12885-022-09350-5.

    PMID: 35264120BACKGROUND
  • Mkuu RS, Tohme S, Rivero-Mendoza D, Salloum RG, Goede D, Bruggeman B, Nicholson K, Hall JM, Bylund C, Woodard JN, Hensley J, Shenkman EA, Donahoo WT, Mulugeta A, Hernandez M, Staras SA. Improving Patient Education Materials for HPV Self-Collection: Insights from Women at High Risk of Developing Cervical Cancer. Cancer Manag Res. 2025 Dec 24;17:3273-3284. doi: 10.2147/CMAR.S552282. eCollection 2025.

    PMID: 41467104BACKGROUND
  • Mkuu RS, Staras SA, Chakrabarti C, Hall J, Harvey I, Salloum RG, Barrow S, Ortega S, Woodard J, Seals K, Rawls A, Meduri Y, Donahoo WT, Goede DL, Shenkman EA. Acceptability of HPV self-collection: A qualitative study of Black women living with type II diabetes and social vulnerability. J Clin Transl Endocrinol. 2024 Feb 25;35:100331. doi: 10.1016/j.jcte.2024.100331. eCollection 2024 Mar.

    PMID: 38444842BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusUterine Cervical NeoplasmsObesityOverweight

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Rahma Mkuu, PhD

CONTACT

Daniela Rivero-Mendoza, MS.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 20, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Deidentified data will be available after the results of the study are published.

Locations