St. Joseph's HPV Self-sampling: Offering a Self-sampling Option in Clinic

NCT05092022 | Recruiting FDA Device

• 1 other identifier: 18767
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of offering self-sampled human papillomavirus (HPV) tests in increasing participation in cervical cancer screening, compared to the standard of care clinician-sampled test. The primary study endpoints are (1) patients' acceptability of self-sampled HPV tests vs. clinician-sampled test, and (2) patients' completion of self-sampled HPV test. The secondary study endpoint to be measured is the increase in cervical cancer screenings of any type in the PSH St. Joseph's residency clinic patient population.

Conditions

Cervical Cancer Screening

Keywords

self-sampling; cervical cancer

Outcome Measures

Primary Outcomes (3)

• Number of patients who request the self-sampled HPV test

  This outcome is measuring the number of patients who select to receive a self-sampled HPV test out of all patients presented with the research opportunity. The results will be presented as the acceptance rate of the self-sampled HPV test. The measurement tool for this outcome is a patient-completed questionnaire where the patient can request 1) a self-sampled HPV test, 2) a clinician-sampled test, or 3) to not receive their cervical cancer screening at this time.

  12 months after enrollment begins

• Number of patients who request the clinician-sampled test

  This outcome is measuring the number of patients who select to receive a clinician-sampled cervical cancer screening out of all patients presented with the research opportunity. The results will be presented as the acceptance rate of the clinician-sampled test. The measurement tool for this outcome is a patient-completed questionnaire where the patient can request 1) a self-sampled HPV test, 2) a clinician-sampled test, or 3) to not receive their cervical cancer screening at this time.

  12 months after enrollment begins

• Number of patients who complete the self-sampled HPV test

  This outcome is measuring the number of patients who complete and return the self-sampled HPV test out of all the patients who receive a self-sampled HPV test. A patient will have up to one month to complete and return the self-sampled HPV test. The final outcome results will be calculated one month after the last patient receives a self-sampled HPV test.

  1 month after patient is given self-sampled HPV test

Secondary Outcomes (1)

• Change in the number of patients considered up-to-date with cervical cancer screening of any type at the Penn State Health St. Joseph's residency clinic

  3 months after study enrollment ends

Study Arms (1)

Requested self-sampled HPV test

EXPERIMENTAL

This group will receive the self-sampled HPV test. Included with the test are the test instructions, a lab requisition form, and a pre-paid mailer so that it can be sent back to the lab for testing. Results of the test will be shared with the participant.

Device: Evalyn Self-Sampling Brush

Interventions

Evalyn Self-Sampling Brush DEVICE

A self-sampling brush to collect cervical cells for screening purposes.

Requested self-sampled HPV test

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible but out-of-date for cervical cancer screening
• Able to speak, read, and communicate well in English or Spanish
• Not at greater than average risk for cervical cancer

You may not qualify if:

• Pregnant
• Incarcerated
• Greater than average risk for cervical cancer, for example:
• Already diagnosed with high-grade precancerous cervical cancer or cervical lesions
• Has a compromised immune system
• Unable to speak, read, and communicate well in English or Spanish
• Unable or unwilling to give implied consent or otherwise complete study requirements

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health St. Joseph's

Reading, Pennsylvania, 19605, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Christina Scartozzi, DO

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Scartozzi, DO

CONTACT

610-208-4610; cscartozzi@pennstatehealth.psu.edu

Leonard Kishel

CONTACT

717-531-0003; lkishel@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 25, 2021
• Study Start: September 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)