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

NCT ID: NCT05092022

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2026-12-31

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.

Detailed Description

Patients will be recruited during their appointment at the PSH St. Joseph's residency clinic. If a patient is due for cervical cancer screening, they will be presented with the study letter that allows them to choose between (1) receiving the self-sampled HPV test after their appointment, (2) scheduling an in-person cervical cancer screening at a later date, or (3) indicating they are not interested in either option at this time (see study letter). If the patient requests the self-sampled HPV test (option 1), they will be given a package that contains the HPV self-sampling test and directions for use, the Summary Explanation of Research, the package cover letter, the Penn State Health Clinical Laboratory Pathology Services Special Account Requisition form, and a pre-paid return envelope. The patient will fill in the Pathology Services Special Account Requisition form with their name, date of birth, sex, and date and time of sample collection. The completed test and Pathology Services Special Account Requisition form will be placed in the pre-paid return envelope and sent to the Penn State Health Clinical Laboratory. A note will be added to the patient's medical record stating that a self-sampled HPV test was provided, including the date it was given.

Patients who choose option 2, to schedule an in-person cervical cancer screening at a later date, will be given the time to do so when checking out from their current clinic appointment. Appointment information will be shared with the study team to ensure that their appointment is kept or rescheduled, if needed.

No additional follow-up is needed for patients who choose option 3. A note will be added to the patient's medical record stating that they declined HPV screening, including the date the screening was declined.

Results of the self-sampled HPV tests will be securely sent from the Penn State Health Clinical Laboratory to the project manager for tracking. Then, the results will be sent to a member of the study team at the PSH St. Joseph residency clinic, who will upload the results into the patient's medical records. If the test result indicates that the patient is positive for low-risk HPV, the patient will be contacted by their primary care physician to schedule a Pap test. If the test result indicates that the patient is positive for high-risk HPV, patient will be contacted by their primary care physician to schedule a colposcopy. Scheduling a Pap test or colposcopy is standard of care for a low-risk or high-risk HPV result, respectively. If the test result indicates that the patient is negative for HPV, the results will be entered into the patient medical record and the patient notified via telephone, but the patient will not receive any follow-up procedures after the self-sampled test.

Conditions

Cervical Cancer Screening

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Requested self-sampled HPV test

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.

Group Type: EXPERIMENTAL

Evalyn Self-Sampling Brush

Intervention Type: DEVICE

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

Interventions

Evalyn Self-Sampling Brush

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christina Scartozzi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Scartozzi, DO

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State Health St. Joseph's

Reading, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina Scartozzi, DO

Role: CONTACT

cscartozzi@pennstatehealth.psu.edu

610-208-4610

Leonard Kishel

Role: CONTACT

lkishel@pennstatehealth.psu.edu

717-531-0003 ext. 321657

Facility Contacts

Christina Scartozzi, DO

Role: primary

cscartozzi@pennstatehealth.psu.edu

610-208-4610

Leonard Kishel, MA

Role: backup

lkishel@pennstatehealth.psu.edu

717-531-0003 ext. 321657

Other Identifiers

18767

Identifier Type: -

Identifier Source: org_study_id