Recruiting

HPV Self-sampling

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT05092022

Conditions

Cervical Cancer Screening

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

Evalyn Self-Sampling Brush

Study Details

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

Study ID

NCT05092022

Start date

Sep 18, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Not accepted

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  • Eligible but out-of-date for cervical cancer screening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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Evalyn Self-Sampling Brush

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

Primary outcome measure

  • Number of patients who request the self-sampled HPV test [ Time Frame: 12 months after enrollment begins ]
  • Number of patients who request the clinician-sampled test [ Time Frame: 12 months after enrollment begins ]
  • Number of patients who complete the self-sampled HPV test [ Time Frame: 1 month after patient is given self-sampled HPV test ]

Central Contacts and Locations

Central contacts

Christina Scartozzi, DO

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

Leonard Kishel

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

Locations

Penn State Health St. Joseph's

Recruiting

Reading, Pennsylvania, United States, 19605

Contacts

Christina Scartozzi, DO

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

Leonard Kishel, MA

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

Principal Investigator:

Christina Scartozzi, DO

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • self-sampling
  • cervical cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-07-06.