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

Part of paid clinical trials in Reading, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT05092022
Status
Recruiting
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Conditions

  • Cervical Cancer Screening

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Evalyn Self-Sampling Brush — DEVICE
    A self-sampling brush to collect cervical cells for screening purposes.

Study Details

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.

Key Dates

Start date
Sep 18, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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.

Primary Outcome Measure

Number of patients who request the self-sampled HPV test [ Time Frame: 12 months after enrollment begins ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Health St. Joseph'sReadingPennsylvania19605
Christina Scartozzi, DO
[email protected]
610-208-4610
Leonard Kishel, MA
[email protected]
717-531-0003
Christina Scartozzi, DO (PRINCIPAL_INVESTIGATOR)

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By research site
Penn State Health St. Joseph's· Reading, PA

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