NCT05092022 · Milton S. Hershey Medical Center
St. Joseph's HPV Self-sampling: Offering a Self-sampling Option in Clinic
What this study is about
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 the usual treatment 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.
View original scientific description
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.
Interventions
DEVICE
Evalyn Self-Sampling Brush
A self-sampling brush to collect cervical cells for screening purposes.
Primary outcome measures
Number of patients who request the self-sampled HPV test
Time frame: 12 months after enrollment begins
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.
Number of patients who request the clinician-sampled test
Time frame: 12 months after enrollment begins
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.
Number of patients who complete the self-sampled HPV test
Time frame: 1 month after patient is given 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Reading, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations