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Cancer Screening

At-Home HPV Self-Sampling for Cervical Cancer Screening

N/A

Recruiting

Led By Christina Scartozzi, DO

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to speak, read, and communicate well in English or Spanish

Be older than 18 years old

Must not have

Already diagnosed with high-grade precancerous cervical cancer or cervical lesions

Has a compromised immune system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after patient is given self-sampled hpv test

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if offering an at-home HPV test will make more women get screened for cervical cancer than the standard clinician-sampled test. #cervicalcancer #HPV

Who is the study for?

This trial is for individuals who are overdue for cervical cancer screening, can communicate in English or Spanish, and are not at high risk for cervical cancer. It's not suitable for those who are pregnant, incarcerated, already have high-grade precancerous lesions, cannot communicate in the required languages, or have a compromised immune system.

What is being tested?

The study tests if offering self-sampling HPV tests increases participation in cervical cancer screenings compared to the standard clinician-sampled test. It measures how acceptable the self-test is to patients and whether they complete it.

What are the potential side effects?

Since this trial involves non-invasive sampling with a brush rather than medication or invasive procedures, significant side effects aren't expected. Minor discomfort during self-sampling may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak, read, and communicate well in English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with high-grade precancerous cervical changes.

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My immune system is weak.

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I can communicate well in either English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after patient is given self-sampled hpv test

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after patient is given self-sampled hpv test

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after patient is given self-sampled hpv test for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients who complete the self-sampled HPV test

Number of patients who request the clinician-sampled test

Number of patients who request the self-sampled HPV test

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Requested self-sampled HPV testExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Evalyn Self-Sampling Brush

2021

N/A

~970

0 / 4Eligibility criteria met