Self-Sampling for Human Papillomavirus (HPV) at Well Women Appointments

Study Overview
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Brief Summary
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This study seeks to compare the accuracy and acceptability of Human Papillomavirus (HPV) testing self-sampling kit versus standard clinician-sampled HPV testing for cervical cancer screening. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test and Pap smear results. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative to clinician sampling.

Detailed Description
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The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018. Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal. Guidelines recommend cytology and/or human papillomavirus (HPV) testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal. To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical screening. However, there are concerns about the comparability and acceptability of self-sampling kits. The impact of the proposed project is to compare HPV self-screening results with Pap smear results and clinician-collected HPV tests to ultimately improve the uptake of HPV screening. This study will be conducted in a normal risk population. Subjects who have an upcoming well-woman appointment will be identified from Penn State Health, Department of Family and Community Medicine, clinic schedules. Clinicians who are a part of the study team will identify these patients two weeks prior to their appointment and send their information to a study coordinator, who will then call these patients to provide more information and assess their interest in participating. Patients who schedule within the two week period or were not contacted by a study team member for any reason will be given a card with general information about the study at their well-woman visit so that these women can contact a study team member if they are interested. A total of 197 participants will be recruited into this study. Interested participants will be screened for eligibility over the phone and sent a self-sampling kit through the mail with a Summary Explanation of Research form, instructions, and pre-paid mailer to return the kit. Participants may collect their sample two weeks before or after their well-woman visit. A study team member will contact the participants at different time points within the 28 day window to determine whether the sample was collected and to administer the follow-up survey.

Official Title
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HPV Self-sampling Among Women at Penn State Hershey Well Women Appointments

Conditions
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HPV

Intervention / Treatment
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* Device: HPV Self-Sampling Kit (Evalyn Brush)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30-65 Years Penn State Health, Family and Community Medicine, patient attending a well-woman visit Able to collect the sample within two weeks of visit Female Intact cervix Speaks, reads, or writes in English Exclusion Criteria: Pregnancy Cognitively Impaired Incarcerated Complete hysterectomy History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Participants who enroll in the study will be asked to complete an HPV self-sampling test in addition to attending their well-woman visit and receiving a clinician-sampled Pap Smear/HPV test. Participants will collect the sample at home and mail it back to the Penn State Health clinical laboratory, where the results will be compared to those obtained from the Pap Smear/HPV test at their clinic appointment. Participants will also complete a follow up survey over the phone after their sample is collected.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Sampling Kit<br>Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening. | Device: HPV Self-Sampling Kit (Evalyn Brush)<br>* The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Concordance of Screening Results of the Self-sampling Kit Compared to Clinical-collected Samples | Number of participants whose results of the self-sampling kit were in concordance with the clinician-sampled HPV test and clinician-sampled Pap smear results. | Within two weeks of the well-woman visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Completed Self-Sampling Kits | The number of participants provided a kit vs. those who completed the sample collection | 28 days (two weeks before or after the well-woman visit) | 
| Number of Participants Who Reported Problems With Using Self-Sampling Kits | The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit. | Within two weeks of the well-woman visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Cervical Cancer, Self-Sampling, Cancer screening