Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy

Study Overview
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Brief Summary
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This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. 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.

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 (Siegel et al., 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 (Shieh et al., 2016). Guidelines recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal (U.S. Preventive Services Task Force, 2018; Saslow et al., 2012). To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical-sampling for HPV testing. However, there are concerns about the comparability and acceptability of self-sampling kits. The main objective of this study is to compare the test characteristics of the human papillomavirus (HPV) self-sampling kit versus clinician-sampled HPV testing for cervical cancer screening. Potential participants will be identified from the Penn State Family and Community Medicine and OBGYN clinics after it is determined that they have abnormal findings on their (clinician-sampled) Pap/HPV test and require a follow-up colposcopy. The patient will be pre-screened by a study team member. If they are found to be eligible, a study team member will invite them to participate in the study. After a participant enrolls in the study, a self-sampling kit is mailed to their home along with a Summary Explanation of Research consent form and instructional sheet. Participants will be asked to complete the kit two weeks before or after their colposcopy, giving them a 28 day collection window. Study team members will perform a follow-up survey after the sample is collected and provide reminder phone calls if needed.

Official Title
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HPV Self-sampling Among Women at the Penn State Hershey Colposcopy Clinics

Conditions
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HPV

Intervention / Treatment
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* Device: Evalyn Brush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Penn State Health Patient Has an intact cervix Found to have abnormal findings on Pap/HPV test that requires a colposcopy Speaks, read, or writes well in English or Spanish Exclusion Criteria: Pregnant Cognitively impaired Incarcerated Complete hysterectomy History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (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 kit in addition to completing their colposcopy exam. Participants will collect the sample at home before or after their exam and mail it back to the Penn State Health laboratory for analysis. The results will be compared to those of the clinician-collected (standard of care) colposcopy exam, Pap, and HPV test. 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>Participants will be mailed a Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening. | Device: 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 Clinician-collected Samples | The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy. | Within two weeks of their colposcopy exam. | 

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 | Within two weeks of their colposcopy exam. | 
| Number of Participants Who Reported Problems 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 their colposcopy exam | 

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