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