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