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

Stopped early · Not applicable

Conditions studied: HPV

In brief

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.

Key facts

Study ID

NCT04591977

Run by

Milton S. Hershey Medical Center

People needed

46

Starts

2021-01-07

Expected to finish

2022-11-10

Last updated by the study team

2023-10-06

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnancy
• Cognitively Impaired
• Incarcerated
• Complete hysterectomy
• History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)

Where it is running

• Penn State College of Medicine — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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