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

Stopped early · Not applicable

Conditions studied: HPV

In brief

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.

Key facts

Study ID

NCT04585243

Run by

Milton S. Hershey Medical Center

People needed

22

Starts

2020-12-09

Expected to finish

2022-10-05

Last updated by the study team

2023-10-11

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• Pregnant
• Cognitively impaired
• Incarcerated
• Complete hysterectomy
• History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))

Where it is running

• Jennifer Moss — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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