Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Atypical Squamous Cell of Undetermined Significance, Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3
About this trial
This is an interventional screening trial for Atypical Squamous Cell of Undetermined Significance focused on measuring Cervical cancer, Atypical squamous cells of undetermined significance, Stage 0 cervical cancer, Cervical intraepithelial neoplasia grade 1, Cervical, intraepithelial neoplasia grade 2, Cervical intraepithelial neoplasia grade 3, Human papillomavirus, HPV
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent in English
Exclusion Criteria:
- Have had hysterectomy
- Currently pregnant
- Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years
- Received colposcopy of cervix within TWO years
- Received Pap test within ONE year
- Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
- Decisionally impaired adults requiring a legally authorized representative
Sites / Locations
- University of Minnesota/Masonic Cancer Center
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (home-based HPV screening)
Group II (clinic-based standard of care screening)
Participants collect 2 vaginal specimens using polyester swabs that are then placed in a specimen tube. Specimens are then submitted to the Harborview Medical Center clinical pathology lab. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.
Participants undergo standard of care cervical cancer screening and follow-up. That is, participants undergo Pap testing. Participants with an abnormal Pap test undergo HPV testing, colposcopy, cervical biopsy and/or ECC. Participants with cervical biopsies showing precancerous changes are offered to undergo LEEP or are referred to appropriate care.