Development of a Self-collection Device for Cervical Cancer Screening
Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
About this trial
This is an interventional screening trial for Human Papilloma Virus Infection Type 16 focused on measuring cervical cancer screening, high risk HPV, hrHPV
Eligibility Criteria
Inclusion Criteria: Group 1: Inclusion Criteria - General Population Group Subject is 25 to 65 years of age and willing to provide informed consent. Subject with intact cervix. Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group) Subject is 25 to 65 years of age and willing to provide informed consent. Subject with intact cervix. Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy. Exclusion Criteria: Subject who reports current menstruation. Subject is pregnant (based on self-reporting). Subject has impaired decision-making capacity or unable to provide informed consent. Subject is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study. Subject has undergone partial or complete hysterectomy including removal of the cervix. Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products. Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.
Sites / Locations
- Crescendo MD
- University of Colorado Anschutz Medical CampusRecruiting
- Woman's HospitalRecruiting
- Boston Metro
- Planned Parenthood Gulf CoastRecruiting
- University of Wisconsin - MadisonRecruiting
Arms of the Study
Arm 1
Experimental
Teal Health Self-Collection Device Group
This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology.