Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

Prior treatment

• GROUP A: Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
• GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
• GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
• GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
• GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection

Other illness

• GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
• GROUP A: Is experiencing unusual bleeding or pelvic pain
• GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
• GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain

Other

• GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
• GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
• GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
• GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records

• GROUP A: Willingness and ability to provide a documented informed consent
• GROUP A: Is 25 years or older
• GROUP A: Has an intact cervix
• GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
• GROUP A: Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
• GROUP B: Willingness and ability to provide a documented informed consent
• GROUP B: Is 25 years or older
• GROUP B: Has an intact cervix
• GROUP B: Eligible for regular cervical cancer screening by current national guidelines