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

Inclusion Criteria:

• 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 whichroutine cervical cancer screening has included positive HPV testing (HPV primaryscreening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 monthspreceding the referral visit

• GROUP A: Willing and able to undergo colposcopy, and if clinically indicated for SOCpurposes, 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 nationalguidelines

Exclusion Criteria:

• GROUP A: Is pregnant when presenting for the referral visit or gave birth within thepast 3 months

• 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: Has had a complete or partial hysterectomy, either supracervical orinvolving removal of the cervix, via self-report or confirmation via medical records

• GROUP A: Known medical conditions that, in the opinion of the investigator, precludestudy participation

• GROUP A: Previous participation in the SHIP trial (participation is defined ascompleting the self-collection sampling) or another cervical cancer screening studythat involved vaginal sampling within the past 12 months

• GROUP A: Is experiencing unusual bleeding or pelvic pain

• GROUP B: Is known to be pregnant when presenting for the screening visit or gavebirth within the past 3 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 thelast 12 months prior to the screening visit

• GROUP B: Has had a complete or partial hysterectomy, either supracervical orinvolving removal of the cervix, via self-report or confirmation via medical records

• GROUP B: Known medical conditions that, in the opinion of the investigator, precludestudy participation

• GROUP B: Previous participation in the SHIP Trial (participation is defined ascompleting the self-collection sampling) or another cervical cancer screening studythat involved vaginal sampling within the past 12 months

• GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain

• GROUP B: Is experiencing any active vaginal infection or has used any vaginalproducts in 48 hours previous to study sample collection