Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

PRIMARY OBJECTIVES:

I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician-collected (CC) samples for the following HPV genotype detections and groupings by Abbott Alinity m high risk (HR) HPV assay:

Ia. Any HR HPV genotype; Ib. HPV16; Ic. HPV16 and/or HPV18; Id. Non-HPV16 high-risk HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68); Ie. Non-HPV16/HPV18 high-risk types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

EXPLORATORY OBJECTIVE:

I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection.

OUTLINE:

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care (SOC) colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one-time), laboratory results available within 60 days are collected for purposes of study outcomes.

Inclusion criteria

• Willingness and ability to provide a documented informed consent
• Is 25 years or older
• Has an intact cervix
• Has had a referral for colposcopy 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, and/or for cervical excisional procedure
• 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

Exclusion criteria

• Is pregnant when presenting for the referral visit or gave birth within the past 3 months
• 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
• Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
• Known medical conditions that, in the opinion of the investigator, preclude study participation
• Previous participation in the SHIP Trial or another cervical cancer screening study within the past 12 months. Participation is defined as completing the self-collection
• Is experiencing unusual bleeding or pelvic pain