Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)

PRIMARY OBJECTIVE:

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 the Roche cobas HPV tests: Any high risk (HR) HPV genotype, HPV16, HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (combined).

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 colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one time), laboratory results available within 90 days are collected for study analysis purposes.

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 and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cell of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
• Willing and able to undergo colposcopy, and if clinically indicated for standard of care (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. Participation is defined as completing the self-collection
• Is experiencing unusual bleeding or pelvic pain