Study of Self-Collected Vaginal Samples for HPV Testing to Improve Cervical Cancer Prevention in Women 25 and Older

What this Trial Is About

Researchers are evaluating the use of self-collected vaginal samples for human papillomavirus HPV testing in patients referred for colposcopy andor cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus that can cause cervical and other cancers. Many cases of cervical cancer occur in individuals who have never been screened or are screened insufficiently, so this study aims to improve screening methods by comparing self-collected samples to clinician-collected cervical samples using a specific HPV test. Participants first collect their own vaginal sample, then undergo a clinician-collected cervical sample. They also receive standard care colposcopy with possible biopsy, endocervical curettage, andor cervical excisional procedures as needed. The study assesses the accuracy of HPV testing on both types of samples and gathers information on usability and preferences for self-collection. Results are collected once, with laboratory outcomes available within 60 days. During the study, participants provide samples and undergo clinical procedures as part of routine care. Researchers measure clinical sensitivity, specificity, false positive and negative rates, and agreement between self-collected and clinician-collected samples. The study also evaluates human factors like acceptability and preferences for self-collection. All data collection is completed within about two months after sample collection, ensuring comprehensive assessment while monitoring safety and accuracy.

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