Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial.

ABSTRACT:

Importance

One-quarter of US women who are at risk for cervical cancer delay screening. Self-collected (SC) cervical screening was recently US Food and Drug Administration (FDA)-approved in the US for use in a health care setting only; an at-home SC option is crucial to address clinic-related barriers to screening.

Objective

To clinically validate the use of an SC device that was designed for optimal at-home performance, safety, ease-of-use, and dry storage and transport.

Design, setting, and participants

This nonrandomized clinical trial used a prospective method comparison study design. Participants aged 25 to 65 years were recruited from 16 clinical sites in the US including community and academic practices from November 20, 2023, to April 5, 2024. Data analysis wa

SUBMITTER: Fitzpatrick MB 

PROVIDER: S-EPMC12090030 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature