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Clinical Trial
. 2025 May 1;8(5):e2511081.
doi: 10.1001/jamanetworkopen.2025.11081.

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

Megan B Fitzpatrick  1   2 , Catherine M Behrens  3 , Karl Hibler  3 , Courtney Parsons  1 , Clair Kaplan  4 , Ronald Orso  5 , Lamar Parker  6 , Lisa Memmel  7 , Ann Collins  8 , Colleen McNicholas  9 , LaShonda Crane  10 , Youri Hwang  11 , Elizabeth Sutton  12 , Jenell Coleman  13 , Lindsay Kuroki  14 , Kimberly Harshberger  15 , Sigrid Williams  15 , Ashley Jennings  2 , Frank Buccini  16 , Laura Gillis  17 , Akiva P Novetsky  18   19 , David Hawkes  20   21 , Marion Saville  20   21 , Trena Depel  1 , Emeline Aviki  22 , Sangini S Sheth  23 , Christine Conageski  24
Affiliations
Clinical Trial

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

Megan B Fitzpatrick et al. JAMA Netw Open. .

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 was conducted from April to August 2024.

Intervention: Eligible participants collected a sample with the SC method, followed by a clinician-collected (CC) sample. The SC sample was eluted into PreservCyt at the laboratory and both samples were tested on an FDA-approved high risk human papillomavirus (hrHPV) test approved for primary screening. Participants were followed up for safety and completed usability and screening preference surveys.

Main outcome and measures: The primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for detection of hrHPV between the SC and CC samples. Other study measures included clinical sensitivity for high grade cervical dysplasia and usability.

Results: Of 609 screening-eligible participants, 599 (262 aged 30-39 years [43.7%]; 583 identified as female [97.3%]) had paired SC-CC samples, of which 582 had valid paired samples included in the end point analysis. Among the 582 evaluable paired samples, the PPA between SC compared with paired CC samples for detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; 278 of 292 participants). The absolute clinical sensitivity for detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; 46 of 48 participants), equivalent to the CC (relative sensitivity, 1.00). Nearly all participants (555 of 601 participants [92.3%]) reported that the device instructions were easy or very easy to understand and also that they would choose SC if they knew the results were comparable to CC results (560 of 602 participants [93.0%]).

Conclusions and relevance: In this nonrandomized clinical trial, SC samples collected with the device showed equivalent clinical sensitivity and exceeded the PPA end point for cervical screening. This SC method was found to be easy to use and to be a preferred option with high clinical performance intended for use in an at-home setting.

Trial registration: ClinicalTrials.gov Identifier: NCT06120205.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Behrens reported receiving personal fees from Antiva Biosciences, having a pending patent for a device system for human papillomavirus (HPV) infection and cervical intraepithelial neoplasia, and owning stock in Roche outside the submitted work. Dr Crane reported receiving personal fees from Planned Parenthood outside the submitted work. Dr Kuroki reported receiving grants from the National Institutes of Health and honoraria from the National Cancer Institute Physician Data Query (Cancer Screening and Prevention Editorial Board) outside the submitted work. Dr Gillis reported receiving consulting fees from Teal Health for statistical design planning and power analysis for other studies outside the submitted work. Dr Hawkes reported receiving nonfinancial support (consumables for HPV research studies including self-collection) from Abbott, AusDiagnostics, Becton Dickinson, Cepheid, Hologic, Roche, and Seegene; nonfinancial support (consumables for self-collection) from Copan, Rovers, and Qiagen; and grants from Copan (commercially funded validation of self-collection device) and V-Veil (commercially funded validation of self-collection device) outside the submitted work. Dr Saville reported receiving nonfinancial support from Abbott, AusDiagnostics, Becton Dickinson, Cepheid, Hologic, Roche, Seegene, Rovers, and Qiagen and grants from Copan (commercially funded validation study) and V-Veil (commercially funded validation study) outside the submitted work. Dr Sheth reported serving on the board of directors (unpaid) for the American Society of Colposcopy and Cervical Pathology outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. The Self-Collection Device
The device is a single patient-use, disposable device intended for the collection of vaginal cells and material to be tested with a US Food and Drug Administration–approved test indicated for high-risk human papillomavirus (HPV) primary screening for cervical cancer. The device consists of biocompatible, medical grade injection molded polymer components that are the diameter of a standard tampon. The distal-most components are fabricated from soft, atraumatic materials.
See this image and copyright information in PMC

References

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