Self-collected HPV testing to help prevent cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants first perform a one-time self-collected vaginal sample, then undergo a clinician-collected cervical sample and the standard-of-care colposcopy with biopsy/endocervical curettage or excisional procedure if indicated. Paired samples are analyzed using the Abbott Alinity m high-risk HPV assay to compare detection of individual genotypes (including HPV16 and HPV18) and grouped high-risk types. The primary outcomes are clinical sensitivity, specificity, false positive and false negative rates, and concordance measures between self- and clinician-collected samples. An exploratory component will collect data on usability, acceptability, and participant preferences for self-collection.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Louisiana State University
  Lafayette, Louisiana, United States Recruiting
• Louisiana State University Health Science Center
  New Orleans, Louisiana, United States Recruiting
• Minneapolis VA Medical Center
  Minneapolis, Minnesota, United States Recruiting
• University of New Mexico Cancer Center
  Albuquerque, New Mexico, United States Recruiting

Study contacts

• Principal investigator: Vikrant V Sahasrabuddhe — National Cancer Institute Division of Cancer Prevention

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.