Self-collected HPV testing to help prevent cervical cancer

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S04

This trial tests whether people referred for colposcopy can collect their own vaginal sample for HPV testing and whether those self-samples match clinician-collected cervical samples.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 25 Years and up
• Sex: Female
• Sponsor: National Cancer Institute (NCI) (nih)
• Locations: 18 sites (Birmingham, Alabama and 17 other locations)
• Trial ID: NCT07281430 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People aged 25 or older with an intact cervix who have been referred for colposcopy or for a cervical excisional procedure because of recent positive HPV testing or abnormal cytology and who can undergo colposcopy and any indicated biopsies.

Not a fit: Those who are pregnant or gave birth within the past three months, or who had excisional or ablative cervical treatment within the last 12 months, would be excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, reliable self-collection could expand screening access and help detect preventable cervical precancers earlier, especially for under-screened individuals.

How similar studies have performed: Previous research has shown that self-collected HPV samples can perform similarly to clinician-collected samples for high-risk HPV detection and can increase screening uptake, though performance varies by assay and population.

Eligibility criteria

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 this trial is running

Birmingham, Alabama and 17 other locations

• 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)
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States (RECRUITING)
• Montefiore Medical Center-Weiler Hospital — The Bronx, New York, United States (RECRUITING)
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (RECRUITING)
• University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States (RECRUITING)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
• University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
• UPMC-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
• University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States (RECRUITING)
• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (RECRUITING)
• West Virginia University Healthcare — Morgantown, West Virginia, United States (RECRUITING)

Study contacts

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

Conditions: Cervical Carcinoma, Human Papillomavirus Infection