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Self-collection of vaginal samples for HPV testing to enhance cervical cancer prevention

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

Not applicable Interventional National Cancer Institute (NCI) · NCT06611540

This study tests if women can accurately collect their own vaginal samples for HPV testing to help prevent cervical cancer, compared to samples collected by doctors.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment500 (estimated)
Ages25 Years and up
SexFemale
SponsorNational Cancer Institute (NCI) NIH
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT06611540 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of self-collected vaginal samples for HPV testing in patients referred for colposcopy and cervical excisional procedures. The study aims to determine the clinical accuracy of self-collected samples compared to clinician-collected samples in detecting cervical precancer and cancer. Participants will undergo both self-collection and clinician-collection of samples, followed by standard care procedures such as colposcopy and biopsies. The trial also explores factors affecting the usability and acceptability of self-collection methods.

Who should consider this trial

Good fit: Ideal candidates are women aged 25 and older who have been referred for colposcopy or cervical excisional procedures and have had recent HPV testing.

Not a fit: Patients who are pregnant or have had recent cervical treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could increase cervical cancer screening rates and early detection through more accessible self-collection methods.

How similar studies have performed: Other studies have shown promise in using self-collection methods for HPV testing, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 and/or cervical excisional procedure in which routine cervical cancer screening has included 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.
* 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. Participation is defined as completing the self-collection.
* Is experiencing unusual bleeding or pelvic pain.

Where this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cervical CarcinomaHuman Papillomavirus Infection
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.