Skip to content
Bored Studies
RecruitingAccepts healthy volunteers

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

National Cancer Institute (NCI) · NCT07281430

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 25+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
500
US sites recruiting
18
Study start
November 24, 2025
Record last updated
July 31, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.

The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Being studied: Biospecimen Collection; Cervical Biopsy; Colposcopy; Electronic Health Record Review; Endocervical Curettage; Excision; HPV Self-Collection; Human Papillomavirus Test; Questionnaire Administration

Conditions: Cervical Carcinoma; Human Papillomavirus Infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Alabama at Birmingham Cancer Center

    Birmingham, AL 35233

    Site contact: Warner K. Huh · whuh@uabmc.edu

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, GA 30322

    Site contact: Lisa C. Flowers · lflowe2@emory.edu

  • Louisiana State University

    Lafayette, LA 70503

    Site contact: Michael E. Hagensee · mhagen@lsuhsc.edu

  • Louisiana State University Health Science Center

    New Orleans, LA 70112

    Site contact: Michael E. Hagensee · mhagen@lsuhsc.edu

  • Minneapolis VA Medical Center

    Minneapolis, MN 55417

    Site contact: Elisheva Danan · elizabeth.danan@va.gov

  • University of New Mexico Cancer Center

    Albuquerque, NM 87106

    Site contact: Cosette M. Wheeler · cwheeler@salud.unm.edu

  • Montefiore Medical Center-Einstein Campus

    The Bronx, NY 10461

    Site contact: Mark H. Einstein · meinstei@montefiore.org

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, NY 10461

    Site contact: Mark H. Einstein · meinstei@montefiore.org

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, NC 27599

    Site contact: Lisa Rahangdale · lisa_rahangdale@med.unc.edu

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, OH 45219

    Site contact: Leeya F. Pinder · pinderl@ucmail.uc.edu

  • University of Oklahoma Health Sciences Center

    Oklahoma City, OK 73104

    Site contact: Jacqueline A. Bohn · jacqueline-bohn@ouhsc.edu

  • University of Oklahoma

    Oklahoma City, OK 73190

    Site contact: Jacqueline A. Bohn · jacqueline-bohn@ou.edu

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, PA 19104

    Site contact: Carmen Guerra · cguerra@pennmedicine.upenn.edu

  • UPMC-Magee Womens Hospital

    Pittsburgh, PA 15213

    Site contact: Harold C. Wiesenfeld · wieshc@upmc.edu

  • UPMC Hillman Cancer Center

    Pittsburgh, PA 15232

    Site contact: Harold C. Wiesenfeld · wieshc@upmc.edu

  • UT MD Anderson Cancer Center

    Houston, TX 77030

    Site contact: Elizabeth Y. Chiao · eychiao@mdanderson.org

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, UT 84112

    Site contact: Deanna L. Kepka · deanna.kepka@hci.utah.edu

  • West Virginia University Healthcare

    Morgantown, WV 26506

    Site contact: Krista S. Pfaendler · krista.pfaendler@hsc.wvu.edu

All healthy volunteers studies in Alabama →
Self-collection for HPV Testing to Improve Cervical Cancer… (NCT07281430) | Bored Studies