Recruiting

HPV Testing

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07281430

Conditions

Cervical Carcinoma

Human Papillomavirus Infection

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Cervical Biopsy

Colposcopy

Electronic Health Record Review

Endocervical Curettage

Study Details

Brief summary:

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.

Conditions

Cervical Carcinoma

Human Papillomavirus Infection

Study ID

NCT07281430

Start date

Nov 24, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prevention (self-collected and clinician-collected samples)

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

Interventions

Biospecimen Collection

Undergo collection of a cervical sample by clinician

Cervical Biopsy

Undergo cervical biopsy

Colposcopy

Undergo colposcopy

Electronic Health Record Review

Ancillary studies

Endocervical Curettage

Undergo endocervical curettage

Excision

Undergo cervical excisional procedure

HPV Self-Collection

Undertake self-collection of vaginal sample

Human Papillomavirus Test

Undergo HPV testing of self-collected vaginal samples and cervical samples

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Clinical sensitivity for self-collected (SC) samples [ Time Frame: One-time, up to 60 days ]
  • Clinical sensitivity for clinician-collected (CC) samples [ Time Frame: One-time, up to 60 days ]
  • Clinical specificity for SC samples [ Time Frame: One-time, up to 60 days ]
  • Clinical specificity for CC samples [ Time Frame: One-time, up to 60 days ]
  • False positive rate (FPR) for SC samples [ Time Frame: One-time, up to 60 days ]
  • FPR for CC samples [ Time Frame: One-time, up to 60 days ]
  • False negative rate (FNR) for SC samples [ Time Frame: One-time, up to 60 days ]
  • FNR for CC samples [ Time Frame: One-time, up to 60 days ]
  • Sensitivity ratio for SC versus CC samples [ Time Frame: One-time, up to 60 days ]
  • Specificity ratio for SC versus CC samples [ Time Frame: One-time, up to 60 days ]
  • False positive (FP) ratio for SC versus CC samples [ Time Frame: One-time, up to 60 days ]
  • False negative (FN) ratio for SC versus CC samples [ Time Frame: One-time, up to 60 days ]
  • Positive percent agreement [ Time Frame: One-time, up to 60 days ]
  • Negative percent agreement [ Time Frame: One-time, up to 60 days ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Warner K. Huh

whuh@uabmc.edu

Principal Investigator:

Warner K. Huh

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Lisa C. Flowers

lflowe2@emory.edu

Principal Investigator:

Lisa C. Flowers

Louisiana State University

Recruiting

Lafayette, Louisiana, United States, 70503

Contacts

Michael E. Hagensee

mhagen@lsuhsc.edu

Principal Investigator:

Michael E. Hagensee

Louisiana State University Health Science Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Michael E. Hagensee

mhagen@lsuhsc.edu

Principal Investigator:

Michael E. Hagensee

Minneapolis VA Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Elisheva Danan

elizabeth.danan@va.gov

Principal Investigator:

Elisheva Danan

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Cosette M. Wheeler

cwheeler@salud.unm.edu

Principal Investigator:

Cosette M. Wheeler

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Mark H. Einstein

meinstei@montefiore.org

Principal Investigator:

Mark H. Einstein

Montefiore Medical Center-Weiler Hospital

Recruiting

The Bronx, New York, United States, 10461

Contacts

Mark H. Einstein

meinstei@montefiore.org

Principal Investigator:

Mark H. Einstein

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Lisa Rahangdale

lisa_rahangdale@med.unc.edu

Principal Investigator:

Lisa Rahangdale

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Leeya F. Pinder

pinderl@ucmail.uc.edu

Principal Investigator:

Leeya F. Pinder

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Jacqueline A. Bohn

jacqueline-bohn@ouhsc.edu

Principal Investigator:

Jacqueline A. Bohn

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73190

Contacts

Jacqueline A. Bohn

jacqueline-bohn@ou.edu

Principal Investigator:

Jacqueline A. Bohn

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Carmen Guerra

cguerra@pennmedicine.upenn.edu

Principal Investigator:

Carmen Guerra

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Harold C. Wiesenfeld

wieshc@upmc.edu

Principal Investigator:

Harold C. Wiesenfeld

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Harold C. Wiesenfeld

wieshc@upmc.edu

Principal Investigator:

Harold C. Wiesenfeld

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Elizabeth Y. Chiao

eychiao@mdanderson.org

Principal Investigator:

Elizabeth Y. Chiao

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Deanna L. Kepka

deanna.kepka@hci.utah.edu

Principal Investigator:

Deanna L. Kepka

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Krista S. Pfaendler

krista.pfaendler@hsc.wvu.edu

Principal Investigator:

Krista S. Pfaendler

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Jul 31, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-07-31.