Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)

July 3, 2026 updated by: National Cancer Institute (NCI)

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S02

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. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal 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. 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by the Roche cobas HPV tests: Any high risk (HR) HPV genotype, HPV16, HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (combined).

EXPLORATORY OBJECTIVE:

I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection.

OUTLINE:

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

After completion of study intervention (one time), laboratory results available within 90 days are collected for study analysis purposes.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • New York
      • New York, New York, United States, 10065
        • NYP/Weill Cornell Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Magee Womens Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 cell 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 standard of care (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Procedure: Cervical Biopsy
Undergo cervical biopsy conducted by clinician
Procedure: Colposcopy
Undergo colposcopy conducted by clinician
Other Names:
  • CP
Procedure: Endocervical Curettage
Undergo endocervical curettage conducted by clinician
Procedure: Excision
Undergo cervical excisional procedure conducted by clinician
Other Names:
  • Abscission
  • Extirpation
  • Surgical Removal
Procedure: Biospecimen Collection
Undergo collection of cervical sample by clinician
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: HPV Self-Collection
Undertake self-collection of vaginal sample
Other Names:
  • At-home HPV Self Collection
  • HPV Self Collection
  • Human Papillomavirus Self-Collection
Procedure: Human Papillomavirus Test
Undergo HPV testing of self-collected vaginal sample and cervical sample
Other Names:
  • HPV Assay
  • HPV Test
  • Human Papillomavirus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical sensitivity for self-collected (SC) samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).
One-time, up to 90 days
Clinical sensitivity for clinician-collected (CC) samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV positive on CC sample given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 90 days
Clinical specificity for SC samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV negative on SC sample given < CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
Clinical specificity for CC samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV negative on CC sample given < CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
False positive rate (FPR) for SC samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV positive on SC sample given < CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
FPR for CC samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV positive on CC sample given < CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
False negative rate (FNR) for SC samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 90 days
FNR for CC samples
Time Frame: One-time, up to 90 days
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 90 days
Sensitivity ratio for SC versus CC samples
Time Frame: One-time, up to 90 days
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
Specificity ratio for SC versus CC samples
Time Frame: One-time, up to 90 days
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
False negative (FN) ratio for SC versus CC samples
Time Frame: One-time, up to 90 days
The FN ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
Positive percent agreement
Time Frame: One-time, up to 90 days
Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.
One-time, up to 90 days
Negative percent agreement
Time Frame: One-time, up to 90 days
Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.
One-time, up to 90 days
False positive (FP) ratio for SC versus CC samples
Time Frame: One-time, up to 90 days
The FP ratio is the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human factors affecting usability
Time Frame: One-time, up to 90 days
Will be assessed by questionnaire data.
One-time, up to 90 days
Human factors affecting acceptability
Time Frame: One-time, up to 90 days
Will be assessed by questionnaire data.
One-time, up to 90 days
Human factors affecting preferences for self-collection
Time Frame: One-time, up to 90 days
Will be assessed by questionnaire data.
One-time, up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2024-07726 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • LMI-001-A-S02 (Other Identifier: DCP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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