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Could a simple Self-Swap replace the speculum for cervical cancer screening?

NCT ID NCT07281430

Diagnosis Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study is testing whether self-collected vaginal samples for HPV testing work as well as samples collected by a doctor during a pelvic exam. The goal is to make cervical cancer screening more accessible and comfortable. About 500 people referred for colposcopy or cervical procedures will provide both a self-collected sample and a clinician-collected sample, and researchers will compare the accuracy of the HPV test results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HPV self-collection test
What this could lead to
If successful, this could make cervical cancer screening easier and more accessible by allowing people to collect their own samples at home.
What could go wrong
This is an early-stage study focused on accuracy, not on preventing cancer directly. The self-collection method may not be as reliable as clinician-collected samples.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical carcinoma human papilloma virus infection Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical carcinoma Human papillomavirus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Louisiana State University

    RECRUITING

    Lafayette, Louisiana, 70503, United States

  • Louisiana State University Health Science Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Minneapolis VA Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55417, United States

  • Montefiore Medical Center-Einstein Campus

    RECRUITING

    The Bronx, New York, 10461, United States

  • Montefiore Medical Center-Weiler Hospital

    RECRUITING

    The Bronx, New York, 10461, United States

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC-Magee Womens Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Alabama at Birmingham Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73190, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania/Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • West Virginia University Healthcare

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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