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Could At-Home HPV tests improve screening for transgender people?

NCT ID NCT05883111

Knowledge-focused Sponsor: Queen Mary University of London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study explores whether transgender individuals can collect their own samples for HPV testing at home or in a clinic. Researchers want to learn how common high-risk HPV is in this group and whether self-sampling is acceptable and effective. About 100 transgender men and women will take swabs from the vagina, anus, urine, and mouth, and complete a survey about their experience.

What this could mean

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

Active substance
HPV DNA methylation assay
What this could lead to
If successful, this could show that self-sampling is a practical and acceptable way to screen transgender people for HPV, potentially increasing screening rates and catching cancer early.
What could go wrong
This is a small pilot study (100 people) focused on feasibility, not on health outcomes. It may not prove that self-sampling is as accurate as clinician-collected samples, and results may not apply to all transgender populations.

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 100 people

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

Started

Feb 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

21 to 65 years

Sex

Anyone

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 for trans men and non-binary adults with a cervix: * Identify as transgender or non-binary * Be between 25 - 65 years of age * Be registered with a general practitioner * Have an intact cervix * Have used testosterone therapy within the last year * Be willing, and able to understand and consent to study procedures Inclusion Criteria for trans women and non-binary adults : * Identify as transgender or non-binary * Be 18 years of age or older * Have undergone vaginoplasty by any method at least 1 year ago * Be willing, and able to understand and consent to study procedures Exclusion Criteria: * Have a variation of sex characteristics (also known as a disorder of sex development) * Have an allergy to any of the ingredients in the oral rinse (Scope) * Be diagnosed with, or under investigation for, an inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease). This does not include irritable bowel syndrome - participants with this are eligible to enroll. * Be a member of a vulnerable population, which includes pregnant people, fetuses, children, prisoners, or anyone unable to independently offer consent.

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection

As listed by the trial registrant

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

HPV infection

Contacts and locations

Locations

  • Ambrose King Centre, Barts Health NHS Trust

    London, United Kingdom

  • CliniQ, Caldicott Centre, Kings College Hospitals

    London, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust Sexual Health Service

    Brighton, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.