Active — Not RecruitingNot Applicable

HPV Self-testing in Transgender Individuals

United Kingdom100 participantsStarted 2024-02-29

Plain-language summary

Human papillomavirus (HPV) is a common virus that spreads through skin-to-skin contact. Some HPV types can cause changes in cells that lead to cancer and are known as 'high-risk' HPV (hrHPV). hrHPV is linked to cancers of the cervix (opening of the womb), throat, and anus (exit of the bowel). It is not known if transgender people (individuals whose gender identity does not align with their sex assigned at birth) are at increased risk of hrHPV or cancers caused by hrHPV compared to cisgender people (individuals whose gender identity does align with their birth sex). There is also little knowledge about HPV in the vagina for transgender women who have surgery to make one. Transgender men may be at higher risk of cervical cancer than cisgender women because they are less likely to go for screening. This can be because of physical discomfort and emotional distress during screening when a swab is taken directly from the cervix. The investigators seek to examine how common hrHPV is in transgender people in different parts of the body. In the study, participants will take swabs from the vagina and anus, a urine sample, and use mouthwash. Transgender men will also have an extra swab taken by a clinician as part of routine cervical screening. This is to see if the swab from the vagina is as good as the one from the cervix for finding cells that might lead to cancer. Participants will also take an online survey to measure the acceptability of self-sampling compared to clinician sampling. This research can inform HPV prevalence and decision-making about HPV screening among transgender people.

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of self-sampling in clinic

Timeframe: Baseline

Acceptability of self-sampling in clinic

Timeframe: Baseline

Feasibility of self-sampling at home

Timeframe: 1 month follow-up

Acceptability of self-sampling at home

Timeframe: 1 month follow up

Trial details

NCT IDNCT05883111

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-29

View on ClinicalTrials.gov More HPV Infection trials