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NCT Number: NCT05883111

HPV Self-testing in Transgender Individuals

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Sussex NHS Foundation Trust Sexual Health Service, Brighton, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HPV DNA methylation assay

Diagnostic Test

HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.

Primary outcomes

  1. Feasibility of self-sampling in clinic

    Time frame: Baseline

    Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.

  2. Acceptability of self-sampling in clinic

    Time frame: Baseline

    Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey

  3. Feasibility of self-sampling at home

    Time frame: 1 month follow-up

    Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples.

  4. Acceptability of self-sampling at home

    Time frame: 1 month follow up

    Acceptability of self-sampling at home as indicated by high satisfaction on an online survey

Secondary outcomes

  1. HPV concordance between vaginal self-sample and clinician-collected cervical swab

    Time frame: Baseline

    Concordance HPV positivity, overall and by genotype, from self-collected vaginal samples to clinician-collected cervical samples in trans men and nonbinary adults with a cervix.

  2. HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people.

    Time frame: Baseline and 1 month follow up

    HPV correlation between self-samples taken at clinic and in-home among trans women and non-binary people.

Other outcomes

  1. HPV correlation between self-samples at each site

    Time frame: Baseline and 1 month follow up

    HPV correlation between self-samples at each site (vaginal, anal, oral, and urine) in each arm.

  2. Performance of HPV methylation assay

    Time frame: Baseline

    Comparison of the performance of HPV methylation testing from self-collected samples to clinician-collected samples for the detection of cervical precancer in trans men and non-binary adults with a cervix.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

HPV Methylation Self-testing Pilot in Transgender Individuals

Acronym: Self-TI

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 31, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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