HPV self-testing for transgender individuals
HPV Methylation Self-testing Pilot in Transgender Individuals
This study is testing a new self-testing method for HPV to see if it works well for transgender individuals who might have trouble with regular screenings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 3 sites (Brighton and 2 other locations) |
| Trial ID | NCT05883111 on ClinicalTrials.gov |
What this trial studies
This study investigates the prevalence of high-risk human papillomavirus (hrHPV) among transgender individuals, including trans men, trans women, and non-binary adults. It aims to assess the effectiveness of an HPV DNA methylation assay for self-testing in this population, who may face barriers to traditional screening methods. The study will include participants aged 18 to 65 with an intact cervix or those who have undergone vaginoplasty, focusing on their willingness to consent and understand the study procedures.
Who should consider this trial
Good fit: Ideal candidates include transgender men and non-binary adults aged 25-65 with an intact cervix, as well as trans women and non-binary adults aged 18 and older who have undergone vaginoplasty.
Not a fit: Patients with variations of sex characteristics or those with allergies to the study's oral rinse ingredients may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve HPV screening accessibility and early detection of related cancers in transgender individuals.
How similar studies have performed: While there is limited research specifically on HPV in transgender populations, studies on HPV self-testing in general have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brighton and 2 other locations
- University Hospitals Sussex NHS Foundation Trust Sexual Health Service — Brighton, United Kingdom (Recruiting)
- Ambrose King Centre, Barts Health NHS Trust — London, United Kingdom (Recruiting)
- CliniQ, Caldicott Centre, Kings College Hospitals — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sarah S Jackson, PhD — National Cancer Institute (NCI)
- Study coordinator: Alison M Berner
- Email: a.m.berner@qmul.ac.uk
- Phone: 44 7738 011636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.