Clinical trial NCT05883111: HPV Self-testing in Transgender Individuals
Official title: HPV Methylation Self-testing Pilot in Transgender Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Infection
Keywords: Transgender
Trans men
Trans women
Non-binary individuals
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Feasibility of self-sampling in clinic
timeFrame: Baseline
measure: Acceptability of self-sampling in clinic
timeFrame: Baseline
measure: Feasibility of self-sampling at home
timeFrame: 1 month follow-up
measure: Acceptability of self-sampling at home
timeFrame: 1 month follow up
Secondary outcomes:
measure: HPV concordance between vaginal self-sample and clinician-collected cervical swab
timeFrame: Baseline
measure: HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people.
timeFrame: Baseline and 1 month follow up
Other outcomes:
measure: HPV correlation between self-samples at each site
timeFrame: Baseline and 1 month follow up
measure: Performance of HPV methylation assay
timeFrame: Baseline
Locations:
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust Sexual Health Service
city: London
country: United Kingdom
facility: Ambrose King Centre, Barts Health NHS Trust
city: London
country: United Kingdom
facility: CliniQ, Caldicott Centre, Kings College Hospitals
Study officials:
affiliation: National Cancer Institute (NCI)
name: Sarah S Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary University of London
name: Alison M Berner, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: