HPV Infection
Conditions
Keywords
Transgender, Trans men, Trans women, Non-binary individuals
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.
Interventions
DIAGNOSTIC_TESTHPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
Sponsors
Queen Mary University of London
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of self-sampling in clinic | Baseline | Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples. |
| Acceptability of self-sampling in clinic | Baseline | Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey |
| Feasibility of self-sampling at home | 1 month follow-up | Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples. |
| Acceptability of self-sampling at home | 1 month follow up | Acceptability of self-sampling at home as indicated by high satisfaction on an online survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV concordance between vaginal self-sample and clinician-collected cervical swab | 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. |
| HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people. | Baseline and 1 month follow up | HPV correlation between self-samples taken at clinic and in-home among trans women and non-binary people. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORSarah S Jackson, PhD
National Cancer Institute (NCI)
PRINCIPAL_INVESTIGATORAlison M Berner, MBBS, PhD
Queen Mary University of London
Outcome results
None listed