HPV Self-testing in Transgender Individuals

Study Overview
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Brief Summary
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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.

Official Title
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HPV Methylation Self-testing Pilot in Transgender Individuals

Conditions
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HPV Infection

Intervention / Treatment
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* Diagnostic Test: HPV DNA methylation assay


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trans men and non-binary people with a cervix<br>Participants will have a clinician-collected cervical screening sample and then collect the following self-samples for research: Vaginal swab, Anal swab, Oral rinse, and Urine sample for the detection of HPV detection. | Diagnostic Test: HPV DNA methylation assay<br>* HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.<br>|
| Experimental: Trans women and non-binary people<br>Participants will collect the following self-samples for research in the clinic: Vaginal swab, Anal swab, Oral rinse, and Urine sample for the detection of HPV detection. Participants will collect the following self-samples for research at home: Vaginal swab, Anal swab, and Oral rinse sample for the detection of HPV detection. | Diagnostic Test: HPV DNA methylation assay<br>* HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of self-sampling in clinic | Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples. | Baseline | 
| Acceptability of self-sampling in clinic | Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey | Baseline | 
| Feasibility of self-sampling at home | Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples. | 1 month follow-up | 
| Acceptability of self-sampling at home | Acceptability of self-sampling at home as indicated by high satisfaction on an online survey | 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV concordance between vaginal self-sample and clinician-collected cervical swab | 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. | Baseline | 
| HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people. | HPV correlation between self-samples taken at clinic and in-home among trans women and non-binary people. | Baseline and 1 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender, Trans men, Trans women, Non-binary individuals