HPV Self-testing in Transgender Individuals (Self-TI)

Queen Mary University of London

Status: Enrolling

Conditions: HPV Infection

Treatments: Diagnostic Test: HPV DNA methylation assay

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05883111

319364

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Trans men and non-binary people with a cervix

Other group

Description:

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.

Treatment:

Diagnostic Test: HPV DNA methylation assay

Trans women and non-binary people

Experimental group

Description:

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.

Treatment:

Diagnostic Test: HPV DNA methylation assay