HPV Self-testing in Transgender Individuals

Trial Title: HPV Self-testing in Transgender Individuals

NCT ID: NCT05883111

Condition: HPV Infection

Conditions: Official terms:
Papillomavirus Infections

Conditions: Keywords:
Transgender
Trans men
Trans women
Non-binary individuals

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: HPV DNA methylation assay
Description: HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
Arm group label: Trans men and non-binary people with a cervix
Arm group label: Trans women and non-binary people

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.

Criteria for 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.

Gender: All

Gender based: Yes

Gender description: Transgender and gender diverse identities.

Minimum age: 21 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University Hospitals Sussex NHS Foundation Trust Sexual Health Service

Address:
City: Brighton
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Sophie Ross
Email: sophie.ross5@nhs.net

Contact backup:
Last name: Lisa Barbour
Email: lisa.barbour@nhs.net

Facility:
Name: Ambrose King Centre, Barts Health NHS Trust

Address:
City: London
Country: United Kingdom

Status: Recruiting

Contact:
Last name: James Hand
Email: james.hand@nhs.net

Contact backup:
Last name: Kyle Ring
Email: kyle.ring@nhs.net

Facility:
Name: CliniQ, Caldicott Centre, Kings College Hospitals

Address:
City: London
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Lucy Campbell
Email: lucy.campbell@kcl.ac.uk

Contact backup:
Last name: Ellen Adams
Email: ellenadams@nhs.net

Start date: February 29, 2024

Completion date: October 2028

Lead sponsor:
Agency: Queen Mary University of London
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Queen Mary University of London

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05883111