HPV Self-testing in Transgender Individuals

HPV Infection Clinical Trial

— Self-TI  

Official title:

HPV Methylation Self-testing Pilot in Transgender Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883111
• Other study ID #: 319364
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: October 2028

Study information

• Verified date: March 2024
• Source: Queen Mary University of London
• Contact: Alison M Berner
• Phone: 44 7738 011636
• Email: a.m.berner[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2028
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections

Intervention

Diagnostic Test:
• HPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Sussex NHS Foundation Trust Sexual Health Service	Brighton
United Kingdom	Ambrose King Centre, Barts Health NHS Trust	London
United Kingdom	CliniQ, Caldicott Centre, Kings College Hospitals	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	National Cancer Institute (NCI)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HPV correlation between self-samples at each site	HPV correlation between self-samples at each site (vaginal, anal, oral, and urine) in each arm.	Baseline and 1 month follow up
Other	Performance of HPV methylation assay	Comparison of the performance of HPV methylation testing from self-collected samples to clinician-collected samples for the detection of cervical precancer in trans men and non-binary adults with a cervix.	Baseline
Primary	Feasibility of self-sampling in clinic	Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.	Baseline
Primary	Acceptability of self-sampling in clinic	Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey	Baseline
Primary	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
Primary	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	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
Secondary	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