HPV Methylation Self-testing Pilot in Transgender Individuals

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
United Kingdom
University Hospitals Sussex NHS Foundation Trust Sexual Health Service
RECRUITING
Brighton
Ambrose King Centre, Barts Health NHS Trust
RECRUITING
London
CliniQ, Caldicott Centre, Kings College Hospitals
RECRUITING
London
Contact Information
Primary
Alison M Berner
a.m.berner@qmul.ac.uk
44 7738 011636
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2028-08-28
Participants
Target number of participants: 100
Treatments
Other: Trans men and non-binary people with a cervix
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.
Experimental: Trans women and non-binary people
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.
Sponsors
Leads: Queen Mary University of London
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov