HPV Self-testing in Transgender Individuals
- Conditions
- HPV Infection
- Interventions
- Diagnostic Test: HPV DNA methylation assay
- Registration Number
- NCT05883111
- Lead Sponsor
- Queen Mary University of London
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trans men and non-binary people with a cervix HPV DNA methylation assay 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. Trans women and non-binary people HPV DNA methylation assay 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.
- Primary Outcome Measures
Name Time Method Feasibility of self-sampling in clinic Baseline Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.
Acceptability of self-sampling in clinic Baseline Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey
Feasibility of self-sampling at home 1 month follow-up Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples.
Acceptability of self-sampling at home 1 month follow up Acceptability of self-sampling at home as indicated by high satisfaction on an online survey
- Secondary Outcome Measures
Name Time Method HPV concordance between vaginal self-sample and clinician-collected cervical swab Baseline 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.
HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people. Baseline and 1 month follow up HPV correlation between self-samples taken at clinic and in-home among trans women and non-binary people.
Trial Locations
- Locations (3)
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, United Kingdom