Self-TI Study

• Research type

  Research Study

• Full title

  HPV Methylation Self-testing Pilot in Transgender Individuals

• IRAS ID

  319364

• Contact name

  Alison Berner

• Contact email

  a.m.berner@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Clinicaltrials.gov Identifier

  NCT05883111

• Clinicaltrials.gov Identifier

  9780516, Worktribe project Number

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  Human papillomaviruses (HPV) is a common virus that spreads by 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).
  We do not know 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). We also do not know much 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.
  In this research we will see how common hrHPV is in transgender people in different parts of the body. We will ask people to take a swab from the vagina and anus, a urine sample, and to use a 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.
  We will also ask people in an online survey what they thought about taking the swab themselves compared to having the doctor take the swab.
  We hope that this research will help make cervical cancer screening easier for transgender people and help us understand if transgender people might be more at risk of hrHPV related cancers

• REC name

  Wales REC 5

• REC reference

  23/WA/0266

• Date of REC Opinion

  7 Nov 2023

• REC opinion

  Further Information Favourable Opinion