Active not recruitingNAINTERVENTIONAL

HPV Self-testing in Transgender Individuals

This study aims to understand how common human papillomavirus (HPV) is among transgender people and to see if self-testing for HPV is a good and private option. HPV is a common virus that can sometimes lead to cancer. We know that certain HPV types are linked to cancers of the cervix, throat, and anus, but we don't fully understand how this affects transgender individuals. For transgender men, routine cervical screening can be uncomfortable or distressing, potentially leading to lower attendance. This research wants to find out if self-swabs are just as good as clinician-taken swabs, making screening easier and more accessible for everyone, and helping to prevent cancer.

At a glance

Status

Active not recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

100

Start

29 Feb 2024

Estimated completion

29 Nov 2026

HPV Infection

What is this study about?

Human papillomavirus, or HPV, is a very common virus that spreads through skin-to-skin contact. While many types of HPV are harmless, some are considered ‘high-risk’ because they can cause changes in cells that might lead to cancer. These high-risk HPVs are linked to cancers in areas like the cervix (the entrance to the womb), the throat, and the anus (the exit of the bowel).

Currently, we don't know enough about how common high-risk HPV is among transgender individuals – people whose gender identity is different from the sex they were assigned at birth. There's also not much information about HPV in the reconstructed vaginas of transgender women. For transgender men who still have a cervix, there's a concern that they might be less likely to attend regular cervical screening appointments. This can be due to physical discomfort or emotional distress during the screening process, which involves a doctor taking a direct swab from the cervix. This situation could put them at a higher risk of cervical cancer.

This study hopes to fill these information gaps. Researchers want to find out how common high-risk HPV is in different body parts for transgender people. Participants will take their own swabs from areas like the vagina and anus, provide a urine sample, and use a special mouthwash. Transgender men will also have an additional swab taken by a doctor during routine cervical screening. This is to compare if the self-taken swabs are as effective as the ones taken by a doctor in finding abnormal cells that could lead to cancer. Participants will also share their thoughts through an online survey about how acceptable or easy it is to do self-sampling compared to having a sample taken by a healthcare professional. Hopefully, this research will provide valuable information to help improve HPV screening and cancer prevention for all transgender individuals.

Key takeaways

The study explores how common HPV is in transgender people.
It investigates if self-testing for HPV is a good and private option.
HPV can lead to certain cancers, including those of the cervix, throat, and anus.
The research aims to improve HPV screening and cancer prevention for transgender individuals.
Participation involves providing self-collected samples and completing an online survey.

Who may be eligible?

This study is looking for transgender or non-binary adults to take part. For transgender men and non-binary individuals who still have a cervix, you might be able to join if you are between 25 and 65 years old, are registered with a GP, and have taken testosterone therapy in the last year.

For transgender women and non-binary individuals, you might be eligible if you are 18 years or older and had surgery to create a vagina at least one year ago. Everyone interested needs to be willing and able to understand what the study involves and agree to take part.

You won't be able to join if you have certain health conditions like inflammatory bowel disease (Crohn's or ulcerative colitis), or if you are allergic to any ingredients in the mouthwash used in the study. Also, pregnant people, children, or anyone unable to give their consent independently cannot participate.

Quick self-check

Do you identify as transgender or non-binary?
If you have a cervix, are you aged between 25 and 65?
If you have a reconstructed vagina, are you aged 18 or older and had surgery over a year ago?
Are you registered with a GP?
Have you used testosterone therapy in the last year (if you have a cervix)?
Do you NOT have an inflammatory bowel disease (like Crohn's or ulcerative colitis)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be asked to provide several samples. This involves taking swabs yourself from your vagina and anus. You will also need to provide a urine sample and use a mouthwash at home. If you are a transgender man who still has a cervix, you will have an extra swab taken by a doctor as part of your usual cervical screening.

Alongside providing these samples, you'll be asked to complete an online survey. This survey will ask about your experience with self-sampling compared to having samples taken by a doctor, to understand what is more comfortable and acceptable. The study aims to gather this information to improve future screening methods. The total duration of your participation in the study is not specified, but it primarily involves providing samples and completing a survey.

Potential risks and benefits

Taking part in this study could offer some benefits by helping us learn more about HPV and improving screening for transgender individuals, potentially leading to earlier detection and better health outcomes for many people. There are generally very few risks involved, mainly discomfort from sample collection or using the mouthwash, and your information will be kept private. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

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

Common questions

What is HPV?

HPV stands for human papillomavirus. It's a common virus that spreads through skin contact. Some types can cause cell changes that might lead to cancer.

Why is this study important for transgender people?

This study is important because we don't know enough about how common HPV is in transgender people or how best to screen them. It aims to make screening easier and more effective.

Will I have to go to a clinic many times?

The study involves collecting samples yourself at home, like swabs, a urine sample, and using a mouthwash. Transgender men will have one extra swab taken by a doctor during routine screening.

What kind of cancers is HPV linked to?

High-risk HPV types are linked to cancers of the cervix (womb entrance), throat, and anus (bowel exit).

Will I get my test results back?

The study brief summary doesn't explicitly state if individual participants will receive their test results. It focuses on gathering overall information for research.