HPV InfectionSelf-TINCT05883111
HPV Self-testing in Transgender Individuals
A study testing HPV DNA methylation assay in people with HPV Infection, run by Queen Mary University of London at 3 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- HPV DNA methylation assay
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 29 Feb 2024to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospitals Sussex NHS Foundation Trust Sexual Health Service
Brighton
Ambrose King Centre, Barts Health NHS Trust
London
CliniQ, Caldicott Centre, Kings College Hospitals
London
About this study
Official title: HPV Methylation Self-testing Pilot in Transgender Individuals
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.
Read more
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.
- Conditions
- HPV Infection
- Being tested
- HPV DNA methylation assay
- Keywords
- Transgender, Trans men, Trans women, Non-binary individuals
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV DNA methylation assayDiagnostic test
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
| Study group | Role | What they receive |
|---|---|---|
| Trans men and non-binary people with a cervix | Other | 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. Receives: Diagnostic Test: HPV DNA methylation assay |
| Trans women and non-binary people | Experimental | 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. Receives: Diagnostic Test: HPV DNA methylation assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of self-sampling in clinic
Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.
Measured: Baseline
Acceptability of self-sampling in clinic
Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey
Measured: Baseline
Feasibility of self-sampling at home
Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples.
Measured: 1 month follow-up
Acceptability of self-sampling at home
Acceptability of self-sampling at home as indicated by high satisfaction on an online survey
Measured: 1 month follow up
Secondary outcomes (2)
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.
Measured: Baseline
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.
Measured: Baseline and 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start29 Feb 2024
- Primary completion29 Aug 2025
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah S Jackson, PhD, Principal investigator, National Cancer Institute (NCI)Alison M Berner, MBBS, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883111
- Sponsor's protocol ID
- 319364
- Acronym
- Self-TI
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson SS, O'Callaghan S, Ward E, Orkin CM, Clarke MA, Berner AM. Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England. BMJ Open. 2024 Jul 4;14(7):e086099. doi: 10.1136/bmjopen-2024-086099.
PubMed 38964803
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Methylation Self-testing Pilot in Transgender Individuals
- ClinicalTrials.gov ID
- NCT05883111
- Acronym / sponsor ID
- Self-TI / 319364
- Conditions
- HPV Infection
- Keywords
- Transgender, Trans men, Trans women, Non-binary individuals
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans men and non-binary people with a cervix | Other | Diagnostic Test: HPV DNA methylation assayParticipants 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 | Experimental | Diagnostic Test: HPV DNA methylation assayParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV DNA methylation assayHPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation. | Diagnostic test | Trans men and non-binary people with a cervix, Trans women and non-binary people |
Primary outcome
Feasibility of self-sampling in clinic
Time frame: Baseline
Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.
Acceptability of self-sampling in clinic
Time frame: Baseline
Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey
Feasibility of self-sampling at home
Time frame: 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
Time frame: 1 month follow up
Acceptability of self-sampling at home as indicated by high satisfaction on an online survey
2 secondary outcomes
HPV concordance between vaginal self-sample and clinician-collected cervical swab
Time frame: Baseline
HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people.
Time frame: Baseline and 1 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 38964803Jackson SS, O'Callaghan S, Ward E, Orkin CM, Clarke MA, Berner AM. Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England. BMJ Open. 2024 Jul 4;14(7):e086099. doi: 10.1136/bmjopen-2024-086099.
- Individual participant dataSharing planned: No
Related trials for HPV Infection
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CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
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A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
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RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
Active, not recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
Cervical Carcinoma, Human Papillomavirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah S Jackson, PhD principal investigator
National Cancer Institute (NCI)
Alison M Berner, MBBS, PhD principal investigator
Queen Mary University of London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV DNA methylation assay in people with HPV Infection, run by Queen Mary University of London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of self-sampling in clinic (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.