Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2024-02-29
2028-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
NCT05981807
Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men
NCT04154358
HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
NCT03222817
Detecting HPV DNA in Anal and Cervical Cancers
NCT04857528
Safety and Immunogenicity of Human Papillomavirus (HPV) Vaccine in Solid Organ Transplant Recipients
NCT00677677
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
HPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
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.
HPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
21 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Queen Mary University of London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah S Jackson, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Alison M Berner, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
319364
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.