HPV Self-testing in Transgender Individuals

NCT05883111 | Active Not Recruiting

• 1 other identifier: 319364
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

HPV Infection

Keywords

Transgender; Trans men; Trans women; Non-binary individuals

Outcome Measures

Primary Outcomes (4)

• Feasibility of self-sampling in clinic

  Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.

  Baseline

• Acceptability of self-sampling in clinic

  Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey

  Baseline

• Feasibility of self-sampling at home

  Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples.

  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

  1 month follow up

Secondary Outcomes (2)

• HPV concordance between vaginal self-sample and clinician-collected cervical swab

  Baseline

• HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people.

  Baseline and 1 month follow up

Other Outcomes (2)

• HPV correlation between self-samples at each site

  Baseline and 1 month follow up

• Performance of HPV methylation assay

  Baseline

Study Arms (2)

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.

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.

Diagnostic Test: HPV DNA methylation assay

Interventions

HPV DNA methylation assay DIAGNOSTIC_TEST

HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.

Trans men and non-binary people with a cervix; Trans women and non-binary people

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Transgender and gender diverse identities.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as transgender or non-binary
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University Hospitals Sussex NHS Foundation Trust Sexual Health Service

Brighton, United Kingdom

Location

Ambrose King Centre, Barts Health NHS Trust

London, United Kingdom

Location

CliniQ, Caldicott Centre, Kings College Hospitals

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38964803 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah S Jackson, PhD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

• Alison M Berner, MBBS, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 31, 2023
• Study Start: February 29, 2024
• Primary Completion: August 29, 2025
• Study Completion (Estimated): November 29, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)