HPV Self-testing in Transgender Individuals (Self-TI)

March 13, 2024 updated by: Queen Mary University of London

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria for trans men and non-binary adults with a cervix:

  • 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

Inclusion Criteria for trans women and non-binary adults :

  • 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: HPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.
Experimental: 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.
Diagnostic test: HPV DNA methylation assay
HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
Acceptability of self-sampling in clinic
Time Frame: Baseline
Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey
Baseline
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.
1 month follow-up
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
1 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV concordance between vaginal self-sample and clinician-collected cervical swab
Time Frame: Baseline
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.
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV correlation between self-samples at each site
Time Frame: Baseline and 1 month follow up
HPV correlation between self-samples at each site (vaginal, anal, oral, and urine) in each arm.
Baseline and 1 month follow up
Performance of HPV methylation assay
Time Frame: Baseline
Comparison of the performance of HPV methylation testing from self-collected samples to clinician-collected samples for the detection of cervical precancer in trans men and non-binary adults with a cervix.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sarah S Jackson, PhD, National Cancer Institute (NCI)
  • Principal Investigator: Alison M Berner, MBBS, PhD, Queen Mary University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 319364

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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