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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV DNA methylation assay | Diagnostic Test | HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| HPV correlation between self-samples taken at clinic and in home among trans women and non-binary people. |
| Measure | Description | Time Frame |
|---|---|---|
| HPV correlation between self-samples at each site | 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 |
Inclusion criteria for trans men and non-binary adults with a cervix:
Inclusion Criteria for trans women and non-binary adults :
Exclusion Criteria:
Transgender and gender diverse identities.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah S Jackson, PhD | National Cancer Institute (NCI) | Principal Investigator |
| Alison M Berner, MBBS, PhD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Sussex NHS Foundation Trust Sexual Health Service | Brighton | United Kingdom | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38964803 | Derived | 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. |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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HPV correlation between self-samples taken at clinic and in-home among trans women and non-binary people. |
| Baseline and 1 month follow up |
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 |
| Ambrose King Centre, Barts Health NHS Trust |
| London |
| United Kingdom |
| CliniQ, Caldicott Centre, Kings College Hospitals | London | United Kingdom |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |