HPV Methylation Self-testing Pilot in Transgender Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Feasibility of self-sampling in clinic
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: HPV DNA methylation assay (Diagnostic Test)
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.
干预措施: HPV DNA methylation assay (Diagnostic Test)
结局指标
主要结局
Feasibility of self-sampling in clinic
时间窗: Baseline
Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.
Acceptability of self-sampling in clinic
时间窗: Baseline
Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey
Feasibility of self-sampling at home
时间窗: 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
时间窗: 1 month follow up
Acceptability of self-sampling at home as indicated by high satisfaction on an online survey
次要结局
- 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)