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  • Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England.
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English
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  • Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England.

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Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England. (English)
1 reference
Persistent infection with high-risk human papillomavirus (HPV) is the causal agent of several cancers including cervical, anal and oropharyngeal cancer. (English)
INTRODUCTION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Transgender men and transmasculine non-binary (TMNB) people with a cervix are much less likely to undergo cervical cancer screening than cisgender women. (English)
INTRODUCTION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Transgender women and transfeminine non-binary (TWNB) people assigned male at birth may be at increased risk of HPV. (English)
INTRODUCTION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Both TMNB and TWNB people face many barriers to HPV testing including medical mistrust due to stigma and discrimination. (English)
INTRODUCTION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
The Self-TI Study (Self-TI) is a pilot study designed to measure acceptability and feasibility of HPV self-testing among transgender and non-binary people in England. (English)
METHODS AND ANALYSIS (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
TMNB people aged 25-65 years, with at least 1 year of testosterone, and TWNB people, aged 18 years and over, are eligible to participate. (English)
METHODS AND ANALYSIS (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Participants self-collect up to four samples: an oral rinse, a first void urine sample, a vaginal swab (if applicable) and an anal swab. (English)
METHODS AND ANALYSIS (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
TMNB participants are asked to have an additional clinician-collected cervical swab taken following their routine Cervical Screening Programme sample. (English)
METHODS AND ANALYSIS (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
TWNB people are asked to take a self-collection kit to perform additional self-collection at home and mail the samples back to the clinic. (English)
METHODS AND ANALYSIS (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Acceptability is assessed by a self-administered online survey and feasibility is measured as the proportion of samples returned in the clinic and from home. (English)
METHODS AND ANALYSIS (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Self-TI received ethical approval from the Research Ethics Committee of Wales 4 and ethical review panel within the Division of Cancer Epidemiology and Genetics at the US National Cancer Institute. (English)
ETHICS AND DISSEMINATION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Self-TI was coproduced by members of the transgender and non-binary community, who served as authors, collaborators and members of the patient and public involvement (PPI) group. (English)
ETHICS AND DISSEMINATION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
Results of this study will be shared with the community prior to being published in peer-reviewed journals and the PPI group will help to design the results dissemination strategy. (English)
ETHICS AND DISSEMINATION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
The evidence generated from this pilot study could be used to inform a larger, international study of HPV self-testing in the transgender and non-binary community. (English)
ETHICS AND DISSEMINATION (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
1 reference
NCT05883111. (English)
TRIAL REGISTRATION NUMBER (English)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. (English)
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4 July 2024
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4 July 2024
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14
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7
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e086099
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e086099
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Competing interests: AMB is a trustee of OUTpatients, of which SOC is the CEO. (English)
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None of the other authors have any conflicts to declare. (English)
1 reference