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

Sep 21, 2026

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Persistent infection with high-risk human papillomavirus (HPV) drives multiple cancers, yet transgender and transmasculine/non-binary groups with a cervix face markedly lower cervical screening uptake than cisgender women, while transgender women and transfeminine non-binary people assigned male at birth may have increased HPV risk. The protocol targets key barriers to testing, including medical mistrust linked to stigma and discrimination.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages8

Reading Time20 min

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ABSTRACT

Introduction

Methods and analysis

Ethics and dissemination

Strengths and limitations of this study

INTRODUCTION

Open access Protocol Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England Sarah S Jackson ,1 Stewart O’Callaghan,2 Elanore Ward,3 Chloe M Orkin ,4 Megan A Clarke ,1 Alison May Berner5 To cite: Jackson SS, O’Callaghan S, Ward E, et al. 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;14:e086099 . doi:10 . 1136/ bmjopen-2024-086099 ► Prepublication history for this paper is available online. To view these files, please visit the journal online ([https://doi](https://doi). org/10 . 1136/bmjopen-2024- 086099) . Received 05 March 2024 Accepted 21 June 2024 © 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. 1Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA 2OUTPatients, London, UK 3Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK 4Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK 5Barts Cancer Institute, Queen Mary University of London, London, UK Correspondence to Dr Sarah S Jackson; [sarah.jackson@nih.gov](sarah.jackson@nih.gov) ABSTRACT Introduction Persistent infection with high-risk human papillomavirus (HPV) is the causal agent of several cancers including cervical, anal and oropharyngeal cancer. Transgender men and transmasculine non-binary (TMNB) people with a cervix are much less likely to undergo cervical cancer screening than cisgender women. Transgender women and transfeminine non-binary (TWNB) people assigned male at birth may be at increased risk of HPV. Both TMNB and TWNB people face many barriers to HPV testing including medical mistrust due to stigma and discrimination. Methods and analysis 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. 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. Participants self-collect up to four samples: an oral rinse, a first void urine sample, a vaginal swab (if applicable) and an anal swab. TMNB participants are asked to have an additional clinician-collected cervical swab taken following their routine Cervical Screening Programme sample. 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. Acceptability is assessed by a selfadministered online survey and feasibility is measured asthe proportion of samples returned in the clinic and from home. Ethics and dissemination 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. 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. 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. 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. Trial registration number NCT05883111. STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ The pilot study addresses the lack of evidence around acceptability of human papillomavirus (HPV) self-sampling in transgender and non-binary people and was codesigned with community members. ⇒ This pilot study collects samples from four body sites including an oral rinse, a urine sampl

FAQs

What is the purpose of the Self-TI Study protocol?

The Self-TI Study is a pilot protocol designed to measure acceptability and feasibility of HPV self-testing among transgender and non-binary people in England.

Who is eligible to participate in the study?

TMNB participants are 25–65 years old and have at least one year of testosterone; TWNB participants are 18 years and over.

How do participants provide samples and how is feasibility evaluated?

Participants self-collect up to four samples (oral rinse, first void urine, and vaginal/anal swabs as applicable). Feasibility is measured by the proportion of samples returned in the clinic and from home.

Sep 21, 2026

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