NCT06414057 | NOT YET RECRUITING | Human Papilloma Virus

Detailed Description:

Component 1: Focusses on assessment of the prevalence of HPV in our study population, and on the provision, and assessment of the uptake, of HPV vaccination (gardesil-9). Intervention - HPV vaccination and self-swab screening will be offered to up to 500 individuals across the three study sites, aiming to recruit 120-180 individuals within each of the three participating health boards over a 6-9 month timeframe. Vaccine provision - All aspects of the vaccine provision in this study will be conducted in line with current clinical practice and follow the site's local GPD for HPV vaccine provision. The cost of vaccine provision in this study is being met by charitable donation of the standard vaccine by the pharmaceutical company (MSD). Vaccine - This study will use Gardasil-9, produced and provided by MSD. It is a nine valent vaccine offering protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52 \& 58, and is the only vaccine available to use in the UK. Number of doses - The risk profile of the participant population is considered to be similar to that of GBMSM. Accordingly, participants will be offered 2/3 doses of the vaccine according to their immunocompetency. HPV testing - Participants will be asked to provide a baseline self-taken vaginal swab for HPV testing. Self-swab sampling is being offered as this is standard practice for Chlamydia and Gonorrhoea testing, increasing uptake for individuals who would decline an examination, such as those with experience of sexual trauma. If participants would rather not take a self-taken swab, then clinician taken sampling will be offered. Swab tests - This study will use the COPAN FloqSwabs™; pictorial instructions for sampling will be provided. Swabs will be dispatched to the Scottish HPV Reference Laboratory (SHPVRL) for HPV genotyping. Laboratory analysis - HPV genotyping will be performed using the AllplexT HPV 28 assay. Follow-up of HPV+ participants - All participants with a positive high-risk type HPV test on their swab will be contacted and advised that a liquid-based cytology (LBC) smear test is recommended. Travel expenses - Participants will be offered travel expenses (up to £25 in total) for attendance at the clinic for repeat vaccine doses or follow-up smear test. ----------------------------------- Component 2: consists of a qualitative exploration of the perspectives of women from our target population on HPV vaccination and screening. In-depth interview study - Investigators will conduct individual interviews with people invited to take part in the vaccine intervention study. This will include individuals who accepted the vaccine and screening and those who declined. Recruitment - Participants will be invited to consider taking part in a research interview at the same time as recruitment to component 1. This will include individuals who choose to undertake the vaginal sampling and HPV vaccination, or after refusing to do so. It will be made clear that this is an additional, optional, component and that the interview would be carried out by a University of Edinburgh researcher, and will be held a safe environment. Up to 30 interviews will be conducted across the three health boards, seeking to include a balance of participants from each of the eligible groups. Participants will be offered a £10 voucher in recognition of their time. The voucher will only be given following the completion of the interview. For participants currently living in custody, £10 will be added to their commissary account. Interview conduct - Interviews will be carried out by an experienced researcher and will explore topics related to cervical cancer/HPV risks, vaccination, and access to current vaccine and cervical screening services. Interviews will take a semi-structured format and the interviewer will be free to pursue any relevant line of conversation appearing to be of importance to that participant. Interviews will be carried out in a private space in person (in either the clinic facility/outreach facility) or via phone, or via the approved NHS digital remote consultation platform if the participant is currently in prison. Interviews will be recorded on an encrypted device and transcribed verbatim. Investigators will use a university approved company (First Class Secretarial Services) with a confidentiality and data-processing agreement in place, and transcripts will be checked for accuracy and fully anonymised by the Lead Research Fellow. Analysis - analysis will be undertaken using an abductive thematic approach (i.e. we will look for patterns, themes, and connections in participants' accounts. Investigators will commence coding and analysis with an outline codebook based on relevant established literature and theories, and will use new insights and perspectives gained directly from the data to add new codes and adapt the coding structure during the analytical process). The NVivo software (QSR NVivo version 10) will be used to store and organise the transcripts, and all coding and analysis undertaken. Interpretation - Individual member checking may be challenging for some participants however, PPI input to the interpretation and reporting of interview findings will be obtained from the study advisory panel which will include representatives from advocacy groups such as Jo's Cervical Cancer Trust, and the Waverly Centre. Where appropriate, the Research Fellow will attend advocacy groups to ensure participant group views are suitably represented in the interpretation of the results.