The factors associated with HIV Pre-Exposure Prophylaxis awareness and use among women aged 40-65 years in SE England: A protocol for the analysis of data from a cross-sectional population survey

Background New HIV diagnoses are increasing among women aged 40-65 years in England. HIV Pre-Exposure Prophylaxis (PrEP), the use of antiretrovirals for HIV prevention, is an effective chemoprophylactic strategy, as part of a comprehensive prevention package, for HIV. Granular data on knowledge about, and access to HIV PrEP for women aged 40-65 years, is lacking. This project will be a secondary analysis of a survey of adults in Brighton and Hove, England. It aims to investigate the sociodemographic and sexual behaviour factors that are associated with HIV PrEP awareness and HIV PrEP use in women aged 40-65 years in Brighton and Hove.

‘Health Counts 2024’, a cross-sectional, self-completion health-related survey was conducted in Brighton and Hove in March 2024. The primary outcomes will be HIV PrEP awareness and HIV PrEP use among women aged 40-65 years in Brighton and Hove and will be analysed using descriptive statistics appropriate to distribution. The secondary outcomes will be to determine whether there are associations between sexual behaviours and/or sociodemographic factors and HIV PrEP awareness and HIV PrEP use for women aged 40-65 years in Brighton and Hove. These will be analysed using descriptive statistics and multifactorial logistic regression models from which odds ratios and 95% confidence intervals will be reported. Ethics and dissemination Ethical approval for the ‘Health Counts’ survey was obtained from the NHS Health Research Authority (HRA: Ref: 23/LO/0825) and the London – Bromley Research Ethics Committee (Ref: 23/LO/0825). Ethical approval for the community enrolment and supported completion pathway was granted by the University of Brighton Cross-School Research Ethics Committee C (2023-12553). Findings from this analysis will be disseminated to stakeholders via a scheduled public engagement event (‘Valuing the voices of women in coastal communities’), presentations at conferences and in peer-reviewed journals. Strengths and limitations of this analysis We will be the first to examine HIV PrEP awareness and HIV PrEP use, and sociodemographic and sexual behavioural correlates among women aged 40-65 years in the UK. ‘Health Counts 2024’ was extensively developed, piloted, and tested to ensure accessibility and therefore representativeness of results. Lack of HIV PrEP awareness and HIV PreP use among women may limit statistical analysis. Cultural sensitivity and stigma around sexual health behaviour may limit response rates on relevant questions and therefore may limit statistical analysis. Generalisability of the findings may be limited due to known regional differences in population awareness of HIV PrEP. Competing Interest Statement The authors have declared no competing interest. Funding Statement Health Counts 2024 was funded by Brighton and Hove City Council Public Health Department. This analysis was funded by a PhD fellowship granted by the University Hospitals Sussex NHS Foundation Trust and Brighton and Sussex Medical School. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval for the Health Counts survey was obtained from the NHS Health Research Authority (HRA: Ref: 23/LO/0825) and the London Bromley Research Ethics Committee (Ref: 23/LO/0825). Ethical approval for the community enrolment and supported completion pathway was granted by the University of Brighton Cross-School Research Ethics Committee C (2023 to 12553). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes (c.d.llewellyn{at}bsms.ac.uk) (stephen.bremner{at}kcl.ac.uk) (n.s.sherriff{at}brighton.ac.uk) (kate.gilchrist{at}brighton-hove.gov.uk). (massimo.mirandola{at}aovr.veneto.it), (j.huber{at}brighton.ac.uk) (r.o.devisser{at}bsms.ac.uk) (k.galvin{at}brighton.ac.uk) (louise.knight{at}brighton-hove.gov.uk) (c.aicken{at}brighton.ac.uk) a.sawyer{at}brighton.ac.uk (c.iwuji{at}bsms.ac.uk) Data Availability statement The ‘Health Counts’ data are stored securely and analysed by health researchers at the University of Brighton and Brighton and Sussex Medical School, and by Brighton and Hove City Council’s Public Health Intelligence team. The joint Data Controllers are the University of Brighton and Brighton & Hove City Council. The ‘Health Counts’ dataset is embargoed for a period to be determined by the Editorial Board and cannot be shared with any external party until the embargo period is lifted at which point, access to the dataset will be governed by the Editorial Board procedures.