HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Individuals with experience of homelessness, substance use/addiction, transactional sex, and incarceration experience significant health inequities across a wide range of health conditions. This inequity includes cervical cancer with individuals in these populations less engaged with both routine human papillomavirus (HPV) vaccination and cervical cancer screening programmes, yet also at higher risk of developing cervical cancer. Opportunistic vaccination is recommended by the Joint Committee on Vaccination and Immunisation for 'other at risk/vulnerable groups' who may benefit (such as people with experience of transactional sex or incarceration) at clinical discretion. However, there is limited evidence on the feasibility, uptake, attitudes and impact of vaccination in these at-risk groups and no nationally funded programme. This mixed methods exploratory study seeks to generate evidence to inform the optimal service design. Core objectives are to: 1) assess the feasibility and acceptability of offering opportunistic HPV vaccination during standard sexual health care to women at high risk of HPV and cervical cancer; 2) identify the type-specific prevalence of HPV among recruited participants; and 3) describe participants' perceptions and experiences of accessing routine HPV vaccination and cervical screening services, and/or this opportunistic (research) service. The investigators will seek to recruit women with experience of homelessness, substance use/addiction, transactional sex, and incarceration. The study will include trans-men and non-binary people at risk of cervical cancer with the same risk experiences. Potential participants will be identified prospectively via attendance at specialist sexual health services in Scotland. Participants will be offered HPV vaccination and testing, and/or an in-depth research interview. Participation can be completed within one clinic visit. The full vaccination course is available via participation (min/max does spacing 6/12 months) and participants testing positive for high-risk type HPV can/will be followed up in full and supported in accessing treatment.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 45
Healthy Volunteers: f
View:

⁃ Individuals will be eligible for participation in components 1 and/or 2 if they:

• have a cervix

• are aged 25-45 years (inclusive)

• are able to provide informed consent for themself

⁃ And have experience of either:

• substance use/addiction

• living in custodial settings

• homelessness

• involvement in transactional sex

Locations
Other Locations
United Kingdom
NHS Lothian
RECRUITING
Edinburgh
Contact Information
Primary
Mia Closs, PhD
mia.closs@ed.ac.uk
0131 650 1000
Backup
Christine Campbell
0131 650 1000
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 500
Treatments
All participants
Investigators will offer Gardasil-9 and HPV self-swab screening 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. Participants will be asked to provide a vaginal swab sample for baseline HPV testing.
Sponsors
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov