RecruitingNCT06414057

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


Sponsor

University of Edinburgh

Enrollment

500 participants

Start Date

Jul 7, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 25 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study explores barriers to cervical cancer screening and HPV vaccination in Scotland for women who face specific vulnerabilities, including those experiencing substance use, homelessness, involvement in sex work, or those who have been in custody (prison or detention). These groups often have lower rates of cancer screening despite higher risk. **You may be eligible if...** - You have a cervix - You are between 25 and 45 years old - You are able to provide informed consent - You have experience with substance use/addiction, homelessness, transactional sex, or living in a custodial setting **You may NOT be eligible if...** - You do not have a cervix (due to surgery or other reasons) - You have already completed the full HPV vaccination schedule (this may affect which parts of the study you can join, but you may still participate in some components) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROffering opportunistic HPV vaccine during routine sexual health clinic visits

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.


Locations(1)

NHS Lothian

Edinburgh, United Kingdom

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NCT06414057


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