HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Prio… (NCT06414057) | Clinical Trial Compass
RecruitingNot Applicable
HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks
United Kingdom500 participantsStarted 2025-07-07
Plain-language 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.
Who can participate
Age range
25 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
Individuals will be excluded from participation if they:
* Do not have a cervix due to surgery or other reasons
* Are known to have completed the full vaccination schedule (as per JCVI criteria for their age and immunocompetency) (Excluded from component 1 (vaccination and HPV screening) only - still able to participate in component 2 (individual interview))
* Meet any of the vaccine exclusion criteria as set out in the local HPV PGD
* Have had a confirmed anaphylactic reaction to a previous dose of HPV vaccine.
* Have had a confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder's SmPC for details of vaccine components.
* Have a history of severe (i.e. anaphylactic reaction) to latex where the vaccine is not latex free.
* Are known to be pregnant.
* Are suffering from an acute severe febrile illness (the presence of a minor infection is not a contraindication for immunisation).
Additionally, PGDs advise caution where a neurological condition is believed to be progressing or there is neurological deterioration and therefore, individuals meeting …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.