NCT06414057 HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks
| NCT ID | NCT06414057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Human Papilloma Virus |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-07-07 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 this criteria will be excluded (from component 1 only).
Contact & Investigator
Christine Campbell
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT06414057 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 45 Years, studying Human Papilloma Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06414057 currently recruiting?
Yes, NCT06414057 is actively recruiting participants. Contact the research team at mia.closs@ed.ac.uk for enrollment information.
Where is the NCT06414057 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT06414057 clinical trial?
NCT06414057 is sponsored by University of Edinburgh. The principal investigator is Christine Campbell at University of Edinburgh. The trial plans to enroll 500 participants.