NCT06414057Recruiting
HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 10 May 2024
- Start date
- 7 Jul 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University of Edinburgh
- Diseases
- Cervical cancer
- NCT number
- NCT06414057
What you commit to
- Study type: Observational
- Planned participants: 500
- From 7 Jul 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Do not have a cervix due to surgery or other reasons
- 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.
Other illness
- Have a history of severe (i.e. anaphylactic reaction) to latex where the vaccine is not latex free.
- 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).
Age
- 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))
Other
- Individuals will be excluded from participation if they:
- Are known to be pregnant.
Who the study is looking for
- 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
Age in the registry: 25 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.