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

Recruiting now

Conditions studied: Human Papilloma Virus

In brief

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.

Key facts

Study ID: NCT06414057
Run by: University of Edinburgh
People needed: 500
Starts: 2025-07-07
Expected to finish: 2027-10-31
Last updated by the study team: 2026-06-09

Who can join

Age: 25 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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).

Where it is running

NHS Lothian — Edinburgh, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.