Improving access to HPV vaccination and self‑swab screening for women with experience of homelessness, substance use, incarceration, or transactional sex in Scotland

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This mixed‑methods exploratory project offers opportunistic Gardasil‑9 vaccination and a baseline self‑taken vaginal swab for HPV testing to up to 500 eligible participants across three health boards in Scotland, aiming for roughly 120–180 people per site over 6–9 months. Vaccination follows local clinical PGDs, uses 2 or 3 doses according to immunocompetence, and the vaccine is supplied by the manufacturer via charitable donation. The study combines quantitative measures of vaccine uptake and HPV prevalence with qualitative interviews to explore barriers, facilitators, and optimal service design. Findings are intended to inform future service models for at‑risk groups who are under‑engaged with routine vaccination and screening.

Why it matters

Who can join: the full rules

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).

Where it's running

• NHS Lothian
  Edinburgh, United Kingdom Recruiting

Study contacts

• Principal investigator: Christine Campbell — University of Edinburgh
• Study coordinator: Mia Closs, PhD
• Email: mia.closs@ed.ac.uk
• Phone: 0131 650 1000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.