Improving access to HPV vaccination and self‑swab screening for women with experience of homelessness, substance use, incarceration, or transactional sex in Scotland
HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks
This project will try offering Gardasil‑9 vaccination and a self‑taken HPV swab to women aged 25–45 in Scotland who have experienced homelessness, substance use, incarceration, or transactional sex to see if uptake and feasibility improve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT06414057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People aged 25–45 who have a cervix, can give informed consent, and have experience of substance use/addiction, homelessness, incarceration, or transactional sex are the intended participants.
Not a fit: People who do not have a cervix, have already completed the full HPV vaccination schedule, or meet vaccine exclusion criteria (including prior anaphylaxis to the vaccine) are unlikely to benefit from the vaccination component.
Why it matters
Potential benefit: If successful, this approach could increase vaccination and screening uptake in underserved women and lower their risk of developing cervical cancer.
How similar studies have performed: Self‑sampling and targeted outreach have improved screening and vaccination uptake in some marginalized populations, but evidence specifically for these priority groups is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Edinburgh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.