Actively Recruiting

Age: 25Years - 45Years
FEMALE
ID06414057

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

Led by University of Edinburgh · Updated on 2026-04-08

500

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to address health inequities related to cervical cancer among women and individuals with a cervix who have experienced homelessness, substance use or addiction, transactional sex, and incarceration. These groups are less engaged with routine HPV vaccination and cervical cancer screening but have higher risks of developing cervical cancer. The study explores the feasibility and acceptability of offering HPV vaccination opportunistically during standard sexual health care, as well as understanding HPV prevalence and participant experiences. Participants will be offered the Gardasil-9 vaccine, which protects against nine HPV types, and a self-taken vaginal swab for HPV testing. Up to 500 individuals across three health boards in Scotland will be recruited over 6 to 9 months. The vaccination course will be offered according to immunocompetency, with 2 or 3 doses spaced 6 to 12 months apart. Those testing positive for high-risk HPV will be supported with follow-up and treatment access. The study also includes in-depth interviews to explore participants' perceptions and experiences of vaccination and screening. Participation usually involves one clinic visit for vaccination and HPV testing, with travel expenses offered for follow-up visits. Interviews may be conducted in person, by phone, or via secure digital platforms, with transcripts anonymized for analysis. Researchers will measure vaccination uptake at baseline, HPV prevalence, vaccine completion at 12 months, and follow-up testing at 6 months. The study will continue monitoring and supporting participants who test positive for high-risk HPV throughout the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 25Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with a cervix
  • Aged 25 to 45 years inclusive
  • Able to provide informed consent
  • Experience of substance use or addiction, homelessness, involvement in transactional sex, or living in custodial settings
Not Eligible

You will not qualify if you...

  • No cervix due to surgery or other reasons
  • Completed full HPV vaccination schedule as per age and immune status (excluded from vaccination and screening only)
  • Meet vaccine exclusion criteria per local HPV guidelines
  • History of anaphylactic reaction to HPV vaccine or its components
  • Severe latex allergy if vaccine is not latex free
  • Currently pregnant
  • Suffering from acute severe febrile illness
  • Neurological conditions believed to be progressing or deteriorating (excluded from vaccination and screening only)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 6 to 9 months

Participants provide a baseline self-taken vaginal swab or clinician-taken sample for HPV testing and are offered Gardasil-9 vaccination according to their immunocompetency. Vaccination and sampling follow routine clinical practice.

Up to 3 visits for vaccination doses and baseline sampling

Follow-up

Duration - Up to 6 months

Participants who test positive for high-risk HPV are contacted and advised to attend a follow-up liquid-based cytology smear test. Travel expenses are offered for repeat vaccine doses or follow-up testing.

1 follow-up visit for smear test

Qualitative Interview

Duration - Variable

A subset of participants may take part in an optional in-depth interview to explore perspectives on HPV vaccination and screening. Interviews are conducted in person, by phone, or via a secure digital platform.

1 interview session

Trial Site Locations

Total: 1 location

1

NHS Lothian

Edinburgh, United Kingdom

Actively Recruiting

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Research Team

M

Mia Closs, PhD

C

Christine Campbell

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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