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

NCT06414057 | Recruiting

• 1 other identifier: AC23210
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• Uptake

  Number of participants taking up HPV screening and initial HPV vaccine dose during the clinic visit

  Baseline

Secondary Outcomes (4)

• Clinician/self sampling

  Baseline

• Vaccine completion

  12 months

• HPV prevalence

  4 weeks

• Follow-up tests

  6 months

Study Arms (1)

All participants

Investigators will offer Gardasil-9 and HPV self-swab screening to up to 500 individuals across the three study sites, aiming to recruit 120-180 individuals within each of the three participating health boards over a 6-9 month timeframe. Participants will be asked to provide a vaginal swab sample for baseline HPV testing.

Other: Offering opportunistic HPV vaccine during routine sexual health clinic visits

Interventions

Offering opportunistic HPV vaccine during routine sexual health clinic visits OTHER

Investigators will offer Gardasil-9 and HPV self-swab screening to up to 500 individuals across the three study sites, aiming to recruit 120-180 individuals within each of the three participating health boards over a 6-9 month timeframe. Participants will be asked to provide a vaginal swab sample for baseline HPV testing.

All participants

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult women, trans men, or non-binery individuals with a cervix attending routine sexual health services who aslo have experience of substance use/addiction, living in custodial settings, homelessness, or involvement in transactional sex.

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))
• 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).

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal swab for HPV genotyping

Study Officials

• Christine Campbell

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Closs, PhD

CONTACT

0131 650 1000; mia.closs@ed.ac.uk

Christine Campbell

CONTACT

0131 650 1000

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 14, 2024
• Study Start: July 7, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)