About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
have a cervix
are aged 25-45 years (inclusive)
are able to provide informed consent for themself
substance use/addiction
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Offering opportunistic HPV vaccine during routine sexual health clinic visits
Other interventionInvestigators 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.
Treatment groups
Trial outcomes
Primary outcomes
Uptake
Number of participants taking up HPV screening and initial HPV vaccine dose during the clinic visit
Secondary outcomes
Clinician/self sampling
Proportion of participants who provide a self-taken vaginal swap/opt for a clinician-taken swab
Vaccine completion
Number of participants completing vaccine schedule, assessed in line with JCVI guidance
HPV prevalence
Number of participants testing HPV + for each sub-type
Follow-up tests
Number of participants undertaking clinical follow-up after testing HPV + for high risk variant
Sponsors and contacts
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