HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Uptake
研究概览
简要总结
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.
详细描述
Component 1: Focusses on assessment of the prevalence of HPV in our study population, and on the provision, and assessment of the uptake, of HPV vaccination (gardesil-9).
Intervention - HPV vaccination and self-swab screening will be offered 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.
Vaccine provision - All aspects of the vaccine provision in this study will be conducted in line with current clinical practice and follow the site's local GPD for HPV vaccine provision. The cost of vaccine provision in this study is being met by charitable donation of the standard vaccine by the pharmaceutical company (MSD).
Vaccine - This study will use Gardasil-9, produced and provided by MSD. It is a nine valent vaccine offering protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52 & 58, and is the only vaccine available to use in the UK.
Number of doses - The risk profile of the participant population is considered to be similar to that of GBMSM. Accordingly, participants will be offered 2/3 doses of the vaccine according to their immunocompetency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Offering opportunistic HPV vaccine during routine sexual health clinic visits (Other)
结局指标
主要结局
Uptake
时间窗: Baseline
Number of participants taking up HPV screening and initial HPV vaccine dose during the clinic visit
次要结局
- Clinician/self sampling(Baseline)
- HPV prevalence(4 weeks)
- Follow-up tests(6 months)
- Vaccine completion(12 months)