The CLEAR Study is exploring the use of the the left lateral position for cervical cancer screening tests. In the UK, the dorsal test position is normally used, where individuals lie on their back with their knees bent up and apart. In 2020, changes to screening guidelines introduced an alternative position, the left lateral test position where the individual lies on their left side, similar to the recovery position, whilst the speculum is inserted into the vagina, and a liquid based cytology sample (swab) taken.

Each year there are over 3000 new diagnoses of Cervical Cancer in the UK, and almost 900 die from the disease. Cervical screening uptake has steadily decreased in all age-groups over the last twenty years, and is currently at a 10-year low. This means more women and people with a cervix are at risk of undetected human papillomavirus (HPV) and cell changes that could lead to cervical cancer. Widely reported reasons for nonattendance include fear of the procedure; lack of knowledge and awareness of the process; previous test discomfort; feelings of vulnerability and embarrassment; and history of sexual trauma. Recent innovation in cervical screening has led to self-sampling kits that offer more choice, and may encourage more people to screen, but in-person screening is still necessary in cases of positive or inconclusive self-test results, and for those individuals who cannot self-sample or would prefer in-person sampling.

The CLEAR Study

Aim: To support implementation of the left lateral test position screening option in primary care. Investigating challenges and facilitators to implementation; and the impact of offering choice on patient experience, acceptability, inclusivity and engagement with the cervical screening programme

Methods: A mixed methods implementation study aligned to Normalisation Process Theory (NPT) and using a realist evaluation approach. The project consists of three work-packages (WP) over 36 months.

1. Co-design workshops with a diverse group of people eligible for cervical screening. Using the Generative Co-design Framework for Healthcare Innovation we will create accessible and acceptable patient facing materials that inform and promote the option of the LLTP for cervical screening.

2. Focus groups with cervical screening healthcare professionals, practice staff and trainers to understand any challenges to introducing the left lateral position as a screening position choice in practice.

3. Generate theories as to why the left lateral position could be beneficial, using a literature review and the knowledge and experience of the research team. This is known as a rapid realist review. We will conduct two focus groups, one with healthcare professionals, the other with people eligible for screening to share our theories and check if participants agree with them. More theories will be generated which we will then test in the next phase of the project.

4. 13 GP case study sites in England will test the theories created in the previous phases of the study. Quantitative evidence regarding screening uptake, patient demographics and screening success rates (sufficient cells for testing) will be collected in advance of introducing the left lateral position. Following the introduction and provision of the co-created materials from the first phase of the project, for at least 9 months we will collect data on the same outcomes. Information on patient satisfaction will be collected through interviews conducted with people who have attended screening during this time period; those who chose not to engage in screening; and healthcare professional screening staff, to understand implementation challenges. All data will be synthesised and processed, which will provide detailed explanations regarding what works, for whom, how and in what circumstances.

Dissemination and Impact: The study will report on the individual and practice level impact of introducing the offer of the left lateral test position into practice. Co-designed patient information materials will be made freely available through Creative Commons. We will work with national organisations to determine the best route for integration of findings into practice. Importantly we will work with charities and grass-roots community organisations to raise awareness of cervical screening and the use of the left lateral test position in practice. Our outputs will also include an implementation toolkit to support practices and commissioning organisations to implement the left lateral test position alongside the other cervical screening options to ensure patients are aware of all choices, as well as screening staff training programmes to support appropriate levels of clinical confidence and competence. All study participants will be offered a summary of study findings in an accessible format. We will also disseminate our findings through academic publications.

Patient and Public Involvement and Engagement (PPIE): Stakeholder engagement has been integral to the development of this study. We have an inclusive PPIE plan for each phase of the work. Diverse PPIE views will also be represented on the Project Management group and on the Study Steering Committee.