Mar 10, 2026
AYEScreen: Using HPV Self-Sampling to Increase Accessibility, Equity, and Participation in Scotland’s National Cervical Screening Programme
- Sharon Hanley1,
- Lisa Iversen1,
- Natalia Calanzani1,
- Sheela Tripathee1,
- Lisa Duncan1,
- Daisy Urquhart-Dixon1
- 1University of Aberdeen
- Sharon Hanley: Chief Investigator
- Lisa Iversen: Co-Investigator
- Natalia Calanzani: Co-Investigator
- Sheela Tripathee: Research Fellow
- Lisa Duncan: PPIE Lead
- Daisy Urquhart-Dixon: PhD Student
Protocol Citation: Sharon Hanley, Lisa Iversen, Natalia Calanzani, Sheela Tripathee, Lisa Duncan, Daisy Urquhart-Dixon 2026. AYEScreen: Using HPV Self-Sampling to Increase Accessibility, Equity, and Participation in Scotland’s National Cervical Screening Programme. protocols.io https://dx.doi.org/10.17504/protocols.io.n92ld4nrol5b/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: March 10, 2026
Last Modified: March 10, 2026
Protocol Integer ID: 312983
Keywords: national cervical screening programme, national cervical screening programme in work package, cervical screening, overdue for cervical screening, nhs research scotland primary care network, participation in scotland, using hpv self, hpv self, nh, economic disadvantage in scotland, cervix, scotland, primary care professional, ayescreen study, sampling being
Funders Acknowledgements:
Cancer Research UK
Grant ID: EDDPJT-Nov24/100049
Disclaimer
This Protocol has regard for the HRA guidance and order of content.
Abstract
In Work package 1 of the AYEScreen study we want to understand what those who are overdue for cervical screening, and those who provide cervical screening think about self-sampling and self-sampling being offered in Scotland. We are especially interested in finding out their views on the different ways that the NHS might use to invite people to take part in self-sampling.
We shall conduct 12 small discussion groups (focus group) of around 8 women and people with a cervix aged 25-64 years, who live in rural/remote areas and areas of high socio-economic disadvantage in Scotland. We shall also carry out interviews with 20 primary care professionals (GPs/nurses/admin staff) involved in cervical screening. Participants will be identified and invited to the study by the NHS Research Scotland Primary Care Network.
Attachments
Troubleshooting
Introduction
Background
The main cause of cervical cancer is a persistent infection with a common virus called HPV. It is both preventable and curable with HPV vaccination and cervical screening. Despite this, 300-400 women and people with a cervix (W/PWC) are diagnosed with cervical cancer in Scotland annually and 100 people die from it (1). It is also a disease of inequity, with a clear deprivation gradient. Between 2015-2019, age-standardised incidence of cervical cancer in Scotland was over two times higher in those from the most deprived backgrounds compared to those from the least deprived (13.9 versus 6.8 per 100,000 person-years, respectively) (1). Inequality is even starker when comparing mortality, where rates are four times higher in the most deprived (4.0 per 100,000 person-years) compared to those from the least deprived backgrounds (1.0 per 100,000 person-years) (2). Among the devolved nations, Scotland also has the highest age-standardised incidence of cervical cancer (12.5 per 100,000 person-years) compared to 9.7, 10.0 and 12.0 per 100,000 person-years in Northern Ireland, England and Wales, respectively (3). The greatest disparity is among those born before 1990, who were never eligible for HPV vaccination, where increasing screening coverage is the key to prevention.
Rationale for the study
Reasons for not attending cervical screening include cultural and psychological factors such as embarrassment, discomfort, and fear (4-6); cognitive factors such as perceived risk (6), and practical factors such as time, cost, and access to care (4-6). Vaginal self-sampling for a high-risk HPV is a less invasive alternative to current clinician-led cervical screening, which could help overcome some of these barriers. It allows W/PWC to take their own vaginal sample using a brush or swab at a time and place of their convenience.
There is growing interest from the Scottish Government to include self-sampling in the National Screening Programme for non-attenders, however, large-scale implementation studies are lacking in Scotland, especially among the most disadvantaged and rural/remote populations.
The AYEScreen study will evaluate how best to introduce self-sampling in Scotland, especially among the most disadvantaged and rural/remote populations.
AYEScreen is comprised of three work packages: work package 1, a qualitative study; work package 2, a pragmatic implementation feasibility trial; and work package 3, a cost-effectiveness analysis.
This document is the protocol for Work Package 1: Qualitative Study.
Study Aim and Objectives (Work Package 1: Qualitative Study)
The primary aim of this study is to understand knowledge of, attitudes towards and acceptance of HPV self-sampling in under screened W/PWC and primary care professionals (GPs, nurses, administrative staff) (PCPs) living and working in rural/remote areas and areas of high socio-economic disadvantage in Scotland.
The specific research questions are:
1. What are the current barriers to cervical screening in under screened W/PWC?
2. What do under screened W/PWC and PCPs know about HPV self-sampling?
3. Where would under screened W/PWC like to perform the self-sample: at home or in primary care?
4. What may make it easier or difficult for under screened W/PWC to take part in an HPV self-sampling screening programme?
5. What may make it easier or difficult for PCPs to offer HPV self-sampling in their primary care practice?
6. What are specific issues of importance for underserved populations with regards to providing HPV self-sampling?
Recruitment
The NHS Research Scotland Primary Care Network (NRSPCN) will identify potential participants (W/PWC) by searching the Patient Management System in participating practices. We anticipate approaching around 22 practices in Scotland. The list generated by the search is screened by a clinician before invitations are sent out on behalf of the practice. PCPs in targeted practices will also be identified by the NRSPCN.
W/PWC will be sent an invitation letter via the post that includes a paper reply slip and a shortened version of the participant information leaflet (PIL) including the research team contact details. If they are interested in taking part, they can contact the research team directly by their preferred method (email, phone, freepost).
The invitation letter will be in English. However, to accommodate potential participants who may have difficulties adequately understanding English, it will contain some brief information in four other languages (Polish, Chinese, Urdu, and Hindi) about how to access the PIL in those languages via the study website. For potential participants being sent the invitation letter by post, a QR code to the website will be included in the letter. Participants who chose to read the PIL in another language will be signposted in that language to email the research team in their preferred language.
Once an interested individual contacts the research team, a designated female member of the research team will contact that person by their preferred contact method (email, phone, post) using the contact details provided. For screening purposes, information on sociodemographic factors including age; self-described gender; ethnicity; location; educational attainment; and cervical screening history will be collected (orally or digitally via MS forms for those who are being contacted by email or phone, and by post for those choosing the postal option). This data is needed at this stage to ensure diversity of potential participants as per protocol. The NRSPCN is only able to check for eligibility with regards to currently being overdue for cervical screening but cannot check for other relevant criteria. For non-English speakers, given they are already part of the target group for sample diversity, this information will be collected on the day of the interview without prior screening.
Eligible participants will then be sent (by post or email) the full PIL and a copy of the consent form for reference only. (Written consent will be taken on the day of the actual focus group/interview). If the research team doesn’t hear back from the interested participant within one week, they will contact them to confirm participation, arrange a mutually suitable date, time, and venue for the focus group or interview.
For PCPs, NRSPCN will advertise the study in their monthly newsletter or via their regular dissemination activities. The NRSPCN will ask interested PCPs to respond directly to the research team or to NRSPCN. If PCPs respond to the NRSPCN and provide contact details to forward to the research team, the NRSPCN will email that information to the research team in a password protected Microsoft Word document.
Interested PCPs will be emailed a copy of the full PIL and a consent form by the research team. If they confirm their participation, a mutually suitable date and time will be arranged for the virtual interview and they will be asked to return a completed consent form by email prior to the interview.
Study Design
This study is an exploratory, qualitative study that will use focus groups and individual semi-structured interviews to understand what under screened W/PWC and PCPs living and working in rural/remote areas and areas of high socio-economic disadvantage in Scotland think about including HPV self-sampling into Scotland’s national cervical screening programme.
- Focus groups (W/PWC):
Focus groups will be conducted in-person by an experienced female researcher/s who will arrange a suitable date, time and venue. Each W/PWC will take part in the focus group only once. In total, there will be 12 focus group with around 8 W/PWC per group. Each focus group will last around 90 minutes and refreshments will be served.
The topic guide for discussions will be informed by discussions between the study team, Patient and Public Involvement and Engagement (PPIE) partners and the scientific literature.
We will prioritize conducting focus group sessions over individual interviews wherever possible. However, if insufficient participants are available to make the focus group study possible or if language barriers exist to participation, or if any interested participants express hesitation about speaking in a group, individual interviews will be adopted instead. These will be in person or virtual as per participant preference and will be around 40 minutes long.
-Semi-structured Interviews (PCP):
An experienced qualitative researcher will arrange a suitable date and time for one-to-one semi-structured interviews with 20 PCPs (GPs, nurses, administrative staff) currently involved with cervical screening. Each PCP will take part in an interview only once. Interviews will be conducted virtually via a Microsoft Teams meeting (or phone at participants end calling via Teams call) and last around 30-45 minutes. The topic guide will be informed by discussions between the study team, PPIE partners and the scientific literature.
The project design, project materials, and the sampling is informed by NIHR INCLUDE Ethnicity Framework and in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist.
Study population
Women and people with a cervix aged between 25-64 years who are eligible for cervical screening in Scotland and are overdue for screening by at least one screening round, and primary care professionals (GPs, nursed, admin staff) who are currently involved in the provision of cervical screening.
W/PWC: A purposive sampling frame informed by the NIHR INCLUDE project has been used to inform the sample size and recruitment strategy. Purposive sampling will ensure that the study includes participants from various underserved groups such as white W/PWC with socio-economic disadvantage living in an urban area, W/PWC living in rural or remote areas and W/PWC from linguistically and culturally diverse backgrounds living in the most deprived areas of Scotland, including from China, Eastern Europe, particularly Poland; Muslim W/PWC; and Sikh W/PWC.
PCPs: We will use purposive sampling to include professionals with a variety of roles in relation to cervical screening and from a range of practices in disadvantaged and rural and remote communities.
Sample Size
Ninety-six W/PWC will be recruited to 12 face-to-face focus groups (around 8 W/PWC per focus group) an
The sample size was determined to ensure a variety of experiences, both within and across the target groups. This is based on a combination of defined information power (7) (the narrow aim) including the diverse characteristics of the population to be sampled (e.g. socio-economic status, rurality), sample specificity, specific theory, and input from our PPIE co-applicants.
Setting
Primary care practices in rural/remote areas and areas of socio-economic disadvantage across Scotland.
Eligibility and Selection of participants
Inclusion Criteria
• W/PWC aged between 25-64 years who are eligible for cervical screening in Scotland, but who have missed more than one full screening round (no attendance since January 2019).
• PCPs, both male and females, aged 18 +, who are involved in the provision of cervical screening at primary care practices in rural/remote areas and areas of high socio-economic disadvantage in Scotland.
Exclusion criteria:
• W/PWC who are:
• Under colposcopy care within previous 36 months
• Due for test of cure (HPV test) to confirm if successfully treated
• Ineligible for cervical screening
• Lacking capacity to consent
Primary care professionals (GPs, nurses, administrative staff) (PCPs), both male and females, aged 18 +, who are not involved in the provision of cervical screening at primary care practices in rural/remote areas and areas of high socioeconomic disadvantage in Scotland.
Non-English-speaking W/PWC may be given the opportunity to have professional interpreting options from a service provider vetted by the University of Aberdeen or the NHS for their interview (or focus group if there are more than one non-English speaker speaking the same language). The full PIL will be discussed in the participant’s preferred language with the interpreter before the focus group/interview begins, and a note will be made of the name of the interpreter, which will be included in the transcription.
The interpreter will be familiar with cultural norms and have prior experience with research and/or sensitive topics. They will be asked to read the PIL and topic guide ahead of the interview (focus group). Before the interview (focus group) they will be briefed on qualitative interviewing techniques and confidentiality requirements. They will be asked to carry out verbatim interpretation. A consecutive interpretation approach will be adopted where the researcher asks the question – the interpreter translates - the participant speaks. Where necessary, for follow-up questions, the researcher will check with the interpreter specific responses during the interview.
We understand that interpreting may disrupt the flow of the interview. However, to make the interview process flow smoothly, short, clear, open-ended questions will be used, avoiding jargon and culturally specific metaphors. The researcher will speak directly to the participant (not the interpreter) and allow extra time for interpreting and reflection. The qualitative researcher conducting the interviews (focus group) has previous experience of working as an interpreter in various settings and is familiar with pragmatic and ethical issues associated with interpreter-assisted interviews. The researcher will note non-verbal cues and emotional tone.
If non-English speaking participants speak a language that one of the researchers can speak, the research team will carry out the interview in that language. It will be documented who has conducted interpretation for each participant.
The audio recording of the interview will be transcribed verbatim in the original language and then translated into English. In reporting the data, it will be clarified that these interviews were not originally conducted in English, but with the assistance of an interpreter. The original language will also be noted.
Identifying and approaching participants
Identifying Participants
The NHS Research Scotland Primary Care Network (NRSPCN) will identify potential participants (W/PWC) by searching the Practice Patient Management System of participating practices. The list generated by the search will be screened by a clinician before invitations are sent out on behalf of the practice. PCPs in targeted practices will also be identified by the NRSPCN.
Approaching Participants
W/PWC will be sent an invitation letter via the post that includes a paper reply slip and a shortened version of the participant information leaflet (PIL) including the research team contact details. If they are interested in taking part, they can contact the research team directly by their preferred method (email, phone, freepost).
Once an interested individual contacts the research team, a designated female member of the research team will contact that person via their preferred method using the contact details they provided to confirm eligibility. A detailed version of the PIL and the consent form will be sent either by email or by post (depending on the individual’s preference). It will be clearly stated in the PIL that the copy of the consent form is for reference only. The research team member will, as per study protocol, confirm intention to participate, arrange a mutually suitable date, time and venue for the focus group/interview.
For PCP interviews, the NRSPCN will advertise the study in their monthly newsletter or via their regular dissemination activities. NRSPCN will ask interested PCPs to respond directly to the research team. (If PCPs respond to the NRSPCN and provide contact details to forward to the research team, the NRSPCN will email that information to the research team in a password protected Microsoft Word document.) If PCPs request further information before contacting the research team, a shortened version of the PIL explaining the study will be sent to them by the NRSPCN.
Consent
- W/PWC (Focus Groups)
Ahead of the focus groups, eligible individuals who responded to the study invitation and expressed an interest to take part will be sent a detailed version of the PIL explaining the study and a copy of the consent form for reference only. They will be provided with the contact details of the research team to ask any questions about the study and/or to confirm their participation within a one-week period. For eligible individuals who expressed an interest to participate but did not respond within the one-week timeframe, a reminder will be sent (phone call, email or text message) according to their preferred contact method. This is to maximise the response rate. Those who consent but do not attend the focus group/ interview will be followed up once to arrange an alternative date or time where suitable.
Focus group participants will be told that they will be provided with a copy of the consent form by the researcher on the day of the focus group and signed consent will be obtained before the focus group begins. At the beginning of each focus group, the researcher will confirm that participation is voluntary and ask participants to confirm verbally if they are happy to participate and record the session. This will be recorded as part of the audio recording using an encrypted Dictaphone.
The same procedure will take place if a participant chooses to have an individual interview.
- PCPs (Semi-structured interviews)
For PCPs virtual interviews, consent forms will be emailed to eligible participants together with the full PIL and they will be asked to email back the signed consent form before the interview.
All participants are free to withdraw at any time. However, data collected up until the point of withdrawal may still be used in analysis. A copy of the signed consent form will be provided to all participants.
Follow-up procedures
Participants will take part in only one focus group or interview. Participants who express an interest to take part in the study and provide contact details will receive reminders to confirm focus group/interview attendance by (phone call, email or text message) according to participants’ choice, to maximise response rates. Those who consent but do not attend the focus group or interviews will be followed up once to arrange an alternative date or time where suitable.
There will not be any follow-up after the focus groups or interviews have been completed, except for sending a summary of the study findings to those participants who consented to receiving it.
Change of Status/Withdrawal procedures
Participants who withdraw after consent (but before the focus groups/interview) will not be included in the study. These participants will not be replaced for that focus group as it will not be pragmatically possible. However, if needed additional participants will be recruited to fulfil the sample size requirements of the study. Those who withdraw after the data is collected will not be contacted again however, with their consent, the data collected until the point of withdrawal will still be used for analysis.
Data Collection and Processing
W/PWC (Focus groups)
Information on sociodemographic factors including participants’ age, ethnicity, educational background, screening history and location etc. will be collected once the participants confirm their intent to participate. Participants will be considered from an ethnic minority background if they identify as being from any census category other than “White (English/Welsh/Scottish/Northern Irish/British)”.
PCP (Semi-structured interviews)
Information on sociodemographic factors including participants’ age, ethnicity, job type and workplace location etc. will be collected at the beginning of the interview. Participants will be considered from an ethnic minority background if they identify as being from any census category other than “White (English/Welsh/Scottish/Northern Irish/British)”.
Each interview will be audio recorded with an encrypted Dictaphone. In accordance with the standards of good qualitative research, we will take and keep electronic versions of the notes on the focus groups/interviews. Recordings will be transcribed verbatim by a third party without the use of AI platforms (approved and preferred by the University of Aberdeen and sent via ZendTo) and
checked for accuracy. All focus group and interview data will be stored in University of Aberdeen computers only accessible by the researchers. (Further detail is provided in the section 9).
Safety
All focus groups/interviews will be conducted by an experienced female qualitative researcher. The topic guides are informed by discussions between the AYEScreen team, PPIE lead partner and the scientific literature.
Focus group discussions about the possibility of including HPV self-sampling for cervical screening might include conversations about previous barriers to cervical screening which may be sensitive, embarrassing or uncomfortable for some W/PWC. Participants will be told that all information given is voluntary and they do not need to divulge anything that might be upsetting. Should any of the participants feel uncomfortable at any point during the discussions, they may ask the researcher to stop the discussions immediately and (if needed) seek to destroy any data collected on them so far.
Wherever possible if a participant is hesitant to speak in a group they will be provided with an option for an individual interview.
The researcher will do their best to support participants who may become upset/distressed and they will also be provided with resources that could help them (Cervical cancer - The Eve Appeal, Home - Wellbeing of Women). The participants will already be aware of these procedures because they will be informed of this in the study PIL, study consent form and at the beginning of the focus group or interview.
Any sensitive, embarrassing or upsetting discussion is not expected during the PCP interviews.
The research team will complete cultural competence and awareness training before beginning the qualitative work. The research team will remain responsive to input from the PPIE group to maximise the design and enactment of the focus groups.
Analysis
Demographic and descriptive data will be analysed using frequency counts and descriptive analyses. This data will be summarised as to avoid identification.
Data from all focus groups/interviews will be analysed using content and thematic analysis which will allow data to be coded both deductively (content informed by the key constructs and domains from within the guiding theoretical frameworks) but also inductively (thematic informed by identification of additional important themes). We will use NVivo 12 for data analysis. Coding of the transcripts will be performed by one research team member and checked by another.
Thematic analysis will be conducted using the Theoretical Framework of Acceptability (8) This framework has been specifically developed to explore how acceptable healthcare interventions might be to both patients, professionals and health care services.
Only those in the immediate study team will have access to the anonymised transcripts.
Integration of data
The findings from the study will be used to generate an initial set of deductive codes (grounded in the Theoretical Framework of Acceptability) and inductive codes relating to recruitment, randomisation, participants preferences and outcomes of importance to participants to inform the AYEScreen Work Package 2: pragmatic implementation feasibility trial design and patient facing materials.
Study Oversight Arrangements
The AYEScreen study team will meet regularly during the study to ensure the study runs smoothly and to address any issues that may arise and a study update will be reported to the Project Management Group.
Project Management Group (PMG)
The study will be supervised by the full AYEScreen Project management Group (PMG). This consists of the grant holders and representatives from the Trial Office. The PMG will meet/Video conference every 3 months on average.
A Research Fellow will oversee Work Package 1 (Qualitative Study) and will be accountable to the CI. The Research Fellow will be responsible for checking the data for completeness, plausibility and consistency. However, this remains the overall responsibility of the CI. Any queries will be resolved by the CI or delegated member of the study team.
A study-specific Delegation Log will be prepared detailing the responsibilities of each member of staff working on the study.
Patient and Public Involvement (PPIE)
In the context of a public health intervention to increase cervical screening uptake, understanding the perspectives of screening-hesitant women rather than cervical cancer survivors is vital. AYEScreen includes a comprehensive PPIE plan underpinned by the INVOLVE values and principles. All our PPIE members are W/PWC who are eligible for screening. Together with the PPIE panel, we will co-create and confirm specific PPIE involvement for each work package of AYEScreen.
Our PPIE lead has been involved in reviewing the Work Package 1: (Qualitative Study) protocol and participants facing documents. She will attend project meetings and will have contact with the CI and research team throughout the project. PPIE input will be sought during recruitment, data collection, analysis and dissemination of the findings.
Research Governance, Data Protection and Sponsorship
Research Governance
The study will be run by the AYEScreen research team (Chief Investigator Dr Sharon J.B. Hanley). The PMG will ensure that adequate systems are in place for monitoring the quality of the study and that reports are prepared to a level suitable to the risk assessment of the study.
Data protection
Data collected during the research will be kept strictly confidential and accessed only by study team members. Data may be looked at by individuals from the Sponsor organisation for monitoring and auditing purposes.
The AYEScreen staff will comply with the requirements of the UK Data Protection Laws. The HRA recommended wording to fulfil transparency requirements under the GDPR for health and care research has been included in the Participant Information Sheet.
The AYEScreen staff will also adhere to the current version of the NHS Scotland Code of Practice on Protecting Patient Confidentiality. Access to collated participant data will be restricted to the CI and appropriate staff. Audio recordings from interviews and focus groups will be securely transferred to a transcription company vetted by the University of Aberdeen for the purpose of transcription and will be destroyed by them once the transcripts are returned to the research team.
Computers used to collate the data will have limited access measures via usernames and passwords.
Remote access to the University network will be subject to robust authentication, and VPN (Virtual Private Network) connections to the network are only permitted for authorised users, ensuring that use is authenticated, and data is encrypted during transit across the network. No personal data will be downloaded or stored on local hard drives. All data input/access will be via the VPN and/or secure website.
Published results will not contain any personal data that could allow identification of individual participants. Participants are allocated an individual study number which is used to identify consent forms.
We anticipate that anonymised data may be shared with other researchers outside of the research team. Consent will be sought for this.
This data will be collected via phone call (during the call when participants confirm their participation) and the researcher will complete the Microsoft word form in a password protected University of Aberdeen computer, or via Microsoft Forms which is an online survey platform that conforms with GDPR requirements, and which has already been approved for use by the University of Aberdeen. Data will be stored on the secure University server. A subject log will be kept in the study master file in a locked cabinet within a secure building or dedicated secure server at the University of Aberdeen. This will be held separately from the research data.
The focus group/interview data (including demographic information) will be treated confidentially. Focus groups/ interviews will be audio-recorded using an encrypted Dictaphone. Recordings will be transferred immediately upon completion of each interview to a secure Dropbox and saved with a unique identifier. All files will be password protected and access will be restricted to the study team. Data will be deleted from the transcriber’s Dropbox within 2 weeks of the transfer (the 2-week period is to ensure correct and full transfer).
Any notes (taken on paper or a University laptop) and transcripts will be anonymised and not shared outside the research team.
All paper-based information such as completed participant study consent forms will be kept in a locked filing cabinet within a locked room and accessed by the research team only.
Contact details will be deleted at the end of the study except for those who consent for receiving summary results and/or consent to be contacted for future research.
All essential data and documents (electronic and hard copy) will be stored securely and confidentially for 10 years in accordance with Sponsor SOPs, after which they will be archived then destroyed. Hard copies will be stored in the University of Aberdeen’s archive facility (basement of Health Science Building). Electronic data will be stored in a folder on the University of Aberdeen server allocated for the project.
Ethics and Regulatory Approvals
Research Ethics Committee and appropriate NHS R&D approvals will be obtained prior to the commencement of recruitment. The study will be conducted according to the principles of Good Clinical Practice Guidelines and any appropriate NHS R&D approvals will be obtained. The final report will be submitted to the Sponsor and the REC within the timelines defined in the regulations.
Protocol compliance and amendment
The Investigators will conduct the study in compliance with the Protocol given favourable opinion by the NHS Research Ethics Committee. In the event that a CI needs to deviate from the protocol, the nature of and reasons for the deviation will be recorded in the CRF, documented and submitted to the Sponsor. If this necessitates a subsequent protocol amendment, this will be submitted to the Sponsor for approval and then to the appropriate REC and lead NHS R&D Office for review and approval. Sponsor will advise if an amendment is substantial / non-substantial and which review bodies need to receive it. Amendments to the protocol or other study documents will not be implemented without these approvals.
In the event that a serious breach of GCP is suspected, this will be reported to the Sponsor immediately using the form “Breach Report Form”.
Monitoring and Audit
The study is monitored to ensure that it is being conducted as per protocol, adhering to Sponsor SOPs, the principles of GCP, and all other appropriate regulations. Investigators and their host institutions are required to permit study related monitoring and audits to take place by the Sponsor and/ or regulatory representatives, providing direct access to source data and documents as requested.
The Chief-Investigator (CI) will be responsible for the ongoing management of the study. The Sponsor will monitor and conduct audits on a selection of studies in its clinical research portfolio. The study will be monitored according to the University of Aberdeen Standard Operating Procedures and in accordance with the Sponsor’s monitoring and audit procedure.
The CI, PIs and all institutions involved in the study shall permit study related monitoring, audits, and REC review.
Risk assessment
An independent risk assessment will be carried out by the sponsor.
Finance and Insurance
AYEScreen is funded by a grant awarded by the Cancer Research UK (CRUK). Funder Number: EDDPJT-Nov24/100049. The necessary study insurance is provided by the University of Aberdeen.
The University of Aberdeen is the study sponsor. The University of Aberdeen holds and maintains policies of indemnity. These policies cover principals, partners, directors, employees and students of the University.
Where the study involves University of Aberdeen staff, who hold an honorary contract with Grampian Health Board, undertaking clinical research on NHS patients, such staff will have cover under Grampian’s membership of the CNORIS scheme.
End of Study
The end of interview or focus group for each participant is defined as the final data capture on that individual.
The end of the study will be reported to the Sponsor and REC within 90 days, or 15 days if the study is terminated prematurely. If terminated prematurely, the Investigators will inform participants and ensure that the appropriate follow-up is arranged for all involved, if appropriate.
The summary of findings from Work Package 1 will be provided to the Sponsor and REC within one year of the end of the study. An end of study report should also be issued to the funders at the end of funding.
Data Handling, Record Keeping and Archiving
The CI and study staff involved with this project will comply with the requirements of the UK data protection laws.
Descriptive/demographic data will be collected anonymously and treated confidentially. This data will be collected via Microsoft Word form (during the phone call with participants when they confirm their participation) or Microsoft Forms which has already been approved for use by the University of Aberdeen.
The focus group/interview data (including any demographic information) will be treated confidentially. Focus groups/ Interviews will be audio-recorded, and recordings will be transferred immediately upon completion of each interview/focus group to the secure network folder and saved with a filename using the unique identifier. The recordings from the Dictaphone will be deleted once the recording is uploaded. Focus groups and interviews recordings will then be securely transferred from the University of Aberdeen to the transcriber. The audio recordings will be deleted once the transcripts are checked. Identifiable data transcripts will be stored in password protected University of Aberdeen computers access to which will be restricted to the study team. Data will be deleted from the transcriber’s Dropbox within 2 weeks of the transfer (the 2 weeks is to ensure correct and full transfer). All paper-based information such as completed participant study consent forms will be kept in a locked filing cabinet, within an office in the Polwarth Building at the University of Aberdeen. Electronic consent will be stored in a secure folder on the University of Aberdeen server allocated for the project.
Computers used to collate the data will have limited access measures via usernames and passwords. Files will only be accessible to University of Aberdeen staff within the immediate study team.
Published results will not contain any personal data that could allow identification of individual participants.
The sponsor is responsible for archiving the data appropriately. All essential data and documents (electronic and hard copy) will be stored securely and confidentially for 10 years in accordance with Sponsor SOPs, after which they will be archived then destroyed.
Data Sharing plan
Qualitative data collected during the study are likely to have value to the scientific community, particularly to those interested in the incorporation of HPV self-sampling in population cervical cancer screening programmes. We will agree finalised plans for data sharing and transparency with our PPIE and AYEScreen study advisory groups.
Data sharing issues will be detailed in all research ethics committee and required regulatory approvals.
All publications will include a data access statement. We anticipate that we will have exclusive use of the data until the AYEScreen study findings are published which is planned within one year of the end of study.
Dissemination
A lay summary of the findings from the qualitative study will be sent to participants if they have requested these. Study findings will also be disseminated to primary care professionals who
participated and other relevant bodies including those responsible for the cervical screening programme in Scotland.
The study results will also be presented at research meetings and published in scientific journals. We will also make results available to the public. Participants will not be identified in any report or publication.
More detailed plans for this dissemination will be considered and developed with input from the PPIE partners through the duration of the study and will be finalised as part of the close-out plans.
Authorship Policy
Ownership of the data arising from this study resides with the study team and their respective employers. On completion of the study, the study data will be analyzed and tabulated, and a clinical study report will be prepared.
Peer review
An independent review has been done by the funder.
Protocol references
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2) Public Health Scotland. Cancer Mortality in Scotland. Available from: https://publichealthscotland.scot/publications/cancer-mortality/cancer-mortality-in-scotland-annual-update-to-2020/data-files/
3) The opportunities and challenges to eliminating cervical cancer in the UK, Jo’s Cervical Cancer Trust 2023 Report. Available from https://www.jostrust.org.uk/sites/default/files/Jos%20Cervical%20Cancer%20Trust%20-%20We%20Can%20End%20Cervical%20Cancer%202023.pdf
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6) Nelson M, Patton A, Robb K, Weller D, Campbell C, et al. Experiences of cervical screening participation and non-participation in women from minority ethnic populations in Scotland, Health Expect. 2021 Aug;24(4):1459-1472.
7) Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10. PMID: 26613970.
8) Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Services Research. 2017;17(1):88.
Acknowledgements
Funded by Cancer Research UK (CRUK)