Background/Objectives: In England, gay, bisexual, and other men who have sex with men (GBMSM) are eligible for vaccination at NHS sexual health services, including human papillomavirus (HPV), hepatitis A virus (HAV), and hepatitis B virus (HBV) vaccines. However, current research shows limited understanding of the factors influencing vaccination uptake among GBMSM. This study aimed to examine the barriers and facilitators affecting the offer and uptake of these vaccination programmes. Methods: A qualitative interview study following the Person-Based Approach (a systematic method for developing and optimising health interventions) involving GBMSM and sexual health service staff from two regions of England. Purposive sampling aimed to include GBMSM with diverse backgrounds and engagement with sexual health services. Patient and public involvement shaped the study design and interview topic guides. The interviews were recorded, transcribed, and thematically analysed to identify barriers and facilitators which were interpreted using the COM-B model of behaviour change. Results: Twenty GBMSM and eleven staff took part. The findings showed that opportunistic delivery of HPV, HAV, and HBV vaccination within sexual health services is mostly acceptable and feasible for GBMSM and staff, while also highlighting areas for optimization. Despite low knowledge of these viruses and their associated risks, willingness to be vaccinated was high, with healthcare provider recommendations and the convenience of vaccine delivery during routine clinic visits acting as important facilitators. However, the reach of opportunistic models was limited, particularly for individuals underserved by sexual health services or disengaged from GBMSM social networks. System-level barriers such as complex vaccine schedules (particularly when multiple schedules are combined), inconsistent access to vaccination histories, and limited system-level follow-up processes (e.g., automated invites and reminders) were also found to act as obstacles to vaccination uptake and delivery. Conclusions: To improve equitable uptake, sexual health services should explore the feasibility of addressing both individual and structural barriers through additional strategies, including targeted and persuasive communication to increase knowledge, leveraging regular contact with GBMSM to promote uptake, and implementing enhanced approaches to support vaccination completion (e.g., automated prompts or reminders).
Background Testing for HIV, linkage to treatment, and access to pre-exposure prophylaxis (PrEP) (medication that reduces the risk of acquiring HIV) is essential for early HIV diagnosis, treatment, and prevention. General practice could play a key role in maximising HIV testing opportunities and supporting access to PrEP. Aim To develop an intervention for general practice to increase HIV testing and facilitate access to PrEP. Design and setting This was a person-based approach (PBA) intervention development study using the capability, opportunity, motivation, behaviour model in South West England. Method A scoping review and semistructured interviews with healthcare professionals (HCPs) and local organisation representatives with an interest in HIV prevention/health care were conducted to understand the challenges and find potential solutions to increase HIV testing and facilitate access to PrEP in general practice. Intervention development used focus groups with HCPs and the public. Purposive sampling ensured diversity of practices and participants. Data were analysed using the PBA table of planning and the collaborative and intensive pragmatic qualitative approach. Results Barriers identified included lack of clinician knowledge of HIV and PrEP, concern about stretched resources, and a lack of systematic testing methods. Proposed strategies included simpler testing approaches to normalise testing and reduce HIV stigma. The intervention developed consists of: education, a prompt to test, simplified and standardised testing, PrEP signposting processes, patient information, and practice champions. Conclusion Research is needed to explore the feasibility and the effectiveness of this multicomponent intervention to increase testing and access to PrEP within general practice. Funding barriers also need to be addressed.
Introduction:Co-production is an important practice for addressing health disparities and developing equitable services with underserved communities. Co-production aims to ensure that underserved communities are central to the design of services that reflect community needs. African and Caribbean heritage communities (ACHC) face heightened risks of HIV due to stigma, discrimination, social, economic and structural factors, leading to significant health inequities. Despite a national target to end new HIV transmissions by 2030, HIV remains prevalent. Common Ambition Bristol (CAB) is a co-production project aiming to increase HIV knowledge and testing. CAB's Project Delivery Group (PDG) involves ACHC community members and sexual health staff working in equal partnership to improve sexual health services for ACHC. Methods:A longitudinal qualitative evaluation explored the process of CAB's co-production over time. Interviews were conducted with members of CAB's PDG at three time points. Interviews examined PDG views and experiences of the co-production process. Data were analysed thematically. Results:Five themes are reported which relate to equitable power-sharing and inclusive decision-making: (1) Acknowledging power imbalances and negotiating roles, (2) Appreciating commonalities and the importance of language, (3) Benefits of sharing lived and sexual health experiences, (4) Negotiating different opinions safely and (5) Co-production: the messy middle. Conclusions:Findings underscore the potential of co-production to drive meaningful progress in health equity. Key elements of co-production which promote equitable power-sharing and effective decision-making are: (1) acknowledging and addressing unequal power structures which may affect group dynamics; (2) fostering reciprocal learning from lived experience and sexual health expertise; (3) recognising and appreciating personal and sexual health commonalities; (4) negotiating and developing ways to ensure equitable decision-making and (5) agreeing a shared language which reflects 1-4.
African and Caribbean communities in high-income countries face disproportionate sexually transmitted infection (STI) risks. In the US, the gonorrhoea rate among non-Hispanic Blacks is 7.7 times greater than that among non-Hispanic Whites, and the chlamydia rate is 5.6 times greater. In the UK, black Caribbeans have the highest gonorrhoea and chlamydia rates among all ethnic minority groups. Identifying barriers to and facilitators of HIV/STI testing is crucial for developing effective interventions. This scoping review maps current evidence on multilevel factors influencing STI testing behaviours among these populations onto the COM-B (Capability, Opportunity, Motivation-Behaviour) model, which posits that capability (i.e., knowledge/skill), opportunity (i.e., social and environmental influence), and motivation (i.e., confidence/beliefs) are essential for engaging in a behaviour (i.e., HIV/STI testing). MEDLINE and Embase were searched for studies published between 2013 and 2024 on STI testing barriers and facilitators among African and Caribbean populations in high-income countries. Qualitative, quantitative, and mixed-methods studies were included. The titles/abstracts were screened, the data were charted, and the findings were synthesised via COM-B as an organizing framework. Fifty-eight studies were included. The key capability barriers were low STI knowledge and language difficulties. Social opportunity barriers included stigma, discrimination, and lack of support. Clinic times and locations impeded physical opportunities. The motivation barriers were fear of positive results, cost, risk perception, confidentiality concerns, and competing priorities. Key facilitators included awareness initiatives, treatment knowledge (capability), supportive networks, outreach (social opportunity), free testing, convenient options (physical opportunity), and risk perceptions, relationships, and incentives (motivation). This review highlights the complex interplay of COM-B factors influencing STI testing among African and Caribbean heritage communities, drawing attention to pervasive stigma and socioeconomic barriers. Multilevel interventions should enhance capability through education, opportunity via community coproduction and convenient testing, and motivation by addressing stigma and leveraging facilitators. Integrating an intersectionality lens and evaluating community-driven approaches are future directions for promoting sexual health equity.
BACKGROUND:A significant challenge to achieving global 2030 elimination goals for blood-borne viruses (BBVs) is identifying undiagnosed individuals and relinking those who are no longer in care. To address this, the UK government has implemented opt-out BBV testing in emergency departments (EDs) to increase access to BBV testing in high prevalence areas. All adult ED patients having a routine blood test are automatically tested for HIV, hepatitis B and C, unless they opt out. This study aimed to identify barriers and facilitators to the implementation of ED opt-out BBV testing and provide recommendations for future rollouts. METHOD:Semi-structured interviews with 23 staff members across five ED sites in very high HIV prevalence areas were analysed thematically, informed by Normalisation Process Theory. RESULTS:While there was some variation in staff knowledge and understanding of the programme, overall acceptance of the opt-out testing approach was found to be high. Training had a positive impact on staff understanding of the purpose of the intervention and the correct process, including the opt-out model. High workloads and competing priorities in EDs were significant barriers to testing. However, some specific systems and processes that facilitated the uptake of testing included automation and BBV champions. Giving the programme time to embed into practice and ensuring feedback loops and flexibility to 'tweak' the process was also essential to sustaining the programme. CONCLUSION:To embed opt-out testing into emergency care, sites should implement automated test ordering, staff training, clear communication and dedicated champions, which can help to support earlier diagnosis, reduce inequalities and improve patient outcomes.
Introduction In 2021, Bristol (UK) became the first city outside London to introduce a policy restricting advertisements of high fat, salt and sugar (HFSS) products and other unhealthy commodities (alcohol, gambling and payday loans) on council-owned advertisement sites, predominantly bus stops. This research evaluates the impact of this policy on household purchasing of HFSS products specifically. Methods Take-home purchasing data for food and drink items recorded from October 2020 to May 2023 (74 weeks before and 59 weeks after policy implementation) by 1012 households from Kantar’s Worldpanel division were included in the analysis: 217 households from Bristol (intervention) and 795 from Cardiff, Sheffield, Gloucestershire and South Gloucestershire (controls). Controlled interrupted time-series analyses adjusted for confounders were used to estimate the change in average weekly household purchases of energy and nutrients from HFSS products in the post-intervention period (from 1 April 2022) compared with the counterfactual (data from controls and pre-intervention in Bristol). Results There was no indication of changes in purchasing of HFSS products in Bristol following the policy; mean change in weekly household purchases of energy and nutrients from take-home HFSS products was 897.6 kcal (95% CI −57.7 to 1.853) or 6.1% (95% CI −0.7 to 12.9) for energy, 4.6% (95% CI −2.6 to 11.9) for fat, 6.1% (95% CI −2.9 to 15.0) for sugar and −1.9% (95% CI −17.4 to 13.6) for salt, respectively, compared with the counterfactual. Stratified analyses by household socio-demographics also showed no evidence of changes in energy purchased from HFSS products in Bristol. Conclusions This study did not observe evidence of changes in purchasing of HFSS products following Bristol’s advertising restriction policy. Bristol City Council owns a relatively small part (~30%) of the city’s outdoor advertisement estate, so changes in exposure may have been too small to lead to measurable effects. Extending similar policies to cover more outdoor spaces and advertising platforms is probably required to impact purchasing behaviour.
BACKGROUND:In England, up to 5% of people living with HIV are undiagnosed and the proportion of late diagnoses remains high. Opt-out testing could help to identify people living with undiagnosed HIV who might not access testing in other settings. We aimed to evaluate the cost-effectiveness of the first phase of UK National Health Service (NHS)-funded opt-out testing for HIV in emergency departments, which scaled up from 2022. METHODS:We adapted a previously developed deterministic model of HIV diagnosis, progression, and transmission to simulate the impact of the first 33 months of the opt-out testing intervention in improving HIV diagnosis, incorporating programme data on CD4 cell count at diagnosis. We conducted a bottom-up costing of the intervention in two sites, from an NHS perspective, and gathered costs of HIV care from the literature. In the base case we assumed 93% of new diagnoses would not have been diagnosed elsewhere during the programme as these individuals had never previously been tested for HIV. Cost-effectiveness is presented as incremental costs per quality-adjusted life-year (QALY) gained over 20 years compared with a £25 000-35 000 per QALY threshold. We explored scenario analyses to address the limitations of the model assumptions. FINDINGS:The mean cost per HIV test was £6·31 (US$7·91). Under base case assumptions, emergency department opt-out testing is projected to avert 187 HIV-related deaths (95% credible interval 182-196) and 28 secondary acquisitions (26-52) over 20 years, costing £18 630 (17 413-23 119) per QALY gained. This result is robust (below £35 000 per QALY) to different assumptions about HIV-related quality of life and HIV care costs, HIV-related mortality, and the rate of diagnosis outside the programme. Under a lower test yield scenario of 0·20 new diagnoses per 1000 tests (compared with 0·29 in the base case), the intervention remains cost-effective at £25 000 per QALY. INTERPRETATION:Emergency department opt-out testing for HIV in England was cost-effective due to averted HIV-related morbidity and mortality resulting from improving diagnosis and linkage to care for people who would otherwise not be tested, many of whom have already reached an advanced stage of HIV progression. Our findings provide evidence to support continuation of the opt-out testing programme as part of the HIV Action Plan for England. FUNDING:National Institute for Health and Care Research and NHS England.
BACKGROUND:People experiencing severe and multiple disadvantage (SMD)- including intersecting experiences of homelessness, substance misuse, poor mental health, and domestic violence and abuse- face high levels of unmet health need but encounter significant barriers to accessing general practice. AIM:We aimed to explore how interventions or aspects of routine general practice care can improve access for people with SMD, examining what works, for whom, and under what circumstances. METHOD:We used a realist review approach as both general practice and access to services for people with SMD are complex; bringing them together required a nuanced understanding of underlying mechanisms. We developed an initial programme theory by consulting experts by experience, professional stakeholders, relevant literature and substantive theory. We searched databases and sought literature from relevant networks, including qualitative, quantitative, mixed-methods, and grey literature. We included full texts with relevant data that could inform programme theory development, and organised these into intervention components. We used a realist analytical approach to synthesise evidence and make conclusions. We collaborated with experts by experience and professionals supporting them throughout, to ensure findings and recommendations were relevant and applicable. RESULTS:Themes of belonging, trust and power are key in improving access to primary care for and with people with SMD. Interventions to improve Inclusion Health in primary care include outreach, partnership working, peer involvement and advocacy, flexible access, specialist clinics, staff training, appointment systems, case management, co-design and challenging unjust systems. CONCLUSION:Using actionable strategies, general practices can better include people with SMD.
OBJECTIVES:To develop and pilot a community pharmacy pre-exposure prophylaxis (PrEP) awareness-raising and referral pathway, informed by a literature review and interviews with pharmacists and community members. METHODS:Using the person-based approach and the Capability, Opportunity, Motivation-Behaviour change (COM-B) model, the pilot aimed to improve HIV/PrEP knowledge/capability and motivation through pharmacist and community awareness-raising. Opportunity was addressed by integrating PrEP consultations into pharmacy services and offering sexually transmitted infection (STI), HIV and kidney function home self-sampling kits. Financial incentives aimed at motivating pharmacists. Pharmacists initiated PrEP discussions and provided self-sampling kits. Individuals interested in starting PrEP were referred to the sexual health clinic, completed the tests and posted them to the clinic for processing. Clinic staff then confirmed PrEP eligibility and prescribed PrEP remotely. National Health Service (NHS) policy restrictions on pharmacies stocking NHS-procured PrEP informed the delivery model. The pilot evaluation focused on staff training impact, number/type of consultations and acceptability and feasibility for staff and community members. RESULTS:The pilot was conducted in five pharmacies across Bristol, North Somerset and South Gloucestershire from October 2024 to April 2025. A total of 55 individuals (aged 18-69 years, n=23 male, n=31 female, n=1 transgender) were made aware of PrEP and offered a referral for PrEP. Visit reasons included emergency contraception (n=14), PrEP (n=14) and opioid substitution therapy (n=11). Twenty-eight community members expressed interest in PrEP; 22 accepted a self-sampling kit, nine returned it and four were prescribed PrEP. Pharmacists and community members viewed the service positively. Barriers included pharmacists' initial lack of confidence initiating PrEP discussions and limited public awareness of PrEP availability in pharmacies. CONCLUSION:Community pharmacies represent a promising site for a PrEP awareness-raising and referral pathway. Successful scale-up requires pharmacist training, public health education and structural and policy changes to support accessible PrEP provision beyond sexual health clinics to reduce inequities.
Background The global response to HIV has achieved major advances, while the uptake of proven prevention, screening, and treatment technologies remains uneven, particularly in resource-limited settings. Implementation initiatives are essential to bridge this gap, but their economic implications are less systematically understood. Methods We conducted a systematic review to synthesize evidence on the implementation costs and economic evaluations of global initiatives designed to improve uptake of HIV-related technologies. We systematically searched MEDLINE, Embase, LILACS, PsycINFO, EconLit, and Web of Science for peer-reviewed studies published between 1981 and December 2024. We included studies that reported economic evaluations of implementation strategies aiming to enhance the uptake of HIV prevention, screening, or treatment technologies in low-, middle-, and high-income countries. We excluded studies based on hypothetical scenarios, technology-only evaluations, or non-HIV interventions. We extracted data on study characteristics, implementation strategies, outcomes, and costs using the ERIC and RE-AIM frameworks. We standardised costs to 2024 USD and synthesised economic findings narratively. We assessed study quality using the Drummond checklist. Results We screened 4,387 records and included 25 eligible studies. The interventions focused on prevention (n = 6), treatment (n = 5), screening (n = 12), or combined aims (n = 2). The most frequent implementation strategies involved engaging patients and communities, modifying infrastructure, and training providers. Implementation costs ranged from $2 to $11,979 per person reached, with lower averages in low- and middle-income countries ($108; range $3–660) than in high- and upper-middle-income settings ($1,694; range $2–11,979). We identified 16 studies that conducted full economic evaluations. Prevention and screening initiatives more frequently reported cost-effective or cost-saving results, while treatment studies showed greater variability, partly due to methodological and contextual differences. Conclusions Implementation costs and cost-effectiveness outcomes varied widely across settings and intervention types. Our findings highlight the need to standardise cost classification, reporting, and analytic methods to strengthen the integration of economic evidence within implementation science. We discussed how to improve methodological consistency to enhance comparability and policy relevance, supporting efficient and equitable progress toward global HIV targets. Registration: Protocol published on PROSPERO international database (CRD42024565223).
Background Policies restricting advertisements of high fat, salt and sugar (HFSS) products and other unhealthy commodities are potentially effective tools to improve diet, reduce diet-related diseases and address public health inequalities. Bristol was the first UK city outside London to introduce such a policy on council-owned advertisement spaces in 2021. This study evaluates the policy’s impact on self-reported exposure to advertisements of HFSS products, alcohol and gambling, and self-reported consumption or use of these products. Methods A repeated cross-sectional survey of Bristol residents (intervention) and neighbouring South Gloucestershire residents (comparator) was administered before (n = 2,543) and after (n = 2,076) the policy was implemented. Self-reported exposure to outdoor adverts on HFSS products, alcohol and gambling in the local area and consumption or use of these products was collected, along with socio-demographic information. The intervention effect was analysed using a weighted controlled before-after design. Result Following the policy, there was no evidence of a change in self-reported exposure to advertising of unhealthy commodities, compared to the comparator group; percentage point change in exposure to advertising was − 6.9% (95% CI -34.9, 35.0) for any unhealthy commodity, -19.2% (95% CI -45.1, 17.4) for HFSS foods/drinks, 33.6% (95% CI -14.8, 100) for alcoholic drinks and − 8.6% (95% CI -38.1, 36.3) for gambling. Likewise, there were non-significant changes in self-reported consumption of HFSS products (-2.0% (95% CI -49.3, 89.6), alcohol (15.0% (95% CI -18.9, 64.9) and participation in gambling (-17.3% (95% CI -45.7, 25.9) following the introduction of the policy in Bristol, compared to comparators. Conclusions Following the implementation of the policy there was no measurable reduction in self-reported exposure to outdoor advertising of unhealthy commodities, nor was there much evidence of changes in reported consumption of HFSS products, alcohol or gambling. This may be attributable to the relatively small Council-owned outdoor advertisement estate (~ 30%), so changes in exposure may have been too small to lead to noticeable effects. However, this policy aligns with Bristol City Council’s ‘Health in all Policies’ approach aimed to support a systems-wide approach to improve health.
To reduce the risk of COVID-19 infection, transmission and illness during the pandemic, the Department for Education (DfE) issued guidance to schools. However, research on how the school community perceives the impact of the COVID-19 mitigation measures outlined remains limited. This qualitative study aims to explore the effects of school closures and in-school mitigation measures on daily school life, as well as their impact on mental health and wellbeing from the perspective of English secondary school staff and students. Participants were purposively sampled from English secondary schools serving diverse communities participating in the COVID-19 Mapping and Mitigation in Schools study (CoMMinS). Selection ensured representation of staff roles and student demographics. Semi-structured interviews were conducted remotely, and data analysed thematically. Interviews took place between January and August 2021 with participants from five secondary schools (20 staff and 25 students). Both staff and students reported significant disruption to school life, with four themes identified: (1) teaching and learning impact, (2) social impact, (3) safeguarding impact, and (4) and mental health and wellbeing impact. Findings highlight widespread negative effects across every aspect of school life, for both staff and students. This study suggests that COVID-19 mitigation measures in UK secondary schools led to a sense of loss and uncertainty as well as increased self-reported stress among both staff and students.
In England, the national Government was responsible for balancing the risks of COVID-19 infection, transmission and illness against the known risks of school closures. The Department for Education (DfE) issued guidance to schools, however, there is limited empirical evidence on the experiences of staff and pupils affected by the guidance and accompanying COVID-19 mitigation measures. This qualitative study explored secondary school staff and pupils’ views and experiences of COVID-19 guidance and mitigation measures. There were two main objectives: (i) to examine implementation effectiveness, and (ii) to explore their effectiveness at promoting safety. Participants were purposively sampled from English schools serving diverse communities participating in the CoMMinS (COVID-19 Mapping and Mitigation in Schools) study. Semi-structured interviews were conducted remotely, and data were analysed thematically. Interviews took place between January and August 2021 with participants from five secondary schools (20 staff and 25 pupils); staff represented a range of roles within the school and pupil demographics varied. Main themes were: (i) negative views of the DfE guidance; (ii) negative experiences of the DfE guidance; (iii) ineffectiveness of the DfE guidance and school mitigation measures at promoting safety and reducing risk; (iv) ineffective implementation of the mitigation measures due to poor adherence and acceptability (with sub-themes for Lateral Flow Testing (LFT), face coverings, physical distancing and ventilation); and (v) positive perceptions (with sub-themes for hygiene measures, and approaches that facilitated implementation and safety which included staff enforcing compliance, having an ethos of co-operation, addressing inconsistencies, and minimising change). Insights from this research will help understand effectiveness of the measures in the ‘real-world school setting’. Understanding the experiences of staff and pupils will help to support policymakers and school leaders in future pandemic decision-making. This research identified challenges with the guidance and measures, minimal impact on perceived safety, and a negative impact on wellbeing. These challenges should be considered when assessing the benefit of the measures in keeping schools safe.
Objectives: To develop and implement a community pharmacy pre-exposure prophylaxis (PrEP) awareness raising and initiation pilot, informed by a literature review and interviews with pharmacists and community members. Methods: Using the Person-Based Approach and the Capability, Opportunity, Motivation-Behaviour change (COM-B) model, the pilot aimed to improve HIV/PrEP knowledge/capability and motivation through pharmacist and community awareness-raising. Opportunity was addressed by integrating PrEP consultations into pharmacy services and offering STI, HIV, and estimated glomerular filtration rate (eGFR) home test kits. Financial incentives also aimed to motivate pharmacists. Pharmacists identified eligible community members, initiated PrEP discussions, and provided home testing kits. Individuals opting to start PrEP completed the tests and posted them to a local sexual health clinic, where staff reviewed the results, confirmed eligibility, and prescribed PrEP remotely. NHS policy restrictions on pharmacies stocking NHS-procured PrEP informed the delivery model. The pilot evaluation focused on staff training impact, number/type of consultations, and feasibility and acceptability of pharmacy PrEP delivery for staff and community members. Results: The pilot was conducted in five pharmacies across Bristol, North Somerset, and South Gloucestershire from October 2024 to April 2025. A total of 55 consultations were held with individuals aged 18-69 (n=23 male, n=31 female, n=1 transgender). Visit reasons included emergency contraception (n=14), PrEP (n=14), and opioid substitution therapy (n=11). Twenty-eight community members expressed interest in PrEP; 22 accepted a home testing kit, seven returned it, and four were prescribed PrEP. Pharmacists and community members viewed the service positively. Barriers included pharmacists' initial lack of confidence initiating PrEP discussions and limited public awareness of PrEP availability in pharmacies. Conclusion: Community pharmacies represent a promising site for PrEP delivery. Successful scale-up requires pharmacist training, public health education, structural and policy changes to support accessible PrEP provision beyond sexual health clinics to reduce inequities. ### Competing Interest Statement RHS is a full-time employee of Gilead Sciences ltd. ### Funding Statement This research was funded by Gilead Sciences, Inc, and supported by the National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West) and the NIHR Health Protection Research Unit (HPRU) in Evaluation and Behavioural Science at the University of Bristol, and NIHR HPRU in Blood Borne and Sexually Transmitted Infections at UCL, both in partnership with UK Health Security Agency UKHSA. The views expressed in this article are those of the authors and not necessarily those of the NIHR, UKHSA or the Department of Health and Social Care. CH's time is funded by Gilead Sciences, Inc., NIHR ARC West and NIHR HPRU in Evaluation and Behavioural Science. HF, JH, JK are partly funded by NIHR ARC West and NIHR HPRU in Evaluation and Behavioural Science. SD's time is supported by NIHR HPRU in Evaluation and Behavioural Science. RHS is a full-time employee of Gilead Sciences ltd ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval for this study was awarded by the National Health Service, Health Research Authority, Research Ethics Committee (345513). All participants gave informed consent to participate in the study before taking part. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data underlying this article are available at data-bris.ac.uk