The Windrush Generation describes a group of individuals who migrated, primarily from the Caribbean to the UK between 1948 and 1971, many of whom are now entering older age. Now entering later life, many face ongoing health inequalities shaped by systemic racism and cultural marginalisation. Despite a growing number of ethnic minority residents in UK care homes, little is known about the lived experiences of Black African Caribbean people in these settings, particularly at the end of life.

This qualitative study explores the experiences of Black African Caribbean care home residents and their families, focusing on how race, identity and marginalisation shape care. Guided by the Silences Framework, semistructured interviews will be conducted with up to 16 participants across diverse care home settings. Data will be analysed thematically, with attention to under-represented narratives. A Patient and Public Involvement group of African Caribbean community members has codeveloped the study and will support analysis and dissemination to ensure cultural relevance.

Ethical approval has been secured (REC: 24/WM/0151; protocol number: RG_21087; IRAS project ID: 302629), and the study will follow rigorous consent and capacity procedures, including caregiver affirmation and UBACC assessment where needed. Given the sensitive, potentially distressing focus on racism, marginalisation and end-of-life experiences, the research will be conducted by an experienced clinician-researcher using a reflexive, ethically grounded approach that safeguards both participants and researcher. Interviews will be held in private, accessible settings with appropriate advocacy, safeguarding concerns will follow care home and national protocols, and all data will be securely stored, anonymised and managed under General Data Protection Regulation and university governance, with the University of Birmingham as sponsor and data controller.

We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment.

A three-arm, parallel-group, open-label randomised feasibility trial.

Tertiary neonatal intensive care in London, UK.

We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (±8.00D) were not included. Infants with retinopathy of prematurity were not excluded.

At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses).

Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term.

Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant).

We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study.

ISRCTN14646770; NCT05048550.

Spinal cord injury (SCI) affects over 18 000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder and sexual function, and overall QoL.

The study is a phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every 3 months. The study will be conducted over a period of 4 years. A total of 36 participants will be enrolled and followed for 1 year.

Bayesian optimisation will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.

Food and Drug Administration and University of Minnesota Institutional Review Board approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations and clinical network reporting.

CE-STAND (Cervical Epidural STimulation After Neurological Damage) seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes and reducing healthcare costs. Future studies could consider a larger sample size, long-term safety, matched-control and randomisation.

NCT06410001

For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

NCT05338944.

Most adolescents fail to achieve recommended levels of vigorous-intensity physical activity, despite the established benefits for cardiorespiratory fitness and vascular health. Supervised interventions can be effective, but are resource-intensive and lack scalability. Mobile health (mHealth) technologies may provide a cost-effective and accessible approach to support structured, individualised training for adolescents. The Motivating Adolescent Fitness (MOTAFIT) trial will assess the feasibility and acceptability of an mHealth-supported exercise intervention for adolescents to inform the design of a definitive randomised controlled trial (RCT).

MOTAFIT is a three-arm feasibility RCT targeting 120 adolescents aged 13–16 years from the Okanagan Valley, British Columbia. Participants will be randomised (1:1:1) to: (1) MOTAFIT, (2) active control or (3) control group. The 12-week intervention targets ≥40 min/week of vigorous-intensity exercise (≥80% HRmax), co-designed with an exercise specialist and supported by mHealth technology. Primary outcomes for feasibility, including recruitment, retention, adherence, fidelity and acceptability, will be assessed as part of a process evaluation. Secondary measures (cardiorespiratory fitness, vascular health and blood pressure) will provide preliminary estimates to guide future sample size calculations.

The study has received approval from the University of British Columbia Clinical Research Ethics Board (H22-03183) and the University of Victoria Human Research Ethics Board. Parental consent and adolescent assent will be obtained prior to participation. Findings will be disseminated via peer-reviewed publications, conferences and community engagement.

NCT06409793.

Premature birth is the leading cause of neonatal morbidity and mortality. Understanding perceptions, beliefs and attitudes towards preterm births, and how these factors influence care provision at health facilities and at home is crucial for improving preterm newborns’ health outcomes.

We conducted an exploratory qualitative study at Batu and Meki communities in the East Shewa Zone of Oromia Region, Ethiopia. We conducted in-depth interviews (n=81) and focus group discussions (n=8) using semistructured guides. The study participants included women who had preterm births, family members, community members, healthcare workers and expert stakeholders. We audio-recorded, transcribed the interviews and coded the transcripts. We employed the socioecological model to present perceptions, beliefs and attitudes towards preterm birth at individual, interpersonal, organisational and societal levels.

Giving birth to a preterm newborn is often associated with fear, stress, unhappiness, concern and worry. At the individual level, preterm newborns’ mothers often feel guilt and self-blame. Families tend to keep preterm birth a secret due to perceptions of ‘incompleteness’. At the interpersonal level, preterm newborns are often stigmatised and families are disappointed by mothers who give birth prematurely. However, some believe that preterm newborns are accepted within the community. At the organisational level, healthcare providers find the causes of preterm birth unpredictable, they do not consider preterm births prevalent, and consider some of them as abortion. There is also a common belief that preterm infants have a low survival rate, leading to the deprioritisation of their care. At the societal level, some believe preterm births are caused by divine will as punishment for sins committed by the mother, while others think they occur naturally. Preterm newborn’s death is often not acknowledged as true loss and families are discouraged from grieving.

Our study found that the beliefs, perceptions and attitudes surrounding preterm birth, held by families, communities, healthcare providers and society at large, influence the care that preterm newborn–mother dyads receive both at home and within health facilities. Addressing these requires a multifaceted approach targeted at deeply ingrained attitudes and perceptions.

To assess the state of the research literature addressing what is known about the quality of continence care from the perspective of older adults in long-term care or in receipt of home care.

Scoping review of the literature according to the Joanna Briggs Institute method, reported according to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Participant: older adults (>65 years of age), either in receipt of home health or social care services or older adult residents of long-term care (nursing homes). Concept: older adult perspectives on quality of continence care (access, care to meet needs, continuity, goals, expectations, delivery, experiences, personalised care, partnerships in care, well-being and social support). Context: older adults in long-term care or in receipt of home care.

We identified 14 articles from the academic literature. Sources originated from the USA (7), Australia (4), Canada (2) and 1 from Italy. Long-term care residents were the focus of 12 of the articles. Older adults reported limited access and information regarding continence care and services and variable abilities of care staff to deliver care. Older adults wanted to be actively involved in decisions about their care, preserve their autonomy and independence and wanted care to enhance their well-being.

Studies examining the perspectives of older adults regarding the quality of their continence care are few. Older adults value person-centredness, expert advice regarding their condition, allowing preservation of self-determination and independence where possible. Older people value meaningful relationships with empathetic care providers. There remains a need for education of care providers in continence care and for policies and practices to support continence in a dignity-preserving framework.

Open Science Framework (https://osf.io/bprq9/).

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

Musculoskeletal (MSK) conditions account for up to one-third of general practice consultations and over one-fifth of emergency department attendances in the UK. Postpandemic, the elective orthopaedic surgery backlog remains one of the most substantial across surgical specialties. Despite this burden, undergraduate exposure to trauma and orthopaedics (T&O) remains limited and inconsistent. Most UK medical students receive only 2–3 weeks of T&O teaching, with up to 40% of foundation doctors feeling underprepared to manage MSK conditions. The Evaluation of Trauma and Orthopaedic Teaching in Medical Schools Nationally (TENDON Study) aims to evaluate the current state of undergraduate T&O education in UK medical schools from both student and educator perspectives.

This national, prospective, cross-sectional survey will be conducted between 25 July and 27 October 2025. A dual-instrument electronic survey was developed through Qualtrics, informed by the British Orthopaedic Association (BOA) Undergraduate Curriculum and UK Medical Licensing Assessment content map. Participants will include medical students (Years 1–6), foundation doctors and orthopaedic educators recruited through British Orthopaedic Medical Students Association and BOA networks, and designated school representatives. Survey domains include curriculum coverage, teaching methods, clinical exposure and self-reported competence. Quantitative data will be analysed using descriptive and inferential statistics; qualitative data will undergo thematic analysis. Reporting will follow the Checklist for Reporting Of Survey Studies framework, with relevant elements drawn from the Checklist for Reporting Results of Internet E-Surveys checklist.

Ethical approval was obtained from the Human Biology Research Ethics Committee, University of Cambridge. Findings will be disseminated via peer-reviewed publication, conference presentations and summary reports to curriculum leads and relevant educational bodies.

Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).

The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.

The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.

NCT05700877.

Research for pandemic response needs to be timely to inform evidence-based decision making. The lack of epidemiological data at the start of the COVID-19 pandemic led experts to call for cohorts that could rapidly supply data about newly emerging infectious diseases. The ‘Bern, get ready’ (BEready) study aims to establish a prospective ‘pandemic preparedness cohort’ in the canton of Bern, Switzerland. This cohort can be pivoted to the needs of a new pandemic pathogen. The aim of this pilot study was to investigate the potential response and to test the feasibility of procedures for BEready.

Closed population-based cohort study.

Random sample of private households in the canton of Bern, Switzerland, that had previously responded to an online survey.

Adults, children and pets.

Enrolment as a percentage, associations between the agreement to participate and the demographic and socioeconomic variables of the invited household member, number of social contacts, proportion of samples collected, proportion of complete questionnaires and proportion of participants responding after 12 months.

After the initial in-person visit with venous blood sampling, participants were followed up for 1 year. We tested remote data collection methods, with online questionnaires and self-collected capillary blood and nasopharyngeal samples, and established a biobank.

The pilot study enrolled 106/1138 (9%) of invited households plus two additional households that had proactively contacted us. In total, we enrolled 193 people in 108 households (1.8 per household) and 44 pets between April and September 2023. We obtained and stored at least one venous and/or capillary baseline blood sample from 184/193 (95%) people and 40/44 (91%) pets. After 1 year, 172/193 (89%) people in 101/108 (94%) of households completed a follow-up survey, as did 22 owners of 34/44 (77%) pets. 151/172 (88%) respondents returned a follow-up capillary blood sample.

The response rate to the pilot study shows that obtaining high levels of participant enrolment in a pandemic preparedness cohort study is challenging. Data collection without face-to-face contact with a study team is feasible for household members and will be needed in BEready if control measures during a pandemic prevent in-person studies.

Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).

This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.

This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.

The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.

Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552

2.02 29/11/2024.

Patient and public involvement (PPI) in health research has gained prominence, with patients and public actively shaping research priorities, study design and knowledge translation. While the benefits and challenges of PPI are well documented, less attention has been given to the complexity of navigating multiple identities as research team members. Often, patients and public, academics and clinicians share many of the same goals and occupy overlapping roles, yet research structures rarely acknowledge or accommodate this fluidity. This commentary explores how shared identities of patients and public, academics and clinicians shape research partnerships, challenging conventional boundaries by questioning whether patients and public can also serve as academics or clinicians and vice versa.

This commentary is written from an interdisciplinary perspective, where insights are synthesised from existing literature, empirical knowledge and lived experience. The authors critically examine the intersection of patient and public, academic and clinician identities and discuss the implications for research partnerships. Recurring points of tension, including questions about the suitability of partnerships and the complexities of identity, are explored. The discussion considers how members of research teams navigate privilege and shared responsibility within collaborative settings.

Although PPI aims to foster inclusivity, research partnerships often confine patients and public, academics and clinicians to rigid titles, overlooking the multidimensional identities of those involved. To advance research, practice and advocacy, it is foundational to embrace one’s authentic self while recognising the full complexity of team members. Every individual brings a unique perspective and lived experience, and together, a research team shares the collective responsibility to produce rigorous, quality research that strengthens the body of evidence.

The HOPSCOTCH study ‘Helping Optimise Primary Care Support During Transition From Children’s Hospice Care’ aims to develop a toolbox to enable engagement of primary care services in the care of young people with life-limiting conditions (LLC) with a specific focus on the point of transition from children’s hospice services.

Individual interviews will be held with young people with LLC, their families and healthcare professionals (HCPs). In alignment with Experience Based Co-Design (EBCD) methodology, extracts of film and audio from young people and family interviews will be combined to professionally produce a ‘catalyst film’ highlighting key points and experiences before, during and after the transition from children’s hospice care. Role-specific workshops will be held with young people with LLC, their families and HCPs working in primary care, children’s hospices and adult hospice services. The catalyst film will be used in feedback workshops to prompt prioritisation of key issues to take forward into toolbox development in a shared young people, family and HCP workshop. A documentary analysis of resources currently used to support transition and communication between care settings will support contextual understanding of the transition process. Young people, parents and professionals have shaped and continue to have influence over the study delivery as advisors alongside a multidisciplinary steering committee.

The study design has been guided by the UK Medical Research Council complex intervention framework. Intervention development draws on the principles of EBCD and is theoretically driven by the Behaviour Change Wheel.

The study is registered with the UK’s Clinical Study Registry (ISCTRN75964234).

Ethical approval was obtained from Wales 3 ethics board on 2 July 2025 (IRAS ID 334486). This study will include ongoing dissemination and knowledge transfer to key audiences (young people, parents, service providers, commissioners) via publications, national bodies, knowledge exchange events, web-based platforms, social media and clinical/academic forums.

People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose.

Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff.

The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression.

IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027.

ISRCTN12234059 registered on 20/2/2025 (ISRCTN).

The UK Health Security Agency and the National Health Service England (NHSE) led a hepatitis C virus (HCV) patient re-engagement exercise beginning in 2018, which entailed sharing public health surveillance data with NHSE Operational Delivery Networks (ODNs) in England. The ODNs used the data to contact and offer testing and treatment to people historically diagnosed with HCV, but who did not have evidence of successfully clearing the virus. A quantitative evaluation found that of 55 329 individuals whose details were shared with ODNs, around 13% had treatment after the exercise commenced. This qualitative evaluation aims to identify the barriers and facilitators to the re-engagement exercise as reported by ODN staff.

Semistructured interviews. The topic guide and analysis were guided by the Theoretical Domains Framework, using a combined deductive framework and inductive thematic analysis approach.

21 staff from 13 ODNs. The sampling frame was designed to capture participants from all regions of England and with varied outcomes from the re-engagement exercise.

Interviewees reported the most barriers in environmental context and resources (including staffing limitations, interruptions during COVID-19, restricted laboratory access), and social influences (with limited responses from general practitioners and patients). Interviewees discussed whether it was appropriate for ODNs and individual staff to be assigned the data validation work and reported some stress and memory/attention barriers due to the volume of the exercise. They had varied beliefs about the consequences of the exercise, with most believing it was worthwhile due to treatment yield, lessons learnt and confirmation that some people had cleared the virus. Further facilitators included the ODN goals fitting with the exercise, and regional resources such as patient databases. Interviewees also reported adaptations to the exercise that facilitated patient contact, and their ongoing work to re-engage patients emphasised outreach partnerships and peer support.

The evaluation revealed insights into methods for re-engaging patients and of sharing and using public health data to support clinical practice. Government support and funding provision for regionally tailored holistic re-engagement approaches, alongside enhancements to health surveillance data, could enable barriers to re-engagement to be overcome.