Cost-Effectiveness of Treating Hepatitis C in Clients on Opioid Agonist Therapy in Community Pharmacies Compared to Primary Healthcare in Australia.

Meeting the World Health Organisation 2030 target of treating 80% of people with hepatitis C virus (HCV) in Australia requires accessible testing and treatment services for at-risk populations. Previous clinical trials, including those in Australia, have demonstrated the efficacy of outreach programmes to community pharmacies offering opioid agonist therapy (OAT). This analysis evaluates the potential cost-effectiveness of introducing an outreach programme in community pharmacies. Using a decision analytic model, we estimated the impact of adding a temporary hepatitis C outreach and treatment programme in community pharmacies to the standard treatment pathway available through general practice. We compared the expected number of tests, diagnoses, cures and costs occurring through the addition of this outreach and treatment programme to those expected through general practice alone over a 12-month time horizon. We examined costs from the perspective of the health system and conducted one-way and probabilistic sensitivity analyses to assess uncertainty in model parameters and test key assumptions. In the model adding the outreach programme pathway increased the number of tests from 4178 to 8737, the number of diagnoses from 615 to 1285 and the number of cures from 223 to 777 among people on OAT over a 12-month period. Each additional cure achieved through the addition of the outreach programme was estimated to incur $48,964 (AUD 2023) to the health system, with > 85% of these costs attributable to medication and dispensing expenses. The average cost per cure was estimated to be $49,152 through routine care and $49,018 in the outreach programme. Although outreach models of care incur large upfront costs, they can capture otherwise unreached populations and result in comparable or favourable cost per cure, due to higher levels of engagement and lower rates of loss to follow-up.

An analysis of prescribing data in attention-deficit hyperactivity disorder for adolescents and adults in Scotland.

BACKGROUND: Medication, combined with environmental and psychosocial support, can mitigate adverse outcomes in attention-deficit hyperactivity disorder (ADHD). There is a need for research into regional and national prescription volumes and patterns, especially among adults. AIMS: This study analysed prescribing patterns for medications commonly used to treat ADHD in adolescents and adults. METHOD: Data was extracted from the NHS Scotland Prescribing Information System on prescriptions for 7806 adolescents (aged 10-19 years) and 4998 adults (aged 20-59 years) in 2019. This included medications listed under Section 4.4 of the British National Formulary. We explored 2019 prescription patterns across different regions and estimated ADHD prevalence levels. Additionally, we assessed changes in dispensed prescriptions, defined daily dose and costs, compared with figures from 2010. RESULTS: Between 2010 and 2019, prescriptions for ADHD medications increased (dispensed prescriptions +233.2%, defined daily dose +234.9%, cost +216.6%). Despite these increases, analysis indicated that in 2019, considering a 5% estimated ADHD prevalence among adolescents, 73% were not prescribed medication, increasing to 81% at a 7% estimated prevalence. Similarly, among adults with a 2% estimated prevalence, 91% were not prescribed medication, rising to 96% at a 4% estimated prevalence. Regional disparities were evident, with 41-96% of adolescents and 85-100% of adults, based on ADHD prevalence estimates, not receiving a prescription, depending on area. CONCLUSIONS: Although prescription rates for ADHD medication have increased over time, the data do not indicate excessive use of medication. Instead, they suggest that for some groups there is a lower use of medication compared with expected prevalence figures, especially among adults.

A Pharmacist Clinician Model as part of a collaborative clinical workforce: A philosophical critique.

The term 'clinician' is not reserved for any healthcare professional group. However, there is a general acceptance that a clinician would have the knowledge, skills and behaviours to enable them to clinically assess and manage a patient autonomously. The expectation, in a modern collaborative healthcare system, is that this work would be completed as a part of a planned and integrated multi-disciplinary care delivery structure, where any given clinician delivers a devolved element of that patient's care. Forthcoming changes to regulation and professional development pathways in the UK will have a profound impact on pharmacist professional identity and practice. From 2026, all new UK pharmacist registrants will have full independent prescribing rights. A paradigm shift is expected to enable the development of a Pharmacist Clinician Model, incorporating pharmaceutical care needs with wider clinical assessment, diagnostic, and clinical management responsibilities. Consideration is given to this model and its implications. Changes to regulation, policy, education, and the governance required to deliver safe and effective pharmacist clinicians are outlined. A philosophical critique on the nature of being a clinician, and the differentiation of pharmacist clinician roles compared to other healthcare professions, is given. A further examination of the projected risks and expected benefits of this transformative practice model are then explored.

REPAIRS Delphi: A UK and Ireland Consensus Statement on the Management of Infected Arterial Pseudoaneurysms Secondary to Groin Injecting Drug Use.

OBJECTIVE: Consensus guidelines on the optimal management of infected arterial pseudoaneurysms secondary to groin injecting drug use are lacking. This pathology is a problem in the UK and globally, yet operative management options remain contentious. This study was designed to establish consensus to promote better management of these patients, drawing on the expert experience of those in a location with a high prevalence of illicit drug use. METHODS: A three round modified Delphi was undertaken, systematically surveying consultant vascular surgeons in the UK and Ireland using an online platform. Seventy five vascular surgery units were invited to participate, with one consultant providing the unit consensus practice. Round one responses were thematically analysed to generate statements for round two. These statements were evaluated by participants using a five point Likert scale. Consensus was achieved at a threshold of 70% or more agreement or disagreement. Those statements not reaching consensus were assessed and modified for round three. The results of the Delphi process constituted the consensus statement. RESULTS: Round one received 64 (86%) responses, round two 59 (79%) responses, and round three 62 (83%) responses; 73 (97%) of 75 units contributed. Round two comprised 150 statements and round three 24 statements. Ninety one statements achieved consensus agreement and 15 consensus disagreement. The Delphi statements covered sequential management of these patients from diagnosis and imaging, antibiotics and microbiology, surgical approach, wound management, follow up, and additional considerations. Pre-operative imaging achieved consensus agreement (97%), with computed tomography angiography being the modality of choice (97%). Ligation and debridement without arterial reconstruction was the preferred approach at initial surgical intervention (89%). Multidisciplinary management, ensuring holistic care and access to substance use services, also gained consensus agreement. CONCLUSION: This comprehensive consensus statement provides a strong insight into the standard of care for these patients.

Viral hepatitis testing and treatment in community pharmacies: a systematic review and meta-analysis.

Background: The World Health Organization seeks to eliminate viral hepatitis as a public health threat by 2030. This review and meta-analysis aims to evaluate the effectiveness of programs for hepatitis B and C testing and treatment in community pharmacies. Methods: Medline, Embase, Cochrane CENTRAL, and Global Health were searched from database inception until 12 November 2023. Comparative and single arm intervention studies were eligible for inclusion if they assessed delivery of any of the following interventions for hepatitis B or C in pharmacies: (1) pre-testing risk assessment, (2) testing, (3) pre-treatment assessment or (4) treatment. Primary outcomes were proportions testing positive and reaching each stage in the cascade. Random effects meta-analysis was used to estimate pooled proportions stratified by recruitment strategy and setting where possible; other results were synthesised narratively. This study was pre-registered (PROSPERO: CRD42022324218). Findings: Twenty-seven studies (4 comparative, 23 single arm) were included, of which 26 reported hepatitis C outcomes and four reported hepatitis B outcomes. History of injecting drug use was the most identified risk factor from pre-testing risk assessments. The pooled proportion hepatitis C antibody positive from of 19 studies testing 5096 participants was 16.6% (95% CI 11.0%-23.0%; heterogeneity I2 = 96.6%). The pooled proportion antibody positive was significantly higher when testing targeted people with specified risk factors (32.5%, 95% CI 24.8%-40.6%; heterogeneity I2 = 82.4%) compared with non-targeted or other recruitment methods 4.0% (95% CI 2.1%-6.5%; heterogeneity I2 = 83.5%). Meta-analysis of 14 studies with 813 participants eligible for pre-treatment assessment showed pooled attendance rates were significantly higher in pharmacies (92.7%, 95% CI 79.1%-99.9%; heterogeneity I2 = 72.4%) compared with referral to non-pharmacy settings (53.5%, 95% CI 36.5%-70.1%; heterogeneity I2 = 92.3%). The pooled proportion initiating treatment was 85.6% (95% CI 74.8%-94.3%; heterogeneity I2 = 75.1%). This did not differ significantly between pharmacy and non-pharmacy settings. Interpretation: These findings add pharmacies to the growing evidence supporting community-based testing and treatment for hepatitis C. Few comparative studies and high degrees of statistical heterogeneity were important limitations. Hepatitis B care in pharmacies presents an opportunity for future research. Funding: None.

Point-of-Care testing of HbA1c levels in community settings for people with established diabetes or people at risk of developing diabetes: A systematic review and meta-analysis.

BACKGROUND: Glycated haemoglobin (HbA1c) measurement using Point of Care (POC) testing may be of huge utility, providing convenient testing for early diagnosis and regular monitoring of hard-to-reach patient groups. This systematic review aimed to identify evidence for the successful deployment of these devices to improve patient outcomes in diabetes. METHODS: A systematic review and meta-analysis was undertaken in February 2023, to identify all relevant articles: (CINAHL, Cochrane, PubMed, Scopus, and Web of Science). Studies were included if they reported outcomes of community POC testing for HbA1c for people with diabetes or at risk of diabetes. The Prospero database and trial registers were searched. Only English language articles were included. Title, abstract screening and full text review was carried out by two reviewers (AG/AR). The Cochrane risk of bias tool for randomised studies and the NIH Quality Assessment tool for observational cohort and cross-sectional studies were used. Publication bias was assessed visually using funnel plot and statistical assessment. We performed a meta-analysis on appropriate studies, applying a fixed effect model. We investigated heterogeneity using visual inspection of forest plots along with evaluative approaches (χ2, I2). Strength of evidence was assessed using GRADE. FINDINGS: 24 studies fulfilled the criteria to be included in the narrative synthesis and 5 could be included in quantitative analysis. 13 studies evaluated HbA1c POC testing in non-diabetic patients, 9 reported results for diabetic patients and 2 included both groups. The narrative synthesis was constructed around 6 key themes: increased test access, diagnosis of people who would otherwise go undiagnosed, intervention/lifestyle change, POC testing effect on HbA1c and glycaemic control, follow-up time and patient satisfaction. INTERPRETATION: The available published data supports the proposed use of POC devices in a community setting, with positive effects on diabetic care with limited evidence that patients can achieve better glycaemic control.

Implementation of point-of-care HbA1C instruments into community pharmacies: Initial development of a pathway for robust community testing.

BACKGROUND: Point-of-care (POC) analysers in community settings can provide opportunistic and regular HbA1c monitoring. Community pharmacies in NHS Scotland are utilised by populations at greatest risk of type two diabetes (T2D). This study describes initial development of an HbA1c pathway using a POC analyser in community pharmacies. METHODS: The Abbott Afinion analyser was compared in (i) NHS Tayside's Blood Sciences Service and (ii) community pharmacies from four Scottish Health Boards. A side by side comparison with standard operating procedures for HbA1c quantification using 80 T2D patient venous samples. The machine was implemented into 11 community pharmacies and 144 samples obtained from patients for comparison to their recent laboratory HbA1c. Four focus groups examined themes around the intervention and an exit questionnaire was administered. RESULTS: Laboratory assessment verified the efficacy of the POC test machine. The value for level 1 quality control was 44 mmol/mol and the mean during testing 42.7 mmol/mol. The greatest percent coefficient of variation (cv) was within-run for both levels of quality control material, at a value of 1.63% and 1.62%, respectively. The analyser performed robustly within the pharmacy assessment, with a mean difference of 1.68 and a standard deviation of 0.71 (CV 0.423). Patients with T2D reported positive experiences of using a pharmacy. The focus groups identified an appreciation of the convenience of pharmacies and of the longitudinal relationships with pharmacy staff. CONCLUSION: POC HbA1c analysers can be successfully established in community pharmacies. The target patient group responded positively to the opportunity to use a pharmacy service.

A multicomponent holistic care pathway for people who use drugs in Tayside, Scotland.

BACKGROUND: People Who Use Drugs (PWUD) are at high risk of non-fatal overdose and other drug-related harms. The United Kingdom drugs policy landscape makes it challenging to support those at risk. Tayside, in East Scotland, has a sizeable population at risk of drug-related harms. In 2021, the National Health Service implemented a care pathway for PWUD to provide multidimensional healthcare interventions. We aimed to quantify drug-related harms; assess wider health and well-being; and understand substance use trends and behaviours, among those engaged in the pathway. METHODS: Existing community-embedded blood-borne virus pathways were adapted to provide multiple healthcare assessments over three visits. We undertook an observational cohort study to analyse uptake and outcomes for the initial cohort of PWUD engaged at appointment one. RESULTS: From August 2021-September 2022, 150 PWUD engaged with the pathway. Median age was 39 (34-42) years, 108 (72%) were male, and 124 (83%) lived in deprived areas. Seventy (47%) had been disengaged from healthcare for over a year. Polysubstance use was reported by 124 (83%), 42 (28%) disclosed injecting daily, and 54 (36%) shared equipment. Fifty-four (36%) experienced recent non-fatal overdose, and there were six overdose fatalities (4.1 [1.5-9.0] per 100PY). The offer of take-home naloxone was accepted by 108 (72%). Fourteen (9%) were diagnosed with Hepatitis C and two (1%) with HIV. Renal, hepatological, and endocrine impairment were observed among 30 (20%), 23 (15%), and 11 (7%), people respectively. Ninety-six (65%) had high risk of clinical depression. Forty-eight (32%) declined Covid-19 vaccination. CONCLUSION: The pathway engaged PWUD with high exposure to recent non-fatal overdose and other drug-related harms, alongside co-morbid health issues. Our results suggest multi-dimensional health assessments coupled with harm reduction in community settings, with appropriate linkage to care, are warranted for PWUD. Service commissioners should seek to integrate these assessments where possible.

Management of the infected arterial pseudoaneurysm secondary to groin injecting drug use and outcomes: a systematic review protocol.

INTRODUCTION: People who inject drugs are at risk of a range of injecting-related infections and injuries, which can threaten life and limb. In parallel to escalating rates of drug-related deaths seen in Scotland and the UK, there has also been an increase in hospital admissions for skin and soft tissue infections related to injecting drug use. One such injecting complication is the infected arterial pseudoaneurysm, which risks rupture and life-threatening haemorrhage. Surgical management options for the infected arterial pseudoaneurysm secondary to groin injecting drug use remain contentious, with some advocates for ligation and debridement alone, whilst others promote acute arterial reconstruction (suture or patch repair, bypass or, more recently, endovascular stent-graft placement). Rates of major lower limb amputations related to surgical management for this pathology vary in the literature. This review aims to evaluate the outcomes of arterial ligation alone compared with arterial reconstruction, including open and endovascular options, for the infected arterial pseudoaneurysm secondary to groin injecting drug use. METHODS AND ANALYSIS: The methods will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Three electronic databases will be searched and the resultant papers screened according to the study inclusion and exclusion criteria (detailed in the Population, Intervention, Comparison, Outcomes and Study design statement). Grey literature will be excluded. All papers at each stage will be screened by two independent authors, with disagreements arbitrated by a third. Papers will be subject to appropriate standardised quality assessments. PRIMARY OUTCOME: Major lower limb amputation. SECONDARY OUTCOMES: Reintervention rate, rebleeding rate, development of chronic limb-threatening ischaemia 30-day mortality and claudication. ETHICS AND DISSEMINATION: This is a systematic review based on previously conducted studies, therefore, no ethical approval is required. The results of this work will be published in a peer-reviewed journal and presented at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42022358209.

Point-of-care testing of HbA1c levels in community settings for people with established diabetes or people at risk of developing type 2 diabetes: a systematic review and meta-analysis protocol.

INTRODUCTION: Diabetes mellitus has increased in prevalence worldwide and is causing an increasing burden on health services. The best patient outcomes occur with early diagnosis to prevent health complications. Glycated haemoglobin (HbA1c) is used to assess glycaemic control over 3-6 months and inform clinical management. Point-of-care (POC) HbA1c devices can be used in community settings, independent of clinical laboratories. This review aims to evaluate how these devices have been implemented in community settings and what patient outcomes have been documented. METHODS AND ANALYSIS: This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis guidance. A systematic search was undertaken in October 2022, using the defined PICOS (population, intervention, comparison, outcomes, study type) statement to identify all relevant articles: CINAHL, Cochrane, PubMed, Scopus and Web of Science were searched (updated February 2023). Studies will be included if they report outcomes of community POC testing for HbA1c for people with diabetes or at risk of diabetes. We will review the PROSPERO database and trial registers.Title, abstract screening and full-text review will be carried out by two reviewers. The Cochrane risk-of-bias tool will be used to assess randomised studies and the National Institutes of Health (NIH) Quality Assessment tool for observational cohort and cross-sectional studies. Publication bias will be assessed visually with a funnel plot and statistical approaches if necessary. If a group of sufficiently comparable studies are identified, we will perform a meta-analysis applying a fixed or random effects model as appropriate. We will investigate heterogeneity using visual inspection of forest plots along with review of evaluative approaches such as Χ2 and the I2 statistic. Strength of evidence will be assessed using Grading of Recommendations, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Ethics approval is not required for this literature review. The results will be disseminated through peer-reviewed publication and conference presentations. Furthermore, this systematic review will be used to inform the design of a community pharmacy-based prediabetes intervention. PROSPERO REGISTRATION NUMBER: CRD42023383784.

Laying the foundations for hepatitis C elimination: evaluating the development and contribution of community care pathways to diagnostic efforts.

BACKGROUND: Hepatitis C Virus (HCV) is a public health threat which contributes substantially to the global burden of liver disease. There is much debate about effective approaches to scaling up diagnosis of HCV among risk groups. Tayside, a region in the East of Scotland, developed low-threshold community pathways for HCV to lay the foundations of an elimination strategy. In this retrospective study, we sought to: quantify the contribution of community pathways to increasing HCV diagnosis; understand if shifting diagnosis to community settings led to a higher proportion of individuals tested for HCV being actively infected; and describe functional characteristics of the care pathways. METHODS: Descriptive statistics were used to for analysis of routinely-collected HCV testing data from 1999 to 2017, and a review of the development of the care pathways was undertaken. Community-based testing was offered through general practices (GP); nurse outreach clinics; prisons; drug treatment services; needle and syringe provision (NSP) sites; community pharmacies; and mosques. RESULTS: Anti-HCV screening was undertaken on 109,430 samples, of which 5176 (4.7%) were reactive. Of all samples, 77,885 (71.2%) were taken in secondary care; 25,044 (22.9%) in GPs; 2970 (2.7%) in prisons; 2415 (2.2%) in drug services; 753 (0.7%) in NSPs; 193 (0.2%) pharmacies; and 170 (0.1%) in mosques. The highest prevalence of HCV infection among those tested was in NSP sites (26%), prisons (14%), and drug treatment centres (12%). CONCLUSIONS: Decentralised care pathways, particularly in harm reduction and other drug service settings, were key to increasing diagnosis of HCV in the region, but primary and secondary care remain central to elimination efforts.

Transformation of identity in substance use as a pathway to recovery and the potential of treatment for hepatitis C: a systematic review.

BACKGROUND AND AIM: People who inject drugs are at high risk of contracting hepatitis C (HCV). The introduction of direct acting antiviral (DAA) drugs to treat HCV has the potential to transform care; however, uptake of DAAs has been slower than anticipated. The strong link between HCV and injecting drug use frames HCV as a shameful, stigmatising disease, reinforcing an 'addict' identity. Linking HCV care to a recovery journey, 'clean' identity and social redemption may provide compelling encouragement for people to engage with treatment and re-evaluate risk and behaviours, reducing the incidence of HCV re-infection. The aim of this review was to identify actions, interventions and treatments that provide an opportunity for a change in identity and support a recovery journey and the implications for HCV care. METHODS: Databases (MEDLINE, EMBASE, PsycINFO, ProQuest Public Health, ProQuest Sociological Abstracts, CINAHL and Web of Science) were searched following our published strategy and a grey literature search conducted. A narrative synthesis was undertaken to collate themes and identify common threads and provide an explanation of the findings. RESULTS: Thirty-two studies fulfilled the inclusion criteria. The narrative synthesis of the studies identified five over-arching analytical themes: social factors in substance use and recovery, therapeutic communities, community treatment, online communities, and finally women and youth subsets. The change from an 'addict' identity to a 'recovery' identity is described as a key aspect of a recovery journey, and this process can be supported through social support and turning point opportunities. CONCLUSIONS: Recovery from addiction is a socially mediated process. Actions, interventions and treatments that support a recovery journey provide social connections, a recovery identity and citizenship (reclaiming a place in society). There is a gap in current literature describing how pathways of care with direct acting antivirals can be designed to promote recovery, as part of hepatitis C care.

The Collaborative Care Model: Realizing healthcare values and increasing responsiveness in the pharmacy workforce.

Healthcare values are fairly ubiquitous across the globe, focusing on caring and respect, patient health, excellence in care delivery, and multi-stakeholder collaboration. Many individual pharmacists embrace these core values. However, their ability to honor these values is significantly determined by the nature of the system in which they work. The paper starts by presenting the prevailing pharmacist workforce model, the 'Atomistic' Model, in Scotland, in which core roles are typically separated into hierarchically disaggregated jobs focused on one professional 'pillar': Clinician/Practice Provider; Educator; Leader/Manager; and Researcher. This skills-segregation yields a workforce of individuals working in isolation rather than collaborating, lacking a shared purpose. Key strategic flaws include suboptimal responsiveness to population needs, inconsistency/inequity of care, erosion of professional agency, and lower job satisfaction. It is conjectured that this results from a lack of congruence between values, professional ethos, and organizational structure. 'Atomism' culminates in a syndrome of widespread professional-level cognitive dissonance. The paper contrasts this with an emerging workforce vision, the Collaborative Care Model. This new model defines a systems-first-approach, built on the principle that all jobs must include all four professional 'pillars'. Vertical skills integration, involving education and task sharing, supports sustainability and succession planning. Horizontal skills integration (across practice, leadership/management, education, and research) is included to improve responsiveness to population need and individual professional agency. The working conditions, supportive ethos, and career structure needed to make the model work are described. Moral and workforce theory are used to justify why the model may be more effective for population health, delivering greater job satisfaction for individuals and ultimately helping systematically realize healthcare values. Finally, the paper sketches the first steps needed to implement the model at the national level, starting with the operationalization of new multi-'pillar' professional curricula across the career spectrum. Potential challenges also are discussed.

Are UK pharmacists ready for consultant-level practice? A cross-sectional survey of self-assessed development needs.

OBJECTIVES: The four nations of the United Kingdom (UK) have endorsed a new curriculum and credentialing process for consultant pharmacists. This study aimed to measure the self-reported consultant-level practice development needs of pharmacists across the UK. METHODS: The study was a cross-sectional electronic survey. Inclusion criteria were: pharmacists registered to practice with the General Pharmaceutical Council; working in any professional sector across the UK; and self-identifying as already working at an advanced level of practice or in an advanced pharmacist role. Participants were asked to rate their confidence that their current practice aligns to the level described in the Royal Pharmaceutical Society Consultant Pharmacist curriculum on a 5-point Likert scale. Predictors of overall confidence with the whole curriculum were analysed using binomial regression. KEY FINDINGS: Nine hundred and forty-four pharmacists participated. Median age was 42 years; 72.6% were female. Research skills and strategic leadership skills had low self-reported confidence. Patient-Centred Care and Collaboration was the domain with the highest reported confidence. 10.2% (96/944) of participants self-reported confidence across the whole curriculum. The strongest predictors of overall confidence across the curriculum were advanced clinical practitioner qualification, research qualifications and self-identifying as a specialist. Increasing age and male gender also predicted confidence. White ethnicity and having an independent prescribing qualification negatively predicted confidence. CONCLUSION: A small minority of pharmacists self-reported confidence across the whole curriculum. A planned approach to develop research skills across the career spectrum, coupled with better identification of workplace-based experiential strategic leadership opportunities, may help deliver a larger cohort of 'consultant-ready' pharmacists.

Future destinations and social inclusion scoping review: how people cured of hepatitis C (HCV) using direct- acting antiviral drugs progress in a new HCV-free world.

BACKGROUND: There has been a paradigm shift in the treatment of Hepatitis C (HCV) from the interferon-era to direct-acting antiviral (DAA) drugs. Cure of HCV for the key risk group, those with a history of injecting drug use, may provide a range of benefits to an individual's quality of life that can be additional to that of a clinical cure. The interferon-era provided evidence that cure of HCV can be a turning point for those who use drugs, supporting a recovery journey. There remains a question if DAAs can provide the same opportunity. METHODS: We employed a scoping review methodology to consider the additional non-clinical benefits that HCV cure may provide. We used the theoretical construct of recovery capital to consider how these benefits may support a recovery journey in the DAA-era. RESULTS: Our search provided 2095 articles, from which 35 were included in the analysis. We developed a thematic synthesis of the non-clinical outcomes identified based on the four over-arching themes of recovery capital: physical, cultural, social and human capital. Our review suggests that identity change is a constituent part of each of the recovery capital domains in relation to HCV treatment. CONCLUSION: We identified Social Identity Model Of Recovery (SIMOR) as a mechanism through which DAAs may provide non-clinical outcomes to increase recovery capital domains. Further research is required to develop an understanding of the impact a cure of HCV with DAAs may have on identity, overall health and wellbeing and social inclusion to support recovery journeys.

Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial.

BACKGROUND: Conventional healthcare models struggle to engage those at risk of hepatitis C virus (HCV) infection. This international study evaluated point-of-care (PoC) HCV RNA diagnostic outreach and direct-acting antiviral (DAA) treatment for individuals receiving opioid agonist therapy (OAT) in community pharmacies. AIMS: We assessed the effectiveness of a roving nurse-led pathway offering PoC HCV RNA testing to OAT clients in community pharmacies relative to conventional care. METHODS: Pharmacies in Scotland, Wales, and Australia were randomised to provide PoC HCV RNA testing or conventional referral. Pharmacists directed OAT clients to on-site nurses (intervention) or local clinics (control). Infected participants were treated with DAAs, alongside OAT. Primary outcome was the number of participants with sustained virologic response at 12 weeks (SVR) and analysed using mixed effects logistic regression in the intention-to-treat (ITT) population. RESULTS: Forty pharmacies were randomised. The ITT population contained 1410 OAT clients. In the conventional arm (n = 648), 62 (10%) agreed to testing, 17 (27%) were tested, 6 (35%) were positive and 5 (83%) initiated treatment. In the intervention arm (n = 762), 148 (19%) agreed to testing, 144 (97%) were tested, 23 (16%) were positive and 22 (96%) initiated treatment. SVR was obtained by 2 (40%; conventional) and 18 (82%; intervention). Intervention arm participants had higher odds of testing, OR 16.95 (7.07-40.64, p < 0.001); treatment, OR 4.29 (1.43-12.92, p = 0.010); and SVR, OR 8.64 (1.82-40.91, p = 0.007). CONCLUSIONS: Nurse-led PoC diagnosis in pharmacies made HCV care more accessible for OAT clients relative to conventional care. However, strategies to improve testing uptake are required. TRIAL REGISTRATION: NCT03935906.

Randomized clinical trial: Direct-acting antivirals as treatment for hepatitis C in people who inject drugs: Delivered in needle and syringe programs via directly observed therapy versus fortnightly collection.

Hepatitis C virus (HCV) treatment in people who inject drugs (PWID) is delivered within settings frequented by PWID, such as needle and syringe programs (NSP). The optimal direct-acting antiviral (DAA) dispensing regimen among NSP clients is unknown. This study compared cures (Sustained virologic response 12 weeks post-treatment, [SVR12 ]) across three dispensing schedules to establish non-inferiority of fortnightly dispensing versus directly observed therapy. The ADVANCE HCV study was a randomized, unblinded trial, recruiting PWID attending NSP in Tayside, Scotland, between January 2018 and November 2019. HCV-positive participants were randomized to receive DAAs via directly observed therapy, fortnightly provision or fortnightly provision with psychological intervention. A modified intention to treat analysis was used to identify differences in cures between the three treatment regimes. The study was registered with clinicaltrials.gov; NCT03236506. A total of 110 participants completed the study. 33 participants received directly observed therapy, with 90.91% SVR12 ; 37 received fortnightly provision, with 86.49% SVR12 and 40 received fortnightly provision and psychological intervention at treatment initiation, with 92.50% SVR12 . Analysis showed no significant difference in SVR12 (p = 0.67). This study did not demonstrate a statistically significant difference in cure rate between groups. This provides evidence of the non-inferiority of fortnightly dispensing of direct-acting antivirals (DAAs) compared to directly observed therapy among PWID. It suggests that tight control of adherence through directly observed therapy dispensing of DAAs among this population offers no therapeutic advantage. Therefore, less restrictive dispensing patterns can be used, tailored to patient convenience.

Transformation of identity in substance use as a pathway to recovery and the potential of treatment for hepatitis C: a systematic review protocol.

INTRODUCTION: Hepatitis C virus (HCV) is a strongly stigmatised disease as it is framed within the context of injecting substance use. HCV provides the identity of 'dirty' or 'junky', with perceptions by others being beyond the control of the individual. People who experience problematic substance use are often viewed as being outside acceptable social behaviours, thus viewed as having tainted identities or second-class citizens. It is suggested that to recover from substance use, people should move towards social networks where substance use is not the norm and there is greater recovery support. The social identity model of recovery advocates that the mechanism to do this is by developing a new identity. It is unclear what catalysts provide this change in identity. This systematic review aims to describe actions, interventions and treatments that provide the opportunity for new identities and considers evidence that supports the hypothesis that curing HCV with direct acting antivirals may provide this opportunity. METHODS AND ANALYSIS: Methods are informed by the Preferred Reporting Items for Systematic reviews and Meta-Analysis statement. Seven electronic peer-reviewed and four grey literature sources were identified and preliminary searches have been conducted. The inclusion and exclusion criteria are broad to capture activities that result in a change in identity, recovery from substance use, quality of life, life satisfaction or the opportunity for the individual to reclaim their place in society (citizenship). Qualitative and quantitative literature are eligible. Papers will be assessed against standardised criteria and checked independently and in duplicate. A narrative synthesis of the findings will be reported, structured around intervention type, population context and outcomes. ETHICS AND DISSEMINATION: This systematic review will be based on studies that have already been conducted and therefore no ethical approvals are required. The resulting findings will be submitted to an international peer-reviewed journal and disseminated at relevant research conferences. PROSPERO REGISTRATION NUMBER: CRD42020209447.

Improving effective contraception uptake through provision of bridging contraception within community pharmacies: findings from the Bridge-it Study process evaluation.

OBJECTIVE: To present process evaluation results from the Bridge-it Study, a pragmatic cluster randomised cross-over trial to improve effective contraception uptake through provision of the progestogen only pill (POP) plus sexual and reproductive health (SRH) clinic rapid-access to women presenting to community pharmacies for emergency contraception (EC). RESEARCH DESIGN AND METHODS: A multimethod process evaluation was conducted to assess intervention implementation, mechanisms of change and contextual factors. Data were gathered from screening logs (n=599), observations of pharmacist training, analysis of data from 4-month follow-up questionnaires (n=406), monitoring of contemporaneous events and qualitative interviews with 22 pharmacists, 5 SRH clinical staff and 36 study participants in three participating UK sites in Lothian, Tayside and London. RESULTS: The intervention was largely delivered as intended and was acceptable. Pharmacists', SRH clinical staff and participants' accounts highlighted that providing a supply of POP with EC from the pharmacy as routine practice may have positive impacts on contraceptive practices in the short term, and potentially longer term. Key mechanisms of change included ease of access, increased awareness of contraception and services, and greater motivation and perceptions of self-efficacy. Few participants took up the offer to attend an SRH service (rapid-access component), and existing barriers within the SRH context were apparent (eg, lack of staff). Participant accounts highlight persistent barriers to accessing and using routine effective contraception remain. CONCLUSIONS: Implementation appeared to be acceptable and feasible, highlighting the potential for provision of POP within EC consultations as routine practice in community pharmacies. However, lack of engagement with the rapid access component of the intervention and existing barriers within the SRH context suggest that signposting to SRH services may be sufficient. Wider implementation should consider ways to address key implementation challenges to increase effectiveness and sustainability, and to overcome persistent barriers to accessing and using effective contraception. TRIAL REGISTRATION NUMBER: ISRCTN70616901.

Real-world outcomes of rapid regional hepatitis C virus treatment scale-up among people who inject drugs in Tayside, Scotland.

BACKGROUND: In 2017, Tayside, a region in the East of Scotland, rapidly scaled-up Hepatitis C Virus (HCV) outreach and treatment among People Who Inject Drugs (PWID) using novel community care pathways. AIMS: We aimed to determine treatment outcomes for PWID during the scale-up against pre-determined targets; and assess re-infection, mortality, and post-treatment follow up. METHODS: HCV treatment was delivered in community pharmacies, drug treatment centres, nurse-led outreach clinics, prisons, and needle exchanges, alongside conventional hospital care. We retrospectively analysed clinical outcomes and compared pathways using logistic regression models. RESULTS: Of 800 estimated HCV-infected PWID, 718 (90%) were diagnosed. 713 treatments commenced among 662 (92%) PWID, delivering 577 (81%) Sustained Virologic Responses (SVR). SVR was 91% among those who attended for testing. Forty-six individuals were treated more than once. Needle exchanges and community pharmacies initiated 49% of all treatments. Regression analyses implied pharmacies had superior follow-up, but there was no difference in likelihood of achieving SVR in community pathways relative to hospital care. Re-infection occurred 39 times over 256.57 person years (PY), yielding a rate of 15.20 per 100 PY (95% CI 10.81-20.78). 54 deaths occurred (29 drug related) over 1,553.04 PY, yielding a mortality rate of 3.48 per 100 PY (95% CI 2.61-4.54). Drug-related mortality was 1.87 per 100 PY (95% CI 1.25-2.68). CONCLUSIONS: Rapid HCV treatment scale-up to PWID in community settings, whilst maintaining high SVR, is achievable. However, other interventions are required to minimise re-infection; reduce drug-related deaths; and improve post-SVR follow-up testing regionally.