Understanding the barriers and facilitators to using self-sampling packs for sexually transmitted infections and blood-borne viruses: Thematic analyses for intervention optimization.

PURPOSE: Self-sampling packs for sexually transmitted infections (STIs) and blood-borne viruses (BBVs) are widely offered. There are ongoing problems with reach and sample return rates. The packs have arisen without formal intervention development. This paper illustrates initial steps of an intervention optimization process to improve the packs. METHODS: Eleven focus groups and seven interviews were conducted with convenience samples of patients recruited from sexual health clinics and members of the public (n = 56). To enable intervention optimization, firstly, we conducted an inductive appraisal of the behavioural system of using the pack to understand meaningful constituent behavioural domains. Subsequently, we conducted a thematic analysis of barriers and facilitators to enacting each sequential behavioural domain in preparation for future behaviour change wheel analysis. RESULTS: Overall, we found that self-sampling packs were acceptable. Participants understood their overall logic and value as a pragmatic intervention that simultaneously facilitated and reduced barriers to individuals being tested for STIs and BBVs. However, at the level of each behavioural domain (e.g., reading leaflets, returning samples) problems with the pack were identified, as well as a series of potential optimizations, which might widen the reach of self-sampling and increase the return of viable samples. CONCLUSIONS: This paper provides an example of a pragmatic approach to optimizing an intervention already widely offered globally. The paper demonstrates the added value health psychological approaches offer; conceptualizing interventions in behavioural terms, pinpointing granular behavioural problems amenable for systematic further improvement.

Using the behaviour change wheel approach to optimize self-sampling packs for sexually transmitted infection and blood borne viruses.

PURPOSE: This paper describes the process of optimizing a widely offered intervention-self-sampling packs for sexually transmitted infections (STIs) and blood borne viruses (BBVs). We drew upon the behaviour change wheel (BCW) approach, incorporating the theoretical domains framework (TDF) and the behaviour change technique taxonomy (BCTTv1) to systematically specify potential intervention components that may optimize the packs. METHODS: A BCW analysis built upon prior thematic analyses of qualitative data collected through focus groups and interviews with members of the public and people recruited from sexual health clinics in Glasgow and London (n = 56). Salient barriers and facilitators to specific sequential behavioural domains associated with the wider behavioural system of pack use were subjected to further analyses, coding them in relation to the TDF, the BCW's intervention functions, and finally specifying potential optimisation using behaviour change techniques (BCTs). RESULTS: Our TDF analysis suggested that across the overall behavioural system of pack use, the most important theoretical domains were 'beliefs about consequences' and 'memory, attention and decision-making'. BCW analysis on the overall pack suggested useful intervention functions should focus on 'environmental restructuring', 'persuasion', 'enablement', 'education' and 'modelling'. Specific ways of optimizing the intervention were also described in relation to potentially useful BCTs. CONCLUSIONS: Through a detailed behavioural analysis and the TDF and wider BCW approach built on earlier qualitative work, we provide a systematic approach to optimizing an existing intervention. The approach enabled the specification of highly specific, evidence-based, and theoretically informed recommendations for intervention optimization.

Going beyond 'regular and casual': development of a classification of sexual partner types to enhance partner notification for STIs.

OBJECTIVES: To develop a classification of sexual partner types for use in partner notification (PN) for STIs. METHODS: A four-step process: (1) an iterative synthesis of five sources of evidence: scoping review of social and health sciences literature on partner types; analysis of relationship types in dating apps; systematic review of PN intervention content; and review of PN guidelines; qualitative interviews with public, patients and health professionals to generate an initial comprehensive classification; (2) multidisciplinary clinical expert consultation to revise the classification; (3) piloting of the revised classification in sexual health clinics during a randomised controlled trial of PN; (4) application of the Theoretical Domains Framework (TDF) to identify index patients' willingness to engage in PN for each partner type. RESULTS: Five main partner types emerged from the evidence synthesis and consultation: 'established partner', 'new partner', 'occasional partner', 'one-off partner' and 'sex worker'. The types differed across several dimensions, including likely perceptions of sexual exclusivity, likelihood of sex reoccurring between index patient and sex partner. Sexual health professionals found the classification easy to operationalise. During the trial, they assigned all 3288 partners described by 2223 index patients to a category. The TDF analysis suggested that the partner types might be associated with different risks of STI reinfection, onward transmission and index patients' engagement with PN. CONCLUSIONS: We developed an evidence-informed, useable classification of five sexual partner types to underpin PN practice and other STI prevention interventions. Analysis of biomedical, psychological and social factors that distinguish different partner types shows how each could warrant a tailored PN approach. This classification could facilitate the use of partner-centred outcomes. Additional studies are needed to determine the utility of the classification to improve measurement of the impact of PN strategies and help focus resources.

How can we make self-sampling packs for sexually transmitted infections and bloodborne viruses more inclusive? A qualitative study with people with mild learning disabilities and low health literacy.

OBJECTIVES: 1.5 million people in the UK have mild to moderate learning disabilities. STIs and bloodborne viruses (BBVs) are over-represented in people experiencing broader health inequalities, which include those with mild learning disabilities. Self-managed care, including self-sampling for STIs/BBVs, is increasingly commonplace, requiring agency and health literacy. To inform the development of a partner notification trial, we explored barriers and facilitators to correct use of an STI/BBV self-sampling pack among people with mild learning disabilities. METHODS: Using purposive and convenience sampling we conducted four interviews and five gender-specific focus groups with 25 people (13 women, 12 men) with mild learning disabilities (July-August 2018) in Scotland. We balanced deductive and inductive thematic analyses of audio transcripts to explore issues associated with barriers and facilitators to correct use of the pack. RESULTS: All participants found at least one element of the pack challenging or impossible, but welcomed the opportunity to undertake sexual health screening without attending a clinic and welcomed the inclusion of condoms. Reported barriers to correct use included perceived overly complex STI/BBV information and instructions, feeling overwhelmed and the manual dexterity required for blood sampling. Many women struggled interpreting anatomical diagrams depicting vulvovaginal self-swabbing. Facilitators included pre-existing STI/BBV knowledge, familiarity with self-management, good social support and knowing that the service afforded privacy. CONCLUSION: In the first study to explore the usability of self-sampling packs for STI/BBV in people with learning disabilities, participants found it challenging to use the pack. Limiting information to the minimum required to inform decision-making, 'easy read' formats, simple language, large font sizes and simpler diagrams could improve acceptability. However, some people will remain unable to engage with self-sampling at all. To avoid widening health inequalities, face-to-face options should continue to be provided for those unable or unwilling to engage with self-managed care.

Accelerated partner therapy (APT) partner notification for people with Chlamydia trachomatis: protocol for the Limiting Undetected Sexually Transmitted infections to RedUce Morbidity (LUSTRUM) APT cross-over cluster randomised controlled trial.

INTRODUCTION: Partner notification (PN) is a process aiming to identify, test and treat the sex partners of people (index patients) with sexually transmitted infections (STIs). Accelerated partner therapy (APT) is a PN method whereby healthcare professionals assess sex partners, by telephone consultation, before giving the index patient antibiotics and STI self-sampling kits to deliver to their sex partner(s). The Limiting Undetected Sexually Transmitted infections to RedUce Morbidity programme aims to determine the effectiveness of APT in heterosexual women and men with chlamydia and determine whether APT could affect Chlamydia trachomatis transmission at population level. METHODS AND ANALYSIS: This protocol describes a cross-over cluster randomised controlled trial of APT, offered as an additional PN method, compared with standard PN. The trial is accompanied by an economic evaluation, transmission dynamic modelling and a qualitative process evaluation involving patients, partners and healthcare professionals. Clusters are 17 sexual health clinics in areas of England and Scotland with contrasting patient demographics. We will recruit 5440 heterosexual women and men with chlamydia, aged ≥16 years.The primary outcome is the proportion of index patients testing positive for C. trachomatis 12-16 weeks after the PN consultation. Secondary outcomes include: proportion of sex partners treated; cost effectiveness; model-predicted chlamydia prevalence; experiences of APT.The primary outcome analysis will be by intention-to-treat, fitting random effects logistic regression models that account for clustering of index patients within clinics and trial periods. The transmission dynamic model will be used to predict change in chlamydia prevalence following APT. The economic evaluation will use mathematical modelling outputs, taking a health service perspective. Qualitative data will be analysed using interpretative phenomenological analysis and framework analysis. ETHICS AND DISSEMINATION: This protocol received ethical approval from London-Chelsea Research Ethics Committee (18/LO/0773). Findings will be published with open access licences. TRIAL REGISTRATION NUMBER: ISRCTN15996256.

Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol).

INTRODUCTION: Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV 'Treatment as Prevention' (TasP) in PWID. METHODS AND ANALYSIS: We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome - chronic HCV prevalence in PWID - is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a 'virtual cohort' of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. ETHICS AND DISSEMINATION: Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials.gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.

Development of an evidence-based brief 'talking' intervention for non-responders to bowel screening for use in primary care: stakeholder interviews.

BACKGROUND: Bowel cancer is the third most common cause of cancer death worldwide. Bowel screening has been shown to reduce mortality and primary care interventions have been successful in increasing uptake of screening. Using evidence-based theory to inform the development of such interventions has been shown to increase their effectiveness. This study aimed to develop and refine a brief evidence-based intervention for eligible individuals whom have not responded to their last bowel screening invitation (non-responders), for opportunistic use by primary care providers during routine consultations. METHODS: The development of a brief intervention involving a conversation between primary care providers and non-responders was informed by a multi-faceted model comprising: research team workshop and meetings to draw on expertise; evidence from the literature regarding barriers to bowel screening and effective strategies to promote informed participation; relevant psychological theory, and intervention development and behaviour change guidance. Qualitative telephone interviews with 1) bowel screening stakeholders and 2) patient non-responders explored views regarding the acceptability of the intervention to help refine its content and process. RESULTS: The intervention provides a theory and evidence-based tool designed to be incorporated within current primary care practice. Bowel screening stakeholders were supportive of the intervention and recognised the importance of the role of primary care. Interviews highlighted the importance of brevity and simplicity to incorporate the intervention into routine clinical care. Non-responders similarly found the intervention acceptable, valuing a holistic approach to their care. Moreover, they expected their primary care provider to encourage participation. CONCLUSIONS: A theory-based brief conversation for use in a primary care consultation was acceptable to bowel screening stakeholders and potential recipients, reflecting a health promoting primary care ethos. Findings indicate that it is appropriate to test the intervention in primary care in a feasibility study.

Is an opportunistic primary care-based intervention for non-responders to bowel screening feasible and acceptable? A mixed-methods feasibility study in Scotland.

OBJECTIVES: We aimed to test whether a brief, opportunistic intervention in general practice was a feasible and acceptable way to engage with bowel screening non-responders. DESIGN: This was a feasibility study testing an intervention which comprised a brief conversation during routine consultation, provision of a patient leaflet and instructions to request a replacement faecal occult blood test kit. A mixed-methods approach to evaluation was adopted. Data were collected from proformas completed after each intervention, from the Bowel Screening Centre database and from questionnaires. Semi-structured interviews were carried out. We used descriptive statistics, content and framework analysis to determine intervention feasibility and acceptability. PARTICIPANTS: Bowel screening non-responders (as defined by the Scottish Bowel Screening Centre) and primary care professionals working in five general practices in Lothian, Scotland. PRIMARY AND SECONDARY OUTCOME MEASURES: Several predefined feasibility parameters were assessed, including numbers of patients engaging in conversation, requesting a replacement kit and returning it, and willingness of primary care professionals to deliver the intervention. RESULTS: The intervention was offered to 258 patients in five general practices: 220 (87.0%) engaged with the intervention, 60 (23.3%) requested a new kit, 22 (8.5%) kits were completed and returned. Interviews and questionnaires suggest that the intervention was feasible, acceptable and consistent with an existing health prevention agenda. Reported challenges referred to work-related pressures, time constraints and practice priorities. CONCLUSIONS: This intervention was acceptable and resulted in a modest increase in non-responders participating in bowel screening, although outlined challenges may affect sustained implementation. The strategy is also aligned with the increasing role of primary care in promoting bowel screening.

Appeals against detention in excessive security (outcomes of appeals against detention in conditions of excessive security in Scotland).

The Mental Health (Care and Treatment) (Scotland) Act 2003 introduced the right for patients in high-security psychiatric care to appeal against detention in conditions of excessive security. A previous study examined the first 100 patients to appeal under this provision. In this study we compare them with the next cohort of 110 patients to lodge an appeal, finding, contrary to expectations, no change in patient characteristics or the outcome of their appeals. The clinical, legal and demographic features of successful and unsuccessful appellants, who made up 38% and 27% of the 110 patients, respectively, were also compared. Those patients with the support of their responsible medical officer and those already included on a transfer list had a significantly better chance of success (p = 0.00). It was also found that a history of excessive alcohol consumption was associated with successful appeals (p = 0.002). A diagnosis of learning disability was associated with unsuccessful appeals (p = 0.018), though the sub-sample was very small. These findings are important given the forthcoming extension of this right of appeal to other levels of security.

The clinical reality of implementing formal risk assessment and management measures within high secure forensic care.

This paper describes the successful implementation of a formal violence risk assessment and management strategy within a high secure forensic care facility. The aim of the implementation was to ensure that each patient had a formal violence risk assessment and management plan that was shared and applied to clinical practice by the patient's clinical team. The process as a whole, from risk assessment to risk management including appropriate care and treatment documentation, is outlined. In this way, this paper also describes the difficulties and problems encountered within the organizational reality of implementation projects. Suggestions and recommendations on how to avoid and manage these are made.