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Objective: Physical distancing is an effective preventative measure during respiratory infectious disease outbreaks. Prior studies on distancing behaviours have largely ignored context characteristics (physical, social) and time. We investigated patterns in physical distancing over time and across situations, as well as sociodemographic variation herein. Methods: We employed data from five rounds of a cohort study conducted throughout the pandemic by the Dutch public health institute (RIVM; N≈50.000 per round). We conducted Latent Class Analyses (LCAs) to investigate patterns of physical distancing in a range of situations, followed by regression models to investigate associations between distancing behaviour and sociodemographic and context characteristics. Results: Participants differed in their general tendency to adhere to distancing guidelines across situations, but there were also substantial differences in distancing behaviour between situations, particularly at work, with friends and family and outdoors. Distancing at work was strongly associated with work environment characteristics. Younger age groups reported less distancing behaviour, particularly with close relations (friends or family) and at work. In periods when the pandemic situation was most severe, people adhered more strongly to distancing guidelines and age-differences were most pronounced during these periods. Conclusion: Physical and social context matters for physical distancing, highlighting the importance of developing strategies for pandemic preparedness that improve opportunities for physical distancing (e.g., reducing crowding, 1-way traffic) and accommodate young people to safely meet even in times of high pandemic severity and lockdowns. Future studies on distancing should account for the physical and social context in which the behaviour is observed.

Background and aims: Behavioural smoking cessation trials have used comparators that vary considerably between trials. Although some previous meta-analyses made attempts to account for variability in comparators, these relied on subsets of trials and incomplete data on comparators. This study aimed to estimate the relative effectiveness of (individual) smoking cessation interventions while accounting for variability in comparators using comprehensive data on experimental and comparator interventions. Methods: A systematic review and meta-regression was conducted including 172 randomised controlled trials with at least 6 months follow-up and biochemically verified smoking cessation. Authors were contacted to obtain unpublished information. This information was coded in terms of active content and attributes of the study population and methods. Meta-regression was used to create a model predicting smoking cessation outcomes. This model was used to re-estimate intervention effects, as if all interventions have been evaluated against the same comparators. Outcome measures included log odds of smoking cessation for the meta-regression models and smoking cessation differences and ratios to compare relative effectiveness. Results: The meta-regression model predicted smoking cessation rates well (pseudo R 2 = 0.44). Standardising the comparator had substantial impact on conclusions regarding the (relative) effectiveness of trials and types of intervention. Compared with a ‘no support comparator’, self-help was 1.33 times (95% CI = 1.16–1.49), brief physician advice 1.61 times (95% CI = 1.31–1.90), nurse individual counselling 1.76 times (95% CI = 1.62–1.90), psychologist individual counselling 2.04 times (95% CI = 1.95–2.15) and group psychologist interventions 2.06 times (95% CI = 1.92–2.20) more effective. Notably, more elaborate experimental interventions (e.g. psychologist counselling) were typically compared with more elaborate comparators, masking their effectiveness. Conclusions: Comparator variability and underreporting of comparators obscures the interpretation, comparison and generalisability of behavioural smoking cessation trials. Comparator variability should, therefore, be taken into account when interpreting and synthesising evidence from trials. Otherwise, policymakers, practitioners and researchers may draw incorrect conclusions about the (cost) effectiveness of smoking cessation interventions and their constituent components.

While the primary goals of medical treatment are typically to shorten illness or relieve symptoms, we explore the idea that an important additional goal for some patients is to communicate need. Drawing on costly signalling theory, we argue that treatments – and in particular aversive treatments – can help patients legitimize their illness and thereby enable access to crucial support during convalescence. Four pre-registered within-subjects experiments (n = 874) show that participants are more inclined to provide care to people who undergo treatment, especially when that treatment is painful. Results show this incentivizes the use of antibiotic treatments for viral infections as well as risky drug treatments for mental illness. A cross-sectional of 194 chronic pain patients shows that those who experience stigma and doubt over the legitimacy of their illness are more likely to accept aversive treatments. Furthermore, two experiments (n = 653) indicate that subtle manipulations to one’s sense of social support may increase willingness to accept treatment. These results indicate that people make decisions to provide care in part based on the presence/absence of treatment and furthermore that patients’ treatment decision making is informed by the social consequences of their choices. Signalling theory may help explain the surprising longevity of some ineffective and costly medical procedures.

Contains fulltext : 282770.pdf (Publisher’s version ) (Open Access) INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) involves the use of antiretroviral medication in HIV-negative individuals considered to be at risk of acquiring HIV. It has been shown to prevent HIV and has been available in Wales since July 2017. Measuring and understanding adherence to PrEP is complex as it relies on the simultaneous understanding of both PrEP use and sexual activity. We aimed to understand the experiences of men who have sex with men (MSM) living in Wales initiating, implementing and persisting with HIV PrEP. METHODS: We conducted semistructured interviews with MSM PrEP users in Wales who participated in a cohort study of PrEP use and sexual behaviour. Following completion of the cohort study, participants were invited to take part in a semistructured interview about their experiences of taking PrEP. We aimed to include both individuals who had persisted with and discontinued PrEP during the study. The interview topic guide was informed by the ABC taxonomy for medication adherence and the theory of planned behaviour. We analysed our data using reflexive thematic analysis. RESULTS: Twenty-one participants were interviewed, five having discontinued PrEP during the cohort study. The developed themes focused on triggers for initiating PrEP, habitual behaviour, drivers for discontinuation and engagement with sexual health services. Stigma surrounding both PrEP and HIV permeated most topics, acting as a driver for initiating PrEP, an opportunity to reduce discrimination against people living with HIV, but also a concern around the perception of PrEP users. CONCLUSION: This is the first study to investigate PrEP-taking experiences incorporating established medication adherence taxonomy. We highlight key experiences regarding the initiation, implementation and persistence with PrEP and describe how taking PrEP may promote positive engagement with sexual health services. These findings may be useful for informing PrEP rollout programmes and need to be explored in other key populations. PATIENT AND PUBLIC CONTRIBUTION: PrEP users, in addition to PrEP providers and representatives of HIV advocacy and policy, were involved in developing the topic guide for this study.

Contains fulltext : 293619.pdf (Publisher’s version ) (Open Access) Stigma may influence the use of HIV pre-exposure prophylaxis (PrEP). However, there is an absence of robust measures for PrEP-related stigma. We describe an adaptation of a HIV stigma scale for use in PrEP users and experiences of PrEP users in Wales (UK) with regards to PrEP-related stigma. A mixed methods study was conducted where PrEP users completed questionnaire items about PrEP-related stigma and a subset were interviewed about their experiences of taking PrEP. We adapted items from the HIV stigma scale and assessed construct validity and internal consistency. We analysed interview data using a framework approach, with themes focussing on enacted and anticipated stigma in order to identify areas for scale refinement. Our measure had good psychometric properties but additional items may be useful (e.g. specific instances of enacted stigma, concerns around homonegativity). Further work is needed to develop this scale and validate it in a larger sample. 01 juli 2023

Background During the coronavirus disease (COVID-19) pandemic, key persons who were formally or informally active in community organisations and networks, such as sports clubs or cultural, educational, day care and healthcare facilities, occupied a key position between governments and citizens. However, their experiences, the dilemmas they faced and the solutions they generated when implementing COVID-19 measures in their respective settings are understudied. Aim We aimed to understand how key persons in different community organisations and networks experienced and responded to the COVID-19 measures in the Netherlands. Methods Between October 2020 and December 2021, the Corona Behavioural Unit at the Dutch national public health institute, conducted qualitative research based on narratives derived from 65 in-depth interviews with 95 key persons from 32 organisations and networks in eight different sectors. Results Firstly, key persons enhanced adherence and supported the resilience and well-being of people involved in their settings. Secondly, adherence was negatively affected where COVID-19 measures conflicted with important organisational goals and values. Thirdly, small changes and ambiguities in COVID-19 policy had substantial consequences, depending on the context. Fourthly, problem-solving was achieved through trial-and-error, peer support, co-creation and transparent communication. Lastly, the COVID-19 pandemic and measures highlighted inequalities in access to resources. Conclusion Pandemic preparedness requires organisational and community preparedness and a multidisciplinary public health approach. Structural engagement of governments with key persons in community organisations and networks is key to enhance public trust and adherence to pandemic measures and contributes to health equity and the well-being of the people involved.

Contains fulltext : 287764.pdf (Publisher’s version ) (Open Access) OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) for breast cancer leads to increased recurrence and mortality risk and healthcare costs. Evidence on feasible, effective AET adherence interventions is scarce. This paper describes the systematic adaptation of the cost-effective adherence improving self-management strategy (AIMS) for patients with HIV to AET for women after breast cancer treatment. METHODS: We followed the intervention mapping protocol for adapting interventions by conducting a needs assessment, reviewing target behaviours and determinants, reassessing behaviour change methods and adapting programme content. Therefore, we performed a literature review, consulted behavioural theory and organised nine advisory board meetings with patients and healthcare professionals. RESULTS: Non-adherence occurs frequently among AET users. Compared to HIV treatment, AET is less effective, and AET side effects are more burdensome. This drives AET treatment discontinuation. However, the key determinants of non-adherence are largely similar to HIV treatment (e.g. motivation, self-regulation and patient-provider relationship); therefore, most strategies in AIMS-HIV also seem suitable for AIMS-AET. Modifications were required, however, regarding supporting patients with coping with side effects and sustaining treatment motivation. CONCLUSION: AIMS seems to be a suitable framework for adherence self-management across conditions and treatments. Intervention mapping offered a transparent, systematic approach to adapting AIMS-HIV to AET.

Contains fulltext : 292876.pdf (Publisher’s version ) (Open Access) We investigated the determinants of daily PrEP use and coverage of condomless anal sex (CAS) by PrEP among men who have sex with men in Wales, UK. We measured PrEP use by electronic monitors and CAS by secure online surveys. We defined PrEP use based on daily medication cap openings and coverage as CAS episodes preceded by ≥ 3 days of PrEP use and followed by ≥ 2 days of PrEP use. We included 57 participants (5463 observations). An STI diagnosis was associated with lower PrEP use but also lower PrEP coverage. Older adults had higher PrEP use. A belief that other PrEP users took PrEP as prescribed was associated with lower PrEP coverage. An STI diagnosis is an important cue for an intervention, reflecting episodes of high-risk sexual behaviour and low PrEP coverage. Other results provide a basis for the development of an evidence-informed intervention for promoting coverage of PrEP.

This pre-print examines well-being, loneliness and life satisfaction over the course of the COVID-19 pandemic in the Netherlands

To inform future Dutch Covid-19 testing policies we did an experimental vignette study to investigate whether inclusion of the less reliable lateral flow tests (self-tests) would change test-uptake sufficiently to improve population-level test sensitivity. A representative sample (n = 3.270) participated in a 2-by-2 online experiment to evaluate the effects of test-guidelines including self-testing advice (IV1), and the effects of self-test availability (IV2) on test uptake (PCR test, self-test or no test) and sensitivity of the overall test strategy (primary outcome). Across four scenarios, changing test advice did not affect testing behaviour. Self-test availability, however, increased the timeliness of testing, the number of people testing, and overall test strategy sensitivity. Based on these findings, we recommend that (national) policy facilitates a supply of self-tests at home, for example through free and pro-active distribution of test-kits. This could substantially enhance the chances of timely detecting and isolating COVID-19 patients.

Reporting of the content and delivery characteristics of comparator interventions in published articles is often incomplete. This study examines the feasibility and validity of two methods for collecting additional information on comparator interventions from trial authors.In a systematic review of smoking cessation trials (IC-Smoke), all trial authors were asked to send unpublished comparator intervention materials and complete a specially-developed comparator intervention checklist. All published and additionally obtained information from authors were coded for behaviour change techniques (BCTs) and other characteristics (type of comparator, provider, provider training, delivery mode and treatment duration). To assess representativeness, we assessed the amount of additional information obtained from trial authors compared with the amount that was published. We examined known-group and convergent validity of comparator intervention data when using only published or also unpublished information.Additional information were obtained from 91/136 (67%) of trial authors. Representativeness, known-group and convergent validity improved substantially based on the data collected by means of the comparator intervention checklist, but not by requesting authors to send any existing comparator materials.Requesting authors for unpublished comparator intervention data, using specially-developed checklists and unpublished materials, substantially improves the quality of data available for systematic reviews.

Objective To understand the barriers and facilitators to single instillation of intravesical chemotherapy (SI-IVC) use following resection of non-muscle-invasive bladder cancer (NMIBC) in Scotland and England using a behavioural theory-informed approach. Materials and methods In a cross-sectional descriptive study of practices at seven hospitals, we investigated care pathways, policies, and interviewed 30 urology staff responsible for SI-IVC. We used the Theoretical Domains Framework (TDF) to organise our investigation and conducted deductive thematic analyses, while inductively coding emergent beliefs. Results Barriers to SI-IVC were present at different organisational levels and professional roles. In four hospitals there was a policy to not instil SI-IVC in theatre. Six hospitals' staff reported delays in MMC ordering and/or local storage. Lack of training, skills and perceived workload affected motivation. Facilitators included access to modern instilling devices (four hospitals) and incorporating reminders operation pro-forma (four hospitals). Performance targets (with audit and feedback) within a national governance framework was present in Scotland but not England. Differences in coordinated leadership, sharing best practices, and disliking being perceived as underperforming, were evident in Scotland. Conclusions High-certainty evidence shows that SI-IVC such as Mitomycin C (MMC), following NMIBC resection reduces recurrences. This evidence underpins international guidance. Numbers of eligible patients receiving SI-IVC is variable indicating suboptimal practice. Improving SI-IVC adherence requires modifications to theatre instilling policies, delivery and storage of MMC, staff training, and documentation. Centralising care with bladder cancer expert leadership and best practices sharing, with performance targets, likely led to improvements in Scotland. National quality improvement, incorporating audit and feedback, with additional implementation strategies targeted to professional role could improve adherence and patient outcomes elsewhere. This process should be controlled to clarify implementation intervention effectiveness.

Despite its importance, underreporting of the active content of experimental and comparator interventions in published literature has not been previously examined for behavioural trials. We assessed completeness and variability in reporting in 142 randomised controlled trials of behavioural interventions for smoking cessation published between 1/1996 and 11/2015. Two coders reliably identified the potential active components of experimental and comparator interventions (activities targeting behaviours key to smoking cessation and qualifying as behaviour change techniques, BCTs) in published, and in unpublished materials obtained from study authors directly. Unpublished materials were obtained for 129/204 (63%) experimental and 93/142 (65%) comparator groups. For those, only 35% (1200/3403) of experimental and 26% (491/1891) of comparator BCTs could be identified in published materials. Reporting quality (#published BCTs/#total BCTs) varied considerably between trials and between groups within trials. Experimental (vs. comparator) interventions were better reported (B(SE) = 0.34 (0.11), p

Background Many global health challenges may be targeted by changing people’s behaviour. Behaviours including cigarette smoking, physical inactivity and alcohol misuse, as well as certain dietary behaviours, contribute to deaths and disability by increasing the risk of cancers, cardiovascular diseases and diabetes. Interventions have been designed to change these health behaviours with a view to reducing these health risks. However, the effectiveness of these interventions has been quite variable and further information is needed to enhance their success. More information is needed about the specific processes that underlie the effectiveness of intervention strategies. Aim Researchers have developed a taxonomy of 93 behaviour change techniques (i.e. the active components of an intervention that bring about behavioural change), but little is known regarding their potential mechanisms of action (i.e. the processes through which a behaviour change technique affects behaviour). We therefore aimed to examine links between behaviour change techniques and mechanisms of action. Method First, we conducted a literature synthesis study of 277 behaviour change intervention studies, from which we extracted information on links, described by authors, between behaviour change techniques and mechanisms of action, and identified an average of 10 links per intervention report. Second, behaviour change experts (n = 105) were engaged in a three-round consensus study in which they discussed and rated their confidence in the presence/absence of ‘links’ and ‘non-links’ between commonly used behaviour change techniques (n = 61) and a set of mechanisms of action (n = 26). Ninety links and 460 ‘non-links’ reached the pre-set threshold of 80% agreement. To enhance the validity of these results, a third study was conducted that triangulated the findings of the first two studies. Discrepancies and uncertainties between the studies were included in a reconciliation consensus study with a new group of experts (n = 25). The final results identified 92 definite behaviour change technique–mechanism of action links and 465 definite non-links. In a fourth study, we examined whether or not groups of behaviour change techniques used together frequently across interventions revealed shared theoretical underpinnings. We found that experts agreed on the underlying theory for three groups of behaviour change techniques. Results Our results are potentially useful to policy-makers and practitioners in selecting behaviour change techniques to include in behaviour change interventions. However, our data do not demonstrate that the behaviour change techniques are effective in targeting the mechanism of action; rather, the links identified may be the ‘best bets’ for interventions that are effective in changing mechanisms of action, and the non-links are unlikely to be effective. Researchers examining effectiveness of interventions in either primary studies or evidence syntheses may consider these links for further investigation. Conclusion To make our results usable by researchers, practitioners and policy-makers, they are available in an online interactive tool, which enables discussion and collaboration (https://theoryandtechniquetool.humanbehaviourchange.org/); accessed 1 March 2020. This work, building on previous work to develop the behaviour change technique taxonomy, is part of an ongoing programme of work: the Human Behaviour Change Project (www.humanbehaviourchange.org/; accessed 1 March 2020). Funding This project was funded by the Medical Research Council via its Methodology Panel: ‘Developing methodology for designing and evaluating theory-based complex interventions: an ontology for linking behaviour change techniques to theory’ (reference MR/L011115/1).

Contains fulltext : 238651.pdf (Publisher’s version ) (Open Access) BACKGROUND: Individuals' perceptions of back pain may shape what they do in response to manage their pain, for example, self-care, medication and seeking healthcare. Illness perceptions encompass a variety of beliefs such as how long pain is expected to last and whether treatments are perceived to control pain. Whether these beliefs meaningfully cluster and whether these clusters are associated with how people manage their back pain are currently unknown. METHODS: 1,343 individuals with back pain from a general population sample completed the brief Illness Perceptions Questionnaire and measures about their pain and illness behaviours. Using a two-stage cluster analysis, we identified four distinct clusters of individuals. Logistic regression was used to investigate relationships between cluster membership and illness behaviours. RESULTS: After adjustment for socio-demographic characteristics, pain severity, interference and duration, relative to a low threat illness perception cluster, a high threat cluster was more likely to have contacted a general practitioner (OR: 3.03, 95% CI: 1.75, 5.23) and a moderate threat-high treatment control cluster was more likely to have consulted a physical therapist (OR: 2.21, 95% CI: 1.26, 3.87). Both the moderate threat-high treatment control cluster and high threat cluster were also less likely to have reported self-care (OR: 0.64, 95% CI: 0.43, 0.95; OR: 0.53, 95% CI: 0.34, 0.83, respectively). CONCLUSIONS: The cluster analysis provided a meaningful classification of individuals based on their cognitive illness perceptions of their back pain, as these clusters were associated with different illness behaviours. Interventions which modify clusters of illness perceptions may be effective in influencing how individuals respond to back pain. SIGNIFICANCE: Within a general population setting, we identified four clearly distinct groups of people based on the perceptions they held about their back pain. These groupings seemed to reflect meaningful characterisations as they differed based on the characteristics of their pain (e.g., severity and duration) and, after adjustment for these characteristics, were associated with different ways of managing pain. Interventions which focus on targeting the sets of illness perceptions that people hold may be effective in influencing how individuals manage back pain.

COVID-19 mitigation measures intend to protect public health, but their adverse psychological, social, and economic effects weaken popular support. Less favorable trade-offs may especially weaken support for more restrictive measures. Support for mitigation measures may also differ between population subgroups who experience different benefits and costs, and decrease over time, a phenomenon termed ‘pandemic fatigue’. We examined self-reported support for COVID-19 mitigation measures in The Netherlands over 12 consecutives waves of data collection between April 2020 – May 2021 in an open population cohort study. Participants were recruited through community panels of the 25 regional public health services, and through links to the online surveys advertised on social media. The 54,010 unique participants in the cohort study on average participated in 4 waves of data collection. Most participants were female (65%), middle-aged (57% 40-69 years), highly educated (57%), not living alone (84%), residing in an urban area (60%), and born in the Netherlands (95%). COVID-19 mitigation measures implemented in the Netherlands remained generally well-supported over time (all scores >3 on 5-point scale ranging 1 (low) – 5 (high)). During the whole period studied, support was highest for personal hygiene measures, quarantine and wearing face masks, high but somewhat lower for not shaking hands, testing and self-isolation, and restricting social contacts, and lowest for limiting visitors at home, and not traveling abroad. Women and higher educated people were more supportive of some mitigation measures than men and lower educated people. Older people were more supportive of more restrictive measures than younger people, and support for more socially restrictive measures decreased most over time in higher educated people or in younger people. This study found no support for pandemic fatigue in terms of a gradual decline in support for all mitigation measures over time. Rather, findings suggest that support for mitigation measures reflects a balancing of benefits and cost, which may change over time, and differ between measures and population subgroups.

Background: During the COVID-19 pandemic, key stakeholders in local organisations like sport clubs, cultural-, education- or day- and healthcare facilities, are positioned between governments and citizens. Yet, their experiences, the dilemmas they face and solutions they generate in implementing COVID-19 prevention policies in their setting are understudied. Aim: To understand how formal and informal stakeholders in different organisations and community networks have experienced and responded to the COVID-19 pandemic policies in the Netherlands. Methods: Between October 2020 - November 2021, the Corona Behavioural Unit at the National Institute of Public Health and the Environment (RIVM, Netherlands) conducted narrative research, including 65 in-depth interviews with 95 key persons from 32 organisations in 8 different sectors. An independent expert-panel reviewed the methodology, analysis and interpretation of data. Results: Five main themes emerged. First, local stakeholders support resilience and wellbeing of people involved, and enhance adherence through context-specific interventions and partnerships. Second, adherence is negatively affected when COVID-19 policies conflict with significant organisational goals and values. Third, small changes and unclarity in policies nationally, can have major impact on stakeholders locally. Fourth problem solving was based on trial-and-error, peer support, co-creation and transparent communication. Lastly, pandemic and COVID-19 prevention policies highlight inequalities in access to resources.

Contains fulltext : 229562.pdf (Publisher’s version ) (Open Access) AIMS: To estimate the strengths of associations between use of behaviour change techniques (BCTs) and clusters of BCTs in behavioural smoking cessation interventions and comparators with smoking cessation rates. METHOD: Systematic review and meta-regression of biochemically verified smoking cessation rates on BCTs in interventions and comparators in randomized controlled trials, adjusting for a priori-defined potential confounding variables, together with moderation analyses. Studies were drawn from the Cochrane Tobacco Addiction Group Specialised Register. Data were extracted from published and unpublished (i.e. obtained from study authors) study materials by two independent coders. Adequately described intervention (k = 143) and comparator (k = 92) groups were included in the analyses (n = 43 992 participants). Using bivariate mixed-effects meta-regressions, while controlling for key a priori confounders, we regressed smoking cessation on (a) three BCT groupings consistent with dual-process theory (i.e. associative, reflective motivational and self-regulatory), (b) 17 expert-derived BCT groupings (i.e. BCT taxonomy version 1 clusters) and (c) individual BCTs from the BCT taxonomy version 1. RESULTS: Among person-delivered interventions, higher smoking cessation rates were predicted by BCTs targeting associative and self-regulatory processes (B = 0.034, 0.041, P

Aims: To examine variability and effectiveness of interventions provided to comparator (control) groups in smoking cessation trials. Methods: Systematic review with meta‐analysis of randomized controlled trials (RCTs) of behavioral interventions for smoking cessation, with or without stop‐smoking medication. We searched the Cochrane Tobacco Addiction Group Specialized Register for RCTs with objective outcomes measured at ≥6months. Study authors were contacted to obtain comprehensive descriptions of their comparator interventions. Meta‐regression analyses examined the relationships of smoking cessation rates with stop‐smoking medication and behavior change techniques. Results: One hundred and four of 142 eligible comparator groups (n=23 706) had complete data and were included in analyses. There was considerable variability in the number of behavior change techniques delivered [mean=15.97, standard deviation (SD)=13.54, range=0–45] and the provision of smoking cessation medication (43% of groups received medication) throughout and within categories of comparator groups (e.g. usual care, brief advice). Higher smoking cessation rates were predicted by provision of medication [B=0.334, 95% confidence interval (CI)=0.030–0.638,P=0.031] and number of behavior change techniques included (B=0.020, 95% CI=0.008–0.032,P Conclusions: Interventions delivered to comparator groups in smoking cessation randomized controlled trials vary considerably in content, and cessation rates are strongly predicted by stop‐smoking medication and number of behavior change techniques delivered.

Background: Highly effective direct-acting antiviral drugs provide the opportunity to eliminate hepatitis C virus (HCV) infection, but established pathways can be ineffective. We aimed to examine whether a community pharmacy care pathway increased treatment uptake, treatment completion, and cure rates for people receiving opioid substitution therapy, compared with conventional care. Methods: This cluster-randomised trial was done in Scottish community pharmacies. Before participants were recruited, pharmacies were randomly assigned (1:1) to refer patients with evidence of HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care). Pharmacies were stratified by location. All pharmacies were trained to offer dried blood spot testing. All eligible participants had received opioid substitution therapy for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration. Neither pharmacists nor patients were masked to treatment allocation. In both groups, assessment blood samples were taken, infection with HCV was confirmed, and daily oral ledipasvir–sofosbuvir (90 mg ledipasivir plus 400 mg sofosbuvir) for 8 weeks for genotype 1 or daily oral sofosbuvir (400 mg) plus oral daclatasvir (60 mg) for 12 weeks for genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group). In the conventional care group, the patient received care at a treatment centre. Once prescribed, medication in both groups was delivered as daily modified directly observed therapy alongside opioid substitution therapy in the participants' pharmacy where treatment was observed on 6 days per week. The primary outcome was the number of patients with sustained virological response 12 weeks after completion of treatment (SVR12) as a proportion of the number of people receiving opioid substitution therapy at participating pharmacies. Participants were monitored at each visit for nausea and fatigue; other adverse events were recorded as free text. Secondary outcomes compared key points on treatment pathway between the two groups. These key points were the proportion of patients having dry blood spot testing, the proportion of patients initiating HCV treatment, the proportion of patients completing the 8 or 12 week HCV course of treatment, and the proportion of patients with sustained virological response at 12 months. This study is registered with ClinicalTrials.gov, NCT02706223. Findings: 56 pharmacies were randomly assigned (28 to each group; one pharmacy withdrew from the conventional care group). The 55 participating pharmacies included 2718 patients receiving opioid substitution therapy (1365 in the pharmacist-led care group and 1353 in the conventional care group). More patients met the primary endpoint of SVR12 in the pharmacist-led care group (98 [7%] of 1365) than in the conventional care group (43 [3%] of 1353; odds ratio 2·375, 95% CI 1·555–3·628, p

Background: The COVID-19 outbreak early 2020 was followed by an unprecedented package of measures. The relative calmness of the pandemic early 2022 provides a momentum to prepare for various scenarios. Objectives: As acceptance of COVID-19 measures is key for public support we investigated citizens’ preferences towards imposing measures in four scenarios: 1) spring/summer scenario with few hospitalizations; 2) autumn/winter scenario with many hospitalizations; 3) a new contagious variant, the impact on hospitalizations is unclear; 4) a new contagious variant, hospitalizations will substantially increase. Methods: Study 1 comprised a Participatory Value Evaluation (PVE) in which 2011 respondents advised their government on which measures to impose in the four scenarios. Respondents received information regarding the impact of each measure on the risk that the health system would be overloaded. To triangulate the results, 2958 respondents in Study 2 evaluated the acceptability of the measures in each scenario. Results: Measures were ranked similarly by respondents in Study 1 and 2: 1) the majority of respondents thought that hygiene measures should be upheld, even in the spring/summer; 2) the majority supported booster vaccination, working from home, encouraging self-testing, and mandatory face masks from scenario 2 onwards; 3) even in scenario 4, lockdown measures were not supported by the majority. Young respondents were willing to accept more risks for the health system than older respondents. Conclusion: The results suggest that policies that focus on prevention (through advising low-impact hygiene measures) and early response to moderate threats (by scaling up to moderately restrictive measures and boostering) can count on substantial support. There is low support for lockdown measures even under high-risk conditions, which further emphasizes the importance of prevention and a timely response to new threats. Our results imply that young citizens’ concerns, in particular, should be addressed when restrictive COVID-19 measures are to be implemented.

There is a need for instruments designed for patients with asthma to self-report their performance of inhaling steps. We aimed to develop an accessible and easy-to-use patient-reported tool for inhaler technique assessment, which could also serve as a training and monitoring resource for any type of inhaler device, and to evaluate its feasibility, validity, and reliability in adults with asthma. The development was based on literature review and pilot testing with clinicians and patients. The Inhaler Technique Questionnaire (InTeQ) asks about the frequency of performing five steps when using inhalers (on a five-point Likert scale). We analyzed data from adults with persistent asthma (n = 361). We examined the measurement model using Mokken scaling analysis, construct validity by assessing hypotheses on expected discrimination among known groups, and reliability based on internal consistency and reproducibility. Means of the InTeQ items were in the range of 0.23-1.61, and coefficients of homogeneity were above the cutoff point, demonstrating the unidimensionality of the scale. Known groups' global score differences were statistically significant between patients reporting having "Discussed in detail" or having "Not discussed/Only in general" the inhaler technique with their healthcare providers (p = 0.023). The Cronbach's alpha coefficient was 0.716, and the intraclass correlation coefficient was 0.775. The InTeQ is a feasible, valid, and reliable instrument for self-reporting inhaler technique on any type of device. The research leading to these results has received funding from the European Community 7th Framework (FP7/2007–2013) under grant agreement number 282593, and the H2020 programme (MSCA-IF) under grant agreement number 706028 for A.L.D. during manuscript preparation. The following researchers have worked on this manuscript while funded by grants: C.L.-B. (University of Costa Rica OAICE-85-2019), K.M. (Instituto de Salud Carlos III FEDER: Fondo Europeo de Desarrollo Regional FI16/00071) and A.L.D. (IDEXLYON 16-IDEX-0005). The Health Services Research Group, IMIM, received funding from Generalitat de Catalunya (2017 SGR 452). Funding information for this article has been deposited with the Crossref Funder Registry. The funding agreements ensure the authors’ independence in designing the study, interpreting the data, and writing and publishing the report.

Contains fulltext : 251351.pdf (Publisher’s version ) (Open Access) Most countries in the world have recommended or mandated face masks in some or all public places during the COVID-19 pandemic. However, mask use has been thought to increase people's face-touching frequency and thus risk of self-inoculation. Across two studies, we video-observed the face-touching behaviour of members of the public in Amsterdam and Rotterdam (the Netherlands) during the first wave of the pandemic. Study 1 (n = 383) yielded evidence in favour of the absence of an association between mask-wearing and face-touching (defined as touches of face or mask), and Study 2 (n = 421) replicated this result. Secondary outcome analysis of the two studies-analysed separately and with pooled data sets-evidenced a negative association between mask-wearing and hand contact with the face and its t-zone (i.e. eyes, nose and mouth). In sum, the current findings alleviate the concern that mask-wearing has an adverse face-touching effect.

BACKGROUND Although emerging adults play a role in the spread of COVID-19, they are less likely to develop severe symptoms after infection. Emerging adults’ relatively high use of social media as source of information raises concerns regarding COVID-19 related behavioral compliance (i.e., physical distancing) in this age group. OBJECTIVE Therefore, the current study investigated physical distancing in emerging adults in comparison to older adults and looked at the role of using social media for COVID-19 news and information in this regard. In addition, this study explored the relation between physical distancing and different social media platforms and sources. METHODS Secondary data of a large-scale national longitudinal survey (N = 123,848, 34.% male) between April and November 2020 were used. Participants indicated, ranging for one to eight waves, how often they were successful in keeping 1.5 meters distance on a 7-point Likert scale. Participants between 18 and 24 years old were considered young adults and older participants were identified as older adults. Also, a dummy variable was created to indicate per wave whether participants used social media for COVID-19 news and information. A subset received follow-up questions asking participants to indicate which platforms they have used and what sources of news and information they had seen on social media. All preregistered hypotheses were tested with Linear Mixed-Effects Models and Random Intercept Cross-Lagged Panel Models. RESULTS Emerging adults reported less physical distancing behaviors than older adults (b = -.08, t(86213.83) = -26.79, p < .001). Also, emerging adults were more likely to use social media for COVID-19 news and information (b = 2.48, SE = .11, Wald = 23.66, p = CONCLUSIONS In conclusion, we should be vigilant for physical distancing of emerging adults, but this study give no reason the to worry about the role of social media for COVID-19 news and information. However, as some social media platforms and sources showed negative associations, future studies should more carefully look into these factors to better understand the associations between social media use for news and information, and behavioral interventions in times of crisis.

Purpose To describe nurses' support interventions for medication adherence, and patients' experiences and desired improvements with this care. Patients and methods A two-phase study was performed, including an analysis of questionnaire data and conducted interviews with members of the care panel of the Netherlands Patients Federation. The questionnaire assessed 14 types of interventions, satisfaction (score 0-10) with received interventions, needs, experiences, and desired improvements in nurses' support. Interviews further explored experiences and improvements. Data were analyzed using descriptive statistics and a thematic analysis approach. Results Fifty-nine participants completed the questionnaire, and 14 of the 59 participants were interviewed. The satisfaction score for interventions was 7.9 (IQR 7-9). The most common interventions were: "noticing when I don't take medication as prescribed" (n = 35), "helping me to find solutions to overcome problems with using medications" (n = 32), "helping me with taking medication" (n = 32), and "explaining the importance of taking medication at the right moment" (n = 32). Fifteen participants missed ≥1 of the 14 interventions. Most mentioned the following: "regularly asking about potential problems with medication use" (33%), "regularly discussing whether using medication is going well" (29%), and "explaining the importance of taking medication at the right moment" (27%). Twenty-two participants experienced the following as positive: improved self-management of adequate medication taking, a professional patient-nurse relationship to discuss adherence problems, and nurses' proactive attitude to arrange practical support for medication use. Thirteen patients experienced the following as negative: insufficient timing of home visits, rushed appearance of nurses, and insufficient expertise about side effects and taking medication. Suggested improvements included performing home visits on time, more time for providing support in medication use, and more expertise about side effects and administering medication. Conclusion Overall, participants were satisfied, and few participants wanted more interventions. Nurses' support improved participants' self-management of medication taking and enabled patients to discuss their adherence problems. Adequately timed home visits, more time for support, and accurate medication-related knowledge are desired.

Recently the Netherlands saw a substantial increase in pro-COVID-19 vaccination intention (48 to 75%). Using qualitative methods we identified vaccination beliefs and contextual factors informing this increase. Quantitative methods confirm that intentions were a function of beliefs: people with stronger intention to vaccinate were motivated most by protecting others and reopening society, those reluctant were mostly concerned by (unknown long-term) side effects. We demonstrate that belief shifts track intentional shifts, and offer insights for improving pro-vaccination campaigns.

Contains fulltext : 202226.pdf (Publisher’s version ) (Closed access) Background: Several promising human immunodeficiency virus (HIV) treatment adherence interventions have been identified, but data about their cost-effectiveness are lacking. This study examines the trial-based cost-effectiveness and cost-utility of the proven-effective Adherence Improving Self-Management Strategy (AIMS), from a societal perspective, with a 15-month time horizon. Methods: Treatment-naive and treatment-experienced patients at risk for viral rebound were randomized to treatment as usual (TAU) or AIMS in a multicenter randomized controlled trial in the Netherlands. AIMS is a nurse-led, 1-on-1 self-management intervention incorporating feedback from electronic medication monitors, delivered during routine clinical visits. Main outcomes were costs per reduction in log10 viral load, treatment failure (2 consecutive detectable viral loads), and quality-adjusted life-years (QALYs). Results: Two hundred twenty-three patients were randomized. From a societal perspective, AIMS was slightly more expensive than TAU but also more effective, resulting in an incremental cost-effectiveness ratio (ICER) of euro549 per reduction in log10 viral load and euro1659 per percentage decrease in treatment failure. In terms of QALYs, AIMS resulted in higher costs but more QALYs compared to TAU, which resulted in an ICER of euro27759 per QALY gained. From a healthcare perspective, AIMS dominated TAU. Additional sensitivity analyses addressing key limitations of the base case analyses also suggested that AIMS dominates TAU. Conclusions: Base case analyses suggests that over a period of 15 months, AIMS may be costlier, but also more effective than TAU. All additional analyses suggest that AIMS is cheaper and more effective than TAU. This trial-based economic evaluation confirms and complements a model-based economic evaluation with a lifetime horizon showing that AIMS is cost-effective. Clinical Trials Registration: NCT01429142.

BACKGROUNDIt remains unclear whether combination antiretroviral therapy (ART) regimens differ in their ability to fully suppress HIV replication. Here, we report the results of two cross-sectional studies that compared levels of cell-associated (CA) HIV markers between individuals receiving suppressive ART containing either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI).METHODSCA HIV unspliced RNA and total HIV DNA were quantified in two cohorts (n=100, n=124) of individuals treated with triple ART regimens consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a NNRTI or a PI. To compare CA HIV RNA and DNA levels between the regimens, we built multivariable models adjusting for age, gender, current and nadir CD4+ count, plasma viral load zenith, duration of virological suppression, NRTI backbone composition, low-level plasma HIV RNA detectability, and electronically-measured adherence to ART.RESULTSIn both cohorts, levels of CA HIV RNA and DNA strongly correlated (rho=0.70 and rho=0.54) and both markers were lower in NNRTI-treated than in PI-treated individuals. In the multivariable analysis, CA RNA in both cohorts remained significantly reduced in NNRTI-treated individuals (padj=0.02 in both cohorts), with a similar but weaker association between the ART regimen and total HIV DNA (padj=0.048 and padj=0.10). No differences in CA HIV RNA or DNA levels were observed between individual NNRTIs or individual PIs, but CA HIV RNA was lower in individuals treated with either nevirapine or efavirenz, compared to PI-treated individuals.CONCLUSIONSAll current classes of antiretroviral drugs only prevent infection of new cells but do not inhibit HIV RNA transcription in long-lived reservoir cells. Therefore, these differences in CA HIV RNA and DNA levels by treatment regimen suggest that NNRTIs are more potent in suppressing HIV residual replication than PIs, which may result in a smaller viral reservoir size.

Background: Face masks have been widely employed as a personal protective measure during the COVID-19 pandemic. However, concerns remain that masks create a false sense of security that reduces adherence to other public health measures, including social distancing. Purpose: This paper tested whether mask-wearing was negatively associated with social distancing compliance. Methods: In two studies, we combined video-observational records of public mask-wearing in two Dutch cities with a natural-experimental approach to evaluate the effect of an area-based mask mandate. Results: We found no observational evidence of an association between mask-wearing and social distancing (Study 1: p = .398; Study 2: p = .511), but found a positive link between crowding and social distancing violations (Study 1: p < .001; Study 2: p < .001). Our natural-experimental analysis showed that an area-based mask mandate did not significantly affect social distancing or crowding levels (Study 2: p = .781 and p = .126, respectively). Conclusions: Our results alleviate the concern that mask use reduces social distancing compliance or increases crowding levels. On the other hand, crowding reduction may be a viable strategy to mitigate social distancing violations.

ObjectivesTo describe the early impact of COVID-19 and associated control measures on the sexual behaviour of pre-exposure prophylaxis (PrEP) users in Wales.MethodsData were obtained from an ecological momentary assessment study of PrEP use and sexual behaviour. Participants were individuals accessing PrEP through the National Health Service (NHS) sexual health clinics across four health boards in Wales. Weekly data documenting condomless sex in the preceding week were analysed between 03/02/2020 and 10/05/2020. The introduction of social distancing measures and changes to sexual health clinics in Wales occurred on the week starting 16/03/2020. Two-level logistic regression models were fitted to condomless sex (yes/no) over time, included an indicator for the week starting 16/03/2020, and were extended to explore differential associations by relationship status and sexual health clinic.ResultsData were available from 56 participants and included 697 person-weeks (89% of the maximum number that could have been obtained). On average, 42% of participants reported condomless sex in the period prior to the introduction of social distancing measures and 20% reported condomless sex after (OR=0.16, 95% CI 0.07 to 0.37, pConclusionsThe introduction of social distancing measures and changes to PrEP services across Wales was associated with a marked reduction in reported instances of condomless sexual intercourse among respondents, with a larger reduction in those who were single compared with those who were not. The long-term impact of COVID-19 and associated control measures on this population’s physical and mental health and well-being requires close examination.

Background:It remains unclear whether combination antiretroviral therapy (ART) regimens differ in their ability to fully suppress human immunodeficiency virus (HIV) replication. Here, we report the results of two cross-sectional studies that compared levels of cell-associated (CA) HIV markers between individuals receiving suppressive ART containing either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI).Methods:CA HIV unspliced RNA and total HIV DNA were quantified in two cohorts (n = 100, n = 124) of individuals treated with triple ART regimens consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus either an NNRTI or a PI. To compare CA HIV RNA and DNA levels between the regimens, we built multivariable models adjusting for age, gender, current and nadir CD4+ count, plasma viral load zenith, duration of virological suppression, NRTI backbone composition, low-level plasma HIV RNA detectability, and electronically measured adherence to ART.Results:In both cohorts, levels of CA HIV RNA and DNA strongly correlated (rho = 0.70 and rho = 0.54) and both markers were lower in NNRTI-treated than in PI-treated individuals. In the multivariable analysis, CA RNA in both cohorts remained significantly reduced in NNRTI-treated individuals (padj = 0.02 in both cohorts), with a similar but weaker association between the ART regimen and total HIV DNA (padj = 0.048 and padj = 0.10). No differences in CA HIV RNA or DNA levels were observed between individual NNRTIs or individual PIs, but CA HIV RNA was lower in individuals treated with either nevirapine or efavirenz, compared to PI-treated individuals.Conclusions:All current classes of antiretroviral drugs only prevent infection of new cells but do not inhibit HIV RNA transcription in long-lived reservoir cells. Therefore, these differences in CA HIV RNA and DNA levels by treatment regimen suggest that NNRTIs are more potent in suppressing HIV residual replication than PIs, which may result in a smaller viral reservoir size.Funding:This work was supported by ZonMw (09120011910035) and FP7 Health (305522).

Contains fulltext : 243553.pdf (Publisher’s version ) (Open Access) Researchers, practitioners, and policymakers develop interventions to change behavior based on their understanding of how behavior change techniques (BCTs) impact the determinants of behavior. A transparent, systematic, and accessible method of linking BCTs with the processes through which they change behavior (i.e., their mechanisms of action [MoAs]) would advance the understanding of intervention effects and improve theory and intervention development. The purpose of this study is to triangulate evidence for hypothesized BCT-MoA links obtained in two previous studies and present the results in an interactive, online tool. Two previous studies generated evidence on links between 56 BCTs and 26 MoAs based on their frequency in literature synthesis and on expert consensus. Concordance between the findings of the two studies was examined using multilevel modeling. Uncertainties and differences between the two studies were reconciled by 16 behavior change experts using consensus development methods. The resulting evidence was used to generate an online tool. The two studies showed concordance for 25 of the 26 MoAs and agreement for 37 links and for 460 "nonlinks." A further 55 links were resolved by consensus (total of 92 [37 + 55] hypothesized BCT-MoA links). Full data on 1,456 possible links was incorporated into the online interactive Theory and Technique Tool (https://theoryandtechniquetool.humanbehaviourchange.org/). This triangulation of two distinct sources of evidence provides guidance on how BCTs may affect the mechanisms that change behavior and is available as a resource for behavior change intervention designers, researchers and theorists, supporting intervention design, research synthesis, and collaborative research.