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Introduction Older adults in care homes experienced some of the highest rates of mortality from SARS-CoV-2 globally and were subjected to strict and lengthy non-pharmaceutical interventions, which severely impacted their daily lives. The VIVALDI ASCOT and Ethnography Study aims to assess the impact of respiratory outbreaks on care home residents’ quality of life, psychological well-being, loneliness, functional ability and use of space. This study is linked to the VIVALDI-CT, a randomised controlled trial of staff’s asymptomatic testing and sickness payment support in care homes (ISRCTN13296529).Methods and analysis This is a mixed-methods, longitudinal study of care home residents (65+) in Southeast England. Group 1—exposed includes residents from care homes with a recent COVID-19 or other respiratory infection outbreak. Group 2—non-exposed includes residents from care homes without a recent outbreak. The study has two components: (a) a mixed-methods longitudinal face-to-face interviews with 100 residents (n=50 from group 1 and n=50 from group 2) to assess the impact of outbreaks on residents’ quality of life, psychological well-being, loneliness, functional ability and use of space at time 1 (study baseline) and time 2 (at 3–4 weeks after the first visit); (b) ethnographic observations in communal spaces of up to 10 care homes to understand how outbreaks and related restrictions to the use of space and social activities impact residents’ well-being. The study will interview only care home residents who have the mental capacity to consent. Data will be compared and integrated to gain a more comprehensive understanding of the impact of outbreaks on residents’ quality of life and well-being.Ethics and dissemination The VIVALDI ASCOT and Ethnography Study obtained ethical approval from the Health Research Authority (HRA) Social Care REC (24/IEC08/0001). Only residents with the capacity to consent will be included in the study. Findings will be published in scientific journals.

Abstract Introduction Globally, sexually transmissible infections (STIs) continue to disproportionately affect young people. Regular STI testing is an important public health strategy but remains low among this age group. Raising awareness of testing is an essential step and requires effective interventions designed for young people. To inform the development of effective interventions that promote STI testing among young people, we conducted a systematic literature review to describe the social marketing and visual design components commonly found in STI testing interventions and explore associations of these components with intervention effectiveness. Methods We used a systemic review methodology to identify peer-reviewed articles that met pre-defined inclusion criteria. Social marketing and visual component analyses were conducted using structured data extraction tools and coding schemes, based on the eight key social marketing principles and 28 descriptive dimensions for visual analysis. Results 18 studies focusing on 13 separate interventions met the inclusion criteria. Most interventions used photograph-based images, using conventionally attractive actors, positioned centrally and making direct eye contact to engage the viewer. The majority of interventions featured text sparingly and drew on a range of tones (e.g. serious, humorous, positive, reassuring, empowering and informative) and three interventions used sexualised content. Four articles explicitly stated that the interventions was informed by social marketing principles, with two explicitly referencing all eight principles. Around half of the articles reported using a formal theoretical framework, but most were considered to have theoretical constructs implicit in interventions materials. Four articles provided detailed information regarding developmental consumer research or pre-testing. All articles suggested segmentation and development of materials specifically for young people. Explicit consideration of motivation and competition was lacking across all articles. This study found that there were some design elements common to interventions which were considered more effective. High social marketing complexity (where interventions met at least seven of the 11 criteria for complexity) seemed to be associated with more effective interventions. Conclusions Our findings suggest that the incorporation of social marketing principles, could be more important for intervention effectiveness than specific elements of visual design. Effective and systematic use of social marketing principles may help to inform future evidence-informed and theoretically based interventions and should be employed within sexual health improvement efforts.

Background Sexually transmitted infections disproportionately affect young people and men who have sex with men. Chlamydia is Britain’s most common sexually transmitted infection. Partner notification is a key intervention to reduce transmission of sexually transmitted infections and human immunodeficiency virus but is hard to implement. Accelerated partner therapy is a promising new approach. Objectives determine the effectiveness, costs and acceptability of accelerated partner therapy for chlamydia in heterosexual people model the cost effectiveness of accelerated partner therapy and impact on chlamydia transmission develop and cost partner notification interventions for men who have sex with men. Design Mixed-methods study to develop a new sex partner classification and optimise accelerated partner therapy; cluster crossover randomised controlled trial of accelerated partner therapy, with process and cost-consequence evaluation; dynamic modelling and health economic evaluation; systematic review of economic studies of partner notification for sexually transmitted infections in men who have sex with men; qualitative research to co-design a novel partner notification intervention for men who have sex with men with bacterial sexually transmitted infections. Settings Sexual health clinics and community services in England and Scotland. Participants Women and men, including men who have sex with men and people with mild learning disabilities. Interventions Accelerated partner therapy offered as an additional partner notification method. Main outcome measures Proportion of index patients with positive repeat chlamydia test (primary outcome); proportion of sex partners treated; costs per major outcome averted and quality-adjusted life-year; predicted chlamydia prevalence; experiences of accelerated partner therapy. Data sources Randomised controlled trial: partnership type, resource use, outcomes, qualitative data: economic analysis, modelling and systematic review: resource use and unit costs from the randomised controlled trial, secondary sources. Results The sex partner classification defined five types. Accelerated partner therapy modifications included simplified self-sampling packs and creation of training films. We created a clinical management and partner notification data collection system. In the randomised controlled trial, all 17 enrolled clinics completed both periods; 1536 patients were enrolled in the intervention phase and 1724 were enrolled in the control phase. Six hundred and sixty-six (43%) of 1536 index patients in the intervention phase and 800 (46%) of 1724 in the control phase were tested for Chlamydia trachomatis at 12–24 weeks after contact tracing consultation; 31 (4.7%) in the intervention phase and 53 (6.6%) in the control phase had a positive Chlamydia trachomatis test result [adjusted odds ratio 0.66 (95% confidence interval 0.41 to 1.04); p = 0.071]. The proportion of index patients with ≥ 1 sex partner treated was 88.0% (775/881) in intervention and 84.6% (760/898) in control phase, adjusted odds ratio 1.27 (95% confidence interval 0.96 to 1.68; p = 0.10). Overall, 293/1536 (19.1%) index patients chose accelerated partner therapy for 305 partners, of which partner types were: committed/established, 166/305 (54.4%); new, 85/305 (27.9%); occasional, 45/305 (14.8%); and one-off, 9/305 (3.0%). Two hundred and forty-eight accepted accelerated partner therapy and 241 partners were sent accelerated partner therapy packs, 120/241 (49.8%) returned chlamydia/gonorrhoea samples (78/119, 65.5%, positive for chlamydia, no result in one), but only 60/241 (24.9%) human immunodeficiency virus and syphilis samples (all negative). The primary outcomes of the randomised trial were not statistically significantly different at the 5% level. However, the economic evaluation found that accelerated partner therapy could be less costly compared with routine care, and mathematical modelling of effects and costs extrapolated beyond the trial end points suggested that accelerated partner therapy could be more effective and less costly than routine care in terms of major outcome averted and quality-adjusted life-years’. Healthcare professionals did not always offer accelerated partner therapy but felt that a clinical management and partner notification data collection system enhanced data recording. Key elements of a multilevel intervention supporting men who have sex with men in partner notification included: modifying the cultural and social context of men who have sex with men communities; improving skills and changing services to facilitate partner notification for one-off partners; and working with dating app providers to explore digital partner notification options. The systematic review found no evaluations of partner notification for men who have sex with men. Modelling of gonorrhoea and human immunodeficiency virus co-infection in men who have sex with men was technically challenging. Limitations In the randomised controlled trial, enrolment, follow-up and repeat infections were lower than expected, so statistical power was lower than anticipated. We were unable to determine whether accelerated partner therapy sped up partner treatment. Mathematical modelling of gonorrhoea/human immunodeficiency virus co-infection in men who have sex with men remained at an experimental stage. It was not feasible to include healthcare professionals in the men who have sex with men intervention development due to the COVID-19 pandemic. Conclusions Although the evidence that the intervention reduces repeat infection was not conclusive, the trial results suggest that accelerated partner therapy can be safely offered as a contact tracing option and is also likely to be cost saving, but is best suited to sex partners with emotional connection to the index patient. The Programme’s findings about classification of sexual partner types can be implemented in sexual health care with auditable outcomes. Future work Further research is needed on how to increase uptake of accelerated partner therapy and increase sexually transmitted infections self-sampling by partners; understand how services can use partnership-type information to improve partner notification, especially for those currently underserved; overcome challenges in modelling sexually transmitted infections and human immunodeficiency virus co-infection in men who have sex with men; develop and evaluate an intervention to optimise partner notification among men who have sex with men, focusing on one-off partnerships. Trial registration This trial is registered as ISRCTN15996256. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0614-20009) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 2. See the NIHR Funding and Awards website for further award information. Plain language summary We aimed to improve the sexual health of people most impacted by sexually transmitted infections and human immunodeficiency virus (young people and men who have sex with men), by preventing transmission and reducing undiagnosed infection. We focused on partner notification (contact tracing and management), particularly accelerated partner therapy. Our research included: a clinical trial interview/focus group studies literature reviews mathematical modelling and health economic evaluations. Firstly, we improved accelerated partner therapy by finding out what people did/didn’t like about it and which types of sex partners might use it. We included some people with mild learning difficulties to see if they could help us improve accelerated partner therapy for people who might find self-managed care tricky. Then, we measured accelerated partner therapy’s value for money in a large clinical trial in people with chlamydia, Britain’s commonest sexually transmitted infection. Finally, we worked with men who have sex with men, sexual healthcare professionals, public health and health planners to make recommendations for new partner notification methods to suit their needs. We found accelerated partner therapy could be less costly than current practices and likely reduce transmission of chlamydia in the population. Our new classification of partnership types showed that accelerated partner therapy suited ‘emotionally connected’, rather than one-off, partners. These partners are important for controlling onward transmission but are traditionally harder to reach. Findings from our stakeholder event suggest that partner notification approaches for men who have sex with men are likely to work best by involving communities as well as clinics, but we were only able to focus on sexually transmitted infections other than human immunodeficiency virus due to COVID-19 impacts. Future research should aim to improve partner notification for one-off partners, simplify the sexually transmitted infection and human immunodeficiency virus self-testing kits used in accelerated partner therapy, explore the pros and cons of immediate antibiotics, and develop and evaluate a system-wide partner notification approach for men who have sex with men, guided by health economics evaluation. Scientific summary Background Sexually transmitted infection (STI) diagnoses have increased since 2010. Young people and men who have sex with men (MSM) are disproportionately affected. Chlamydia is the most commonly reported STI in Britain. Two-thirds of chlamydia infections are diagnosed in heterosexual people under 25 years, while gonorrhoea, syphilis and human immunodeficiency virus (HIV) infections are more common in MSM. Preventing onward transmission is essential to STI and HIV control. Partner notification (PN), also known as contact tracing and management, is a key intervention in which sex partners (SPs) of people with diagnosed infections are identified, tested and treated. PN also provides opportunities to engage people at high risk of infection who might not present for care. Better PN for MSM with infections such as gonorrhoea could enable earlier HIV diagnosis in partners because co-infection is common in this group. However, PN is challenging, and monitoring of performance is limited by the lack of standardised outcome measures and blunt classifications of sex partnership types. Accelerated partner therapy (APT) is a promising new PN method, but its role in preventing transmission is unknown. Aims and objectives The Limiting Undetected Sexually Transmitted infections to RedUce Morbidity (LUSTRUM) Programme aimed to improve the sexual health of people at high risk of STIs and HIV by improving PN outcomes. The Programme had three interconnecting streams: STREAM A: Accelerated partner therapy trial preparation and implementation Specific objectives: Develop a clinically useful SP classification. Optimise the acceptability of the APT intervention. Determine the effectiveness and costs of APT and understand how APT worked in practice. STREAM B: Mathematical modelling and health economic analysis Specific objectives: Quantify the effects of APT on chlamydia transmission and re-infection. Estimate the cost effectiveness of APT, compared with standard PN. STREAM C: Development of partner notification interventions for men who have sex with men Specific objectives: Explore costs and outcomes of PN and testing for HIV. Investigate PN for gonorrhoea in MSM to identify undiagnosed HIV infection using mathematical modelling. Explore barriers and facilitators to PN for bacterial STIs and develop a PN intervention. Methods A1. Development of a clinically usable sex partner classification We synthesised evidence about partnership types from: the third British National Survey of Sexual Attitudes and Lifestyles, 259 dating applications and published literature. Then, we conducted qualitative interviews with members of the public and patients (n = 57), and health professionals (n = 27). We developed definitions for partnership types through external multidisciplinary expert consultation. A2. Optimisation of the accelerated partner therapy intervention We analysed videos of APT role-play consultations and synthesised published evidence about relevant behaviours; explored barriers and facilitators to receiving or delivering APT, including focused work with 25 people with mild learning disabilities, 56 members of the public and patients and 30 healthcare professionals (HCPs); modified and specified key components of APT, wrote a manual and training package, and created online videos. A3. Randomised controlled trial of accelerated partner therapy We conducted a cluster crossover randomised controlled trial with a process and cost-consequence evaluation. Dynamic modelling is described in Stream B. Clusters were 17 sexual health clinics in diverse areas of England and Scotland. Participants [index patients (IPs)] were heterosexual women and men, aged ≥ 16 years with a positive test for Chlamydia trachomatis and/or a clinical diagnosis of pelvic inflammatory disease or cervicitis (women) or non-gonococcal urethritis or epididymo-orchitis (men) and reporting at least one contactable sexual partner in the past 6 months. Intervention: APT was offered as an additional partner notification method for IPs. A HCP assessed their SP(s) by telephone, then sent or gave the IP antibiotics and STI and HIV self-sampling kits for their partner(s). The control arm received standard PN alone. The intervention was implemented at the level of the sexual health clinic, with clinics randomised to intervention or control arm in the first phase by random permutation. The primary outcome was the proportion of IPs testing positive for C. trachomatis 12–24 weeks after the PN consultation. Secondary outcomes included: the proportion of SPs treated; the proportion of partners notified; costs; cost effectiveness; model-predicted chlamydia prevalence. The primary outcome analysis was by intention to treat, fitting random-effects logistic regression models that account for clustering of IPs within clinics and trial periods. Process evaluation: We collected qualitative data through six focus groups and individual interviews (n = 10) with purposively sampled HCPs (n = 34 from 14 sites), IPs (n = 15) and SPs who received APT (n = 17). Quantitative data were collected within a clinical management and PN data collection system (RELAY). Cost-consequence analysis (CCA): We collected data on costs and resource use during the trial and used unit costs from the trial and the Personal Social Services Research Unit. B1 and B2. Modelling the effects of accelerated partner therapy on Chlamydia trachomatis transmission We developed a new deterministic transmission model with a dedicated PN module, which allowed us to identify the effects of different index-partner combinations on chlamydia prevalence. We considered a population aged 16–34 years and calibrated the model to data from the third British National Survey of Sexual Attitudes and Lifestyles. We then extended a previous modelling framework, informed by data from the C. trachomatis transmission model and the trial, to quantify expected rates of chlamydia reinfection (Estcourt CS, Stirrup O, Copas A, Low N, Mapp F, Saunders J, et al. Accelerated partner therapy contact tracing for people with chlamydia (LUSTRUM): a crossover cluster-randomised controlled trial. Lancet Public Health 2022;7(10):e853–65. https://doi.org/10.1016/S2468-2667(22)00204-3). B3. Cost-effectiveness analysis of accelerated partner therapy compared with standard partner notification We developed a spreadsheet-based model using output from the C. trachomatis transmission model to estimate the impact of APT on healthcare costs, major outcomes averted (MOA) and quality-adjusted life-years (QALYs) in a simulated population of 100,000 adults aged 16–34 years. We calculated incremental cost-effectiveness ratios (ICERs) for APT, compared with standard PN and undertook sensitivity and scenario analyses. C1. Systematic review of economic studies of interventions related to partner notification for sexually transmitted infections in men who have sex with men We searched six electronic databases up to June 2020. We included economic evaluation and cost analysis studies if participants were MSM with any STI and/or HIV and the intervention was related to PN, testing or treatment and summarised evidence using a narrative synthesis. C2. Partner notification for bacterial sexually transmitted infections in men who have sex with men as a way to detect undiagnosed human immunodeficiency virus infection in partners We reviewed modelling studies of PN and pre-exposure prophylaxis interventions in MSM and attempted to model PN with co-infections with gonorrhoea HIV. C3. Barriers and facilitators of accelerated partner therapy and development of a novel partner notification intervention for men who have sex with men First, we conducted a stakeholder event with 45 participants from across Britain [MSM, public health experts, service commissioners, multidisciplinary sexual HCPs, non-governmental organisations (NGOs), academics and dating app providers]. We explored the diverse and multilevelled social, cultural and healthcare system-level context shaping poor PN outcomes for one-off partners. We conducted qualitative in-depth interview studies with men who had experienced PN (n = 14, Stream A) and focus groups with MSM (n = 28), clinical and other stakeholders (n = 11) to explore barriers and facilitators to PN. We used the behaviour change wheel within co-design of a potential new PN intervention. Results A1. We created usable definitions for five SP types (committed/established, new, occasional, one-off, sex work), broadly predicated on duration of the relationship, likelihood of future sex and degree of emotional connection. A2. Modifications to the APT intervention included simplification of the patient packs, creation of ‘how to’ training films for participants and HCPs. People with mild learning disabilities found APT acceptable but described feeling overwhelmed by the packs. They recommended using photographs instead of diagrams of anatomical sites for self-sampling, and an ‘easy read’ format. The new partner types and APT processes were built into a new clinical management and PN data collection system called RELAY. A3. In the trial, all 17 clinics completed both periods. One thousand five hundred and thirty-six and 1724 IPs provided data in intervention and control phases. In intervention and control phases, 666 (43.4%) and 800 (46.4%) IPs were tested for C. trachomatis; 31 (4.7%) and 53 (6.6%) were positive, adjusted odds ratio (aOR) 0.66 [95% confidence interval (CI) 0.41 to 1.04; p = 0.07]. The proportion with ≥ 1 SP treated was 775/881 (88.0%) in intervention and 760/898 (84.6%) in the control phase, aOR 1.27 (95% CI 0.96 to 1.68; p = 0.10) (Estcourt C, Mapp F, Stirrup O, Copas A, Howarth A, Owusu M, et al. O18.2 Does Accelerated partner therapy improve partner notification outcomes for people with chlamydia? The LUSTRUM cluster cross-over randomised control trial. Sex Transm Infect 2021;97:A57–8. http://doi.org/10.1136/sextrans-2021-sti.153). In total, 4807 SPs were reported, of whom 1636 (34%) were committed/established partners. Overall, 293/1536 (19.1%) of IPs in intervention phase chose APT for a total of 305 partners, of whom 248 accepted. Partner types were committed/established, 166/305 (54.4%); new, 85/305 (27.9%); occasional, 45/305 (14.8%); and one-off, 9/305 (3.0%). Common reasons for IPs to decline APT included: preferred face-to-face conversation 400/1832 (21.8%), partner already in clinic 388/1832 (21.2%), unwilling to engage with partner 206/1832 (11.2%), preferred partner to attend clinic 202/1832 (11.0%) and partner overseas 150/1832 (8.2%). Of 241 partners sent APT packs, 120/241 (49.8%) returned chlamydia and gonorrhoea testing samples, of which 78/119 (65.5%) were positive for chlamydia (no result in one), but only 60/241 (24.9%) HIV and syphilis samples (all negative). In an unplanned analysis, 2/106 (2.0%) IPs, who were offered APT and accepted it for one or more partners, tested positive for chlamydia at 12–24 weeks. Of IPs not selecting APT or whose partners refused, 29/560 (5.2%) had a positive result on repeat testing. The process evaluation showed that overall intervention fidelity was good and APT was well liked by those who delivered and received it. Overall, we found a mixed picture of an intuitive, coherent intervention struggling to gain purchase within already pressured services. HCPs preferred RELAY to their clinic systems because it helped them standardise PN. However, many sites struggled to scale up the trial processes owing to continual external pressures to adapt services to achieve efficiencies. In some services, APT was perceived as time-consuming and without palpable impact. This observation was related to the absence of a reduction in patient numbers in clinic waiting rooms. In this way, the ‘invisibility’ of the effectiveness of APT curtailed the establishment of positive feedback loops driving normalisation within services. In the CCA, APT cost more than standard PN (£91.23 vs. £75.21). Where accepted, it was more effective than standard PN with an absolute effect difference of 5.26%. B1 and B2. In the model, chlamydia positivity was highest for symptomatic index cases of low sexual activity, with infected partners who were typically asymptomatic and highly sexually active. Partner notification for this index–partner combination would prevent the most transmission. Increasing the number of treated partners from current levels in Britain (0.51, 95% credible interval, CI 0.21 to 0.80) by 25% would reduce chlamydia prevalence by 18% (95% CI 5% to 44%) in both women and men within 5 years. Reducing the time to partner treatment alone had a minor effect on reducing prevalence. Together, these results suggest that PN typically identifies sexual partners who are likely to further transmit chlamydia and that APT could further reduce prevalence if PN uptake increases. B3. In the cost-effectiveness analysis, the base-case results showed APT cost less and was more effective than standard PN in terms of MOA and QALYs, and therefore cost-saving. The results were supported by deterministic sensitivity analysis and scenario analysis for most scenarios, with ICERs very low and well within accepted thresholds. C1. There was very little published evidence on health economic aspects of PN in MSM. This supports the need for new interventions with parallel economic evaluation. C2. Published models have not examined the impact on HIV diagnosis of PN for bacterial STIs, and interventions cannot be extrapolated between countries. There were challenges in fitting the model of gonorrhoea/HIV co-infection to data, including issues with parameter identifiability. C3. We considered APT for MSM (and their more emotionally connected partners) and developed recommendations for a multilevel, multistakeholder intervention targeting MSM with other types of partners for whom PN is known to be more challenging. Key intervention elements included: a co-ordinated and coproduced mass and social media intervention to change norms and beliefs to challenge stigma and other barriers to PN; NGO peer-led work reducing STI-related stigma and persuading MSM to participate actively in PN to protect others and their communities; working with MSM to enable them to prepare for PN interactions and encourage HCP action, monitoring systems to directly address one-off PN outcomes; dating app providers promoting appropriate PN messaging. Conclusions The Programme provides findings about APT, which show promise for future PN. RELAY could be added to clinic systems for recording PN outcomes and processes. The Programme identified gaps in research about PN for one-off, and other partnerships with poor outcomes and high potential for onward sexual transmission. Data from the trial also suggested that APT uptake might be lower for people belonging to ethnic minority groups, although it was not powered to formally evaluate any such differences. The process evaluation and the work in Stream C identify a need for interventions that reach beyond sexual health services. Future work Future work should identify PN approaches for one-off partners; determine how to provide real-time or fast feedback for practitioners on the impact of interventions whose value is not obvious; further research is needed on how to increase uptake of APT, explore the pros and cons of immediate antibiotics, and optimise the uptake of self-sampling in partners, particularly people with mild learning disabilities; understand how services can use sex partnership-type information to improve PN methods, especially for hard-to-reach groups; develop and evaluate a system intervention to increase readiness in MSM for and engagement with PN for bacterial STIs, focusing on one-off partnerships and addressing economic factors and partnership type. Trial registration This trial is registered as ISRCTN15996256. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0614-20009) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 2. See the NIHR Funding and Awards website for further award information.

Care home residents are vulnerable to severe outcomes from infections such as COVID-19 and influenza. However, measures to control outbreaks, such as care home closures to visitors and new admissions, have a detrimental impact on their quality of life. Many infections and outbreaks could be prevented but the first step is to measure them reliably. This is challenging in care homes due to the lack of data and research infrastructure. During the pandemic, the VIVALDI study measured COVID-19 infections in residents and staff by partnering with care providers and using routinely collected data. This study aims to establish sentinel surveillance and a research database to enable observational and future interventional studies in care homes. The project has been co-produced with care providers, staff, residents, relatives, and researchers. The study (October 2023 to March 2025) will explore the feasibility of establishing a network of 500-1500 care homes for older adults in England that is underpinned by a linked data platform. No data will be collected from staff. The cohort will be created by regularly extracting resident identifiers from Digital Social Care Records (DSCR), followed by pseudonymisation and linkage to routinely collected datasets. Following extensive consultation, we decided not to seek informed consent from residents for data collection, but they can ‘opt out’ of the study. Our goal is to be inclusive, and it is challenging to give every resident the opportunity to ‘opt in’ due to cognitive impairment and the requirement for consultees. The project, and all requests to use the data will be overseen by relatives, residents, staff, and care providers. The study has been approved by the Health Research Authority Confidentiality Advisory Group (23/CAG/0134&0135) and the South-West Frenchay Research Ethics Committee (23/SW/0105). It is funded by the UK Health Security Agency.

Introduction Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.Methods and analysis The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.The trial will be delivered by a multidisciplinary research team through a series of five work packages.The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.Ethics and dissemination The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.Trial registration number ISRCTN13296529.

Background: Gay, bisexual and other men who have sex with men (GBMSM) are at far greater risk of experiencing poor mental health (MH) than wider society. This disparity was exacerbated by additional ‘unique to sexual minority status’ COVID-19 stressors.Objective: This sequential, mixed-methods study examined remote MH help-seeking among GBMSM in the U.K. and Ireland during the first COVID-19 lockdown.Methods and Results: Quantitative survey data (n = 1368), analysed with logistic regression, suggested GBMSM experiencing moderate-to-severe anxiety and those with a past MH diagnosis were most likely to seek MH support. Thematic analysis of qualitative interview (n = 18) data identified multiple barriers and enablers to GBMSM seeking remote MH help, with the help primarily sought from GBMSM-facing organisations and generic online resources. Finally, the behaviour change wheel was used to generate theoretically informed recommendations to promote MH help-seeking among GBMSM in Scotland.Implications: We discuss how applying these recommendations in the short, medium and long term will begin to address GBMSM’s MH needs, post COVID-19.

IntroductionHIV pre-exposure prophylaxis (PrEP), in which people take HIV medication to prevent HIV acquisition, underpins global HIV transmission elimination strategies. Effective prevention needs people to adhere to PrEP and remain in care during periods of risk, but this is difficult to achieve. We undertook a process evaluation of Scotland's PrEP programme to explore barriers and facilitators to PrEP adherence and retention in care and to systematically develop evidence-based, theoretically-informed recommendations to address them.MethodsWe conducted semi-structured interviews and focus groups (09/2018-07/2019) with patients who identified as gay or bisexual men and were either using PrEP, had declined the offer of PrEP, had stopped PrEP, or had been assessed as ineligible for PrEP (n = 39 of whom n = 5 (13%) identified as trans, median age 31 years and interquartile range 14 years), healthcare professionals involved in PrEP provision (n = 54 including specialist sexual health doctors and nurses of various grades, PrEP prescribing general practitioners, health promotion officers, midwifes, and a PrEP clinical secretary), and clients (n = 9) and staff (n = 15) of non-governmental organisations with an HIV prevention remit across Scotland. We used thematic analysis to map key barriers and facilitators to priority areas that could enhance adherence and retention in care. We used implementation science analytic tools (Theoretical Domains Framework, Intervention Functions, Behaviour Change Technique Taxonomy, APEASE criteria) and expert opinion to systematically generate recommendations.ResultsBarriers included perceived complexity of on-demand dosing, tendency for users to stop PrEP before seeking professional support, troublesome side-effects, limited flexibility in the settings/timings/nature of review appointments, PrEP-related stigma and emerging stigmas around not using PrEP. Facilitators included flexible appointment scheduling, reminders, and processes to follow up non-attenders. Examples of the 25 recommendations include: emphasising benefits of PrEP reviews and providing appointments flexibly within individualised PrEP care; using clinic systems to remind/recall PrEP users; supporting PrEP conversations among sexual partners; clear on-demand dosing guidance; encouraging good PrEP citizenship; detailed discussion on managing side-effects and care/coping planning activities.ConclusionsPrEP adherence and retention in care is challenging, reducing the effectiveness of PrEP at individual and population levels. We identify and provide solutions to where and how collaborative interventions across public health, clinical, and community practice could address these challenges.

Abstract Background Gay, bisexual and other men who have sex with men (GBMSM) are at a greater risk of mental health problems, such as anxiety and depression, than heterosexual adults. Numerous factors and stressors have been reported to impact men’s mental health, although it has been suggested that resilience could have a protective effect. The aim of this study is to explore mental health, minority stressors, and resilience among a large online cross-sectional survey of GBMSM in the Celtic nations. Methods Data for this cross-sectional study were collected from the Social Media, GBMSM and Sexual and Holistic Health (SMMASH2) self-report online survey. Participants (n = 3077) were recruited via gay sociosexual media in Scotland, Wales, Northern Ireland, and the Republic of Ireland. Binary logistic regression analyses were conducted to identify factors that increased the odds of moderate-to-severe anxiety and depression. Potentially relevant variables (p

Background: Viral sequencing of SARS-CoV-2 has been used for outbreak investigation, but there is limited evidence supporting routine use for infection prevention and control (IPC) within hospital settings. Methods: We conducted a prospective non-randomised trial of sequencing at 14 acute UK hospital trusts. Sites each had a 4-week baseline data collection period, followed by intervention periods comprising 8 weeks of ‘rapid’ (

Background: Psychological interventions have mixed effects on improving employee outcomes, partly due to significant variability across studies and a lack of focus on mechanisms of action. This scoping review reports on the parameters of these interventions and examines intervention content to bring clarity to this heterogeneous topic area and direct future systematic review work. Method: Six databases were searched (Cinahl, Cochrane, Embase, Medline, PsychINFO and Web of Science) from April 2010 to August 2020, and a grey literature search was undertaken. Screening was undertaken independently by two authors. The results summarised country, participant and employment characteristics, psychological interventions and work, health and wellbeing outcomes. 10% of the papers were analysed to determine the feasibility of coding intervention descriptions for theory and behaviour change technique (BCT) components. Results: Database searches yielded 9341 titles, of which 91 studies were included. Most studies were conducted in Europe (78%) and included males and females (95%) ranging in age from 31-56.6 years although other demographic, and employment information was lacking. Musculoskeletal pain was common (87%). Psychological interventions commonly included cognitive behavioural therapy (30%) and education (28%). Most studies employed a randomised control trial design (64%). Over half contained a control group (54%). Interventions were delivered in mostly healthcare settings (72%) by health professionals. Multiple outcomes were often reported, many of which involved measuring sickness absence and return-to-work (62%) and pain and general health (53%). Within the feasibility analysis, most papers met the minimum criteria of containing one paragraph of intervention description, but none explicitly mentioned theory or BCTs. Conclusion: Psychological interventions for employees with chronic pain vary in their nature and implementation. We have shown scoping reviews can be used to assess the feasibility of applying tools from health psychology to identify the content of these interventions in future systematic review work to improve intervention development.

Objectives Nosocomial transmission of SARS-CoV-2 has been a significant cause of mortality in National Health Service (NHS) hospitals during the COVID-19 pandemic. The COG-UK Consortium Hospital-Onset COVID-19 Infections (COG-UK HOCI) study aims to evaluate whether the use of rapid whole-genome sequencing of SARS-CoV-2, supported by a novel probabilistic reporting methodology, can inform infection prevention and control (IPC) practice within NHS hospital settings.Design Multicentre, prospective, interventional, superiority study.Setting 14 participating NHS hospitals over winter–spring 2020/2021 in the UK.Participants Eligible patients must be admitted to hospital with first-confirmed SARS-CoV-2 PCR-positive test result >48 hour from time of admission, where COVID-19 diagnosis not suspected on admission. The projected sample size is 2380 patients.Intervention The intervention is the return of a sequence report, within 48 hours in one phase (rapid local lab processing) and within 5–10 days in a second phase (mimicking central lab), comparing the viral genome from an eligible study participant with others within and outside the hospital site.Primary and secondary outcome measures The primary outcomes are incidence of Public Health England (PHE)/IPC-defined SARS-CoV-2 hospital-acquired infection during the baseline and two interventional phases, and proportion of hospital-onset cases with genomic evidence of transmission linkage following implementation of the intervention where such linkage was not suspected by initial IPC investigation. Secondary outcomes include incidence of hospital outbreaks, with and without sequencing data; actual and desirable changes to IPC actions; periods of healthcare worker (HCW) absence. Health economic analysis will be conducted to determine cost benefit of the intervention. A process evaluation using qualitative interviews with HCWs will be conducted alongside the study.Trial registration number ISRCTN50212645. Pre-results stage. This manuscript is based on protocol V.6.0. 2 September 2021.

COVID-19 lockdown presented a novel opportunity to study the experiences of people attempting to maintain friendships in the context of worldwide, government-enforced physical distancing and lockdown. Here we report on an experiential, idiographic qualitative project with a purposive sample of Scottish students. Data was collected via one-to-one on-line interviews with nine student participants (N = 9). Data was transcribed and analyzed using Interpretative Phenomenological Analysis (IPA). Analysis highlighted three group-level experiential themes (GETs) and associated subthemes. Participants’ shared experiences of maintaining friendships were reflected in a dynamic process by which (1) ‘changes to communication’ were associated with experiences of (2) ‘effort and balance’ across friendships. Participants reported becoming particularly aware of the psychological processes involved in maintaining friendships, in turn, this was associated with (3) ‘reflection and growth.’ These experiential findings resonate well with several longstanding classic theories; however, they also speak to the particularities of the context in which the study was conducted. They suggest the need for a pandemic psychology that moves beyond the typical focus on the direct impacts of infectious disease to address the wider psychosocial impacts with equal vigor.

Abstract Background Antimicrobial stewardship (AMS) describes activities concerned with safe-guarding antibiotics for the future, reducing drivers for the major global public health threat of antimicrobial resistance (AMR), whereby antibiotics are less effective in preventing and treating infections. Appropriate antibiotic prescribing is central to AMS. Whilst previous studies have explored the effectiveness of specific AMS interventions, largely from uni-professional perspectives, our literature search could not find any existing evidence evaluating the processes of implementing an integrated national AMS programme from multi-professional perspectives. Methods This study sought to explain mechanisms affecting the implementation of a national antimicrobial stewardship programme, from multi-professional perspectives. Data collection involved in-depth qualitative telephone interviews with 27 implementation lead clinicians from 14/15 Scottish Health Boards and 15 focus groups with doctors, nurses and clinical pharmacists (n = 72) from five Health Boards, purposively selected for reported prescribing variation. Data was first thematically analysed, barriers and enablers were then categorised, and Normalisation Process Theory (NPT) was used as an interpretive lens to explain mechanisms affecting the implementation process. Analysis addressed the NPT questions ‘which group of actors have which problems, in which domains, and what sort of problems impact on the normalisation of AMS into everyday hospital practice’. Results Results indicated that major barriers relate to organisational context and resource availability. AMS had coherence for implementation leads and prescribing doctors; less so for consultants and nurses who may not access training. Conflicting priorities made obtaining buy-in from some consultants difficult; limited role perceptions meant few nurses or clinical pharmacists engaged with AMS. Collective individual and team action to implement AMS could be constrained by lack of medical continuity and hierarchical relationships. Reflexive monitoring based on audit results was limited by the capacity of AMS Leads to provide direct feedback to practitioners. Conclusions This study provides original evidence of barriers and enablers to the implementation of a national AMS programme, from multi-professional, multi-organisational perspectives. The use of a robust theoretical framework (NPT) added methodological rigour to the findings. Our results are of international significance to healthcare policy makers and practitioners seeking to strengthen the sustainable implementation of hospital AMS programmes in comparable contexts.

BackgroundMultiple studies have highlighted the negative impact of COVID-19 and its particular effects on vulnerable sub-populations. Complementing this work, here, we report on the social patterning of self-reported positive changes experienced during COVID-19 national lockdown in Scotland.MethodsThe CATALYST study collected data from 3342 adults in Scotland during weeks 9-12 of a national lockdown. Using a cross-sectional design, participants completed an online questionnaire providing data on key sociodemographic and health variables, and completed a measure of positive change. The positive change measure spanned diverse domains (e.g., more quality time with family, developing new hobbies, more physical activity, and better quality of sleep). We used univariate analysis and stepwise regression to examine the contribution of a range of sociodemographic factors (e.g., age, gender, ethnicity, educational attainment, and employment status) in explaining positive change.ResultsThere were clear sociodemographic differences across positive change scores. Those reporting higher levels of positive change were female, from younger age groups, married or living with their partner, employed, and in better health.ConclusionOverall our results highlight the social patterning of positive changes during lockdown in Scotland. These findings begin to illuminate the complexity of the unanticipated effects of national lockdown and will be used to support future intervention development work sharing lessons learned from lockdown to increase positive health change amongst those who may benefit.

Globally, gay, bisexual and other men who have sex with men (GBMSM) experience an increased burden of poor sexual, mental and physical health. Syndemics theory provides a framework to understand comorbidities and health among marginalised populations. Syndemics theory attempts to account for the social, environmental, and other structural contexts that are driving and/or sustaining simultaneous multiple negative health outcomes, but has been widely critiqued. In this paper, we conceptualise a new framework to counter syndemics by assessing the key theoretical mechanisms by which pathogenic social context variables relate to ill-health. Subsequently, we examine how salutogenic, assets-based approaches to health improvement could function among GBMSM across diverse national contexts. Comparative quantitative secondary analysis of data on syndemics and community assets are presented from two international, online, cross-sectional surveys of GBMSM (SMMASH2 in Scotland, Wales, Northern Ireland and the Republic of Ireland and Sex Now in Canada). Negative sexual, mental and physical health outcomes were clustered as hypothesised, providing evidence of the syndemic. We found that syndemic ill-health was associated with social isolation and the experience of stigma and discrimination, but this varied across national contexts. Moreover, while some of our measures of community assets appeared to have a protective effect on syndemic ill-health, others did not. These results present an important step forward in our understanding of syndemic ill-health and provide new insights into how to intervene to reduce it. They point to a theoretical mechanism through which salutogenic approaches to health improvement could function and provide new strategies for working with communities to understand the proposed processes of change that are required. To move forward, we suggest conceptualising syndemics within a complex adaptive systems model, which enables consideration of the development, sustainment and resilience to syndemics both within individuals and at the population-level.

Abstract Background Carbapenemase Producing Enterobacteriaceae (CPE) has spread rapidly and presents a growing challenge in antimicrobial resistance (AMR) management internationally. Screening for CPE may involve a rectal swab, there are limited treatment options for affected patients, and colonised patients are cared for in isolation to protect others. These measures are sound infection prevention precautions; however, the acceptability of CPE screening and its consequences are currently unknown. The aim of this study was ‘To determine factors influencing acceptability of CPE screening from the perspectives of nursing staff and the general public.’ Methods National cross-sectional surveys of nursing staff (n = 450) and the general public (n = 261). The Theoretical Domains Framework (TDF) guided data collection and analysis. Regression modelling was used to identify factors that predicted acceptability of CPE screening. Results For nursing staff, the following predictor variables were significant: intention to conduct CPE screening (OR 14.19, CI 5.14–39.22); belief in the severity of the consequences of CPE (OR 7.13, CI 3.26–15.60); knowledge of hospital policy for screening (OR 3.04, CI 1.45–6.34); preference to ask patients to take their own rectal swab (OR 2.89, CI 1.39–6.0); awareness that CPE is an organism of growing concern (OR 2.44, CI 1.22–4.88). The following predictor variables were significant for the general public: lack of knowledge of AMR (β − .11, p = .01); social influences (β .14, p = .032); social norms (β .21p = .00); acceptability of being isolated if colonised (β .22, p = .000), beliefs about the acceptability of rectal swabbing (β .15, p = .00), beliefs about the impact of careful explanation about CPE screening from a health professional (β .32, p = .00). Integrating results from staff and public perspectives points to the importance of knowledge of AMR, environmental resources, and social influences in shaping acceptability. Conclusions This is the first study to systematically examine the acceptability of CPE screening across nursing staff and the public. The use of TDF enabled identification of the mechanisms of action, or theoretical constructs, likely to be important in understanding and changing CPE related behaviour amongst professionals and public alike.

Abstract Background Antimicrobial resistance (AMR) is a growing public health problem across the world. As the negative consequences of AMR become apparent at local, national and international levels, more attention is being focussed on the variety of mechanisms by which AMR is potentiated. We explore how interactions between pet owners and veterinarians represent a key arena in which AMR-related behaviours can be shaped. Methods In depth semi-structured interviews were carried out with pet owners (n = 23) and vets (n = 16) across the UK in 2017. A thematic analysis approach was taken, with inductively gathered data analysed deductively using a behavioural framework to identified key behaviours emerging from participant accounts which were amenable to change. Results Interactions between vets and pet owners were characterised by misunderstandings and misconceptions around antibiotics by pet owners, and a lack of clarity about the positions and intentions of the other party. Vets and pet owners had differing perceptions of where pressure to prescribe antibiotics inappropriately originated. Vets perceived it was mostly pet owners who pushed for inappropriate antibiotics, whereas pet owners reported they felt it was vets that overprescribed. Low levels of understanding of AMR in general were apparent amongst pet owners and understandings with regard to AMR in pets specifically were almost non-existent in the sample. Conclusions Improved use of antibiotics could be assisted by educating the pet owning public and by guideline development for companion animal vets, concurrent development of mandatory legislation, increased consultation time to facilitate better communication, development of vet training on antimicrobial therapy and stewardship led interactions with pet owners, and increased levels of knowledge of pet-related AMR amongst pet owners.

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.

Vaccination is central to controlling COVID-19. Its success relies on having safe and effective vaccines and also on high levels of uptake by the public over time. Addressing questions of population-level acceptability, stability of acceptance, and sub-population variation in acceptability are imperative. Using a prospective design, a repeated measures two-wave online survey was conducted to assess key sociodemographic variables and intention to accept a COVID-19 vaccine. The first survey (Time 1) was completed by 3436 people during the period of national lockdown in Scotland and the second survey (n = 2016) was completed two months later (Time 2) when restrictions had been eased. In the first survey, 74% reported being willing to receive a COVID-19 vaccine. Logistic regression analyses showed that there were clear sociodemographic differences in intention to accept a vaccine for COVID-19 with intention being higher in participants of white ethnicity as compared with Black, Asian, and minority ethnic (BAME) groups, and in those with higher income levels and higher education levels. Intention was also higher in those who had “shielding” status due to underlying medical conditions. Our results suggest that future interventions, such as mass media and social marketing, need to be targeted at a range of sub-populations and diverse communities.

The lived experience of both interferon-based and new interferon-free treatments in patients with hepatitis C virus remains understudied. To explore their journey through hepatitis C virus treatment, we interviewed seven post-transplant patients with recurrent hepatitis C virus. Three themes were identified using interpretative phenomenological analysis. Participants reported an ongoing sense of ontological uncertainty characterized by lack of control over their condition and treatment. Furthermore, an apposition of scepticism and hope accompanying each stage of hepatitis C virus treatment was described. A staged approach to psychological intervention tailored to the needs of the patient and their associated ‘stage’ of hepatitis C virus treatment was recommended.

Background: Timely diagnosis of human immunodeficiency virus (HIV) enables access to antiretroviral treatment, which reduces mortality, morbidity and further transmission in people living with HIV. In the UK, late diagnosis among black African people persists. Novel methods to enhance HIV testing in this population are needed. Objectives: To develop a self-sampling kit (SSK) intervention to increase HIV testing among black Africans, using existing community and health-care settings (stage 1) and to assess the feasibility for a Phase III evaluation (stage 2). Design: A two-stage, mixed-methods design. Stage 1 involved a systematic literature review, focus groups and interviews with key stakeholders and black Africans. Data obtained provided the theoretical base for intervention development and operationalisation. Stage 2 was a prospective, non-randomised study of a provider-initiated, HIV SSK distribution intervention targeted at black Africans. The intervention was assessed for cost-effectiveness. A process evaluation explored feasibility, acceptability and fidelity. Setting: Twelve general practices and three community settings in London. Main outcome measure: HIV SSK return rate. Results: Stage 1 – the systematic review revealed support for HIV SSKs, but with scant evidence on their use and clinical effectiveness among black Africans. Although the qualitative findings supported SSK distribution in settings already used by black Africans, concerns were raised about the complexity of the SSK and the acceptability of targeting. These findings were used to develop a theoretically informed intervention. Stage 2 – of the 349 eligible people approached, 125 (35.8%) agreed to participate. Data from 119 were included in the analysis; 54.5% (65/119) of those who took a kit returned a sample; 83.1% of tests returned were HIV negative; and 16.9% were not processed, because of insufficient samples. Process evaluation showed the time pressures of the research process to be a significant barrier to feasibility. Other major barriers were difficulties with the SSK itself and ethnic targeting in general practice settings. The convenience and privacy associated with the SSK were described as beneficial aspects, and those who used the kit mostly found the intervention to be acceptable. Research governance delays prevented implementation in Glasgow. Limitations: Owing to the study failing to recruit adequate numbers (the intended sample was 1200 participants), we were unable to evaluate the clinical effectiveness of SSKs in increasing HIV testing in black African people. No samples were reactive, so we were unable to assess pathways to confirmatory testing and linkage to care. Conclusions: Our findings indicate that, although aspects of the intervention were acceptable, ethnic targeting and the SSK itself were problematic, and scale-up of the intervention to a Phase III trial was not feasible. The preliminary economic model suggests that, for the acceptance rate and test return seen in the trial, the SSK is potentially a cost-effective way to identify new infections of HIV. Future work: Sexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities. Study registration: This study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223. Funding: The National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.

Background: Men who have sex with men (MSM) experience significant inequalities in health and well-being. They are the group in the UK at the highest risk of acquiring a human immunodeficiency virus (HIV) infection. Guidance relating to both HIV infection prevention, in general, and individual-level behaviour change interventions, in particular, is very limited. Objectives: To conduct an evidence synthesis of the clinical effectiveness of behaviour change interventions to reduce risky sexual behaviour among MSM after a negative HIV infection test. To identify effective components within interventions in reducing HIV risk-related behaviours and develop a candidate intervention. To host expert events addressing the implementation and optimisation of a candidate intervention. Data sources: All major electronic databases (British Education Index, BioMed Central, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Educational Resource Index and Abstracts, Health and Medical Complete, MEDLINE, PsycARTICLES, PsycINFO, PubMed and Social Science Citation Index) were searched between January 2000 and December 2014. Review methods: A systematic review of the clinical effectiveness of individual behaviour change interventions was conducted. Interventions were examined using the behaviour change technique (BCT) taxonomy, theory coding assessment, mode of delivery and proximity to HIV infection testing. Data were summarised in narrative review and, when appropriate, meta-analysis was carried out. Supplemental analyses for the development of the candidate intervention focused on post hoc realist review method, the assessment of the sequential delivery and content of intervention components, and the social and historical context of primary studies. Expert panels reviewed the candidate intervention for issues of implementation and optimisation. Results: Overall, trials included in this review (n = 10) demonstrated that individual-level behaviour change interventions are effective in reducing key HIV infection risk-related behaviours. However, there was considerable clinical and methodological heterogeneity among the trials. Exploratory meta-analysis showed a statistically significant reduction in behaviours associated with high risk of HIV transmission (risk ratio 0.75, 95% confidence interval 0.62 to 0.91). Additional stratified analyses suggested that effectiveness may be enhanced through face-to-face contact immediately after testing, and that theory-based content and BCTs drawn from ‘goals and planning’ and ‘identity’ groups are important. All evidence collated in the review was synthesised to develop a candidate intervention. Experts highlighted overall acceptability of the intervention and outlined key ways that the candidate intervention could be optimised to enhance UK implementation. Limitations: There was a limited number of primary studies. All were from outside the UK and were subject to considerable clinical, methodological and statistical heterogeneity. The findings of the meta-analysis must therefore be treated with caution. The lack of detailed intervention manuals limited the assessment of intervention content, delivery and fidelity. Conclusions: Evidence regarding the effectiveness of behaviour change interventions suggests that they are effective in changing behaviour associated with HIV transmission. Exploratory stratified meta-analyses suggested that interventions should be delivered face to face and immediately after testing. There are uncertainties around the generalisability of these findings to the UK setting. However, UK experts found the intervention acceptable and provided ways of optimising the candidate intervention. Future work: There is a need for well-designed, UK-based trials of individual behaviour change interventions that clearly articulate intervention content and demonstrate intervention fidelity. Study registration: The study is registered as PROSPERO CRD42014009500. Funding: The National Institute for Health Research Health Technology Assessment programme.

BACKGROUND:Recent clinical trials suggest that pre-exposure prophylaxis (PrEP) may reduce HIV transmission by up to 86% for men who have sex with men (MSM), whilst relatively high levels of PrEP acceptability have been reported to date. This study examines PrEP awareness amongst sub-groups of MSM communities and acceptability amongst MSM in a low prevalence region (Scotland, UK), using a mixed methods design. METHODS:Quantitative surveys of n = 690 MSM recruited online via social and sociosexual media were analysed using descriptive statistics and multivariate logistic regression. In addition, n = 10 in-depth qualitative interviews with MSM were analysed thematically. RESULTS:Under one third (29.7%) of MSM had heard of PrEP, with awareness related to living in large cities, degree level education, commercial gay scene use and reporting an HIV test in the last year. Just under half of participants (47.8%) were likely to use PrEP if it were available but there was no relationship between PrEP acceptability and previous PrEP awareness. Younger men (18-25 years) and those who report higher risk UAI were significantly more likely to say they would use PrEP. Qualitative data described specific PrEP scenarios, illustrating how risk, patterns of sexual practice and social relationships could affect motivation for and nature of PrEP use. CONCLUSION:These findings suggest substantial interest PrEP amongst MSM reporting HIV risk behaviours in Scotland. Given the Proud results, there is a strong case to investigate PrEP implementation within the UK. However, it appears that disparities in awareness have already emerged along traditional indicators of inequality. Our research identifies the need for comprehensive support when PrEP is introduced, including a key online component, to ensure equity of awareness across diverse MSM communities (e.g. by geography, education, gay scene use and HIV proximity), as well as to responding to the diverse informational and sexual health needs of all MSM communities.