Mpox knowledge, behaviours and barriers to public health measures among gay, bisexual and other men who have sex with men in the UK: a qualitative study to inform public health guidance and messaging.

BACKGROUND: The 2022-23 mpox epidemic is the first-time sustained community transmission had been reported in countries without epidemiological links to endemic areas. During that period, the outbreak almost exclusively affected sexual networks of gay, bisexual, or other men who have sex with men (GBMSM) and people living with HIV. In efforts to control transmission, multiple public health measures were implemented, including vaccination, contact tracing and isolation. This study examines knowledge, attitudes, and perceptions of mpox among a sample of GBMSM during the 2022-23 outbreak in the UK, including facilitators for and barriers to the uptake of public health measures. METHODS: Interviews were conducted with 44 GBMSM between May and December 2022. Data were analysed using reflexive thematic analysis. Positive and negative comments pertaining to public health measures were collated in a modified version of a 'table of changes' to inform optimisations to public health messages and guidance. RESULTS: Most interviewees were well informed about mpox transmission mechanisms and were either willing to or currently adhering to public health measures, despite low perceptions of mpox severity. Measures that aligned with existing sexual health practices and norms were considered most acceptable. Connections to GBMSM networks and social media channels were found to increase exposure to sexual health information and norms influencing protective behaviours. Those excluded or marginalized from these networks found some measures challenging to perform or adhere to. Although social media was a key mode of information sharing, there were preferences for timely information from official sources to dispel exaggerated or misleading information. CONCLUSIONS: There are differential needs, preferences, and experiences of GBMSM that limit the acceptability of some mitigation and prevention measures. Future public health interventions and campaigns should be co-designed in consultation with key groups and communities to ensure greater acceptability and credibility in different contexts and communities.

Exploration of attitudes regarding uptake of COVID-19 vaccines among vaccine hesitant adults in the UK: a qualitative analysis.

BACKGROUND: The aim of this work was to explore barriers and facilitators to uptake of COVID-19 vaccines and to explore views and reactions to efforts to improve vaccine uptake among vaccine hesitant individuals. METHODS: Semi-structured interviews were conducted with people between the age of 18-29 years who had not had a COVID-19 vaccine, and those between 30 and 49 years who had not had a second dose of a COVID-19 vaccine. RESULTS: A total of 70 participants took part in the study, 35 participants had received one dose, and 35 had not been vaccinated. Participants described a willingness to be vaccinated to keep themselves and those around them safe and to avoid restrictions. Barriers to uptake included: (1) perceived lack of need for COVID-19 vaccinations, (2) concerns about the efficacy of vaccinations, (3) concerns about safety, and (4) access issues. Uptake appeared to be influenced by age and health status, trust in government, and knowledge and understanding of science. Introduction of vaccine passes may provide a motive for having a vaccine but may be viewed as coercive. CONCLUSION: Participants were hesitant, rather than opposed, and had questions about their need for, and the safety and efficacy of the vaccine. Young people did not consider themselves to be at risk of becoming ill from COVID-19, did not think the vaccination was effective in preventing transmission, and did not think sufficient research had been conducted regarding possible long-term side-effects. Concerns were exacerbated by a lack of trust in government, and misunderstanding of science. To promote uptake, public health campaigns should focus on the provision of information from trusted sources that explains the benefits of vaccination and addresses safety concerns more effectively. To overcome inertia in people with low levels of motivation to be vaccinated, appointments must be easily accessible.

Feasibility and acceptability of daily testing at school as an alternative to self-isolation following close contact with a confirmed case of COVID-19: a qualitative analysis.

BACKGROUND: Daily testing using a rapid Lateral Flow Device (LFD) has been suggested as an alternative to self-isolation. A randomised trial comparing daily contact testing (DCT) in schools with self-isolation found that SARS-CoV-2 transmission within school was comparable and low in both groups. However, if this approach is to be adopted widely, it is critical that we understand the perspective of those who will be delivering and receiving DCT. The aim of this qualitative process study embedded in the randomised controlled trial (RCT) was to improve understanding of a range of behavioural factors that could influence implementation. METHODS: Interviews were conducted with 63 participants, including staff, students, and parents of students who had been identified as being in close contact with someone with COVID-19. The topic guide explored perceptions of daily testing, understanding of positive and negative test results, and adherence to guidance. Data were analysed using an inductive thematic approach. RESULTS: Results were organised under three main headings: (1) factors influencing daily testing (2) interpretation of test results (3) behaviour during testing period. Participants recognized that daily testing may allow students to remain in school, which was viewed as necessary for both education and social needs. Whilst some felt safer as a result of daily testing, others raised concerns about safety. Participants did not always understand how to interpret and respond to test results, and although participants reported high levels of adherence to the guidance, improved communications were desired. CONCLUSION: Daily testing may be a feasible and acceptable alternative to self-isolation among close contacts of people who test positive. However, improved communications are needed to ensure that all students and parents have a good understanding of the rationale for testing, what test results mean, how test results should be acted on, and how likely students are to test positive following close contact. Support is needed for students and parents of students who have to self-isolate and for those who have concerns about the safety of daily testing.

A qualitative process analysis of daily contact testing as an alternative to self-isolation following close contact with a confirmed carrier of SARS-CoV-2.

BACKGROUND: In July 2021, a randomised controlled trial was conducted to compare the effect on SARS-CoV-2 transmission of seven days of Daily Contact Testing (DCT) using Lateral Flow Test (LFT) and two Polymerase Chain Reaction (PCR) tests as an alternative to 10 days of standard self-isolation with one PCR, following close contact with a SARS-CoV-2 carrier. In this qualitative study, we used a nested process evaluation to aid interpretation of the trial and provide insight into factors influencing use of tests, understanding of test results, and how tests were used to inform behavioural decisions. METHODS: Interviews were conducted with 60 participants (42 randomised to DCT and 18 randomised to self-isolation) who had been in close contact with a confirmed SARS-CoV-2 carrier and had consented to take part in the trial. RESULTS: Data were organised into three overarching themes: (1) assessing the risks and benefits of DCT (2) use of testing during the study period and (3) future use of testing. Attitudes toward DCT as an alternative to self-isolation and behaviour during the testing period appeared to be informed by an assessment of the associated risks and benefits. Participants reported how important it was for them to avoid isolation, how necessary self-isolation was considered to be, and the ability of LFTs to detect infection. Behaviour during the testing period was modified to reduce risks and harms as much as possible. Testing was considered a potential compromise, reducing both risk of transmission and the negative impact of self-isolation, and was regarded as a way to return to normal. CONCLUSION: Participants in this study viewed DCT as a sensible, feasible, and welcome means of avoiding unnecessary self-isolation. Although negative LFTs provided reassurance, most people still restricted their activity as recommended. DCT was also highly valued by those in vulnerable households as a means of providing reassurance of the absence of infection and as an important means of detecting infection and prompting self-isolation when necessary.

Effectiveness of digital interventions to improve household and community infection prevention and control behaviours and to reduce incidence of respiratory and/or gastro-intestinal infections: a rapid systematic review.

BACKGROUND: Digital interventions have potential to efficiently support improved hygiene practices to reduce transmission of COVID-19. OBJECTIVE: To evaluate the evidence for digital interventions to improve hygiene practices within the community. METHODS: We reviewed articles published between 01 January 2000 and 26 May 2019 that presented a controlled trial of a digital intervention to improve hygiene behaviours in the community. We searched MEDLINE, Embase, PsycINFO, Cochrane Controlled Register of Trials (CENTRAL), China National Knowledge Infrastructure and grey literature. Trials in hospitals were excluded, as were trials aiming at prevention of sexually transmitted infections; only target diseases with transmission mechanisms similar to COVID-19 (e.g. respiratory and gastrointestinal infections) were included. Trials had to evaluate a uniquely digital component of an intervention. Study designs were limited to randomised controlled trials, controlled before-and-after trials, and interrupted time series analyses. Outcomes could be either incidence of infections or change in hygiene behaviours. The Risk of Bias 2 tool was used to assess study quality. RESULTS: We found seven studies that met the inclusion criteria. Six studies reported successfully improving self-reported hygiene behaviour or health outcomes, but only one of these six trials, Germ Defence, confirmed improvements using objective measures (reduced consultations and antibiotic prescriptions). Settings included kindergartens, workplaces, and service station restrooms. Modes of delivery were diverse: WeChat, website, text messages, audio messages to mobiles, electronic billboards, and electronic personal care records. Four interventions targeted parents of young children with educational materials. Two targeted the general population; these also used behaviour change techniques or theory to inform the intervention. Only one trial had low risk of bias, Germ Defence; the most common concerns were lack of information about the randomisation, possible bias in reporting of behavioural outcomes, and lack of an analysis plan and possible selective reporting of results. CONCLUSION: There was only one trial that was judged to be at low risk of bias, Germ Defence, which reduced incidence and severity of illness, as confirmed by objective measures. Further evaluation is required to determine the effectiveness of the other interventions reviewed. TRIAL REGISTRATION: PROSPERO CRD42020189919 .

Infection Control Behavior at Home During the COVID-19 Pandemic: Observational Study of a Web-Based Behavioral Intervention (Germ Defence).

BACKGROUND: To control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors. OBJECTIVE: This study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved. METHODS: This was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors. RESULTS: Current behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31). CONCLUSIONS: Self-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.

Sexual Aging: A Systematic Review of Qualitative Research on the Sexuality and Sexual Health of Older Adults.

Negative stereotypes regarding the sex lives of older adults persist, despite sexuality being an important factor that influences the quality of life. We conducted a systematic review of the qualitative literature on the sexuality and sexual health of older adults to address which topics have been researched and the quality of research within this field. We searched PsycINFO, SocINDEX, MEDLINE, and CINAHL for qualitative articles investigating the sexuality of adults aged 60+ years. We analyzed 69 articles using thematic analysis to synthesize their findings. We identified two overarching thematic categories: psychological and relational aspects of sexuality (personal meanings and understandings of sex, couplehood aspects, and sociocultural aspects) and health and sexuality (effects of illness and/or treatment on sexuality, and help-seeking behaviors). Research is needed into male sexual desire and pleasure, culture-specific and sexual/gender identities and their effect on outcomes such as help-seeking behavior and sexual satisfaction, and sexual risk-taking in older adults.

Sex and Relationships in Later Life: Older Adults' Experiences and Perceptions of Sexual Changes.

The aim of this study was to explore the sexual lives of older adults in the UK to elucidate their experiences of sexual changes and problems, and the role of intimacy and interpersonal support in coping with these changes. We conducted in-depth semi-structured interviews with 31 participants (aged 66-92, mean = 74, 16 women and 15 men), analyzed using reflexive thematic analysis. Our analysis generated three themes: Sexual Changes are "Natural," Sex is the Icing on the Cake, and Maintaining Sexual Connection and Relationship Satisfaction. The participants often rationalized and accepted sexual changes and problems as part of the natural aging process, or as a consequence of other age-related health issues. Sexual activity was seen by many as the "icing on the cake" of a satisfying romantic relationship, built on strong foundations of intimacy, connection, and companionship. Relationship satisfaction and sexual wellbeing can be maintained despite changes to sexual function by retaining a sexual connection through shared experiences, emotional closeness, and support. The findings have important implications for researchers and health providers, and suggest that adopting an "affirmative older age" perspective would be useful for not only future research but also when providing support for older adults with sexual difficulties.

Applying machine-learning to rapidly analyze large qualitative text datasets to inform the COVID-19 pandemic response: comparing human and machine-assisted topic analysis techniques.

Introduction: Machine-assisted topic analysis (MATA) uses artificial intelligence methods to help qualitative researchers analyze large datasets. This is useful for researchers to rapidly update healthcare interventions during changing healthcare contexts, such as a pandemic. We examined the potential to support healthcare interventions by comparing MATA with "human-only" thematic analysis techniques on the same dataset (1,472 user responses from a COVID-19 behavioral intervention). Methods: In MATA, an unsupervised topic-modeling approach identified latent topics in the text, from which researchers identified broad themes. In human-only codebook analysis, researchers developed an initial codebook based on previous research that was applied to the dataset by the team, who met regularly to discuss and refine the codes. Formal triangulation using a "convergence coding matrix" compared findings between methods, categorizing them as "agreement", "complementary", "dissonant", or "silent". Results: Human analysis took much longer than MATA (147.5 vs. 40 h). Both methods identified key themes about what users found helpful and unhelpful. Formal triangulation showed both sets of findings were highly similar. The formal triangulation showed high similarity between the findings. All MATA codes were classified as in agreement or complementary to the human themes. When findings differed slightly, this was due to human researcher interpretations or nuance from human-only analysis. Discussion: Results produced by MATA were similar to human-only thematic analysis, with substantial time savings. For simple analyses that do not require an in-depth or subtle understanding of the data, MATA is a useful tool that can support qualitative researchers to interpret and analyze large datasets quickly. This approach can support intervention development and implementation, such as enabling rapid optimization during public health emergencies.

Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform.

BACKGROUND: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. METHODS: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. RESULTS: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. CONCLUSIONS: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Older adults' embodied experiences of aging and their perceptions of societal stigmas toward sexuality in later life.

RATIONALE: Sexuality is an important part of life for many older adults, and research is beginning to demonstrate the diversity of sexual agency and sexual expression in middle and later life. There is a lack of qualitative research, however, on the lived experiences of older adults concerning this topic. OBJECTIVE: The aim of this study was to explore older adults' embodied experiences and perceptions of aging in relation to sexuality, and whether differences based on gender and/or sexual orientation exist amongst this participant group. METHODS: Thirty-one United Kingdom adults aged 66-92 years (M age 74; 16 women and 15 men) completed in-depth semi-structured interviews; these were analysed using reflexive thematic analysis. RESULTS: Three themes were generated. Changing Body; Media and Society; and "I still feel the same inside." Older adults reported being seen as "past it" and irrelevant, but some saw this as freedom from societal expectations. Health and functional aspects of their bodies were prioritised over aesthetics and "overly glamourous" older celebrities were rejected as appropriate role models. Aging "well" meant resisting decline, but outward appearances did not always align with internal perceptions and experience. Many of our participants had internalised narratives of "successful aging" that centred around retaining youth. CONCLUSIONS: Findings support affirmative aging narratives. Aging as a time of difference without a sense of loss or decline. Implications for how later life is presented in advertising and service provision are discussed.

Adapting Behavioral Interventions for a Changing Public Health Context: A Worked Example of Implementing a Digital Intervention During a Global Pandemic Using Rapid Optimisation Methods.

Background: A rigorous approach is needed to inform rapid adaptation and optimisation of behavioral interventions in evolving public health contexts, such as the Covid-19 pandemic. This helps ensure that interventions are relevant, persuasive, and feasible while remaining evidence-based. This paper provides a set of iterative methods to rapidly adapt and optimize an intervention during implementation. These methods are demonstrated through the example of optimizing an effective online handwashing intervention called Germ Defense. Methods: Three revised versions of the intervention were rapidly optimized and launched within short timeframes of 1-2 months. Optimisations were informed by: regular stakeholder engagement; emerging scientific evidence, and changing government guidance; rapid qualitative research (telephone think-aloud interviews and open-text surveys), and analyses of usage data. All feedback was rapidly collated, using the Table of Changes method from the Person-Based Approach to prioritize potential optimisations in terms of their likely impact on behavior change. Written feedback from stakeholders on each new iteration of the intervention also informed specific optimisations of the content. Results: Working closely with clinical stakeholders ensured that the intervention was clinically accurate, for example, confirming that information about transmission and exposure was consistent with evidence. Patient and Public Involvement (PPI) contributors identified important clarifications to intervention content, such as whether Covid-19 can be transmitted via air as well as surfaces, and ensured that information about difficult behaviors (such as self-isolation) was supportive and feasible. Iterative updates were made in line with emerging evidence, including changes to the information about face-coverings and opening windows. Qualitative research provided insights into barriers to engaging with the intervention and target behaviors, with open-text surveys providing a useful supplement to detailed think-aloud interviews. Usage data helped identify common points of disengagement, which guided decisions about optimisations. The Table of Changes was modified to facilitate rapid collation and prioritization of multiple sources of feedback to inform optimisations. Engagement with PPI informed the optimisation process. Conclusions: Rapid optimisation methods of this kind may in future be used to help improve the speed and efficiency of adaptation, optimization, and implementation of interventions, in line with calls for more rapid, pragmatic health research methods.

Infection control in the home: a qualitative study exploring perceptions and experiences of adhering to protective behaviours in the home during the COVID-19 pandemic.

OBJECTIVES: We sought to explore people's experiences and perceptions of implementing infection control behaviours in the home during the COVID-19 pandemic, guided by an online behavioural intervention. DESIGN: Inductive qualitative study. SETTING: UK public during the COVID-19 pandemic. PARTICIPANTS: Thirteen people took part in telephone interviews, and 124 completed a qualitative open-text survey. All were recruited from the public. Most survey participants were aged over 60 years, while interview participants were more distributed in age. Most reported being at increased risk from COVID-19, and were white British. INTERVENTION: Online behavioural intervention to support infection control behaviours in the home during the COVID-19 pandemic. DATA COLLECTION: Telephone think-aloud interviews and qualitative survey data. DATA ANALYSIS: The think-aloud interview data and qualitative survey data were analysed independently using inductive thematic analysis. The findings were subsequently triangulated. RESULTS: Thematic analysis of the telephone interviews generated seven themes: perceived risk; belief in the effectiveness of protective behaviours; acceptability of distancing and isolation; having capacity to perform the behaviours; habit forming reduces effort; having the confidence to perform the behaviours; and social norms affect motivation to engage in the behaviours. The themes identified from the survey data mapped well onto the interview analysis. Isolating and social distancing at home were less acceptable than cleaning and handwashing, influenced by the need for intimacy with household members. This was especially true in the absence of symptoms and when perceived risk was low. People felt more empowered when they understood that even small changes, such as spending some time apart, were worthwhile to reduce exposure and lessen viral load. CONCLUSIONS: The current study provided valuable insight into the acceptability and feasibility of protective behaviours, and how public health guidance could be incorporated into a behaviour change intervention for the public during a pandemic.

Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. TRIAL DESIGN: A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. PARTICIPANTS: Setting: All Primary care GP practices in England. PARTICIPANTS: All patients aged 16 years and over who were granted access by participating GP practices. INTERVENTION AND COMPARATOR: Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website ( http://GermDefence.org/ ) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users' personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. MAIN OUTCOMES: The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice RANDOMISATION: GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. BLINDING (MASKING): The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. TRIAL STATUS: Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry ( isrctn.com/ ISRCTN14602359 ) on 12 August 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Assessing the perceived benefits of a new condom wrapper/integrated applicator: an exploratory study.

Errors and problems associated with male condom use are very prevalent and increase the likelihood of inconsistent and incomplete use, thereby compromising condom effectiveness. The aim of this study was to assess the perceived benefits of a new condom wrapper/integrated applicator designed to reduce barriers to condom use and lessen the likelihood of user errors and problems. After viewing videos depicting features of the wrapper/applicator, participants (N = 547; 62.9% male, M age = 29.2) completed online questionnaires. Most participants reported that the product would make condom application easier and quicker, make them more confident that condoms had been applied correctly and make sex more pleasurable and playful. The majority of participants who had recent experience of condom use errors/problems reported that the use of the product would likely prevent these issues from occurring. Reduced chance of condom damage, the design features of the wrapper and not having to touch the condom itself during application were perceived as particular benefits of the product. The findings suggest that the product might reduce the likelihood of a range of condom user errors and problems and enhance pleasure during condom-protected sex. Future larger-scale studies that involve participants physically testing the condom wrapper/applicator are warranted.