Public understanding and awareness of and response to monkeypox virus outbreak: A cross-sectional survey of the most affected communities in the United Kingdom during the 2022 public health emergency.

OBJECTIVES: Our objective was to examine the public response to public health and media messaging during the human monkeypox virus (MPXV) outbreak in the UK, focusing on at-risk communities. METHODS: A co-produced, cross-sectional survey was administered in June and July 2022 using community social media channels and the Grindr dating app. Basic descriptive statistics, logistic regression, and odds ratio p values are presented. RESULTS: Of 1932 survey respondents, 1750 identified as men, 88 as women, and 64 as gender non-conforming. Sexual identity was described as gay/lesbian/queer (80%), bisexual (12%), heterosexual (4%), and pansexual (2%); 39% were aged <40 years; 71% self-identified as White, 3% as Black, 8% as Asian, 2%as LatinX, and 11% as 'Mixed or Other' heritage groups. In total, 85% were employed and 79% had completed higher education. A total of 7% of respondents identified themselves as living with HIV. Overall, 34% reported limited understanding of public health information, 52% considered themselves at risk, 61% agreed that people with MPXV should isolate for 21 days, 49% reported they would first attend a sexual health clinic if symptomatic, 86% reported they would accept a vaccine, and 59% believed that MPXV originated from animals. The most trusted sources of information were healthcare professionals (37%), official health agencies (29%), and mainstream media (12%). CONCLUSIONS: Vaccine acceptability was very high, yet the understanding and acceptance of public health information varied. Social determinants of health inequalities already shaping the UK landscape risk were compounded in this new emergency. Engagement with structurally disadvantaged members of affected communities and better dissemination of public health messaging by trusted healthcare professionals are essential for the public health response.

The Impact of First UK-Wide Lockdown (March-June 2020) on Sexual Behaviors in Men and Gender Diverse People Who Have Sex with Men During the COVID-19 Pandemic: A Cross-Sectional Survey.

The global COVID-19 pandemic resulted in strict social distancing measures restricting close physical contact. Men (cis and trans) and other gender diverse people who have sex with men (MGDSM) are at higher risk of sexually transmitted infections (STIs) and may have experienced changes in sexual behavior during government restrictions on social and sexual contact. We aimed to examine self-reported sexual behavior of MGDSM during the first UK-wide lockdown to identify the characteristics of the individuals who might most require sexual health promotion and clinical support. In April-May 2020, we conducted an online survey of MGDSM, promoted on social media and Grindr. Our exploratory approach used descriptive analysis to identify self-reported changes in sexual behavior and performed regression analyses to identify correlates of casual sex during the lockdown. A total of 1429 respondents completed the survey: mean age 36 years, 84% White, 97% male or trans male, 98% assigned male sex at birth, 2% female or non-binary, 65% degree educated or higher. During the lockdown, 76% reported not having any casual sex partners. While the majority reported reduced casual sex, 3% reported an increase in casual sex with one person and 2% with three or more people (group sex). About 12% of the sample engaged in casual sex with only one person and 5% with four or more sexual partners during the lockdown. Reporting casual sex during lockdown was associated with: lower level of education OR = 2.37 [95% CI 1.40-4.01]; identifying as a member of an ethnic minority OR = 2.27[1.40-3.53]; daily usage of sexual networking apps OR = 2.24[1.54-3.25]; being less anxious about contracting SARS-CoV-2 through sex OR = 1.66[1.12-2.44]; using PrEP before lockdown OR = 1.75[1.20-2.56]; continuing to use PrEP OR = 2.79[1.76-4.57]; and testing for STIs during lockdown OR = 2.65[1.76-3.99]. A quarter of respondents remained sexually active with casual partners, indicating a need to provide STI screening services and health promotion targeted to groups most likely to have need over this period. Future research is required to better understand how to support sexual and gender minorities to manage sexual risk in the context of pandemic public health initiatives.

"Sex without fear": exploring the psychosocial impact of oral HIV pre-exposure prophylaxis on gay men in England.

Gay, bisexual, and other men who have sex with men (GBMSM) experience a high prevalence of psychosocial health problems, such as harmful substance use and depression, as well as being disproportionately affected by HIV. HIV Pre-Exposure Prophylaxis (PrEP) may provide psychosocial benefits beyond its intended purpose of reducing HIV infection. We explore the psychosocial impact of oral PrEP use on gay men in England using qualitative data from the PROUD study. From February 2014 to January 2016, semi-structured in-depth interviews were conducted with 40 gay men and one trans woman. Participants were purposively recruited based on trial arm allocation, adherence, and sexual risk behaviours. By removing HIV risk from sex, PrEP improves users' wellbeing by reducing HIV-related anxiety and internalised stigma and increasing HIV prevention self-efficacy, sexual pleasure, and intimacy. In turn, these psychological changes may influence behaviour in the form of greater sexual freedom, reduced harmful drug use, and more protective sexual health behaviours. However, PrEP may create internal conflict for some gay men, due to its disruption of social norms around condom use and its perceived influence on their sexual behaviour leading to reduced condom self-efficacy. These findings provide a baseline of PrEP's psychosocial impact amongst some of the first PrEP users in England and supports calls to consider the psychosocial impact of PrEP in prescribing guidelines.

Perceptions and Practicalities Influencing Pre-exposure Prophylaxis Adherence Among Men Who Have Sex with Men in England.

PrEP is highly effective for HIV prevention but requires adequate adherence. In this paper we use the perceptions and practicalities approach (PAPA) to identify factors that influenced PrEP adherence using qualitative data from the PROUD study. From February 2014 to January 2016, we interviewed 41 gay, bisexual and other men-who-have-sex-with-men and one trans woman who were enrolled in the study. We purposively recruited participants for interview based on trial arm allocation, adherence and sexual risk behaviours. The interviews were conducted in English, audio-recorded, transcribed, coded and analysed using framework analysis. Participants in general were highly motivated to use and adhere to PrEP, and this was linked to strong perceptions of personal necessity for PrEP as they felt at risk of HIV and viewed PrEP as highly effective. On the other hand, concerns about side effects and HIV resistance did inhibit PrEP initiation and adherence although this was uncommon. Practical factors such as daily routine, existing habitual pill-taking and pill storage impacted adherence. Drug and alcohol use rarely caused participants to miss doses. These findings indicate that using the principals of PAPA to unpick influencers of PrEP use, could help tailor adherence support in PrEP programmes.

High monkeypox vaccine acceptance among male users of smartphone-based online gay-dating apps in Europe, 30 July to 12 August 2022.

We assess monkeypox vaccination acceptance among male adults in the European Region. We conducted an online survey through two dating apps targeting men who have sex with men, from 30 July to 12 August 2022. We developed Bayesian hierarchical logistic regression models to investigate monkeypox vaccination acceptance. Overall crude vaccination acceptance was 82% and higher in north-western compared to south-eastern European regions. Acceptance strongly rose with perception of increased disease severity and transmission risk, and in individuals linked to healthcare.

Factors associated with reporting antibiotic use as STI prophylaxis among HIV PrEP users: findings from a cross-sectional online community survey, May-July 2019, UK.

OBJECTIVES: The use of antibiotics as pre-exposure or postexposure prophylaxis for sexually transmitted infection (STI) prevention (STI prophylaxis) is not currently recommended in the UK, but there is evidence that self-prescribing occurs among those at greatest risk. We present the prevalence and factors associated with STI prophylaxis among a community sample of HIV pre-exposure prophylaxis (PrEP) users. METHODS: The 2019 online PrEP User Survey ran between 17 May and 1 July. Eligible participants included UK residents reporting HIV PrEP use or having tried to obtain HIV PrEP since January 2017. STI prophylaxis use was defined as reporting buying antibiotics to prevent STIs, either privately or through the internet; this question was only asked to HIV PrEP users. Factors associated with STI prophylaxis use were assessed using univariable and multivariable logistic regression. RESULTS: Overall, 9% (167/1856) of HIV PrEP users reported STI prophylaxis use; 97% were gay or bisexual men, 84% reported white ethnicity, 55% resided in London and 69% were aged ≥35 years. Factors associated with STI prophylaxis included: reporting ≥5 compared with 1-4 condomless sex partners in the past 6 months (12% vs 5.6%, adjusted odds ratio (aOR)=1.80; 95% CI 1.22 to 2.64), reporting chemsex drug use compared with no sexualised drug use in the past 12 months (13% vs 6.0%, aOR=1.88; 95% CI 1.20 to 2.93) and reporting an STI diagnosis in the past 12 months (12% vs 6.6%, aOR=1.54; 95% CI 1.08 to 2.18). Variables not significant in multivariable analyses included: ethnicity, age, residence and HIV PrEP sourcing. CONCLUSIONS: Approximately 1 in 10 HIV PrEP users from this community sample reported self-prescribed STI prophylaxis. STI prophylaxis was associated with sexual behaviour known to facilitate STI transmission and with a history of recent STIs acquisition. Given the potential risk of antimicrobial resistance, sexual health clinicians should consider asking attendees, especially HIV PrEP users, about the use of antibiotics as STI prophylaxis, to inform appropriate counselling, testing and management.

What are the motivations and barriers to pre-exposure prophylaxis (PrEP) use among black men who have sex with men aged 18-45 in London? Results from a qualitative study.

BACKGROUND: Black men who have sex with men (BMSM) have higher HIV incidence and prevalence when compared with other men who have sex with men, despite similar risk profiles. New prevention technologies, including pre-exposure prophylaxis (PrEP), may be effective in responding to these inequalities, provided they are appropriately targeted and acceptable to their intended beneficiaries. This study aims to understand the motivations and barriers of BMSM aged 18-45 to PrEP uptake. METHODS: Twenty-five BMSM recruited through geolocation social networking apps took part in in-depth interviews between April and August 2016. Intersectionality theory was used as an organising principle. Interviews were transcribed verbatim and analysed using a thematic framework analysis. RESULTS: For BMSM with heterogeneous social groups, discussions about sexual health were challenging because of the intersection of ethnic background, family history and religion. This limited conversations about PrEP to gay male friends who often held stigmatising views of condomless anal intercourse. BMSM reported exclusion from gay male spaces (online and offline) which could serve to restrict exposure to PrEP messages. Stereotypes of BMSM intersected with negative conceptions of PrEP users, limiting acknowledgement of PrEP candidacy. For those who had attempted to or successfully accessed it, PrEP was framed as a strategy to mitigate risk and to guard against further stigma associated with HIV infection. DISCUSSION: BMSM operate within a complex set of circumstances related to the intersection of their sexual, ethnic, cultural and religious identities, which shape PrEP acceptability. Interventions which seek to facilitate uptake in this group must be attentive to these. Health promotion and clinical services could seek to facilitate nuanced discussions about the merits of PrEP for those at frequent risk, perhaps while also providing publicly visible PrEP role models for BMSM and other marginalised groups.

The Context of Sexual Risk Behaviour Among Men Who Have Sex with Men Seeking PrEP, and the Impact of PrEP on Sexual Behaviour.

There are still important gaps in our understanding of how people will incorporate PrEP into their existing HIV prevention strategies. In this paper, we explore how PrEP use impacted existing sexual risk behaviours and risk reduction strategies using qualitative data from the PROUD study. From February 2014 to January 2016, we conducted 41 in-depth interviews with gay, bisexual and other men who have sex with men (GBMSM) enrolled in the PROUD PrEP study at sexual health clinics in England. The interviews were conducted in English and were audio-recorded. The recordings were transcribed, coded and analysed using framework analysis. In the interviews, we explored participants' sexual behaviour before joining the study and among those using or who had used PrEP, changes to sexual behaviour after starting PrEP. Participants described the risk behaviour and management strategies before using PrEP, which included irregular condom use, sero-sorting, and strategic positioning. Participants described their sexual risk taking before initiating PrEP in the context of the sexualised use of drugs, geographical spaces linked with higher risk sexual norms, and digitised sexual networking, as well as problematic psychological factors that exacerbated risk taking. The findings highlight that in the main, individuals who were already having frequent condomless sex, added PrEP to the existing range of risk management strategies, influencing the boundaries of the 'rules' for some but not all. While approximately half the participants reduced other risk reduction strategies after starting PrEP, the other half did not alter their behaviours. PrEP provided an additional HIV prevention option to a cohort of GBMSM at high risk of HIV due to inconsistent use of other prevention options. In summary, PrEP provides a critical and necessary additional HIV prevention option that individuals can add to existing strategies in order to enhance protection, at least from HIV. As a daily pill, PrEP offers protection in the context of the sex cultures associated with sexualised drug use, digitised sexual applications and shifting social norms around sexual fulfilment and risk taking. PrEP can offer short or longer-term options for individuals as their sexual desires change over their life course offering protection from HIV during periods of heightened risk. PrEP should not be perceived or positioned in opposition to the existing HIV prevention toolkit, but rather as additive and as a tool that can and is having a substantial impact on HIV.

Current experiences of accessing and using HIV pre-exposure prophylaxis (PrEP) in the United Kingdom: a cross-sectional online survey, May to July 2019.

The 2019 online pre-exposure prophylaxis (PrEP) user survey in the United Kingdom was conducted to assess HIV PrEP access, and user characteristics. One in five respondents continued experiencing difficulties accessing PrEP; users were almost exclusively gay or bisexual men at high risk of HIV. The majority obtained PrEP through health service clinics and rated PrEP positively. High STI rates were reported among users. Renal and sexual health checks are advised for those sourcing PrEP privately.

Findings from the 'Ask Me About PrEP' HIV Pre-Exposure Prophylaxis Awareness Programme in England.

RATIONALE: HIV incidence has decreased in England by over a third since 2019. Despite the early success of HIV Pre-Exposure Prophylaxis (PrEP) in reducing HIV transmission in the United Kingdom, many people who could benefit from HIV PrEP do not yet know about it, or know how to access it. AIMS AND OBJECTIVES: This paper presents the findings of the first England-wide national peer-to-peer based diffusion model to disseminate information about PrEP. Ask Me About PrEP (AMAP) was a 5-month pilot programme which commenced in November 2021. Volunteer mobilisers were encouraged to use their existing knowledge of their communities and geographical areas to assist them in discussing PrEP with their peers. METHOD: 12 enrolled mobilisers took part in three project evaluation focus groups between November 2021 and March 2022, and five AMAP project staff took part in one focus group in March 2022. Additionally, descriptive statistical analysis explored volunteer mobiliser recruitment to the AMAP project, demographical data of project staff and volunteer mobilisers, volunteer mobiliser attrition rates, and the project's impact. RESULTS: 96 volunteers enrolled, completed training and volunteered as mobilisers. Thoroughout the project, mobilisers engaged their peers in 11,889 conversations about PrEP through individual conversations, online group conversations, online workplace educational events, and social media. The focus groups enabled key stakeholders to reflect on their experiences of the pilot programme. Four key themes were identified during the focus groups: motivations to mobilise and recruitment experiences; training, learning, and materials; mobilisation activity; and support and social networking. CONCLUSION: Our evaluation demonstrates that peer-to-peer diffusion models used to increase awareness of HIV PrEP in key unreached groups, offer an acceptable public health intervention model for volunteers and project staff.

Co-creating a Mpox Elimination Campaign in the WHO European Region: The Central Role of Affected Communities.

Between May 2022 and September 2023, the World Health Organization (WHO) Regional Office for Europe engaged in a collaborative effort with affected communities to address the outbreak of mpox in the region. This concerted endeavor led to the development of a risk communication campaign specifically tailored to address the perceptions and needs of the target audience, thereby contributing to the control and the long-term goal of mpox elimination. Various community engagement interventions were implemented, including the establishment of an informal civil society organizations' working group to provide feedback on the WHO mpox campaign, webinars targeting event organizers, and roundtable discussions with country-level responders. The invaluable feedback garnered from the community was utilized to customize materials and extend outreach to groups that may have been overlooked in the initial response. This successful initiative underscored the immense potential of placing communities at the forefront of emergency response efforts, equipping them with the necessary resources, engagement, and empowerment. This offers 1 model of co-creation that can be applied to health emergencies. It is asserted that the pivotal role played by communities in this response should be recognized as a valuable lesson and incorporated into all emergency responses, ensuring sustained community involvement and empowerment throughout the entire emergency cycle.

'We go where we know': Reflections from Mobilizing for PrEP and Sexual Health (MobPrESH) - A peer-led PrEP education programme across England, for and by women and non-binary people.

BACKGROUND: Pre-exposure prophylaxis is a highly effective method of HIV prevention but few women know about it, have access to it, or see it as relevant to them. In 2019, grassroots organization PrEPster piloted a peer-led intervention, MobPrESH (Mobilizing for Pre-Exposure prophylaxis (PrEP) and Sexual Health), across three sites in England, to mobilize for PrEP and sexual health with communities of women and non-binary people most affected by HIV, including Black women and non-binary people, people of colour, migrants, and transgender (trans) women. OBJECTIVES: We aimed to explore the accessibility, feasibility, acceptability, and 'fidelity' of MobPrESH, from the perspectives of peer mobilizers and project staff. METHODS: We conducted focus group discussions and qualitative interviews with nine peer mobilizers (most identified as Black cisgender (cis) women) and six project staff (including Black and white cis women and non-binary people). We analysed data thematically, iteratively, and inductively, informed by concepts of reproductive and social justice. RESULTS: We present findings in five thematic areas: connecting and relating to situate sexual health discussions, navigating silence and stigma, connecting within and across communities, competing pressures and structural hostilities, and resources and continuity. Community knowledge-building about PrEP is a slow, iterative process that needs investment and creation of trusted spaces that centre communities' needs and concerns. Peer mobilizers and the communities they engaged with had competing demands in their lives, and knowledge-raising about PrEP was impacted by intersecting stigmas, discrimination, and oppressions around HIV status, racism, misogyny, transphobia, homophobia, and anti-sex worker rhetoric. CONCLUSIONS: Peer-led PrEP interventions require funding and foregrounding, particularly for women and non-binary people who are Black, trans, migrants, and people of colour, situated relative to their wider health needs, life pressures, and priorities. This requires concurrent challenge of the racist and patriarchal structures that continue to obscure the sexual and reproductive health needs of racially minoritized and marginalized women and non-binary people.

Mental Well-Being and Sexual Intimacy among Men and Gender Diverse People Who Have Sex with Men during the First UK COVID-19 Lockdown: A Mixed-Methods Study.

This mixed-methods study aimed to explore mental well-being, circumstances and strategies around managing sexual intimacy and risk during the first UK COVID-19 lockdown (Spring 2020) among men and gender diverse people who have sex with men (MGDPSM), commencing while lockdown was in progress. n = 1429 MGDPSM completed the survey and 14 undertook an in-depth interview. Low mental well-being was reported by 49.6% of the survey participants. Low mental well-being was not predicted by relationship and living circumstance, sexual networking app use, or by casual sexual partners. Low mental well-being was associated with more frequent COVID-19 anxiety (OR = 5.08 CI: 3.74, 6.88 p < 0.001) and with younger age (18−24 years OR = 2.23 CI:1.41−3.53 p = 0.001, 25−34 years OR = 1.45 CI:1.04−2.02 p = 0.029, 35−44 years OR = 1.41 CI:1.00−1.99 p = 0.052). The interview participants understood their lockdown experiences as being relative to normalcy, and those experiencing more dramatic changes faced greater challenges. Living with partners was felt to protect well-being. Many participants reported intimacy interruption challenges. The findings indicate that mental well-being is predicted by age and COVID-19 impact, highlighting opportunities for targeting MGDPSM who are most vulnerable to poor mental health. Services that support MGDPSM during COVID-19 recovery efforts must provide non-judgemental and affirming support.

Experiences and challenges in sexual health service access among men who have sex with men in Kenya.

Men who have sex with men (MSM) in Kenya bear a heavy burden of HIV/STIs and are a priority population in the national HIV/AIDS response, yet remain criminalised and stigmatised within society. HIV pre-exposure prophylaxis (PrEP) offers an opportunity to significantly impact the HIV epidemic, as does the concept of U = U, whereby those who are living with HIV and on treatment are uninfectious when their viral load has been suppressed so as to be undetectable. However, the value of such innovations will not be realised without sufficient understanding of, and respect for, the sexual health service provision needs of MSM. This paper describes findings from 30 in-depth interviews with MSM living in Nairobi that explored engagement with sexual health service providers, barriers to access and perceived opportunities to improve service design and delivery. Findings indicate concern relating to the professionalism of some staff working within public hospitals as well as feelings that many sexual health services were not considered safe spaces for the discussion of MSM-specific sexual behaviour. Diverse views were expressed relating to comfort in public, community and private sexual health services as well as how these are and should be organised.

Is mpox an STI? The societal aspects and healthcare implications of a key question.

This letter explores the societal aspects and healthcare implications that underlie thinking about mpox (formerly known was monkeypox), in the 2022 outbreak, as a sexually transmitted infection (STI). The authors examine what underlies this question, exploring what is an STI, what is sex, and what is the role of stigma in sexual health promotion. The authors argue that, in this specific outbreak, mpox is an STI among men who have sex with men (MSM). The authors highlight the need of critically thinking about how to communicate effectively, the role of homophobia and other inequalities, and the importance of the social sciences.

Online socializing among men who have sex with men and transgender people in Nairobi and Johannesburg and implications for public health-related research and health promotion: an analysis of qualitative and respondent-driven sampling survey data.

INTRODUCTION: There is little published literature about gay, bisexual and other men who have sex with men and transgender individuals (MSM and TG)'s use of social media in sub-Saharan Africa, despite repressive social and/or criminalizing contexts that limit access to physical HIV prevention. We sought to describe MSM and TG's online socializing in Nairobi and Johannesburg, identifying the characteristics of those socializing online and those not, in order to inform the development of research and health promotion in online environments. METHODS: Respondent-driven sampling surveys were conducted in 2017 in Nairobi (n = 618) and Johannesburg (n = 301) with those reporting current male gender identity or male sex assigned at birth and sex with a man in the last 12 months. Online socializing patterns, sociodemographic, sexual behaviour and HIV-testing data were collected. We examined associations between social media use and sociodemographic characteristics and sexual behaviours among all, and only those HIV-uninfected, using logistic regression. Analyses were RDS-II weighted. Thirty qualitative interviews were conducted with MSM and TG in each city, which examined the broader context of and motivations for social media use. RESULTS: Most MSM and TG had used social media to socialize with MSM in the last month (60% Johannesburg, 71% Nairobi), mostly using generic platforms (e.g. Facebook), but also gay-specific (e.g. Grindr). HIV-uninfected MSM and TG reporting riskier recent sexual behaviours had raised odds of social media use in Nairobi, including receptive anal intercourse (adjusted OR = 2.15, p = 0.006), buying (aOR = 2.24, p = 0.015) and selling sex with men (aOR = 2.17, p = 0.004). Evidence for these associations was weaker in Johannesburg, though socializing online was associated with condomless anal intercourse (aOR = 3.67, p = 0.003) and active syphilis (aOR = 13.50, p = 0.016). Qualitative findings indicated that while online socializing can limit risk of harm inherent in face-to-face interactions, novel challenges were introduced, including context collapse and a fear of blackmail. CONCLUSIONS: Most MSM and TG in these cities socialize online regularly. Users reported HIV acquisition risk behaviours, yet this space is not fully utilized for sexual health promotion and research engagement. Effective, safe and acceptable means of using online channels to engage with MSM/TG that account for MSM and TG's strategies and concerns for managing online security should now be explored, as complements or alternatives to existing outreach.

What qualities in a potential HIV pre-exposure prophylaxis service are valued by black men who have sex with men in London? A qualitative acceptability study.

Black men who have sex with men (BMSM) have higher HIV incidence and prevalence when compared to other MSM, despite similar levels of condom use and testing. Pre-exposure prophylaxis (PrEP) could be a useful intervention to reduce these inequalities. This research therefore aims to understand the dimensions of acceptability of a potential PrEP service for BMSM aged 18-45 years in London. In-depth semi-structured interviews were conducted with 25 PrEP-eligible BMSM between April and August 2016. Interviews were recorded and transcribed verbatim, then subject to a thematic framework analysis, informed by intersectionality theory. BMSM had distinct preferences for sexual health services, which have implications for PrEP service development. Three primary domains emerged in our analysis: proximity and anonymity; quality, efficiency and reassurance; and understanding, empathy and identity. These relate, respectively, to preferences regarding clinic location and divisions from community, features of service delivery and staff characteristics. Due to concerns about confidentiality, community-based services may not be useful for this group. Careful consideration in regards to components used in service development will facilitate ongoing engagement. Interpersonal skills of staff are central to service acceptability, particularly when staff are perceived to be from similar cultural backgrounds as their patients.

DIY HIV prevention: Formative qualitative research with men who have sex with men who source PrEP outside of clinical trials.

Pre-exposure prophylaxis (PrEP) with antiretroviral medication is an effective, evidence-based option for HIV prevention. In England, issues of cost-effectiveness and of responsibility for commissioning prevention services have so far led National Health Service (NHS) England to decide not to commission PrEP. Given the significant lag between the awareness of PrEP efficacy and the opportunity to obtain PrEP through traditional health care routes, many gay and other men who have sex with men (MSM) have turned to 'DIY PrEP', purchasing generic formulations of PrEP for themselves on the internet or via other alternative routes. However, there is very little research on DIY PrEP practices and no qualitative study with DIY PrEP users in the UK. A formative qualitative study was conducted in 2017 to inform the development of an intervention (PrEP Club) to support DIY PrEP users and improve the safety and experience of this prevention strategy. Focus groups were held with 20 MSM who are based in London and are obtaining PrEP through means other than clinical trials, to explore their accounts of sourcing and using PrEP and the experiential meanings of these. In this article, we report findings from this first, formative study and present the different practices involved in finding out about PrEP, buying it and ascertaining legitimacy of sellers and products. We reflect on the uncertainties participants described related to actually using PrEP, including deciding on drug dosing and monitoring their health. Finally, we present the results of the discussions participants had about the kind of support they had received, the help they would have liked, and their views on proposed interventions to support DIY PrEP users, such as PrEP Club.

Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study.

BACKGROUND: PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. METHODS: Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. RESULTS: Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. CONCLUSION: The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.