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Objectives: SELPHI (HIV Self‐Testing Public Health Intervention) is the largest randomized controlled trial (RCT) of HIV self‐testing (HIVST) in a high‐income setting to date, and has recruited 10 000 men who have sex with men (cis‐ and transgender) and transgender women who have sex with men. This qualitative substudy aimed to explore how those utilizing self‐tests experience HIVST and the implications for further intervention development and scale‐up. This is the first qualitative study in Europe investigating experiences of HIVST among intervention users, and the first globally examining the experience of using blood‐based HIVST. Methods: Thirty‐seven cisgender MSM SELPHI participants from across England and Wales were purposively recruited to the substudy, in which semi‐structured interviews were used to explore testing history, HIVST experiences and intervention preferences. Interviews were audio‐recorded, transcribed and analysed through a framework analysis. Results: Men accessed the intervention because HIVST reduced barriers related to convenience, stigma and privacy concerns. Emotional responses had direct links to acceptability. Supportive intervention components increased engagement with testing and addressed supportive concerns. HIVST facilitated more frequent testing, with the potential to reduce sexually transmitted infection (STI) screening frequency. Substudy participants with an HIV‐positive result (n = 2) linked to care promptly and reported very high acceptability. Minor adverse outcomes (n = 2; relationship discord and fainting) did not reduce acceptability. Ease of use difficulties were with the lancet and the test processing stage. Conclusions: Intervention components shaped acceptability, particularly in relation to overcoming a perceived lack of support. The intervention was broadly acceptable and usable; participants expressed an unexpected degree of enthusiasm for HIVST, including those with HIV‐positive results and individuals with minor adverse outcomes. [ABSTRACT FROM AUTHOR]

Background: The risk of onwards HIV transmission is strongly influenced by the interval between HIV infection and its diagnosis. The SELPHI trial examined whether this interval could be reduced by offering free HIV self-testing kits to men-who-have-sex with-men (MSM)., Setting: Internet-based RCT of MSM aged ≥16 years, resident in England/Wales, recruited via sexual and social networking sites., Methods: The second-stage randomisation of SELPHI was open to participants who used an initial free HIV self-test kit, were HIV-seronegative, and reported recent condomless anal sex. They were randomised to receive a free HIV self-test kit every 3 months (repeat testing[RT] group) versus no such offer (nRT group). The primary outcome was time from randomisation to a confirmed HIV diagnosis, determined from linkage to national HIV surveillance databases. The key secondary outcome was the frequency of HIV testing regardless of test modality., Results: 2308 eligible participants (1161 RT,1147 nRT) were randomised between April-2017 and June-2018, and followed for 15-27 months. The proportion of participants reporting an HIV test in the previous 3 months was much higher in the RT group (86%) than in the nRT group (39%). Overall, 16 (9 RT,7 nRT) confirmed HIV diagnoses were observed (0.35/100 person-years), with no difference in the time to a confirmed HIV diagnosis (hazard ratio=1.27 [95% CI 0.47-3.41], P=0.63)., Conclusions: Providing regular free self-testing kits to sexually-active MSM was highly acceptable and markedly increased HIV testing. However, in this low incidence cohort it did not result in a demonstrably more rapid diagnosis of incident infections., Competing Interests: The authors report no conflicts of interest related to this work., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: HIV self-testing (HIVST) may facilitate marginalised populations' uptake of HIV testing, but whether the extent of marginalisation challenges individual uptake of HIVST remains under-researched. We aim to explore the perspectives of multiply marginalised cis-gender gay, bisexual and other men who have sex with men (GBMSM) and trans women on whether HIVST might increase their uptake of HIV testing., Methods: We reanalysed qualitative interview data from SELPHI (the UK's largest HIVST randomised trial) collected between 2017 and 2020 from marginalised populations, defined as people self-identifying as non-heterosexual, transgender, non-White ethnicity and/or with low educational attainment. Thirty-eight interviews with multiply marginalised individuals were thematically examined using the framework method. We specifically focussed on kit usability (a function of the interaction between blood-based HIVST kits and users), perspectives on how HIVST can improve access to HIV testing and suggestions on need-based scale-up of HIVST., Results: HIVST kits were considered usable and acceptable by multiply marginalised GBMSM and trans women. The majority of interviewees highlighted multi-levelled barriers to accessing HIV testing services due to structural and social marginalisation. Their multiply marginalised identities did not impede HIVST uptake but often form motivation to self-test. Three potential roles of HIVST in the HIV testing landscape were identified: (1) alternation of HIVST and facility-based testing, (2) integration of HIVST into sexual health services and (3) substituting facility-based testing with HIVST in the future. Perceived beneficiaries of HIVST included trans communities, individuals with undisclosed sexuality and people with physical disabilities., Discussion: HIVST can facilitate marginalised populations' access and uptake of HIV testing by alternating with, integrating into and substituting for facility-based services in the UK. Marginalised identities did not present challenges but rather opportunities for person-centred scale-up of HIVST. Future implementation programmes should ensure equitable access to HIVST among trans people, men unable to disclose their sexuality, and perhaps people with physical disabilities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Chu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Understanding how HIV self-testing (HIVST) can meet the testing needs of gay, bisexual and other men who have sex with men (GBMSM) and trans people whose social networks vary is key to upscaling HIVST implementation. We aim to develop a contextual understanding of social networks and HIV testing needs among GBMSM (cis and transgender) and trans women in SELPHI (An HIV Self-testing Public Health Intervention), the UK's largest randomised trial on HIVST., Methods: This study re-analysed qualitative interviews conducted from 2015 to 2020. Forty-three in-person interviews were thematically analysed using the Framework Method. Our analytic matrix inductively categorised participants based on the unmet needs for HIV testing and the extent of social network support. The role of social networks on HIVST behaviour was explored based on individuals' testing trajectories., Results: Four distinct groups were identified based on their unmet testing needs and perceived support from social networks. Optimisation advocates (people with high unmet needs and with high network support, n = 17) strived to tackle their remaining barriers to HIV testing through timely support and empowerment from social networks. Privacy seekers (people with high unmet needs and with low network support, n = 6) prioritised privacy because of perceived stigma. Opportunistic adopters (people with low unmet needs and with high network support, n = 16) appreciated social network support and acknowledged socially privileged lives. Resilient testers (people with low unmet needs and with low network support, n = 4) might hold potentially disproportionate confidence in managing HIV risks without sustainable coping strategies for potential seroconversion. Supportive social networks can facilitate users' uptake of HIVST by: (1) increasing awareness and positive attitudes towards HIVST, (2) facilitating users' initiation into HIVST with timely support and (3) affording participants an inclusive space to share and discuss testing strategies., Conclusions: Our proposed categorisation may facilitate the development of differentiated person-centred HIVST programmes. HIVST implementers should carefully consider individuals' unmet testing needs and perceived levels of social support, and design context-specific HIVST strategies that link people lacking supportive social networks to comprehensive HIV care., (© 2024. The Author(s).)

Background: In the Republic of Ireland, the COVID-19 crisis led to sexual health service closures while clinical staff were redeployed to the pandemic response. Gay, bisexual and other men who have sex with men (gbMSM) face pre-existing sexual health inequalities which may have been exacerbated. The aim of this study is to understand sexual health service accessibility for gbMSM in Ireland during the COVID-19 crisis., Methods: EMERGE recruited 980 gbMSM in Ireland (June-July 2021) to an anonymous online survey investigating well-being and service access through geo-location sexual networking apps (Grindr/Growlr), social media (Facebook/Instagram/Twitter) and collaborators. We fit multiple regression models reporting odds ratios (ORs) to understand how demographic and behavioural characteristics (age, sexual orientation, HIV testing history/status, region of residence, region of birth and education) were associated with ability to access services., Results: Of the respondents, 410 gbMSM accessed sexual health services with some or no difficulty and 176 attempted but were unable to access services during the COVID-19 crisis. A further 382 gbMSM did not attempt to access services and were excluded from this sample and analysis. Baseline: mean age 35.4 years, 88% gay, 83% previously tested for HIV, 69% Dublin-based, 71% born in Ireland and 74% with high level of education. In multiple regression, gbMSM aged 56+ years (aOR = 0.38, 95%CI:0.16, 0.88), not previously tested for HIV (aOR = 0.46, 95%CI:0.23, 0.93) and with medium and low education (aOR = 0.55 95%CI:0.35, 0.85) had lowest odds of successfully accessing services. GbMSM with HIV were most likely to be able to access services successfully (aOR = 2.68 95%CI:1.83, 6.08). Most disrupted services were: STI testing, HIV testing and PrEP., Conclusions: Service access difficulties were found to largely map onto pre-existing sexual health inequalities for gbMSM. Future service development efforts should prioritise (re)engaging older gbMSM, those who have not previously tested for HIV and those without high levels of education., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: TCW reports speaking honoraria from Gilead Sciences between 2018-2023. All other authors declare no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Shanley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: This qualitative sub-study aimed to explore how cisgender gay, bisexual, and other men who have sex with men (cis-GBMSM) and transgender people who reported non-consensual sex (NCS) accessed health care services, what barriers they faced, and how this experience influenced subsequent HIV testing., Methods: SELPHI is an online randomized controlled trial evaluating both acceptability and efficiency of HIV-self testing among cis-GBMSM and transgender people. Semi-structured interviews were conducted, audio-recorded, transcribed, and analysed through a framework analysis, as a qualitative sub-study. We identified narratives of NCS from interviews and investigated experiences of cis-GBMSM and transgender people accessing health care services following sexual assault., Results: Of 95 participants, 15 (16%) spontaneously reported NCS. Participants reported a broad range of NCS, including partner's coercive behaviours, non-consensual removal of condoms, and rapes. All feared HIV transmission, leading them to test for HIV, underlining a marked lack of awareness of post-exposure prophylaxis (PEP). Most had negative experiences in communicating with reception staff in sexual health clinics following these incidents. A lack of confidentiality and empathy was described in these situations of psychological distress. Clinic visits were primarily focused on testing for HIV and sexually transmitted infection, and generally no specific psychological support was offered. Getting a negative HIV result was a key step in regaining control for people who experienced NCS., Conclusions: Sexual health care providers should take care to more fully address the issue of NCS with cis-GBMSM and transgender people when it arises. Recognizing and managing the emotional impact of NCS on affected patients would prevent negative experiences and increase confidence in care., (© 2024 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

Background: Chemsex is the intentional combining of specific drugs with sex, primarily by gay, bisexual, and other men who have sex with men (GBMSM), to enhance intimacy, pleasure, and prolong sexual sessions. Practices vary across geographic and social settings. Participants report benefits and risks of chemsex. Studies have previously reviewed chemsex practices and harm reduction interventions separately. This review aims to examine both together by describing and understanding practices that men employ to navigate the perceived benefits and risks of chemsex., Methods: We conducted a systematic meta-ethnographic review of published qualitative literature, screening titles, abstracts, and full texts on defined inclusion and exclusion criteria. Using reciprocal and refutational translation techniques, we analysed study participants' (first-order) and researchers' (second-order) accounts of benefit-enhancing and risk-reducing chemsex practices. Finally, we employed line-of-argument synthesis techniques to develop our own higher-level interpretations (third-order constructs) of these chemsex practices., Results: Our search yielded 6356 records, from which, we included 23 articles in our review. Most studies were conducted in high-income Western countries. Across studies, participants acted at the individual, interpersonal, and community levels to enhance benefits and reduce risks, which made up our third-order constructs. Eight themes emerged from first- and second-order constructs to describe these practices, which included personal preparation, personal boundaries, biomedical measures, structured use of drugs, leaning on partners, injecting practices, group organising, watching out for others, and teaching and learning. Contextual factors like trust, agency, access, stigma, and setting moderated whether and how participants engaged in these practices, and if practices enhanced benefits or reduced risks., Conclusion: Health promotion programmes and research focused on chemsex must account for the benefits and the risks that GBMSM associate with this type of sexualised drug use and target the moderating factors that shape the practices they employ to navigate these benefits and risks., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Background: The 2022-2024 global mpox outbreak, occurring primarily in the sexual networks of gay, bisexual and other men who have sex with men (GBMSM), has not been accompanied by a focus on patient perspectives of illness. We explore the experiences of GBMSM diagnosed with mpox in England to understand needs for social and clinical support., Methods: In-depth interviews (March/July 2023) were conducted with 22 GBMSM diagnosed with mpox in 2022, randomly selected from a national mpox surveillance database, and 4 stakeholders from clinical/community-based organisations. Interviews covered experiences of illness, testing, diagnosis, treatment and contact tracing, and were recorded, transcribed and analysed with a thematic framework., Findings: Media coverage drawing on homophobic stereotypes around sex between men contributed to feelings of stigma and shame. GBMSM living with HIV appeared to cope better with mpox stigma, drawing on their experiences of being diagnosed with HIV for resilience. Younger GBMSM with less experience of stigmatising illness found mpox diagnosis more traumatic and sometimes required support beyond what was provided. Accessing testing could be complicated when healthcare professionals did not recognise mpox symptoms. Men felt information on course of illness, isolation and vaccination after recovery was often inconsistent and contradictory. GBMSM described that care from sexual health and infectious disease units usually better met their emotional and medical needs. This was frequently linked by men to these services having skills in working with the GBMSM community and managing infection risk sensitively. General hospital services and centralised contact tracing could increase feelings and experiences of stigma as some staff were perceived to lack skills in supporting GBMSM and, sometimes, clinical knowledge. Long-term impacts described by men included mental health challenges, urethral/rectal symptoms and life-changing disability., Interpretation: In this study stigma was a central feature of mpox illness among GBMSM and could be exacerbated or lessened depending on the clinical and social support provided. Involving communities affected by outbreaks in co-producing, planning and delivering care (including contact-tracing) may help improve support provided., Funding: TCW, AJR, AS and FMB received support from the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research Programme (Ref: NIHR202038). CS and JS receive support from the National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL in partnership with UKHSA; RV receives support from the NIHR HPRU in Emerging and Zoonotic Infections and NIHR HPRU in Gastrointestinal Infections. The views expressed are those of the author(s) and not necessarily those of the NIHR, UK Health Security Agency, World Health Organization or the Department of Health and Social Care., Competing Interests: TCW reports grant funding from the Wellcome Trust, NIHR and the European Union Horizon 2020. TCW and CS report honoraria for preparing educational materials from Gilead Sciences. CS reports honoraria for preparing education and presentation materials from ViiV healthcare., (© 2024 The Author(s).)

Background: The potential of HIV self-testing (HIVST) to cause harm is a concern hindering widespread implementation. The aim of this paper is to understand the relationship between HIVST and harm in SELPHI (An HIV Sel f-testing P ublic H ealth I ntervention), the largest randomised trial of HIVST in a high-income country to date., Methods: 10 111 cis and trans men who have sex with men (MSM) recruited online (geolocation social/sexual networking apps, social media), aged 16+, reporting previous anal intercourse and resident in England or Wales were first randomised 60/40 to baseline HIVST (baseline testing, BT) or not (no baseline testing, nBT) (randomisation A). BT participants reporting negative baseline test, sexual risk at 3 months and interest in further HIVST were randomised to three-monthly HIVST (repeat testing, RT) or not (no repeat testing, nRT) (randomisation B). All received an exit survey collecting data on harms (to relationships, well-being, false results or being pressured/persuaded to test). Nine participants reporting harm were interviewed in-depth about their experiences in an exploratory substudy; qualitative data were analysed narratively., Results: Baseline: predominantly cis MSM, 90% white, 88% gay, 47% university educated and 7% current/former pre-exposure prophylaxis (PrEP) users. Final survey response rate was: nBT=26% (1056/4062), BT=45% (1674/3741), nRT=41% (471/1147), RT=50% (581/1161).Harms were rare and reported by 4% (n=138/3691) in exit surveys, with an additional two false positive results captured in other study surveys. 1% reported harm to relationships and to well-being in BT, nRT and RT combined. In all arms combined, being pressured or persuaded to test was reported by 1% (n=54/3678) and false positive results in 0.7% (n=34/4665).Qualitative analysis revealed harms arose from the kit itself (technological harms), the intervention (intervention harms) or from the social context of the participant (socially emergent harms). Intervention and socially emergent harms did not reduce HIVST acceptability, whereas technological harms did., Discussion: HIVST harms were rare but strategies to link individuals experiencing harms with psychosocial support should be considered for HIVST scale-up., Trial Registration Number: ISRCTN20312003., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

The use of specific drugs (e.g. methamphetamine, GHB/GBL and other stimulants) to enhance sex among men who have sex with men (MSM), is the focus of global public health concern because of links to social harms, poor mental and sexual health. Often called 'chemsex' in Western settings or 'hi-fun' in Southeast Asia, this type of sexualised drug use is increasingly visible in Thailand where the unique sociocultural and legislative environments shape sexual cultures and harms. This study aimed to develop an understanding of key informants' perspectives on hi-fun contexts, harms and current responses in Bangkok. In-depth interviews were conducted with thirteen key informants from clinical, community, policy and development organisations. Four key informants had personal experience of hi-fun. Interviews covered hi-fun contexts, harms and support, were transcribed verbatim, translated to English (where necessary) and analysed using a thematic framework. MSM hi-fun 'influencers' shape norms and provide support online, primarily through Twitter. Hi-fun was linked to Westernisation and wealth; complex hierarchies emerged from asymmetries in social/financial capital. Police coercion towards MSM engaged in hi-fun was a concern. Given the nature of their funding, HIV/HCV/STI transmission was the most pressing focus for many organisations, however key informants were concerned especially about drug overdoses and mental health/well-being impacts. The political and economic context means funding for MSM health in Thailand focuses primarily on HIV prevention/treatment; restrictions on development aid constrain holistic hi-fun focused service development. Most hi-fun support was informally developed; successful strategies relied on partnership working and peer developed/delivered services, some of which were adapted from high-income settings. Despite substantial barriers, organisations developed services responding to the needs of MSM engaged in hi-fun. Given that many were informally developed or adapted from high-income settings, establishing a theoretical basis for further interventions that is grounded in this unique context is a priority., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Witzel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., (© 2022. The Author(s).)

Background: High levels of HIV testing in men who have sex with men remain key to reducing the incidence of HIV. We aimed to assess whether the offer of a single, free HIV self-testing kit led to increased HIV diagnoses with linkage to care., Methods: SELPHI was an internet-based, open-label, randomised controlled trial that recruited participants via sexual and social networking sites. Eligibility criteria included being a man or trans woman (although trans women are reported separately); being resident in England or Wales, UK; being aged 16 years or older; having had anal intercourse with a man; not having a positive HIV diagnosis; and being willing to provide name, email address, date of birth, and consent to link to national HIV databases. Participants were randomly allocated (3:2) by computer-generated number sequence to receive a free HIV self-test kit (BT group) or to not receive this free kit (nBT group). Online surveys collected data at baseline, 2 weeks after enrolment (BT group only), 3 months after enrolment, and at the end of the study. The primary outcome was confirmed (linked to care) new HIV diagnosis within 3 months of enrolment, analysed by intention to treat. Those assessing the primary outcome were masked to allocation. This study is registered with the ISRCTN Clinical Trials Register, number ISRCTN20312003., Findings: 10 111 participants (6049 in BT group and 4062 in nBT group) enrolled between Feb 16, 2017, and March 1, 2018. The median age of participants was 33 years (IQR 26-44 years); 9000 (89%) participants were White; 8118 (80%) participants were born in the UK; 81 (1%) participants were transgender men; 4706 (47%) participants were university educated; 1537 (15%) participants had never been tested for HIV; and 389 (4%) participants were taking pre-exposure prophylaxis. At enrolment, 7282 (72%) participants reported condomless anal sex with at least one male partner in the previous 3 months. In the BT group, of the 4511 participants for whom HIV testing information was available, 4263 (95%) reported having used the free HIV self-test kit within 3 months.Within 3 months of enrolment there were 19 confirmed new HIV diagnoses (0·31%) in 6049 participants in the BT group and 15 (0·37%) of 4062 in the nBT group (p=0·64)., Interpretation: The offer of a single, free HIV self-test did not lead to increased rates of new HIV diagnoses, which could reflect decreasing HIV incidence rates in the UK. Nonetheless, the offer of a free HIV self-testing kit resulted in high HIV testing rates, indicating that self-testing is an attractive testing option for a large group of men who have sex with men., Funding: UK National Institute for Health and Care Research., Competing Interests: Declaration of interests MB has received speaker's fees from Gilead and Bristol Myers Squibb. FB and TCW have received consultancy fees from Gilead. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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.

Background: HIV self-testing (HIVST) could play an important role in improving access to testing and therefore reducing inequalities related to late diagnosis of HIV, while also improving access to HIV prevention interventions such as HIV pre-exposure prophylaxis. This study sought to understand the potential role of HIVST by exploring the experiences of Asian, Black and Latin American men who have sex with men (MSM) accessing the gay scene and the circulation of HIV testing norms; experiences of accessing HIV testing services; HIVST acceptability and preferences for intervention adaptations., Methods: Twenty-nine qualitative interviews were conducted with Asian, Black and Latin American MSM who had participated in SELPHI, an HIVST randomised controlled trial. Topics included HIV testing history, HIV testing patterns, experiences of accessing sexual health services, mental health, engagement with HIVST and SELPHI, and experiences of the gay scene. Interviews were audio recorded, transcribed and then analysed using a thematic framework., Results: The gay scene was identified as an important site for learning about HIV and being exposed to norms reinforcing the importance of protective behaviours. However, experiences of discomfort due to perceptions of 'whiteness' on the scene or experiences of racism may hinder the protective function the scene could play in developing norms influencing HIV testing behaviour. Discomfort in clinic waiting rooms was identified as a substantial barrier to accessing clinical services and many interviewees expressed preferences regarding the personal characteristics of healthcare providers. HIVST was found to be acceptable and some interviewees suggested potential adaptations of the HIVST offer, such as packaging HIVST with at home sexually transmitted infections testing options., Conclusions: HIVST responds to some service access barriers experienced by Asian, Black and Latin American MSM. The decoupling of HIV testing and clinic attendance may be particularly valuable for MSM of minority ethnic backgrounds who are likely to experience anxiety and discomfort in clinic waiting rooms more acutely than White MSM due to concerns around implied disclosure. This suggests that HIVST may have the potential to increase testing uptake and frequency, particularly for those with complex relationships with clinical services., Trial Registration: SELPHI was prospectively registered with the ISRCTN (ref: ISRCTN 20312003 )., (© 2022. The Author(s).)

Background: Men who have sex with men experience disproportionately high levels of HIV and other sexually transmitted infections (STIs), sexual risk behavior, substance use, and mental ill-health. These experiences are interrelated, and these interrelations are potentiated by structural conditions of discrimination, stigma, and unequal access to appropriate health services, and they magnify each other and have intersecting causal pathways, worsening both risk for each condition and risk for the negative sequelae of each condition. eHealth interventions could address these issues simultaneously and thus have wide-ranging and greater effects than would be for any 1 outcome alone., Objective: We systematically reviewed the evidence for the effectiveness of eHealth interventions in addressing these outcomes separately or together., Methods: We searched 19 databases for randomized trials of interactive or noninteractive eHealth interventions delivered via mobile phone apps, internet, or other electronic media to populations consisting entirely or principally of men who have sex with men to prevent HIV, STIs, sexual risk behavior, alcohol and drug use, or common mental illnesses. We extracted data and appraised each study, estimated meta-analyses where possible by using random effects and robust variance estimation, and assessed the certainty of our findings (closeness of the estimated effect to the true effect) by using GRADE (Grading of Recommendations, Assessment, Development and Evaluations)., Results: We included 14 trials, of which 13 included active versus control comparisons; none reported mental health outcomes, and all drew from 12 months or less of follow-up postintervention. Findings for STIs drew on low numbers of studies and did not suggest consistent short-term (<3 months postintervention; d=0.17, 95% CI -0.18 to 0.52; I 2 =0%; 2 studies) or midterm (3-12 months postintervention, no meta-analysis, 1 study) evidence of effectiveness. Eight studies considering sexual risk behavior outcomes suggested a short-term, nonsignificant reduction (d=-0.14, 95% CI -0.30 to 0.03) with very low certainty, but 6 studies reporting midterm follow-ups suggested a significant impact on reducing sexual risk behavior (d=-0.12, 95% CI -0.19 to -0.05) with low certainty. Meta-analyses could not be undertaken for alcohol and drug use (2 heterogeneous studies) or for HIV infections (1 study for each of short-term or midterm follow-up), and alcohol outcomes alone were not captured in the included studies. Certainty was graded as low to very low for most outcomes, including all meta-analyses., Conclusions: To create a comprehensive eHealth intervention that targets multiple outcomes, intervention evaluations should seek to generalize both mechanisms and components that are successfully used to achieve change in 1 outcome over multiple outcomes. However, additional evaluations of interventions seeking to address outcomes other than sexual risk behavior are needed before development and evaluation of a joined-up intervention., (©GJ Melendez-Torres, Rebecca Meiksin, T Charles Witzel, Peter Weatherburn, Jane Falconer, Chris Bonell. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 06.04.2022.)

Background: We conducted a systematic review and network meta-analysis to identify which human immunodeficiency virus (HIV) self-testing (HIVST) distribution strategies are most effective., Methods: We abstracted data from randomized controlled trials and observational studies published between 4 June 2006 and 4 June 2019., Results: We included 33 studies, yielding 6 HIVST distribution strategies. All distribution strategies increased testing uptake compared to standard testing: in sub-Saharan Africa, partner HIVST distribution ranked highest (78% probability); in North America, Asia, and the Pacific regions, web-based distribution ranked highest (93% probability), and facility based distribution ranked second in all settings. Across HIVST distribution strategies HIV positivity and linkage was similar to standard testing., Conclusions: A range of HIVST distribution strategies are effective in increasing HIV testing. HIVST distribution by sexual partners, web-based distribution, as well as health facility distribution strategies should be considered for implementation to expand the reach of HIV testing services., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: We updated a 2017 systematic review and compared the effects of HIV self-testing (HIVST) to standard HIV testing services to understand effective service delivery models among the general population., Methods: We included randomized controlled trials (RCTs) comparing testing outcomes with HIVST to standard testing in the general population and published between January 1, 2006 and June 4, 2019. Random effects meta-analysis was conducted and pooled risk ratios (RRs) were reported. The certainty of evidence was determined using the GRADE methodology., Findings: We identified 14 eligible RCTs, 13 of which were conducted in sub-Saharan Africa. Support provided to self-testers ranged from no/basic support to one-on-one in-person support. HIVST increased testing uptake overall (RR:2.09; 95% confidence interval: 1.69-2.58; p  < 0.0001;13 RCTs; moderate certainty evidence) and by service delivery model including facility-based distribution, HIVST use at facilities, secondary distribution to partners, and community-based distribution. The number of persons diagnosed HIV-positive among those tested (RR:0.81, 0.45-1.47; p  = 0.50; 8 RCTs; moderate certainty evidence) and number linked to HIV care/treatment among those diagnosed (RR:0.95, 0.79-1.13; p  = 0.52; 6 RCTs; moderate certainty evidence) were similar between HIVST and standard testing. Reported harms/adverse events with HIVST were rare and appeared similar to standard testing (RR:2.52: 0.52-12.13; p  = 0.25; 4 RCTs; very low certainty evidence)., Interpretation: HIVST appears to be safe and effective among the general population in sub-Saharan Africa with a range of delivery models. It identified and linked additional people with HIV to care. These findings support the wider availability of HIVST to reach those who may not otherwise access testing., Competing Interests: Dr. Corbett reports grants from London School of Hygiene & Tropical Medicine, outside the submitted work. Dr. Geng reports a Viiv Healthcare research grant. Ms. Johnson reports grants from the Bill and Melinda Gates Foundation, Unitaid, and the United States Agency for International Development, during the conduct of the study; grants from the Bill and Melinda Gates Foundation, Unitaid, and the United States Agency for International Development outside the submitted work. Dr. Witzel, Dr. Rodger and Dr. Weatherburn report grants from the National Instituet of Health Research during the conduct of the study. All other authors have nothing to declare., (© 2021 The Authors.)

Background: Transgender, or trans, people experience a number of barriers to accessing gender-affirming healthcare and have a range of barriers and facilitators to primary care and specialist services, commonly citing discrimination and cisgenderism playing a central role in shaping accessibility. The pathway through primary care to specialist services is a particularly precarious time for trans people, and misinformation and poorly applied protocols can have a detrimental impact on wellbeing., Method: We recruited trans participants from an HIV Self-Testing Public Health Intervention (SELPHI) trial to interviews which explored contemporary gender-affirming service experiences, with an aim to examine the path from primary care services through to specialist gender services, in the UK., Results: A narrative synthesis of vignettes and thematic analysis of in-depth qualitative interviews were conducted with twenty trans individuals. We summarise positive and negative accounts of care under three broad categories: Experiences with primary care physicians, referrals to gender identity clinics (GICs), and experiences at GICs., Conclusions: We discuss implications of this research in terms of how to improve best practice for trans people attempting to access gender-affirming healthcare in the UK. Here we highlight the importance of GP's access to knowledge around pathways and protocols and clinical practice which treats trans patients holistically.

Background: Men who have sex with men (MSM) face disproportionate risks concerning HIV and other sexually transmitted infections, substance use, and mental health. These outcomes constitute an interacting syndemic among MSM; interventions addressing all 3 together could have multiplicative effects. eHealth interventions can be accessed privately, and evidence from general populations suggests these can effectively address all 3 health outcomes. However, it is unclear how useable, accessible, or acceptable eHealth interventions are for MSM and what factors affect this., Objective: We undertook a systematic review of eHealth interventions addressing sexual risk, substance use, and common mental illnesses among MSM and synthesized evidence from process evaluations., Methods: We searched 19 databases, 3 trials registers, OpenGrey, and Google, and supplemented this by reference checks and requests to experts. Eligible reports were those that discussed eHealth interventions offering ongoing support to MSM aiming to prevent sexual risk, substance use, anxiety or depression; and assessed how intervention delivery or receipt varied with characteristics of interventions, providers, participants, or context. Reviewers screened citations on titles, abstracts, and then full text. Reviewers assessed quality of eligible studies, and extracted data on intervention, study characteristics, and process evaluation findings. The analysis used thematic synthesis., Results: A total of 12 reports, addressing 10 studies of 8 interventions, were eligible for process synthesis. Most addressed sexual risk alone or with other outcomes. Studies were assessed as medium and high reliability (reflecting the trustworthiness of overall findings) but tended to lack depth and breadth in terms of the process issues explored. Intervention acceptability was enhanced by ease of use; privacy protection; use of diverse media; opportunities for self-reflection and to gain knowledge and skills; and content that was clear, interactive, tailored, reflective of MSM's experiences, and affirming of sexual-minority identity. Technical issues and interventions that were too long detracted from acceptability. Some evidence suggested that acceptability varied by race or ethnicity and educational level; findings on variation by socioeconomic status were mixed. No studies explored how intervention delivery or receipt varied by provider characteristics., Conclusions: Findings suggest that eHealth interventions targeting sexual risk, substance use, and mental health are acceptable for MSM across sociodemographic groups. We identified the factors shaping MSM's receipt of such interventions, highlighting the importance of tailored content reflecting MSM's experiences and of language affirming sexual-minority identities. Intervention developers can draw on these findings to increase the usability and acceptability of integrated eHealth interventions to address the syndemic of sexual risk, substance use, and mental ill health among MSM. Evaluators of these interventions can draw on our findings to plan evaluations that explore the factors shaping usability and acceptability., (©Rebecca Meiksin, G J Melendez-Torres, Jane Falconer, T Charles Witzel, Peter Weatherburn, Chris Bonell. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 23.04.2021.)

Background: Globally, trans people are disproportionately affected by HIV, but research on strategies to increase testing are limited. SELPHI is a randomised-controlled-trial (RCT) of 10,135 cis men, trans men, and trans women reporting lifetime anal intercourse with male partners ( cis or trans), evaluating whether the offer of free HIV self-testing (HIVST) increases diagnosis. This subgroup analysis from the SELPHI RCT aims to describe key HIVST outcomes and HIVST acceptability for trans people., Methods: SELPHI recruited using social networking and trans focused social media. Participants were randomised 60/40 to baseline HIVST (Biosure™) (BT) vs no baseline HIVST (nBT); and at 3-months (if completed the survey and reported recent CAI) 50/50 to 3-monthly HIVST (RT) vs no repeat HIVST (nRT). Outcomes were self-reported through online surveys. We conducted a qualitative study of semi-structured peer-led participant interviews ( n  = 20) exploring HIVST motivations and experiences. These were analysed using a framework approach., Findings: SELPHI recruited and randomised 118 trans men and trans women (94 trans men, 24 trans women), of whom 20 (16 trans men, 4 trans women) underwent the second randomisation. Median age at baseline was 29 (IQR: 22, 37), 79% were white, 79% were UK born, 37% had degree level education, and 31% had never tested for HIV. 62% ( n  = 59) of trans men completed the 3-month survey, but survey completion by trans women in nBT was too low (1/11) for randomised comparison. In trans men HIV testing uptake by 3 months was significantly higher in BT (95% 36/38) vs nBT (29%, 6/21) (RR=3.32 (1.68, 6.55) p <0.001). Trans people randomised to RT reported 3 times higher rate of HIV testing compared to nRT during the two-year follow-up (IRR 3.66 (1.86, 8.01) p <0.0001). STI testing frequency (mean number of tests during each 13 week period/ 2-year follow-up) was not significantly different across interventions: RT (0.03) and nRT (0.01) (IRR=1.86 95%CI; 0.77, 5.15; p  = 0.15). Social harms were rare. Acceptability was very high in BT: 97% (38/39) found instructions easy to understand, 97% (37/38) found the HIVST simple to use and 100% (39/39) reported good overall experience. In interviews, reported HIVST benefits included increased autonomy, privacy, convenience and avoidance of health care providers perceived to be discriminatory and services that increased dysphoria. Minor lancet and test processing issues were reported., Interpretation: HIVST significantly increased testing uptake and frequency in trans men and trans people overall, although recruitment and retention of trans women was low. HIVST acceptability was high and indicates easy access to this novel technology may increase HIV testing access for this key population., Competing Interests: Prof. Rodger reports grants from NIHR, during the conduct of the study; Prof. Phillips reports grants from NIHR, during the conduct of the study; Prof. Bonell reports grants from NIHR, during the conduct of the study; Dr. Burns reports grants from NIHR, during the conduct of the study; Prof. Dunn reports grants from NIHR, during the conduct of the study; Prof McCormack reports grants from NIHR, during the conduct of the study; Dr. Lampe reports grants from NIHR, during the conduct of the study; Prof. McCormack reports grants from NIHR, during the conduct of the study; Dr. Speakman reports grants from NIHR, during the conduct of the study; Dr. Witzel reports grants from NIHR, during the conduct of the study; Peter Weatherburn reports grants from NIHR, during the conduct of the study. All other authors report no conflicts of interest., (© 2021 The Authors.)

Background: Sexual risk, substance use, and mental ill health constitute a syndemic of co-occurring, mutually reinforcing epidemics amongst men who have sex with men (MSM). Developed since 1995, e-health interventions offer accessible, anonymous support and can be effective in addressing these outcomes, suggesting the potential value of developing e-health interventions that address these simultaneously amongst MSM. We conducted a systematic review of e-health interventions addressing one or more of these outcomes amongst MSM and in this paper describe the theories of change underpinning relevant interventions, what these offer and how they might complement each other., Methods: We identified eligible reports via expert requests, reference-checking and database and Google searches. Results were screened for reports published in 1995 or later; focused on MSM; reporting on e-health interventions providing ongoing support to prevent HIV/STIs, sexual risk behaviour, substance use, anxiety or depression; and describing intervention theories of change. Reviewers assessed report quality, extracted intervention and theory of change data, and developed a novel method of synthesis using diagrammatic representations of theories of change., Results: Thirty-three reports on 22 intervention theories of change were included, largely of low/medium-quality. Inductively grouping these theories according to their core constructs, we identified three distinct groupings of theorised pathways. In the largest, the 'cognitive/skills' grouping, interventions provide information and activities which are theorised to influence behaviour via motivation/intention and self-efficacy/perceived control. In the 'self-monitoring' grouping, interventions are theorised to trigger reflection, self-reward/critique and self-regulation. In the 'cognitive therapy' grouping, the theory of change is rooted in cognitive therapy techniques, aiming to reframe negative emotions to improve mental health., Conclusions: The synthesised theories of change provide a framework for developing e-health interventions that might holistically address syndemic health problems amongst MSM. Improving reporting on theories of change in primary studies of e-health interventions would enable a better understanding of how they are intended to work and the evidence supporting this. The novel diagrammatic method of theory of change synthesis used here could be used for future reviews where interventions are driven by existing well-defined behaviour and behaviour change theories., Systematic Review Registration: PROSPERO CRD42018110317.

Background: We update a previous systematic review to inform new World Health Organization HIV self-testing (HIVST) recommendations. We compared the effects of HIVST to standard HIV testing services to understand which service delivery models are effective for key populations., Methods: We did a systematic review of randomised controlled trials (RCTs) which compared HIVST to standard HIV testing in key populations, published from 1 January 2006 to 4 June 2019 in PubMed, Embase, Global Index Medicus, Social Policy and Practice, PsycINFO, Health Management Information Consortium, EBSCO CINAHL Plus, Cochrane Library and Web of Science. We extracted study characteristic and outcome data and conducted risk of bias assessments using the Cochrane ROB tool version 1. Random effects meta-analyses were conducted, and pooled effect estimates were assessed along with other evidence characteristics to determine the overall strength of the evidence using GRADE methodology., Results: After screening 5909 titles and abstracts, we identified 10 RCTs which reported on testing outcomes. These included 9679 participants, of whom 5486 were men who have sex with men (MSM), 72 were trans people and 4121 were female sex workers. Service delivery models included facility-based, online/mail and peer distribution. Support components were highly diverse and ranged from helplines to training and supervision. HIVST increased testing uptake by 1.45 times (RR=1.45 95% CI 1.20, 1.75). For MSM and small numbers of trans people, HIVST increased the mean number of HIV tests by 2.56 over follow-up (mean difference = 2.56; 95% CI 1.24, 3.88). There was no difference between HIVST and SoC in regard to positivity among tested overall (RR = 0.91; 95% CI 0.73, 1.15); in sensitivity analysis of positivity among randomised HIVST identified significantly more HIV infections among MSM and trans people (RR = 2.21; 95% CI 1.20, 4.08) and in online/mail distribution systems (RR = 2.21; 95% CI 1.14, 4.32). Yield of positive results in FSW was not significantly different between HIVST and SoC. HIVST reduced linkage to care by 17% compared to SoC overall (RR = 0.83; 95% CI 0.74, 0.92). Impacts on STI testing were mixed; two RCTs showed no decreases in STI testing while one showed significantly lower STI testing in the intervention arm. There were no negative impacts on condom use (RR = 0.95; 95% CI 0.83, 1.08), and social harm was very rare., Conclusions: HIVST is safe and increases testing uptake and frequency as well as yield of positive results for MSM and trans people without negative effects on linkage to HIV care, STI testing, condom use or social harm. Testing uptake was increased for FSW, yield of positive results were not and linkage to HIV care was worse. Strategies to improve linkage to care outcomes for both groups are crucial for effective roll-out.

Background: The PROUD trial, a HIV prevention trial in men who have sex with men and trans women, set out to involve community representatives and trial participants in several ways. PROUD also aimed to evaluate participant involvement, to learn lessons and make recommendations for future clinical trials., Methods: Two structured surveys, one of participant and community representatives involved in the PROUD study, and the other of researchers from the PROUD team, were carried out in 2017. The results from the surveys were reviewed quantitatively and qualitatively, and themes emerging from the data identified and synthesised., Results: Survey invitations were sent to 88 involved participants, 11 community representatives and 10 researchers. The overall response rate was 55% (60/109). Overall, participants were younger than community representatives, and the majority were from Greater London. As expected, participants were predominantly involved in participant involvement meetings and community representatives in management committees.Participants and community representatives cited different motivations for getting involved in PROUD. Overall, participants were positive about their involvement; only two participants rated their experience unfavourably. Community representatives were also broadly positive. Most participants and all community representatives felt their involvement made a difference to the trial, themselves and / or the organisations they represented. However, some participant answers reflected the impact of participation in the trial rather than involvement in PPI activities.Researchers felt that PPI had positive impact across the entire trial cycle. Half felt they would have liked there to have been more PPI activity in PROUD. Researchers noted some challenges and recommendations for the future, including need for adequate funding, more engagement in PPI by all researchers, the need for PPI expertise to facilitate involvement activities and training and mentoring in PPI., Conclusions: Involving clinical trial participants and wider community representatives as active partners in PPI is feasible and valuable in trials. Researchers are encouraged to consider and appropriately resource participant involvement and prospectively evaluate all PPI within their trials., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

SELPHI involves two interventions: (A) It provides one HIV self-testing (HIVST) kit; (B) It offers 3-monthly repeat HIVST kits if participants report ongoing risk. A logic model underpinned by the Behaviour Change Wheel informed the design of the intervention. SELPHI recruited 10,135 cis-men and trans people in England and Wales, all reporting anal sex with a man. This paper explores how the interventions were experienced and the pathways to impact for different groups of trial participants. In-depth interviews with 37 cis-men who have sex with men (MSM) were used to inductively categorise participants based on sexual and HIV testing histories. Themes relating to intervention experiences and impacts were mapped onto SELPHI-hypothesised intermediate outcomes to consider intervention impacts. Three groups were identified: 'Inexperienced testers' engaged with SELPHI to overcome motivational and social and physical opportunity testing barriers. For 'pro self-testers', testing frequency was constrained by psychological and social barriers and lack of opportunity. 'Opportunistic adopters' engaged in HIVST for novelty and convenience. Perceived impacts for inexperienced testers were most closely aligned with the logic model, but for opportunistic adopters there was little evidence of impact. Distinctive groups were discernible with divergent intervention experiences. Using COM-B as a model for understanding behaviour change in relation to HIVST, our results indicate how HIVST interventions could be adapted to respond to different needs based on the target population's demographic and behavioural features., Competing Interests: The authors declare no conflicts of interest.

Background: The SELPHI study (An HIV Self-Testing Public Health Intervention) is an online randomised controlled trial (RCT) of HIV self-testing (HIVST). The aim of this study was to assess the feasibility of recruiting UK men who have sex with men (cis and trans) and trans women who have sex with men to the SELPHI pilot, and the acceptability of the HIVST intervention used among those randomised to receive a kit., Methods: A mixed-methods approach to assessing trial feasibility and intervention acceptability was taken, using quantitative data from advertising sources and RCT surveys alongside qualitative data from a nested sub-study., Results: Online recruitment and intervention delivery was feasible. The recruitment strategy led to the registration of 1370 participants of whom 76% (1035) successfully enrolled and were randomised 60/40 to baseline testing vs no baseline testing. Advertising platforms performed variably. Reported HIVST kit use increased from 83% at two weeks to 96% at three months. Acceptability was very high across all quantitative measures. Participants described the instructions as easy to use, and the testing process as simple. The support structures in SELPHI were felt to be adequate. Described emotional responses to HIVST varied., Conclusions: Recruiting to a modest sized HIVST pilot RCT is feasible, and the recruitment, intervention and HIVST kit were acceptable. Research on support needs of individuals with reactive results is warranted.

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., Competing Interests: Competing interests: TCW has provided research methods training for HIV clinicians on an educational programme organised and paid for by Gilead Sciences., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: Among men who have sex with men (MSM) in the UK, an estimated 28% have never tested for HIV and only 27% of those at higher risk test at least every 6 months. HIV self-testing (HIVST), where the person takes their own blood/saliva sample and processes it themselves, offers the opportunity to remove many structural and social barriers to testing. Although several randomised controlled trials are assessing the impact of providing HIVST on rates of HIV testing, none are addressing whether this results in increased rates of HIV diagnoses that link to clinical care. Linking to care is the critical outcome because it is the only way to access antiretroviral treatment (ART). We describe here the design of a large, internet-based randomised controlled trial of HIVST, called SELPHI, which aims to inform this key question., Methods/design: The SELPHI study, which is ongoing is promoted via social networking website and app advertising, and aims to enroll HIV negative men, trans men and trans women, aged over 16 years, who are living in England and Wales. Apart from the physical delivery of the test kits, all trial processes, including recruitment, take place online. In a two-stage randomisation, participants are first randomised (3:2) to receive a free baseline HIVST or no free baseline HIVST. At 3 months, participants allocated to receive a baseline HIVST (and meeting further eligibility criteria) are subsequently randomised (1:1) to receive the offer of regular (every 3 months) free HIVST, with testing reminders, versus no such offer. The primary outcome from both randomisations is a laboratory-confirmed HIV diagnosis, ascertained via linkage to a national HIV surveillance database., Discussion: SELPHI will provide the first reliable evidence on whether offering free HIVST via the internet increases rates of confirmed HIV diagnoses and linkage to clinical care. The two randomisations reflect the dual objectives of detecting prevalent infections (possibly long-standing) and the more rapid diagnosis of incident HIV infections. It is anticipated that the results of SELPHI will inform future access to HIV self-testing provision in the UK., Trial Registration: DOI 10.1186/ISRCTN20312003 registered 24/10/2016.

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.

Background: Hepatitis C (HCV) diagnosis and care is a major challenge for people who use illicit drugs, and is characterised by low rates of testing and treatment engagement globally. New approaches to fostering engagement are needed. We explored the acceptability of remote forms of HCV testing including self-testing and self-sampling among people who use drugs in London, UK., Methods: A qualitative rapid assessment was undertaken with people who use drugs and stakeholders in London, UK. Focus groups were held with men who have sex with men engaged in drug use, people who currently inject drugs and people who formerly injected drugs (22 participants across the 3 focus groups). Stakeholders participated in semi-structured interviews (n = 5). We used a thematic analysis to report significant themes in participants' responses., Results: We report an overarching theme of 'tension' in how participants responded to the acceptability of remote testing. This tension is evident across four separate sub-themes we explore. First, choice and control, with some valuing the autonomy and privacy remote testing could support. Second, the ease of use of self testing linked to its immediate result and saliva sample was preferred over the delayed result from a self administered blood sample tested in a laboratory. Third, many respondents described the need to embed remote testing within a supportive care pathway. Fourth, were concerns over managing a positive result, and its different meanings, in isolation., Conclusions: The concept of remote HCV testing is acceptable to some people who use drugs in London, although tensions with lived experience of drug use and health system access limit its relevance. Future development of remote testing must respond to concerns raised in order for acceptable implementation to take place.

Background: HIV testing has seen a rapid evolution over the last decade with multiple modalities now in use globally. In recent years HIV self-testing (HIVST) has been legalised in the UK paving the way for further expansion of testing. Interventions are delivered in particular social contexts which shape uptake. It is therefore important to understand how novel interventions are likely to be received by their intended users. This study aims to understand how HIVST compliments existing testing strategies considered or adopted by men who have sex with men (MSM). We do this by analysing normative discourses surrounding HIV testing and their perceptions of HIVST's potential future roles., Methods: Six focus group discussions (FGDs) were conducted with 47 MSM in London, Manchester and Plymouth. One focus group included only MSM who reported higher risk behaviours and one with those who had never tested for HIV. Data were analysed through a thematic framework analysis., Results: Three main narratives for testing for HIV were identified: (i) testing in response to a specific risk event; (ii) as reassurance when there was a small amount of doubt or anxiety related to HIV; and (iii) in response to social norms perpetuated through peers, HIV community groups and the medical establishment to test regularly for HIV. HIVST had limited utility for men when testing in response to specific risk events except in the case of significant structural barriers to other testing opportunities. HIVST was considered to have utility when seeking reassurance, and was thought to be very useful when testing to satisfy the needs and expectations of others around regular testing. There was some ambivalence about the incursion of a clinical intervention into the home., Conclusions: HIVST following risk events will likely be limited to those for whom existing service provision is insufficient to meet immediate needs based on structural or personal barriers to testing. Obligations of biological citizenship are central to MSM's understanding of the utility of HIVST. In the context of discourses of biocitizenship, men perceive HIVST to have dual roles: firstly as a tool to manage (mild) anxiety around one's HIV status based on an acknowledgment of HIV vulnerability arising from being homosexually active. Secondly, HIVST is useful in complying with social norms and meeting the perceived demands of biomedicine.

Background: HIV self-testing (HIVST) is becoming popular with policy makers and commissioners globally, with a key aim of expanding access through reducing barriers to testing for individuals at risk of HIV infection. HIV self-sampling (HIVSS) was available previously to self-testing but was confined mainly to the USA and the UK. It remains to be seen whether the momentum behind HIVST will also energise efforts to expand HIVSS. Recent years have seen a rapid growth in the type of evidence related to these interventions as well as several systematic reviews. The vast majority of this evidence relates to acceptability as well as values and preferences, although new types of evidence are emerging. This systematic map aims to consolidate all emerging evidence related to HIVST and HIVSS to respond to this rapidly changing area., Methods: We will systematically search databases and the abstracts of five conferences from 2006 to the present date, with monthly-automated database searches. Searches will combine key terms relating to HIV (e.g. HIV, AIDS, human immune-deficiency syndrome) with terms related to self-testing (e.g. home-test, self-test, mail-test, home dried blood spot test). Abstracts will be reviewed against inclusion criteria in duplicate. Data will be manually extracted through a standard form and then entered to an open access relational map (HIVST.org). When new and sufficient evidence emerges which addresses existing knowledge gaps, we will complete a review on a relevant topic., Discussion: This innovative approach will allow rapid cataloguing, documenting and dissemination of new evidence and key findings as they emerge into the public domain., Systematic Review Registration: This protocol has not been registered with PROSPERO as they do not register systematic maps.

Introduction: HIV testing and counselling (HTC) interventions are key to controlling the HIV epidemic in East and Southern Africa where HTC is primarily delivered through voluntary counselling and testing (VCT), provider initiated testing and counselling (PITC), and home-based counselling and testing (HBVCT). Decision making processes around uptake of HTC models must be taken into account when designing new interventions. Counselling in HTC aims to reduce post-test risk taking behaviour and to link individuals to care but its efficacy is unclear. This meta-ethnography aims to understand the contexts of HTC uptake in East and Southern Africa and to analyse the perceived impacts of counselling-based interventions in relation to sexual behaviour and linkage to care., Methods: We conducted a systematic literature review of studies investigating HTC in East and Southern Africa from 2003 -April 2014. The search and additional snowballing identified 20 studies that fit our selection criteria. These studies were synthesised through a thematic framework analysis., Results: Twenty qualitative and mixed-methods studies examining impacts of HTC models in East and Southern Africa were meta-synthesised. VCT decisions were made individually while HBVCT decisions were located in family and community units. PITC was associated with coercion from healthcare providers. Low quality counselling components and multiple-intersecting barriers faced by individuals mean that counselling in HTC was not perceived to be effective in reducing post-test risk behaviour and had limited perceived effect in facilitating linkage to care., Conclusion: HBVCT is associated with minimal stigma and should be considered as an area of priority. Counselling components in HTC interventions were effective in transmitting information about HIV and sexual risk, but were perceived as ineffective in addressing the broader personal circumstances preventing sexual behaviour change and modulating access to care.

Purpose of Review: The purpose of this review is to describe the most recent literature on outcomes and issues associated with HIV self-testing (HIVST)., Recent Findings: HIVST is acceptable to a range of populations in a variety of contexts, particularly if users' values and preferences are taken into account in intervention development. Approaches being explored in ongoing and planned studies are the efficacy of HIVST to increase diagnosis of long-standing prevalent infections and to reduce the interval between HIV transmission and diagnosis, particularly in high-incidence groups. Though there is little evidence of harms related to HIVST, this remains a potential issue. Concerns remain about the reliability of currently available HIVST kits, which have lower sensitivity than testing options available in clinical settings, particularly in early HIV infection. Evidence on linkage to care for confirmatory testing after a reactive HIVST result and the cost-effectiveness of HIVST to increase rates of HIV diagnosis is currently limited., Summary: HIVST is a relatively new innovation that is acceptable to key populations and which could increase HIV testing rates and rates of HIV diagnosis, especially in at-risk groups. Concerns remain about test sensitivity (particularly in early infection), and linkages to care for confirmatory testing after a reactive HIVST.

Objectives: The British HIV Association's (BHIVA) testing guidelines recommend men who have sex with men (MSM) test annually or more frequently if ongoing risk is present. We identify which groups of MSM in England are less likely to have tested for HIV and their preferences for future tests by testing model, in order to inform health promotion programmes., Methods: Data come from the Gay Men's Sex Survey 2014, a cross-sectional survey of MSM, aged 16 years or older and living in the UK. Only men who did not have diagnosed HIV and were living in England were included in this analysis. We used logistic regression models to understand how social determinants of health were associated with not testing for HIV in the past 12 months, and never having tested. We then cross-tabulated preferred testing location by demographic characteristics., Results: Younger men, older men and men who were not gay identified were least likely to have tested for HIV. Higher educational attainment, migrancy, Black ethnicity and being at higher of risk were associated with greater levels of HIV testing. Men who were less likely to have tested for HIV preferred a wider range of options for future HIV testing., Conclusions: If the BHIVA's HIV testing policy of 2008 was used to guide testing priorities among MSM focus would be on increasing the rate of annual testing among MSM at less risk of HIV (ie, younger men, older men and non-gay identified MSM). Instead the promotion of more frequent testing among the groups most at risk of infection should be prioritised in order to reduce the time between infection and diagnosis., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Introduction: Innovative strategies, such as HIV self-testing (HIVST), could increase HIV testing rates and diagnosis. Evidence to inform the design of an HIVST intervention in the UK is scarce with very little European data on this topic. This study aims to understand values and preferences for HIVST interventions targeting MSM in the UK. We explore the acceptability of HIVST among MSM in the context of known barriers and facilitators to testing for HIV; assess preferences for, and the concerns about, HIVST., Methods: Six focus group discussions (FGD) were conducted with 47 MSM in London, Manchester and Plymouth. HIVST as a concept was discussed and participants were asked to construct their ideal HIVST intervention. OraQuickTM and BioSureTM kits were then demonstrated and participants commented on procedure, design and instructions. FGDs were recorded and transcribed verbatim, then analysed thematically., Results: Convenience and confidentiality of HIVST was seen to facilitate testing. Issues with domestic privacy problematised confidentiality. HIVST kits and instructions were thought to be unnecessarily complicated, and did not cater to the required range of abilities. The window period was the most important element of an HIVST, with strong preference for 4th generation testing. Kits which used a blood sample were more popular than those using saliva due to higher perceived accuracy although phobia of needles and/or blood meant some would only access HIVST if a saliva sample option was available. A range of access options was important to maintain convenience and privacy. HIVST kits were assumed to increase frequency of testing, with concerns related to the dislocation of HIVST from sexual health care pathways and services., Discussion: Utility of HIVST arises from relatively high levels of confidentiality and convenience. Until 4th generation assays are available HIVST will be seen as supplementary in a UK context., Competing Interests: The authors have declared that no competing interests exist.

Unlabelled: Background As efforts continue to increase rates of HIV testing and condom use among at-risk communities in England, organisations have sought use social media for health promotion interventions. As part of a wider evaluation of It Starts With Me (ISWM), a sexual health promotion intervention in England targeting gay and bisexual men and African people through Facebook, this study sought to explore how the online environment shapes end user engagement with sexual health interventions. A primary objective was to explore how privacy concerns can act as a barrier to engagement for the audience of ISWM., Methods: A purposive sample of 40 individuals were recruited, who were targeted by the intervention for in-depth interviews. Data collection was in two phases. In the first phase, individuals were sampled based on engagement with online health interventions in general, while in the second phase, all individuals were sampled on the basis of engagement with the intervention., Results: Privacy concerns related to the ecology of social networking sites, issues with implied disclosure and discrimination, as well as uncertainty over control of data. These concerns limited the organic reach of the intervention by confining the intervention to those who already held the norms diffused through it, and by discouraging participants from sharing and commenting on content., Conclusions: Care should be taken to address concerns when designing interventions delivered through social media. Gated interventions may be more beneficial for marginalised communities, while large-scale interventions such as ISWM may provide a useful backdrop for face-to-face interventions.