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Abstract 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.

Background Rates of human immunodeficiency virus diagnoses in UnitedKingdom men who have sex with men were at a 10-year high in 2014; many recent infections indicated ongoing transmission. There was a need to increase testing rates, reduce late diagnosis and understand how to best allocate human immunodeficiency virus prevention resources. Objective We aimed to assess (1) the feasibility of human immunodeficiency virus self-testing among men who have sex with men, (2) whether the offer of free human immunodeficiency virus self-testing resulted in earlier diagnosis of human immunodeficiency virus in an online randomised controlled trial, (3) the cost-effectiveness of strategies for preventing human immunodeficiency virus in men who have sex with men, including free human immunodeficiency virus self-testing. Design We produced a systematic evidence map and conducted focus groups and interviews with men who have sex with men and relevant stakeholders to identify barriers and facilitators to human immunodeficiency virus self-testing. We conducted an internet-based randomised controlled trial (a human immunodeficiency virus Self-testing Public Health Intervention to assess whether free human immunodeficiency virus self-testingwith reminders results in earlier diagnosis of human immunodeficiency virus compared with standard of care. We evaluated the cost-effectiveness of human immunodeficiency virus prevention strategies in men who have sex with men in the UnitedKingdom using a simulation model. Data sources Databases included MEDLINE, EMBASE, Global Health, Social Policy and Practice, PsycInfo, Health Management Information Consortium, EBSCO CINAHL Plus, Cochrane Library and Web of Science. Review methods Searches combined key terms relating to human immunodeficiency virus with terms related to self-testing. Data were manually extracted through a standard form and then entered into an open-access relational map (HIVST.org). Setting Internet-based study conducted in England and Wales. Participants Participants were men (including trans men) and trans women aged ≥ 16 years old, resident in England or Wales, and not known to be human immunodeficiency virus-positive, who had ever had anal sex with a man. The qualitative work also included human immunodeficiency virus service providers and commissioners. Intervention At baseline participants were randomised (randomisation A) to the offer of a single, free baseline human immunodeficiency virus self-test versus no free human immunodeficiency virus self-test (no baseline test). At 3 months, eligible participants from the baseline test group were randomised (randomisation B) to regular offers of free human immunodeficiency virus self-testingevery 3 months for up to 24 months (regular test) versus no offer of free self-tests (no regular test). Main outcome measure The primary outcome for randomisation A was a confirmed new human immunodeficiency virus diagnosis within 3 months of randomisation (detection of prevalent infections, binary outcome). The primary outcome for randomisation B was the time from randomisation to a confirmed new human immunodeficiency virus diagnosis (detection of incident infections, time-to-event outcome). Results Focus groups (n = 47 men who have sex with men) and interviews (n = 18 key informants) showed that human immunodeficiency virus self-testing was a highly acceptable intervention for men who have sex with men, with potential to reduce barriers related to convenience, stigma and privacy. The Self-testing Public Health Intervention randomised controlled trial randomised 10,135 men whohave sex with menand trans women 3 : 2 to baseline test or no baseline test. There was no significant difference at 3 months in confirmed new human immunodeficiency virusdiagnoses [p = 0.64, 19/6049 (0.3%) in baseline test vs. 15/4062 (0.4%) in no beseline test], but human immunodeficiency virus testing rates were higher in baseline test. Following the second randomisation (n = 2308) to regular test versus no regular test there was no significant difference between groups in confirmed human immunodeficiency virus diagnoses although there was a substantial increase in testing rate in regular test versus no regular testwith no reduction in sexually transmitted infectiontesting. Modelling suggested that provision of oral tenofovir/emtricitabine pre-exposure prophylaxis increased human immunodeficiency virus testing, with anti-retroviral therapy initiation at diagnosis, and reductions in the level of condom-less sex, that each played an important role in decreasing human immunodeficiency virus incidence among men who have sex with men, and that the current human immunodeficiency virus incidence would have been double what it is if any one of them had not occurred. A combined substantial increase in human immunodeficiency virus testing and pre-exposure prophylaxis could avert 34% of infections. However, at the current cost-effectiveness threshold, a 16% reduction in the cost of delivery of testing and pre-exposure prophylaxis would be required for this scenario to offer value for money. Limitations The decline in human immunodeficiency virus incidence over the study period resulted in under-powering of the trial. However, we recruited a large number of men at risk of human immunodeficiency virus. A further limitation of the study is the low (but typical) completion rates of surveys, which may have introduced bias into the analysis of the secondary end points, although not the primary end point. Finally, the majority of the participants were white gay men, which may make our results less generalisable. Conclusions Human immunodeficiency virus self-testing is highly acceptable to men who have sex with men with potential to increase first and repeat human immunodeficiency virus testing and broaden testing options, particularly in among key sub-populations at risk of human immunodeficiency virus. The trial did not demonstrate that self-testing increased human immunodeficiency virus diagnoses linked to care, but was underpowered to do so. Future work Future research includes investigating the role of marginalisation based on ethnicity, migration status, sexual orientation and education in making testing decisions, and how social exclusion and health inequalities shape engagement with human immunodeficiency virus self-testing. Study registration This study is registered as ISRCTN20312003. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-1212-20006) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 8. See the NIHR Funding and Awards website for further award information. Plain language summary Background In 2014, new human immunodeficiency virus diagnoses among gay men in the UnitedKingdom were increasing year on year. New ways of testing for human immunodeficiency virus, such as self-testing (whereby a person can do the test themselves without a health worker there and then read the result within 15 minutes) had been developed, but it was not known whether offering self-testing would increase the number of new human immunodeficiency virus diagnoses in gay men. Methods We did an internet trial to see whether giving gay men a free human immunodeficiency virus self-testing kit would increase the number diagnosed with human immunodeficiency virus compared to not being given a free human immunodeficiency virus self-testing kit. We also looked at whether regular provision of human immunodeficiency virus self-testing kits every 3 months over a 2-year period would allow a more prompt diagnosis among those who got a new human immunodeficiency virus infection. Finally, we looked at value for money of providing free human immunodeficiency virus self-testing and other interventions including pre-exposure prophylaxis and early human immunodeficiency virus treatment (at the point of diagnosis), to prevent human immunodeficiency virus infection. Results The ease and privacy of human immunodeficiency virus self-testing meant that it was an acceptable way of testing for men who have sex with men. Over 10,000 men who have sex with menand trans people took part in the trial but there was no difference after 3 months in the number of gay men who were newly diagnosed with human immunodeficiency virus who had been provided with a free self-test kit compared to the group that had not. We found that a combination of human immunodeficiency virus-prevention interventions including an increase in human immunodeficiency virus testing, pre-exposure prophylaxis, early human immunodeficiency virus treatment at the point of diagnosis, and a reduction in the levels of condom-less sex each played an important role in decreasing human immunodeficiency virus incidence among men who have sex with men. Conclusions Human immunodeficiency virus self-testing was acceptable to men who have sex with men. Although human immunodeficiency virus self-testing increased how often men who have sex with men tested, it did not increase human immunodeficiency virus diagnosis. Scientific summary Background In 2014, the number of newly human immunodeficiency virus (HIV) diagnosed men who have sex with men (MSM) was at an all-time high and the 3000 new infections/year were a significant cost to the NHS, accruing £1 billion in future costs every year. Approximately 25% of all HIV-positive MSM were unaware of their infection and disproportionately contributed to onward transmission (between 60% and 80% of transmissions) and late presentations, with greatly increased risk of death. Uptake and frequency of HIV testing among MSM in 2014 was low. Innovative strategies, such as HIV self-testing (HIVST), which, due to associated confidentiality and convenience, could increase initial and repeat testing rates and diagnosis, had not been evaluated. It was also unclear whether other HIV prevention initiatives in addition to self-testing could offer value for money. In practice, assessing the cost-effectiveness of a range of prevention interventions required modelling. Aims and objectives Our aim was to assess the acceptability, effectiveness and cost-effectiveness of HIVST, and to examine the best economic value of a wider set of HIV prevention initiatives. Main research questions For MSM in the UK: Does provision of free HIVST result in the earlier diagnosis of HIV infection? Which HIV prevention initiatives are most cost-effective? Specific objectives Workstream 1: feasibility To identify the most up-to-date evidence of HIVST among MSM (systematic review and systematic mapping process). To increase understanding of accessibility and feasibility of HIVST among MSM and identify barriers and facilitators to HIVST in a range of models and contexts (focus groups and interviews). To explore how those utilising self‐tests experience HIVST and the implications for further intervention development and scale‐up. To explore how the HIV Self-testing Public Health Intervention (SELPHI) intervention might be experienced by and the pathways to impact on behaviour for different groups of randomised controlled trial (RCT) participants. To develop and undertake a process evaluation to assess what worked well about the RCT intervention and for whom. Workstream 2: intervention To assess whether free self-testing for HIV with reminders to test results in earlier diagnosis of HIV infection compared with standard of care through an internet-based, randomised trial (SELPHI). To explore testing pathways, practices, effects and perspectives on self-testing through qualitative interviews, including in key groups (Asian, black and Latin American MSM and trans people). Workstream 3: modelling and economic evaluation To estimate HIV incidence and predictors and describe risk behaviours in HIV-negative MSM at the time of HIV infection and after diagnosis through a web-based longitudinal cohort study to provide key parameters for the cost-effectiveness model. To identify efficacious existing HIV prevention strategies in MSM from high-income countries (systematic review). To estimate the cost of health care for people diagnosed with HIV living in England and Wales. To model the cost-effectiveness of HIV prevention strategies, including HIV testing interventions, using a simulation model to determine the cost-effectiveness (from an NHS perspective with outcomes as quality-adjusted life-years) of strategies for preventing HIV transmission, alone and in combination. Methods We divided the programme into three workstreams that were undertaken between 2015 and 2021. Workstream 1: feasibility Study 1A: we conducted a systematic mapping process from which the outputs were used to populate the HIV self-testing and research policy hub website HIVST.org. We collaborated with the World Health Organization (WHO) on four systematic reviews to provide the foundation for the updated WHO Global Guidelines on HIVST, which was launched in December 2019. Study 1B: we undertook six focus-group discussions (FGDs) with MSM to increase understanding of accessibility and feasibility of HIV self-testing among MSM and identify barriers and facilitators in a range of models and contexts to inform development of the intervention. Eighteen key informant interviews were conducted with service providers and commissioners to explore similar themes as the MSM FGD. Study 1C: development of manual and materials to promote and support the interventions in the RCT and RCT study website design. Study 1D: we undertook a process evaluation to examine the implementation of the planned intervention in the SELPHI RCT. The process evaluation explored the mechanisms of impact, and contextual factors that affect impact and potential normalisation of the intervention with the target population. Workstream 2: intervention Study 2A: building on the work from workstream (WS) 1 to inform the design of the trial and intervention, we undertook a RCTto assess whether offering free HIVST kits via the internet increased the rate of HIV diagnosis in MSM and trans people with linkage to clinical care. The trial aimed to enrol 10,000 HIV-negative participants, age > 16 years, resident in England or Wales, who were willing to provide name, date of birth and a valid e-mail address and who gave consent to linkage with surveillance and clinical databases. Online advertising was used to recruit men potentially interested in HIVST through the geo-location social-sexual networking applications (apps) (Grindr, Growlr, Scruff and Hornet) as well as targeted Facebook advertising. In a two-stage randomisation process, participants were first randomised (3 : 2) to receive a free baseline HIVST or no free baseline HIVST (randomisation A). At 3 months, participants allocated to receive a baseline HIVST were subsequently randomised (1 : 1) to receive the offer of regular (every 3 months) free HIVST, with testing reminders, versus no such offer (randomisation B) if they met further eligibility criteria. The primary outcome for randomisation A was a confirmed new HIV diagnosis within 3 months of randomisation (detection of prevalent infections, binary outcome). The primary outcome for randomisation B was the time from randomisation to a confirmed new HIV diagnosis (detection of incident infections, time-to-event outcome). The primary analyses compared the randomised groups as allocated (intention to treat). New HIV diagnoses were principally identified through linkage to national HIV surveillance databases maintained by the UK Health Security Agency (UKHSA). During the pilot phase, we conducted a mixed-methods study to assess trial feasibility and intervention acceptability using quantitative data from advertising sources and RCT surveys alongside qualitative data from a nested substudy. Study 2B: as part of the extensive qualitative work in WS2, we conducted a series of face-to-face and remote interviews with MSM and trans people participating in SELPHI (from both intervention arms) to examine experiences of those utilising HIVST and the implications for further intervention development and scale-up. We focused on interviewing specific groups of participants who may have unique experiences with HIVST, including trans people, and MSM from Asian, black and Latin American backgrounds and a small group of MSM who reported harm from the study. Workstream 3: modelling and economic evaluation Study 3A: we conducted a 3-year web-based longitudinal prospective cohort study in MSM, the Attitudes to and UnderstandingRisk of Acquisition of HIV (AURAH2) study, which used 4-monthly online questionnaires to collect information on HIV status, HIV testing history, recent sexual behaviour, health and lifestyle factors and sexually transmitted infection (STI) diagnoses from 2015 to 2018. We linked all AURAH2 study participants data to the national HIV surveillance database managed by UKHSA (previously called Public Health England till October 2021). Study 3B: to inform the cost-effectiveness modelling, we undertook a systematic review of HIV prevention strategies for MSM among high-income settings using published studies from 2012 up until 2021. The systematic review identified and described studies evaluating the efficacy or effectiveness of behavioural HIV-prevention interventions for reducing HIV incidence among MSM in high-income countries. Study 3C: to better understand the cost-effectiveness of preventing HIV infection, we estimated the healthcare costs of people diagnosed with HIV living in England and Wales using data from a large English HIV treatment centre’s electronic patient record system which was combined with National Reference Costs for England to estimate the frequency of hospital attendances (including inpatient episodes, day-case visits and outpatient visits) and costs. Study 3D: finally we developed an existing individual-based stochastic model that simulates the UK population of MSM from the start of the epidemic, tracking detailed levels of condom-less anal sex with long-term and casual partners and hence risk of HIV acquisition. The Synthesis model was calibrated using longitudinal patterns of condom-less sex, particularly around the time of HIV infection, changes in risk behaviour as a result of receiving a diagnosis of HIV in MSM, and the proportion of men likely to have been infected by a long-term partner, so that the cost-effectiveness of all relevant prevention activities could be estimated. Results Workstream 1: feasibility The systematic map consolidated all emerging evidence related to HIVST and populated HIVST.org by systematically searching databases and the abstracts of five conferences from 2006, with monthly automated database searches until June 2019. We conducted four systematic reviews using the results from the systematic map to identify eligible studies for each review. The main review was a meta-analysis of RCT data relating to key populations that compared the effects of HIVST with standard HIV testing. It demonstrated that HIVST was safe and increased testing uptake, frequency and yield of positive results for MSM and trans people without negative effects on linkage to HIV care, STI testing, condom use or social harm for MSM and trans people. The FGDs showed that HIVST was a widely acceptable intervention. MSM reported that HIVST reduced barriers related to convenience, stigma and privacy concerns and that HIVST facilitated more frequent testing, with the potential to reduce STI screening frequency. Interviews with key informants demonstrated the value of the increased choice that HIVST provides but highlighted the need to provide direct pathways into standard testing services and HIV care. Workstream 2: intervention An internet-based, open-label, randomised trial was developed informed by the feasibility work in WS1. The mixed-methods study evaluating the pilot phase of the RCT demonstrated that recruiting to the RCT was feasible, that the intervention was acceptable to participants and the kit had high reported usability. In total 10,111 men were randomized, 6049 to a free HIV self-test at baseline (BT), and 4062 to no baseline test (nBT). Results from randomisation A demonstrated that of those randomised to a free HIV self-test at baseline, 73.5% reported using the HIVST kit. There were 34 new HIV diagnoses across both arms of the study (19 in BT and 15 in nBT) and, of those newly diagnosed, a large proportion had not tested for HIV in the previous 12 months. There was no significant difference between arms at 3 months in confirmed new HIV diagnoses that had linked to care (the primary outcome of the trial). Participants randomised to BT were more likely to self-report testing for HIV in the 3 months after enrolment than nBT [BT 4368/4511 (97%) vs. nBT 670/1574 (43%)]. In randomisation B, 2308 men were randomised, 1161 to the offer of regular (3-monthly) HIVST [regular test(RT)] and 1147 to no regular HIVST offer (nRT). Men in RT were much more likely to HIV test in each 3-month period compared with men in nRT. As expected, survey completion rates decreased over time and ranged from 47% to 4%. However, there was no significant difference in confirmed HIV diagnoses between arms [RT 10/1161 (0.9%) vs. nRT 8/1147 (0.7%)]. There were also no statistical differences in STI testing, STI diagnoses, or reported CAI between the groups. HIVST facilitated more frequent testing, with the potential to reduce STI screening frequency. Our mixed-methods substudy which interviewed trans people, and also used trial data, demonstrated that HIVST increased testing uptake and frequency by three times compared with standard care. Trans people reported HIVST benefits included increased autonomy, privacy, convenience and the avoidance of healthcare providers perceived to be discriminatory and services that increased gender dysphoria. The study of Asian, black and Latin American MSM showed that these groups were often excluded from lesbian gay bisexual trans queer + social environments because of their ethnicity. This had a potential downstream impact constraining the development of testing norms drawn from community and society. In addition, MSM from ethnic minority backgrounds sometimes had difficulty accessing bricks-and-mortar sexual health services, which HIVST mitigated. The study of harms arising in the RCT found that these were very uncommon (reported by 1–2%). Harms were transient and most resolved without requiring intervention. Workstream 3: modelling and economic evaluation The AURAH2 study recruited 1167 MSM into the baseline study, of whom 622 joined the online component and were followed up over 3 years. In line with national data, the study demonstrated that there had been a substantial decline in HIV incidence among MSM over the study period and that factors associated with incident HIV were injecting drug use, chemsex and high-risk sexual behaviour. Results from the study also showed that pre-exposure prophylaxis (PrEP) awareness and use increased substantially over the study period. The systematic review of HIV prevention strategies among MSM in high-income countries identified 36 original papers, which were included in the review. Overall, PrEP was identified as the most effective intervention for reducing HIV incidence. The cost of caring for people with diagnosed HIV infection using routinely collected data in combination with information on national unit costs was estimated to be £522 per quarter, excluding the costs of antiretroviral treatment. Outpatient visits accounted for most of the hospital activity, and for total costs. A higher quarterly cost was associated with being a new patient and having a low cluster of differentiation 4 count category, followed by current viral non-suppression or previous virological failure. Results from the model-based economic evaluation showed that combination prevention, including a PrEP strategy, played a major role in the reduction in HIV incidence observed so far in the UK among MSM. Continuation of current activities may allow achievement of virtual HIV elimination among MSM in the UK and our modelling suggests they are likely to be cost-effective activities according to standard UK norms. Future steps Further work should aim to support the roll-out of HIVST at a national level to help address inequalities in access to HIV testing services that are experienced in particular by marginalised groups of MSM. Conclusion Human immunodeficiency virus self-testing is an acceptable and feasible HIV prevention tool for MSM and trans people. Although HIVST broadens the options for testing, and increases testing regularity, the trial results did not demonstrate that HIVST increased rates of HIV diagnosis. This likely reflects major national declines in HIV infections in MSM in the UK, which occurred after the study was planned and meant the study was not sufficiently powered to detect a difference. There were also no statistical differences in STI testing, STI diagnoses, or reported CAI between the groups. The cost-effectiveness evaluation found that strategies to increase the demand for HIV testing and condom and PrEP use are likely to substantially improve health outcomes. A reduction in the cost of delivery of HIV testing and PrEP is necessary in order to provide value for money. Trial registration This study is registered as ISRCTN20312003. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-1212-20006) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 8. See the NIHR Funding and Awards website for further award information.

Abstract Background Country level comparisons of HIV prevalence among men having sex with men (MSM) is challenging for a variety of reasons, including differences in the definition and measurement of the denominator group, recruitment strategies and the HIV detection methods. To assess their comparability, self-reported data on HIV diagnoses in a 2010 pan-European MSM internet survey (EMIS) were compared with pre-existing estimates of HIV prevalence in MSM from a variety of European countries. Methods The first pan-European survey of MSM recruited more than 180,000 men from 38 countries across Europe and included questions on the year and result of last HIV test. HIV prevalence as measured in EMIS was compared with national estimates of HIV prevalence based on studies using biological measurements or modelling approaches to explore the degree of agreement between different methods. Existing estimates were taken from Dublin Declaration Monitoring Reports or UNAIDS country fact sheets, and were verified by contacting the nominated contact points for HIV surveillance in EU/EEA countries. Results The EMIS self-reported measurements of HIV prevalence were strongly correlated with existing estimates based on biological measurement and modelling studies using surveillance data (R2=0.70 resp. 0.72). In most countries HIV positive MSM appeared disproportionately likely to participate in EMIS, and prevalences as measured in EMIS are approximately twice the estimates based on existing estimates. Conclusions Comparison of diagnosed HIV prevalence as measured in EMIS with pre-existing estimates based on biological measurements using varied sampling frames (e.g. Respondent Driven Sampling, Time and Location Sampling) demonstrates a high correlation and suggests similar selection biases from both types of studies. For comparison with modelled estimates the self-selection bias of the Internet survey with increased participation of men diagnosed with HIV has to be taken into account. For most countries self-reported EMIS prevalence is higher than measured prevalence, which is likely due to a combination of different time points of measurement, measurement errors for small sample sizes, different sampling methods, and an indicator-inherent overestimate of prevalence among the untested fraction of MSM.

Abstract Background A significant research literature exists that details the sexual health and sexual behaviour of gay and bisexual men who have diagnosed HIV. However, much of this research has focussed on HIV transmission risk behaviours among this group, rather than seeking to understand their sexual health and sexual well-being more broadly. There have been growing calls for interventions to support people with diagnosed HIV to achieve health and well-being, including sexual health and well-being. A detailed understanding of the problems people in this group face, and how they might be overcome, is required to facilitate such interventions. Methods One thousand two hundred and seventeen gay and bisexual men with diagnosed HIV were recruited by convenience sampling through charitable AIDS service organisations, genitourinary medicine clinics and local authority agencies to complete a survey of their health and social care needs. Respondents were asked to report any problems they had with regards to sex during the 12 months prior to survey completion. They were also asked to describe what support might help them to overcome any problems they experienced. Results Overall, 70.5% of the gay and bisexual men with diagnosed HIV completing the survey reported one or more problems with sex within the previous 12 months. Most commonly reported problems include loss of libido (44.0%, n=540), poor self-image or low self confidence (43.9%, n=534), worries about passing HIV to potential sexual partners (37.3%, n=454), and fears of rejection from sexual partners (34.7%, n=422). Responses varied according to age, time since diagnosis, and whether or not the respondent was currently taking anti-retroviral therapy. Qualitative analysis of data relating to what support might help men overcome problems with sex indicate a need for therapeutic support to increase self esteem and confidence, clarity on criminalisation of HIV transmission, the tackling of HIV related stigma and help to achieve a higher quality (as opposed to quantity) of sex. Conclusions The findings indicate a need for the maintenance and expansion of services to meet the significant needs of people with diagnosed HIV, especially as these intersect with their ability to negotiate sex that is satisfying.

Abstract 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 ).

Abstract Introduction The population of men‐who‐have‐sex‐with‐men (MSM) includes people who are on the masculine spectrum but were assigned female at birth (AFAB), that is trans MSM. This study aims to identify current circumstances regarding sexual happiness and safety among German trans MSM. To date, there is no health information about trans MSM in Germany, limiting the ability of MSM sexual health programmes to meet their needs. Methods Data were used from the European MSM Internet Survey (EMIS‐2017), where people identifying as men and/or trans men were recruited through dating apps for MSM, community websites and social media to participate in an online survey. We analysed parameters on sexual happiness and satisfaction with sexual safety among Germany‐based trans MSM and compared those to outcomes of MSM assigned male at birth (cis MSM) living in Germany using descriptive methods and logistic regression models adjusting for age. Results In total, 23,001 participants from Germany were included, of which 122 (0.5%) indicated to be AFAB (i.e. trans MSM). Trans MSM were markedly younger than cis participants (median age: 28.5 vs. 39 years). Trans MSM more often reported being unhappy with their current sex life (adjusted odds ratio [aOR] = 1.82, 95% CI 1.24–2.67), had higher odds of disagreeing with the statements “the sex I have is always as safe as I want” ([aOR] = 1.82, 95% CI 1.24–2.67) and “I find it easy to say no to sex that I don't want” ([aOR] = 1.80, 95% CI 1.18–2.77). Trans MSM were more likely to not be living comfortably financially ([aOR] = 2.43, 95% CI 1.60–3.67) and to be living with severe anxiety and/or depression ([aOR] = 3.90, 95% CI 2.22–6.83). Trans MSM were less likely to have ever tested for HIV ([aOR] = 0.63, 95% CI 0.43–0.93). Conclusions Sexual happiness, control of sexual boundaries, satisfaction with sexual safety, financial security, mental wellbeing and HIV testing were all lower in German trans MSM compared with cis MSM. Tailored sexual health interventions, contextualized with regard to needs and vulnerabilities, could address this inequality.

Abstract 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.

Abstract Background There has been an increase in the numbers of patients presenting to primary care with suspected colorectal malignancy and subsequently an increase in demand for endoscopy. This study aims to forecast the cost of faecal immunochemical testing (FIT) compared to conventional diagnostic tests as a primary investigation for patients with symptoms suggestive of colorectal malignancy. Methods Retrospectively, 1950 patients with symptoms suggestive of colorectal malignancy who were referred through primary care and underwent investigations through standard endoscopic evaluation were included. These patients were used to forecast the cost of faecal immunochemical testing creating theoretical data for sensitivity and specificity. Outcome measures included: the number of investigations under current protocol; cost of current investigations; number of predicted false negatives and false positives and positive/negative predictive values using current sensitivity data for FIT; the cost forecast of using FIT as the primary investigation for colorectal malignancy. Results Median age was 65 (IQR 47–82) with 43.7% male and 56.3% female. A total of 1950 investigations were carried out with a diagnostic yield of 26 cancers (18 colon, 8 rectal), 138 polyps and 29 high risk adenomas (HGD ± > 10 mm). In total, £713,948 was spent on the investigations. The commonest investigation was colonoscopy totalling £533,169. The total cost per cancer diagnosis was £27,459. Sensitivity (92.1% CI 86.9–95.3) and specificity (85.8% CI 78.3–90.1) for FIT in colorectal cancer was taken from NICE and was costed via the manufacturer(s). The projected total cost of FIT for the same population using a ≥ 4 μg haemoglobin cut off was £415,680 (£15,554 per cancer). The total cost of high-risk polyps using ≥ 4 μg cut off was £404,427 (sensitivity 71.2% CI 60.5–87.2, specificity 79.8%CI 76.1–83.7) or £13,945 per polyp. Conclusions FIT is a cheaper and effective alternative test with the potential to replace current expensive methods. The forecast is based on the limited data available for sensitivity/specificity in the current literature. FIT has now been commenced for symptomatic patients in the UK and therefore sensitivity may change in the future.

We use a sample of 78,160 cases involving adults who pleaded guilty to drunk driving in a New South Wales (NSW) court between 2014 and 2019 to assess the contribution of neighbourhood disadvantage to charge dismissal. Data are analysed using a multilevel random effects model with controls for magistrate identity and legal factors that must be considered by the magistrate when deciding whether to dismiss a PCA charge against an offender. Findings indicate that magistrates with a higher dismissal rate are more lenient towards individuals from advantaged or highly advantaged socio-economic neighbourhoods. Magistrates with a lower dismissal rate, are less lenient toward those from advantaged or highly advantaged socio-economic neighbourhoods. Neighbourhood disadvantage has a statistically significant effect on judicial willingness to dismiss a charge of drink driving and record no conviction. The effect is small but affects many people. [ABSTRACT FROM AUTHOR]

Abstract 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

Abstract 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.

BackgroundMen 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. ObjectiveWe systematically reviewed the evidence for the effectiveness of eHealth interventions in addressing these outcomes separately or together. MethodsWe 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). ResultsWe 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 (

Abstract Background Partner concurrency, (having sexual partnerships overlapping in time), especially when condoms are not used, can facilitate sexually transmitted infections (STI) transmission. In Britain, STI diagnoses rates and the reporting of concurrency are higher among black Caribbeans than other ethnic groups. We explored attitudes towards, drivers, characteristics, and contexts of concurrent partnerships, and their implications for STI risk among black Caribbeans in England. Methods Purposive sampling, by sex and age-groups, was used to recruit participants (overall n = 59) from five sexual health clinics and community settings in London and Birmingham, England. Audio-recorded four focus group discussions (n = 28 participants), and in-depth interviews (n = 31) were conducted (June 2014–December 2015). Transcribed data were thematically analysed using Framework Analysis. Results ‘Main plus’ and ‘non-main’ concurrency were identified in this population. Main plus concurrency involves an individual having a main partner with whom s/he has a “relationship” with, and the individual and/or their partner secretly or explicitly have other non-main partners. In contrast, non-main concurrency entails having multiple, non-committed partners overlapping in time, where concurrency is usually taken as a given, making disclosure to partners irrelevant. While main partnerships were usually long-term, non-main partnerships ranged in duration from a single event through to encounters lasting several months/years. Condomless sex was common with ex/long-term/married/cohabiting partners; whereas condoms were typically used with non-main partners. However, condom use declined with partnership duration and familiarity with partners. Awareness of partners’ concurrency facilitated condom use, STI-testing, and partner notification. While unresolved feelings, or sharing children with ex-partners, usually facilitated main plus concurrency; non-main concurrency was common among young, and single people. Gender norms, notions of masculinity, and sexual desires influenced concurrency. Black Caribbean popular music, social media, peer pressure, and relationship norms among black Caribbeans were also perceived to encourage concurrency, especially among men and young people. Conclusions Concurrency among black Caribbeans is shaped by a complex interaction between emotional/psychological, interpersonal, sociocultural, and structural factors. Concurrency type, its duration, and awareness influence sexual health choices, and thus STI risk in this population. Collecting these data during clinic consultations could facilitate offering partner notification methods tailored to concurrency type. Gender- and age-specific, culturally-sensitive interventions addressing STI risks associated with concurrency are needed.

Introduction Considerable evidence supports an association between poor impulse control (impulsivity) and violent crime. Furthermore, impulsivity and aggression has been associated with reduced levels of serotonergic activity in the brain. Selective serotonin reuptake inhibitors (SSRIs) are a class of anti­depressants that aim to regulate brain serotonin concentrations. Several small studies in psychiatric populations have administered SSRIs to impulsive­–aggressive individuals, resulting in reduced impulsivity, anger, aggression and depression. However, no clinical trial has been undertaken in a criminal justice population. This protocol describes the design and implementation of the first systematic study of the potential benefits of SSRIs in impulsive­­–violent offenders who are at high risk of reoffending.Methods and analysis A randomised, double-blinded, multicentre trial to test the clinical efficacy of an SSRI, sertraline hydrochloride, compared with placebo on recidivism and behavioural measures (including impulsivity, anger, aggression, depression and self-reported offending) over 12 months. 460 participants with histories of violence and screening positive for impulsivity are recruited at several local courts and correctional service offices in New South Wales, Australia.Ethics and dissemination Results will be submitted for publication in a peer-reviewed journal. Possible implications of the effectiveness of this pharmacological intervention include economic benefits of reducing prison costs and societal benefits of improving safety. This study has received ethical approval from the University of New South Wales, Aboriginal Health & Medical Research Council, Corrective Services NSW and the NSW Justice Health and Forensic Mental Health Network.Trial registration number ACTRN12613000442707.

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

This study examines the correlates of First Nations contact with the criminal justice system. Key risk factors include membership of the stolen generation, psychological distress, and having used illicit drugs and alcohol over the preceding 12 months. The latter increases the marginal risk of arrest by 14 percentage points. The strongest protective factors are completing school, having an income in the top four deciles, having a permanent home, being aged 51 or over and living in a remote area. Completing school is the strongest protective factor, reducing the risk of arrest by eight percentage points. Further research using a longitudinal dataset specifically designed to identify causal effects is required. [ABSTRACT FROM AUTHOR]

BackgroundMen 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. ObjectiveWe undertook a systematic review of eHealth interventions addressing sexual risk, substance use, and common mental illnesses among MSM and synthesized evidence from process evaluations. MethodsWe 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. ResultsA 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. ConclusionsFindings 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.

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