Understanding sexual health service access for gay, bisexual and other men who have sex with men in Ireland during the COVID-19 crisis: Findings from the EMERGE survey.

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.

Experiences of mpox illness and case management among cis and trans gay, bisexual and other men who have sex with men in England: a qualitative study.

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.

Exploring practices to enhance benefits and reduce risks of chemsex among gay, bisexual, and other men who have sex with men: A meta-ethnography.

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.

Experiences with health care services and HIV testing after sexual assault in cisgender gay, bisexual and other men who have sex with men and transgender people.

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.

Hi-fun among men who have sex with men in Bangkok: A scoping study exploring key informants' perspectives on hi-fun contexts, harms and support strategies.

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.

Understanding experiences of potential harm among MSM (cis and trans) using HIV self-testing in the SELPHI randomised controlled trial in England and Wales: a mixed-methods study.

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 Self-testing Public Health Intervention), 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.

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

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

Free HIV self-test for identification and linkage to care of previously undetected HIV infection in men who have sex with men in England and Wales (SELPHI): an open-label, internet-based, randomised controlled trial.

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.

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

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

Experiences of and attitudes towards HIV testing for Asian, Black and Latin American men who have sex with men (MSM) in the SELPHI (HIV Self-Testing Public Health Intervention) randomized controlled trial in England and Wales: implications for HIV self-testing.

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 ).

eHealth Interventions to Address HIV and Other Sexually Transmitted Infections, Sexual Risk Behavior, Substance Use, and Mental Ill-health in Men Who Have Sex With Men: Systematic Review and Meta-analysis.

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; I2=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.

A Systematic Review and Network Meta-analyses to Assess the Effectiveness of Human Immunodeficiency Virus (HIV) Self-testing Distribution Strategies.

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.

Examining the effects of HIV self-testing compared to standard HIV testing services in the general population: A systematic review and meta-analysis.

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.

Accessing and utilising gender-affirming healthcare in England and Wales: trans and non-binary people's accounts of navigating gender identity clinics.

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.

eHealth Interventions to Address Sexual Health, Substance Use, and Mental Health Among Men Who Have Sex With Men: Systematic Review and Synthesis of Process Evaluations.

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.

Impact and acceptability of HIV self-testing for trans men and trans women: A mixed-methods subgroup analysis of the SELPHI randomised controlled trial and process evaluation in England and Wales.

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.

Theories of change for e-health interventions targeting HIV/STIs and sexual risk, substance use and mental ill health amongst men who have sex with men: systematic review and synthesis.

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.

Comparing the effects of HIV self-testing to standard HIV testing for key populations: a systematic review and meta-analysis.

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.

"PROUD to have been involved": an evaluation of participant and community involvement in the PROUD HIV prevention trial.

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.

Exploring Mechanisms of Action: Using a Testing Typology to Understand Intervention Performance in an HIV Self-Testing RCT in England and Wales.

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.