Psychological and Behavioural Within-participant Predictors of Adherence to Oral HIV Pre-Exposure Prophylaxis (PrEP).

Oral PrEP's effectiveness relies on adequate adherence during periods of substantial HIV risk. Since most PrEP users will miss doses, understanding predictors within participants can help to explain adherence. We used a cross-sectional, within-participant design with 67 gay, bisexual, and other men who have sex with men taking PrEP daily. Using a questionnaire, informed by the Information Motivation Behavioral Skills Model, participants were asked about an adherent and a non-adherent episode. PrEP non-adherence was associated with non-normality of the day (p < .001), being out of the home (p < .001), weekend days (p = .01), having company (p = .02), using substances (p = 0.02), not using reminders (p = .03), lower PrEP information (p = .04), lower behavioural skills (p < .001) and less positive affect (p = .002). PrEP adherence assessment could focus on situational variations, supporting the construction of alternative strategies to facilitate adherence in these situations.

Understanding the contexts in which female sex workers sell sex in Kampala, Uganda: a qualitative study.

BACKGROUND: Structural, interpersonal and individual level factors can present barriers for HIV prevention behaviour among people at high risk of HIV acquisition, including women who sell sex. In this paper we document the contexts in which women selling sex in Kampala meet and provide services to their clients. METHODS: We collected qualitative data using semi-structured interviews. Women were eligible to participate if they were 18 years or older, self-identified as sex workers or offered sex for money and spoke Luganda or English. Ten women who met clients in venues and outdoor locations were selected randomly from a clinic for women at high risk of HIV acquisition. Ten other women who met clients online were recruited using snowball sampling. Interviews included demographic data, and themes included reasons for joining and leaving sex work, work locations, nature of relationships with clients and peers, interaction with authorities, regulations on sex work, and reported stigma. We conducted interviews over three months. Data were analysed thematically using a framework analysis approach. The coding framework was based on structural factors identified from literature, but also modified inductively with themes arising from the interviews. RESULTS: Women met clients in physical and virtual spaces. Physical spaces included venues and outdoor locations, and virtual spaces were online platforms like social media applications and websites. Of the 20 women included, 12 used online platforms to meet clients. Generally, women from the clinic sample were less educated and predominantly unmarried, while those from the snowball sample had more education, had professional jobs, or were university students. Women from both samples reported experiences of stigma, violence from clients and authorities, and challenges accessing health care services due to the illegality of sex work. Even though all participants worked in settings where sex work was illegal and consequently endured harsh treatment, those from the snowball sample faced additional threats of cybersecurity attacks, extortion from clients, and high levels of violence from clients. CONCLUSIONS: To reduce risk of HIV acquisition among women who sell sex, researchers and implementers should consider these differences in contexts, challenges, and risks to design innovative interventions and programs that reach and include all women.

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.

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

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

Establishing the health and wellbeing needs of mining host community in Brazil, Chile and Peru: a mixed-method approach to identify priority areas for action to help communities meet their SDG3 targets.

BACKGROUND: The global mining industry is an important partner in advancing the 2030 Agenda for Sustainable Development. In 2018, Anglo American plc published their Sustainable Mining Plan, containing a goal for improving health and wellbeing aligned with the Sustainable Development Goal 3 (SDG3) targets. Having formed an independent multidisciplinary research consortium, we designed and implemented a mixed-methods approach to attain a deeper understanding of SDG3 priorities within the local context of communities hosting Anglo American mining operations located in Latin America. METHODS: In 2019, within the host communities of three mining operations in Chile, three in Brazil, and one in Peru, we conducted a qualitative study which included stakeholder workshops and key informant interviews. We also quantitatively appraised existing health data. Findings emerging from the qualitative and quantitative assessments were compared to identify health and wellbeing priority areas for action relevant to each community. RESULTS: Across the three countries, 120 people took part in workshops and 35 in interviews. In these workshops and interviews, non-communicable diseases (SDG3.4), harmful alcohol consumption (SDG3.5), and pollution, particularly air pollution (SDG3.9), were consistently identified as areas for priority action. There were similarities in the reporting of individual, interpersonal, community, societal, and structural factors underlying these priority areas across the different communities. The availability of quantitative data was generally good at the state level, becoming increasing sparse as we focused on smaller geographies. The priorities identified in the quantitative assessments generally aligned with those highlighted in the qualitative data. CONCLUSIONS: We highlight the importance of engaging with local populations to understand and address health needs. To address the priorities identified, intervention packages tailored to the specific needs of host communities, that tackle associated upstream societal level factors, are required. To facilitate this, appropriate monitoring systems and epidemiological investigations should be implemented to better understand the local context and quantify health issues. In the host communities, it is essential for the mining sector to be a key health partner in promoting integrated programmes that contribute to achieving the priority objectives and targets aligned with the SDG3 agenda.

Boys' perspectives on girls' marriage and school dropout: a qualitative study revisiting a structural intervention in Southern India.

Girls' education has for many decades been central to the global development agenda, due to its positive impact on girls' health and wellbeing. In this paper, the authors revisit boys' attitudes, behaviours and norms related to girls' education, following the Samata intervention to prevent girls' school dropouts in Northern-Karnataka, South India. Data were collected from 20 boys in intervention villages before and after the intervention, and analysis was undertaken using a thematic-framework approach. Findings suggest that while boys did hold some attitudes and beliefs that supported girls' education and delayed-marriage, these remained within the framework of gender-inequitable norms concerning girls' marriageability, respectability/family-honour. Participants criticised peers who sought to jeopardise girls' respectability by teasing and community gossip about girls-boys' communication in public. Boys who rejected prevailing norms of masculinity were subjected to gossip, ridicule and violence by the community. Boys' attitudes and beliefs supported girls' education but were conditional on the maintenance of gendered hierarchies at household and interpersonal levels. Social norms concerning girls' honour, respectability and the role of boys as protectors/aggressors appeared to influence boys' response to girls' school dropouts. Future interventions aiming to address girls' education and marriage must invest time and resources to ensure that intervention components targeting boys are relevant, appropriate and effective.

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

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

Health and wellbeing needs and priorities in mining host communities in South Africa: a mixed-methods approach for identifying key SDG3 targets.

BACKGROUND: The global mining industry has an opportunity to mobilize resources to advance progress against the Sustainable Development Goals (SDGs). In 2018, the Anglo-American Group outlined aspirations for mining host communities to meet the SDG3 health targets. To progress from aspiration to action we designed and implemented a mixed-methods approach to attain a deeper understanding of the health and wellbeing priorities within the local context of host communities of fifteen mines in South Africa. METHODS: To identify local needs and priorities relating to SDG3 targets in host communities, stakeholder workshops and key informant interviews were conducted between June and August 2019. A baseline assessment of health data, related to each of the SDG3 targets and indicators and to each host community location, was also conducted. Findings emerging from the qualitative and quantitative baseline assessments were compared to identify the extent to which health issues aligned and health and wellbeing priority areas for action. RESULTS: A total of 407 people participated in the workshops, and 85 key informants were interviewed. Quantitative data were available at sub-national level for seven of the nine SDG3 targets and eleven of the 21 indicators. Key priority areas for action identified through alignment of the qualitative and quantitative data were maternal mortality (SDG3.1), HIV (SDG3.3.1), tuberculosis (SDG3.3.2), substance abuse (SDG3.5), and road traffic accidents (SDG3.6) We found consistency in the individual, interpersonal, community, societal, and structural factors underlying these priority areas. At a structural level, poor access to quality healthcare was raised at every workshop as a key factor underlying the achievement of all SDG3 targets. Of the five priority areas identified, HIV, TB and substance abuse were found to overlap in the study communities in terms of risk, burden, and underlying factors. CONCLUSIONS: We demonstrate a mixed method approach for identifying local health needs and prioritised SDG3 targets in mining host communities. Consistency in reporting suggests the need for effective, efficient and feasible interventions to address five priority areas. Given the prominent economic role of the mining sector in South Africa, it can play a critical role in implementing programmatic activities that further progress towards achieving the SDG3 targets.

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 ).

Mental health challenges and perceived risks among female sex Workers in Nairobi, Kenya.

BACKGROUND: Female sex workers (FSWs) in Kenya are at an increased risk of violence, poverty, police arrest, and problematic alcohol and other substance use, all of which are linked to poor mental health and suicidal ideation. Despite the psychological stressors experienced by FSWs, there is no published qualitative methods research investigating their mental health experiences in Kenya. In this paper, we draw on data from in-depth interviews to examine FSWs' lifetime mental health experiences and perceived risk factors. METHODS: We used baseline in-depth interviews of the Maisha Fiti longitudinal study of FSWs in Nairobi. We randomly selected 40 FSWs from 1003 FSWs who attended a baseline behavioural-biological interview as part of the Maisha Fiti study. The interview guide was semi-structured, and participants were asked to detail their life stories, including narrating specific events such as entry into sex work, experiences of violence, mental health experiences, and use of alcohol and other substances. Interviews were recorded in Kiswahili/ English and transcribed in English. Data were coded and thematically analysed in Nvivo (v.12). RESULTS: Results indicated that the majority of participants understood 'mental health' as 'insanity', 'stress', 'depression', and 'suicide'; nevertheless, a number described mental health symptomatically, while a few believed that mental health problems were caused by witchcraft. Interestingly, poverty, low levels of education, poor job opportunities, a lack of family support, harmful gender norms, intimate partner violence and subsequent relationship breakdowns, and family bereavement all contributed to poor mental health and subsequent entry into sex work. In addition, the consequences of sex work such as sexual risks, and ongoing violence from police and clients, further exacerbated poor mental health. CONCLUSIONS: There is a need for both micro- and macro interventions to address poverty and violence against FSWs in Kenya, thereby reducing mental health problems. Addressing violence against women and girls may also reduce entry into sex work. Improving mental health literacy and providing mental health intervention services for 'at-risk' populations such as FSWs should enhance coping strategies and help-seeking efficacy.

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.

The dapivirine vaginal ring from the perspective of married men in Uganda.

Background: Men play a key role in influencing uptake of women's health products, such as female condoms and vaginal microbicides used for family planning and HIV prevention.Method: We explored men's perceptions of the dapivirine vaginal ring (DVR), a vaginal microbicide, in Kalungu District, rural south-western Uganda. In June/July 2018, we conducted in-depth interviews with 10 partners of women participating in the DREAM study, a phase 3B open-label extension trial of the DVR. Data were analysed thematically, drawing on the socio-ecological model theoretical framework.Results: Influencing factors such as individual and interpersonal characteristics, perception of HIV risk, lack of knowledge about the DVR, misconceptions, and product characteristics acting at different levels (individual, societal and organisational) affected men's knowledge, attitudes and perceptions towards the DVR, which in turn impacted on their willingness to allow their partners to use it. Above all, men wanted to be involved in the decision- making process about the use of the DVR. All the men were happy that there was a new HIV prevention option in the pipeline and were not concerned about the degree of effectiveness, saying it was better than nothing.Conclusion: The use of the DVR in an environment where men expect to make decisions about sex on behalf of women may affect its usage and success. Given this context, women may not always be able to independently choose to use it. If the DVR is approved and rolled out, increased sensitisation of men about it will be critical to ensure its uptake.

Chemsex-related drug use and its association with health outcomes in men who have sex with men: a cross-sectional analysis of Antidote clinic service data.

PURPOSE: Chemsex-related drug use (CDU) is an escalating public health issue among men who have sex with men (MSM), associated with significant physical, biomedical and psychosocial harm. Few interventions exist to help MSM engaging in chemsex and little data exist on which to build. This cross-sectional analysis, using data from Antidote, the UK's only lesbian, gay, bisexual, and transgender specialist drug service, aims to remedy this paucity of data. METHODS: Modified Poisson regression was used to assess associations between CDU and a range of health outcomes; CDU+ subanalysis disaggregated MSM by primary chemsex drug of concern; and HIV+ subanalysis investigated whether CDU was associated with self-reported treatment adherence, HIV seroconversion and other HIV-specific issues. FINDINGS: Compared with CDU- MSM, MSM presenting for CDU were more likely to be HIV+, current or previous injectors, to have used postexposure prophylaxis in the last year, and have had ≥6 sexual partners in the last 90 days, though less likely to be hazardous alcohol consumers or to have experienced previous suicidal ideation (all p<0.0005). CDU+ subanalysis revealed health outcome differences-those selecting mephedrone were less likely to be hepatitis C+, HIV+, current or previous injectors, or to have experienced previous suicidal ideation (all p<0.0005), whereas those selecting methamphetamine were more likely (all p<0.0005, except suicidal ideation p=0.009). IMPLICATIONS: This analysis shows MSM presenting for CDU are a heterogeneous high-risk population with unmet health needs. There is a need for standardised chemsex surveillance and for improved intersectorial working between sexual health and drug treatment services. Future research should investigate typological differences between MSM presenting for CDU. ORIGINALITY/VALUE: To date, this is the world's largest analysis of MSM seeking treatment for CDU. Further, the publication of 'real-world' service data is a valuable addition to the literature alongside surveys and recruited studies.

'I have the confidence to ask': thickening agency among adolescent girls in Karnataka, South India.

Gender norms serve to normalise gender inequalities and constrain girls' agency. This paper examines how girls' agency, along a continuum, is influenced by the interplay between constraining and enabling influences in the girls' environments. We analyse data from a qualitative study nested within a cluster randomised evaluation of Samata, a multi-layered programme supporting adolescent girls to stay in school and delay marriage in Karnataka, South India. Specifically, we compare agency among 22 girls from intervention communities and 9 girls in control communities using data from the final round of interviews in a qualitative cohort. Using the concept of 'thin' and 'thick' agency on a continuum, we identified shocks like mothers' death or illness, poverty stress, gender norms and poor school performance as thinning influences. Good school examination results; norms in support of education; established educational aspirations; supportive parents, siblings and teachers; and strategic government and Samata resources enabled thicker agency. The intervention programme's effect increased in parallel to the gradient from thin to thicker agency among girls in progressively supportive family contexts. Engagement with the programme was however selective; families adhering to harmful gender norms were not receptive to outreach. In line with diffusion theory, late adopters required additional peer encouragement to change norms.

Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India.

We evaluated the impact of Samata, a 3-year multilayered intervention among scheduled caste/scheduled tribe (SC/ST) adolescent girls in rural northern Karnataka, on family-level (parents or guardian) attitudes and direct and indirect norms related to child marriage and girl's education. Endline data from 1840 family members were used to assess the effect of Samata on attitudes and norms related to schooling and child marriage, while data from 4097 family members (including 2257 family members at baseline) were used to understand the shifts in attitudes and norms over the period 2014-2017. Overall, we found that the programme had little impact on family-level attitudes and norms. However, there were shifts in some attitudes, norms and perceived sanctions between baseline (when girls were aged 13-14 years) and endline (when girls were aged 15-16 years), with some becoming more progressive (e.g. direct norms related to child marriage) and others more restrictive (e.g. norms around girls completing secondary education and norms related to child marriage and educational drop-out, blaming girls for eve teasing and limiting girls' mobility so as to protect family honour). Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting. Norms hypothesised to be important for marriage and schooling outcomes were indeed associated with these outcomes, but the intervention was not able to significantly shift these norms. In part, this may have been due to the intervention focusing much of its initial efforts on working with girls alone rather than family members, the relevant reference group. Future interventions that seek to affect norms should conduct formative research to clarify the specific norms affecting the outcome(s) of interest; likewise, programme planners should ensure that all activities engage those most influential in enforcing the norm(s) from the beginning. ClinicalTrials.gov registration number: NCT01996241.

Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP: a secondary analysis of the PROUD trial.

OBJECTIVES: Pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention for men who have sex with men (MSM). However, uncertainty remains around the optimal eligibility criteria for PrEP, specifically whether there are subgroups at low risk of HIV for whom PrEP might not be warranted. METHODS: PROUD was an open-label waitlist trial design that randomised MSM attending participating sexual health centres in England to receive PrEP immediately (IMM) or after a deferral period of 1 year (DEF). This analysis is based on participants who were randomised to the deferred arm, when they did not have access to PrEP. HIV incidence was compared between subgroups defined by baseline characteristics. RESULTS: Overall, 21 participants acquired HIV infection over 239.3 person-years (PY) follow-up, yielding an incidence rate of 8.8/100 PY (95% CI 5.4 to 13.4). Two highly significant predictors for HIV acquisition were identified. Men with a self-reported diagnosis of syphilis, rectal chlamydia (CT) or rectal gonorrhoea (GC) in the previous 12 months had an incidence of 17.2/100 PY (95% CI 9.7 to 28.5); those reporting receptive anal intercourse without a condom (ncRAI) with two or more partners in the previous 3 months had an incidence of 13.6/100 PY (95% CI 7.9 to 21.7). The incidence rate among participants lacking both of these risk factors was 1.1/100 PY (1/87.6, 95% CI 0.03 to 6.4). CONCLUSIONS: The high HIV incidence in PROUD suggests that most participants appropriately judged their need for PrEP. Eligibility criteria for a PrEP programme can therefore be broad, as in the current guidelines. However, a recent history of syphilis or rectal CT/GC, or multiple ncRAI partners indicates a high imminent risk of HIV infection. MSM with any of these characteristics should be offered PrEP as a matter of urgency.

Alcohol Availability, Marketing, and Sexual Health Risk Amongst Urban and Rural Youth in South Africa.

South Africa has high rates of HIV prevalence and incidence and very high binge drinking rates amongst youth. GIS mapping of alcohol outlets and participatory research methods were used to explore and understand youth's perception of alcohol availability and marketing, and their associated risks for HIV and sexual violence. Twenty seven youth 18-24 years from an urban and rural area participated in the study. There was high density of alcohol outlets at both sites with 97% within 500 m radius to a school; 76% of outlets had alcohol advertising signage on the exterior. Youth reported that alcohol is easily accessible to them. Alcohol advertising and marketing are appealing and entice them to consume alcohol, including binge drinking. Young women reported exposure to unsafe and transactional sex, and sexual violence at alcohol outlets. Effective policies are needed to regulate alcohol availability and marketing to youth.

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

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

Pilot phase of an internet-based RCT of HIVST targeting MSM and transgender people in England and Wales: advertising strategies and acceptability of the intervention.

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

Intimate partner violence, depression, and sexual behaviour among gay, bisexual and other men who have sex with men in the PROUD trial.

BACKGROUND: Little is known about the prevalence and correlates of intimate partner violence (IPV) among gay, bisexual and other men who have sex with men (GBMSM) in the UK. The aim of this study was to investigate the prevalence of IPV, associations of socio-economic and psychosocial factors with IPV, and the association of IPV with depression and sexual behaviour, among GBMSM in the PROUD trial of pre-exposure prophylaxis (PrEP). METHODS: PROUD enrolled 544 HIV-negative participants in England from 2012 to 2014; participants were randomised to immediate or deferred PrEP. This analysis included 436 GBMSM who had IPV data at month-12 and/or 24. Prevalence of IPV victimization and perpetration (lifetime, and in the past year) was assessed at these time-points. Generalized estimating equations were used to investigate associations with IPV, using pooled data from both time-points. RESULTS: At month-12 (N = 410), 44.9% of men reported ever being a victim of IPV, 15.6% in the last year, and 19.5% reported ever perpetrating IPV, 7.8% in the last year. At month-24 (N = 333), the corresponding prevalence was 40.2 and 14.7% for lifetime and past year IPV victimization and 18.0 and 6.9% for lifetime and past year IPV perpetration. IPV prevalence did not differ by randomised arm. Men reporting internalized homophobia and sexualized drug use were more likely to report IPV. Lifetime and last year experience of IPV victimization and perpetration were strongly associated with depressive symptoms (PHQ-9 ≥ 10) (adjusted for socio-demographics: lifetime IPV victimization PR 2.57 [95% CI: 1.71, 3.86]; past year IPV victimization PR 2.93 [95% CI: 1.96, 4.40]; lifetime IPV perpetration PR 2.87 [95% CI: 1.91, 4.32]; past year IPV perpetration PR 3.47 [95% CI: 2.13, 5.64], p < 0.001 for all); IPV was not consistently associated with measures of condomless anal sex or high partner numbers. CONCLUSIONS: GBMSM at high-risk of HIV who are seeking/taking PrEP may experience a high burden of IPV, which may be linked to depression. Training on awareness of and enquiry for IPV among GBMSM in sexual health clinics is recommended. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02065986 . Registered 19 February 2014 (retrospectively registered).