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

This study investigated contraceptive use among women in rural KwaZulu-Natal, South Africa. Of 866 sexually active women not intending pregnancy and screened for a microbicide feasibility study, 466 (54%) reported currently using modern contraceptives: injectables (31%), condoms (12%), sterilization (6%) and pills (4%). Multivariable logistic regression analyses revealed statistically significantly higher odds of current contraceptive use among married vs. engaged/unmarried women (aOR 1.64), multiparous vs. nulliparous (aOR 4.45) and women who completed secondary education or above vs. primary or less (aOR 1.64). Significantly lower odds of use were observed among women aged 40+ vs. age 15-19 (aOR 0.38). Age, marital status, education level and parity were associated with different contraceptive method choices. Among 195 women followed longitudinally for 9 months, contraceptive use increased significantly from 56% to 70%, largely due to increased condom use (15% to 28%). Results highlight the importance of integrating family planning and HIV/STI prevention counseling and informing promotion of further contraceptive uptake among women not intending pregnancy. [ABSTRACT FROM AUTHOR]

Abstract Background A safe and effective vaginal microbicide could substantially reduce HIV acquisition for women. Consistent gel use is, however, of great importance to ensure continued protection against HIV infection, even with a safe and effective microbicide. We assessed the long-term correlates of consistent gel use in the MDP 301 clinical trial among HIV-negative women in sero-discordant couples in south-west Uganda. Methods HIV-negative women living with an HIV-infected partner were enrolled between 2005 and 2008, in a three-arm phase III microbicide trial and randomized to 2% PRO2000, 0.5% PRO2000 or placebo gel arms. Follow-up visits continued up to September 2009. The 2% arm was stopped early due to futility and the 229 women enrolled in this arm were excluded from this analysis. Data were analyzed on 544 women on the 0.5% and placebo arms who completed at least 52 weeks of follow-up, sero-converted or became pregnant before 52 weeks. Consistent gel use was defined as satisfying all of the following three conditions: (i) reported gel use at the last sex act for at least 92% of the 26 scheduled visits or at least 92% of the visits attended if fewer than 26; (ii) at least one used applicator returned for each visit for which gel use was reported at the last sex act; (iii) attended at least 13 visits (unless the woman sero-converted or became pregnant during follow-up). Logistic regression models were fitted to investigate factors associated with consistent gel use. Results Of the 544 women, 473 (86.9%) were followed for at least 52 weeks, 29 (5.3%) sero-converted and 42 (7.7%) became pregnant before their week 52 visit. Consistent gel use was reported by 67.8%. Women aged 25 to 34 years and those aged 35 years or older were both more than twice as likely to have reported consistently using gel compared to women aged 17 to 24 years. Living in a household with three or more rooms used for sleeping compared to one room was associated with a twofold increase in consistent gel use. Conclusion In rural Uganda younger women and women in houses with less space are likely to require additional support to achieve consistent microbicide gel use. Trial registration Protocol Number ISRCTN64716212

Background: Innovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies in macaques; we aimed to assess efficacy and safety of 2% and 0·5% PRO2000 gels against vaginal HIV-1 transmission in women in sub-Saharan Africa.Methods: Microbicides Development Programme 301 was a phase 3, randomised, double-blind, parallel-group trial, undertaken at 13 clinics in South Africa, Tanzania, Uganda, and Zambia. We randomly assigned sexually active women, aged 18 years or older (≥16 years in Tanzania and Uganda) without HIV-1 infection in a 1:1:1 ratio to 2% PRO2000, 0·5% PRO2000, or placebo gel groups for 52 weeks (up to 104 weeks in Uganda). Randomisation was done by computerised random number generator. Investigators and participants were masked to group assignment. The primary efficacy outcome was incidence of HIV-1 infection before week 52, which was censored for pregnancy and excluded participants without HIV-1 follow-up data or with HIV-1 infection at enrolment. HIV-1 status was established by rapid tests or ELISA at screening at 12 weeks, 24 weeks, 40 weeks, and 52 weeks, and confirmed in a central reference laboratory. The primary safety endpoint was an adverse event of grade 3 or worse. Use of 2% PRO2000 gel was discontinued on Feb 14, 2008, on the recommendation of the Independent Data Monitoring Committee because of low probability of benefit. This trial is registered at http://isrctn.org, number ISRCTN 64716212.Findings: We enrolled 9385 of 15 818 women screened. 2591 (95%) of 2734 participants enrolled to the 2% PRO2000 group, 3156 (95%) of 3326 in the 0·5% PRO2000 group, and 3112 (94%) of 3325 in the placebo group were included in the primary efficacy analysis. Mean reported gel use at last sex act was 89% (95% CI 86-91). HIV-1 incidence was much the same between groups at study end (incidence per 100 woman-years was 4·5 [95% CI 3·8-5·4] for 0·5% PRO2000 vs 4·3 [3·6-5·2] for placebo, hazard ratio 1·05 [0·82-1·34], p=0·71), and at discontinuation (4·7 [3·8-5·8] for 2% PRO2000 gel, 3·9 [3·0-4·9] for 0·5% PRO2000 gel, and 3·9 [3·1-5·0] for placebo gel). Incidence of the primary safety endpoint at study end was 4·6 per 100 woman-years (95% CI 3·9-5·4) in the 0·5% PRO2000 group and 3·9 (3·2-4·6) in the placebo group; and was 4·5 (3·7-5·5) in the 2% PRO2000 group at discontinuation.Interpretation: Although safe, 0·5% PRO2000 and 2% PRO2000 are not efficacious against vaginal HIV-1 transmission and are not indicated for this use.Funding: UK Department for International Development, UK Medical Research Council, European and Developing Countries Clinical Trials Partnership, International Partnership for Microbicides, and Endo Pharmaceuticals Solutions. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) is highly effective at reducing HIV acquisition. We aimed to estimate usage of oral-PrEP, and factors associated with adherence among female sex workers (FSWs) in Nairobi, Kenya, using a novel point-of-care urine tenofovir lateral flow assay (LFA). The Maisha Fiti study randomly selected FSWs from Sex Worker Outreach Program clinics in Nairobi. Data were collected from 1003 FSWs from June-October 2019, including surveys on self-reported oral-PrEP adherence. Adherence was also measured using the LFA for HIV-negative FSWs currently taking oral-PrEP. Informed by a social-ecological theoretical framework, we used hierarchical multivariable logistic regression models to estimate associations between individual, interpersonal/community, and structural/institutional-level factors and either self-reported or LFA-assessed adherence. Overall, 746 HIV-negative FSWs aged 18-40 participated in the study, of whom 180 (24.1%) self-reported currently taking oral-PrEP. Of these, 56 (31.1%) were adherent to oral-PrEP as measured by LFA. In the multivariable analyses, associations with currently taking oral-PrEP included having completed secondary education, high alcohol/substance use, feeling empowered to use PrEP, current intimate partner, no recent intimate partner violence, having support from sex worker organisations, experiencing sex work-related stigma, and seeking healthcare services despite stigma. Associations with oral-PrEP LFA-measured adherence measured included having only primary education, experience of childhood emotional violence, belonging to a higher wealth tertile, and being nulliparous. Oral-PrEP adherence, measured by self-report or objectively, is low among FSWs in Nairobi. Programs to improve oral-PrEP usage among FSWs should work to mitigate social and structural barriers and involve collaboration between FSWs, healthcare providers and policymakers., (© 2024. Crown.)

Violence, poor mental health, and harmful substance use are commonly experienced by female sex workers (FSWs) in sub-Saharan Africa, all of which are associated with increased HIV susceptibility. We aimed to investigate the associations between violence, poor mental health and harmful alcohol/substance use with hair cortisol concentration (HCC) levels as a potential biological pathway linking the experiences of these stressors and HIV vulnerability. We used the baseline data of the Maisha Fiti study of FSWs in Nairobi, Kenya. Participants reported recent violence, poor mental health, and harmful alcohol/substance use. Hair samples proximal to the scalp were collected to measure cortisol levels determined by ELISA. We analysed the data of 425 HIV-negative respondents who provided at least 2 cm of hair sample. The prevalence of recent violence was 89.3% (physical 54.6%; sexual 49.4%; emotional 77.0% and financial 66.5%), and 29.1% had been arrested due to sex work. 23.7% of participants reported moderate/severe depression, 11.6% moderate/severe anxiety, 13.5% PTSD and 10.8% recent suicidal thoughts and/or attempts. About half of the participants (48.8%) reported recent harmful alcohol and/or other substance use. In multivariable linear regression analyses, both physical and/or sexual violence (adjusted geometric mean ratio (aGMR) = 1.28; 95% CI 1.01-1.62) and harmful alcohol and/or other substance use (aGMR = 1.31; 95% CI 1.03-1.65) were positively and independently associated with increased HCC levels. Findings suggest a role of violence and substance use in elevated HCC levels, which could increase HIV risk due to cortisol-related T cell activation. However, longitudinal and mechanistic studies are needed to confirm this hypothesis., (© 2024. The Author(s).)

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

Background: 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., (© 2024. The Author(s).)

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.

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

Background: The World Health Organization (WHO) plays a crucial role in producing global guidelines. In response to previous criticism, WHO has made efforts to enhance the process of guideline development, aiming for greater systematicity and transparency. However, it remains unclear whether these changes have effectively addressed these earlier critiques. This paper examines the policy process employed by WHO to inform guideline recommendations, using the update of the WHO Consolidated HIV Testing Services (HTS) Guidelines as a case study., Methods: We observed guideline development meetings and conducted semi-structured interviews with key participants involved in the WHO guideline-making process. The interviews were recorded, transcribed, and analysed thematically. The data were deductively coded and analysed in line with the main themes from a published conceptual framework for context-based evidence-based decision making: introduction, interpretation, and application of evidence., Results: The HTS guideline update was characterized by an inclusive and transparent process, involving a wide range of stakeholders. However, it was noted that not all stakeholders could participate equally due to gaps in training and preparation, particularly regarding the complexity of the Grading Recommendations Assessment Development Evaluation (GRADE) framework. We also found that WHO does not set priorities for which or how many guidelines should be produced each year and does not systematically evaluate the implementation of their recommendations. Our interviews revealed disconnects in the evidence synthesis process, starting from the development of systematic review protocols. While GRADE prioritizes evidence from RCTs, the Guideline Development Group (GDG) heavily emphasized "other" GRADE domains for which little or no evidence was available from the systematic reviews. As a result, expert judgements and opinions played a role in making recommendations. Finally, the role of donors and their presence as observers during GDG meetings was not clearly defined., Conclusion: We found a need for a different approach to evidence synthesis due to the diverse range of global guidelines produced by WHO. Ideally, the evidence synthesis should be broad enough to capture evidence from different types of studies for all domains in the GRADE framework. Greater structure is required in formulating GDGs and clarifying the role of donors through the process., Competing Interests: HI is employed by Unitaid, a hosted partnership of the World Health Organization. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ingold, Gomez, Stuckler, Vassall and Gafos.)

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., (© 2023. The Author(s).)

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

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., (© 2023. The Author(s).)

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., (© 2023. The Author(s).)

Background and Objective: Although HIV prevention science has advanced over the last four decades, evidence suggests that prevention technologies do not always reach their full potential. Critical health economics evidence at appropriate decision-making junctures, particularly early in the development process, could help identify and address potential barriers to the eventual uptake of future HIV prevention products. This paper aims to identify key evidence gaps and propose health economics research priorities for the field of HIV non-surgical biomedical prevention., Methods: We used a mixed-methods approach with three distinct components: (i) three systematic literature reviews (costs and cost effectiveness, HIV transmission modelling and quantitative preference elicitation) to understand health economics evidence and gaps in the peer-reviewed literature; (ii) an online survey with researchers working in this field to capture gaps in yet-to-be published research (recently completed, ongoing and future); and (iii) a stakeholder meeting with key global and national players in HIV prevention, including experts in product development, health economics research and policy uptake, to uncover further gaps, as well as to elicit views on priorities and recommendations based on (i) and (ii)., Results: Gaps in the scope of available health economics evidence were identified. Little research has been carried out on certain key populations (e.g. transgender people and people who inject drugs) and other vulnerable groups (e.g. pregnant people and people who breastfeed). Research is also lacking on preferences of community actors who often influence or enable access to health services among priority populations. Oral pre-exposure prophylaxis, which has been rolled out in many settings, has been studied in depth. However, research on newer promising technologies, such as long-acting pre-exposure prophylaxis formulations, broadly neutralising antibodies and multipurpose prevention technologies, is lacking. Interventions focussing on reducing intravenous and vertical transmission are also understudied. A disproportionate amount of evidence on low- and middle-income countries comes from two countries (South Africa and Kenya); evidence from other countries in sub-Saharan Africa as well as other low- and middle-income countries is needed. Further, data are needed on non-facility-based service delivery modalities, integrated service delivery and ancillary services. Key methodological gaps were also identified. An emphasis on equity and representation of heterogeneous populations was lacking. Research rarely acknowledged the complex and dynamic use of prevention technologies over time. Greater efforts are needed to collect primary data, quantify uncertainty, systematically compare the full range of prevention options available, and validate pilot and modelling data once interventions are scaled up. Clarity on appropriate cost-effectiveness outcome measures and thresholds is also lacking. Lastly, research often fails to reflect policy-relevant questions and approaches., Conclusions: Despite a large body of health economics evidence on non-surgical biomedical HIV prevention technologies, important gaps in the scope of evidence and methodology remain. To ensure that high-quality research influences key decision-making junctures and facilitates the delivery of prevention products in a way that maximises impact, we make five broad recommendations related to: improved study design, an increased focus on service delivery, greater community and stakeholder engagement, the fostering of an active network of partners across sectors and an enhanced application of research., (© 2023. The Author(s).)

Due to its widespread use in the sex work industry, female sex workers (FSWs) in low- and middle-income countries (LMICs) are at high risk of harmful alcohol use and associated adverse health outcomes. Factors associated with harmful alcohol use include violence, mental health problems, drug use, sexual risk behaviors and HIV/STIs. To our knowledge, there has been no quantitative synthesis of FSW alcohol use data to date. This systematic review and meta-analysis aims to provide an estimate of the prevalence of harmful alcohol use among FSWs in LMICs and to examine associations with common health and social concerns. The review protocol was registered with PROSPERO, number CRD42021237438. We searched three electronic databases for peer-reviewed, quantitative studies from inception to 24th February 2021. Studies were selected for inclusion that reported any measure of prevalence or incidence of alcohol use among FSWs aged 18 or older from countries defined as LMIC in accordance with the World Bank income groups 2019. The following study designs were included: cross-sectional survey, case-control study, cohort study, case series analysis, or experimental study with baseline measures for alcohol use. Study quality was assessed with the Center for Evidence-Based Management (CEBMa) Critical Appraisal Tool. Pooled prevalence estimates were calculated for (i) any hazardous/harmful/dependent alcohol use, (ii) harmful/dependent alcohol use only, both overall and by region and (iii) daily alcohol use. Meta-analyses examined associations between harmful alcohol use and violence, condom use, HIV/STIs, mental health problems and other drug use. In total, 435 papers were identified. After screening, 99 papers reporting on 87 unique studies with 51,904 participants from 32 LMICs met the inclusion criteria. Study designs included cross-sectional (n = 89), cohort (n = 6) and experimental (n = 4). Overall, 5 scored as high quality, 79 studies scored as moderate and 15 scored as weak quality. Twenty-nine papers reporting on 22 unique studies used validated alcohol use tools including AUDIT, CAGE and WHO CIDI. The pooled prevalence of any hazardous/harmful/dependent alcohol use was 41% (95% CI: 31-51%), and of daily alcohol use was 26% (95% CI: 17-36%). There was variation in harmful alcohol use by global region (Sub-Saharan Africa: 38%; South Asia/Central Asia/ East Asia and Pacific: 47% and Latin America and the Caribbean:44%). Harmful alcohol use was significantly associated with inconsistent condom use (pooled unadjusted RR: 1.65; 95% CI: 1.01-2.67), STIs (pooled unadjusted OR: 1.29; 95% CI 1.15-1.46); and other drug use (pooled unadjusted OR of 2.44; 95% CI 1.24-4.80), but not with HIV, violence or mental health problems. We found a high prevalence of problem alcohol use and daily alcohol use among FSWs in LMICs. Harmful drinking was associated with important HIV risk factors such as inconsistent condom use, STIs and other drug use. Major limitations included heterogeneity in tools and cut-off scores to measure alcohol use and other common risk factors, and a paucity of longitudinal studies. There is an urgent need for tailored interventions for FSWs in LMICs that address alcohol use as well as the associated sex work risk environment., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Beksinska et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: To explore the structural and social co-factors that shape the early lives of women who enter sex work in Nairobi, Kenya., Design: Thematic analysis of qualitative data collected as part of the Maisha Fiti study among female sex workers (FSWs) in Nairobi., Participants and Measures: FSWs aged 18-45 years were randomly selected from seven Sex Workers Outreach Programme clinics in Nairobi and participated in baseline behavioural-biological surveys. Participants in this qualitative study were randomly selected from the Maisha Fiti study cohort and were interviewed between October 2019 and July 2020. Women described their lives from childhood, covering topics including sex work, violence and financial management., Results: 48 out of 1003 Maisha Fiti participants participated in the in-depth qualitative interviews. FSWs described how physical and sexual violence, poverty and incomplete education in their childhood and adolescence intertwined with early pregnancy, marriage, intimate partner violence and relationship breakdown in their adolescence and early adulthood. The data analysis found clear syndemic relationships between these risk factors, particularly childhood violence, poverty and incomplete education and highlighted pathways leading to financial desperation and caring for dependents, and subsequent entry into sex work. Women perceived sex work as risky and most would prefer alternative work if possible, but it provided them with some financial independence and agency., Conclusions: This is the first study in Kenya to qualitatively explore the early lives of sex workers from a syndemic perspective. This method identified the pivotal points of (1) leaving school early due to poverty or pregnancy, (2) breakdown of early intimate relationships and (3) women caring for dependents on their own. Complex, multi-component structural interventions before these points could help increase school retention, reduce teenage pregnancy, tackle violence, support young mothers and reduce entry into sex work and the risk that it entails by expanding livelihood options., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Intergenerational differences in inequitable gender attitudes may influence developmental outcomes, including education. In rural Karnataka, India, we examined the extent of intergenerational (adolescent girls [AGs] vs. older generation family members) dis/agreement to attitudes around gendered power inequities, including gender roles and violence against women (VAW). Unadjusted and adjusted logistic regression examined associations between intergenerational dis/agreement to attitude statements and AGs' future educational and career aspirations. Of 2,457 AGs, 90.9% had a matched family member (55% mothers). While traditional gender roles were promoted intergenerationally, more AGs supported VAW than family members. In adjusted models, discordant promotion of traditional gender roles and concordant disapproval of VAW were associated with greater aspirations. Results highlight the need for family-level programming promoting positive modeling of gender-equitable attitudes.

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., (© 2022. The Author(s).)

Background: Female sex workers (FSWs) are at high risk of mental health problems and suicide risk. Few longitudinal studies have examined risk factors for poor mental health among FSWs., Methods: Maisha Fiti is a longitudinal study among FSWs randomly selected from Sex Worker Outreach Programme clinics across Nairobi. Behavioural-biological survey data were collected at baseline ( n = 1003, June-December 2019), midline ( n = 366) (Jan-March 2020) and endline ( n = 877) (June 2020-Jan 2021). Women reporting mental health problems were offered counselling services. Multivariable mixed logistic regression models were used to examine factors associated with mental health problems and suicidal behaviours., Results: There was a decline in the proportion of women reporting any mental health problem (depression and/or anxiety and/or PTSD) (baseline: 29.9%, midline: 13.3%, endline: 11.8%). There was strong evidence that any mental health problem was associated with recent hunger (aOR 1.99; 95% CI 1.37-2.88) and recent violence from non-intimate partners (2.23; 95% CI 1.55-3.19). Recent suicidal behaviour prevalence was similar across survey rounds (baseline: 10.2%; midline: 10.2%; endline: 10.4%), and was associated with recent violence from non-intimate partners (aOR 1.96; 95% CI 1.31-2.95), recent hunger (aOR 1.69; 95% CI 1.15-2.47) and having an additional employment to sex work (aOR 1.50; 95% CI 1.00-2.23)., Conclusions: Our study found a decline in mental health problems but high levels of persistent suicidal behaviours among FSWs. Syndemic risk factors including food insecurity and violence were longitudinally associated with mental health problems and recent suicidal behaviours. There is a need for accessible mental health services for FSWs, alongside structural interventions addressing poverty and violence., (© The Author(s) 2022.)

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., (© 2022. The Author(s).)

This paper explores adolescent girls' and young women's (AGYW) aspirations, factors that influence aspirations, and how their aspirations inform their sexual decision-making and behaviour. This study employed a qualitative design involving six participatory focus group discussions and 17 in-depth interviews with AGYW in - and out-of-school. Fieldwork was undertaken in rural and urban Tanzania. Thematic analysis was conducted using NVIVO software. Aspirations of AGYW's were categorised as short and long-term. Short-term aspirations were associated with the social status derived from obtaining trendy items such as nice clothing, or smart phones. Long-term aspirations included completing secondary education, having a professional job, being respected, getting married and having children. Aspirations were influenced by aspects of the social context, such as peers and structural factors that dictated what was acceptable for respectable AGYW. AGYW lacked the independent capabilities to meet long-term aspirations such as completing education. In pursuit of their short - and long-term aspirations, AGYW engaged in higher risk sexual behaviours such as transactional sex, age-disparate sex and condomless sex. AGYW's aspirations were important in determining their sexual decision making. Interventions should capitalise on AGYW's aspirations when addressing their SRH risks by finding innovative ways of engaging them based on their circumstances and aspirations.

Background: Pre-exposure prophylaxis (PrEP) is the use of HIV antiretroviral medications to reduce the risk of HIV acquisition. PrEP is highly effective when used during periods of potential HIV exposure. Gay and bisexual men (GBM) who engage in unprotected chemsex (without condoms or PrEP) are at high-risk of acquiring HIV. Substance use has been shown to detrimentally impact on the effective use of HIV treatment among GBM living with HIV. This study aims to qualitatively explore PrEP uptake and adherence among GBM who engage in chemsex in the United Kingdom., Methods: Nineteen semi-structured in-depth telephone interviews were conducted with self-identifying HIV-negative GBM who reported recently engaging in chemsex and currently using or had recently used PrEP. We explored the ways in which chemsex influenced GBM's motivation to use, access to and effective use of PrEP. Interviews were audio recorded, transcribed, and coded using thematic analysis., Results: Most of the men identified as gay, were of white ethnicity and had a median age of 41. Eighteen men were still using PrEP at the time of the interview and most used daily dosing. The perception of being at high risk of HIV acquisition was a key factor influencing PrEP initiation and after initiation, continued to influence high levels of adherence which was reported by the majority of participants. The few individuals who reported sub-optimal adherence, explained that psychosocial stressors or periods of impaired mental health led to more frequent or intense chemsex sessions, which in turn contributed to occasional non-adherence. Most participants used a variety of strategies to help them adhere, which included restricting the amount or intensity of chemsex they engaged in, strategic placement of PrEP and external triggers to remind them to take PrEP., Conclusions: In this study, the majority of GBM who engaged in chemsex, initiated PrEP in recognition of their potential risk of HIV acquisition and reported high levels of PrEP adherence. They used multiple strategies to support effective PrEP access and adherence. These findings support a growing body of evidence that PrEP is a viable prevention tool for GBM who engage in chemsex, and that chemsex does not negatively impact PrEP adherence., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

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

Background: 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., (© 2021. The Author(s).)

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

Background : Men 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.

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

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.

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.

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

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

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

Objectives: The aim of this analysis is to: (i) assess the prevalence of clinically significant depressive symptoms at baseline and follow-up for participants in the PROUD trial of HIV pre-exposure prophylaxis (PrEP), examining changes in prevalence over time and (ii) investigate the association of socioeconomic and psychosocial factors with depression., Methods: PROUD was an open label randomised trial evaluating the benefit of PrEP for 544 HIV-negative gay, bisexual and other men who have sex with men (GBMSM) in England. Enrolment was between 2012 and 2014, with at least 2 years follow-up. Prevalence of depression (score ≥10 on Patient Health Questionnaire-9) was assessed and compared across time-points (using McNemar's χ 2 tests) and between trial arms (using χ 2 tests). Cross-sectional associations with socioeconomic and psychosocial factors were examined using baseline data in modified Poisson regression models and combined 12 and 24 month follow-up data in generalised estimating equations (GEEs). Prevalence ratios (PRs) were presented as unadjusted PR and adjusted PR (aPR) for age, UK birth, sexual identity, university education, London study clinic site and calendar time (and follow-up time-point in GEEs)., Results: Depression increased significantly from baseline (9.1%; 49/540) to the 12 month (14.4%; 59/410) and 24 month (14.4%; 48/333) follow-ups, possibly explained by underreporting at baseline. The prevalence of depression did not differ by study trial arm, at any time-point. In the baseline analysis, younger age, unemployment and crystal methamphetamine use, was associated with depression. In combined analysis of 12 and 24 month data, measures of intimate partner violence (IPV) (lifetime IPV victimisation aPR 2.57 (95% CI: 1.71 to 3.86)), internalised homophobia (aPR 1.91 (95% CI: 1.29 to 2.83)) and concealment of sexual identity (aPR 1.75 (95% CI: 1.16 to 2.65)), were strongly associated with depression., Conclusions: There is a high concomitant burden of psychosocial factors with depression among GBMSM., Trial Registration Number: ISRCTN (ISRCTN94465371) and ClinicalTrials.gov (NCT02065986)., Competing Interests: Competing interests: The PROUD study was provided drug free of charge by Gilead Sciences plc which also distributed it to participating clinics and provided funds for additional diagnostic tests for HCV and drug levels. AP has received payments for presentations made at meetings sponsored by Gilead in spring 2015. EW has had tuition fees and a stipend paid by Gilead. AC received advisory board fees from Gilead Sciences plc and GSK/ViiV; speaker fees from Gilead and conferences bursaries from Gilead & Janssen. SM reports grants from the European Union H2020 scheme, EDCTP 2, the National Institute of Health Research and Gilead Sciences; other support from Gilead Sciences, and the Population Council Microbicide Advisory Board and is Chair of the Project Advisory Committee for USAID grant awarded to CONRAD to develop tenofovir-based products for use by women (non-financial)., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)