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Sexual consent is a growing topic in public and legal debates, but often overlooks sexual subcultures among gay, bisexual and other men who have sex with men (GBM). As part of the Flux study, we studied unwanted sexual encounters among a cohort of GBM in Australia. Launched in 2014, Flux was a prospective observational study exploring health-related behaviours among GBM in Australia. In 2021, specific survey items were introduced to examine unwanted sexual encounters in the past 3 months. Binary logistic regression analysis on 967 surveys collected between June 2021 and June 2022 found that 12.2% reported at least one experience of unwanted sex in the previous three months and 39.8% reported it occurring with an anonymous partner. Most events (64.0%) occurred at their home, while 24.7% were at a sex-on-premises venue. Compared to individuals who did not report any unwanted sexual encounters, those who reported such experiences had higher pre-encounter scores on measures of anxiety (OR:1.13;95%CI:1.09-1.18) and depression (OR:1.09;95%CI:1.06-1.13). After unwanted encounters, those individuals had higher scores on measures of anxiety (OR:1.13;95%CI:1.09-1.18) and depression (OR:1.10;95%CI:1.06-1.14). We conclude that sexual consent education that specifically targets GBM is essential to mitigate the risks of unwanted sexual encounters, and that educational campaigns should consider the unique sexual subcultures within the GBM community.

Successful use of biomedical forms of HIV risk-reduction may have predisposed many gay and bisexual men (GBM) to vaccination against COVID-19, which may, in turn, affect their sexual behavior. A total of 622 Australian GBM provided weekly data on COVID-19 vaccination history and sexual behaviour between 17 January 2021 and 22 June 2021. We identify factors associated with COVID-19 vaccination, and compare sexual behavior before and since vaccination. Mean age was 47.3 years (SD 14.0). At least one-dose vaccination coverage had reached 57.2%, and 61.3% reported that the majority of their friends intended to be vaccinated. Vaccinated men reported a mean of 1.11 (SD 2.10) weekly non-relationship sex partners before vaccination and 1.62 (SD 3.42) partners following vaccination. GBM demonstrated high confidence in COVID-19 vaccines. Their sexual activity increased following vaccination suggesting that greater sexual freedom may be a specific motivation for vaccine uptake among some men.

INTRODUCTION: The International AIDS Society convened a multidisciplinary committee of experts in December 2020 to provide guidance and key considerations for the safe and ethical management of clinical trials involving people living with HIV (PLWH) during the SARS-CoV-2 pandemic. This consultation did not discuss guidance for the design of prevention studies for people at risk of HIV acquisition, nor for the programmatic delivery of antiretroviral therapy (ART). DISCUSSION: There is strong ambition to continue with HIV research from both PLWH and the research community despite the ongoing SARS-CoV-2 pandemic. How to do this safely and justly remains a critical debate. The SARS-CoV-2 pandemic continues to be highly dynamic. It is expected that with the emergence of effective SARS-CoV-2 prevention and treatment strategies, the risk to PLWH in clinical trials will decline over time. However, with the emergence of more contagious and potentially pathogenic SARS-CoV-2 variants, the effectiveness of current prevention and treatment strategies may be compromised. Uncertainty exists about how equally SARS-CoV-2 prevention and treatment strategies will be available globally, particularly for marginalized populations, many of whom are at high risk of reduced access to ART and/or HIV disease progression. All of these factors must be taken into account when deciding on the feasibility and safety of developing and implementing HIV research. CONCLUSIONS: It can be assumed for the foreseeable future that SARS-CoV-2 will persist and continue to pose challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment studies will evolve accordingly. The risks and benefits of performing an HIV clinical trial must be carefully evaluated in the local context on an ongoing basis. With this document, we hope to provide a broad guidance that should remain viable and relevant even as the nature of the pandemic continues to develop.

While HIV pre-exposure prophylaxis (PrEP) is highly effective, it has arguably disrupted norms of 'safe sex' that for many years were synonymous with condom use. This qualitative study explored the culture of PrEP adoption and evolving concepts of 'safe sex' in Sydney, Australia, during a period of rapidly escalating access from 2015-2018, drawing on interviews with sexually active gay men (n = 31) and interviews and focus groups with key stakeholders (n = 10). Data were analysed thematically. Our results explored the decreasing centrality of condoms in risk reduction and new patterns of sexual negotiation. With regards to stigma, we found that there was arguably more stigma related to not taking PrEP than to taking PrEP in this sample. We also found that participants remained highly engaged with promoting the wellbeing of their communities through activities as seemingly disparate as regular STI testing, promotion of PrEP in their social circles, and contribution to research. This study has important implications for health promotion. It demonstrates how constructing PrEP as a rigid new standard to which gay men 'should' adhere can alienate some men and potentially create community divisions. Instead, we recommend promoting choice from a range of HIV prevention options that have both high efficacy and high acceptability.

Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.

Background: HIV pre-exposure prophylaxis (PrEP) has been rapidly implemented in Australia, initially through restricted access in demonstration studies, and then through prescribing across sexual health clinics and general practice settings. In 2018, PrEP was publicly subsidised for people with Medicare (universal health insurance for citizens, permanent residents and those from countries with reciprocal arrangements). There is little research examining the experiences of PrEP providers in Australia, and existing research has been primarily conducted before public subsidy. Methods: In this qualitative study, we examine the challenges that have emerged for PrEP-providing clinicians after public subsidy for PrEP was introduced. We conducted 28 semi-structured interviews in 2019-20 with PrEP providers in two Australian states, and analysed data thematically. Participants included general practitioners (GPs), sexual health nurses and sexual health physicians. Results: Sexual health services have been reconfigured to meet changing patient demand, with an emphasis on ensuring equitable financial access to PrEP. Restrictions to nurse-led PrEP frustrated some participants, given that nurses had demonstrated competence during trials. GPs were believed to be less effective at prescribing PrEP, but GP participants themselves indicated that PrEP was an easy intervention, but difficult to integrate into general practice. Participants expressed discomfort with on-demand PrEP. Conclusions: Our findings indicate that supporting ways for patients without Medicare to access PrEP inexpensively, advocating for nurse-led PrEP, and developing guidelines adapted to general practice consultations could ensure that PrEP is delivered more effectively and equitably. Additionally, PrEP providers require encouragement to build confidence in providing on-demand PrEP.

Issues addressed: This study examined the navigation of health care interactions by health consumers attending Sydney Sexual Health Centre (SSHC), an inner-city sexual health clinic in Sydney, Australia. We aimed to assess the accessibility and appropriateness of communications between SSHC and patients in the context of health literacy. Methods: We conducted 20 semi-structured interviews with health consumers, assessed health literacy using the Short Health Literacy Assessment for English-Speaking Adults (SAHL-E) and conducted a focus group with clinical staff. Results: We identified dissonances around assumed knowledge in communications between health professionals and health consumers, which were most apparent when lack of knowledge about sexual health, HIV and pre-exposure prophylaxis (PrEP) intersected with poor English fluency. So what?: This study suggests that existing models of access for HIV treatment and PrEP in Australia have been developed for high health literacy and may not support consumers who experience communication barriers due to low health literacy. The Australian Commission on Safety and Quality in Health Care recommends addressing health literacy systemically, including embedding assessment of health literacy into organisational systems and policies. We recommend developing tools to assess knowledge levels of consumers accessing sexual health services and incorporating health literacy into clinician training on working with patients from non-English–speaking backgrounds.

Intoxication can be a factor in unwanted sex, but research on the extent of the issue in both women and men is limited. We assessed the prevalence, correlates, and 10-year time-trends of unwanted sex due to intoxication among a representative sample of 4,279 women and 3,875 men aged 16–69 years in Australia and considered how these vary by gender. In 2012–13, 16% of women and 10% of men reported ever having had a sexual experience when they “did not want to because they were too drunk or high at the time.” For both women and men, this was associated with younger age, bisexual activity, and reports of lifetime injection drug use, sexually transmitted infections, and forced sex. Among women only, it was associated with drinking above guideline levels and ever having terminated a pregnancy. Among men only, it was associated with current tobacco smoking, elevated psychosocial distress, and poor general health. Compared with 2001–02 data, fewer men reported unwanted intoxicated sex, while there were no changes for women as a whole. Interpreting these findings through an intersectional assemblage framework supports stronger understanding of the multiple factors influencing sexuality and substance use with implications for promoting equity, safety, and sexual health.

BACKGROUND: In response to the novel coronavirus disease (COVID-19) pandemic, Australia introduced public health and physical distancing restrictions in late March 2020. We investigated the impact of these restrictions on HIV pre-exposure prophylaxis (PrEP) use among Australian gay and bisexual men (GBM). METHODS: Participants in an ongoing online cohort study previously reported PrEP use from 2014 to 2019. In April 2020, 847 HIV-negative and untested participants completed questionnaires assessing changes in PrEP use as a result of COVID-19 public health measures. Binary logistic multiple regression was used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95%CI) to compare changes in PrEP use behaviours. RESULTS: Among 847 men, mean age was 44.1 years (SD: 12.7). PrEP use rose from 4.9% in 2015 to 47.2% in 2020. Among those, 41.8% (n=167) discontinued PrEP use during COVID-19 restrictions. Discontinuing PrEP during COVID-19 restrictions was independently associated with being less likely to have recently tested for HIV (aOR: 0.17; 95%CI: 0.09-0.34; p<0.001), and less likely to report sex with casual partners (aOR: 0.28; 95%CI: 0.14-0.54; p<0.001). CONCLUSION: By April 2020, following the introduction of COVID-19 restrictions, GBM dramatically reduced PrEP use, coinciding with a reduction in sexual activity. Longer term impacts of COVID-19 restrictions on sexual behaviours among GBM need to be monitored as they may foreshadow fluctuations in prevention coverage and risk of HIV infection. Our findings indicate a potential need for clear, targeted information about resumption of PrEP and on-demand optimal dosing regimens in response to ongoing changes in restrictions.

The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID‐19‐related clinical trials in sub‐Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial‐related physical, psychological, financial, and/or social harms; trial accrual, follow‐up, exit trial closure and results dissemination; and post‐trial access to trial products or procedures. The norms, values, and practices of collectivist societies in Sub‐Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil‐society organizations, members of community advisory boards and ethics committees, young persons, COVID‐19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID‐19 related clinical trials. Adapting ethics guidelines to the socio‐cultural context of the region can facilitate achieving the aim of stakeholder engagement.

Background:The number of international students at Australian universities is rapidly increasing, and they contribute significantly to Australia's economy. However, concerns have been raised for the health and wellbeing of international students, and there is limited information concerning international students with regard to their sexual health. Methods: Overall, 13 individual semi-structured in-depth interviews were conducted with 13 international students at an Australian university, aiming to understand the views and experiences of international students with regard to their sexual health and wellbeing. The interviews were analysed thematically, generating four themes. Results: Participants had a varied understanding of sexual consent, which often included concerns about the practicalities of saying 'no' to unwanted sexual interactions and misinformation about the effect of reporting sexual misconduct on their privacy and visa status. Cultural and familial taboos were often inherited, but many participants described an evolution of personal views and attitudes regarding topics such as sex before marriage and same-sex relationships, which had occurred since moving to Australia. Participants expressed that they received large amounts of information about sexual health, but often lacked the skills to navigate that information and access relevant support. Conclusions: These data, along with participants' suggestions for future support and education, are important for understanding the complex experiences of international students at Australian universities, and should be considered when implementing future sexual health education and support programs.

BackgroundMany gay and bisexual men (GBM) experience HIV anxiety, particularly around condomless anal intercourse (CLAI). HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy that may reduce HIV anxiety among GBM.Methods:The Following Lives Undergoing Change (Flux) Study is a national, online, open prospective observational study of licit and illicit drug use among GBM in Australia. In 2018, participants responded to newly included items regarding anxiety about HIV transmission. Stratifying GBM as high or low risk as determined by the Australian PrEP Guidelines, we assess whether PrEP use is associated with lower levels of HIV anxiety. Multivariate logistic regression was used to compare factors associated with PrEP use among GBM at high risk (PrEP-eligible) and low risk (PrEP-ineligible) of HIV infection. Results are reported as adjusted odds ratios (aOR) and corresponding 95% confidence intervals (95%CI).Results:Among 1547 men, mean age was 37.1 years (SD 13.1). Men aged 25 years or younger had higher HIV anxiety scores than older men. Among PrEP-eligible men, men who use PrEP reported lower levels of HIV anxiety (aOR=0.92; 95%CI=0.87-0.99; p<0.001). No differences were observed on HIV anxiety among PrEP-ineligible men.Conclusions:Among PrEP-eligible men, PrEP use was independently associated with lower levels of HIV anxiety. In addition to avoiding HIV infection, PrEP use may help reduce anxiety among men at risk of HIV. This feature of PrEP could be promoted as part of demand creation initiatives to increase PrEP uptake.

Although abortion rates appear to be declining in high-income nations, there is still a need for accessible, safe abortion services. However, limited attention has been paid to understanding the social contexts which shape access to abortion information and services for communities who are less engaged with sexual and reproductive health care more generally. This paper explores the views and experiences of 27 migrant and refugee young people (16–24 years old) living in Sydney, Australia, regarding unintended pregnancy and abortion. Pregnancy outside marriage was described by all participants as a shameful prospect as it revealed pre-marital sexual activity. Even when abortion was described as culturally and/or religiously unacceptable, it was believed many families would find an abortion preferable to continuing an unintended pregnancy outside marriage. However, a pervasive culture of silence regarding sexual and reproductive health may limit access to quality information and support in this area. To better meet the needs of these young people, greater attention must be paid to strengthening youth and community awareness of the availability of contraception including emergency contraception, pregnancy options, and access to abortion information and services.

Background: Media exposés and academic literature reveal high rates of bullying and harassment of medical students, most commonly by consultant physicians and/or surgeons. Recent reports reveal the medical profession to be characterised by hierarchy, with verbal abuse a 'rite of passage', as well as sexist and racist behaviours. Methods: Semi-structured in-depth interviews were conducted with ten current or recently graduated medical students from Sydney-based medical schools. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Results: Hierarchy, and a culture of self-sacrifice, resilience and deference, were identified as problematic elements of the medical profession. In the minds of participants, these factors created barriers to reporting mistreatment, as participants felt reporting led to being labelled a 'troublemaker', affecting career progression. Additionally, participants stated that avenues of recourse were unclear and did not guarantee confidentiality or desired outcomes. Conclusions: Mistreatment is continuing in clinical teaching and has negative consequences on medical students' mental health and learning. Structural change is needed to combat institutionalised mistreatment to ensure the wellbeing of future doctors and high quality patient care.

Novel sexually transmissible infection (STI) prevention strategies are needed to combat increasing bacterial STI incidences alongside decreasing condom use among gay and bisexual men (GBM) in Australia. Sexually transmissible infection pre-exposure prophylaxis (STI-PrEP) using regular doxycycline is one such strategy that is the subject of ongoing research. However, a lack of qualitative data regarding the conceptualisation, perceived risks, perceived benefits and preferred dosing strategies of STI-PrEP may impede future research and implementation efforts. Methods: Semistructured in-depth interviews were conducted with 13 high-risk GBM residing in Sydney, Australia. Interviews were audio recorded, transcribed verbatim and then analysed thematically. Results: STI-PrEP was largely conceptualised using pre-existing knowledge of HIV-PrEP. The perceived benefits, including a reduced incidence of STIs, destigmatisation and a 'peace of mind', often outweighed the perceived risks, including side effects, antibiotic resistance and stigmatisation of consumers. A daily dosing regimen was preferred unanimously by participants when compared with event-driven or episodic strategies. Conclusions: Participants of this study were cautiously optimistic regarding the concept of STI-PrEP. The findings suggest that, in addition to examining the effectiveness of STI-PrEP, future implementation studies should also focus on concerns regarding side effects and monitoring antibiotic resistance, as well as considering the acceptability and potential for stigmatisation of STI-PrEP consumers.

While medical advocacy is mandated as a core professional commitment in a growing number of ethical codes and medical training programs, medical advocacy and social justice engagement are regularly subordinated to traditional clinical responsibilities. This study aims to provide insight into factors that motivate clinician engagement and perseverance with medical advocacy, so as to inform attempts by policymakers, leaders and educators to promote advocacy practices in medicine. Furthermore, this study aims to provide an analysis of the role of medical advocates in systems where patients’ rights are perceived to be infringed and consider how we might best support and protect these medical advocates as a profession, by exploring the experiences and perspectives of Australian clinicians defending the health of detained asylum seekers. In this qualitative study thirty-two medical and health professionals advocating on asylum seeker health in immigration detention were interviewed. Transcripts were coded both inductively and deductively from interview question domains and thematically analysed. Findings suggested that respondents’ motivations for advocacy stemmed from deeply intertwined professional and personal ethics. Overall, advocacy responses originated from the union of three integral stimuli: personal ethics, proximity and readiness. We conclude that each of these three integral factors must be addressed in any attempt to foster advocacy within the medical profession. In light of current global trends of increasingly protectionist immigration practices, promoting effective physician advocacy may become essential in ensuring patients’ universal right to health.

Background: Many gay and bisexual men (GBM) experience sex-related HIVanxiety, particularly around condomless anal intercourse with casual partners(CLAIC). HIV pre-exposure prophylaxis (PrEP) may reduce HIV-related anxiety among GBM. We compare PrEP use between high-risk and low-HIV-risk GBM to explore associations with HIV-related anxiety.Methods: In 2018, 1574 non-HIV-positive GBM responded to a national online study of gay men’s health. Participants reported PrEP use and sexual behaviours in the previous six months. GBM were classified as high-risk or low-risk in accordance with Australian PrEP guidelines. HIV anxiety was measured by a newly-developed scale about anxiety regarding HIV. Categorical variables were analysed using Pearson’s chi-square tests, and t-tests were used for continuous variables. Multivariate logisticregression was used to identify factors associated with PrEP use. Results arereported as adjusted odds ratios (aOR) and corresponding 95% confidence intervals (95%CI).Results: Mean age of the sample was 37.1 years (SD=13.1). Overall, one-third(37.2%) reported PrEP use. One quarter (24.5%) of low-risk men and 72.7% of highrisk men reported PrEP use.The mean HIV anxiety score was 8.85 (SD=4.01). One in six participants (259;16.7%) had an HIV anxiety score of 3, indicating they did not feel any anxiety about HIV. Men aged 25 years or less (mean=9.59 vs. 8.35, p<0.001) and men who reported receptive CLAIC (mean=9.59 vs. 8.74, p=0.033) scored higher on measures of HIV-related anxiety. Among high-risk GBM (406 men; 26.2%), those who used PrEP had lower HIV anxiety scores (mean: 10.42 vs 8.54, aOR=0.91; 95%CI=0.85-0.97).Conclusion: Among high-risk men, PrEP use was independently associated with lower levels of HIV anxiety. In addition to preventing HIV infection, PrEP use may reduce anxiety among men who were previously at risk of HIV. This feature of PrEP could be promoted as part of demand creation initiatives to increase PrEP uptake.

This edited collection uses the #MeToo movement as a starting point for interrogating contemporary debates in anti-sexual violence activism and justice-seeking.

Bacterial sexually transmitted infections (STI) have been increasing over the past two decades in gay, bisexual, and other men who have sex with men (MSM). With the widespread use of early HIV treatment, which virtually eliminates transmission risk, and the availability of HIV pre-exposure prophylaxis there have been attitudinal changes regarding HIV infection with resultant increases in sexual contact and declines in condom use. Doxycycline is used for primary prophylaxis in a number of infectious diseases.

Objective: HIV prevention tools such as pre-exposure prophylaxis require equitable access and uptake to protect all at-risk populations. This project assessed the perceived barriers to accessible HIV prevention for Aboriginal and Torres Strait Islander gay and bisexual men (GBM) and evaluated the presence of health promotion for pre-exposure prophylaxis (PrEP) for this population from the perspective of service providers. Methods: Eighteen semi-structured interviews with healthcare providers, researchers and AIDS Council employees were qualitatively analysed for themes and concepts related to PrEP-specific health promotion. Results: Respondents noted AIDS Councils and affiliated sexual health clinics had been instrumental in promoting PrEP to at-risk GBM. However, many Aboriginal gay and bisexual men who are not well connected with these communities and services may not have been exposed to this health promotion and therefore have not accessed PrEP effectively. Conclusions: Aboriginal community and gay community controlled health organisations need to collaborate to ensure they deliver effective and tailored health promotion to Aboriginal communities. Implications for public health: The rising HIV notification rates in Aboriginal Australians is an example of the health gap experienced by First Nation people. Effective HIV prevention is required to ensure this gap does not widen further, and that Australia meets its goal of preventing all new HIV infections. However, these efforts will be hampered by ineffective health promotion of HIV prevention tools, such as PrEP, for Aboriginal Australians.

Binding, or the non-invasive compression of chest tissue, is often used to facilitate a more comfortable expression of individuals’ gender prior to, or in lieu of, surgical intervention for assigned people. This study aims to provide insight into the ways in which gender-diverse individuals in Sydney, Australia perceive the health impacts of ad ascribe meaning to binding. It also explores how individuals negotiate available resources and support around this practice. Ten trans or gender-diverse participants who were assigned female at birth were recruited via social media and community organisations. Data were collected through in-depth, semi-structured interviews and thematically analysed by a peer researcher. Four main themes were identified: (1) diversity of experiences; (2) negotiating (dis)comfort: participants negotiated between physical, emotional and social comforts and discomforts; (3) perceptions of safety: in the absence of formal research, participants mediate public narratives of fear; and (4) interactions with health care: insensitivity and incomprehension present barriers to care. These findings have implications for the way binding should be approached by health-care practitioners. Approaches require culturally competent care and appropriate harm reduction strategies which consider the importance of binding in individuals’ daily lives as well as the diversity of experiences.

Culturally responsive evaluation recognises the existence of diverse ontologies and epistemologies or understandings of existence and ways that people know, reason and perceive the world respectively. Its exponents argue that these should be reflected in evaluation practice. Buddhism has a significant global influence today, particularly in some countries in South East and East Asia, where it is practised by a large majority of the population. In this article, we suggest an applied approach to culturally responsive evaluation by first analysing the ontologies and epistemologies underpinning Buddhism and the Most Significant Change technique, a participatory method for monitoring and evaluation that involves the collection of stories of significant change. We then identify where these converge and diverge. Finally, we suggest practical ways in which the Most Significant Change technique could be adapted to enhance its compatibility with a Buddhist world view.

Background: Gay and bisexual men (GBM) report distinctive patterns and contexts of drug use, yet little has been published about their attitudes toward drug use. Objectives: We developed measures of attitudes and perceived social norms toward drug use, and examined covariates of more accepting attitudes and norms among GBM in Australia. Methods: We analyzed baseline data from the Following Lives Undergoing Change (Flux) study. Flux is an online prospective observational study of drug use among Australian GBM. We used principal components factor analysis to generate two attitudinal scales assessing “drug use for social and sexual enhancement” and “perceptions of drug risk.” A third perceived social norms scale examined “acceptability of drug use among gay friends.” Results: Among 2,112 participants, 61% reported illicit drug use in the preceding six months. Stronger endorsement of drug use for social and sexual engagement and lower perceptions of drug risk were found among men who were more socially engaged with other gay men and reported regular drug use and drug use for sex. In multivariate analyses, all three scales were associated with recent drug use (any use in the previous six months), but only the drug use for social and sexual enhancement scale was associated with regular (at least monthly) use. Conclusions: Drug use and sex are difficult to disentangle for some GBM, and health services and policies could benefit from a better understanding of attitudinal and normative factors associated with drug use in gay social networks, while recognizing the role of pleasure in substance use.

In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for disaster research ethics. In particular, Calain proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals. In this commentary, I argue that the separation of patient care goals from research goals is also unhelpful in the context of other forms of participant disadvantage even when that disadvantage is less severe than an ongoing public health emergency. I contend that recognising that research in disadvantaged populations is an intervention that could and should aim to produce positive outcomes for participants, just as it should in disaster contexts, therefore seems a well-justified lesson that can be extrapolated from the experience of the Ebola epidemic.

BACKGROUND: Like a number of other countries, Australia mandates that a man who has had sex with men is deferred from donation until 12 months has elapsed since the sexual activity. This review examined whether this deferral period is justified by current evidence. STUDY DESIGN AND METHODS: Databases (Medline, EMBASE, Scopus) were searched using terms “blood donation” and “gay” or “MSM” and “HIV risk” from the mid-1980s to the present to investigate the history of donor deferral policy and its rationale in Australia. RESULTS: Gay and bisexual men in Australia face a higher risk of human immunodeficiency virus and other blood-borne viruses (BBVs) than other populations. All blood donations, however, are tested for BBVs, and with current testing technologies the window period during which infection may be present but not detected is now less than 1 week. While there is a moral imperative to maintain blood safety, there is also a moral imperative to ensure that differential treatment of population groups with regard to donation eligibility is scientifically justified. Potential social harms that may flow from a dissonance between deferral policy and its evidence base include loss of trust and increased nonadherence to policy. CONCLUSIONS: A 12-month deferral for gay and bisexual men exceeds what is required to maintain blood safety. This disparity potentially causes social harm without any additional benefit to public health. Reducing the deferral period to 3 months will not increase health risk to recipients and may have the social benefit of increasing inclusiveness.

Background: Gamma-hydroxybutyrate (GHB) use among gay and bisexual men (GBM) has increased in recent years. It is commonly cited as a sexual-enhancement drug. There is, however, little evidence for factors associated with GHB use or the consequences of its use among GBM. Aim: Factors associated with GHB use, its relationship to sexual risk behaviour, and the contexts, consequences, and motivations for its use were examined. Methods: The Following Lives Undergoing Change (Flux) Study is an online prospective observational study of Australian GBM. At baseline, a total of 3190 GBM provided details about their use of GHB. Data on frequency, methods, pleasures and consequences of their drug use, alongside key demographic variables were collected. Results: Mean age was 35.0 years. One in five men (19.5%) had a history of GHB use and 5.4% reported use within the past 6 months, with 2.7% having used it monthly or more frequently. Overdose had been experienced by 14.7%, this was more common among men who used GHB at least monthly. Being HIV-positive, having more gay friends, greater social engagement with gay men who use drugs, a greater number of sexual partners, group sex, and condomless anal intercourse with casual partners were independently associated with GHB use in the past 6 months. Greater social engagement with gay men who use drugs and group sex were independently associated with at least monthly use. More frequent GHB use was independently associated with experiencing overdose among GHB users. Conclusion: Most men used GHB infrequently and it was often used explicitly to enhance sexual experiences, often in the context of intensive sex partying. Men who used GHB frequently, were at greater risk of overdose and other negative health outcomes. GHB use should be considered alongside other drugs that have been implicated in sexual risk behaviour and HIV transmission. Harm-reduction interventions need to consider the particular impact of frequent GHB use.

© 2016 Folayan et al. Background: The global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed. Discussion: The recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola (such as in home care settings) are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics. Summary: Successful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites.

Evidence that treating people with HIV early in infection prevents transmission to sexual partners has reframed HIV prevention paradigms. The resulting emphasis on HIV testing as part of prevention strategies has rekindled the debate as to whether laws that criminalise HIV transmission are counterproductive to the human rightsbased public health response. It also raises normative questions about what constitutes 'safe(r) sex' if a person with HIV has undetectable viral load, which has significant implications for sexual practice and health promotion. This paper discusses a recent high-profile Australian case where HIV transmission or exposure has been prosecuted, and considers how the interpretation of law in these instances impacts on HIV prevention paradigms. In addition, we consider the implications of an evolving medical understanding of HIV transmission, and particularly the ability to determine infectiousness through viral load tests, for laws that relate to HIV exposure (as distinct from transmission) offences. We conclude that defensible laws must relate to appreciable risk. Given the evidence that the transmissibility of HIV is reduced to negligible level where viral load is suppressed, this needs to be recognised in the framing, implementation and enforcement of the law. In addition, normative concepts of 'safe(r) sex' need to be expanded to include sex that is 'protected' by means of the positive person being virally suppressed. In jurisdictions where use of a condom has previously mitigated the duty of the person with HIV to disclose to a partner, this might logically also apply to sex that is 'protected' by undetectable viral load.

Background: The current Ebola Virus Disease (EVD) outbreak in West Africa is the largest in history. As of February 18th 2015, 23,258 cases of EVD have been cumulatively reported from Nigeria, Senegal, Guinea, Liberia, Mali, Sierra Leone, Spain, the United Kingdom and the United States of America resulting in more than 9,000 deaths. It is therefore exigent to develop prevention and treatment therapies for EVD. Discussion: Several new EVD treatments are in clinical development at this time. Based on lessons learned, four critical processes need to be implemented before clinical trials begin. First, all global EVD research need to be coordinated to promote data sharing and synergistic overlap, while reducing unnecessary duplication of efforts. The World Health Organization is well-placed to undertake such an endeavor. Second, governments of affected nations where trials are being proposed need to lead discussions regarding immediate access to any proven medications for epidemics. Also, governments need to leverage international resources to support and expand existing national expertise to jointly conduct high-caliber clinical research; and resources must be used to enhance local technical skills and expand existing personnel. Third, ethics committees must review protocols, monitor the research process, and work closely with research scientists to insure the ethical integrity of research throughout the trials. Fourth, community advisory boards (CAB) need to be formed, linked with existing community leadership structures and organized in conjunction with trial implementation. These community structures should work together with ethics committees to facilitate the study design, informed consent process, and study implementation. Summary: We must facilitate communication and mutual understanding between trial communities and research teams, and promote positive collaborations between all stakeholders engaged in EVD research. The community engagement process for EVD resea