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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.

INTRODUCTION: In March 2020, Australian state and federal governments introduced physical distancing measures alongside widespread testing to combat COVID-19. These measures may decrease people's sexual contacts and thus reduce the transmission of HIV and other sexually transmissible infections (STIs). We investigated the impact of physical distancing measures due to COVID-19 on the sexual behavior of gay and bisexual men in Australia. METHODS: Between April 4, 2020, and April 29, 2020, 940 participants in an ongoing cohort study responded to questions to measure changes in sexual behaviors during the COVID-19 pandemic. Men reported the date they become concerned about COVID-19 and whether they engaged in sexual behavior with regular or casual partners or "fuckbuddies" in the 6 months before becoming concerned about COVID-19 (hereafter referred to as "before COVID-19"), and following the date, they become concerned about COVID-19 (hereafter referred to as "since COVID-19"). Before and since COVID-19 was based on individual participants' own perceived date of becoming concerned about COVID-19. RESULTS: The mean age of was 39.9 years (SD: 13.4). Most participants (88.3%) reported sex with other men during the 6 months before COVID-19. Of the 587 men (62.4%) who reported sex with casual partners before COVID-19, 93 (15.8%) continued to do so in the period since COVID-19, representing a relative reduction of 84.2%. CONCLUSION: Gay and bisexual men in Australia have dramatically reduced their sexual contacts with other men since COVID-19. These behavioral changes will likely result in short-term reductions in new HIV and STI diagnoses. If sexual health screenings are undertaken before resuming sexual activity, this could present a novel opportunity to interrupt chains of HIV and STI transmission.

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.

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.

Strategies for HIV prevention among infants, children, and adolescents have evolved significantly over the past 20 years. These include the global scale-up of simplified multidrug HIV regimens for pregnant women, leading to impressive reductions in new child HIV infections. However, significant gaps remain, especially in high HIV-burden sub-Saharan African countries. For example, many pregnant women living with HIV (WLHIV) are unable to access and sustain HIV testing and treatment partly due to low agency and harmful gender norms. Among pregnant WLHIV, adolescent girls face an additional layer of societal and health-system barriers in accessing care for themselves and their exposed infants. Legal and structural barriers limit access to HIV prevention-related sexual and reproductive health services among high-risk adolescents, including girls and young men who have sex with men. Key ethical issues underlying HIV prevention gaps for infants, children, and adolescents prevail. This narrative review explores these issues and highlights counter-measures for programming and policy, including gender empowerment, improving access to and appropriateness of critical health services, rights-based policy and legislation, closing research gaps, and considering the values and preferences of young people for HIV prevention and treatment services.

HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical HIV prevention strategy, yet some gay and bisexual men (GBM) who are eligible to access PrEP are not using it. We report the incidence of PrEP uptake, factors predicting its initiation, and identify characteristics associated with nonuptake of PrEP among Australian GBM who meet the eligibility criteria.The Following Lives Undergoing Change (Flux) Study is a national, online, prospective observational study among GBM focusing on licit and illicit drug use. Participants (N = 1257) responded to baseline and 6-monthly follow-up questionnaires. Incidence per 100 person-years and incidence rate ratios of PrEP initiation are presented. Multivariate Poisson regression was used to examine associations with PrEP initiation and logistic regression to examine associations with nonuptake of PrEP among eligible GBM.Among GBM who met the eligibility criteria, 69.8% of men did not commence PrEP. Factors independently associated with nonuptake of PrEP were younger age, living in an Australian state without a PrEP trial, lower social engagement with other gay men, less use of illicit party drugs or use of illicit party drugs for sex, and less likely to have engaged in HIV sexual risk behaviors such as group sex or any condomless anal intercourse.Despite meeting formal eligibility criteria for PrEP, men who were relatively less sexually active or less socially connected were less likely to initiate PrEP. Men who did not initiate PrEP may assess their risk as insufficient relative to others to warrant using PrEP because they engaged in less frequent "risky" behaviors.

Background: In response to the threat of COVID-19 infection, Australia mandated a 14 day quarantine period in a designated facility for all travellers returning from overseas from late March 2020. These facilities were usually hotels, or hotel-like serviced apartments, and also included a repurposed former mining village in the Northern Territory. This study aimed to investigate the perspectives and experiences of people quarantined in designated supervised facilities in Australia, which has not been systematically explored before.Methods: In this qualitative study semi-structured interviews were conducted with 58 participants quarantined between March 2020 and January 2021. Participants were returned Australian citizens and residents who were required to undergo mandatory supervised quarantine for COVID-19. Interviews were conducted using video teleconferencing (via Zoom), transcribed and coded, then analysed thematically. The theoretical orientation of the study was empirical bioethics.Results: While participants generally supported the concept of quarantine to protect the Australian public, they were critical of elements of it where they felt exposed to risk (COVID-related or not). They also described instances where infection control within the system seemed inadequate. For some, particularly those quarantined with small children, they reported that the facilities were inadequate or inappropriate for health and wellbeing. Using thematic analysis, three major themes were identified that related to problems in the existing system: Feeling at risk in the quarantine process, risks to the community identified in quarantine, and alternatives to hotel quarantine. Conclusions: There are systemic issues with infection control in hotel quarantine, which can be further undermined by individual non-compliance. Risks to safety for those in quarantine can be reduced, both in terms of infection control within hotel quarantine and, in the case of the Northern Territory facility, timely in-person medical care as needed for non-COVID conditions. Systems of infection control need ongoing review to ensure that people entering quarantine are protected from known risks of infection at every stage. Medical services in quarantine facilities should be examined to ensure timely and appropriate non-COVID medical services are available.

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.

Introduction This study aimed to explore the experiences of healthcare access in a diverse sample of trans and gender diverse individuals with complex needs using qualitative methods. We recruited 12 individuals using trans community-based networks facilitated by the Gender Centre. Each individual participated in an in-depth, semi structured interview conducted by a peer interviewer. Interviews were analysed thematically. Findings Participants had a range of complex health needs to manage, including ongoing access to gender-affirming hormones, mental health care and sexual health care. Some also had chronic diseases. Accordingly, scheduling appointments and affording the co-payments required were major preoccupations. Most participants were not in full time work, and economic hardship proved to be a major compounding factor in issues of healthcare access, impacting on the choice of clinician or practice. Other barriers to accessing health included issues within health services, such as disrespectful attitudes, misgendering, ‘deadnaming’ (calling the person by their previous name), displaying an excessive interest is aspects of the participants’ life that were irrelevant to the consultation, and displaying ignorance of trans services such that the participants felt an obligation to educate them. In addition, participants noted how stereotyped ideas of trans people could result in inaccurate assumptions about their healthcare needs. Positive attributes of services were identified as respectful communication styles, clean, welcoming spaces, and signs that indicated professionalism, care and openness, such as relevant information pamphlets and visibility of LGBTIQ service orientation. Participants valued peer-based advice very highly, and some would act on and trust medical advice from peers above advice from medical professionals. Conclusion These findings demonstrate a need for comprehensive wrap-around service provision for trans people with complex needs which includes a substantial peer-based component, and addresses physical and mental health and social services conveniently and affordably.

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 preexposure 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 behaviors. 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 to 0.34; P < 0.001) and less likely to report sex with casual partners (aOR: 0.28; 95% CI: 0.14 to 0.54; P < 0.001). Conclusions: 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 behaviors among GBM need to be monitored because 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.

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.

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.

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.

BACKGROUND Many gay and bisexual men (GBM) experience HIV anxiety, particularly around condomless anal intercourse. 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 and corresponding 95% confidence intervals. RESULTS Among 1547 men, the 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 (adjusted odds ratio = 0.92; 95% confidence interval = 0.87 to 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.

The provision of effective antiretroviral therapy is an ethical imperative, and global access to antiretroviral drugs is an important aspect of this. The other less recognised aspect of effective HIV management is in ensuring that HIV does not become resistant to the drugs used in treatment (and increasingly also in prevention), as multi-drug resistant HIV poses a major threat to the sustainability of current responses to HIV control. In resource-constrained environments, the rapid scale up of access to life-saving anti-HIV treatment was achieved using a public health approach that standardised antiretroviral regimens, minimised laboratory monitoring, and devolved responsibilities from clinicians where necessary. In recent years demand for antiretroviral treatment has increased due to new understandings of the clinical importance of early treatment, but global investment has declined. Exponential growth of the population using antiretrovirals without careful monitoring increases the risk of significant antiretroviral drug resistance. In this chapter, I consider the example of single-drug interventions to prevent parent-to-child HIV transmission, and how the implementation of that strategy increased health risks for mothers. I argue that while global antiretroviral scale up must continue, laboratory monitoring at individual and national levels needs to improve to maintain treatment effectiveness, and protocols for moving people from failing regimens need to be strengthened.

Use of crystal methamphetamine (crystal) among gay and bisexual men (GBM) has been associated with condomless anal intercourse with casual partners (CLAIC) and HIV infection. Pre-exposure prophylaxis (PrEP) and undetectable viral load (UVL) are important biomedical HIV prevention strategies. We investigate the relationship between crystal use and HIV sexual risk behaviours in the context of PrEP and UVL. In 2018, 1367 GBM provided details about crystal use and HIV prevention strategies. Binary logistic regression was used to estimate associations between crystal use and behaviour. Recent crystal use was independently associated with greater social engagement with gay men and having more sexual partners. Crystal use was also independently associated with use of PrEP and UVL among GBM who engaged in CLAIC. Although GBM who used crystal were more likely to have engaged in CLAIC, they were also more likely to use biomedical HIV prevention which mitigates against the risks of HIV infection.

Background and aims Gay, bisexual and other men who have sex with men (GBM) use alkyl nitrites ('poppers') at higher rates than other populations to functionally enhance sexual experiences. Their use has been associated with HIV sexual risk behaviours including receptive anal sex. We investigate the prevalence, frequency, and motivations for poppers use and their relationship with HIV risk. We also discuss the implications of the recent scheduling changes to poppers by the Australian Therapeutic Goods Administration. Methods Data were drawn from the Following Lives Undergoing Change (Flux) study, a prospective observational study of licit and illicit drug use among GBM. Between 2014 and 2018, 3273 GBM enrolled in the study. In 2018, 1745 GBM provided data relating to frequency of and motivations for poppers use and were included in this analysis. Results Median age was 33 years (IQR 25–46) and 801 GBM (45.9%) had used poppers in the previous six months (‘recent use’). Among these men, 195 (24.3%) had used them weekly or more frequently. Most recent users (77.4%) reported using poppers for a ‘buzz’ during sex or to facilitate receptive anal intercourse (60.8%). The majority (57.7%) of HIV-negative men reporting recent poppers use were concurrently taking HIV pre-exposure prophylaxis. Recent poppers use was independently associated with receptive anal intercourse with casual partners (aOR 1.71; 95%CI 1.35–2.16) and chemsex (aOR 4.32; 95%CI 3.15–5.94). Poppers use was not associated with anxiety, depression, or drug-related harms. Only 15.4% of current users indicated they would stop using poppers if they were criminalised; 65.0% said they would ‘find other ways’ to obtain them. Conclusions Poppers are commonly used by Australian GBM to functionally enhance sexual experiences, particularly to facilitate receptive anal intercourse. Few men experienced drug-related harms from poppers use. Regulatory changes must ensure potential harms from popper use are minimised without increasing barriers to access or perpetuating stigma.

Background Gay and bisexual men (GBM) increasingly use HIV Pre-exposure prophylaxis (PrEP) to prevent HIV infection. Eligibility for PrEP in Australia is based on behavioral criteria including methamphetamine use or condomless sex. It is unclear what proportions of GBM initiating PrEP meet these criteria over time. Methods The Flux prospective cohort study enrolled Australian GBM between 2014 and 2018, following them every six months. We report PrEP use and behavioral eligibility for PrEP over time. Sexually transmissible infections data were not collected. Results Among 1518 non HIV-positive men who were not using PrEP at baseline, mean age was 37.2 years (SD 13.13). Incident PrEP use increased from 2.8% at visit 2 to 11.9% at visit 6 (p-trend Conclusion Although PrEP use or non-use was largely consistent with behavioral criteria for eligibility for its use, a substantial minority of GBM did not appear to use PrEP according to eligibility guidelines. About one-quarter of men who used PrEP were not eligible at the time while a similar proportion of PrEP non-users were eligible for its use, suggesting some underestimation of HIV risk. Greater efforts are needed to address these discrepancies between PrEP eligibility and its use, as engagement in risk behaviors changes over time. Disclosure No significant relationships.

Background Many gay and bisexual men (GBM) experience anxiety about HIV, particularly in relation to sex. Use of HIV pre-exposure prophylaxis (PrEP) as an HIV prevention strategy may affect levels of HIV-related anxiety among GBM. Methods Flux is an Australian online prospective study of GBM enrolled between 2014 and 2018. We measured anxiety using the generalized anxiety disorder assessment (GAD7) scale and a newly developed HIV anxiety scale developed using Principal Components Analysis. We assessed behavioral eligibility for PrEP based on Australian PrEP clinical prescribing guidelines. We used multivariate logistic regression to assess associations between use of PrEP and both GAD7 and HIV-specific anxiety. Results Among 1574 men who completed the HIV anxiety scale, mean age was 37.2 years (SD 13.13). Men aged 25 years or younger had higher HIV anxiety scores than their older counterparts (p Conclusion Among men who were eligible for PrEP, its use was independently associated with lower levels of anxiety in general, and of HIV anxiety specifically. PrEP use may help reduce anxiety among men who are at risk of HIV and may therefore offer perceived benefits in addition to avoiding HIV infection. This perceived benefit may be an important consideration in recommendations for PrEP use. Disclosure No significant relationships.

Bacterial sexually transmitted infections (STIs) have been increasing over the past 2 decades in gay, bisexual, and other men who have sex with men. With the widespread use of early human immunodeficiency virus (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. We conducted a state-of-the-art review to examine the current state of research, knowledge gaps, and challenges around the use of doxycycline prophylaxis to prevent syphilis and other STIs. International academic and government experts met in March 2019 to frame the initial inquiry, which was supplemented by focused literature searches. Two small short-term randomized controlled trials examining doxycycline prophylaxis found high efficacy. Five additional clinical studies are underway or in development. Studies differed in design, population, outcomes, and safety measures. Doxycycline prophylaxis for bacterial STIs shows promise. Better and more robust data are needed on efficacy; target population; community acceptability; behavioral risk compensation; doxycycline dose, regimen, and formulation; long-term safety; antimicrobial resistance; cost-effectiveness; and risk–benefit., Sexually transmitted infections have been increasing among men who have sex with men. Doxycycline prophylaxis for syphilis and chlamydia has been effective in initial trials. Future research should focus on populations with high incidence/morbidity, dose and regimen, and antimicrobial resistance.

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.

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.

The Ebola Virus Disease (EVD) outbreak in Liberia, Sierra Leone and Guinea – also known as the Mano River States - was a public health emergency of international concern. We reviewed ethical discussions pertaining to the obligation of patients infected with EVD to seek medical care; and criminalisation of both “reckless” EVD transmission as well as wilful non-disclosure of disease status. We argue that where the public health care system cannot provide needed care, and there is a historical distrust of public health care systems often resulting from dysfunctional political system, it is challenging to require patients infected with EVD to seek medical care from that sector. Strengthening the public health care system to provide isolation and quarantine services, building the capacity of trusted alternative health care systems to respond to the epidemic, and the use of incentives to get people to seek medical care in public health care institution, where EVD related health care services is being offered during an epidemic, are critical for disease containment. Measures such as criminalisation of EVD transmission and non-disclosure maybe counterproductive as they may further alienate community members from health authorities. We advocate for increased efforts for community mobilization and awareness creation. These help build supportive environments that encourage collective risk-free status disclosure, as well as support for EVD management in the wake of an outbreak.

This chapter analyzes media responses to the Shitty Media Men list, an open-source document briefly circulated on the Internet in late 2017 that enabled women to anonymously report instances of sexual misconduct and violence perpetrated by men working in the US media industry. The chapter employs an ethical lens to explore concepts of moral communication in the social media age alongside the concepts of sexual misconduct and violence that the list allegedly documents. In describing and discussing the claims and counter-claims made by key commentators, including Katie Roiphe, Andrew Sullivan and the list creator Moira Donegan herself, the chapter considers how these were taken up in social media to contribute to a re-ordering of cultural expectations about sexual behavior and work practices, as well as techno-libertarian concepts of free expression in cyberspace.

Adequate adherence to pre-exposure prophylaxis (PrEP) is critical to prevent HIV infection, but accurately measuring adherence remains challenging. We compared two biological [blood drug concentrations in plasma and peripheral blood mononuclear cells (PBMC)] and two self-reported measures (facilitated recall to clinicians and self-report in online surveys) and identified predictors of daily PrEP adherence among gay and bisexual men (GBM) in their first 12 months on PRELUDE, an open-label, single-arm PrEP demonstration project in New South Wales, Australia. 327 participants were enrolled; 263 GBM attended their 12-month follow-up visit (81% retention). Overall, 91% of blood samples had plasma drug concentrations indicative of taking 7 pills/week, and 99% had protective drug concentrations (≥ 4 pills/week). Facilitated recall to clinicians identified 99% of participants with protective adherence as measured by PBMC drug concentrations. Daily adherence measured by facilitated recall was associated with behavioural practices including group sex (aOR 1.33, 95% CI 1.15–1.53, p

Community engagement in research, including public health related research, is acknowledged as an ethical imperative. While medical care and public health action take priority over research during infectious disease outbreaks, research is still required in order to learn from epidemic responses. The World Health Organisation developed a guide for community engagement during infectious disease epidemics called the Good Participatory Practice for Trials of Emerging (and Re-emerging) Pathogens that are Likely to Cause Severe Outbreaks in the Near Future and for which Few or No Medical Counter-Measures Exist (GPP-EP). This paper identified priorities for community engagement for research conducted during infectious disease outbreaks drawing on discussions held with a purposive sample of bioethicists, social scientists, researchers, policy makers and laypersons who work with ethics committees in West Africa. These perspectives were considered in the light of the GPP-EP, which adds further depth and dimension to discussions on community engagement frameworks. It concludes that there is no presumptive justification for the exclusion of communities in the design, implementation and monitoring of clinical trials conducted during an infectious disease outbreak. Engagement that facilitates collaboration rather than partnership between researchers and the community during epidemics is acceptable.

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.

The Kirby Institute, UNSW Australia, Sydney, Australia; Division of Infectious Diseases, The Warren Alpert Medical School of Brown University, Providence, RI, United States; Centre for Values, Ethics and the Law in Medicine, University of Sydney, Sydney, Australia; Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, United States; Treatment Action Group, New York, NY, United States; International Network of People Who Use Drugs, Canberra, Australia; Australian Injecting and Illicit Drug Users League, Canberra, Australia; National AIDS Treatment Advocacy Project, New York, NY, United States; Arud Centres for Addiction Medicine, Zurich, Switzerland

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 rights-based 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.

Dental caries is the main oral health challenge for children in Nigeria. Concern about its negative impact makes screening for caries in children an attractive public health strategy. The ability to detect the preclinical phase of caries, the availability of screening tools with high accuracy, and the possibility of treatment before onset of clinical symptoms with significant cost and health benefits, makes it appropriate for screening. However in Nigeria, the poor availability of highly specific and sensitive screening tools, poor access to oral health care and concerns with pre-screening consent, raise the question of the appropriateness of conducting screening programmes for children. We argue that a number of structural challenges associated with poor uptake of oral health care services need to be addressed before screening for caries can be considered ethically appropriate. These include facilitating access of children to quality oral health care and a systematic national approach to oral health implementation. Failure to address challenges associated with dental service utilization by children in Nigeria increases the risk of screening programmes promoting inequitable access to oral health care services.

Objectives This paper presents the results of the consultations conducted with various stakeholders in Africa and other experts to document community perspectives on the types of research to be prioritised in outbreak conditions. The Delphi method was used to distill consensus. Results Our consultations highlighted as key, the notion that in an infectious disease outbreak situation, the need to establish an evidence base on how to reduce morbidity and mortality in real time takes precedence over the production of generalizable knowledge. Research studies that foster understanding of how disease transmission could be prevented in the future remain important, implementation research that explores how to mitigate the impact of outbreaks in the present should be prioritized. Clinical trials aiming to establish the safety profile of therapeutic interventions should be limited during the acute phase of an epidemic with high fatality—and should preferably use adaptive designs. We concluded that community members have valuable perspectives to share about research priorities during infectious disease emergencies. Well designed consultative processes could help identify these opinions. Electronic supplementary material The online version of this article (10.1186/s13104-018-3263-3) contains supplementary material, which is available to authorized users.

Background:\ud \ud We report prevalence and incidence of drug use initiation in Australian gay and bisexual men (GBM) participating in an online cohort study.\ud Methods:\ud \ud Between September 2014 and June 2015, 1,710 GBM were enrolled in the Following Lives Undergoing Change Study and followed-up six monthly. Participants were asked about measures of lifetime use at baseline and recent use (last six months) at all visits. Drug use initiation was defined as men who reported having never used a specific drug prior to baseline and reported recent use at follow-up.\ud Results:\ud \ud Participants’ median age was 31 years (range: 16–81). Prevalence of lifetime use was significantly associated with older age for all individual drugs (p trend

Introduction The effectiveness of daily pre-exposure prophylaxis (PrEP) is well established. However, there has been increasing interest in non-daily dosing schedules among gay and bisexual men (GBM). This paper explores preferences for PrEP dosing schedules among GBM at baseline in the PRELUDE demonstration project. Materials and methods Individuals at high-risk of HIV were enrolled in a free PrEP demonstration project in New South Wales, Australia, between November 2014 and April 2016. At baseline, they completed an online survey containing detailed behavioural, demographic, and attitudinal questions, including their ideal way to take PrEP: daily (one pill taken every day), event-driven (pills taken only around specific risk events), or periodic (daily dosing during periods of increased risk). Results Overall, 315 GBM (98% of study sample) provided a preferred PrEP dosing schedule at baseline. One-third of GBM expressed a preference for non-daily PrEP dosing: 20% for event-driven PrEP, and 14% for periodic PrEP. Individuals with a trade/vocational qualification were more likely to prefer periodic to daily PrEP [adjusted odds ratio (aOR) = 4.58, 95% confidence intervals (95% CI): (1.68, 12.49)], compared to individuals whose highest level of education was high school. Having an HIV-positive main regular partner was associated with strong preference for daily, compared to event-driven PrEP [aOR = 0.20, 95% CI: (0.04, 0.87)]. Participants who rated themselves better at taking medications were more likely to prefer daily over periodic PrEP [aOR = 0.39, 95% CI: (0.20, 0.76)]. Discussion Individuals’ preferences for PrEP schedules are associated with demographic and behavioural factors that may impact on their ability to access health services and information about PrEP and patterns of HIV risk. At the time of data collection, there were limited data available about the efficacy of non-daily PrEP schedules, and clinicians only recommended daily PrEP to study participants. Further research investigating how behaviours and PrEP preferences change correspondingly over time is needed. Trial registration ClinicalTrials.gov NCT02206555. Registered 28 July 2014.

Introduction Gay and bisexual men (GBM) often use illicit drugs to enhance sexual pleasure, commonly referred to as ‘chemsex' or ‘party n play'. In particular, the use of methamphetamine and Viagra™, and other erectile dysfunction medications, both together and separately are strongly predictive of subsequent HIV infection. Truvada™, as pre-exposure prophylaxis (PrEP), virtually eliminates HIV transmission during condomless anal intercourse (CLAI). HIV-negative GBM in intensive sex partying networks may be adding PrEP to their drug regimen to actively reduce the possibility of HIV transmission during chemsex. Aim We describe the prevalence and context of concurrent use of methamphetamine, Truvada™ (or its generic formulations), and Viagra™ or other erectile dysfunction medication (collectively, MTV). Method The Following Lives Undergoing Change study is an online prospective observational study of licit and illicit drug use among Australian GBM. Between January and July 2017, 1831 GBM provided details about their use of MTV. Binary logistic multiple regression analysis were used to estimate adjusted odds ratios (aOR) and associated 95% confidence intervals (95%CI). Results Concurrent MTV use was reported by 6.0% of participants; 3.1% used methamphetamine and Viagra™ or other erectile dysfunction medication (‘MV only') and 11.2% used Truvada™ as PrEP (‘T only'). In multivariate analysis, compared to use of ‘MV only', MTV was independently associated with CLAI with casual partners (aOR = 6.78;95%CI = 1.42–32.34) and ‘fuckbuddies' (aOR = 3.47;95%CI = 1.41–8.56) in the previous six months. Compared to use of ‘T only', MTV was independently associated with being older (aOR = 3.95;95%CI = 1.55–10.03) and engaging in group sex (aOR = 3.31;95%CI = 1.82–6.00). Greater social engagement with other gay men (aOR = 1.44;95%CI = 1.18–1.76) and having more sexual partners (aOR = 2.30;95%CI = 1.10–4.82) were independently associated with use of MTV compared to use of ‘MV only' or ‘T only'. Conclusion GBM in intensive sex partying networks are increasingly adding PrEP alongside other drugs they use to enhance sexual experiences. Interventions that promote the use of PrEP during chemsex could mitigate HIV risk.

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.

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.

Background 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.

In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis (PrEP) for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively.

HIV prevention is a critical health issue in Nigeria; a country that has one of the worst HIV epidemic profiles in the world. With 270,000 new infections in 2012, Nigeria is a prime site for HIV prevention research. One effect of the HIV epidemic has been to revolutionalise ethical norms for the conduct of research: it is now considered unethical to design and implement HIV related studies without community engagement. Unfortunately, there is very little commensurate effort in building the capacity of local persons to engage actively with researchers, and there is no existing platform to facilitate dialogue between researchers and communities engaged in research in Nigeria. In an effort to address this gap, we undertook a series of three community dialogues (Phase One) and two community-researcher interface meetings (Phase Two) in Nigeria. This paper aims to give an empirical account of the dialogue from these community engagement processes and provide a resulting critique of the implementation of research ethics practices in Nigeria. It is anticipated that the outputs will: (i) support researchers in designing community-based research protocols; (ii) inform ethics committees of key considerations during research protocol reviews from a community perspective; and (iii) inform policy makers and research sponsors about issues of primary concern to communities with respect to HIV research.

There is increasing interest in the need to address the ethical dilemmas related to the engagement of adolescents in sexual and reproductive health (SRH) research. Research projects, including those that address issues related to STIs and HIV, adverse pregnancy outcomes, violence, and mental health, must be designed and implemented to address the needs of adolescents. Decisions on when an individual has adequate capacity to give consent for research most commonly use age as a surrogate rather than directly assessing capacity to understand the issues and make an informed decision on whether to participate in research or not. There is a perception that adolescents participating in research are more likely to be coerced and may therefore not fully comprehend the risk they may be taking when engaging in research. This paper examines the various ethical issues that may impact stakeholders' decision making when considering engaging adolescents in SRH research in Nigeria. It makes a case for lowering the age of consent for adolescents. While some experts believe it is possible to extrapolate relevant information from adult research, studies on ethical aspects of adolescents' participation in research are still needed, especially in the field of sexual and reproductive health where there are often differences in knowledge, attitudes and practices compared to adults. The particular challenges of applying the fundamental principles of research ethics to adolescent research, especially research about sex and sexuality, will only become clear if more studies are conducted.

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account.

Background: UNAIDS guidelines require that participants in HIV prevention trials are provided with “state-of-the-art” risk reduction measures. Published data showing that new HIV prevention strategies are highly, but not completely, effective problematize “standard of prevention” packages that provide access to condoms and counseling only. This qualitative study asks how principal investigators on HIV prevention studies determine appropriate standards of prevention. It builds on previous work mapping standards of care in HIV prevention trials by investigating how decisions were arrived at, in addition to reporting what was decided. Methods: Semistructured interviews were conducted with 14 principal investigators of biomedical HIV prevention trials. Interviews were transcribed, coded, and analyzed thematically using predetermined categories derived from the ethics literature and spontaneous coding. Results: A spectrum of views was given by informants as to how standard of prevention should be determined, r...

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population.

Published data show that new HIV prevention strategies including treatment-as-prevention and pre-exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV-based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment-as-prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment-as-prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment-as-prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV-based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations.

Little is known about the experiences of people with HIV in the small island nation of Timor-Leste. This study explored the HIV-related stigma experiences of adults aged between 18 and 40 living with HIV in Dili, Timor-Leste. Participants were interviewed on topics related to living with HIV, both as key informants describing the experience of others with HIV known to them, and also with respect to their own personal experiences. Findings suggest that people with HIV in Timor-Leste face stigma and discrimination in various contexts. In this predominantly Catholic country, perceptions of HIV and attitudes towards people with HIV appear to be commonly shaped by religious beliefs. In families and communities, participants encountered gossip, social exclusion and threats of violence. In health settings, participants experienced discrimination from health providers in the form of failing to maintain confidentiality and inappropriate treatment. The impact of stigma was profoundly negative and influenced participants' decision to disclose their status to others. Participants attributed stigma to a lack of information about HIV among the general public. Unless stigma reduction interventions also address the Church's role in shaping perceptions of HIV, education campaigns are unlikely to be effective in reducing HIV-related stigma.

Morenike O Folayan1,2Bridget G Haire3Brandon Brown4 1Institute of Public Health, 2Department of Child Dental Health, Obafemi Awolowo University, Ile-Ife, Nigeria; 3Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, NSW, Australia; 4Center for Healthy Communities, Department of Social Medicine and Population Health, University of California Riverside School of Medicine, Riverside, CA, USA Abstract: The devastation caused by the Ebola virus disease (EVD) outbreak in West Africa has brought to the fore a number of important ethical debates about how best to respond to a health crisis. These debates include issues related to prevention and containment, management of the health care workforce, clinical care, and research design, all of which are situated within the overarching moral problem of severe transnational disadvantage, which has very real and specific impacts upon the ability of citizens of EVD-affected countries to respond to a disease outbreak. Ethical issues related to prevention and containment include the appropriateness and scope of quarantine and isolation within and outside affected countries. The possibility of infection in health care workers impelled consideration of whether there is an obligation to provide health services where personal protection equipment is inadequate, alongside the issue of whether the health care workforce should have special access to experimental treatment and care interventions under development. In clinical care, ethical issues include the standards of care owed to people who comply with quarantine and isolation restrictions. Ethical issues in research include appropriate study design related to experimental vaccines and treatment interventions, and the sharing of data and biospecimens between research groups. The compassionate use of experimental drugs intersects both with research ethics and clinical care. The role of developed countries also came under scrutiny, and we concluded that developed countries have an obligation to contribute to the containment of EVD infection by contributing to the strengthening of local health care systems and infrastructure in an effort to provide fair benefits to communities engaged in research, ensuring that affected countries have ready and affordable access to any therapeutic or preventative interventions developed, and supporting affected countries on their way to recovery from the impact of EVD on their social and economic lives. Keywords: Ebola, ethics, global comparison

In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure.