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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., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2019 Elsevier B.V. All rights reserved.)

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.

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 < 0.001). Retained participants maintained high adherence to daily PrEP over 12 months, confirmed by four different measures. Facilitated recall to clinicians is a suitable measure for assessing PrEP adherence in populations engaged in care where there is established trust and rapport with patients. Trial registration: ClinicalTrials.gov NCT02206555.

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.

Background: In Australia, pre-exposure prophylaxis (PrEP) is targeted to individuals at high risk for HIV infection. We describe the HIV risk profile and characteristics of PRELUDE participants, and evaluate the population validity of the sample in representing high-risk gay and bisexual men (GBM) eligible for PrEP., Methods: PRELUDE is an on-going, open-label, single-arm observational study. Participants were identified in clinics and screened for eligibility using a paper-based risk assessment tool which followed the New South Wales (NSW) PrEP guidelines. Selection was validated using an independent online behavioural survey, completed by study participants upon enrolment. Demographic information was analysed using descriptive statistics, and kappa tests were used to determine agreement between reporting of high-risk practices in the risk assessment and behavioural survey., Results: During 2014-15, 471 individuals were targeted for enrolment; 341 were assessed for PrEP eligibility and 313 were enrolled. Of these, 303 (97%) identified as GBM. Overall, 85% of GBM met at least one high-risk criterion; 68% reported receptive intercourse with an HIV-positive or unknown status casual male partner, and 37% reported methamphetamine use in the three months preceding enrolment. The remaining 15% were enrolled based on medium-risk behaviours, or at the clinicians' discretion. We found an 82% total agreement between self-reported high-risk behaviour and clinicians' categorisation of GBM as being at high risk for HIV based on PrEP eligibility criteria., Conclusions: Behavioural eligibility criteria used by clinicians successfully identified individuals at high risk for HIV infection. This targeted approach ensures that the greatest public health and HIV prevention benefits can be derived in a setting without universal access to PrEP.

The ethical conduct of HIV prevention researchers is subject to scrutiny. Many clinical trials take place in low and middle income countries where HIV incidence is high, but the benefits of research are often first enjoyed in high income countries. The provision of ancillary care--medical care provided to clinical trial participants during a trial, which is not related to the research question--is one way in which trial participants can receive direct benefits from their participation in research. We argue that such care is a legitimate benefit of research participation. This care does not constitute 'undue inducement' if the research study itself involves minimal risk and is subject to ethical and regulatory oversight. We also argue that research teams working with populations who have sub-optimal healthcare access have a duty to provide ancillary care within agreed limits. These limits should be negotiated to ensure that the research remains feasible and economically viable.

Nigerian research ethics committees are charged with the responsibility to monitor ongoing research to ensure compliance with ethical standards. Recent evidence from qualitative studies on research conduct however, indicate that many research studies fail to implement their protocols as written, and that this is not reported due to a failure of comprehensive monitoring. As Nigeria is in many respects a highly suitable country in which to conduct HIV biomedical prevention research, we argue there is a need to reprioritise the strengthening of the monitoring capacity of ethics committees so that such vital and ethically complex research can be conducted with confidence. We identify the need for (i) improved resourcing and training of ethics committee members, and (ii) comprehensive planning of research monitoring as part of the ethics committee protocol review process. We also highlight the significance of community collaboration and the establishment of a central pool of national monitors, as essential components for reinvigorating monitoring capacity.

While international standards are important for conducting clinical research, they may require interpretation in particular contexts. Standard of care in HIV prevention research is now complicated, given that there are now two new biomedical prevention interventions - 'treatment-as-prevention', and pre-exposure prophylaxis--in addition to barrier protection, counselling, male circumcision and treatment of sexually transmissible infections. Proper standards of care must be considered with regard to both normative guidance and the circumstances of the particular stakeholders--the community, trial population, researchers and sponsors. In addition, the special circumstances of the lives of participants need to be acknowledged in designing trial protocols and study procedures. When researchers are faced with the dilemma of interpretation of international ethics guidelines and the realities of the daily lives of persons and their practices, the decisions of the local ethics committee become crucial. The challenge then becomes how familiar ethics committee members in these local settings are with these guidelines, and how their interpretation and use in the local context ensures the respect for persons and communities. It also includes justice and the fair selection of study participants without compromising data quality, and ensuring that the risks for study participants and their community do not outweigh the potential benefits.

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.

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities., (© 2011 Blackwell Publishing Ltd.)