The last few years have seen dramatic progress in the development of HIV pre-exposure prophylaxis (PrEP). These developments have been met by ethical concerns. HIV interventions are often thought to be ethically difficult. In a context which includes disagreements over human rights, controversies over testing policies, and questions about sexual morality and individual responsibility, PrEP has been seen as an ethically complex intervention. We argue that this is mistaken, and that in fact, PrEP does not raise new ethical concerns. (...) Some of the questions posed by PrEP are not specific to HIV prophylaxis, but simply standard public health considerations about resource allocation and striking a balance between individual benefit and public good. We consider sexual disinhibition in the context of private prescriptions, and conclude that only unjustified AIDS-exceptionalism or inappropriate moralism about sex supports thinking that PrEP raises new ethical problems. This negative conclusion is significant in a context where supposed ethical concerns about PrEP have been raised, and in the context of HIV exceptionalism. (shrink)

Antiretroviral pre-exposure prophylaxis (PrEP) is protective against HIV. Low utilization rates amongst HIV vulnerable populations are due in part to the high cost of PrEP. Generic PrEP offers the potential to improve health at significantly reduced costs. In this study, we examine early utilization patterns and prices for generic PrEP. We discuss the opportunities and challenges for generic PrEP to improve health among HIV vulnerable populations.

The impending implementation of pre-exposure prophylaxis has prompted complicated bioethical and public health ethics concerns regarding the moral distribution of antiretroviral medications to ostensibly healthy populations as a form of HIV prevention when millions of HIV-positive people still lack access to ARVs globally. This manuscript argues that these questions are, in part, concerns over the ethics of the knowledge production practices of epidemiology. Questions of distribution, and their attendant cost-benefit calculations, will rely on a number of presupposed, and therefore, (...) normatively cultural assumptions within the science of epidemiology specifically regarding the ability of epidemiologic surveillance to produce accurate maps of HIV throughout national populations. Specifically, ethical questions around PrEP will focus on who should receive ARVs given the fact that global demand will far exceed supply. Given that sexual transmission is one of the main modes of HIV transmission, these questions of ‘who’ are inextricably linked to knowledge about sexual personhood. As a result, the ethics of epidemiology, and how the epidemiology of HIV in particular conceives, classifies and constructs sexual populations will become a critical point of reflection and contestation for bioethicists, health activists, physicians, nurses, and researchers in the multi-disciplinary field of global health. This paper examines how cultural conundrums within the fields of bioethics and public health ethics are directly implicated within the ethics of PrEP, by analyzing the problems of population inaugurated by the construction of the men who have sex with men epidemiologic category in the specific national context of South Africa. (shrink)

Over the past decade AIDS research has turned toward the use of pharmacology in HIV prevention, including pre-exposure prophylaxis (PrEP): the use of HIV medication as a means of preventing HIV acquisition in those who do not have it. This paper explores the contradictory reasons offered in support of PrEP—to empower women, to provide another risk-reduction option for gay men—as the context for understanding the social meaning of the experimental trials that appear to show that PrEP works in gay (...) men and heterosexual couples but not single women. The PrEP debates reveal the different ideas about “demedicalization” in the earlier gay health and women’s health movements and highlight the relationship between health activism and critique of research ethics in the context of a global pharmaceutical market. (shrink)

Stellen Kondome einen potenten Schutz sowohl vor HIV als auch von anderen sexuell übertragbaren Infektionen (STIs) dar, und besteht außerdem ein barrierefreier Zugang zur HIV-Postexpositionsprophylaxe (PEP) (z. B. nach Kondom-Fatigue), muss präzise sondiert werden, wann die sich zunehmend etablierende HIV-Präexpositionsprophylaxe (PrEP) die bessere Wahl darstellt. Vor dem Hintergrund einer generalisierten everyone at risk-Annahme über MSM wird die PrEP zunehmend zu einem standard of care. Zwar kann kein Zweifel daran bestehen, dass dies für bestimmte MSM mit einem bestimmten Risikoprofil wünschenswert ist. (...) Es ist aber von Variabilitäten (z. B. casual condomless sex versus random condomless sex) auszugehen, die zur Vermeidung einer unverhältnismäßigen Medikalisierung berücksichtigt werden müssen. Im Spannungsfeld von hochpotenter HIV-Prävention und Medikalisierung insbesondere von Männern, die Sex mit Männern praktizieren, soll im Sinn einer Güterabwägung gefragt werden, wann genau eine PrEP (dauerhaft oder on demand) mehr Vorteile und weniger Nachteile bietet als der Gebrauch von Kondom oder PEP. Dazu gehört ein Fokus auf den aktuellen Stand der klinischen Forschung und ein Fokus auf die medizinethische Debatte. Die Medizingeschichte der Prävention und der HIV-Erkrankung erweist sich dabei als relevanter Erörterungszusammenhang für die weitgehend noch ausstehende ethische Untersuchung der PrEP. Methodisch basiert diese Arbeit auf einer Auswertung der interdisziplinären Fachliteratur über die HIV-Präexpositionsprophylaxe im Besonderen und über HIV-Prävention im Allgemeinen. Basierend auf den PRISMA (Prefered Reporting Items for Systematic Reviews and Meta-Analyses) Guidelines wurden aus der Datenbank PubMed/MEDLINE solche Studien ausgewählt, die die aktuelle klinische Praxis der PrEP oder eine medizinethische Diskussion der PrEP zum Gegenstand haben. Auf der Basis dieser Literatur erfolgt eine diskursive Erörterung und Abwägung der verfügbaren Pros und Cons zur PrEP. Präventionsmaßnahmen treten regelmäßig als ambivalente Instrumente der Gesundheitsförderung zwischen Liberalisierung und Restringierung des Individuums hervor. Insgesamt bietet daher die PrEP on demand gegenüber der kontinuierlichen PrEP im Sinne der Personalisierung die Option einer individuellen Anpassung an konkretes Risikoverhalten. Auch im Sinne einer Güterabwägung hat die PrEP gewichtige Vorteile gegenüber der kontinuierlichen PrEP und gegenüber einer PEP, wenn kein dauerhaft gleichhohes Risiko vorliegt. In dieser medizinethischen Untersuchung wird darauf hingewiesen, dass es sich bei MSM um eine heterogene Gruppe handelt, deren individuelles Sexualverhalten eine ebenfalls individualisierte HIV-Präventions-Strategie benötigt. Diese Studie argumentiert daher für ein stark personalisiertes decision making bei möglicher Indikation für eine PrEP bei MSM. Damit soll ein wesentlicher Faktor zur Vermeidung einer Medikalisierung von MSM dargestellt werden. (shrink)

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. (shrink)

Post-exposure prophylaxis in the form of combination drug therapy is now recommended for healthcare workers following occupational HIV exposure. The expansion of this form of preventive medicine to include other types of HIV transmission, notably through sexual activity, raises a number of ethical concerns.

The introduction of pre-exposure prophylaxis (PrEP) for HIV has triggered critical analysis within the social sciences. For example, some have signalled how PrEP may lead to a renewed medicalisation of gay and other homosexually-active men’s sexuality. This chapter challenges some of those accounts. Adopting a public health ethics perspective, it argues that gay men should be understood as agentic in their use of PrEP, as opposed to being the passive victims of medicalisation, and that greater attention should be paid (...) to questions of pleasure in PrEP use. Applying a reproductive justice framework, the chapter argues that the worldwide inaccessibility of PrEP constitutes a more serious ethical issue than the potential problem of the medicalisation of gay men’s sexuality. (shrink)

Inequities in HIV pre-exposure prophylaxis (PrEP) use persist in the United States. Although scientific advancement in delivery options and social acceptance of PrEP has occurred in the past decade, gaps remain in ensuring that this sexual health program is available to all. Components of what a national PrEP program for all would look like are discussed.

The implementation of pre-exposure prophylaxis (PrEP) as a new tool for prevention against HIV raised particular ethical concerns regarding the individuals’ and the collective's best interests in France. It was questioned whether the beneficence of taking or prescribing PrEP regarding its high efficacy to protect people from HIV is always more important than the maleficence represented by the risks involved, such as healthy people taking a pill with side effects, the growth of sexually transmitted infections or the potential generalization (...) of risk-taking sexual behaviour. The main objective of this study was to explore patients’ and health professionals’ ethical questioning on PrEP. Sixty-nine qualitative interviews were conducted with 45 users and 24 healthcare professionals. Overall, this study shows that those primarily concerned by PrEP tend to dismiss ethical questions regarding PrEP itself in the name of its efficacy and the empowerment it allows, but they would rather stress the impact PrEP can have on individuals’ sexual behaviour and how it can affect their autonomy if it is prescribed blindly without taking into consideration the specific living context and life history of each PrEP user. (shrink)

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, (...) and/or limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. (shrink)

The ethics of safe sex in the gay community has, for many years, been focused on debates surrounding the responsibility regarding the use of condoms to prevent HIV transmission, once the only tool available. With the development of Truvada as a pre-exposure prophylaxis for HIV, for the first time in the history of the HIV/AIDS epidemic there is the potential to significantly reduce the risk of HIV transmission during sex without the use of condoms. The introduction of PrEP necessitates (...) a renewed discussion about the politics and ethics of safe sex for men who have sex with men. We present the arguments of authors who hold radically opposite positions with regard to the ethics of condom use by gay men, but who currently both criticize the use of PrEP. We offer a critique of their arguments and advance the position that the use of PrEP, even without condoms, can be acceptable and part of a safe sex ethics framework for MSM. (shrink)

The paper identifies common barriers and challenges to Pre-Exposure Prophylaxis (PrEP) uptake and offers considerations for state and local public health departments to address barriers and retool infrastructure to increase access to PrEP to new users. Authors identify synergistic opportunities with federal agencies and funders to advance PrEP-related HIV prevention efforts, that prioritize strategies and investments to provide PrEP to people who could benefit from the intervention but are unaware of PrEP or struggle to access it. Barriers discussed and (...) examined include financing strategies to reduce financial burden of PrEP medication, expanding PrEP access and outreach beyond clinical settings, and increasing the network and reach of the provider community to serve people we oppress through policy choices and discourses of racial and socioeconomic inferiority. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

In this article, I challenge the risk assessment approach to the ethics of pre-exposure prophylaxis (PrEP) as HIV prevention among men who have sex with men (MSM). Traditional risk assessment focuses on the medical risks and benefits of using medical technologies, but this emphasizes certain risks and benefits over others. The medical risks of using PrEP are presently being overblown and its social and political risks are being overlooked. By recontextualizing risk within the history of HIV and considering the (...) lived experiences of MSM with sex, HIV, and HIV prevention, we can broaden the present risk assessment framework to include all of the relevant risks involved in using PrEP. We can also better situate risk as one of several moral concepts, including trust and solidarity, which move us towards a more nuanced analysis of the social and political effects of PrEP on the relationships and communities of MSM. (shrink)

The effectiveness of antiretroviral regimes (ARVs) to reduce risk of HIV transmission from mother to child and as post-exposure prophylaxis has been known for almost two decades. Recent research indicates ARVs can also reduce the risk of HIV transmission via sexual intercourse in two other ways. With pre-exposure prophylaxis (PrEP), ARVs are used to reduce risk of HIV acquisition among persons who are HIV negative and significantly exposed to the virus. With treatment as prevention (TasP), ARVs are used (...) to reduce risk of HIV transmission from persons who are already HIV positive. The development of these new prevention strategies raises a rationing problem: given the chronic shortage of ARVs for HIV-infected persons in need of treatment, is it ethically justified to allocate ARVs for PrEP and/or TasP? This article examines the intuitively appealing view that allocation of ARVs for treatment should be the highest priority, the use of ARVs for TasP should be a secondary priority, and that utilizing ARVs for PrEP would be unethical. I will argue that selective, evidence-based allocation of ARVs for prevention in certain cases could be ethically justified even when there is insufficient anti-retroviral access for all those needing it for treatment. (shrink)

This dossier article contains four short and varied contributions from activists and other service and healthcare providers who have been agitating and working on the frontlines of HIV/AIDS in Ireland since the early 1980s. The dossier contains: (1) a history, by Bill Foley, of the early collective efforts of a group of gay men to provoke government action and healthcare under the umbrella of Gay Health Action (GHA) (2) a speech delivered by Dr. Erin Nugent to government officials on the (...) re-branding of HIV Ireland in 2015; (3) a brief history, recounted by Noel Donnellan, of ACT UP Dublin since it was revitalized in 2016 by a small cohort of dedicated activists from a dormant group into a vibrant collective that has achieved great legislative change with regards to pre-exposure prophylaxis (PrEP); and (4) a polemic, written by Thomas Strong, on living with HIV as a queer man in Ireland that demonstrates the ways in which HIV stigma not only thrives in but molds and shapes twenty-first-century gay men’s communities, both in real life and online. (shrink)

In 2004, the first ever multi‐sited clinical trials studied the prospect of HIV biomedical prevention (referred to as pre‐exposure prophylaxis—‘PrEP’). The trials were implemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised concerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and (...) protocol. While some of the disputes, especially those pertaining to community engagement mechanisms, were ultimately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scientific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized. (shrink)

Vaccination, meaning induction of immunity through controlled exposure to antigens, has been mainly used as a prophylactic measure, but more recently as a therapeutic measure. As far as ethical dilemmas from therapeutic vaccines resemble those occurring for conventional treatment clinical trials, this chapter will focus only on prophylactic vaccines. Analogously, some of the ethical aspects of pre-exposure prophylaxis through medication or passive immunity are shared with prophylactic vaccines. This chapter will discuss the implications of having most vaccine trials not (...) conducted in combination with health care, the compensation of vaccine study participants, the preventive misconception, the need to keep participant commitment in vaccine studies, post-trial access in vaccine trials, controlled human infection models, studies in special populations, and vaccine community-based studies. (shrink)

In his ‘When conscientious objection runs amok: A physician refusing human immunodeficiency virus preventative to a bisexual patient’, Brummett has argued that Catholic physicians should not be able to raise conscientious objections to HIV pre-exposure prophylaxis for bisexual patients, as this constitutes discrimination. Brummett argues that such a conscientious objection represents an instance of conscience creep, which he argues is undesirable. Here I re-analyse the case presented by Brummett using a teleological framework and making reference to Catholic teaching on (...) cooperation with evil. While I agree with Brummett that in this case the physician should not have had the right to conscientiously object, I argue that the teleological framework offers advantages over the argument Brummett has presented. I also comment on why only considering empirically measurable harm as a publicly defensible reason for one to hold a conscientious objection is problematic, as well as on the difficulties associated with cases of discrimination in a pluralistic society. (shrink)

In order to demedicalize the ethics of pre-exposure prophylaxis as HIV prevention, I consider the social effects on men who have sex with men. The Centers for Disease Control and Prevention considers MSM to be the highest risk group for contracting HIV in the USA. The ethics of using PrEP as HIV prevention among MSM, however, has both a medical dimension and a social dimension. While the medical dimension of the ethics of PrEP includes concerns about side effects, drug (...) resistance and distribution, the social dimension of the ethics of PrEP includes concerns about stigmatization, sexual and romantic relationships and sexual freedom. The medical concerns of the ethics of PrEP may take precedence over the social concerns, but there is a growing body of literature that already addresses the medical concerns. Much less attention has been given to the social concerns of the ethics of PrEP, and in this article, I aim to fill this gap in the literature. Therefore, I focus on the often-overlooked social dimension of the ethics of PrEP to help understand the connection between the risks, relationships and communities of MSM using PrEP as HIV prevention. (shrink)

Amidst growing global endorsements of new biomedical HIV prevention strategies, ARV‐based pre‐exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at‐risk groups than conventional prevention strategies (such as sexual partner reduction, condom use, and prevention of mother‐to‐child transmission), PrEP is more costly. PrEP requires more ongoing contact between individuals and providers, and a level of surveillance from the health system that is not necessary with (...) other preventive measures. In this sense, it represents a new bio‐technology for HIV prevention that poses particular challenges for worldwide implementation, given developing countries’ struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation, this paper explores the ethical parameters of a likely scenario for PrEP usage in a single, resource‐poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research, while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho, we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEP's potential successes and pitfalls in a developing country, given the country's high HIV prevalence, struggles to achieve universal access to HIV treatment regimes, continued existence of stigma around the epidemic, and difficulties in addressing persistent social inequalities that fuel infections. (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

In this article we explore how two enactments of HIV – the UN’s AIDS Clock and clinical trials for an HIV biomedical prevention technology or pre-exposure prophylaxis – entail particular globalizing and localizing dynamics. Drawing on Latour’s and Whitehead’s concept of proposition, and Serres’ call for a philosophy of prepositions, we use the composite notion of pre/pro-positions to trace the shifting topological status of HIV. For example, we show how PrEP emerges through topological entwinements of globalizing biomedical standardization, localizing (...) protests against PrEP trials and globalizing ethical principles. We go on to examine how our own analysis manifests a parallel topological pattern in which we deploy a globalizing argument about the localizing of the globalizing found in the AIDS Clock and the PrEP trails. Finally, we consider how the movement of ‘topology’ into the social sciences might itself benefit from a topological treatment. (shrink)

The United States has the fastest growing prison population in the world, and elevated incarceration rates, substance use, and human immunodeficiency virus (HIV) prevalence are fueling each other. Yet without a national guideline mandated for HIV care within the prison system, standards for state and federal prisons vary greatly.

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 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. (shrink)

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing (...) the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm. (shrink)

Amidst growing global endorsements of new biomedical HIV prevention strategies, ARV-based pre-exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at-risk groups than conventional prevention strategies (such as sexual partner reduction, condom use, and prevention of mother-to-child transmission), PrEP is more costly. PrEP requires more ongoing contact between individuals and providers, and a level of surveillance from the health system that is not necessary with other (...) preventive measures. In this sense, it represents a new bio-technology for HIV prevention that poses particular challenges for worldwide implementation, given developing countries’ struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation, this paper explores the ethical parameters of a likely scenario for PrEP usage in a single, resource-poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research, while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho, we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEP's potential successes and pitfalls in a developing country, given the country's high HIV prevalence, struggles to achieve universal access to HIV treatment regimes, continued existence of stigma around the epidemic, and difficulties in addressing persistent social inequalities that fuel infections. (shrink)

In this paper, I consider how trust affects the decisions of men who have sex with men (MSM) around using pre-exposure prophylaxis (PrEP) as HIV prevention in their sexual and romantic relationships, and how the use of PrEP affects their relationships with healthcare providers. MSM have to trust their sexual and romantic partners as well as their healthcare providers for PrEP to be successful as a relatively new HIV prevention strategy. This trust includes both interpersonal trust and institutional trust (...) and it is complicated by different kinds of relationship dynamics and the history of prejudice against MSM in healthcare institutions. (shrink)

In three experiments, picture quality between test items was manipulated to examine whether subjects’ expectations about the fluency normally associated with these different stimuli might influence the effects of fluency on preference or familiarity-based recognition responses. The results showed that fluency due to pre-exposure influenced responses less when objects were presented with high picture quality, suggesting that attributions of fluency to preference and familiarity are adjusted according to expectations about the different test pictures. However, this expectations influence depended on subjects’ (...) awareness of these different quality levels. Indeed, imperceptible differences seemed not to induce expectations about the test item fluency. In this context, fluency due to both picture quality and pre-exposure influenced direct responses. Conversely, obvious, and noticed, differences in test picture quality did no affect responses, suggesting that expectations moderated attributions of fluency only when fluency normally associated with these different stimuli was perceptible but difficult to assess. (shrink)

In three experiments, picture quality between test items was manipulated to examine whether subjects’ expectations about the fluency normally associated with these different stimuli might influence the effects of fluency on preference or familiarity-based recognition responses. The results showed that fluency due to pre-exposure influenced responses less when objects were presented with high picture quality, suggesting that attributions of fluency to preference and familiarity are adjusted according to expectations about the different test pictures. However, this expectations influence depended on subjects’ (...) awareness of these different quality levels. Indeed, imperceptible differences seemed not to induce expectations about the test item fluency. In this context, fluency due to both picture quality and pre-exposure influenced direct responses. Conversely, obvious, and noticed, differences in test picture quality did no affect responses, suggesting that expectations moderated attributions of fluency only when fluency normally associated with these different stimuli was perceptible but difficult to assess. (shrink)

This study explored pre-service teachers’ (N = 37) perceptions about teaching controversial global and local topics. Additionally, it examined participants’ level of preparedness, motivation and perceived hindrances to teaching controversial issues. To do so, the study used a interpretive phenomenological approach (IPA). Data from written reflections and semi-structured interviews showed 80 percent of participants lacked exposure to college work that examined controversial issues prior to taking Social Studies Methods course. However, after taking the course, participants were able to identify controversial (...) topics, but they still displayed limited critical awareness and conceptualization of teaching controversial issues. Other findings pointed to the benefits of teaching controversial topics in a planned and intentional manner. (shrink)

Using a sample of US stocks over the period 1991–2019, we test whether stocks with high exposure to a social index exhibit high returns. Using a univariate analysis, our in‐sample results show that stocks with high sensitivities to the MSCI KLD 400 Social Index underperform stocks with low sensitivities by an annual risk‐adjusted performance of 7.02%. The negative premium is also larger in the post‐crisis period of 2007–2019 and is equal to 10.25%. The out‐of‐sample results offer, however, only weak evidence (...) of such a finding, with a risk‐adjusted performance difference of merely −0.84% over the full sample period and no significant differences between the pre‐crisis and post‐crisis periods. In the multivariate regression, we find evidence of a negative relationship between exposure to the social index and stock performance. Moreover, we find that stocks with high exposure to the social index display a low corporate social responsibility score, a high Tobin’s Q, high long‐term debt, a large size, high total risk, a high market beta, a high SMB coefficient, a low HML coefficient, and a small MOM coefficient. (shrink)

BackgroundAcrophobia is a specific phobia characterized by a severe fear of heights. The purpose of the present study was to investigate the efficacy of two therapies that may ameliorate symptoms of acrophobia and anxiety sensitivity, i.e., virtual reality exposure therapy (VRET) and eye movement desensitization and reprocessing (EMDR) therapy with a Waiting List Control Condition (WLCC).MethodsWe applied a three-armed randomized controlled pre-post-test design with 45 female adolescent students. Students who met DSM-5 criteria for acrophobia were randomly assigned to either VRET (...) (N = 15;Mage = 17.26; SD = 1.32), EMDR (N = 15;Mage = 17.15; SD = 1.57), or a WLCC (N = 15;Mage = 17.50; SD = 1.26). The study groups were evaluated one week before the intervention and one week after the last intervention session regarding symptoms of acrophobia (Severity Measure for Acrophobia) and anxiety sensitivity (Anxiety Sensitivity Index).ResultsThe data showed that both the application of VRET and EMDR therapy were associated with significantly reduced symptoms of acrophobia (d = 1.03 for VRET and d = 1.08 for EMDR) and anxiety sensitivity (d = 1.15 for VRET and d = 1.13 for EMDR) in comparison to the Waiting List.LimitationsThe sample consisted only of adolescent women. Due to the recognizable differences between the two interventions, the therapists and the participants were not blind to the conditions.ConclusionThe results suggest that both VRET and EMDR are interventions that can significantly improve symptoms of acrophobia and anxiety sensitivity in female adolescents.Clinical Trial Registrationhttps://www.irct.ir/trial/57391, identifier: IRCT20210213050343N1. (shrink)

While there is significant consensus that undergraduate medical education should include bioethics training, there is widespread debate about how to teach bioethics to medical students. Educators disagree about course methods and approaches, the topics that should be covered, and the effectiveness and metrics for UME ethics training. One issue that has received scant attention is the timing of bioethics education during medical training. The existing literature suggests that most medical ethics education occurs in the pre-clinical years. Follow-up studies indicate that (...) medical students in their clinical rotations have little recall or ability to apply ethics concepts that were learned in their pre-clinical training. Trainees also report a desire for medical ethics to be taught in the context of practical application, which would suggest that the timing of pre-clinical ethics education is flawed. However, moving bioethics training to the clinical years should not be assumed to be the solution to the problems of recall and theory application. We argue that the effectiveness of timing bioethics education will depend on when medical students witness or experience particular categories of ethical dilemmas during their training. Our overarching hypothesis is that ethics education will be most effective when the bioethics training on a particular topic correlates to experiential exposure to that ethical issue. The purpose of our current study was to describe medical students exposure to particular categories of ethical conflicts, dilemmas, or issues. Our results may help bioethics educators better strategize about the most effective timing of medical ethics training in UME. (shrink)

We investigated the effects of everyday language exposure on the prediction of orthographic and phonological forms of a highly predictable word during listening comprehension. Native Japanese speakers in Tokyo (Experiment 1) and Berlin (Experiment 2) listened to sentences that contained a predictable word and viewed four objects. The critical object represented the target word (e.g., /sakana/;fish), an orthographic competitor (e.g., /tuno/;horn), a phonological competitor (e.g., /sakura/;cherry blossom), or an unrelated word (e.g., /hon/;book). The three other objects were distractors. The Tokyo (...) group fixated the target and the orthographic competitor over the unrelated objects before the target word was mentioned, suggesting that they pre-activated the orthographic form of the target word. The Berlin group showed a weaker bias toward the target than the Tokyo group, and they showed a tendency to fixate the orthographic competitor only when the orthographic similarity was very high. Thus, prediction effects were weaker in the Berlin group than in the Tokyo group. We found no evidence for the prediction of phonological information. The obtained group differences support probabilistic models of prediction, which regard the built-up language experience as a basis of prediction. (shrink)

Did Beethoven and Mozart have more in common with each other than Clapton and Hendrix? The current research demonstrated the widely reported Mozart Effect as only partly significant. Event-related brain potentials were recorded from 16 professional classical and rock musicians during a standard 2 stimulus visual oddball task, while listening to classical and rock music. During the oddball task participants were required to discriminate between an infrequent target stimulus randomly embedded in a train of repetitive background or standard stimuli. Consistent (...) with previous research, the P3 and N2 ERPs were elicited in response to the infrequent target stimuli. Own genre preference resulted in a reduction in amplitude of the P3 for classical musicians exposed to classical music and rock musicians exposed to rock music. Notably, at the pre-attentive stage of processing beneficial effects of exposure to classical music were observed for both groups of musicians. These data are discussed in terms of short and long-term music benefits on both conscious and unconscious cognitive processes. (shrink)

Mass media play an important role in changing body image. This study aimed to determine the role of media (magazines and television) in body weight concern among university females in five Arab countries. A total sample of 1134 female university students was selected at convenience from universities in five Arab countries: Bahrain, Egypt, Jordan, Oman and Syria. The females' ages ranged from 17 to 32. A pre-tested questionnaire was used to assess the exposure to mass media regarding weight concerns. For (...) the variables on exposure to mass media, girls were divided into two groups: infrequently exposed and frequently exposed. In general, the females who were exposed to mass media had a greater risk of having dieted to lose weight and changing their ideas of a perfect body shape than those who were not exposed or infrequently exposed. The association of exposure to magazines with having dieted to lose weight was only significant among females in Bahrain (p<0.044), Egypt (p<0.001) and Jordan (p<0.001). Exposure to television had a weaker association than exposure to magazines with body weight concerns of females. The association of exposure to television with females' idea of a perfect body shape was only statistically significant in females in Egypt (p<0.019) and Oman (p<0.019). The pressure from mass media on the body weight concern of female university students may lead these women to practise unhealthy weight control diets. (shrink)

Previous research suggests that exposure to nature may reduce delay discounting and thereby facilitate healthier dietary intake. This pre-registered study examined the impact of online exposure to images of natural scenes on delay discounting and food preferences. It was predicted that exposure to images of natural scenes would be associated with: lower delay discounting; higher desirability for fruits and vegetables ; and delay discounting would mediate the effect of nature-image exposure on food desirability. Adult participants were recruited to an online (...) between-subjects experiment in which they viewed a timed sequence of six images either showing natural landscape scenes or urban scenes. They then completed measures of mood, delay discounting and rated their momentary desire to eat four fruits and vegetables, and four energy-dense foods. There was no statistically significant effect of experimental condition on delay discounting or food desirability. Bayes factors supported the null hypothesis for discounting, and energy-dense food desirability, but provided no strong evidence for either hypothesis for F&V desirability. These findings indicate that brief online exposure to images of nature does not affect momentary impulsivity or energy-dense food preference, whereas for preference for less-energy dense foods, the evidence was inconclusive. (shrink)

This study examines the influence of underwriter–auditor relationship on pre-initial public offering earnings management. Using a sample of Chinese to-be-listed firms, we find that a close UAR, as reflected in repeated collaborations between an underwriter and an audit firm in IPOs, is positively associated with pre-IPO earnings management. This association is more pronounced for firms with politically connected auditors/underwriters, firms with less reputable auditors/underwriters, firms located in provinces with weak legal environment, firms to-be-listed on boards with lax listing requirements, and (...) firms whose auditors are with low industry specialization, and legal liability exposures. We provide further evidence that UAR is associated with greater likelihood of irregular activities in post-IPO period and poorer post-IPO financial performance. To the extent that we control for alternative explanations and potential endogeneity, our results suggest that the collusion incentive is likely to drive repeated collaborations between underwriters and auditors in the Chinese IPO market. Our findings provide interesting implications for auditors, investors, and regulators seeking to understand the Chinese IPO market. (shrink)

Fast and accurate recognition of teammates is crucial in contexts as varied as fast-moving sports, the military, and law enforcement engagements; misrecognition can result in lost scoring opportunities in sport or friendly fire in combat contexts. Initial studies on teammate recognition in sport suggests that athletes are adept at this perceptual ability but still susceptible to errors. The purpose of the current proof-of-concept study was to explore the trainability of teammate recognition from very brief exposure to vision of the whole-body (...) form and motion of a previously unknown individual. Participants were divided into three groups: a 4-week training group who were also the actors for the test and training footage, a 2-week training group, and a no-training group. Findings revealed significant differences between the training groups and their improvement from the pre-to post-test on Response Accuracy and Movement Time. The current study found the best performance in the 4-week Training group. The biggest improvement was found in the 2-week training group, whilst no significant improvement was made in the Control group. These results suggest that training was effective, but also indicate that having initially performed the movements as actors may have led to improvements in baseline testing and ultimately the best results, thus physical performance of skills combined with video-based training may reduce the amount of time needed to improve teammate identification. (shrink)

Aims: Attentional bias, alcohol craving, and anxiety have important implications in the development and maintenance of alcohol use disorder. The current study aims to test the effectiveness of a Virtual Reality Cue-Exposure Therapy to reduce levels of alcohol craving and anxiety and prompt changes in AB toward alcohol content.Method: A 49-year-old male participated in this study, diagnosed with severe AUD, who also used tobacco and illicit substances on an occasional basis and who made several failed attempts to cease substance misuse. (...) The protocol consisted of six VR-CET booster sessions and two assessment sessions over the course of 5 weeks. The VR-CET program consisted of booster therapy sessions based on virtual reality exposure to preferred alcohol-related cues and contexts. The initial and final assessment sessions were focused on exploring AB, alcohol craving, and anxiety using paper-and-pencil instruments and the eye-tracking and VR technologies at different time points.Results: Pre and post assessment sessions indicated falls on the scores of all instruments assessing alcohol craving, anxiety, and AB.Conclusions: This case report, part of a larger project, demonstrates the effectiveness of the VR-CET booster sessions in AUD. In the post-treatment measurements, a variety of instruments showed a change in the AB pattern and an improvement in craving and anxiety responses. As a result of the systematic desensitization, virtual exposure gradually reduced the responses to significant alcohol-related cues and contexts. The implications for AB, anxiety and craving are discussed. (shrink)