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)

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)

Few other social technologies and institutions are more consequential to human societies than money. Yet money remains a deeply perplexing phenomenon. On the one hand, it is a pan-human system of valuation, but on the other, it is conventional and variable in its uses. While it is controversial if money instantiates a fully-fledged sign system, it is rife with semiotic capacities. To present an illuminating analysis of money is thus a test case for the Motivation & Sedimentation Model (MSM) of (...) meaning making, with roots in the phenomenology of Husserl and Merleau-Ponty. Using MSM, we analyze two origin accounts of money: the commodity money account evidenced in archaic and classical Greek coinage, and the credit money account exemplified by early findings in Mesopotamia. Both accounts focus on the interactions between the three levels of MSM: the pre-signitive Embodied, the cultural Sedimented, and the interactional Situated levels of meaning and propose different series of “loops” to account for the genesis of money. Despite key differences in the two origins, both imply semiotic processes operating according to motivated, and hence non-arbitrary, conventions developing within institutional formations that ultimately influenc present-day concepts of money. (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)

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)

In 2015, the FDA revised its indefinite deferral policy towards MSM blood donors. I develop an empirical case for the revised policy and show why rights-based objections fail. I introduce and defend a distinction between “ordinary” and “exact” justification that accounts for the worries in the empirical case. I conclude that the FDA is committed to further revising the policy to let MSM donors with exact justification donate.

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)

Precision medicine and molecular systems medicine (MSM) are highly utilized and successful approaches to improve understanding, diagnosis, and treatment of many diseases from bench-to-bedside. Especially in the COVID-19 pandemic, molecular techniques and biotechnological innovation have proven to be of utmost importance for rapid developments in disease diagnostics and treatment, including DNA and RNA sequencing technology, treatment with drugs and natural products and vaccine development. The COVID-19 crisis, however, has also demonstrated the need for systemic thinking and transdisciplinarity and the limits (...) of MSM: the neglect of the bio-psycho-social systemic nature of humans and their context as the object of individual therapeutic and population-oriented interventions. COVID-19 illustrates how a medical problem requires a transdisciplinary approach in epidemiology, pathology, internal medicine, public health, environmental medicine, and socio-economic modeling. Regarding the need for conceptual integration of these different kinds of knowledge we suggest the application of general system theory (GST). This approach endorses an organism-centered view on health and disease, which according to Ludwig von Bertalanffy who was the founder of GST, we call Organismal Systems Medicine (OSM). We argue that systems science offers wider applications in the field of pathology and can contribute to an integrative systems medicine by (i) integration of evidence across functional and structural differentially scaled subsystems, (ii) conceptualization of complex multilevel systems, and (iii) suggesting mechanisms and non-linear relationships underlying the observed phenomena. We underline these points with a proposal on multi-level systems pathology including neurophysiology, endocrinology, immune system, genetics, and general metabolism. An integration of these areas is necessary to understand excess mortality rates and polypharmacological treatments. In the pandemic era this multi-level systems pathology is most important to assess potential vaccines, their effectiveness, short-, and long-time adverse effects. We further argue that these conceptual frameworks are not only valid in the COVID-19 era but also important to be integrated in a medicinal curriculum. (shrink)

Policymakers increasingly draw on scientific methods, including simulation modeling, to justify their decisions. For these purposes, scientists and policymakers face an extensive choice of modeling strategies. Discussing the example of smallpox epidemiology, this paper distinguishes three types of strategies: Massive Simulation Models (MSMs), Abstract Simulation Models (ASMs) and Macro Equation Models (MEMs). By analyzing some of the main smallpox epidemic models proposed in the last 20 years, it discusses how to justify strategy choice with reference to the core characteristics of (...) these respective strategies. First, I argue that MEMs often suffice for policy purposes, and need to be replaced only if they are insufficiently robust. Such robustness results, however, only requires the use of ASMs, not MSMs. Second, I argue that although MSMs have larger potentials than ASMs in various dimensions, they are also more likely to fail—and that in many cases, this probability of failing outweighs their higher potential. In particular, these dimensions include the representation of the relevant target, the accurate measurement of the relevant parameters, the number of parameters included, the number of mechanisms modeled simultaneously, and the ways of dealing with structural uncertainty. While this in no way excludes the prospect that some MSMs provide good justifications for policy decisions, my arguments caution against a general preference for MSMs over ASMs for policy decision purposes in general and vaccination problems in particular. (shrink)

Marginal structural models can be used to estimate the causal effect of a potentially time-varying treatment in the presence of time-dependent confounding via weighted regression. The standard approach of using inverse probability of treatment weighting can be sensitive to model misspecification and lead to high-variance estimates due to extreme weights. Various methods have been proposed to partially address this, including covariate balancing propensity score to mitigate treatment model misspecification, and truncation and stabilized-IPTW to temper extreme weights. In this article, we (...) present kernel optimal weighting, a convex-optimization-based approach that finds weights for fitting the MSMs that flexibly balance time-dependent confounders while simultaneously penalizing extreme weights, directly addressing the above limitations. We further extend KOW to control for informative censoring. We evaluate the performance of KOW in a simulation study, comparing it with IPTW, sIPTW, and CBPS. We demonstrate the use of KOW in studying the effect of treatment initiation on time-to-death among people living with human immunodeficiency virus and the effect of negative advertising on elections in the United States. (shrink)

U.S. Food and Drug Administration policy prohibits blood donation from men who have had sex with men even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different approach to analyzing discrimination claims. I draw on an institutional understanding of injustice to discern and describe five features of the MSM policy (...) and its FDA context that contribute to its discriminatory effect. I note significant similarities in the 1980s policy of deferring Haitians, suggesting an historical pattern of discrimination in FDA deferral policy. Finally, I point to changes needed to move toward a nondiscriminatory deferral policy. (shrink)

Sometimes, people who are otherwise eligible to donate blood are unduly deferred from donating. “Unduly” indicates a gap where a deferral policy misstates what exposes potential donors to risk and so defers more donors than is justified. Since the error is at the policy-level, it’s natural and understandable to focus criticism on reformulating or eliminating the offending policies. Policy change is undoubtedly the right goal because the policy is what prevents otherwise safe eligible donors from donating needed blood. But focusing (...) exclusively at the policy-level passes over a largely undiscussed question: if policy change takes time and there is an urgent need for blood now, then what should unduly deferred donors do in the meanwhile? Blood banks and federal agencies recommend that deferred donors donate their time or money until they become eligible, but blood is a non-fungible good: donated cash or volunteered time cannot replace a transfusion. Further, this request ignores that otherwise eligible donors could safely donate their blood in addition to their time and money. Here is the central question I will focus on in this paper: is a donor morally justified in lying on a questionnaire to donate blood if they justifiably believe that their blood poses no risk to a recipient and knows that honestly answering a donor questionnaire would unduly defer them from donating? (shrink)

Alternatives to convenience sampling (CS) are needed for HIV/STI surveillance of most-at-risk populations in Latin America. We compared CS, time space sampling (TSS), and respondent driven sampling (RDS) for recruitment of men who have sex with men (MSM) and transgender women (TW) in Lima, Peru. During concurrent 60-day periods from June-August, 2011, we recruited MSM/TW for epidemiologic surveillance using CS, TSS, and RDS. A total of 748 participants were recruited through CS, 233 through TSS, and 127 through RDS. The TSS (...) sample included the largest proportion of TW (30.7 %) and the lowest percentage of subjects who had previously participated in HIV/STI research (14.9 %). The prevalence of newly diagnosed HIV infection, according to participants' self-reported previous HIV diagnosis, was highest among TSS recruits (17.9 %) compared with RDS (12.6 %) and CS (10.2 %). TSS identified diverse populations of MSM/TW with higher prevalences of HIV/STIs not accessed by other methods. (shrink)

Many men who have sex with men (MSM) express feeling marginalized by discourses within public health and sexual health nursing that determine bareback sex is deviant and unsafe. Their resistance to risk‐based discourses can be seen within radical sex practices such as deliberately becoming‐infected with HIV (bug‐chasing) and breeding‐infection (gift‐giving). The metaphors of bug‐chasing and gift‐giving, particularly those spread across global online spaces, can influence the sexual experiences and practices of MSM. A metaphor analysis was conducted of Internet forums discussing (...) HIV chasing and gifting metaphors, and showed a variety of discursive meanings, tactics and effects to the radical sex practice. A radical research approach was used to explore the processes of becoming‐infected and breeding‐infection as determinant steps in the symbolic resistance of risk‐based discourses, as well as the creation of new forms of life and community among MSM. Our analyses demonstrate how the gifting/chasing metaphors express MSM's marginalization as well as their lines of flight from having their practices captured within public health discourses. We hope to offer alternative nursing approaches for thinking through and engaging with transgressive and queer sexual practices. (shrink)

Despite billions of dollars spent in risk-reduction measures, the HIV rate in men who have sex with men continues to soar. Although MSM represent approximately 4 percent of the male population in the United States, in 2010 male-to-male sex accounted for 78 percent of new HIV infections among males. More emphasis needs to be given to risk-avoidance measures. The Catholic Church is both courageous and medically correct in stating that homosexual acts are harmful. The health risks of homosexual sex are (...) scarcely mentioned in the public debate, as misguided political correctness seems increasingly to hold science and medical data hostage. Our brothers should be informed about the dangers of an active homosexual lifestyle and encouraged to live chastely. National Catholic Bioethics Quarterly 14.4 : 637–645. (shrink)

Would metaphors used in the context of psychotherapy by people who experience various forms of anxiety disorders differ from those used by people who experience stress? We investigated this question with the help of the Motivation & Sedimentation Model (MSM), a theory of meaning-making developed within the synthetic new discipline of cognitive semiotics. The analysis of a sample of ten transcripts of psychotherapy sessions concerning the topic of anxiety, and a comparable sample concerning stress, showed a significantly stronger proportion of (...) conventionalized metaphors in the stress sample, and a marginally significant difference in the number of innovative metaphors in the anxiety sample. These results suggest that lived experience of an anxiety disorder or another form of maladaptive anxiety affects metaphorical meaning-making, and manifests itself in spontaneous metaphor use. Furthermore, as a result of the conceptual and the empirical investigations of the topic, we propose novel theoretical and operational definitions of the notion of metaphoricity. (shrink)

There is a prevailing conviction that if traditional medicine (TRM) or complementary and alternative medicine (CAM) are integrated into healthcare systems, modern scientific medicine (MSM) should retain its principal status. This paper contends that this position is misguided in medical contexts where TRM is established and remains vibrant. By reflecting on the Chinese policy on three entrenched forms of TRM (Tibetan, Mongolian and Uighur medicines) in western regions of China, the paper challenges the ideology of science that lies behind the (...) demand that all traditional forms of medicine be evaluated and reformed according to MSM standards. Tibetan medicine is used as a case study to indicate the falsity of a major premise of the scientific ideology. The conclusion is that the proper integrative system for TRM and MSM is a dual standard based system in which both TRM and MSM are free to operate according to their own medical standards. (shrink)

U.S. Food and Drug Administration policy prohibits blood donation from men who have had sex with men even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different approach to analyzing discrimination claims. I draw on an institutional understanding of injustice to discern and describe five features of the MSM policy (...) and its FDA context that contribute to its discriminatory effect. I note significant similarities in the 1980s policy of deferring Haitians, suggesting an historical pattern of discrimination in FDA deferral policy. Finally, I point to changes needed to move toward a nondiscriminatory deferral policy. (shrink)

Evidence‐based interventions have been developed and used to prevent HIV infections among black men who have sex with men (MSM) in Canada and the United States; however, the degree to which interventions address racism and other interlocking oppressions that influence HIV vulnerability is not well known. We utilize integrative antiracism to guide a review of HIV prevention intervention studies with black MSM and to determine how racism and religious oppression are addressed in the current intervention evidence base. We searched CINAHL, (...) PsychInfo, MEDLINE and the CDC compendium of evidence‐based HIV prevention interventions and identified seventeen interventions. Three interventions targeted black MSM, yet only one intervention addressed racism, religious oppression, cultural assets and religious assets. Most interventions' samples included low numbers of black MSM. More research is needed on interventions that address racism and religious oppression on HIV vulnerability among black MSM. Future research should focus on explicating mechanisms by which multiple oppressions impact HIV vulnerability. We recommend the development and integration of social justice tools for nursing practice that aid in addressing the impacts of racism and other oppressions on HIV vulnerability of black MSM. (shrink)

Blood service organizations employ various ways to ensure transfusion blood safety, including the testing of all donations for transfusion-transmissible infections (TTI) and the exclusion of donors who are at increased risk of a recent infection. As some TTIs are more common among men who have sex with men (MSM), many jurisdictions (temporarily) defer the donation of blood by sexually active MSM. This boils down to a categorical exclusion of a large group solely on the basis of their sexual orientation, which (...) is seen as unduly discriminatory and stigmatizing. Blood service organizations in the U.K. and the Netherlands have recently changed their deferral policies for MSM. The problem of the MSM deferral involves a conflict between fundamental rights: the right of MSM to equal treatment and the right to health of the recipients of blood and blood products. We distinguish and discuss three broad alternative options to the current categorical deferral of MSM donations: (1) completely abandoning donor selection on the basis of sexual behavior, (2) individual risk assessment of the sexual activities of each potential donor, and (3) individual risk assessment of the sexual activities of MSM only. The new U.K. policy falls within the second category, and the new Dutch policy is in the third category. We argue that each approach comes with moral costs but that the most reasonable option is different from the policies of both the U.K. and the Netherlands. (shrink)

Blood service organizations employ various ways to ensure transfusion blood safety, including the testing of all donations for transfusion-transmissible infections (TTI) and the exclusion of donors who are at increased risk of a recent infection. As some TTIs are more common among men who have sex with men (MSM), many jurisdictions (temporarily) defer the donation of blood by sexually active MSM. This boils down to a categorical exclusion of a large group solely on the basis of their sexual orientation, which (...) is seen as unduly discriminatory and stigmatizing. Blood service organizations in the U.K. and the Netherlands have recently changed their deferral policies for MSM. The problem of the MSM deferral involves a conflict between fundamental rights: the right of MSM to equal treatment and the right to health of the recipients of blood and blood products. We distinguish and discuss three broad alternative options to the current categorical deferral of MSM donations: (1) completely abandoning donor selection on the basis of sexual behavior, (2) individual risk assessment of the sexual activities of each potential donor, and (3) individual risk assessment of the sexual activities of MSM only. The new U.K. policy falls within the second category, and the new Dutch policy is in the third category. We argue that each approach comes with moral costs but that the most reasonable option is different from the policies of both the U.K. and the Netherlands. (shrink)

This article seeks to model the agenda-setting strategies of stakeholders equipped with online and other media in three cases involving protests against multinational corporations (MNCs). Our theoretical objective is to widen agenda-setting theory to a dynamic and nonlinear networked stakeholder context, in which stakeholder-controlled media assume part of the role previously ascribed to mainstream media (MSM). We suggest system dynamics (SD) methodology as a tool to analyse complex stakeholder interactions and the effects of their agendas on other stakeholders. We find (...) that largely similar dynamics of interactions occur among stakeholders in these cases, and that the costs for managements of maintaining their agendas steadily rises. We conclude that the “web of watchdogs” comprises a powerful reason for managers to engage in responsibility negotiations with their stakeholders. (shrink)

Of these two books by Jon Elster, Making Sense of Marx is the more substantial. In it the most substantial parts of Explaining Technical Change reappear; and in it - in its impoverished conception of contradiction - the most striking omission of ETC takes the heaviest toll. ETC is to a very considerable extent taken up with reviews of other people's work on the economics of technical change. Its Part One survey of the philosophy of social science is very rapid, (...) with little novelty in- tended or offered. The survey is not systematically, or even incessantly, drawn upon in the Part Two discussion of technical change. MSM, by contrast, is a library of penetrating and provocative discussion, which ranks in quality with books by G.A. Cohen and John Roemer or Richard Miller among the number of recent exactingly analytical studies of Marx's theories, and is more comprehensive than any of these. (shrink)

Modelling contagious diseases needs to include a mechanistic knowledge about contacts between hosts and pathogens as specific as possible, e.g., by incorporating in the model information about social networks through which the disease spreads. The unknown part concerning the contact mechanism can be modelled using a stochastic approach. For that purpose, we revisit SIR models by introducing first a microscopic stochastic version of the contacts between individuals of different populations (namely Susceptible, Infective and Recovering), then by adding a random perturbation (...) in the vicinity of the endemic fixed point of the SIR model and eventually by introducing the definition of various types of random social networks. We propose as example of application to contagious diseases the HIV, and we show that a micro-simulation of individual based modelling (IBM) type can reproduce the current stable incidence of the HIV epidemic in a population of HIV-positive men having sex with men (MSM). (shrink)

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)

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)