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IntroductionThe World Health Organization recently released guidelines on the use of pre‐exposure prophylaxis (PrEP) for prevention of HIV infection among men and transgender women (TGW) who have sex with men based on results of randomized clinical trials. The aim of this commentary is to discuss the opportunities and challenges of incorporating PrEP into the Brazilian continuum of HIV care and prevention for men who have sex with men (MSM) and TGW.DiscussionKey aspects of the AIDS epidemic among MSM and TGW in Brazil and the comprehensive Brazilian response to the epidemic are presented. The universal access to health care provided through the Brazilian Unified Health System (SUS) and the range of prevention and care services already available countrywide to HIV‐positive individuals and at‐risk MSM and TGW are identified as the main facilitators for the implementation of PrEP. Limited PrEP awareness among MSM, TGW and health care providers, low HIV testing frequency and low HIV risk perception among MSM and TGW represent the core challenges to be addressed. Data generated by demonstration projects in Brazil will provide an important contribution to PrEP rollout in Brazil.ConclusionsThe implementation of PrEP in Brazil is feasible. A synergistic rollout of treatment as prevention and PrEP will maximize public health and individual benefits of the country's comprehensive response to the AIDS epidemic.

IntroductionIt is increasingly clear that the HIV response will not be sustainable if the number of infections is not significantly reduced.DiscussionFor two decades, research has been ongoing to identify new behavioural and biomedical strategies to prevent HIV infection. In the past few years, the efficacy of several new strategies has been demonstrated, including oral pre‐exposure prophylaxis (PrEP; i.e. daily use of tenofovir/emtricitabine). Because several social, political and logistic barriers remain, however, optimal PrEP implementation will require a better dissemination of new evidence in a number of areas and additional implementation research from various disciplinary perspectives (i.e. social science, policy and ethics; health systems; and economics, including cost‐effectiveness studies). Discussion of new evidence on those topics, as well as case studies of potential PrEP implementation in diverse environments, can improve the understanding of the role that PrEP may play in addressing the global HIV/AIDS epidemic.In light of these needs, the Network for Multidisciplinary Studies in ARV‐based HIV Prevention (NEMUS) and the World Health Organization (WHO) were honoured to co‐organize a special issue of JIAS aimed at contributing to a scholarly discussion of current conditions surrounding PrEP implementation, potential impact and efficiency, social science concerns and the study of PrEP implementation in specific country cases. The papers included in this monograph identify and cover many of the main aspects of the complex yet promising discussions around PrEP implementation today.ConclusionsThis is a collection of timely contributions from global leaders in HIV research and policy that addresses geographic diversity, uses a trans‐disciplinary approach and covers a variety of the complex issues raised by PrEP. As this publication will become accessible to all, we hope that it will remain a valuable resource for policy makers, programme managers, researchers and activists around the world at a moment of a paradigm shift of the global response to HIV.

IntroductionThe extraordinary feat of proving the effectiveness of oral pre‐exposure prophylaxis (PrEP) in clinical trials in different populations in a variety of settings may prove to have been easier than ensuring it is used well. Decision‐makers must make difficult choices to realize the promise of antiretroviral prophylaxis for their countries. This paper outlines key economic, regulatory and distributive justice issues that must be addressed for effective and acceptable PrEP implementation.DiscussionIn considering the role that PrEP can play in combination prevention programmes, decision‐makers must determine who can benefit most from PrEP, how PrEP can be provided safely and efficiently, and what kind of health system support will ensure successful implementation. To do this, they need contextualized information on disease burden by population, analyses of how PrEP services might best be delivered, and projections of the human resource and infrastructure requirements for each potential delivery model. There are cost considerations, varying cost‐effectiveness results and regulatory challenges. The principles of ethics can inform thorny discussions about who should be prioritized for oral PrEP and how best to introduce it fairly. We describe the cost‐effectiveness of PrEP in different populations at higher risk of HIV exposure, its price in low‐ and middle‐income countries, and the current regulatory situation. We explore the principles of ethics that can inform resource allocation decision‐making about PrEP anchored in distributive justice, at a time when universal access to antiretroviral treatment remains to be assured. We then highlight the role of advocacy in moving the PrEP agenda forward.ConclusionsThe time is ripe now for decisions about whether, how and for whom PrEP should be introduced into a country's HIV response. It has the potential to contribute significantly to high impact HIV prevention if it is tailored to those who can most benefit from it and if current regulatory and pricing barriers can be overcome. Advocacy at all levels can help inform decision‐making and push the access agenda to avert HIV infections among those at highest risk of HIV exposure. The benefits will accrue beyond the individual level to slow HIV transmission at the population level.

IntroductionTowards the end of the twentieth century, significant success was achieved in reducing incidence in several global HIV epidemics through ongoing prevention strategies. However, further progress in risk reduction was uncertain. For one thing, it was clear that social vulnerability had to be addressed, through research on interventions addressing health systems and other structural barriers. As soon as antiretroviral treatment became available, researchers started to conceive that antiretrovirals might play a role in decreasing either susceptibility in uninfected people or infectiousness among people living with HIV. In this paper we focus on the origin, present status, and potential contribution of pre‐exposure prophylaxis (PrEP) within the combination HIV prevention framework.DiscussionAfter a phase of controversy, PrEP efficacy trials took off. By 2015, daily oral PrEP, using tenofovir alone or in combination with emtricitabine, has been proven efficacious, though efficacy seems heavily contingent upon adherence to pill uptake. Initial demonstration projects after release of efficacy results have shown that PrEP can be implemented in real settings and adherence can be high, leading to high effectiveness. Despite its substantial potential, beliefs persist about unfeasibility in real‐life settings due to stigma, cost, adherence, and potential risk compensation barriers.ConclusionsThe strategic synergy of behavioural change communication, biomedical strategies (including PrEP), and structural programmes is providing the basis for the combination HIV prevention framework. If PrEP is to ever become a key component of that framework, several negative beliefs must be confronted based on emerging evidence; moreover, research gaps regarding PrEP implementation must be filled, and appropriate prioritization strategies must be set up. Those challenges are significant, proportional to the impact that PrEP implementation may have in the global response to HIV.

IntroductionPre‐exposure prophylaxis (PrEP) is recommended by the World Health Organization as an effective method of HIV prevention for individuals at risk for infection. In this paper, we describe the unique role that Thailand has played in the global effort to combat the HIV epidemic, including its role in proving the efficacy of PrEP, and discuss the opportunities and challenges of implementing PrEP in a middle‐income country.DiscussionThailand was one of the first countries in the world to successfully reverse a generalized HIV epidemic. Despite this early success, HIV prevalence has remained high among people who inject drugs and has surged among men who have sex with men (MSM) and transgender women (TGW). Two pivotal trials that showed that the use of oral antiretroviral medication as PrEP can reduce HIV transmission were conducted partially or entirely at Thai sites. Demonstration projects of PrEP, as well as clinical trials of alternative PrEP regimens, began or will begin in 2014–2015 in Thailand and will provide additional data and experience on how to best implement PrEP for high‐risk individuals in the community. Financing of drug costs, the need for routine laboratory monitoring and lack of awareness about PrEP among at‐risk groups all present challenges to the wider implementation of PrEP for HIV prevention in Thailand.ConclusionsAlthough significant challenges to wider use remain, PrEP holds promise as a safe and highly effective method to be used as part of a combined HIV prevention strategy for MSM and TGW in Thailand.

IntroductionDespite scale‐up of antiretroviral therapy (ART) for treating HIV‐positive persons, HIV incidence remains elevated among those at high risk such as persons in serodiscordant partnerships. Antiretrovirals taken by HIV‐negative persons as pre‐exposure prophylaxis (PrEP) has the potential to avert infections in individuals in serodiscordant partnerships. Evaluating the cost‐effectiveness of implementing time‐limited PrEP as a short‐term bridge during the first six months of ART for the HIV‐positive partner to prevent HIV transmission compared to increasing ART coverage is crucial to informing policy‐makers considering PrEP implementation.MethodsTo estimate the real world delivery costs of PrEP, we conducted micro‐costing and time and motion analyses in an open‐label prospective study of PrEP and ART delivery targeted to high‐risk serodiscordant couples in Uganda (the Partners Demonstration Project). The cost (in USD, in 2012) of PrEP and ART for serodiscordant couples was assessed, with and without research components, in the study setting. Using Ministry of Health costs, the cost of PrEP and ART provision within a government programme was estimated, as was the cost of providing PrEP in addition to ART. We parameterized an HIV transmission model to estimate the health and economic impacts of 1) PrEP and ART targeted to high‐risk serodiscordant couples in the context of current ART use and 2) increasing ART coverage to 55% of HIV‐positive persons with CD4 ≤500 cells/µL without PrEP. The incremental cost‐effectiveness ratios (ICERs) per HIV infection and disability‐adjusted life year (DALY) averted were calculated over 10 years.ResultsThe annual cost of PrEP and ART delivery for serodiscordant couples was $1058 per couple in the study setting and $453 in the government setting. The portion of the programme cost due to PrEP was $408 and $92 per couple per year in the study and government settings, respectively. Over 10 years, a programme of PrEP and ART for high‐risk serodiscordant couples was projected to avert 43% of HIV infections compared to current practice with an ICER of $1340 per infection averted. This was comparable to ART expansion alone, which would avert 37% of infections with an ICER of $1452.ConclusionsUsing Uganda's gross domestic product per capita of $1681 as a threshold, PrEP and ART for high‐risk persons have the potential for synergistic action and are cost‐effective in preventing HIV infections in high prevalence settings. The annual cost of PrEP in this programme is less than $100 per serodiscordant couple if implemented in public clinics.

IntroductionAfter the initial approval of the use of tenofovir disoproxil fumarate‐emtricitabine (TDF/FTC) by the US Food and Drug Administration in 2012 for anti‐HIV pre‐exposure prophylaxis (PrEP), uptake was initially limited, but more recent community surveys and expert opinion suggest wider acceptance in some key populations.DiscussionDemonstration projects are underway to determine the best practices in the United States to identify at‐risk individuals in primary care and sexually transmitted disease clinics who could benefit from PrEP. Studies of PrEP in combination with behavioural interventions are being evaluated. Studies to evaluate the use of PrEP by HIV‐uninfected women in HIV‐discordant couples interested in safe conception are also getting underway. The optimal deployment of PrEP as part of a comprehensive national HIV/AIDS strategy in the United States has been limited by lack of knowledge among some at‐risk people and by some medical providers indicating that they do not feel sufficiently knowledgeable and comfortable in prescribing PrEP. Studies are underway to determine how to assist busy clinicians to determine which of their patients could benefit from PrEP. Although most federal health insurance programmes will cover most of the costs associated with PrEP, underinsured patients in states that have not enacted health reform face additional challenges in paying for PrEP medication and appropriate clinical monitoring.ConclusionsPrEP implementation in the United States is a work in progress, with increasing awareness and uptake among some individuals in key populations.

Social scientists have much to contribute to the analysis of the real and potential contribution of pre‐exposure prophylaxis (PrEP) to HIV prevention around the world. Beyond just a matter of clinical efficacy and getting pills into people's mouths, PrEP raises a number of important social‐psychological questions that must be attended to in order to translate biomedical and clinical findings into uptake of PrEP among enough people at risk of HIV infection to produce population‐level effectiveness. PrEP is a dynamic phenomenon with "dialectical" attributes that invite both optimism and cynicism as a desirable and effective HIV prevention strategy. PrEP disrupts traditional notions of "safe" and "unsafe" sex; it confers on its users a level of agency and control not generally achieved with condoms; and it affects sexual practices and sexual cultures in meaningful ways. As these dynamics play out in different contexts, and as new modes of PrEP administration emerge, it will be important for social scientists to be engaged in assessing their impact on PrEP implementation and effectiveness.