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Introduction: Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high‐impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, "grey areas," or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. Discussion: A group of IS experts affiliated with NIMH‐funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH‐related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence‐based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. Conclusions: HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high‐impact HIV/MH implementation research. [ABSTRACT FROM AUTHOR]

Introduction: While there is a global consensus on monitoring Human Immunodeficiency Virus (HIV) treatment progress, there has been less attention to the degree of consistency of the measurement of HIV prevention programmes—and the global prevention response is not on‐track to achieve 2020 goals. In this paper, we assess the degree of variability in primary prevention indicators selected by national strategic plans (NSPs) and global stakeholder monitoring and evaluation (M&E) strategies. Methods: We obtained the most recent NSPs from low and middle income Joint United Nations Programme on HIV/AIDS (UNAIDS) Fast‐Track countries, and M&E documents from The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund), President's Emergency Plan for AIDS Relief (PEPFAR), UNAIDS, the Global HIV Prevention Coalition and the World Health Organization (WHO). We extracted HIV primary prevention indicators from each document, standardized and aggregated them by age/ sex, categorized indicators by topic, and evaluated the frequency of matched indicators between countries and stakeholders. Data were collected between February and April of 2019. Results: Twenty‐one NSPs and five global stakeholder documents were assessed; 736 primary prevention indicators were identified; 284 remained following standardization and aggregation. NSPs contained from 3 to 48 primary prevention indicators, with an average of 23; categories included: HIV education and outreach (17.6%), testing (17.3%) and condom use (16.2%). Of unique national indicators, only 34% was shared between two or more countries. Sixty‐nine per cent was applied in a single country only. 56% of NSP indicators did not appear in any global stakeholder document. Conversely, 42% of global indicators did not appear in any surveyed NSPs. Within global indicators, 63% was only measured by one global body, and no single indicator was measured by all five. Conclusions: These analyses reveal a lack of consensus both between and within countries' and global stakeholders' measurement of HIV prevention. Though some variability is expected, these findings point to a need to refocus attention on achieving greater consensus on a global measurement framework for HIV prevention. [ABSTRACT FROM AUTHOR]

Introduction: In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. Discussion: USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. Conclusions: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example. [ABSTRACT FROM AUTHOR]

Introduction: The transition from paediatric to adult care poses risks to the health of young adults living with HIV if unsuccessful, including interruptions in care and poor health outcomes. Evolving best practices in HIV healthcare transition should ideally be informed by real-world qualitative and quantitative clinical healthcare transition outcomes. There has been a recent proliferation of HIV healthcare transition outcome research, largely from Europe and North America. Methods: A literature search was undertaken using the online databases PubMed, Web of Science, and Google Scholar. Medical subject and text word searches were combined for terms relating to HIV, paediatric transition outcomes, and internal and external factors were used to identify peer-reviewed articles. Results: In this paper, we review data on HIV healthcare transition outcomes in North America and Europe. Internal and external factors which may impact the success of HIV healthcare transition are examined. We describe ongoing research efforts to capture transition outcomes in the North America and Europe. Clinical, operational, and implementation science research gaps that exist to date are highlighted. Efforts to improve HIV healthcare transition research through country-level surveillance networks and large multicentre cohorts, including data integration and linkage between paediatric and adult cohorts are discussed. Conclusions: We identified the need for a comprehensive approach to implementing empirically supported protocols to support healthcare transition for ALHIV. While there is limited prospective longitudinal cohort data available at this time, cohorts linking the paediatric and adolescent with ongoing surveillance into adulthood are being developed. Through a review of existing qualitative and quantitative healthcare transition outcomes studies, we identify emerging areas of consensus surrounding healthcare transition research implementation. Successful healthcare transition programmes in Europe and North America often share several characteristics, including implementation of a youth friendly multidisciplinary approach, consistent communication and integration between paediatric and adult care teams, and an individualized approach which is attuned the adolescent's transition readiness. Moving forward, the voices of youth and young adults living with HIV should be included in the development and evaluation of healthcare transition protocols to ensure that the definition of successful transition reflects all of the stakeholders in the transition process. [ABSTRACT FROM AUTHOR]

Introduction: The transition from paediatric to adult care poses risks to the health of young adults living with HIV if unsuccessful, including interruptions in care and poor health outcomes. Evolving best practices in HIV healthcare transition should ideally be informed by real-world qualitative and quantitative clinical healthcare transition outcomes. There has been a recent proliferation of HIV healthcare transition outcome research, largely from Europe and North America. Methods: A literature search was undertaken using the online databases PubMed, Web of Science, and Google Scholar. Medical subject and text word searches were combined for terms relating to HIV, paediatric transition outcomes, and internal and external factors were used to identify peer-reviewed articles. Results: In this paper, we review data on HIV healthcare transition outcomes in North America and Europe. Internal and external factors which may impact the success of HIV healthcare transition are examined. We describe ongoing research efforts to capture transition outcomes in the North America and Europe. Clinical, operational, and implementation science research gaps that exist to date are highlighted. Efforts to improve HIV healthcare transition research through country-level surveillance networks and large multicentre cohorts, including data integration and linkage between paediatric and adult cohorts are discussed. Conclusions: We identified the need for a comprehensive approach to implementing empirically supported protocols to support healthcare transition for ALHIV. While there is limited prospective longitudinal cohort data available at this time, cohorts linking the paediatric and adolescent with ongoing surveillance into adulthood are being developed. Through a review of existing qualitative and quantitative healthcare transition outcomes studies, we identify emerging areas of consensus surrounding healthcare transition research implementation. Successful healthcare transition programmes in Europe and North America often share several characteristics, including implementation of a youth friendly multidisciplinary approach, consistent communication and integration between paediatric and adult care teams, and an individualized approach which is attuned the adolescent's transition readiness. Moving forward, the voices of youth and young adults living with HIV should be included in the development and evaluation of healthcare transition protocols to ensure that the definition of successful transition reflects all of the stakeholders in the transition process. [ABSTRACT FROM AUTHOR]

The social, economic, political and environmental structural factors that increase susceptibility to HIV infection and undermine prevention and treatment efforts continue to pose a challenge. The papers in this series highlight the importance of sustaining those efforts to address the structural drivers of the HIV epidemic, and that initiatives to achieve HIV elimination will only come about through a comprehensive HIV response, that includes meaningful responses to the social, political, economic and environmental factors that affect HIV risk and vulnerability. In the context of declining resources for HIV/AIDS, the papers speak to the need to integrate responses to the structural drivers of HIV/AIDS into future HIV investments, with both initiatives to integrate HIV into broader gender and development initiatives, as well as adaptations of current service models, to ensure that they are sensitive to and able to respond to the broader economic and social responsibilities that their clients face. [ABSTRACT FROM AUTHOR]

Introduction It is increasingly clear that the HIV response will not be sustainable if the number of infections is not significantly reduced. Discussion For 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. Conclusions This 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. [ABSTRACT FROM AUTHOR]

Introduction The 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. Discussion In 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. Conclusions The 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. [ABSTRACT FROM AUTHOR]

The article discusses research which examined the role of pre-exposure prophylaxis (PrEP) in addressing the global HIV/AIDS epidemic. Topics discussed include the papers on the PrEP implementation, potential impact and efficiency, social science concerns and the study of modern PrEP implementation and cost-effectiveness analysis targeting PrEP and antiretroviral (ART).

Women continue to be at special risk for HIV acquisition due to a complex mix of biological, behavioural, structural, cultural and social factors, with unacceptable rates of new infection. Scientific advances over the past decade have highlighted the use of antiretroviral (ARV) drugs as pre-exposure prophylaxis (PrEP) to prevent HIV acquisition (sexually, parenterally and vertically) and ARV treatment (ART) for HIV-positive patients to prevent onward transmission (treatment as prevention - TasP). This paper reviews the evidence base for PrEP and TasP, describes new products in development and the need to translate research findings into programmes with impact at the population level. [ABSTRACT FROM AUTHOR]

Women continue to be at special risk for HIV acquisition due to a complex mix of biological, behavioural, structural, cultural and social factors, with unacceptable rates of new infection. Scientific advances over the past decade have highlighted the use of antiretroviral (ARV) drugs as pre-exposure prophylaxis (PrEP) to prevent HIV acquisition (sexually, parenterally and vertically) and ARV treatment (ART) for HIV-positive patients to prevent onward transmission (treatment as prevention - TasP). This paper reviews the evidence base for PrEP and TasP, describes new products in development and the need to translate research findings into programmes with impact at the population level. [ABSTRACT FROM AUTHOR]

Background The fact that HIV prevention often deals with politicised sexual and drug taking behaviour is well known, but structural HIV prevention interventions in particular can involve alteration of social arrangements over which there may be further contested values at stake. As such, normative frameworks are required to inform HIV prevention decisions and avoid conflicts between social goals. Methods This paper provides a conceptual review and discussion of the normative issues surrounding structural HIV prevention strategies. It applies political and ethical concepts to explore the contested nature of HIV planning and suggests conceptual frameworks to inform future structural HIV responses. Results HIV prevention is an activity that cannot be pursued without making value judgements; it is inherently political. Appeals to health outcomes alone are insufficient when intervention strategies have broader social impacts, or when incidence reduction can be achieved at the expense of other social values such as freedom, equality, or economic growth. This is illustrated by the widespread unacceptability of forced isolation which may be efficacious in preventing spread of infectious agents, but conflicts with other social values. Conclusions While no universal value system exists, the capability approach provides one potential framework to help overcome seeming contradictions or value trade-offs in structural HIV prevention approaches. However, even within the capability approach, valuations must still be made. Making normative values explicit in decision making processes is required to ensure transparency, accountability, and representativeness of the public interest, while ensuring structural HIV prevention efforts align with broader social development goals as well. [ABSTRACT FROM AUTHOR]

The Joint Learning Initiative on Children and AIDS recently recommended that programmes for children affected by HIV and AIDS in sub-Saharan Africa direct more support to families. Interest has grown in including men in such family-orientated interventions by researchers, policy makers, and community and non-governmental organizations. However, there is a lack of good quality data on men's involvement with children in the diverse settings in sub-Saharan Africa. In addition, limited research has examined their role in providing emotional, material support and protection for HIV- and AIDS-affected children and families. In this paper, we describe the availability of data about men and families, in particular fathers, in ongoing sub-Saharan African surveys and longitudinal population cohorts. We discuss the conceptual and measurement issues associated with data collection on men's involvement in these types of studies. We consider the opportunities for improving the collection of data about men and families in household surveys and population cohorts in order to inform the design and evaluation of family-centred interventions for children affected by HIV and AIDS. [ABSTRACT FROM AUTHOR]

In the history of public health, HIV/AIDS is unique; it has widespread and long-lasting demographic, social, economic and political impacts. The global response has been unprecedented. AIDS exceptionalism - the idea that the disease requires a response above and beyond "normal" health interventions - began as a Western response to the originally terrifying and lethal nature of the virus. More recently, AIDS exceptionalism came to refer to the diseasespecific global response and the resources dedicated to addressing the epidemic. There has been a backlash against this exceptionalism, with critics claiming that HIV/AIDS receives a disproportionate amount of international aid and health funding. This paper situations this debate in historical perspective. By reviewing histories of the disease, policy developments and funding patterns, it charts how the meaning of AIDS exceptionalism has shifted over three decades. It argues that while the connotation of the term has changed, the epidemic has maintained its course, and therefore some of the justifications for exceptionalism remain. [ABSTRACT FROM AUTHOR]

As the published literature on HIV therapy continues to grow, it becomes increasing difficult for treating physicians to keep up to date with the latest developments. For example, several thousands of papers have been published since HIV10 in the HIV literature. Websites such as HIV Drug Therapy, which includes a section on new HIV publications, can be a great help, providing a brief summary of interesting papers that have been recently published. In my presentation, I will review what I believe to be some of the most useful and key papers that have been published in the last 2 years. [ABSTRACT FROM AUTHOR]

An abstract of the research paper "Fatal and Non-Fatal AIDS and Non-AIDS events in HIV-1 Infected Patients with High CD4 counts," by J. Reekie and colleagues which was presented at the Tenth International Congress on Drug Therapy in HIV Infection held at Glasgow, Scotland from November 7-11, 2010 is presented.