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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: 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 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]

Introduction: The HIV response has long recognized that certain "key populations" such as individuals in detention, adolescent girls and young women, sex workers, people who use drugs, LGBTQ individuals, migrants and others face higher barriers to access to, uptake of, and retention in HIV prevention and treatment services. One approach to addressing these barriers is the training of community paralegals to advocate for the rights of individuals and to address discrimination in health settings. Discussion: Community paralegal programmes have been able to successfully address rights violations that impact access to health services and underlying determinants of health across a range of countries and populations, focusing upon issues such as discrimination and the denial of health services; unlawful detention of outreach workers, sex workers, persons who use drugs and men who have sex with men; and harmful traditional practices and gender‐based violence. In addition to resolving specific cases, evaluations of paralegal programmes have found that these programmes increased legal literacy among key populations at risk of HIV and increased understanding of human rights among healthcare providers, resulting in improved access to HIV services. Some evaluations have noted challenges related to the sustainability of paralegal programmes similar to those raised with community health worker programmes more broadly. Conclusions: To achieve global HIV goals, funding for legal literacy and paralegal programmes should be increased and interventions should be rigorously evaluated. Efforts should target discrimination in access to HIV prevention and treatment and criminalization of key populations, two key barriers to ensuring access to HIV prevention and treatment services. [ABSTRACT FROM AUTHOR]

ARV-based HIV prevention methods available in pill, gel or ring formulations (broadly referred to as microbicides) offer the possibility of protection against HIV for women who find it difficult because they cannot ask their partners to use condoms or even refuse sex. Partial efficacy of ARV-based medications has been demonstrated in a number of clinical trials around the world among various populations, building the evidence that ARV-based technologies will contribute to reducing the AIDS epidemic worldwide. Disappointing results, however, from two trials in sub-Saharan Africa, where poor adherence contributed to study closure due to futility, have raised questions about whether women at the centre of the epidemic are able to effectively use products that require routine use. Also, there are fears by some of risk compensation by decreased condom use because of the availability of microbicides when only partial efficacy has been demonstrated in microbicide trials to date. Of note, sub-analyses of biologic measures of adherence in trials where this was possible have shown a strong correlation between good adherence and efficacy, reinforcing the necessity of good adherence. Research conducted in conjunction with clinical trials and post-trials in advance of possible rollout of ARV-based products have examined social and cultural factors, gender-related and otherwise, influencing adherence and other aspects of women's use of products. These include HIV stigma, women's perception of risk, partner and community influences and the differing needs of women in various stages of life and in different circumstances. It is the purpose of this supplement to give voice to the needs of women who can benefit from woman-initiated methods by presenting research results and commentary to contribute to the global conversation about optimizing women's experience with ARV-based prevention. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: In 2014, the Government of Thailand recommended pre‐exposure prophylaxis (PrEP) as an additional HIV prevention programme within Thailand's National Guidelines on HIV/AIDS Treatment Prevention. However, to date implementation and uptake of PrEP programmes have been limited, and evidence on the costs and the epidemiological and economic impact is not available. Methods: We estimated the costs associated with PrEP provision among men having sex with men (MSM) participating in a facility‐based, prospective observational cohort study: the Test, Treat and Prevent HIV Programme in Thailand. We created a suite of scenarios to estimate the cost‐effectiveness of PrEP and sensitivity of the results to the model input parameters, including PrEP programme effectiveness, PrEP uptake among high‐risk and low‐risk MSM, baseline and future antiretroviral therapy (ART) coverage, condom use, unit cost of delivering PrEP, and the discount rate. Results: Drug costs accounted for 82.5% of the total cost of providing PrEP, followed by lab testing (8.2%) and personnel costs (7.8%). The estimated costs of providing the PrEP package in accordance with the national recommendation ranges from US$223 to US$311 per person per year. Based on our modelling results, we estimate that PrEP would be cost‐effective when provided to either high‐risk or all MSM. However, we found that the programme would be approximately 32% more cost‐effective if offered to high‐risk MSM than it would be if offered to all MSM, with an incremental cost‐effectiveness ratio of US$4,836 per disability‐adjusted life years (DALY) averted and US$7,089 per DALY averted respectively. Cost‐effectiveness acceptability curves demonstrate that 80% of scenarios would be cost‐effective when PrEP is provided solely to higher‐risk MSM. Conclusion: We provide the first estimates on cost and cost‐effectiveness of PrEP in the Asia‐Pacific region, and offer insights on how to deliver PrEP in combination with ART. While the high drug cost poses a budgeting challenge, incorporating PrEP delivery into an existing ART programme could be a cost‐effective strategy to prevent HIV infections among MSM in Thailand. [ABSTRACT FROM AUTHOR]

Introduction According to UNAIDS, the world currently has an adequate collection of proven HIV prevention, treatment and diagnostic tools, which, if scaled up, can lay the foundation for ending the AIDS epidemic. HIV operations research (OR) tests and promotes the use of interventions that can increase the demand for and supply of these tools. However, current publications of OR mainly focus on outcomes, leaving gaps in reporting of intervention characteristics, which are essential to address for the utilization of OR findings. This has prompted WHO and other international public health agencies to issue reporting requirements for OR studies. The objective of this commentary is to review experiences in HIV OR intervention design, implementation, process data collection and publication in order to identify gaps, contribute to the body of knowledge and propose a way forward to improve the focus on 'implementation' in implementation research. Discussion Interventions in OR, like ordinary service delivery programmes, are subject to the programme cycle, which continually uses insights from implementation and the local context to modify service delivery modalities. Given that some of these modifications in the intervention may influence study outcomes, the documentation of process data becomes vital in OR. However, a key challenge is that study resources tend to be skewed towards documentation and the reporting of study outcomes to the detriment of process data, even though process data is vital for understanding factors influencing the outcomes. Conclusions Interventions in OR should be viewed using the lens of programme evaluation, which includes formative assessment (to determine concept and design), followed by process evaluation (to monitor inputs and outputs) and effectiveness evaluation (to assess outcomes and effectiveness). Study resources should be equitably used between process evaluation and outcome measurement to facilitate inclusion of data about fidelity and dose in publications in order to enable explanation of the relationship between dosing and study outcomes for purposes of scaling up and further refinement through research. [ABSTRACT FROM AUTHOR]

The Volume 18, Supplement 6, December 2015 issue of the "Journal of the International Aids Society" is presented. The publication covers various topics related to AIDS including ending the pediatric HIV epidemic, reducing mortality in HIV-infected infants, and challenges for HIV treatment and prevention in the first week of life.

Introduction: Within healthcare settings, HIV‐related stigma is a recognized barrier to access of HIV prevention and treatment services and yet, few efforts have been made to scale‐up stigma reduction programs in service delivery. This is in part due to the lack of a brief, simple, standardized tool for measuring stigma among all levels of health facility staff that works across diverse HIV prevalence, language and healthcare settings. In response, an international consortium led by the Health Policy Project, has developed and field tested a stigma measurement tool for use with health facility staff. Methods: Experts participated in a content‐development workshop to review an item pool of existing measures, identify gaps and prioritize questions. The resulting questionnaire was field tested in six diverse sites (China, Dominica, Egypt, Kenya, Puerto Rico and St. Christopher & Nevis). Respondents included clinical and non‐clinical staff. Questionnaires were self‐ or interviewer‐administered. Analysis of item performance across sites examined both psychometric properties and contextual issues. Results: The key outcome of the process was a substantially reduced questionnaire. Eighteen core questions measure three programmatically actionable drivers of stigma within health facilities (worry about HIV transmission, attitudes towards people living with HIV (PLHIV), and health facility environment, including policies), and enacted stigma. The questionnaire also includes one short scale for attitudes towards PLHIV (5‐item scale, α = 0.78). Conclusions: Stigma‐reduction programmes in healthcare facilities are urgently needed to improve the quality of care provided, uphold the human right to healthcare, increase access to health services, and maximize investments in HIV prevention and treatment. This brief, standardized tool will facilitate inclusion of stigma measurement in research studies and in routine facility data collection, allowing for the monitoring of stigma within healthcare facilities and evaluation of stigma‐reduction programmes. There is potential for wide use of the tool either as a stand‐alone survey or integrated within other studies of health facility staff. [ABSTRACT FROM AUTHOR]

There is no question that the stigma and discrimination associated with HIV and AIDS can be reduced through intervention. The inclusion of stigma and discrimination reduction as a critical component of achieving an AIDS‐free generation in recent UNAIDS, UN and PEPFAR political initiatives is promising. Yet national governments need evidence on effective interventions at the individual, community and societal levels in order to strategically incorporate stigma and discrimination reduction into national AIDS plans. Currently, the heterogeneity of stigma and discrimination reduction approaches and measurement makes it challenging to compare and contrast evaluated interventions. Moving forward, it is critical for the research community to: (1) clearly link intervention activities to the domains of stigma to be shifted; (2) assess the stigma domains in a consistent manner; and (3) link stigma and discrimination reduction with HIV prevention, care and treatment outcomes (e.g., uptake, adherence and retention of ART). These steps would further advance the scientific evidence base of stigma and discrimination reduction and allow for the identification of effective interventions that could be scaled up by national governments. [ABSTRACT FROM AUTHOR]

There is no question that the stigma and discrimination associated with HIV and AIDS can be reduced through intervention. The inclusion of stigma and discrimination reduction as a critical component of achieving an AIDS-free generation in recent UNAIDS, UN and PEPFAR political initiatives is promising. Yet national governments need evidence on effective interventions at the individual, community and societal levels in order to strategically incorporate stigma and discrimination reduction into national AIDS plans. Currently, the heterogeneity of stigma and discrimination reduction approaches and measurement makes it challenging to compare and contrast evaluated interventions. Moving forward, it is critical for the research community to: (1) clearly link intervention activities to the domains of stigma to be shifted; (2) assess the stigma domains in a consistent manner; and (3) link stigma and discrimination reduction with HIV prevention, care and treatment outcomes (e.g., uptake, adherence and retention of ART). These steps would further advance the scientific evidence base of stigma and discrimination reduction and allow for the identification of effective interventions that could be scaled up by national governments. [ABSTRACT FROM AUTHOR]

Introduction: Since 2003, US government funding to address the HIV and AIDS pandemic has been subject to an anti-prostitution clause. Simultaneously, the efficacy of some HIV prevention efforts for sex work in areas receiving US government funding has diminished. This article seeks to explain why. Methods: This analysis utilizes a case story approach to build a narrative of defining features of organizations in receipt of funding from the President's Emergency Plan for AIDS Relief (PEPFAR) and other US funding sources. For this analysis, multiple cases were compiled within a single narrative. This helps show restrictions imposed by the anti-prostitution clause, any lack of clarity of guidelines for implementation and ways some agencies, decision-making personnel, and staff on the ground contend with these restrictions. Results: Responses to PEPFAR's anti-prostitution clause vary widely and have varied over time. Organizational responses have included ending services for sex workers, gradual phase-out of services, cessation of seeking US government HIV funds and increasing isolation of sex workers. Guidance issued in 2010 did not clarify what was permitted. Implementation and enforcement has been dependent in part on the interpretations of this policy by individuals, including US government representatives and organizational staff. Conclusions: Different interpretations of the anti-prostitution clause have led to variations in programming, affecting the effectiveness of work with sex workers. The case story approach proved ideal for working with information like this that is highly sensitive and vulnerable to breach of anonymity because the method limits the potential to betray confidences and sources, and limits the potential to jeopardize funding and thereby jeopardize programming. This method enabled us to use specific examples without jeopardizing the organizations and individuals involved while demonstrating unintended consequences of PEPFAR's anti-prostitution pledge in its provision of services to sex workers and clients [ABSTRACT FROM AUTHOR]

Background HIV/AIDS in India disproportionately affects women, not by their own risks, but by those of their partners, generally their spouses. We address two marginalized populations at elevated risk of acquiring HIV: women who are married to men who also have sex with men (MSM) and wives of injection drug users (IDUs). Methods We used a combination of focus groups (qualitative) and structured surveys (quantitative) to identify the risks that high-risk men pose to their low-risk wives and/or sexual partners. Married MSM were identified using respondent-driven recruitment in Tamil Nadu, India, and were interviewed by trainer assessors. A sample of wives of injection drug users in Chennai were recruited from men enrolled in a cohort study of the epidemiology of drug use among IDUs in Chennai, and completed a face-to-face survey. Focus groups were held with all groups of study participants, and the outcomes transcribed and analyzed for major themes on family, HIV and issues related to stigma, discrimination and disclosure. Results Using mixed-methods research, married MSM are shown to not disclose their sexual practices to their wives, whether due to internalized homophobia, fear of stigma and discrimination, personal embarrassment or changing sexual mores. Married MSM in India largely follow the prevailing norm of marriage to the opposite sex and having a child to satisfy social pressures. Male IDUs cannot hide their drug use as easily as married MSM, but they also avoid disclosure. The majority of their wives learn of their drug-using behaviour only after they are married, making them generally helpless to protect themselves. Fear of poverty and negative influences on children were the major impacts associated with continuing drug use. Conclusions We propose a research and prevention agenda to address the HIV risks encountered by families of high-risk men in the Indian and other low- and middle-income country contexts. [ABSTRACT FROM AUTHOR]