Face masks: benefits and risks during the COVID-19 crisis.

BACKGROUND: The German government has made it mandatory to wear respiratory masks covering mouth and nose (MNC) as an effective strategy to fight SARS-CoV-2 infections. In many countries, this directive has been extended on shopping malls or public transportation. The aim of this paper is to critically analyze the statutory regulation to wear protective masks during the COVID-19 crisis from a medical standpoint. METHODS: We performed an extensive query of the most recent publications addressing the prevention of viral infections including the use of face masks in the community as a method to prevent the spread of the infection. We addressed the issues of practicability, professional use, and acceptability based on the community and the environment where the user resided. RESULTS: Upon our critical review of the available literature, we found only weak evidence for wearing a face mask as an efficient hygienic tool to prevent the spread of a viral infection. However, the use of MNC seems to be linked to relevant protection during close contact scenarios by limiting pathogen-containing aerosol and liquid droplet dissemination. Importantly, we found evidence for significant respiratory compromise in patients with severe obstructive pulmonary disease, secondary to the development of hypercapnia. This could also happen in patients with lung infections, with or without SARS-CoV-2. CONCLUSION: Epidemiologists currently emphasize that wearing MNC will effectively interrupt airborne infections in the community. The government and the politicians have followed these recommendations and used them to both advise and, in some cases, mandate the general population to wear MNC in public locations. Overall, the results seem to suggest that there are some clinically relevant scenarios where the use of MNC necessitates more defined recommendations. Our critical evaluation of the literature both highlights the protective effects of certain types of face masks in defined risk groups, and emphasizes their potential risks.

Evaluating the impact of policies recommending PrEP to subpopulations of men and transgender women who have sex with men based on demographic and behavioral risk factors.

INTRODUCTION: Developing guidelines to inform the use of antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention in resource-limited settings must necessarily be informed by considering the resources and infrastructure needed for PrEP delivery. We describe an approach that identifies subpopulations of cisgender men who have sex with men (MSM) and transgender women (TGW) to prioritize for the rollout of PrEP in resource-limited settings. METHODS: We use data from the iPrEx study, a multi-national phase III study of PrEP for HIV prevention in MSM/TGW, to build statistical models that identify subpopulations at high risk of HIV acquisition without PrEP, and with high expected PrEP benefit. We then evaluate empirically the population impact of policies recommending PrEP to these subpopulations, and contrast these with existing policies. RESULTS: A policy recommending PrEP to a high risk subpopulation of MSM/TGW reporting condomless receptive anal intercourse over the last 3 months (estimated 3.3% 1-year HIV incidence) yields an estimated 1.95% absolute reduction in 1-year HIV incidence at the population level, and 3.83% reduction over 2 years. Importantly, such a policy requires rolling PrEP out to just 59.7% of MSM/TGW in the iPrEx population. We find that this policy is identical to that which prioritizes MSM/TGW with high expected PrEP benefit. It is estimated to achieve nearly the same reduction in HIV incidence as the PrEP guideline put forth by the US Centers for Disease Control, which relies on the measurement of more behavioral risk factors and which would recommend PrEP to a larger subset of the MSM/TGW population (86% vs. 60%). CONCLUSIONS: These findings may be used to focus future mathematical modelling studies of PrEP in resource-limited settings on prioritizing PrEP for high-risk subpopulations of MSM/TGW. The statistical approach we took could be employed to develop PrEP policies for other at-risk populations and resource-limited settings.

Getting youth PrEPared: adolescent consent laws and implications for the availability of PrEP among youth in countries outside of the United States.

INTRODUCTION: Youth under the age of 25 are at high risk for HIV infection. While pre-exposure prophylaxis (PrEP) has the potential to curb new infections within this population, it is unclear how country-specific laws and policies that govern youth access to sexual and reproductive health (SRH) services impact access to PrEP. The purpose of this review was to analyse laws and policies concerning PrEP implementation and SRH services available to youth in countries with a high HIV incidence. To the best of our knowledge this is the first systematic assessment of country-level policies that impact the availability of PrEP to adolescent populations. METHODS: We conducted a review of national policies published on or before 12 June 2018 that could impact adolescents' access to PrEP, SRH services and ability to consent to medical intervention. Countries were included if: (1) there was a high incidence of HIV; (2) they had active PrEP trials or PrEP was available for distribution; (3) information regarding PrEP guidelines were publicly available. We also included a selected number of countries with lower adolescent HIV incidence. Internet and legal database searches were used to identify policies relevant to adolescent PrEP (e.g. age of consent to HIV testing). RESULTS AND DISCUSSION: Fifteen countries were selected for inclusion in this review. Countries varied considerably in their respective laws and policies governing adolescents' access to PrEP, HIV testing and SRH services. Six countries had specific polices around the provision of PrEP to youth under the age of 18. Five countries required people to be 18 years or older to access HIV testing, and six countries had specific laws addressing adolescent consent for- and access to- contraceptives. CONCLUSIONS: Adolescents' access to PrEP without parental consent remains limited or uncertain in many countries where this biomedical intervention is needed. Observational and qualitative studies are needed to determine if and how adolescent consent laws are followed in relation to adolescent PrEP provisions. Intensified efforts to amend laws that limit adolescent access to PrEP and restrict the establishment of national guidelines supporting adolescent PrEP are also needed to address the epidemic in this group.

Moving Metaphors: Shifting Institutional Responsibilities and Evidentiary Boundaries in the Commissioning of Pre-Exposure Prophylaxis for HIV.

In this article, we investigate how speakers in the U.K.'s House of Commons cited the same legislative context and medical research to arrive at contradictory conclusions regarding the Government's responsibility to fund pre-exposure prophylaxis (PrEP) as an HIV intervention. Because the Government had expressed that it would not comment on institutional responsibilities directly, given the likelihood of a legal challenge in response to the National Health Service withdrawing PrEP from the drug commissioning process, the Government's support of this decision could not be explicitly detailed. Our discourse analytic approach reveals how members of parliament adopted positions in the debate by using distinct metaphorical frames and lexical choices to linguistically encode assumptions that imply contrary interpretations of mutually agreed upon facts. This suggests that the concrete discursive practices used to cite evidence in policy-making discussions, regardless of the quality of the evidence, may have material consequences for evidence-based policy.

Prevention is Better than Cure, But who Foots the Bill? R (National AIDS Trust) v NHS England.

This case note discusses R (on the Application of National Aids Trust) v The National Health Service Commissioning Board (NHS England), The Local Government Association, The Secretary of State For Health [2016] EWCA Civ 1100. The case is an appeal on an earlier finding by the High Court that the power to commission pre-exposure prophylaxis (PrEP) lies within National Health Service (NHS) England's competence, instead of being within the realm of local authorities' responsibilities. It now forms the sole piece of judicial guidance on NHS England's duties under the National Health Service Act 2006 and is significant for the process by which the Court of Appeal reached its decision. Rather than adhere to the literal meaning of relevant legislation, the judges engaged in a holistic examination of the issue to reach a functional and sensible decision. Examining this case under the lens of both legal theory and pragmatism, comment is made on the soundness of the judges' approach and it is argued that the decision reached was the correct one. This case now forms binding precedent on this issue and the clear process by which the judges reached their conclusion may form instructive guidance for similar such problems in the future.

Translating PrEP effectiveness into public health impact: key considerations for decision-makers on cost-effectiveness, price, regulatory issues, distributive justice and advocacy for access.

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.

Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

PURPOSE: The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. METHODS: Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. RESULTS: A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. CONCLUSIONS: The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.