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The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the (...) feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population. (shrink)

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As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS /World Health Organization guidance recommends that participants in prevention trials receive ‘access to all state of the art HIV risk reduction methods’, and that decisions about adding new tools to the prevention package be (...) made in consultation with ‘all relevant stakeholders’. The guidance, however, leaves open questions of both process and implementation. In March 2009, the Global Campaign for Microbicides, UNAIDS and the Centers for Disease Control and Prevention convened a consultation to develop practical answers to these questions. Fifty-nine diverse participants, including researchers, ethicists, advocates and policymakers, worked to develop consensus criteria on when to include new HIV prevention tools in future trials. Participants developed a set of questions to guide decision-making, including: whether the method has been recommended by international bodies or adopted at a national level; the size of the effect and weight of the evidence; relevance to the trial population; whether the tool has been approved or introduced in the trial country; whether adding the tool might lead to trial futility; outstanding safety issues and status of the trial. Further work is needed to develop, implement and evaluate approaches to facilitate meaningful stakeholder participation in this deliberative process. (shrink)

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In a recent issue of the Journal of Medical Ethics, Svoboda and Van Howe commented on the 2012 change in the American Academy of Pediatrics policy on newborn male circumcision, in which the AAP stated that benefits of the procedure outweigh the risks. Svoboda and Van Howe disagree with the AAP conclusions. We show here that their arguments against male circumcision are based on a poor understanding of epidemiology, erroneous interpretation of the evidence, selective citation of the literature, statistical manipulation (...) of data, and circular reasoning. In reality, the scientific evidence indicates that male circumcision, especially when performed in the newborn period, is an ethically and medically sound low-risk preventive health procedure conferring a lifetime of benefits to health and well-being. Policies in support of parent-approved elective newborn circumcision should be embraced by the medical, scientific and wider communities. (shrink)

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