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Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials.

ABSTRACT: Despite the recent success of antiretrovirals for HIV prevention, additional, more effective, or more acceptable biomedical interventions will ultimately be needed to end the HIV epidemic. Designing clinical trials to evaluate the efficacy of new products that reduce HIV infection risk is challenging because of the existence of highly effective interventions to prevent HIV. However, the implementation of these interventions is uneven, and the fact that multiple HIV prevention efficacy trials are currently evaluating new products means the field confronts uncertainty in the emerging standard of prevention. In this Viewpoint, we take stock of the current state of HIV prevention, and subsequently discuss the key challenges in designing future trials to evaluate the next generation of HIV prevention products. We also highlight gaps in the knowledge base that need to be addressed to advance the design of research. Future trials are tenable, even in the context of existing and effective interventions, and should involve careful statistical approaches and multidisciplinary collaborative design.

SUBMITTER: Janes H

PROVIDER: S-EPMC6612578 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials.

Janes Holly H Donnell Deborah D Gilbert Peter B PB Brown Elizabeth R ER Nason Martha M

The lancet. HIV 20190508 7

Despite the recent success of antiretrovirals for HIV prevention, additional, more effective, or more acceptable biomedical interventions will ultimately be needed to end the HIV epidemic. Designing clinical trials to evaluate the efficacy of new products that reduce HIV infection risk is challenging because of the existence of highly effective interventions to prevent HIV. However, the implementation of these interventions is uneven, and the fact that multiple HIV prevention efficacy trials are ...[more]

PMID: 31078451

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Project description:BACKGROUND:Ethics teaching is globally considered an essential part of medical education fostering professionalism. It does not only provide knowledge for good clinical conduct, but also trains medical students as virtuous practitioners. Although Turkey has had a considerable experience in ethics education of healthcare professionals, the general state of ethics curricula at medical schools in Turkey is unknown. METHODS:The purpose of this study was to collect comprehensive data about the ethics education programs at medical schools in Turkey. To this aim, we designed a cross-sectional descriptive questionnaire survey which focuses on the content, teaching years, teaching, assessment and evaluation methodologies, workforce and infrastructure. We delivered the questionnaire to all medical schools in Turkey. Seventy-nine medical schools participated in this study (response rate: 78%). RESULTS:Although most institutions had an undergraduate ethics curriculum (91.1%), the findings suggest deficiency of teaching personnel (34.2% had no instructors). Furthermore, the distribution and composition of the workforce was imbalanced. The content varies largely among institutions. Medical schools with an ethics department were more likely to diversify teaching topics. However, ethics education was largely based on the four-principle approach. The content was usually conveyed to students theoretically. Around 90% of schools had classroom lectures. It is the only method used at one-third of them. Clinical ethics education was mostly lacking. Multiple-choice tests were widely used to assess and evaluate student attainments (86.1%). CONCLUSIONS:Staff qualified to teach ethics and ethics education integrated into the six-year medical curriculum given by a multidisciplinary team are urgent necessities. Considering teaching, assessment and evaluation methodologies used, most medical schools seem to fall short of fostering students to develop ethical attitudes. Endeavors aiming for modern topics should be encouraged. As the organization ethics education change continuously, we think that a platform for monitoring ethics education at medical schools in Turkey should be established. Such a body would help ethics instructors to network and find solutions to current problems and build shared wisdom.

Project description:Since December 2019 the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has produced an outbreak of pulmonary disease which has soon become a global pandemic, known as COronaVIrus Disease-19 (COVID-19). The new coronavirus shares about 82% of its genome with the one which produced the 2003 outbreak (SARS CoV-1). Both coronaviruses also share the same cellular receptor, which is the angiotensin-converting enzyme 2 (ACE2) one. In spite of these similarities, the new coronavirus has expanded more widely, more faster and more lethally than the previous one. Many researchers across the disciplines have used diverse modeling tools to analyze the impact of this pandemic at global and local scales. This includes a wide range of approaches – deterministic, data-driven, stochastic, agent-based, and their combinations – to forecast the progression of the epidemic as well as the effects of non-pharmaceutical interventions to stop or mitigate its impact on the world population. The physical complexities of modern society need to be captured by these models. This includes the many ways of social contacts – (multiplex) social contact networks, (multilayers) transport systems, metapopulations, etc. – that may act as a framework for the virus propagation. But modeling not only plays a fundamental role in analyzing and forecasting epidemiological variables, but it also plays an important role in helping to find cures for the disease and in preventing contagion by means of new vaccines. The necessity for answering swiftly and effectively the questions: could existing drugs work against SARS CoV-2? and can new vaccines be developed in time? demands the use of physical modeling of proteins, protein-inhibitors interactions, virtual screening of drugs against virus targets, predicting immunogenicity of small peptides, modeling vaccinomics and vaccine design, to mention just a few. Here, we review these three main areas of modeling research against SARS CoV-2 and COVID-19: (1) epidemiology; (2) drug repurposing; and (3) vaccine design. Therefore, we compile the most relevant existing literature about modeling strategies against the virus to help modelers to navigate this fast-growing literature. We also keep an eye on future outbreaks, where the modelers can find the most relevant strategies used in an emergency situation as the current one to help in fighting future pandemics.

Dataset Information

Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials.

Publications

Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials.

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