Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States

Background An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

Subprime Attention Crisis: Advertising and the Time Bomb at the Heart of the Internet

In 2020, Tim Hwang, a writer, lawyer and technology policy researcher based in New York, published a short book entitled Subprime Attention Crisis: Advertising and the Time Bomb at the Heart of the Internet, which seeks to analyse the issues that are developing around the business model associated with the continued operation of the Internet, at least in its current manifestation, and the weaknesses and potential instability associated with that model. The book is of particular interest because the problems and possible next developments of the “time bomb” are set out in a plausible manner, together with some discussion on possible solutions. In particular, the author makes a credible comparison of the business model of the Internet with the subprime mortgage securities sector, the collapse of which contributed to the Global Financial Crisis in 2008.

R2P at 15: Reflections of a Policymaker

The Responsibility to Protect (R2P) was embraced at the World Summit 15 years ago, before nations and civil society had built the tools, knowledge and political endurance to implement its approach. Written by a policy researcher with R2P expertise who became a US diplomat involved in these issues, this piece reflects on the experience of the Obama administration’s efforts to bring US government focus to atrocity prevention. It considers what it got right, what it missed, and options for looking forward to address R2P in the decade ahead.

The Future of Hospital Sound: Transforming Healthcare Through Sound Experience

Several years ago, a classically trained electronic musician got sick and spent many hours in hospitals. Being a musician, sensitive to sound, she was disturbed by the noise around her: people talking and screaming, doors getting slammed, phones and pagers ringing non-stop, overhead speakers announcing emergencies… and the cacophony of alarms beeping in the dissonance of tritones. Since then, she and her husband (co-author and innovation policy researcher) have embarked on a mission to transform sound experience in hospitals, in collaboration with Johns Hopkins Sibley Memorial Hospital, Stanford Medicine X, TEDMED, and medical device companies. When we listen to people talking about sound, their stories are always more than about sound; they reveal what it means to be a human during the most vulnerable times of their lives. In this article, we explore noise as a symptom of culture, how sound reveals the importance of caring for caregivers, the future of auditory alarm design, and the aesthetic realm in palliative care. These perspectives result from a human-centric (rather than technology-centric) approach to innovation, and how transforming the sound of healthcare means focusing on people and their experiences.

Fairness, generosity and conditionality in the welfare system: the case of UK disability benefits

This paper represents a collaboration between a policy researcher and a behavioural scientist who studies cooperation. Our goal was to develop a shared understanding of one particular policy topic, the reforms to the UK system of disability benefits initiated during the last term of the New Labour Government and accelerated under the Conservative-led administrations since 2010. These reforms introduced much stronger focus on conditionality and assessment, aiming to reduce the cost of the benefit by identifying and removing ‘cheaters’ or ‘undeserving’ recipients from the system. The reforms have failed by even their own stated goals. Here, we seek to understand why they seemed appealing and intuitively likely to succeed. We argue that humans are vigilant cooperators, sensitive to cues of need in others, but also highly susceptible to the idea that others are cheating. This vigilance is particularly marked where they lack a reassuring stream of direct personal evidence to the contrary. The vigilance of human cooperative psychology makes ideas of greater conditionality and punishment easy for politicians to conceive of and sell. However, set against this, there are principles that can be used and successfully appealed to in advocating greater generosity in welfare systems. These include the fundamental social similarity of recipients and non-recipients, and the idea that resources are not generated individually but represent the common windfall of a whole group.<br /><br />Key messages<br /><ul><li>Humans are vigilant cooperators, motivated to help others, but attuned to cues of cheating.</li><br /><li>Vigilant cooperation drives popular intuitions about how welfare systems should work.</li><br /><li>This can be illustrated by examining changes to UK disability benefits.</li><br /><li>Appealing to popular intuitions does not necessarily lead to optimal policy making.</li></ul>

A Revolutionary Look at Health Policy Analysis in Developing Countries

Health policy analysis has been the focus of attention of a number of scholars, health practitioners and policy makers. However, there has been much less attention given to how to do policy analysis, what research designs, theories or methods best inform policy analysis. This study begins by looking at the health policy environment, and some of the challenges to researching this highly complex phenomenon. It focuses on research in middle and low income countries. Attention is drawn to the roles of the policy researcher and the importance of reflexivity and researcher's position in the research process and finally ways of advancing the field of health policy analysis is discussed.