Willingness to Risk Death Endpoint in HIV Cure-Related Research with Otherwise Healthy Volunteers is Misleading

This viewpoint article critiques two recent articles examining 'willingness to risk death' to advance HIV cure-related research. The 'willingness to risk death' endpoint sends the wrong signal to the HIV cure-related research community about ongoing research in otherwise healthy volunteers living with HIV. Socio-behavioural scientists have examined the acceptability of a 99% risk of death scenario, which is unrealistic and would not be acceptable by current regulatory and ethical standards. We believe that the field needs robust and relevant socio-behavioural research reflecting ongoing biomedical HIV cure-related trials. These studies will need to withstand regulatory and ethical scrutiny if cure or remission regimens are to proceed to the licensing stage. The HIV cure-related research community must continue to protect the public trust in the HIV cure-related research field and sustain societal value generated by such research. We call for the utmost prudence in designing biomedical HIV cure trials as well as in setting up socio-behavioural research experiments related to these complex trials

What Lessons it Might Teach Us! Community Engagement in HIV Research

Purpose of review Partnerships between academia and the community led to historic advances in HIV and paved the way for ongoing community engagement in research. Three decades later, we review the state of community engagement in HIV research, discuss best practices as supported by literature, explore innovations, and identify ongoing gaps in knowledge. Recent findings The community of people living with and at risk for HIV remains actively involved in the performance of HIV research. However, the extent of participation is highly variable despite long standing and established principles and guidelines of good participatory practices (GPP) and community-based participatory research (CBPR). Current literature reveals that known barriers to successful community engagement continue to exist such as power differences, and poor scientific or cultural competency literacy. Several high-quality studies share their experiences overcoming these barriers and demonstrate the potential of CBPR through reporting of qualitative and quantitative outcomes. Summary Greater time and attention should be placed on the development of community engagement in HIV research. A large body of literature, including innovative cross-cutting approaches, exists to guide and inform best practices and mitigate common barriers. However, we recognize that true growth and expansion of CBPR within HIV and in other fields will require a greater breadth of research reporting qualitative and quantitative outcomes

Crucial but Understudied: Incentives in HIV Research

In this issue of The Lancet HIV, Katherine Kranzer and colleagues report that economic incentives for caregivers in Zimbabwe increased uptake of HIV testing and counselling by children aged 8–17 years compared with caregivers with no financial incentive. HIV testing of groups that are hard to reach is a formidable challenge worldwide, and innovative strategies to reach adolescents in particular are crucial to reaching UNAIDS’ 90-90-90 goal

A Note in the Skyrme Model with Higher Derivative Terms

Another stabilizer term is used in the classical Hamiltonian of the Skyrme Model that permits in a much simple way the generalization of the higher-order terms in the pion derivative field. Improved numerical results are obtained.Comment: Latex. Figure not include; available upon request. 7 pages, report

Framing Expectations in Early HIV Cure Research

Language used to describe clinical research represents a powerful opportunity to educate volunteers. In the case of HIV cure research there is an emerging need to manage expectations by using the term ‘experiment’. Cure experiments are proof-of-concept studies designed to evaluate novel paradigms to reduce persistent HIV-1 reservoirs, without any expectation of medical benefit

Ethical considerations for HIV remission clinical research involving participants diagnosed during acute HIV infection

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval

Applying the Functional Behavioral and Social Sciences Research (BSSR) Framework to HIV Cure Research

Introduction The search for an HIV cure involves important behavioural and social processes that complement the domains of biomedicine. However, the field has yet to tap into the full potential of behavioural and social sciences research (BSSR). In this article, we apply Gaist and Stirratt’s BSSR Functional Framework to the field of HIV cure research. Discussion The BSSR Functional Framework describes four key research domains: (1) basic BSSR (understanding basic behavioural and social factors), (2) elemental BSSR (advancing behavioural and social interventions), (3) supportive BSSR (strengthening biomedically focused clinical trials), and (4) integrative BSSR (building multi-disciplinary combination approaches for real-world implementation). In revisiting and applying the BSSR Functional Framework, we clarify the importance of BSSR in HIV cure research by drawing attention to such things as: how language and communication affect the meaning of “cure” to people living with HIV (PLHIV) and broader communities; how cure affects the identity and social position of PLHIV; counselling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision-making processes of potential study participants related to different cure strategies; HIV care providers’ perceptions and attitudes about their patients’ participation in cure research; potential social harms or adverse social events associated with cure research participation; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment. We also discuss the BSSR Functional Framework in the context of ATIs, which involve processes at the confluence of the BSSR domains. Conclusions To move HIV cure regimens through the translational research pathway, attention will need to be paid to both biomedical and socio-behavioural elements. BSSR can contribute an improved understanding of the human and social dimensions related to HIV cure research and the eventual application of HIV cure regimens. The BSSR Functional Framework provides a way to identify advances, gaps and opportunities to craft an integrated, multi-disciplinary approach at all stages of cure research to ensure the real-world applicability of any strategy that shows promise

Antiretroviral therapy experience, satisfaction, and preferences among a diverse sample of young adults living with HIV

Youth and young adults living with HIV (YLWH) have a high HIV infection rate and suboptimal oral medication adherence. Biomedical researchers hope that long-acting antiretroviral therapy (LAART) modalities can help those who struggle with daily oral adherence. While adults living with HIV have expressed interest in LAART, little research has explored perspectives of YLWH. This study explores ART experiences and perspectives on LAART through qualitative interviews with twenty diverse YLWH (18–29) in the United States. Data were analyzed using framework analysis. Most participants were satisfied with their current ART yet had experienced side effects or had struggled with daily adherence. Preferences for improving daily oral ART included making pills smaller and reformulating ART into flavored chewable gummies. Most expressed enthusiasm for LAART, although needle aversion and previous injection drug use were potential barriers for some. Approximately half were interested in an ART patch, though its visibility and fear of stigmatization was concerning. Few expressed interest in implantable ART, calling it unappealing. Although younger people are most likely to benefit from these advancements in HIV treatment, additional research is needed to identify gaps in uptake and to further explore perspectives of YLWH to improve the success of new treatment modalities

Perceptions of HIV Virologic Control Strategies among Younger and Older Age Groups of People Living with HIV in the United States: A Cross-Sectional Survey

Two HIV virologic control advances are in various stages of development, including long-acting antiretroviral therapy (ART) formulations and strategies aimed at sustained ART-free HIV control. Perceptions of risks and benefits toward HIV virologic control strategies may be different based on an individual's age due to differing experiences of the impacts of the domestic HIV epidemic, altruistic attitudes toward research participation, and general levels of engagement in health care. We examined preferences of HIV virologic control strategies by age groups. In 2018, we conducted a nationwide, online cross-sectional survey to examine differences in HIV virologic control strategies among a sample of people living with HIV who were = 50 years of age. From a total of 281 participants, 3 findings were noteworthy: (1) Participants = 50 years; (2) participants >= 50 years of age were more motivated by altruistic notions compared with those = 50 years. Our analysis provides a deeper understanding of differences in perceptions among various age groups regarding desirable future ART characteristics, and motivations and barriers to participating in HIV cure-related strategies. Our findings can help inform community engagement and education, and assist researchers in tailoring study design and recruitment efforts to major age groups

Secondary HIV Infection and Mitigation in Cure-Related HIV Trials During Analytical Treatment Interruptions

To the Editor—We are writing to express concerns regarding facts reported in 2 recent Journal of Infectious Diseases articles pertaining to the ANRSLIGHT study, conducted in 18 clinical sites in France between September 2013 and May 2015. Initially, we were delighted to see the authors implemented several inclusion criteria that we believe were likely to ensure safety of participants during the analytical treatment interruption (ATI) that occurred during the trial, for example a nadir of CD4+ T-cell count of ≥300 cells/mm3 and an initial CD4+ T-cell count of ≥600/mm3. However, other aspects are dismaying, including the detailed identifying information about the index participant and partner. We fear it is possible to identify both persons from the elaborate medical and nonmedical history provided. After contacting the study Principal Investigator, Dr Lelièvre, through a European colleague, it appears there were no consents to disclose this information. Thus, we feel strongly that it was inappropriate to include such comprehensive, potentially identifying details