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A Review of Public Health, Social and Ethical Implications of Voluntary Medical Male Circumcision Programs for HIV Prevention in Sub-Saharan Africa

January 20, 2022

Ideally, the benefits of public health interventions should outweigh any associated harms, burdens, and adverse unintended consequences. The intended benefit of voluntary medical male circumcision (VMMC) programs in eastern and southern Africa (ESA) is the reduction of HIV infections. We review the literature for evidence of reductions in HIV incidence, evaluate the extent to which decreases in HIV incidence can be reasonably attributed to VMMC programs, and summarize social harms and ethical concerns associated with these programs. Review findings suggest that HIV incidence had been declining across ESA since before the large-scale rollout of VMMC as a public health intervention, and that this decline may be due to the combined effects of HIV prevention and treatment interventions, such as expanded antiretroviral therapy. The independent effect of VMMC programs in reducing HIV infections at the population level remains unknown. On the other hand, VMMC-associated evidence is increasing for the existence of negative social impacts such as stigmatization and/or discrimination, and ethically problematic practices, including lack of informed consent. We conclude that the relationship between the benefits and burdens of VMMC programs may be more unfavorable than what has been commonly suggested by proponents of global VMMC campaigns.

Attitudes About Analytic Treatment Interruption (ATI) in HIV Remission Trials with Different Antiretroviral Therapy (ART) Resumption Criteria

January 20, 2022

HIV remission trials often require temporary stopping of antiretroviral therapy (ART)—an approach called analytic treatment interruption (ATI). Trial designs resulting in viremia raise risks for participants and sexual partners. We conducted a survey on attitudes about remission trials, comparing ART resumption criteria (lower-risk “time to rebound” and higher-risk “sustained viremia”) among participants from an acute HIV cohort in Thailand. Analyses included Wilcoxon-Ranks and multivariate logistic analysis. Most of 408 respondents supported ATI trials, with slightly higher approval of, and willingness to participate in, trials using time to rebound versus sustained viremia criteria. Less than half of respondents anticipated disclosing trial participation to partners and over half indicated uncertainty or unwillingness about whether partners would be willing to use PrEP. Willingness to participate was higher among those who rated higher trial approval, lower anticipated burden, and those expecting to make the decision independently. Our findings support acceptability of ATI trials among most respondents. Participant attitudes and anticipated behaviors, especially related to transmission risk, have implications for future trial design and informed consent.

Ethical Considerations for HIV Remission Clinical Research Involving Participants Diagnosed During Acute HIV Infection

January 20, 2022

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.

Justice, Inequality, and Health

January 20, 2022
First published Tue Dec 23, 2008; substantive revision Mon Nov 1, 2021

Among American men, there is a 14.6 year difference in life expectancy between the top 1% and the bottom 1% of the income distribution (Chetty et al. 2016). Among American women, the corresponding difference is 10.1 years. In a recent survey, 38.2% of U.S. respondents in the bottom third of the income distribution reported fair or poor health, compared to 21.4% of respondents in the middle third, and 12.3% of respondents in the top third (Hero, Zaslavsky, & Blendon 2017). These disparities were reduced but not eliminated by adjustment for health insurance status.

Translational Science: A Survey of US Biomedical Researchers’ Perspectives and Practices

January 19, 2022

This national survey aimed to identify how biomedical researchers using vertebrate animals viewed issues of significance for translational science, including oversight and public engagement, and to analyze how researcher characteristics and animal model choice correlate with those views. Responses from 1,187 researchers showed awareness of, and concerns about, problems of translation, reproducibility and rigor. Surveyed scientists were nevertheless optimistic about the value of animal studies, were favorable about research oversight and reported openness with non-scientists in discussing their animal work. Differences in survey responses among researchers also point to diverse perspectives within the animal research community on these matters. Most significant was variability associated with the primary type of animal that surveyed scientists used in their work. Other significant divergence in opinion appeared on the basis of professional role factors, including the type of degree held, workplace setting, type of funding, experience on an institutional animal care and use committee and personal demographic characteristics of age and gender.

Attitudes About Analytic Treatment Interruption (ATI) in HIV Remission Trials with Different Antiretroviral Therapy (ART) Resumption Criteria

January 19, 2022

HIV remission trials often require temporary stopping of antiretroviral therapy (ART)—an approach called analytic treatment interruption (ATI). Trial designs resulting in viremia raise risks for participants and sexual partners. We conducted a survey on attitudes about remission trials, comparing ART resumption criteria (lower-risk “time to rebound” and higher-risk “sustained viremia”) among participants from an acute HIV cohort in Thailand. Analyses included Wilcoxon-Ranks and multivariate logistic analysis. Most of 408 respondents supported ATI trials, with slightly higher approval of, and willingness to participate in, trials using time to rebound versus sustained viremia criteria. Less than half of respondents anticipated disclosing trial participation to partners and over half indicated uncertainty or unwillingness about whether partners would be willing to use PrEP. Willingness to participate was higher among those who rated higher trial approval, lower anticipated burden, and those expecting to make the decision independently. Our findings support acceptability of ATI trials among most respondents. Participant attitudes and anticipated behaviors, especially related to transmission risk, have implications for future trial design and informed consent.

Online Training as a Means to Improve the Understanding of Ethical, Legal, and Social Aspects of Biobanking Research: Stakeholder Perspectives from South Africa

January 19, 2022

Introduction: The proliferation of biobanking activities demand a review of current training opportunities for service providers and researchers, specifically related to the ethical, legal, and social issues (ELSI) of biobanking research. Such information could be useful for planning and developing an educational course. However, it is equally important to explore the platform for offering such a course.

Ending the Evidence Gap for Pregnancy, HIV and Co-Infections: Ethics Guidance from the PHASES Project

January 19, 2022

Abstract

Introduction

While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research.