In public health and the social sciences, there is growing recognition of the role that social context plays in determining health. Frequently, social relations of inequality are among the most important features of social context identified in this work, and emphasis is placed on identifying and addressing these inequalities in order to improve health. Within the field of HIV/AIDS prevention as well, researchers have begun to look beyond individuals for an understanding of the structural causes of HIV-related risk. This (...) research demands that greater attention be paid to the social mechanisms and contextual factors that lead to HIV risk. Among these factors are law and social policy, which form a part of the context in which risk-taking occurs and which can promote both HIV transmission and prevention. On the one hand, laws limiting access to sterile injection equipment have contributed to HIV-related risk behavioxs among injection drug users. (shrink)

In public health and the social sciences, there is growing recognition of the role that social context plays in determining health. Frequently, social relations of inequality are among the most important features of social context identified in this work, and emphasis is placed on identifying and addressing these inequalities in order to improve health. Within the field of HIV/AIDS prevention as well, researchers have begun to look beyond individuals for an understanding of the structural causes of HIV-related risk. This (...) research demands that greater attention be paid to the social mechanisms and contextual factors that lead to HIV risk. Among these factors are law and social policy, which form a part of the context in which risk-taking occurs and which can promote both HIV transmission and prevention. On the one hand, laws limiting access to sterile injection equipment have contributed to HIV-related risk behavioxs among injection drug users. (shrink)

Criminal law is one of the regulatory tools being used in the United States to influence risk behavior by people who have HIV/AIDS. Several different types of laws have been or could be used in this way These include:HIV-specific exposure and transmission laws — i.e., laws that explicitly mention and exclusively apply to conduct by people with HIV;public health statutes prohibiting conduct that would expose others to communicable diseases and/or sexually transmitted diseases ; andgeneral criminal laws governing attempted murder (...) and assault. (shrink)

Criminal law is one of the regulatory tools being used in the United States to influence risk behavior by people who have HIV/AIDS. Several different types of laws have been or could be used in this way These include:HIV-specific exposure and transmission laws — i.e., laws that explicitly mention and exclusively apply to conduct by people with HIV;public health statutes prohibiting conduct that would expose others to communicable diseases and/or sexually transmitted diseases ; andgeneral criminal laws governing attempted murder (...) and assault. (shrink)

Smartphones with Global Positioning System (GPS) apps offer simple and accurate tools to collect data on human mobility. However, their associated ethical challenges remain to be assessed. We used the Emanuel framework to assess the ethical concerns of using smartphone GPS to record mobility patterns of young adults in rural South Africa for a larger study on mobility and HIV risk (Sesikhona). We conducted four focus groups (FGDs) with individuals eligible for the Sesikhona study. FGD data were coded using (...) the Emanuel framework. Participants perceived use of smartphone GPS to study human mobility and HIV risk as valuable. They raised concerns about invasion of privacy and confidentiality. Also mentioned were risk/benefit ratio, informed consent and ongoing respect. Concerns expressed provided a useful evidence-base for the development of a guide to inform future participants about ethical issues arising in the use of GPS technology to track mobility and health-related issues. (shrink)

The relationships between female sex workers and their noncommercial male partners are typically viewed as sites of HIV risk rather than meaningful unions. This ethnographic case study presents a nuanced portrayal of the relationship between Cindy and Beto, a female sex worker who injects drugs and her intimate, noncommercial partner who live in Tijuana, Mexico. On the basis of ethnographic research in Tijuana and our long-term involvement in a public health study, we suggest that emotions play a central role (...) in sex workers’ relationships and contribute in complex ways to each partner's health. We conceptualize Cindy and Beto's relationship as a “dangerous safe haven” in which HIV risk behaviors such as unprotected sex and syringe sharing convey notions of love and trust and help sustain emotional unity amid broader uncertainties but nevertheless carry very real health risks. Further attention to how emotions shape vulnerable couples’ health remains a task for anthropology. (shrink)

Modern antiretroviral therapies are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical (...) prospect associated with participation in cure research thus look poor. Are the risks and burdens that HIV cure research places on participants so high that it is unethical, at present, to conduct it? In this paper, I answer ‘no’. I start my argument by describing a foundational way of thinking about the ethical justification for regulatory limits on research risk; I then apply this way of thinking to HIV cure trials. In offering this analysis, I confine my attention to studies enrolling competent adults and I also do not consider risks research may pose to third parties or society. Rather, my concern is to engage with the thought that some trials are so risky that performing them is an ethically unacceptable way to treat the participants themselves. I reject this thought and instead argue that there is no level of risk, no matter how high, that inherently mistreats a participant. (shrink)

This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or protect basic goods; (...) (b) In cases where one party is gambling with basic goods and the other party is not, the distribution of benefits and burdens must be arranged so that they are of greatest benefit to the worst off; (c) In relationships where one party is gambling for basic goods and the other party is not, the party gambling for basic goods must be assured of some guaranteed benefits in addition to the chance of gaining some potential benefits.These principles are applied to the case of HIV international research. I conclude that the research (as described) is mutually advantageous but still exploitative because the distribution of surplus benefits is unfair. It is unfair because research subjects are gambling with and for basic goods but they are not assured of a fair ex-post distribution of benefits. Principles (b) and (c) are not satisfied. Research participants are not accorded enough guaranteed benefits to outweigh the risks they undertake. (shrink)

In this article, I challenge the risk assessment approach to the ethics of pre-exposure prophylaxis (PrEP) as HIV prevention among men who have sex with men (MSM). Traditional risk assessment focuses on the medical risks and benefits of using medical technologies, but this emphasizes certain risks and benefits over others. The medical risks of using PrEP are presently being overblown and its social and political risks are being overlooked. By recontextualizing risk within the history of HIV and (...) considering the lived experiences of MSM with sex, HIV, and HIV prevention, we can broaden the present risk assessment framework to include all of the relevant risks involved in using PrEP. We can also better situate risk as one of several moral concepts, including trust and solidarity, which move us towards a more nuanced analysis of the social and political effects of PrEP on the relationships and communities of MSM. (shrink)

Some early phase clinical studies of candidate HIV cure and remission interventions appear to have adverse medical risk–benefit ratios for participants. Why, then, do people participate? And is it ethically permissible to allow them to participate? Recent work in decision theory sheds light on both of these questions, by casting doubt on the idea that rational individuals prefer choices that maximise expected utility, and therefore by casting doubt on the idea that researchers have an ethical obligation not to enrol (...) participants in studies with high risk–benefit ratios. This work supports the view that researchers should instead defer to the considered preferences of the participants themselves. This essay briefly explains this recent work, and then explores its application to these two questions in more detail. (shrink)

The United States has the fastest growing prison population in the world, and elevated incarceration rates, substance use, and human immunodeficiency virus (HIV) prevalence are fueling each other. Yet without a national guideline mandated for HIV care within the prison system, standards for state and federal prisons vary greatly.

As the frequency of internet-based research has increased, it is important for researchers to consider how the conditions in which data are collected may influence the risks to participants. In particular, because internet-based data collection often occurs outside a clinical or research setting, there may be unintentional disclosures of a participant's involvement in a research study of which the researcher is unaware. The current analysis examined the responses of men who have sex with men participating in an internet-based HIV behavioural (...) risk study when queried about the possible disclosure of their participation in the study. Fewer than 2% of participants indicated that their participation in the research study was disclosed, and all but one indicated no negative outcomes associated with the disclosure. As the field of online research continues to expand, it is important to consider risks that are unique to internet-based research, and to monitor these risks to ensure that the confidentiality of research subjects is maintained. (shrink)

The paper advances a consequence-based argument in support of the American Medical Association's policy that a physician may not ethically refuse to treat a person with HIV solely because the patient is seropositive. A limited number of alternative arguments, both in support of and in opposition to this policy are also considered, but are found wanting. The paper then concludes with a discussion of some of the other obstacles to quality health care that persons with HIV must often confront.

Bioethicists broadly agree that there is a limit to the level of net risk that biomedical research may permissibly impose on participants, even in cases where the potential of that research to improve the health of the population health would be great. Although some may permissibly volunteer to take on some degree of pro‐social risk, no one, not even a willing volunteer, may ever be outright sacrificed for others. One might think this perspective, if correct, makes it effectively (...) impossible to study interventions with high intrinsic risks. But I describe a method – risk dilution – by which an extremely high‐risk intervention can nonetheless be effectively studied in the context of an acceptably low‐risk trial. I then defend risk dilution from objections. (shrink)

Despite global acknowledgement of HIV/AIDS reaching pandemic proportions with 37.8 million people living with the infection, progress towards developing effective international responses to curb its spread has been slow. The focus of current debate tends to focus on the medical treatment and prevention of HIV/AIDS, leading to emphasis being placed on the rapid increase in HIV infection as well as opportunistic diseases such as tuberculosis and malaria. The traditional view of responding to these challenges has been probing the high cost (...) factors associated with antiretroviral treatment and burgeoning medical care needs. This article argues that these responses are limited in their effect as they have a narrow, medical focus. This article presents a broader perspective. It investigates the implications of HIV/AIDS to the goals of national sustainable development using theoretical standpoints provided by reflexive modernization, namely, the concepts of risk and reflexive judgement. Attention is given to those regions of the world—Africa and Asia—where HIV/AIDS are acute policy issues. (shrink)

This article examines the home rapid HIV test as a new practice of US biocitizenship. Via an analysis of discourse surrounding self-diagnostics, I conclude that while home HIV tests appear to expand consumer rights, they are in fact the vanguard of a new form of self-testing that carries a moral urgency to protect one’s own body and to manage societal risk. In addition, these tests extend biomedical authority into the private domain, while appearing to do the exact opposite. Furthermore, (...) access to these tests may be stratified, contradicting the intent expressed by the manufacturer to reach populations in need of it most and reinforcing stigma against them. Lastly, diagnostics such as the rapid home HIV test represent new obligations for surveillance of one’s own health and that of others. The new public health effort to test the population at large has given rise to a new ‘risky’ population: the untested bodies. (shrink)

Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance (...) use or sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee. (shrink)

Volume 20, Issue 10, October 2020, Page 47-49.

The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against (...) the relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa. (shrink)

A commentary on “Time to Decriminalize HIV Status,” from the September‐October 2013 issue.

Summary Recent research has highlighted the risk of HIV infection for married teenage women compared with their unmarried counterparts (Clark, 2004). This study assesses whether a relationship exists, for women who have completed their adolescence (age 20–29 years), between HIV status with age at first marriage and the length of time between first sex and first marriage. Multivariate analysis utilizing the nationally representative 2004 Cameroon Demographic and Health Survey shows that late-marrying women and those with a longer period of (...) pre-marital sex have the highest risk of HIV. Although women in urban areas overall marry later than their rural counterparts, the positive relationship between age at marriage and HIV risk is stronger in rural areas. The higher wealth status and greater number of lifetime sexual partners of late-marrying women contribute to their higher HIV risk. Given that the age at first marriage and the gap between first marriage and first sex have increased in recent years, focusing preventive efforts on late-marrying women will be of much importance in reducing HIV prevalence among females. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal (...) decision-making study nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

This study explored perceived benefits and risks of participation in HIV research among 33 female sex workers in Tecún Umán, Guatemala. Stigma associated with sex work and HIV was a critical barrier to research participation. Key benefits of participation included access to HIV/sti prevention and testing, as well as positive and trusting relationships between sex workers and research teams. Control exerted by managers had mixed influences on perceived research risks and benefits. Results underscore the critical need for HIV investigators to (...) develop population-tailored procedures to reduce stigma; engage managers; and reinforce trusting, reciprocal relationships between sex work communities and researchers. (shrink)

The old literature on whether medical confidentiality may be breached to warn a spouse of a risk of contracting syphilis from his/her partner — a deep and rich literature — has become relevant once again in the context of HIV infection and AIDS. This paper examines the reasoning and method employed in: the Catholic approach centered around the patient's (property) right to the secret; a (generic) model of justice, utilizing minimal principles of non-aggression and restitution; and an approach involving (...) the elimination of unstable alternatives: the view that public health officials, but not the spouse, may/must be notified; and, that maintaining that the physician is at liberty to disclose but is not obliged to do so. The theory and method behind confidentiality turns out to be deeper than you might have anticipated. (shrink)

Background There has been growing interest in the use of incentives to increase the uptake of health-related behaviours and achieve desired health outcomes at the individual and population level. However, the use of incentives remains controversial for ethical reasons. An area in which incentives have been not only proposed but used is HIV prevention, testing, treatment and care—each one representing an interconnecting step in the "HIV Cascade." Methods The main objective of this qualitative case study was to document the experiences (...) of health care and service providers tasked with administrating incentivized HIV testing, treatment, and care in British Columbia, Canada. A second objective was to explore the ethical and professional tensions that arise from the use of incentives as well as strategies used by providers to mitigate them. We conducted interviews with 25 providers and 6 key informants, which were analyzed using applied thematic analysis. We also collected documents and took field notes. Results Our findings suggest that incentives target populations believed to pose the most risk to public health. As such, incentives are primarily used to close the gaps in the HIV Cascade by getting the "right populations" to test, start treatment, stay on treatment, and, most importantly, achieve viral suppression. Participants considered that incentives work because they "bring people through the door." However, they believed the effectiveness of incentives to be superficial, short-lived and one-dimensional—thus, failing to address underlying structural barriers to care and structural determinants of health. They also raised concerns about the unintended consequences of incentives and the strains they may put on the therapeutic relationship. They had developed strategies to mitigate the ensuing ethical and professional tensions and to make their work feel relational rather than transactional. Conclusions We identify an urgent need to problematize the use of incentives as a part of the "HIV Cascade" agenda and interrogate the ethics of engaging in this practice from the perspective of health care and service providers. More broadly, we question the introduction of market logic into the realm of health care—an area of life previously not subject to monetary exchanges. (shrink)

The advances in treatment of HIV and the introduction of polymerase chain reaction assay for the virus now make it acceptable for HIV discordant couples where the male partner is seropositive to attempt to conceive through artificial insemination by husband or via in vitro fertilisation. With undetectable viral load and washed sperm, there is minimal risk of transmission of HIV to the female partner, children, other patients, or staff. We describe the development of a programme of AIH for HIV (...) discordant couples and the reasoning behind offering such a programme. (shrink)

School-based sexuality education is a type of sexology directed at specific bodies: `unfinished' adolescent bodies in the process of becoming sexual bodies. This article explores notions of the adolescent `unfinished' body in the context of HIV/aids education for young people. Drawing on empirical research carried out in Australian secondary schools, we look at the concepts of the project of the self and reflexivity as they are articulated by young people in their evaluation of HIV/aids education. The open character of self (...) identity and the reflexively monitored nature of the body were emphasized by the young people in their attempted construction of intimacy and sexuality. The discourses of openness and trust and the reliance on both `expert' and `experiential' knowledges were evident in the ways in which they dealt with the risk of HIV/aids. The article concludes with a discussion of the implications of these data for the theorizing of risk and reflexivity. (shrink)

The global response to managing the spread of HIV has recently undergone a significant shift with the advent of ‘treatment as prevention’, a strategy which presumes that scaling-up testing and treatment for people living with HIV will produce a broader preventative benefit. Treatment as prevention includes an array of diagnostic, technological and policy developments that are creating new understandings of how HIV circulates in bodies and spaces. Drawing on the work of Michel Foucault, we contextualize these developments by linking them (...) to systems of governance and discursive subjectivation. The goal of this article is to problematize the growing importance of viral suppression in the management of HIV and the use of related surveillance technologies. For people living with HIV, we demonstrate how treatment-as-prevention’s emphasis on individual and collective viral load is transforming the performative dimensions of embodied risk, affect, subjectivity and sex. (shrink)

HIV/AIDS strikes with the greatest frequency in sub-Saharan Africa, a region lacking resources to deal with this epidemic. To keep millions more people from dying, wealthy countries must provide more help. Yet deeply ingrained biases may distance the sick from those who could provide far more aid. One such prejudice is viewing disease as punishment for sin. This 'punishment theory of disease" ascribes moral blame to those who get sick or those with special relations to them. Religious versions hold that (...) God punishes them in order to castigate, encourage virtue, warn, rehabilitate, or maintain some cosmic order. Its various religious and secular forms are untenable; they lack cogency, risk blaming people unjustly, and jeopardize compassionate care for people. These views are not only irrational but also dangerous because they influence policies and cost lives. We need to cooperate and respond as befits this global public-health disaster and not engage in the misguided and bad faith activity of dividing the world into the blameworthy and blameless. (shrink)