Improvements in the health capital of citizens are central to the development of countries. By exploiting steep decreases in antiretroviral drug prices and the subsequent increases in antiretroviral therapy (ART) coverage, we test whether the resulting improvements in the health of the population are associated with the prevalence of entrepreneurial activity and whether entrepreneurial activity strengthens the relationship between ART coverage and a country’s development. Drawing on a sample of 87 low- and middle-income countries (2006–2019), we find that (...) a 1% increase in ART coverage is associated with a 1.5% increase in the number of newly registered limited liability firms; however, there is no significant relationship with (male or female) self-employment. Higher ART coverage is particularly associated with development—as proxied by gross domestic product (GDP) per capita and the Human Development Index—in countries with low levels of new business formation and high proportions of self-employment. (shrink)

The effectiveness of antiretroviral regimes (ARVs) to reduce risk of HIV transmission from mother to child and as post-exposure prophylaxis has been known for almost two decades. Recent research indicates ARVs can also reduce the risk of HIV transmission via sexual intercourse in two other ways. With pre-exposure prophylaxis (PrEP), ARVs are used to reduce risk of HIV acquisition among persons who are HIV negative and significantly exposed to the virus. With treatment as prevention (TasP), ARVs are used to (...) reduce risk of HIV transmission from persons who are already HIV positive. The development of these new prevention strategies raises a rationing problem: given the chronic shortage of ARVs for HIV-infected persons in need of treatment, is it ethically justified to allocate ARVs for PrEP and/or TasP? This article examines the intuitively appealing view that allocation of ARVs for treatment should be the highest priority, the use of ARVs for TasP should be a secondary priority, and that utilizing ARVs for PrEP would be unethical. I will argue that selective, evidence-based allocation of ARVs for prevention in certain cases could be ethically justified even when there is insufficient anti-retroviral access for all those needing it for treatment. (shrink)

Universal access to antiretroviral treatment (ART) in Chad was officially declared in December 2006. This presidential initiative was and is still funded 100% by the country’s budget and external donors’ financial support. Many factors have triggered the spread of AIDS. Some of these factors include the existence of norms and beliefs that create or increase exposure, the low-level education that precludes access to health information, social unrest, and population migration to areas of high economic opportunities and gender-based discrimination. Social (...) forces that influence the distribution of dimensions of well-being and shape risks for infection also determine the persistence of access barriers to ART. The universal access policy is quite revolutionary but should be informed by the systemic barriers to access so as to promote equity. It is not enough to distribute ARVs and provide health services when health systems are poorly organized and managed. Comprehensive access to ART raises many organizational, ethical and policy problems that need to be solved to achieve equity in access. This paper argues that the persistence of access barriers is due to weak health systems and a poor public health leadership. AIDS has challenged health systems in a manner that is essentially different from other health problems. (shrink)

ABSTRACT Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/aids treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: (...) that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals. (shrink)

Aim To explore the way people living with HIV and healthcare providers in Togo judge the priority of HIV-infected patients regarding the allocation of antiretroviral drugs. Method From June to September 2015, 200 adults living with HIV and 121 healthcare providers living in Togo were recruited for the study. They were presented with stories of a few lines depicting the situation of an HIV-infected patient and were instructed to judge the extent to which the patient should be given priority (...) for antiretroviral drugs. The stories were composed by systematically varying the levels of four factors: the severity of HIV infection, the financial situation of the patient, the patient's family responsibilities and the time elapsed since the first consultation. Results Five clusters were identified: 65% of the participants expressed the view that patients who are poor and severely sick should be treated as a priority, 13% prioritised treatment of patients who are poor and parents of small children, 12% expressed the view that the poor should be treated as a priority, 4% preferred that the sickest be treated as a priority and 6% wanted all patients to get treatment. Conclusions WHO's guideline regarding antiretroviral therapy allocation currently in use in many African countries does not reflect the preferences of Togolese people living with HIV. For most HIV-infected patients in Togo, patients who cannot get treatment on their own should be treated as a priority. (shrink)

The 2011 Varsity Medical Debate, between Oxford and Cambridge Universities, brought students and faculty together to discuss the waiving of patents for antiretroviral therapies in the developing world. With an estimated 29.5 million infected by Human Immunodeficiency Virus (HIV) in low- and middle-income countries and only 5.3 million of those being treated, the effective and equitable distribution of anti-retroviral therapy (ART) is an issue of great importance. The debate centred around three areas of contention. Firstly, there was disagreement about (...) whether patents were the real barrier to the access of anti-retroviral therapy in the developing world. Secondly, there were differing views on the effectiveness of a patent pool. Thirdly, concerns were raised over the impact of waiving patents on research to produce new and better anti retro-viral drugs. (shrink)

Often celebrated as a model of development in Africa, Botswana nonetheless endured a severe HIV epidemic. This article describes the singularity of the Botswana experience in facing AIDS and creating the widest possible access to antiretroviral medications for its citizens. Through exploration of different sets of actors and the construction of their ethics of treatment, it is possible to examine how free and universal access was created within the national antiretroviral program. This article underscores the importance of the (...) site and the local dynamics in the advent of an ethics of access to treatment for Botswana citizens. At the intersection of national citizenship, pharmaceutical philanthropy, and biomedical collaborations, Botswana is an exemplary case (one of the first and unique in its kind) of global health programs for access to drugs in which patients' rights are tied to science and pharmaceutical development. As such it also bears some limitations and concerns over its sustainability. (shrink)

Over the past two decades we have seen dramatic improvements in the efficacy, safety and availibity of antiretroviral therapy (ART). In the USA and Europe, life expectancy in people living with HIV disease approaches that of the HIV-uninfected.1 Even in regions hardest hit by the HIV epidemic, effective HIV therapy has reversed more than a decade of HIV-related decreased survival. Despite these advances in ART, motivations to pursue HIV cure remain strong due to the toxicity, adherence challenges, cost and (...) access to care issues associated with HIV therapy, as well as the persistant stigma associated with having HIV infection. Further and renewed motivation comes from a single case of HIV cure after stem cell transplantation for acute leukaemia. Given the tremendous improvements in ART, it is important to assess how effective and safe an HIV cure would need to be in order to be a viable option compared to ART. We argue that this should be done prior to the availability of a cure to provide realistic goals for researchers and policy makers. One methodology that has been increasingly popular over the past decade is the use of mathematical simulation modelling to assess the clinical impact, cost-effectiveness and clinical role of different treatment strategies in HIV disease, as well as in medicine broadly.2 Such models provide a framework and approach for using the best available data at any point in time, and assessing the potential impact of emerging innovations. Further, unlike individual trials focused on a single endpoint, these models can integrate multiple data sources to project beyond the timeline or outcomes of individual studies and project long-term outcomes in many domains, including virologic, immunologic, clinical and cost.3 Mathematical models have particular value in their ability to assess uncertainty in clinical care. Examples include parameters determined in …. (shrink)

The way Cambodian patients and health professionals judge the priority of HIV-infected patients in relation to the allocation of antiretroviral drugs was examined. Participants were either HIV-infected patients attending the HIV/AIDS Care and Support Centre for People Living with HIV/AIDS in Phnom Penh (29 females and 21 males) or members of the staff (9 physicians, 6 pharmacists and 15 health counsellors and health educators). They were presented with stories of a few lines depicting a patient's situation and were instructed (...) to judge the extent to which the patient should be given priority for HIV drugs. The stories were composed according to a four within-subject factor design: (a) the patient's family responsibilities, (b) the severity of infection, (c) the time elapsed since the first consultation, and (d) the financial difficulties of the family. Most patients expressed the view that the drugs should be used for the patients who are most important from a familial point of view, namely, when the family contains small children and/or is already in a precarious financial condition. (shrink)

BackgroundAdolescents living with human immunodeficiency virus (HIV) experience challenges, including lack of involvement in their care as well nondisclosure of HIV status, which leads to poor adherence to antiretroviral therapy (ART). Parents have authority over their children, but during adolescence there is an increasing desire for independence. The aim of the study was to explore adolescents’ experience of challenges identified by adolescents ages 10–19 years attending HIV care and treatment at Temeke Regional Referral Hospital in Tanzania. MethodsAn exploratory descriptive (...) qualitative design was employed in the HIV Care and Treatment Centre (CTC) in the Out-Patient Department at the Temeke Regional Referral Hospital in Tanzania with adolescents living with HIV who were 10–19 years of age. A total of 22 adolescents participated in semi-structured face-to-face interviews after parental consent and adolescent assent were obtained. Participants were interviewed about their participation in decisions to be tested for HIV and enrolled in the CTC, concerns surrounding disclosure of their HIV status to the adolescent or to others, stigma and discrimination, and the effect of these challenges on their adherence to medication. All interviews were audio-taped, transcribed verbatim in Swahili, and back-translated to English. Data analysis included both inductive and deductive thematic analysis.ResultsQualitative themes identified included lack of participation in decisions about HIV testing, challenges to enrollment in care and treatment; issues around disclosure of HIV status, such as delays in disclosure to the adolescent and disclosure to other persons and benefits and harms of such disclosures; and factors supporting and interfering with adherence to ART, such as parental support, organizational (clinic) support and problems, and self-stigmatization and shame.ConclusionLack of adolescents’ involvement in their care decision making and delayed disclosure of HIV status to the adolescent were identified concerns, leading to poor adherence to ART among adolescents. Disclosure to others, especially teachers, helped adolescents at school to take their medication properly. Disclosure to others led to stigma and discrimination for some adolescents. More research is needed to better understand the role of disclosure and its benefits and challenges for HIV-positive adolescents in Tanzania. (shrink)

A two strain HIV/AIDS model with treatment which allows AIDS patients with sensitive HIV-strain to undergo amelioration is presented as a system of non-linear ordinary differential equations. The disease-free equilibrium is shown to be globally asymptotically stable when the associated epidemic threshold known as the basic reproduction number for the model is less than unity. The centre manifold theory is used to show that the sensitive HIV-strain only and resistant HIV-strain only endemic equilibria are locally asymptotically stable when the associated (...) reproduction numbers are greater than unity. Qualitative analysis of the model including positivity, boundedness and persistence of solutions are presented. The model is numerically analysed to assess the effects of treatment with amelioration on the dynamics of a two strain HIV/AIDS model. Numerical simulations of the model show that the two strains co-exist whenever the reproduction numbers exceed unity. Further, treatment with amelioration may result in an increase in the total number of infective individuals (asymptomatic) but results in a decrease in the number of AIDS patients. Further, analysis of the reproduction numbers show that antiretroviral resistance increases with increase in antiretroviral use. (shrink)

The aim of the study was to determine how the health of people living with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) is affected by social and structural factors conducive to non-adherence to antiretroviral treatment. In a qualitative study conducted at Victoria Hospital in Alice, a town in the Eastern Cape, South Africa, 23 isiXhosa-speaking participants (including both men and women) between the ages of 18 and 60 years were interviewed. Guided by the social-ecological framework of Bronfenbrenner (...) (1979), which is based on the notion that the health-seeking behaviour of people living with HIV/AIDS (PLWHA) is influenced by their social, institutional and physical environments, the analysis of the data identified the following themes conducive to non-adherence to antiretroviral treatment: food insecurity, financial constraints, poor service from health workers, unfair dismissal, fear of the consequences of disclosure, and rejection by church members. Based on these findings, and given that there is no single model of best practice that can appropriately address the various social and structural factors complicating the treatment of HIV/AIDS and hence the containing of the pandemic, the study suggests the need for not only supportive community initiatives, but a collaborative approach at both local and national level, and particularly in impoverished communities, by the appropriate departments of state to promote adherence to anti-retroviral treatment by making treatment and counselling facilities more accessible to PLWHA and educating communities about the implications and prevention of the disease. (shrink)

In 1999, Médecins Sans Frontières set out to explore and demonstrate the feasibility of preventing and treating HIV/AIDS in a so-called resource-poor, economically and socially disadvantaged setting. The first MSF mission to incorporate antiretroviral treatment into its HIV-AIDS-oriented medical program was undertaken in Bangkok. The second project was launched in Khayelitsha where MSF has been providing ARV treatment for persons with HIV/AIDS since May 2001. Khayelitsha is an enclave of some 500,000 inhabitants, most of whom live in corrugated-iron shacks, (...) without running water or electricity. Unemployment is extremely high; crime and violence are rampant. The general prevalence of HIV/AIDS is 26%, measured among pregnant women. The tuberculosis incidence rate is one of the world's highest for open-space sites. Unsurprisingly, TB/HIV coinfection is very high too: 63% of those with TB are also infected with HIV. (shrink)

Effective therapies are now available that can stop the progression of HIV infection and significantly delay the onset of AIDS. The “highly active antiretroviral therapy” (HAART) is a combination of potent antiretroviral drugs such as viral protease inhibitors or nucleoside-analogue reverse-transcriptase inhibitors, that has a variety of serious side effects, including lipodystrophy, a pathology characterized by accumulation of visceral fat, breast adiposity, cervical fat-pads, hyperlipidemia, insulin resistance as well as fat wasting in face and limbs. There is still (...) an open debate that concerns the precise responsibility of HAART as well as metabolic pathways and mechanisms that are involved in the onset of lipodystrophy. The similarities with multiple symmetric lipomatosis (MSL), in which mitochondria impairment plays a crucial role, lead to the hypothesis that drug-induced damages to mitochondrial DNA are able to alter mitochondria functionality to an extent that is similar to what occurs in MSL. In addition, several evidences indicate that HAART is also linked to a deregulated production of tumour necrosis factor-α, which uses mitochondria as intracellular targets. In this paper, we review data concerning the role of mitochondria in the pathogenesis of lipodystrophy, and advance a unifying hypothesis involving either direct or indirect effects of the drugs employed during HAART. BioEssays 23:1070–1080, 2001. © 2001 John Wiley & Sons, Inc. (shrink)

The word “epidemic” seems inadequate to describe the spread of the HIV virus in sub-Saharan Africa. The latest estimates suggest that 28.5 million people in this region are infected, including 5 million in South Africa alone. The HIV and AIDS pandemic, with infection rates of over 20 percent in seven African countries, rivals the worst of history's disease outbreaks, including the bubonic plague of medieval times. The devastating effects of the disease on the continent are compounded by extreme poverty in (...) the region and the lack of medical infrastructure essential for delivering the full range of available treatments for HIV infection, AIDS, and the opportunistic infections associated with the disease. Of the 40 million people infected with HIV worldwide, only 730,000 receive combination antiretroviral therapies. In the entire African continent, only 30,000 infected people currently receive such forms of treatment. (shrink)

It is widely acknowledged that the HIV and AIDS pandemic is a global emergency and that cheap, effective treatment should be provided for as many people as possible worldwide. But there are many challenges to rolling out antiretroviral treatment in resource-poor settings. These include the cost of drugs, sustaining their supply and distribution, the complexity of treatment regimens, selection of patients for treatment, shortage of medical and nursing personnel, inadequacy of healthcare facilities, the need for uninterrupted, lifelong treatment, and (...) monitoring for drug resistance. Great efforts, nationally and internationally, are required to meet these challenges. (shrink)

Although clarity about HIV transmission biology and effective therapy should mean that an AIDS diagnosis is more socially acceptable today, for some groups the cultural stigma of HIV infection has changed little in the last 30 years. This paper will examine why representations of HIV-positive gay men suggest they pose a special civic risk and how these conceptualizations have harnessed cultural anxieties about racial and sexual minorities to shape public policy and behavior since the advent of Highly Active Antiretroviral (...) Therapy (HAART) in 1996. (shrink)

The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative (...) socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non‐exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process. (shrink)

Each of the antiretroviral drugs that are currently used to stop the progression of HIV infection causes its own specific side effects. Despite the expansion, multiplication, and simplification of treatment options over the past decade, side effects continue to affect people living with HIV. Yet, we see a clear disconnect between the way side effects are normalized, routinized, and framed in clinical practice and the way they are experienced by people living with HIV. This paper builds on the premise (...) that new approaches are needed to understand side effects in a manner that is more reflective of the subjective accounts of people living with HIV. Drawing on the work of Deleuze and Guattari, it offers an original application of the theory of ‘assemblage’. This theory offers a new way of theorizing side effects, and ultimately the relationship between the body and antiretroviral drugs (as technologies). Combining theory with examples derived from empirical data, we examine the multiple ways in which the body connects not only to the drugs but also to people, things, and systems. Our objective is to illustrate how this theory dares us to think differently about side effects and allows us to originally (re)think the experience of taking antiretroviral drugs. (shrink)

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and (...) regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. (shrink)

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and (...) the feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population. (shrink)

Some participants will get HIV-infected in HIV prevention trials, despite risk reduction measures. The subsequent treatment responsibilities of sponsor-investigators have been widely debated, especially where access to antiretroviral therapy (ART) is not available. In this paper, we explore two accounts of beneficence to establish whether they can shed light on sponsor-investigator responsibilities. We find the notion of general beneficence helpful insofar as it clarifies that some beneficent actions will be obligatory where they can be dispensed without scuppering the trial. (...) We find the notion of specific beneficence helpful insofar as it directs investigators to attend to the needs of trial participants; however the range of interventions that could be provided remains unhelpfully broad. We then examine accounts of the investigator-participant relationship to narrow the range of interventions that investigators should provide, concluding that health-care, and HIV infection, are appropriate foci. We conclude that when investigators are able to meet the ART needs of their participants (e.g. referral, assisted referral or direct provision) without sacrificing trial quality, they must do so. However, there is little of this explicit direction to be found in the account of specific beneficence itself, but rather it is found in accounts of the relationship that are compatible with beneficence. (shrink)

Recent evidence confirming that the administration of antiretroviral drugs (ARVs) to HIV-infected persons may effectively reduce their risk of transmission has revived the discussion about priority setting in the fight against HIV/AIDS. The fact that the very same drugs can be used both for treatment purposes and for preventive purposes (Treatment as Prevention) has been seen as paradigm-shifting and taken to spark a new controversy: In a context of scarce resources, should the allocation of ARVs be prioritized based on (...) the goal of providing treatment, or on the goal of preventing the spread of the HIV epidemic? Contributions to this discussion tend to assume that treatment and prevention constitute two divergent goals that entail conflicting priorities. We challenge that assumption on the basis of both conceptual and empirical examination. We argue that, as far as the provision of ARVs to HIV-infected persons is concerned, the goals of treatment and prevention do not entail conflicting priorities; to the contrary, they dictate converging strategies for the optimal allocation of ARVs. In light of the current evidence, the concept of Treatment as Prevention can indeed be seen as paradigm-shifting, yet in a novel way: Rather than extending the tension between the goals of treatment and prevention to the level of drug-allocation, it dissolves this tension by providing a rationale for a unified strategy for allocating ARVs. (shrink)

Fragile states have been raising increasing concern among donors since the mid-2000s. The policies of the Global Fund to fight HIV/AIDS, Malaria, and Tuberculosis have not excluded fragile states, and this source has provided financing for these countries according to standardized procedures. They represent interesting cases for exploring the meaning and role of measurement in a globalized context. Measurement in the field of HIV/AIDS and its treatment has given rise to a private outsourcing of expertise and auditing, thereby creating a (...) new form of value based on the social process of registration and the creation of realities produced by the intervention itself. These “scriptural economies” must be questioned in terms of the production of knowledge, but also in terms of social justice. Governing HIV/AIDS treatments by numbers in a fragile state is explored in this article through the experience of the Central African Republic in terms of epidemiology and access to antiretroviral drugs. The unexpected effects of performance-based programs in this context underline the need for global health governance to be re-embedded into a social justice framework. (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)

Published data show that new HIV prevention strategies including treatment-as-prevention and pre-exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV-based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the (...) provision of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment-as-prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment-as-prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment-as-prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV-based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations. (shrink)

Antiretroviral pre-exposure prophylaxis (PrEP) is protective against HIV. Low utilization rates amongst HIV vulnerable populations are due in part to the high cost of PrEP. Generic PrEP offers the potential to improve health at significantly reduced costs. In this study, we examine early utilization patterns and prices for generic PrEP. We discuss the opportunities and challenges for generic PrEP to improve health among HIV vulnerable populations.

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)

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants (...) are infected perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)

The advent of new antiretroviral medicines means that the effects of HIV can now be curbed, but only one in twenty infected people have so far benefited. For those living in developing countries, the new treatments are practically unattainable. Governments, UNAIDS and pharmaceutical companies recognise this only too well and have rethought established assumption in order to try and overcome the challenges posed by cost, inadequate health services and unreliable local supply of medicines.

This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. But what sorts of (...) "use" are morally permissible? What is it to exploit people? Suppose that a trial conducted in a developing country would not be ethically permissible in the developed world. Can we automatically conclude from this that the trial is unethical, that some sort of morally problematic double standard is in operation? Or might the differences in the two settings justify differences in trial design? This collection of philosophical essays examines these important questions about what exploitation is and when clinical research counts as exploitative. -/- "This is an outstanding contribution to the growing literature on the ethics of research with human subjects and a fine example of what bioethics can offer at its best. Anyone with a serious interest in these issues will need to read this book from start to finish." -Daniel Wikler, Harvard School of Public Health "This book contributes significantly to the literature on exploitation in clinical research conducted in the developing world."--Patricia Marshall, Case Western Reserve University . (shrink)

To reduce the spread of the human immunodeficiency virus (HIV), Granich et al. 1 ( 2009 ) have proposed a new strategy for universal voluntary HIV testing immediately followed by antiretroviral therapy. Although this proposal is likely to benefit the partners of those affected and thus promote public health, it is by no means clear that it benefits the infected people themselves and indeed it may be harmful. Since the proposal involves an intervention that is not clinically indicated, it (...) falls foul of the normal ethical standards of clinical medicine, which is to act in the best interests of patients. Neither is it a measure that would be imposed under the protection of public health law on people who are seen as representing such danger to others that significant restrictions in liberty are appropriate. Thus, the proposal represents a third category of public health measure. We argue that a coherent ethical framework including a robust process is appropriate to proposals of this kind and that medical research offers a useful model since some research, like this proposal, is motivated not by the interests of the individual participants but by the common good. We outline some possible elements of such an ethical framework. (shrink)

Abstract:Although the idea of intellectual property (IP) rights—proprietary rights to what one invents, writes, paints, composes or creates—is firmly embedded in Western thinking, these rights are now being challenged across the globe in a number of areas. This paper will focus on one of these challenges: government-sanctioned copying of patented drugs without permission or license of the patent owner in the name of national security, in health emergencies, or life-threatening epidemics. After discussing standard rights-based and utilitarian arguments defending intellectual property (...) we will present another model. IP is almost always a result of a long history of scientific or technological development and numbers of networks of creativity, not the act of a single person or a group of people at one moment in time. Thus thinking about and evaluating IP requires thinking about IP as shared rights. A network approach to IP challenges a traditional model of IP. It follows that the owner of those rights has some obligations to share that information or its outcomes. If that conclusion is applied to the distribution of antiretroviral drugs, what pharmaceutical companies are ethically required to do to increase access to these medicines in the developing world will have to be reanalyzed from a more systemic perspective. (shrink)

Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a four month (...) period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidisation of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants. (shrink)

The world’s first living donor liver transplant from an HIV-positive mother to her HIV-negative child, performed by our team in Johannesburg, South Africa (SA) in 2017, was necessitated by disease profile and health system challenges. In our country, we have a major shortage of donor organs, which compels us to consider innovative solutions to save lives. Simultaneously, the transition of the HIV pandemic, from a death sentence to a chronic illness with excellent survival on treatment required us to rethink our (...) policies regarding HIV infection and living donor liver transplantation. Although HIV infection in the donor is internationally considered an absolute contraindication for transplant to an HIV-negative recipient, there have been a very small number of unintentional transplants from HIV-positive deceased donors to HIV-negative recipients. These transplant recipients do well on antiretroviral medication and their graft survival is not compromised. We have had a number of HIV-positive parents in our setting express a desire to be living liver donors for their critically ill children. Declining these parents as living donors has become increasingly unjustifiable given the very small deceased donor pool in SA; and because many of these parents are virally suppressed and would otherwise fulfil our eligibility criteria as living donors. This paper discusses the evolution of HIV and transplantation in SA, highlights some of the primary ethical considerations for us when embarking on this case and considers the new ethical issues that have arisen since we undertook this transplant. (shrink)

BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern (...) bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.ResultsKey recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.ConclusionParticipatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)

There is no cure or vaccine for HIV/AIDS. The only life-prolonging treatment available is antiretroviral (ARV) therapy. WHO estimates, however, that less than 5 percent of those who require treatment in developing countries currently enjoy access to these medicines. In Africa fewer than 50,000 people–less than 2 percent of the people in need–currently receive ARV therapy. These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely.The intensity of the debate concerning (...) access to life-prolonging medicines for the treatment of HIV/AIDS, and the heated rhetoric with which they are often conducted, suggest that these disagreements may be rooted in deeper disagreements of value. It is not obvious, however, what disagreements of value are at stake in this debate. By analyzing the statements of scholars, public officials, activist organizations, and private sector representatives, each of whom may endorse very different policy recommendations on access to HIV/AIDS drugs, we have identified and created a typology of the different sources of disagreement in the debate. We conclude that the central disagreements concerning access to medicines arise from competing understandings of how responsibilities for bringing remedy to hardships should be allocated to different agents and institutions. A central lesson that emerges from our analysis is that thinking about “health equity” must extend beyond the explanation and justification of goals, values, and ideals, and engage more honestly with the difficult question of how responsibilities for bringing remedy to health crises should be allocated in complex social contexts. (shrink)

This chapter critically explores the extent to which pharmaceutical companies have a moral obligation to assist poor patients in least developed countries who currently have no or inadequate access to lifesaving medications. Focusing on the ongoing HIV/AIDS epidemic in LDCs, the first section of this essay begins with some background information of the disproportionate burden of HIV/AIDS in LDCs. The second section provides a brief overview of some of the salient arguments for holding multinational antiretroviral treatment manufacturers as morally (...) responsible for easing the disproportionate global disease burden. The third section explains that these arguments regarding pharmaceutical companies’ duty to assist are going too far on the one hand by downplaying other non-pharmacological contributors to the slow response, but are also not going far enough on the other hand in upholding reciprocity-based duties. As the international community and researchers battle the reemergence of Ebola in Africa, the fourth section explores how lessons from the HIV/AIDS situation can help to address what pharmaceutical companies may subsequently owe patients in this region and how the international community should respond to ongoing unequal disease burden. (shrink)

BackgroundWhile most studies on HIV/AIDS often identify stigmatization and patients’ unwillingness to access health care as critical problems in the control of the pandemic, very few studies have focused on the possible consequences of accessing health care by sero-positives. This paper examines the socio-psychological trauma patients experience in their desire to access health care in two health facilities in the Ashanti Region of Ghana.MethodsThrough participant observation, informal conversation and in-depth interviews, data were collected from health workers and clients of the (...) voluntary counselling and antiretroviral therapy units in the two hospitals.The data gathered were analysed and categorized into themes and supported with illustrative quotes obtained from health workers and clients.ResultsThe study found that the mere presence of a person at the HIV counselling centre or clinic is enough for the person to be labelled as or suspected to be HIV patient. It demonstrates that stigmatization may occur not only in the community but also overtly or covertly, in the health facility itself. Consequently, for many HIV/AIDS patients, access to antiretroviral therapy and treatment of related nosocomial infections are problematic. Besides, the study found that many clients and potential users of services were uncomfortable with the quality of care given by some health workers, especially as they overtly and covertly breached confidentiality about their clients’ health status. This has compelled many patients and potential users of the services to adopt a modus vivendi that provides them access to some care services while protecting their identity.ConclusionThe paper argues that by examining issues relating to privacy and confidentiality in the provision of care for and use of services by seropositives, more light will be shed on the whys of the limited uptake of HIV-related health care services in Ghana. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; (...) and third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

In spite of much candid protest and overt criticism against the service delivery record and corruption of the South African government, the governing party, the African National Congress, once again secured a persuasive victory in the 2014 national elections. This situation begs the question whether the ballot box is really the only efficient instrument for disgruntled voters to influence government policy and behaviour. This article examines the possibilities that the mobilisation of civil society offers in this regard. The central theoretical (...) argument is that civil society can be an important instrument through which the citizenry can exercise their critical function with regard to the government in an effort to address poor service delivery and corruption and to influence government policy. Christian organisations can play a crucial role in this process. Two examples of past efficient action by civil society serve to illustrate this argument. With the assistance of churches and Christian organisations,these organisations profoundly influenced government policy and are consequently presented as models for action today. The first example is the ‘United Democratic Front’ that forced the pre-1994 South African apartheid government to a negotiated settlement despite the strict security laws that the state utilised to keep the UDF in check. The second example is the ‘Treatment Action Campaign’ that forced the post-1994 Thabo Mbeki government to adopt a policy of free provision of antiretroviral drugs to HIV-positive patients. These two influential civil organisations offer models of how civil society can act as critical watchdog. In future, these models can be used to mobilise civil society, including churches and Christian organisations, to act correctively in defining and enacting government policy, despite the ANC’s strong position in government and the large majority that the governing party can secure at the voting polls. (shrink)

Background. Decisions to test, enrol and disclose HIV status are among the ethical challenges that may influence adherence to antiretroviral therapy (ART) and HIV care and treatment in adolescents living with HIV. In the Tanzanian setting, how parental perceptions of ethical issues affect adolescents’ adherence to HIV care and treatment is not well known.Objective. To explore parental perceptions of ethical issues in adolescent HIV care and treatment. Methods. The study employed a descriptive qualitative exploratory design and was conducted at (...) Temeke Regional Referral Hospital in Dar es Salaam Care and Treatment Centre (CTC) in the Outpatient Department (OPD). The study population were parents and non-parent caregivers of HIV-infected adolescents 10 - 19 years of age. A total of 16 persons participated in semi-structured interviews after their consent was obtained. All interviews were audiotaped, transcribed verbatim in Swahili and back-translated into English. An inductive content analysis was used, and standards of qualitative rigour applied. Results. Three qualitative themes emerged: balancing adolescents’ autonomy with parents’ desire to protect their children; parental dilemmas regarding disclosure of adolescents’ HIV status; and parental reasons for delayed disclosure.Conclusion. Participants perceived that parental authority should override adolescents’ autonomy in HIV care and treatment. Disclosure of HIV status to adolescents is a challenge to parents. Delays in disclosure often occur because parents feel guilty and because they have fears of rejection by their adolescent children. (shrink)

With a global commitment to scaling up AIDS care and treatment in resource-poor settings for some of the most HIV-affected countries in Africa, availability of antiretroviral treatment is no longer the principal obstacle to expanding access to treatment. A shortage of trained healthcare personnel to initiate treatment and manage patients represents a more challenging barrier to offering life-saving treatment to all patients in need. Physician-centered treatment policies accentuate this challenge. Despite evidence that task shifting for nurse-centered AIDS patient care (...) is effective and can alleviate severe physician shortages that currently obstruct treatment scale-up, political commitment and policy action to support task shifting models of care has been slow to absent. In this paper we review the evidence in support of task shifting for AIDS treatment in Africa and argue that continued policy inaction amounts to unwarranted healthcare rationing and as such is ethically untenable. (shrink)

The impending implementation of pre-exposure prophylaxis has prompted complicated bioethical and public health ethics concerns regarding the moral distribution of antiretroviral medications to ostensibly healthy populations as a form of HIV prevention when millions of HIV-positive people still lack access to ARVs globally. This manuscript argues that these questions are, in part, concerns over the ethics of the knowledge production practices of epidemiology. Questions of distribution, and their attendant cost-benefit calculations, will rely on a number of presupposed, and therefore, (...) normatively cultural assumptions within the science of epidemiology specifically regarding the ability of epidemiologic surveillance to produce accurate maps of HIV throughout national populations. Specifically, ethical questions around PrEP will focus on who should receive ARVs given the fact that global demand will far exceed supply. Given that sexual transmission is one of the main modes of HIV transmission, these questions of ‘who’ are inextricably linked to knowledge about sexual personhood. As a result, the ethics of epidemiology, and how the epidemiology of HIV in particular conceives, classifies and constructs sexual populations will become a critical point of reflection and contestation for bioethicists, health activists, physicians, nurses, and researchers in the multi-disciplinary field of global health. This paper examines how cultural conundrums within the fields of bioethics and public health ethics are directly implicated within the ethics of PrEP, by analyzing the problems of population inaugurated by the construction of the men who have sex with men epidemiologic category in the specific national context of South Africa. (shrink)

Retroviruses are unusual amongst animal viruses in their capacity to integrate into host genomes and be transmitted vertically to host progeny. Vertebrate genomes contain numerous and diverse retrovirus‐derived sequences reflecting a long co‐evolutionary history during which genome invasion has occurred repeatedly, with wide‐ranging evolutionary consequences. Over the past 10 years, a detailed picture of retroviral diversity throughout vertebrate genomes has emerged, revealing striking and informative patterns that differ markedly across species. The power of these data to deliver far‐reaching insights into (...) the biology and evolution of retroviruses has been significantly advanced by recent studies identifying ongoing genome invasion in wild populations,(1) and by the characterisation of conserved mechanisms of innate antiretroviral defence.(2,3) BioEssays 28: 1153–1156, 2006. © 2006 Wiley Periodicals, Inc. (shrink)

To help eliminate perinatal HIV transmission, the US Department of Health and Human Services recommends against breastfeeding for women living with HIV, regardless of viral load or combined antiretroviral therapy status. However, cART radically improves HIV prognosis and virtually eliminates perinatal transmission, and breastfeeding's health benefits are well-established. In this setting, pregnancy is increasing among American women with HIV, and a harm reduction approach to those who breastfeed despite extensive counseling is suggested. We assess the evidence and ethical justification (...) for current policy, with attention to pertinent racial and health disparities. We first review perinatal transmission and breastfeeding data relevant to US infants. We compare hypothetical risk of HIV transmission from breastmilk to increased mortality from sudden infant death syndrome, necrotizing enterocolitis and sepsis from avoiding breastfeeding, finding that benefits may outweigh risks if mothers maintain undetectable viral load on cART. We then review maternal health considerations. We conclude that avoidance of breastfeeding by women living with HIV may not maximize health outcomes and discuss our recommendation for revising national guidelines in light of autonomy, harm reduction and health inequities. (shrink)