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)

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)

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)

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 (...) class='Hi'>Antiretroviral Therapy (HAART) in 1996. (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)

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)

Objectives: To test the range of beliefs regarding the ethics of testing, in resource poor settings, new therapies that are less efficacious but more affordable and feasible than the best current therapeutic standard. Design: Using a web-based survey, we presented a hypothetical scenario proposing to test a therapy for HIV disease ("therapeutic inoculation") known to be less efficacious than highly active antiretroviral therapy (HAART). Respondents evaluated various trial designs as ethical or unethical. Participants: 604 subscribers to two (...) listservs for individuals interested in international health research ethics. Main outcome measures: Proportion of respondents endorsing trials testing this "substandard" therapy, and proportion endorsing placebo-controlled trials. Results: There were 215 respondents from 47 countries. Forty-five percent of respondents were from low or middle income countries; 96% devoted at least some time to research activities; and 75% had "some" or "considerable" research experience in developing countries. Of respondents, 97% (95% CI 94.7 to 99.4) endorsed testing therapeutic inoculation, without HAART, in patients with HIV disease; 86% (95% CI 81.4% to 90.7%) endorsed testing against placebo. Sixty-eight percent explicitly endorsed principles where the standard of care for subjects in clinical trials is determined by local, not universal, standards. There were no differences in responses based on respondent education-level or the income-level of their country of citizenship. Conclusion: There was broad agreement that a therapy of potential local benefit may be tested, even when that therapy is known to be inferior to the standard of care in wealthy countries. Most agreed that a placebo control may be used in some circumstances. (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)

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 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)

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)

The number of people in immediate need of anti‐retroviral treatment (ART) in the southern African region continues to significantly exceed the capacity of health systems there to provide it. Approaches to this complex rationing dilemma have evolved in different directions. The ethical concepts of fairness and equity have been suggested as a basis to guide the development of approaches to select patients for ART. This article reports the results of a case study on patient selection at a rural ART clinic (...) in Lesotho. The purpose of the study was to examine whether or not such concepts had relevance or operative value for a treatment team providing ART in rural Lesotho. The study found that while concepts of fairness and equity were relevant to the work of the treatment team, patient selection practices did not necessarily reflect what these concepts entail. The idea of fairness as a structured, formalized selection process did not figure in the approach to ART provision at the site. A less formal, ‘first‐come‐first‐served’ approach was adopted. While there was knowledge among some team members that social, economic or geographic conditions inhibit individuals and groups from gaining access to ART and that this was inequitable, it was felt that there was little they could do to try to mediate the impact of these conditions. The study's findings pose importance questions about the approach to ART programming in resource constrained settings. The findings also question the relevance of trying to achieve fairness and equity when the gap between need for care and capacity to provide it remains so large. (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)

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)

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)

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)

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)

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)

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)

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)

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)

A published case report of an infant who inadvertently developed remission of HIV viral expression has prompted research to determine if this observation is reproducible and can offer a potentially novel clinical approach to inducing sustained viral remission of HIV.Typically HIV-infected mothers receive antiretroviral therapy before delivery and infants receive between one and three drugs at “low doses” for prevention. In the case report, the mother delivered before she could receive ART. The infant was placed on a three-drug (...) approach with “higher” doses by her doctor than are typically used for treatment. When HIV infection was confirmed, the three-drug regimen was continued. For most.. (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)

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)

In lieu of an abstract, here is a brief excerpt of the content:Closing the Gaps in Pediatric HIV/AIDS Care, One Step at a TimeLisa V. Adams, Helga Naburi, Goodluck Lyatuu, Paul Palumbo, and C. Fordham von ReynFatuma's* doctors were completely perplexed. It was 2003 and she had returned to the DARDAR clinic in her hometown of Dar es Salaam, Tanzania three times that week with vague complaints of various pains and aches. Her doctors were considering whether these symptoms were due (...) to the initiation of her recent treatment with antiretroviral medications for her HIV infection or related to the last administration of the investigational tuberculosis (TB) vaccine that the DARDAR Health Study was evaluating. Fatuma's doctor, Dr. Lillian Mtei, consulted with Dartmouth's chief of Infectious Disease, Dr. Ford von Reyn, who happened to be in Dar that week on a site visit. Neither physician could determine the basis for her symptoms. Dr. Mtei returned to the exam room once more and this time emerged with the answer: Fatuma had just learned that her three year old daughter was HIV-infected, likely contracted from Fatuma during or shortly after she gave birth to her daughter. Fatuma believed that her HIV diagnosis was a death sentence for her daughter since antiretroviral therapy was not widely available for children.Dr. von Reyn, Dartmouth's lead clinical researcher in Africa and a father, knew too well the harsh reality of inequities in a resource-limited country. He turned to Dr. Mtei and said decidedly, "we need to do something about this."Thus the DARDAR Pediatric Program was born.Pediatric HIV: A Neglected DiseaseThe need for HIV treatment among children in Tanzania, as in most of sub-Saharan Africa, is compelling. At the end of 2009, approximately 160,000 children aged zero to fourteen in Tanzania were living with HIV (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2011). Even with successful roll out of prevention of mother to child transmission programs in Tanzania, there were nearly 29,000 perinatal infections in 2009. As of December 2010, only 18% of these were enrolled in HIV treatment programs (UNAIDS, 2011; World Health Organization [WHO], 2011). Without antiretroviral therapy (ART), one-half of HIV-infected children will die before their second birthday. Since clinical research to determine efficacy and safety of new medical treatments is conducted almost exclusively in adults, provision of new medical treatments to [End Page 75] children always lags behind advances for adults. Furthermore, children are often underrepresented in programs for antiretroviral drugs for the following reasons: 1) they are not prioritized for care; 2) facilities lack infant diagnostic capabilities; 3) there is limited pediatric HIV training and consequently, a shortage of pediatric providers; and 4) pediatric antiretroviral formulations are frequently unavailable. The unacceptable delays in pediatric HIV drug development and treatment access led the international organization Drugs for Neglected Diseases initiative to publish an editorial in which they referred to pediatric HIV as a "neglected disease" (Lallemant, Chang, Cohen, & Pecoul, 2011).The Tip of the Iceberg: More than Just MedicinesWith a grant from the New York-based Foundation for the Treatment of Children with AIDS, the DARDAR Pediatric Program, a joint collaboration between Geisel School of Medicine at Dartmouth and Muhimbili University of Health and Allied Sciences, began seeing patients in May 2006. It was the first dedicated pediatric HIV Care and Treatment Center in Tanzania and operates in accordance with Tanzania's National AIDS Control Programme's guidance. Testing for both children and infants (the latter of which requires a more sophisticated assay) is available.The day the clinic opened we celebrated this collaborative effort that would provide HIV-infected children in Dar es Salaam access to antiretroviral treatment. One of our first patients was a six-year-old boy whose mother, like Fatuma, was a participant in our TB vaccine trial. She had been advised to bring her son to us for HIV screening. Her son looked healthy so she was surprised and understandably distraught when his test results indicated that not only was he HIV-infected, but his CD4 percentage was very low. His mother was reluctant to have him started on antiretrovirals given his general appearance and young age—and that he was... (shrink)

Task shifting is increasingly used to address human resource shortages impacting HIV service delivery in low- and middle-income countries. By shifting basic tasks from higher- to lower-trained cadres, such as Community Health Workers, task shifting can reduce overhead costs, improve community outreach, and provide efficient scale-up of essential treatments like antiretroviral therapies. Although there is rich evidence outlining positive outcomes that CHWs bring into HIV programs, important questions remain over their place in service delivery. These challenges often reflect concerns (...) over whether CHWs can mitigate HIV through a means that does not overlook the ethical and practical constraints that undergird their work. Ethical and practical guidance thus needs to become the cornerstone of CHW deployment. This paper analyzes such challenges through the lens of Ethical Principlism. We examined papers identifying substantive and ethical challenges impacting CHWs as they provide HIV services in low- and middle-income contexts. To do this, we analyzed papers written in English and published from year 2000 or later. These articles were identified using MEDLINE, Cochrane Database of Systematic Reviews, and Google Scholar databases. In total, 465 articles were identified, 78 of which met our inclusion criteria. Article reference lists and grey literature were also examined. CHWs experience specific challenges while carrying out their duties, such as conducting emotionally- and physically-demanding tasks with often inadequate training, supervision and compensation. CHWs have also been poorly integrated into health systems, which not only impacts quality of care, but can hinder their prospects for promotion and lead to CHW disempowerment. As we argue, these challenges can be addressed if a set of ethical principles is prioritized, which specifically entail the principles of respect for persons, justice, beneficence, proportionality and cultural humility. CHWs play a crucial role in HIV service delivery, yet the ethical challenges that can accompany their work cannot be overlooked. By prioritizing ethical principles, policymakers and program implementers can better ensure that CHWs are combatting HIV through a means that does not exploit or take their critical role within service delivery for granted. (shrink)

This paper reflects on the meanings of ‘post-AIDS’ in the Global North and South. I bring together contemporary arguments to suggest that the notion of ‘post-AIDS’ is, at best, misplaced, not least because its starting point remains a biotechnical one. Drawing on aspects of the sub-Saharan African experience, this essay suggests that, despite significant shifts in access to antiretroviral therapy, HIV continues to be fundamentally shaped by economic determinants and social and cultural practices. In this essay, I question (...) the certainty of the discourse of ‘positive progress’, which underpins the ‘post-AIDS’ narrative, and suggest that living with HIV and AIDS in our contemporary global context is a life lived with ongoing complexity, stigma and chronicity. I suggest that HIV in the Global North shares many characteristics with HIV in the Global South yet differs in significant ways, not least in the fact that a resource-rich context generates an environment where health and social care support is possible, and, mostly, usual. In both contexts, however, the experience of living with a highly stigmatized illness with no cure in both the Global South and North suggests that this is a point of shared experience. (shrink)

Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there (...) is little published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community's perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty-nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu-Natal participated in in-depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants' considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust. (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)

This book analyses contemporary gay "pig" masculinities, which have emerged alongside antiretroviral therapies, online porn, and new sexualised patterns of recreational drug use, examining how they trouble modern European understandings of the male body, their ethics, and their political underpinnings. This is the first book to reflect on an increasingly visible new form of sexualised gay masculinity, and the first monograph to move debates on condomless sex amongst gay men beyond discourses of HIV and/or AIDS. It contributes to existing (...) critical histories of sexuality, pornography and other sex media at a crucial juncture in the history of gay male sex cultures and the HIV epidemic. The book draws from fieldwork, interviews, archival research, visual analysis, philosophy, queer theory, and cultural studies, using empirical, critical, and speculative methodologies to better think gay "pig" masculinities across their material, affective, ethical and political dimensions, in a future-oriented, politically-inflected, reflection on what queer bodies may become. Spanning historical context to empirical and theoretical study, Bareback Porn, Porous Masculinities, Queer Futures will be of key interest to academics and students in sexuality studies, film, media, visual culture, cultural studies, and porn studies concerned with masculinities, sex and sexualities and their circulation across an array of media. (shrink)

Definition of the problem: Attitudes and practice of doctors regarding physician-assisted suicide (PAS) in patients with AIDS became considerably more liberal over the last 15 years in large U.S. cities. However, it remains an open question how the highly active antiretroviral therapies (HAART) have influenced the situation since the late 1990s. Methods and results: In 1999/2000 a nonrepresentative sample of medical doctors, psychologists, social workers, nurses and other health care professionals (n=69) in San Francisco und New York gave semistructured (...) interviews about the present situation of PAS in patients with AIDS. On the basis of written protocols a qualitative evaluation of the expert interviews has been performed. The majority of the health care professionals are familiar with PAS in their professional work. With HAART the requests for PAS in gay patients with AIDS dropped rapidly. PAS has not been noted in other subgroups of patients. However, unsolved problems exist in timing, execution and accompaniment of PAS and in competence assessment of PAS patients. No hints of a slippery slope abuse could be identified in the interviews. Conclusion: Although tolerated, the majority of the doctors still feel uncomfortable with PAS and regard PAS as alien to their professional ethos. In practice PAS takes place on request of a subgroup of AIDS patients only. However, the professional experience with PAS in patients with AIDS has changed the attitude of doctors toward a stronger acceptance of their patients autonomy and partnership with them. Open questions remain regarding the competence assessment of seriously ill and dying patients. (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)

The discovery of a stable latent reservoir for HIV‐1 in resting memory CD4+ T cells provides a mechanism for lifelong persistence of HIV‐1. The long‐lived latently infected cells persist in spite of prolonged highly active antiretroviral therapy and present a major barrier to a cure of HIV‐1 infection. In this review, we discuss the current understanding of HIV‐1 persistence and latent viral infection in the context of effective antiretroviral therapy and the recent progress in purging latent (...) viral reservoirs. Recent studies demonstrate that reactivation of latent HIV‐1 is a promising strategy for the depletion of these viral reservoirs. A thorough evaluation of the anti‐latency activity of drug candidates should include the measurement of changes in intracellular viral RNA, plasma virus levels, and the size of latent viral reservoirs, as well as potential adverse effects. Currently, there are several technical barriers to the evaluation of anti‐latency drugs in vivo. We also discuss these challenging issues that remain unresolved. (shrink)

Despite several research on HIV/aids, it is still incumbent to investigate more effective control measures to mitigate its infection level. Therefore, we introduce an HIV/aids-resistant model with behavior change and study its basic properties. In order to determine the most sensitive parameters that are responsible for disease transmission with respect to the basic reproduction number and those responsible for disease prevalence with respect to the endemic equilibrium, the sensitivity analysis was established and it was confirmed that the influx rate of (...) people into the infected population and total abstinence from all risk practices and endemic areas are some of the most sensitive parameters for disease spread and disease eradication, respectively. Furthermore, by considering controls u1\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$u_1$$\end{document} denoting the government’s intervention in promoting and encouraging behavior change, u2\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$u_2$$\end{document} representing intake of balanced nutritional supplementation, and u3\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$u_3$$\end{document} connoting antiretroviral therapy (ART), an optimal control problem was developed and analyzed. Before the establishment of the necessary conditions of the optimal control using Pontryagin’s Maximum Principle, we proved the existence of the optimal control triplet (u1(t),u2(t),u3(t)∈Φ,\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$(u_1(t),u_2(t),u_3(t)\in \Phi,$$\end{document} where Φ\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\Phi$$\end{document} is the control set at time t,) which has been neglected by many researchers in recent years. Using the Runge–Kutta scheme, the optimal control problem was solved to understand the best combination of control strategies. Using the demographic and epidemiological data for South Africa on HIV/aids, a numerical simulation was carried out and results are presented on 3D surface plots. The obtained results suggested that the combination of all the considered control measures is the best method to ensure disease eradication. (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)

I defend a certain claim about rationing in the context of HIV/AIDS, namely, the 'priority thesis' that the state of a developing country with a high rate of HIV should provide highly active anti-retroviral treatment (HAART) to those who would die without it, even if doing so would require not treating most other life-threatening diseases. More specifically, I defend the priority thesis in a negative way, by refuting two influential and important arguments against it inspired by the Kantian principle of (...) respect for persons. The 'equality argument' more or less maintains that prioritizing treatment for HIV/AIDS would objectionably treat those who suffer from it as more important than those who do not. The 'responsibility argument' says, roughly, that to ration life-saving treatment by prioritizing those with HIV would wrongly fail to hold people responsible for their actions, since most people infected with HIV could have avoided the foreseeable harm of infection. While it appears that a Kantian must think that one of these two arguments is sound, I maintain that, in fact, respect for persons grounds neither the equality nor responsibility argument against prioritizing HAART and hence at least permits doing so. If this negative defence of the priority thesis succeeds, then conceptual space is opened up for the possibility that respect for persons requires prioritizing HAART, which argument I sketch in the conclusion as something to articulate and defend in future work. (shrink)

Explanations of former South African President Thabo Mbeki’s public and private views on the aetiology of the HIV/AIDS epidemic in the country remain partial at best without the recognition that the latter presuppose and imply a postmodernist/postcolonialist philosophy of science that erases the line separating the political from the scientific. Evidence from Mbeki’s public speeches, interviews, and private and anonymous writings suggests that it was postmodernist/postcolonialist theory that inspired him to doubt the “Western” scientific consensus on HIV/AIDS and to implement (...) a public health policy that dragged its feet on full roll-out of antiretroviral therapy, causing thousands of avoidable deaths. A weak reductio ad absurdum allows us to conclude from this premise that postmodernist/postcolonial critique of “Western” science ought to be shunned. A comparative argument from consequences further suggests that in a situation where a misguided health policy has lead to a humanitarian catastrophe, and where postmodernist/postcolonialist critique of science can and has been used to justify this policy, an alternative theory ought to be preferred on which such justification would not be possible. The paper closes with a call for a non-relativist alternative to postmodernist/postcolonialist philosophy of science, and evaluates the potential of recent developments in ‘Studies of Expertise” to yield such. (shrink)

On 18 November 2014, the United Nations launched an urgent new campaign to end AIDS as a global health threat by 2030. With its proposed strategy, the UN follows leading scientists who had declared the failure of former prevention strategies and now were promoting a ‘Seek and Treat for Optimal Prevention’ (STOP) approach as the most cost‐effective response to the pandemic to meet the goal of ‘an AIDS‐free generation’. STOP combines antiretroviral therapy and routine HIV screening to find (...) persons unaware that they are HIV‐positive, because research has shown that people consistently change their behaviour (i.e. increase condom use, have fewer partners) after an HIV diagnosis. AIDS activists have broadly criticized this strategy on different levels. In this article, we go beyond these criticisms and try to analyse the political rationalities behind this ‘new’ strategy. We believe that it is necessary to put the rationale underpinning the STOP programme into the context of broader societal transformations that can best be captured as the development of advanced liberal societies and the new emphasis on self‐controlling or self‐responsibility rather than on disciplining behaviour. (shrink)

: In 1998, 39 pharmaceutical manufacturers sued the government of South Africa to prevent the implementation of a law designed to facilitate access to AIDS drugs at low cost. The companies accused South Africa, the country with the largest population of individuals living with HIV/AIDS in the world, of circumventing patent protections guaranteed by intellectual property rules that were included in the latest round of world trade agreements. The pharmaceutical companies dropped their lawsuit in the spring of 2001 after an (...) avalanche of negative publicity. Yet, despite the government's victory, AIDS drugs remain very expensive in South Africa, and the government still refuses to provide antiretroviral therapy to adults. These events have shone a spotlight, not only on the possibilities for coordinated political activism in the era of instant global communications, but also on the tangled social, economic, and political dimensions of AIDS treatment in poor countries. (shrink)

Problems posed by HIV/AIDS differ from those ofpast epidemics by virtue of unique propertiesof the causative agent, dramatic societalchanges of the late 20th century, and thetransition of medical practice from aprofessional ethic to a technology-dependentbusiness ethic. HIV/AIDS struck during thecoming-of-age of molecular biology and also ofbioethics, and the epidemic stimulated thegrowth of both disciplines. The number ofarticles published about AIDS and ethics (asidentified by a MEDLINE search) peaked in 1990,just before the peak incidence of AIDS in theUnited States. The character (...) of ethicaldialogue has now shifted from familiar moralquandaries such as civil liberty versus publicwelfare to concerns about vaccine trials andpublic policy toward the developing world.Physicians and other health care workers whowere involved from the onset endured somethingof an emotional roller coaster. Theircompassion-based work ethic was to a largeextent replaced by a competence-based workethic after the introduction in 1996 of highlyactive antiretroviral therapy. The abundantrecent literature on ``professionalism'' inmedicine makes scant mention of AIDS/HIV. Thedisruptive effect of AIDS/HIV on society wouldhave been substantially greater had relevanttechnology such as the ability to isolateretroviruses and potent therapy againsttuberculosis not been in place. This soberingconsideration, along with such recent events asthe use of bioterrorism against civilianpopulations, suggests new relevance forPotter's definition of ``bioethics'' as a scienceof survival in which the biology of ecosystemsmust be taken into account. (shrink)

ABSTRACTMother‐to‐child transmission of HIV represents a particularly dramatic aspect of the HIV epidemic with an estimated 600,000 newborns infected yearly, 90% of them living in sub‐Saharan Africa. Since the beginning of the HIV epidemic, an estimated 5.1 million children worldwide have been infected with HIV. MTCT is responsible for 90% of these infections. Two‐thirds of the MTCT are believed to occur during pregnancy and delivery, and about one‐third through breastfeeding. As the number of women of child bearing age infected with (...) HIV rises, so does the number of infected children. It is apparent that voluntary testing in Botswana has made some valuable inroads in decreasing perinatal HIV transmission, but the statistics showing the increased rate of HIV infection among women 15–24 years of age are not very promising. After reviewing all the pertinent scientific data it is clear that mandatory HIV testing of all pregnant women in conjunction with the implementation of a full package of interventions would save thousands of lives – mothers, newborns and others who could be infected as a result of these women not being aware of their HIV status. If the protection and preservation of human life is a priority in Botswana, then it is time to allow for mandatory HIV testing of all pregnant women, before it is too late for those who are the most vulnerable. To do less would be medically inappropriate and ethically irresponsible. (shrink)

Recent global advances in available technology to prevent mother-to-child HIV transmission necessitate a rethinking of contemporary and previous ethical debates on HIV testing as a means to preventing vertical transmission. In this paper, we will provide an ethical analysis of HIV-testing strategies of pregnant women. First, we argue that provider-initiated opt-out HIV testing seems to be the most effective HIV test strategy. The flip-side of an opt-out strategy is that it may end up as involuntary testing in a clinical setting. (...) We analyse this ethical puzzle from a novel perspective, taking into account the moral importance of certain hypothetical preferences of the child, as well as the moral importance of certain actual preferences of the mother. Finally, we balance the conflicting concerns and try to arrive at an ethically sound solution to this dilemma. Our aim is to introduce a novel perspective from which to analyse testing strategies, and to explore the implications and possible benefits of our proposal. The conclusion from our analysis is that policies that recommend provider-initiated opt-out HIV testing of pregnant mothers, with a risk of becoming involuntary testing in a clinical setting, are acceptable. The rationale behind this is that the increased availability of very effective and inexpensive life-saving drugs makes the ethical problems raised by the possible intrusiveness of HIV testing less important than the child's hypothetical preferences to be born healthy. Health care providers, therefore, have a duty to offer both opt-out HIV testing and available PMTCT (preventing mother-to-child transmission) interventions. (shrink)

Enormous gaps between HIV burden and health care availability in low-income countries raise severe ethical problems. This article analyzes four HIV-priority dilemmas with interest across contexts and health systems. We explore principled distributive conflicts and use the Atkinson index to make explicit trade-offs between health maximization and equality in health. We find that societies need a relatively low aversion to inequality to favor treatment for children, even with large weights assigned to extending the lives of adults: higher inequality aversion is (...) needed to share resources equally between high-cost and low-cost treatment; higher inequality aversion is needed to favor treatment rather than prevention, and the highest inequality aversion is needed to favor sharing treatment between urban and rural regions rather than urban provision of treatment. This type of ethical sensitivity analysis may clarify the ethics of health policy choice. (shrink)

Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government programs. (...) Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006–2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights. (shrink)

Since the introduction of drugs to prevent vertical transmission of HIV, the purpose of and approach to HIV testing of pregnant women has increasingly become an area of major controversy. In recent years, many strategies to increase the uptake of HIV testing have focused on offering HIV tests to women in pregnancy-related services. New global guidance issued by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) specifically notes these services as an entry point for (...) provider-initiated HIV testing and counseling (PITC). The guidance constitutes a useful first step towards a framework within which PITC sensitive to health, human rights and ethical concerns can be provided to pregnant women in health facilities. However, a number of issues will require further attention as implementation moves forward. It is incumbent on all those involved in the scale up of PITC to ensure that it promotes long-term connection with relevant health services and does not result simply in increased testing with no concrete benefits being accrued by the women being tested. Within health services, this will require significant attention to informed consent, pre- and post-test counseling, patient confidentiality, referrals and access to appropriate services, as well as reduction of stigma and discrimination. Beyond health services, efforts will be needed to address larger societal, legal, policy and contextual issues. The health and human rights of pregnant women must be a primary consideration in how HIV testing is implemented; they can benefit greatly from PITC but only if it is carried out appropriately. (shrink)

HIV/AIDS is a major public health problem in Africa. Stigmatization, discrimination and lack of appropriate health care are among the commonest challenges that HIV infected persons and their families face. It has been suggested that among the tools available in the fight against stigmatization and discrimination is public disclosure of a person’s HIV seropositive status. While public disclosure of HIV status has a place in the fight against HIV and AIDS, especially by resulting in behavioural change among people who know (...) of an HIV infected person, we argue that such disclosure also has potential attendant harms. The posthumous disclosure of HIV status is particularly problematic. Public disclosure should be accompanied by appropriate individual counselling and preparation of the community to deal with the situation, and should have regard for cultural sensitivity after consideration of the risks and benefits to individuals, families and the community. Health practitioners should keep in mind that their main duty is to the best interest of the patient, the family and the community, in that order. (shrink)

We conducted a study to review the consenting process in a vaginal Microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not (...) attained from most of the participants since 77% of the participants had numerous questions about the study and 34% did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations. (shrink)

In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the ‘Brazilian model’ of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through (...) a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. (shrink)

Amidst growing global endorsements of new biomedical HIV prevention strategies, ARV-based pre-exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at-risk groups than conventional prevention strategies (such as sexual partner reduction, condom use, and prevention of mother-to-child transmission), PrEP is more costly. PrEP requires more ongoing contact between individuals and providers, and a level of surveillance from the health system that is not necessary with other preventive (...) measures. In this sense, it represents a new bio-technology for HIV prevention that poses particular challenges for worldwide implementation, given developing countries’ struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation, this paper explores the ethical parameters of a likely scenario for PrEP usage in a single, resource-poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research, while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho, we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEP's potential successes and pitfalls in a developing country, given the country's high HIV prevalence, struggles to achieve universal access to HIV treatment regimes, continued existence of stigma around the epidemic, and difficulties in addressing persistent social inequalities that fuel infections. (shrink)