Bridget Haire

Excluding people who use drugs or alcohol from access to hepatitis C treatments – Is this fair, given the available data?

The Kirby Institute, UNSW Australia, Sydney, Australia; Division of Infectious Diseases, The Warren Alpert Medical School of Brown University, Providence, RI, United States; Centre for Values, Ethics and the Law in Medicine, University of Sydney, Sydney, Australia; Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, United States; Treatment Action Group, New York, NY, United States; International Network of People Who Use Drugs, Canberra, Australia; Australian Injecting and Illicit Drug Users League, Canberra, Australia; National AIDS Treatment Advocacy Project, New York, NY, United States; Arud Centres for Addiction Medicine, Zurich, Switzerland

How Good Is “Good Enough”? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention

In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it.

Preexposure prophylaxis-related stigma: strategies to improve uptake and adherence - a narrative review.

Despite high levels of efficacy, the implementation of preexposure prophylaxis (PrEP) as a strategy to prevent new HIV infection has been slow. Studies show that PrEP works so long as it is taken, making adherence one of the great challenges of effective PrEP implementation alongside issues of access and uptake. Given that effective PrEP use requires ongoing self-administration of pills by people at high risk of HIV acquisition, it is a strategy best understood not as simply biomedical, but as biobehavioral or biopsychosocial, meaning that that social, psychological, cultural, and structural factors all contribute to the success or failure of the intervention. The willingness of people at risk of HIV to take up and adhere to PrEP depends greatly upon social understandings – whether it is seen as effective, as a healthy option, and a socially acceptable strategy for preventing HIV. Stigma – unfavorable associations – can negatively influence the implementation of PrEP. Because it is associated with high-risk sexual activity, PrEP risks multiple stigmas that can differ according to specific cultural conditions. This includes the stigma of being related to HIV (which may also relate to other stigmas, such as homosexuality, sex work, and/or drug use) and the stigma of PrEP being an alternative to condoms (as condom use is associated with responsible sexual activity). PrEP-related stigma has emerged as a significant social harm that can arise from PrEP research participation, reported by trial participants from a range of different trial sites, different trial populations, and spanning different continents. Social marketing needs to redress PrEP-related stigmas through health promotion campaigns aimed at clinicians, HIV-affected communities, and people at high risk of HIV who might benefit from PrEP access. PrEP access needs to be reframed as a positive and responsible option to help people remain HIV-negative.

Ethics of ARV Based Prevention: Treatment‐as‐Prevention and PrEP

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 persons 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.

ETHICAL CONSIDERATIONS IN DETERMINING STANDARD OF PREVENTION PACKAGES FOR HIV PREVENTION TRIALS: EXAMINING PREP

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.

Ethical challenges for doctors working in immigration detention.

The health of asylum seekers in Australia’s immigration detention centres has been the subject of a doctors’ letter of concern and two recent reports.1-3 Here, we present an analysis of the ethical dilemmas faced by health practitioners working in these centres1 and seek to promote a strong and considered policy discussion. Australia’s Department of Immigration and Border Protection (DIBP) contracts a private health service provider, International Health and Medical Services (IHMS), to provide health care to immigration centre detainees at an Australian standard.4 However, media and other reports from Christmas Island,1 Manus Island2 and Nauru3 have raised serious concerns about the quality of care provided and whether health care professionals have been able to fulfil their professional and ethical obligations to patients in these facilities.1-3

The Health Care Consequences Of Australian Immigration Policies

Deborah Zion and colleagues discuss the “dual loyalty” conflict affecting Australian health care providers involved in the care of asylum seekers.

Ebola vaccine development plan: ethics, concerns and proposed measures

BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola (such as in home care settings) are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites.

Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials

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.

‘They say God punishes people with HIV’: experiences of stigma and discrimination among adults with HIV in Dili, Timor-Leste

Abstract Little is known about the experiences of people with HIV in the small island nation of Timor-Leste. This study explored the HIV-related stigma experiences of adults aged between 18 and 40 living with HIV in Dili, Timor-Leste. Participants were interviewed on topics related to living with HIV, both as key informants describing the experience of others with HIV known to them, and also with respect to their own personal experiences. Findings suggest that people with HIV in Timor-Leste face stigma and discrimination in various contexts. In this predominantly Catholic country, perceptions of HIV and attitudes towards people with HIV appear to be commonly shaped by religious beliefs. In families and communities, participants encountered gossip, social exclusion and threats of violence. In health settings, participants experienced discrimination from health providers in the form of failing to maintain confidentiality and inappropriate treatment. The impact of stigma was profoundly negative and influenced participants’ decision to disclose their status to others. Participants attributed stigma to a lack of information about HIV among the general public. Unless stigma reduction interventions also address the Church’s role in shaping perceptions of HIV, education campaigns are unlikely to be effective in reducing HIV-related stigma.