Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...) participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

BackgroundCritical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/aids pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate (...) and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs.Main bodyNecessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities.ConclusionsIn the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic. (shrink)

This paper explores three selected issues which present ethical challenges unique to the development and testing of preventive HIV vaccines. The issues are: when to move forward with large scale efficacy testing of vaccines, how to incorporate behavioral interventions into the study of vaccine efficacy, and how to plan for and mitigate social harms associated with participation in an HIV vaccine trial. Careful and ongoing consideration must be given to the ethical implications of these decisions. Proposed solutions include planning for (...) a more complex prevention trial which would integrate the evaluation of behavioral interventions and vaccine efficacy; scrupulous attention to the process of individual informed consent and community participation; and serious and deliberate attempts to plan for, educate about, and minimize the social harms. Keywords: behavioral interventions, HIV, subject protection, trial design, vaccines CiteULike Connotea Del.icio.us What's this? (shrink)

Provides comprehensive coverage of recent developments in the biomedical prevention of HIV -/- Raises critical questions about present and future directions in HIV prevention and care -/- Highlights the importance of continued community ownership of the HIV response -/- .

IN THE UNITED STATES, 25 PERCENT OF PEOPLE LIVING WITH HIV/AIDS HAVE spent time in the correctional system. HIV is known to spread among incarcerated individuals through high-risk behaviors including unprotected sex, injection drug use, tattooing, and body piercing. When released from prison, persons living with HIV can spread the disease in the wider community. This essay explores the complex problem of HIV infection among US prisoners from a common good approach rooted in Catholic social teachings by examining available data (...) on US prison populations, describing recent trends in the prosecution of drug-related crimes, and proposing concrete policy recommendations for HIV prevention interventions in US prisons. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research (...) evidence will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research (...) evidence will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Ethical challenges surrounding the implementation of male circumcision as an HIV prevention strategyResearchers have been exploring the possibility of a correlation between male circumcision and lowered risk of HIV infection almost since the beginning of the HIV/AIDS epidemic.1 Results from a randomised controlled trial in South Africa in 2005 indicate that male circumcision protects men against the acquisition of HIV through heterosexual intercourse,2 confirming the findings from 20 years of observational studies.3 Circumcised men in the South African trial were (...) 60% less likely to acquire HIV than their uncircumcised counterparts. A mathematical modelling study, based on the South African trial, estimates that the practice of male circumcision could avert two million new HIV infections and 300 000 HIV-related deaths over the next 10 years in sub-Saharan Africa.4 More recently, two randomised controlled trials in Kisumu, Kenya and Rakai, Uganda showed, respectively, 53% and 48% reductions in HIV acquisition among circumcised men than uncircumcised men in the trial.5 These results strongly suggest that male circumcision could play an important role in the struggle against the continued rise in new HIV infections. However, as observers noted at the 2006 XVI International AIDS Conference in Toronto, Canada, excitement about the potential epidemiological impact has overshadowed the debate over the difficult translation of research on male circumcision, into policy and practice.6 Similar calls for caution have been raised before and elsewhere.7,8The topic of male circumcision carries an enormous amount of ethical baggage. Male infants, worldwide, are circumcised for various medical, social and/or religious reasons. Circumcision is a cultural act and a surgical procedure; medical reasons are not the only reasons to circumcise that people have found and continue to find as compelling. Benatar and Benatar9 have argued that—when …. (shrink)

Volume 31, Issue 1, December 2020, Page 47-66.

The complexity and inefficiency of the U.S. health care system complicates the distribution of life-saving medical technologies. When the public health is at stake, however, there are alternatives. The proposal for a national PrEP program published in this issue of the Journal applies some of the lessons of the national COVID vaccine campaign to HIV prevention. In doing so, it draws on other examples of public health approaches to the financing of medical technology, from vaccines for children to hepatitis (...) C treatment. (shrink)

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven (...) effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. (shrink)

Comparing estimates of the cost-effectiveness of human immunodeficiency virus (HIV) interventions can help communities select an HIV prevention portfolio to meet local needs efficiently. The authors developed a spreadsheet tool to estimate the relative cost-effectiveness of 26 HIV prevention interventions. HIV prevalence of the population at risk and the cost per person reached were the two most important factors determining cost-effectiveness. In low-prevalence populations, the most cost-effective interventions had a low per-person cost. Among the most cost-effective interventions overall (...) were showing videos in sexually transmitted disease clinics and raising alcohol taxes. (shrink)

In 2004, the first ever multi‐sited clinical trials studied the prospect of HIV biomedical prevention (referred to as pre‐exposure prophylaxis—‘PrEP’). The trials were implemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised concerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and protocol. (...) While some of the disputes, especially those pertaining to community engagement mechanisms, were ultimately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scientific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized. (shrink)

Issues: We present key aspects of our paper, commissioned by UNAIDS in 2005, entitled, “Revisiting the ethics of HIV prevention research in developing countries.” In 2004 and 2005 we witnessed the closure or suspension of three international clinical trials testing tenofovir in the prevention of HIV infection in high risk groups due to the failure to provide free treatment to those who seroconvert during the conduct of the study. We examine critically moral claims for the provision of treatment (...) to those who seroconvert in HIV prevention trials and ask whether it is a matter of moral obligation or moral negotiation?Description: Using the tools of philosophical and regulatory analysis we examine the moral foundations of research ethics, international regulation, and the contemporary literature in search of valid arguments in support of a moral obligation to treat. Arguments supporting the obligation to provide such treatment are found in a wide variety of documents. These claims are variously rooted in the demand to compensate for research-related injury, maximization of research benefit, justice as reciprocity, and justice as equality.Lessons learned: Our analysis reveals that there is as of yet no robust moral argument supporting a moral obligation to provide treatment to participants in HIV prevention trials who seroconvert. We argue that moral negotiation offers distinct advantages over moral obligation. Moral negotiation finds support in the principle of respect for communities that holds researchers responsible to respect communal values, protect and empower social institutions and abide by the decisions of accepted communal authorities.Recommendations: Moral negotiation, rather than moral obligation, reduces the chance of polarization of positions by inviting trial participants, sponsors, researchers and all other involved parties to the table for discussion. Moral negotiation favors middle ground solutions that fit the specific health needs and priorities of the community in question. (shrink)

More than 25 years into the HIV epidemic, in excess of 2 million new infections continue to occur each year. HIV prevention research is crucial for groups at heightened risk for HIV, but the design and conduct of HIV prevention research with vulnerable populations worldwide raises considerable ethical challenges. The HIV Prevention Trials Network (HPTN) is a global collaborative network that conducts clinical and behavioural studies on non-vaccine interventions to reduce the transmission of HIV. In 2003, the (...) HPTN developed ethical guidance to enhance the responsible conduct of its research activities and as a distinctive contribution to global research ethics. In what follows, the developments that motivated the drafting of a revised ethics document in 2009 are described, including the process by which that revision took place and some of the key differences between the HPTN ethics guidance and other relevant guidelines in the field. (shrink)

Researchers and sponsors are required to assist HIV prevention trial participants to remain HIV-uninfected by ensuring access to prevention services. Ethics guidelines require that these HIV risk-reduction services be state of the art. This and related ethics recommendations have been intensely debated. This descriptive study aimed to identify actual HIV prevention practices for two HIV vaccine trials at five South African sites, to explore whether actual practices meet guideline recommendations and to discuss implications for practices and ethics (...) guidelines. Practices were examined through a review of site documents and interviews with site staff and network representatives, as well as community advisory board and research ethics committee representatives. A thematic analysis of HIV prevention practices, perspectives and perceived challenges was undertaken. Findings indicated that there was a high degree of correspondence between actual practices in South African HIV vaccine trials and guideline recommendations. Key challenges for implementing prevention services were identified as partnerships, provider-promotion of services and participant uptake of services. Practices deviated most from guidelines with regard to the description of prevention plans in informed consent forms. Recommendations are made for both practices and ethics guidelines. (shrink)

The response many gay men took to the HIV epidemic in the United States was largely informal, especially given distant state and federal governments. The condom code, a set of informal norms that encouraged the use of condoms, is one instance of this informal response, which was wholly uncoordinated. Yet, it is not clear why these informal norms emerged or why they have since eroded. This paper explores how gay men in particular generated expectations and normative beliefs regarding condom usage, (...) which helped to establish the condom code as an informal norm. Furthermore, the erosion of the condom code is viewed as a result of changing expectations, which change as bio-medical means of HIV treatment and prevention develop and as online and digital communities facilitate serosorting, all of which provide alternatives to condoms as a means of prevention and their associated informal norms. Future HIV prevention campaigns should recognize the extent to which informal norms coordinate and encourage preventative behavior, as well as how beliefs and expectations alter the informal norms people adopt. (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)

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)

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)

The present situation of the HIV/aids epidemic is very grim in China. The probability of China becoming a country with a high prevalence of HIV/aids cannot be excluded because there have been factors which promote the wide spread of HIV if we fail to take timely action to prevent it at the opportune moment. However, China's HIV prevention policy is inadequate. Health professionals and programmers believed that they could take a conventional public health approach to cope with the HIV (...) epidemic. They simply ignored the fact that HIV infection is an epidemic so special that their approach is not effective to deter the epidemic. Many health professionals and programmers bypassed ethical issues that had emerged in the prevention of the HIV epidemic. Even some health educators, sexologists and officials believe that `AIDS is the punishment for promiscuity', and this belief has led to discrimination and stigmatization of AIDS patients, HIV positive people, their family members and high risk groups. Although homosexuality is not illegal, the police can always find any reason to detain homosexuals. A difficult ethical issue is about the laws prohibiting prostitution and drug use in China which force prostitutes and intravenous drug users underground, giving them no chance to access information, education and the services needed to protect them. The dilemma facing China is whether to stay with a restrictive policy for the reason of ideology cleansing or to turn to a more supportive policy. It is necessary to have some change in the ethical framework to evaluate the action in HIV prevention. Tolerance should be the first ethical principle. (shrink)

The present situation of the HIV/AIDS epidemic is very grim in China. The probability of China becoming a country with a high prevalence of HIV/AIDS cannot be excluded because there have been factors which promote the wide spread of HIV if we fail to take timely action to prevent it at the opportune moment. However, China's HIV prevention policy is inadequate. Health professionals and programmers believed that they could take a conventional public health approach to cope with the HIV (...) epidemic. They simply ignored the fact that HIV infection is an epidemic so special that their approach is not effective to deter the epidemic. Many health professionals and programmers bypassed ethical issues that had emerged in the prevention of the HIV epidemic. Even some health educators, sexologists and officials believe that `AIDS is the punishment for promiscuity', and this belief has led to discrimination and stigmatization of AIDS patients, HIV positive people, their family members and high risk groups. Although homosexuality is not illegal, the police can always find any reason to detain homosexuals. A difficult ethical issue is about the laws prohibiting prostitution and drug use in China which force prostitutes and intravenous drug users underground, giving them no chance to access information, education and the services needed to protect them. The dilemma facing China is whether to stay with a restrictive policy for the reason of ideology cleansing or to turn to a more supportive policy. It is necessary to have some change in the ethical framework to evaluate the action in HIV prevention. Tolerance should be the first ethical principle. (shrink)

Stellen Kondome einen potenten Schutz sowohl vor HIV als auch von anderen sexuell übertragbaren Infektionen (STIs) dar, und besteht außerdem ein barrierefreier Zugang zur HIV-Postexpositionsprophylaxe (PEP) (z. B. nach Kondom-Fatigue), muss präzise sondiert werden, wann die sich zunehmend etablierende HIV-Präexpositionsprophylaxe (PrEP) die bessere Wahl darstellt. Vor dem Hintergrund einer generalisierten everyone at risk-Annahme über MSM wird die PrEP zunehmend zu einem standard of care. Zwar kann kein Zweifel daran bestehen, dass dies für bestimmte MSM mit einem bestimmten Risikoprofil wünschenswert ist. (...) Es ist aber von Variabilitäten (z. B. casual condomless sex versus random condomless sex) auszugehen, die zur Vermeidung einer unverhältnismäßigen Medikalisierung berücksichtigt werden müssen. Im Spannungsfeld von hochpotenter HIV-Prävention und Medikalisierung insbesondere von Männern, die Sex mit Männern praktizieren, soll im Sinn einer Güterabwägung gefragt werden, wann genau eine PrEP (dauerhaft oder on demand) mehr Vorteile und weniger Nachteile bietet als der Gebrauch von Kondom oder PEP. Dazu gehört ein Fokus auf den aktuellen Stand der klinischen Forschung und ein Fokus auf die medizinethische Debatte. Die Medizingeschichte der Prävention und der HIV-Erkrankung erweist sich dabei als relevanter Erörterungszusammenhang für die weitgehend noch ausstehende ethische Untersuchung der PrEP. Methodisch basiert diese Arbeit auf einer Auswertung der interdisziplinären Fachliteratur über die HIV-Präexpositionsprophylaxe im Besonderen und über HIV-Prävention im Allgemeinen. Basierend auf den PRISMA (Prefered Reporting Items for Systematic Reviews and Meta-Analyses) Guidelines wurden aus der Datenbank PubMed/MEDLINE solche Studien ausgewählt, die die aktuelle klinische Praxis der PrEP oder eine medizinethische Diskussion der PrEP zum Gegenstand haben. Auf der Basis dieser Literatur erfolgt eine diskursive Erörterung und Abwägung der verfügbaren Pros und Cons zur PrEP. Präventionsmaßnahmen treten regelmäßig als ambivalente Instrumente der Gesundheitsförderung zwischen Liberalisierung und Restringierung des Individuums hervor. Insgesamt bietet daher die PrEP on demand gegenüber der kontinuierlichen PrEP im Sinne der Personalisierung die Option einer individuellen Anpassung an konkretes Risikoverhalten. Auch im Sinne einer Güterabwägung hat die PrEP gewichtige Vorteile gegenüber der kontinuierlichen PrEP und gegenüber einer PEP, wenn kein dauerhaft gleichhohes Risiko vorliegt. In dieser medizinethischen Untersuchung wird darauf hingewiesen, dass es sich bei MSM um eine heterogene Gruppe handelt, deren individuelles Sexualverhalten eine ebenfalls individualisierte HIV-Präventions-Strategie benötigt. Diese Studie argumentiert daher für ein stark personalisiertes decision making bei möglicher Indikation für eine PrEP bei MSM. Damit soll ein wesentlicher Faktor zur Vermeidung einer Medikalisierung von MSM dargestellt werden. (shrink)

As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS /World Health Organization guidance recommends that participants in prevention trials receive ‘access to all state of the art HIV risk reduction methods’, and that decisions about adding new tools (...) to the prevention package be made in consultation with ‘all relevant stakeholders’. The guidance, however, leaves open questions of both process and implementation. In March 2009, the Global Campaign for Microbicides, UNAIDS and the Centers for Disease Control and Prevention convened a consultation to develop practical answers to these questions. Fifty-nine diverse participants, including researchers, ethicists, advocates and policymakers, worked to develop consensus criteria on when to include new HIV prevention tools in future trials. Participants developed a set of questions to guide decision-making, including: whether the method has been recommended by international bodies or adopted at a national level; the size of the effect and weight of the evidence; relevance to the trial population; whether the tool has been approved or introduced in the trial country; whether adding the tool might lead to trial futility; outstanding safety issues and status of the trial. Further work is needed to develop, implement and evaluate approaches to facilitate meaningful stakeholder participation in this deliberative process. (shrink)

Adolescents are increasingly at risk for sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) infection. The prolonged latency period, sometimes in excess of five years, and the incubation period of up to 10 years before the manifestation of symptoms, may foster adolescents’ false sense of invincibility and denial as they often do not see the devastating effects of the disease in their peers until they are older. In turn, their practice of safer sex may be hindered and thereby contribute (...) to the escalation of this public health crisis among sexually active adolescents. Prevention-focused recommendations were made in the USA as a result of this crisis. Recommendations were made to: (1) include STD/HIV education in the curricula of grades kindergarten to 12; (2) increase to at least 75% the proportion of primary care and mental health professionals who provide age-appropriate STD/HIV prevention counselling to adolescents; and (3) expand HIV prevention services to include age-appropriate HIV education curricula for students in grades 4-12 in 95% of schools. Yet, in the USA, the provision of school-based comprehensive STD/HIV education has been difficult to achieve owing to certain limitations and, in some instances, legal action. These limitations include: limited student access; restricted content; and the implementation of sporadic and/or brief educational programmes. Given these recommendations and the fact that adolescents are acquiring STDs and HIV infections at increasing rates, and despite the limitations and legal actions, do health care professionals not have an ethical obligation to provide adolescents with comprehensive STD/HIV prevention education? This ethical dilemma will be discussed using the ethical decision-making principles of ‘autonomy’ and ‘beneficence’, and a decision-making model proposed by Thompson and Thompson, and by Chally and Loric. (shrink)

The American Journal of Bioethics, Volume 12, Issue 6, Page 31-32, June 2012.

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 (...) class='Hi'>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)

This paper seeks to highlight the benefits of prioritizing moderate African communitarian principles as partly demonstrated in the HIV prevention strategies implemented in Uganda in the late 1980s. Pertinent lessons could be drawn so as to achieve the HIV prevention targets envisioned in the post-2015 development era. Communitarianism emphasizes the importance of communities as part of healthy human existence. Its core ethical values include the virtues of generosity, compassion, and solidarity. Persuasion through communication, consensus through dialogue, and the (...) awareness and commitment to responsibilities towards other members of the community, are chief practices relied upon to achieve appropriate social behaviour. All these elements signify individual rootedness in communities and contribute to the healthy existence of its members. Communitarianism is usually classified as either authoritarian/radical or responsive/moderate, depending on the primacy given to either community interests or the individual will and rights. Moderate communitarianism recognizes the individual's capacity for moral reasoning, virtue and free choice. The ensuing form of society is deemed more ethical as it relies on education in the virtues, moral persuasion and informal social controls, without stifling individual identity, agency, and capacity for self-determination. If moderate African communitarianism, in particular, can to a certain extent be associated with the significant aspects of Uganda's HIV prevention strategies in the stated period, then its present-day relevance for HIV prevention and other public health interventions may be emphasized accordingly. This applies especially in view of the ongoing efforts to achieve a balance between individual and collective interests in bioethics. (shrink)

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

In this paper, I consider how trust affects the decisions of men who have sex with men (MSM) around using pre-exposure prophylaxis (PrEP) as HIV prevention in their sexual and romantic relationships, and how the use of PrEP affects their relationships with healthcare providers. MSM have to trust their sexual and romantic partners as well as their healthcare providers for PrEP to be successful as a relatively new HIV prevention strategy. This trust includes both interpersonal trust and institutional (...) trust and it is complicated by different kinds of relationship dynamics and the history of prejudice against MSM in healthcare institutions. (shrink)

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

BackgroundThe ethical concerns associated with HIV prevention and treatment research have been widely explored in South Africa over the past 3 decades. However, HIV cure research is relatively new to the region and significant ethical and social challenges are anticipated. There has been no published empirical enquiry in Africa into key informant perspectives on HIV cure research. Consequently, this study was conducted to gain preliminary data from South African HIV clinicians, researchers and activists.MethodsIn-depth interviews were conducted on a purposive (...) sample of fourteen key informants in South Africa. Audiotaped interviews were transcribed verbatim with concurrent thematic analysis. The perspectives of HIV clinicians, researchers and activists were captured. Analyst triangulation occurred as the data were analysed by three authors independently.ResultsThe rapid evolution of HIV cure research agendas was prominent with participants expressing some concern that the global North was driving the cure agenda. Participants described a symbiotic relationship between cure, treatment and prevention research necessitating collaboration. Assessing and managing knowledge and expectations around HIV cure research emerged as a central theme related to challenges to constructing ‘cure’ - how patients understand the idea of cure is important in explaining the complexity of cure research especially in the South African context where understanding of science is often challenging. Managing expectations and avoiding curative misconception will have implications for consent processes. Unique strategies in cure research could include treatment interruption, which has the potential to create therapeutic and ethical conflict and will be perceived as a significant risk. Ethical challenges in cure research will impact on informed consent and community engagement.ConclusionsIt was encouraging to note the desire for synergy amongst researchers and clinicians working in the fields of prevention, treatment and cure. Translation of complex HIV cure science into lay language is critical. Moving forward, RECs must be adequately constituted with scientific expertise and community representation when reviewing cure protocols. It is hoped that knowledge and resource sharing in the context of collaboration between research scientists working in cure and those working in treatment and prevention will accelerate progress towards cure. (shrink)

BackgroundThe prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports.MethodologyThis paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately (...) to such reports.ResultsThis review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal.ConclusionSocial harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence‐based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials. (shrink)

Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents (...) from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised. (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)

Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation.

Evidence‐based interventions have been developed and used to prevent HIV infections among black men who have sex with men (MSM) in Canada and the United States; however, the degree to which interventions address racism and other interlocking oppressions that influence HIV vulnerability is not well known. We utilize integrative antiracism to guide a review of HIV prevention intervention studies with black MSM and to determine how racism and religious oppression are addressed in the current intervention evidence base. We searched (...) CINAHL, PsychInfo, MEDLINE and the CDC compendium of evidence‐based HIV prevention interventions and identified seventeen interventions. Three interventions targeted black MSM, yet only one intervention addressed racism, religious oppression, cultural assets and religious assets. Most interventions' samples included low numbers of black MSM. More research is needed on interventions that address racism and religious oppression on HIV vulnerability among black MSM. Future research should focus on explicating mechanisms by which multiple oppressions impact HIV vulnerability. We recommend the development and integration of social justice tools for nursing practice that aid in addressing the impacts of racism and other oppressions on HIV vulnerability of black MSM. (shrink)

In order to demedicalize the ethics of pre-exposure prophylaxis as HIV prevention, I consider the social effects on men who have sex with men. The Centers for Disease Control and Prevention considers MSM to be the highest risk group for contracting HIV in the USA. The ethics of using PrEP as HIV prevention among MSM, however, has both a medical dimension and a social dimension. While the medical dimension of the ethics of PrEP includes concerns about side (...) effects, drug resistance and distribution, the social dimension of the ethics of PrEP includes concerns about stigmatization, sexual and romantic relationships and sexual freedom. The medical concerns of the ethics of PrEP may take precedence over the social concerns, but there is a growing body of literature that already addresses the medical concerns. Much less attention has been given to the social concerns of the ethics of PrEP, and in this article, I aim to fill this gap in the literature. Therefore, I focus on the often-overlooked social dimension of the ethics of PrEP to help understand the connection between the risks, relationships and communities of MSM using PrEP as HIV prevention. (shrink)

In their recent paper‘Undue inducement: a case study in CAPRISA 008’, Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not ‘unduly induced’ to participate by the offer of an experimental product. This paper argues that while the authors’ conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy. We (...) suggest that the critical research ethics question raised by Mngadi et al ’s case study is not ‘undue inducement’, but the exclusion of pregnant women from research studies where the risks are acceptable to the potential participant, and benefits likely. We also suggest that current regulatory paradigms regarding pregnancy are both overly paternalistic and value the fetus over the mother. In order to ensure timely provision of new HIV prevention agents, we argue that there is a need for expeditious testing of proven effective agents in pregnancy, with due consideration given to situations where preliminary efficacy data exist but fall short of licensure standards. This requires a paradigm shift from researchers, funders, regulators and ethical review bodies towards practices that critically examine the legitimacy of the exclusion of pregnant women on a study-by-study basis. (shrink)

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...) limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. (shrink)

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties (...) of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission. (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

Here are the 18 guidance points contained in the UNAIDS document on Ethical Considerations in HIV Preventive Vaccine Research, reproduced by kind permission of the Joint United Nations Programme on HIV/AIDS.

The use of targets to direct public health programmes, particularly in global initiatives, has become widely accepted and commonplace. This paper is an ethical analysis of the utilisation of targets in global public health using our fieldwork on and experiences with voluntary medical male circumcision initiatives in Kenya. Among the many countries involved in VMMC for HIV prevention, Kenya is considered a success story, its programmes having medically circumcised nearly 2 million men since 2007. We describe ethically problematic practices (...) in Kenyan VMMC programmes revealed by our fieldwork, how the problems are related to the pursuit of targets and discuss possible approaches to their management. Although the establishment and pursuit of targets in public health can have many benefits, assessments of target-driven programmes tend to focus on quantifiable outcomes rather than the processes by which the outcomes are obtained. However, in order to speak more robustly about programmatic ‘success’, and to maintain community trust, it is vital to ethically evaluate how a public health initiative is actually implemented in the pursuit of its targets. (shrink)

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. (shrink)

In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, (...) it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure. (shrink)