Ethical considerations related to the provision of care and treatment in vaccine trials.

Ethical principles of beneficence and justice combined with international human rights norms and standards create certain obligations on researchers, sponsors and public health authorities. These include treatment provision for participants enrolled in clinical trials of vaccines, drugs and other new preventive and curative technologies and methods. However, these obligations are poorly defined in practical terms, inconsistently understood or inadequately applied. Vaccine clinical trial designs normally define standards of prevention applicable to the population where the trial is to take place. The present document addresses specifically the setting of standards applicable to care and treatment in vaccine trials. The lack of clear guidance on how to achieve the optimal synergy between the development of new health technologies, on the one hand, and the promotion and protection of ethical and human rights principles, on the other, is a barrier to the progress of health research and therefore to the advancement of public health. The World Health Organization and UNAIDS have engaged in a series of consultations in Africa, the Americas, Asia and Europe to reflect on how this aim could best be achieved. This document highlights the outcome of these consultations. It proposes a structured approach to consensual decision making in the context of the clinical trial of vaccines against such public health challenges as HIV and newly emerging or threatening epidemics. A structured approach involving investigators and sponsors in a consultative process with trial communities and other stakeholders in research will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health.

Placing ethics in the centre: negotiating new spaces for ethical research in conflict situations.

Issues of power and consent, confidentiality, trust, and benefit, risks to researchers, and potential harm to participants, are all contested when working with different cultures and within environments marked by violence and insecurity. Difficulty resolving these dilemmas may paralyse ethics committees, may fail to give the guidance sought by researchers, and will not help populations who are among the world's most vulnerable. Even where efforts are made to respond to ethical guidelines and to improve practice, considerable impediments are present in many developing countries, including lack of formal ethical review structures in unstable settings, lack of required skills, limited political and institutional recognition of ethical issues, competing interests, and limitations in clinical and research practice (Elsayed 2004, Macklin 2004). In conflict settings, these limitations are more marked, and the responsibilities of the researcher for ethical practice are greater, but the mechanisms for oversight are weaker. Moreover, the constant focus on vulnerabilities and problems, and the often almost total lack of recognition of strengths and resilience, can further disempower already exploited groups and individuals. The capacity of refugees and communities in conflict to take an active role in the research process is seldom acknowledged, and undermines the potential for more innovative research which can help generate the evidence for better policy and practice.

HIV/AIDS and human rights revisited.

In their article, Sofia Gruskin and Daniel Tarantola demonstrate how, as the number of people living with HIV and with AIDS continues to grow in nations with different economies, social structures, and legal systems, HIV/AIDS-related human rights issues are not only becoming more apparent, but also increasingly diverse. In the 1980s, the relationship of HIV/AIDS to human rights was only understood as it involved people with HIV or AIDS and the discrimination to which they were subjected. The concerns included mandatory HIV testing; restrictions on international travel; barriers to employment and housing, access to education, medical care, or health insurance; and the many issues raised by named reporting, partner notification, and confidentiality. Almost 20 years into the epidemic, these issues remain serious and most often have not been resolved. In the 1990s, however, there was increased understanding of the importance of human rights as a factor in determining people's vulnerability to HIV infection and their consequent risk of acquiring HIV infection and their chances of accessing appropriate care and support. And most recently, human rights have also come to be understood to be directly relevant to every element of the risk/vulnerability paradigm. Gruskin and Tarantola identify three situations and three levels of governmental obligations that should be considered when identifying the specific needs and related rights of individuals in the context of HIV/AIDS. They conclude that policymakers, program managers, and service providers must become more comfortable using human rights norms and standards to guide and limit government action in all matters affecting the response to HIV/AIDS; and that those involved in HIV/AIDS advocacy must become more familiar with the practicalities of using international human rights law when they strive to hold governments accountable.

Country-specific estimates and models of HIV and AIDS: methods and limitations.

OBJECTIVE: This paper presents the methods used to calculate the end of 1997 country-specific estimates of HIV and AIDS produced by the UNAIDS/WHO Working Group on Global HIV/AIDS and STD Surveillance. The objective of this exercise was to improve estimates on HIV/AIDS by using country-specific models of HIV/AIDS epidemics. The paper describes and discusses the processes and obstacles that were encountered in this multi-partner collaboration including national and international experts. METHODS: The 1997 estimates required two basic steps. First, point prevalence estimates for 1994 and 1997 were carried out and the starting year of the epidemic was determined for each country. The procedures used to calculate the estimates of prevalence differed according to the assumed type of the epidemic and the available data. The second step involved using these estimates of prevalence over time and the starting date of the epidemic to determine the epidemic curve that best described the spread of HIV in each particular country. A simple epidemiological program (EPIMODEL) was used for the calculation of estimates on incidence and mortality from this epidemic curve. RESULTS: Regional models that were used in previous estimation exercises were not able to capture the diversity of HIV epidemics between countries and regions. The result of this first country-specific estimation process yielded higher estimates of HIV infection than previously thought likely, with over 30 million people estimated to be living with HIV/AIDS. The application of survival times that are specific to countries and regions also resulted in higher estimates of mortality, which more accurately describe the impact of the epidemics. At the end of 1997, it was estimated that 11.7 million people worldwide had died as a result of HIV/AIDS since the beginning of the epidemic. CONCLUSION: This exercise is an important step in improving understanding of the spread of HIV in different parts of the world. There are, however, shortcomings in the current systems of monitoring the epidemic. Improvements in HIV surveillance systems are needed in many parts of the world. In addition, further research is needed to understand fully the effects of the fertility reduction as a result of HIV, differing sex ratios in HIV infection and other factors influencing the course and measurement of the epidemic.

Government responses to HIV/AIDS in Africa: what have we learnt?

While we should not lose sight of the development of vaccines and cures, more immediate priorities include the implementation of effective STD control. The syndromic management approach developed in Zimbabwe to overcome laboratory constraints is a cost-effective way of managing STD. Of urgency is the integration of STD services into primary health-care services, appropriate training of staff, adequate provision and control over drugs and condoms, and incorporation of traditional healers and community-based education on STD. A second area of priority is the strengthening of the interaction between prevention, care and support activities, which act in synergy. Effective prevention and care require easy access to testing facilities with pre- and post-test counselling, appropriate structures and services to provide affordable and sustained care and support to those found to be infected with HIV, provision of drugs for the treatment of opportunistic infections, and the creation of a social environment and a legislation which protect against any form of discrimination the rights of people living with HIV, their sexual partners and their families.

Global expansion of HIV infection and AIDS.

The decline of new HIV infections among subgroups in industrialized countries has created a false sense of security; globally, about 13,000 new infections occur each day. In developing countries, limited health care spending bars all but a privileged few from access to new treatment. In the absence of an effective vaccine and intensified prevention, spread of the virus will continue unabated.

Mortality impact of AIDS in Abidjan, 1986-1992.

OBJECTIVES: To quantify the mortality impact of AIDS in the city of Abidjan (Côte d'Ivoire) by a full scale analysis of mortality trends before and after the onset of the epidemic. DESIGN: Data on deaths registered in the 10 vital registration centers of the city between 1973 and 1992, and data on causes of deaths in the four public hospitals were coded and investigated. Data on deaths were compared with census data in order to compute death rates. METHODS: Life tables were computed for each of the 20 years of the study. The trends in death rates were analysed during the 10 years before the onset of the AIDS epidemic (1973-1982) and compared with the changing death rates in the following 10 years (1983-1992). Deaths attributable to AIDS were defined as those in excess of the original trends. The evolution in the number of deaths in the hospital allowed an analysis by cause of death. RESULTS: There was a marked increase in death rates starting in 1986, date of the first diagnosed AIDS cases in the city. This increase was significant for both sexes, but more pronounced among men. It was concentrated primarily among young adults (aged 25-44 years) and among older children (aged 5-14 years), and most of it was considered to be attributable to AIDS and related infections, tuberculosis in particular. When data were cumulated from 1986 to 1992, approximately 25,000 persons were estimated to have died of AIDS. CONCLUSIONS: The high number of AIDS deaths estimated in Abidjan underlines the heavy toll already paid by African populations, and calls for intensive action.

Risk and vulnerability reduction in the HIV / AIDS pandemic.

PIP: An estimated 13.2 million men, 10 million women, and 2.7 million children worldwide have been infected with HIV since the beginning of the pandemic, and more than 10,000 people daily acquire HIV infection. 67% and 19% of these infections have occurred in sub-Saharan Africa and Southeast Asia, respectively. Even though the annual number of new HIV infections appears to have reached a plateau in Western Europe and the Caribbean and may be approaching one in sub-Saharan Africa, and the rise of new infection seems to be on the decline in North America, Oceania, and the southeastern Mediterranean, the HIV/AIDS pandemic has not been controlled anywhere in the world and its major impact has yet to come. Prevention activities undertaken by individuals, communities, nations, and international bodies have shown that the spread of HIV can be effectively reduced. Public health interventions against HIV/AIDS emphasize risk reduction strategies through the provision of HIV/AIDS-related information about safe behavior and the promotion of prevention methods. Exclusive reliance upon risk reduction strategies, however, fails to address the contextual issues in which the pandemic is rooted. In order to significantly affect the pandemic, short-term risk reduction interventions must be expanded considerably, adapted to local needs, and replicated worldwide. An expanded response to the pandemic also calls for medium- and long-term risk reduction interventions, including the linking of HIV/AIDS prevention, care, and support work with other actions in the health and social sector, and the remodeling of services to respond more effectively to growing needs. Until recently, such interventions have been neglected or misconstrued as the process of spreading thinly and irresponsibly HIV/AIDS actions within health and social programs. The sustainability and eventual success of HIV prevention will depend upon the capacity of health systems to integrate HIV/AIDS-related activities with other initiatives, while retaining the ability to track the epidemic and account for what is done about it. The influence of contextual factors on vulnerability to HIV/AIDS is discussed.^ieng

AIDS and human rights.

PIP: HIV/AIDS is a health problem that is inseparable from individual and collective behavior and social forces, particularly linked with societal respect for human rights and dignity. In its second decade, the HIV/AIDS pandemic continues to thrive. Where organized communities have access to adequate information, education, and services, the incidence of infection has begun to decline. Elsewhere, HIV continues to reach new populations and new geographic areas. Lessons learned in more than a decade of prevention work point to new directions for expanding national responses, at a time when the UNAIDS program, to be launched in January 1996, offers opportunities for innovative, broad-based, coordinated, and expanded global action. Prevention activities have shown that the spread of HIV can be effectively reduced. Public health interventions, including providing information and applying prevention methods, reduce the probability of infection, the risk of transmission, and the chances of not accessing appropriate care or support once infection has set in. These are proximal interventions that yield the short-term benefits of the decline of incidence and improved quality and duration of life for those infected. Societal vulnerability translates today into the focus the pandemic has on individuals, communities, and nations that are disadvantaged, marginalized, or discriminated against for reasons of gender, age, race, sexual orientation, economic status, or cultural, religious, or political affiliation. A fully expanded response to HIV/AIDS requires a combination of risk-reduction (proximal) and contextual interventions--those directed at reducing vulnerability through social change to enable people to exert control over their own health. Contextual actions can be implemented in the short term (changing laws, policies, practices that discriminate, promoting human rights, developing the most vulnerable communities) and in the long term (cultural changes, gender equality in power, education, and employment, and bridging the poverty gap).^ieng

The global AIDS pandemic. Toward a new vision of health.

The AIDS pandemic has not been brought under control in any community or nation as its impact continues to worsen. The program-based strategy developed in the mid-1980s was important in placing AIDS on national and global agendas. From the laboratory and healthcare facilities will come many answers to the AIDS pandemic, some opening new prospects for effective prevention and care. The global fight against AIDS has now reached a critical stage in which complacency and loss of direction threaten the opportunity to effectively curb the course of the pandemic, mitigate its impact, and stimulate the emergence of a modern concept of health and society.

Assessing and planning home-based care for persons with AIDS.

The HIV/AIDS pandemic continues to gather momentum in many developing countries, increasing the already heavy burden on health care facilities. As a result, donors, implementing partners and communities are beginning to create home-based care programmes to provide care for persons with HIV/AIDS. This paper recommends reorienting this home care provision as a service founded in, and coming from, the community rather than the health system. A methodology, in the form of an assessment matrix, is provided to facilitate the assessment of a community's capacity to provide care for people with AIDS. The focus is on rapid assessment methods using, where possible, readily available information to clearly and systematically define current circumstances. The matrix created for a specific community is then used in the development of an action plan with interventions prioritized and tailored to local needs. A case study from a hypothetical developing country, where HIV/AIDS is a significant problem, is used to illustrate the process.

PIP: Any AIDS program should strive to strengthen the capacity of the home and community to care for people with AIDS by building on traditional family structures which support all chronically ill people. A rapid assessment tool has been developed to resolve potential conflicts and to facilitate the design of an AIDS program tailored to local needs. It was designed with developing countries in mind. It uses an assessment matrix for systematic community evaluation of the problems and resources with current home care. The 3 levels are individual, household, and community. The key categories are HIV prevalence and awareness, perceived needs, community capability, and health and social system. For example, community capability and its operation are examined at the individual, household, and community level. Each country or program must come up with its own process and outcome indicators. They should choose indicators based on data that will always be available and permit measurement of progress towards selected goals/objectives (e.g., percentage of HIV seropositive TB patients). After completion and review of the matrix, the strengths, weaknesses, and barriers (which will become apparent) are used to develop an action plan. There are general guidelines for data analysis and the development of the action plan. Every program should be area-specific and community-based. Neither donors nor implementers should misjudge the obstacles to care within the community. Incremental steps will result in improved capacity of the community to cope with people with AIDS. All people who are involved in home care (e.g., prostitutes) must be included in the team to evaluate home care. Outside help (e.g., donors) must not undermine community initiatives to care for members with AIDS. The information and conclusions should be presented to the community and key informants for verification before implementing any interventions.