Q&A III: Selected issues: prevention and care
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UNAIDS Questions & Answers provide information on UNAIDS, its work and issues related to the AIDS epidemic.
Q&A I: International programmes, initiatives and funding issues
Q&A II: Basic facts about the AIDS epidemic and its impact
Q&A III: Selected issues: prevention and care
Section I: Prevention success
Section II: Injecting drug use
Section III: Blood safety
Section IV: HIV vaccines
Section V: Microbicides
Section VI: Condoms and safer sex
Section VII: Religious organizations and the response to HIV/AIDS
Section VIII: Sexually Transmitted Infections
Section IX: Partner notification
Section X: UN peacekeepers
Section XI: Mother-to-Child Transmission
Section XII: Human rights
Section XIII: HIV Testing
Section: XIV: Care, treatment and support
Section XV: Comprehensive care issues beyond ARV treatment
Section I: Prevention success
I/1 What have been the elements of successful prevention campaigns and what are some examples where these have occurred?
HIV prevalence levels among pregnant women have declined or become relatively stable in Cambodia, Senegal, Thailand, Uganda and in parts of Ethiopia, Malawi and Zambia. UNAIDS has identified the following programmatic elements it believes have led to these developments. The elements have been highlighted and endorsed in the Declaration of Commitment on HIV/AIDS adopted by the United Nations General Assembly Special Session on HIV/AIDS in June 2001.
They are:
• National and community leadership
• Multisectoral partnerships
• Advocating for expanded involvement in HIV/AIDS prevention and care by all sectors of society through a national strategic plan involving alliances among government agencies, NGOs and CBOs, business, and communities
• Focused actions with steadily expanding coverage
• Focused actions on the vulnerability to HIV infection, covering the components of multiple vulnerable populations, especially young people
• Development of a package of targeted information and a mix of mass media to educate and motivate behavioural change
• Focused actions on all prevention behaviours (delaying age of first sexual activity, abstinence, faithfulness and reduction in 'risky' behaviour)
• Focused action on means of protection
• Building general awareness and knowledge, especially among young people
• Raising the awareness of youth and the general population on safer behaviour
• Reducing discrimination against people living with HIV/AIDS and their families
• Preparing communities to support and care for those affected
• Implementing risk reduction programmes to make young people aware of HIV/AIDS by training in safer sex negotiation skills
• Starting HIV prevention and care as early as possible to prevent the epidemic from spreading
• Integrating prevention with care
• Supporting community approaches, in addition to individual approaches
• Creating a supportive environment in the community to encourage healthy behaviour by changing norms and making risk behaviour less socially accepted within the community
I/2 How are prevention achievements measured?
Successes in HIV prevention have been identified and measured through monitoring and evaluation of both the epidemiology of national HIV epidemics, as well as the risk behaviours involved. For monitoring of behavioural change, tools include second-generation surveillance systems, behavioural surveillance and community surveys.
Section II: Injecting drug use
The sharing of injecting drug equipment contaminated with HIV remains one of the critical activities fuelling the epidemic among drug users and beyond them in many parts of the world. To stop this form of transmission, a comprehensive package of interventions must be mounted to reach out to injecting drug users and their partners. Such a package should include "harm reduction" activities, such as information and education, needle-syringe exchange, condoms, substitution treatment and treatment of sexually transmitted infections (STIs), as well as "demand reduction" activities. Programmes must be supported by clear authorization and sufficient funding to enable them to go to scale.
II/1 What is the best way to prevent HIV transmission through injecting drug use?
HIV transmission through injecting drug use is best prevented by providing a comprehensive package of interventions and services in outreach to injecting drug users (IDUs) and their injecting or sex partners. Any single activity on its own will not work. Critical HIV prevention measures among drug users include:
• Provision of HIV information and education to drug users and their sex partners about HIV risks and about safer injecting and safer sexual practices
• Making condoms available to drug users
• Needle-syringe exchange programmes
• Integration of HIV prevention and care into drug (addiction) treatment programmes
• Provision of counselling, care and support for drug users living with HIV infection or AIDS
• Access to treatment for sexually transmitted infections and other health care services for drug users and their partners
• Substitution treatment
II/2 What are "harm reduction" and "demand reduction"?
The measures described above have at times been called 'harm reduction' in that they are aimed at reducing at least one harm associated with injecting drug use, that of HIV transmission among drug users and beyond. 'Demand reduction' programmes aim to dissuade people from using drugs in the first place, i.e. to reduce the number of IDUs within the population.
Harm reduction and demand reduction programmes should be conducted together, but in ways that allow each approach to be effective. There needs to be clear government policy and legislation that authorizes each type of programme and related activities, as well as sufficient funding so that they can be carried out on a sufficiently large scale. An example of a developing country that has set up appropriate policies and laws in this field is Brazil, where they have helped achieve substantially lower HIV prevalence rates among IDUs in several cities.
II/3 Is there a risk that needle-syringe exchange programmes might "send the wrong message" and result in more injecting drug use?
The evidence does not support this view. Studies conducted in Australia, Canada, Sweden, the UK and the USA have all shown that needle- syringe exchange programmes—particularly when carried out in concert with other interventions—help reduce the sharing of injecting equipment and the transmission of HIV. There was no evidence that needle exchange programmes increased either the number of people using drugs or the frequency of injecting drug use.
When clean-needle services were offered in California in the 1990s, the percentage of new initiates into injecting drug use fell (from 3% to 1%), regular users injected less frequently, and needle-sharing decreased by more than 70%. A global review of clean-needle/syringe programmes implemented between 1988 and1993 found that, in 29 cities with needle-exchange programmes, HIV prevalence among injecting drug users fell by an average of 5.8% a year, and the number of users did not increase. In contrast, in 52 cities lacking such programmes, HIV prevalence among injecting drug users rose by almost 6% each year.
However, research in Canada has highlighted the limitations of some needle/syringe-exchange programmes. For example, studies in Vancouver and Montreal, where cocaine injection is prevalent, have shown the importance of tailoring programmes to meet local conditions. Cocaine injectors tend to inject much more frequently than heroin injectors, and therefore require much greater quantities of sterile needles and syringes than usually provided by most needle-exchange programmes.
Another current limitation of needle-exchange and other interventions targeting drug users is that they often miss occasional or recreational drug users. This is an increasingly important issue, especially among young people, as this population is missed by many programmes targeting self-identified injecting drug users.
II/4 Are there recent examples where comprehensive programmes for IDUs reduced unsafe behaviour?
In Svetlogorsk, Belarus, an HIV prevention programme included education about safe injecting and safe sex, and provided clean syringes and condoms. In 1997, before the programme began, 92% of those surveyed said they shared syringes. By 1999, this percentage had dropped sharply to 35%. This part of the programme cost about US$ 0.36 per disposable syringe distributed. While some people did continue to re-use syringes, the proportion who cleaned them before using them again rose to 55% (up from just 16% prior to the prevention campaign). As for condom use, by 1999, nearly two-thirds said they sometimes or always used condoms - twice as many as two years earlier. The programme is estimated to have prevented over 2 000 cases of HIV infection by its second year of operation, at a cost of around US$ 66 per infection prevented - far below the cost of an AIDS case to a family or a health system. The Belarus campaign was bolstered by a change in the law, which made it legal to possess syringes. This change facilitated the funding and implementation of AIDS education and needle exchange among drug users - a change that was also critical in Brazil's programme, which helped reduce syringe- and needle-sharing from 70% to 41% in 1999-2000. As a result, between 1996 and 2000, HIV prevalence among injecting drug users dropped in several cities. In Santos, São Paulo State, the drop was from 65% to 42%; in Salvador, from 49% to 7%; and in the city of Rio de Janeiro, from 25% to 8%.
II/5 Are there any global or regional networks that focus on HIV and substance use?
The International Harm Reduction Association (IHRA) is one such global network. There are currently four regional networks serving Asia, Latin America, Eastern Europe, and Africa. Details of these harm reduction networks can be found on the IHRA website. There are also two important international task forces working on AIDS and substance use. These serve the Asia-Pacific and Eastern European regions. UNAIDS works closely with these networks and task forces, providing them with technical support and helping them identify sources of funding.
Section III: Blood safety
III/1 What progress have countries made in their efforts to provide safe blood for transfusions?
All countries in the world have recognized the importance of blood safety and are screening blood for HIV antibodies, although in many developing countries this is done as a matter of course only in the main urban centres. WHO takes the lead on blood safety.
III/2 What resources are available for improving blood safety?
WHO has developed distance-learning training materials for technical and clinical staff responsible for blood safety. Training courses in quality management for blood transfusion safety are being developed at a regional level, and quality assessment schemes for HIV and other transfusion transmissible infections have been established in several regions. Learning materials for the clinical use of blood and blood products have also been developed.
III/3 Should paid donors and a "hidden paid donor system" with family replacement donors be discouraged, and replaced by blood donation from a voluntary non-remunerated blood donor system?
Yes. Blood transfusion services should be non-profit and not for gain. There is a much higher risk of infectious agents—in particular HIV—being passed on from the blood of paid donors than from the blood of voluntary donors. As early as 1975 WHO adopted a directive (WHA 28.72) urging countries to develop blood transfusion services based on voluntary, non-remunerated blood donation.
III/4 How big a factor are unsafe injections in Africa's AIDS epidemic?
Some researchers in 2003 claimed that unsanitary medical practices—such as the use of contaminated needles—may be responsible for almost one-third of HIV transmission in Africa. The study claimed that needles and syringes are reused in medical treatment as much as 50% of the time in sub-Saharan Africa.
However, the evidence does not bear out such conclusions. Epidemiological and biomedical data show that children between 5-14 years (who are generally not yet sexually active) have very low infection rates, while age-specific infection rates among young women and men strongly follow patterns of sexual behaviour and those of other sexually transmitted infections (such as herpes simplex virus-2). In sexually active couples, both partners are often infected. There is also no consistent association between higher HIV rates and lower injection safety standards. Accordingly, an expert group hosted by WHO and UNAIDS in March 2003 confirmed that unsafe sexual practices are responsible for the vast majority of HIV infections in sub-Saharan Africa.
While a combination of prevention measures are required to tackle all modes of HIV transmission, safer sex promotion must remain the primary feature of prevention programmes in the region. Discussions about the importance of other modes of transmission should at no time weaken this central part of the response.
III/5 Does that mean unsafe injections are a negligible factor in the epidemic?
No, it does not. It is estimated that as much as 2.5% of cases in sub-Saharan Africa may be caused by unsafe injections. The vast majority of HIV infections in the region, though, are sexually transmitted.
III/6 What should be done to reduce infections through unsafe injections?
Injections are vital for immunization programmes and for the provision of life-saving treatment. Injections should be used only when medically necessary, and should be given using single-use equipment which is then disposed of safely.
Major efforts have been devoted to enhancing injection safety in the healthcare setting through better planning of services including immunization, training of care providers and vaccinators, provision of single-use injection equipment and proper "sharps" disposal. But more needs to be done to eliminate unsafe injection practices throughout the world. To further this work, WHO has just issued a framework to assist countries with all aspects of the provision of safe injections, entitled "Managing an Injection Safety Policy".
Section IV: HIV vaccines
A future HIV vaccine will not be a "magic bullet". But future vaccination against HIV, applied alongside prevention measures focused on safer behaviour and STI control, holds out realistic hope for ending the AIDS epidemic. HIV vaccine development is unusually challenging for reasons that relate to the virus itself, ethical considerations in the conduct of vaccine trials, and the socioeconomic context.
IV/1 Will it be possible to develop a vaccine for HIV?
Scientists know that animals can be protected against HIV infection with a vaccine, but they remain uncertain as to whether that success can be extrapolated to humans. The search for an HIV vaccine therefore has to include human trials, which are costly and time-consuming.
IV/2 Why is it taking so long to develop an HIV vaccine?
The peculiarities of the human immunodeficiency virus make the development of an HIV vaccine a difficult and expensive process. For most infectious diseases, a successful vaccine stimulates an effective immune response in order to protect the body and help it recover from disease. But HIV immobilizes the body's immune responses and leaves them incapable of controlling infection or preventing disease. Furthermore, most existing vaccines contain an entire micro-organism (virus or bacterium) that has been killed or rendered harmless. In the case of HIV, however, this approach is not considered safe, and experimental HIV vaccines are based on parts of the virus to make absolutely sure that vaccination does not result in HIV infection. This makes the development of a vaccine even more challenging.
IV/3 Will it be necessary to develop a vaccine for each genetic subtype of HIV?
It would clearly be desirable to have an HIV vaccine that would be effective against all subtypes of HIV. However, at present it is not known whether this will be feasible, or if different vaccines will be needed for different subtypes. That, coupled with the fact that the subtypes in developing countries differ from those prevalent in the industrialized world, makes it essential that experimental vaccines be developed simultaneously in high-income and low-income countries, and in different regions of the world.
The practical approach adopted by the majority of HIV vaccine experts exploits the development of candidate vaccines based on globally prevalent HIV strains, such as subtypes C, A and B. Those candidate vaccines are then evaluated in specially designed efficacy trials in order to measure the efficacy of the vaccine in protecting individuals against different subtypes. The UNAIDS Virus Network serves as an important source of epidemiologically relevant HIV strains and related vaccine reagents for the development of various candidate HIV vaccines, suitable for testing and eventual use on a global basis, especially in developing countries.
Sub-typing does influence vaccine testing. For example, in Thailand when molecular epidemiologists reported that the dominant subtype B had been replaced with another—subtype E—in a population of injecting drug users among whom the trial was to be conducted, the vaccine makers modified the vaccine to include two different vaccine components so as to target both subtypes.
IV/4 What is the difference between Phase I, II and III trials?
Phase I tests are done on 20-40 volunteers. These tests are intended to confirm the vaccine's safety and determine whether it triggers strong enough levels of HIV-specific immune responses. Phase II tests involve hundreds of volunteers and are intended to further check vaccine safety and assess the potency of immune responses. Phase III trials are large-scale field trials involving thousands of volunteers. The aim is to gauge whether the candidate vaccine indeed protects people against HIV infection or the onset of AIDS. Moving vaccines through the three phases can last for up to four years.
IV/5 Have HIV vaccines already been tested in humans?
Yes, around 30 different HIV candidate vaccines have been tested since 1987 in over 80 phase I/II clinical trials, involving more than 10 000 human volunteers free from HIV infection. Most of these trials have been conducted in the US and Europe, but some have been held in developing countries (Botswana, Brazil, China, Cuba, Haiti, Kenya, Peru, South Africa, Thailand, Trinidad and Tobago, and Uganda). The aim of Phase I/II trials is to assess candidate vaccines with regard to their safety and their immunogenicity (that is, the vaccine's ability to induce an immune response against HIV).
Only two phase III trials have been conducted to date to determine vaccine efficacy of one vaccine approach, using a recombinant rgp120 vaccine derived from the envelope of the virus and targeting at induction of protective antibody responses. These trials have been conducted in the United States (among men who have sex with men, MSM) and in Thailand (among injecting drug users, IDUs). Unfortunately, the results from these trials did not demonstrate any significant level of efficacy. On the other hand, these trials should be viewed as an important step forward, as well as an example of highly successful trials, since these trials for the first time have produced definitive answers to a number of key scientific and logistic challenges that are required to move forward the whole field of HIV vaccine development.
The same gp120 candidate vaccine is being used in a third phase III efficacy trial in a prime-boost combination, which started in Thailand late in 2003, with results expected to be available by the year 2007. These trials will produce valuable information, regardless of the success or failure of the vaccine itself. That information will enable us to move ahead in the search for an effective vaccine.
IV/6 What were the results from these Phase I/II trials?
The candidate vaccines were shown to be safe. The only side effects were minor pain at the site of inoculation. The candidate vaccines induced anti-HIV immune responses (of varying quality and quantity, depending on the candidate vaccine). However, Phase I and II trials are not designed to assess the efficacy of the candidate vaccine in protecting humans against HIV.
IV/7 What type of trials are needed to see if a vaccine actually works?
Large-scale Phase III trials are the only trials that can provide information on the efficacy of protection. These are field trials conducted in populations with a relatively high incidence of naturally-occurring HIV infection (usually more than 1% per year). Half the volunteers receive the candidate vaccine and half receive a control injection. All receive HIV prevention counselling. To avoid biases in the interpretation of the results, neither the volunteers nor the investigators know who is receiving which. This is known as a double-blind controlled trial. The population, usually several thousand volunteers (depending on HIV incidence), is tracked for 2-4 years to see if fewer of the vaccinated volunteers become infected with HIV than the control volunteers.
IV/8 If you need to have a certain rate of HIV infection to assess the efficacy of the vaccine, would you encourage people to be exposed to the virus?
No, that would be unethical. Populations enrolled in HIV vaccine efficacy trials should be counselled on how to avoid exposure to HIV. They are told that nobody knows if the vaccine will work, and that they should continue low-risk practices. Nevertheless, we know that 'behavioural' prevention programmes are not 100% effective and that some residual risk of HIV infection will remain. That residual level of HIV infection is what allows vaccine efficacy to be gauged.
IV/9 Are there any candidate vaccines that are now being tested in Phase III trials?
Yes, large-scale Phase III efficacy trials began in June 1998 in the US, and in March 1999 in Thailand, using candidate vaccines based on gp120 (an external protein of HIV), produced by VaxGen, a US-based biotechnology company. These are the first HIV candidate vaccines to be evaluated for their efficacy in protecting humans against HIV infection or disease. Injection of this protein stimulates the production of antibodies capable of neutralizing the virus. VaxGen has developed two types of gp120 candidate vaccine. Both of them are bivalent (they contain HIV proteins from two different HIV strains). The one tested in the USA is based on two different strains of HIV subtype B, which is prevalent in the USA. Results from that trial were released in early 2003 (see below). The other contains gp120 of subtypes B and E, both of which are prevalent in Thailand, where the other efficacy trial is being conducted. That trial, which involves more than 2500 volunteers, mostly injecting drug users, is expected to provide additional valuable information about the potential efficacy of this type of candidate vaccine. Results were released in November 2003.
VaxGen is also currently conducting pre-clinical research to develop a vaccine against the most common subtype, subtype C, which accounts for approximately 50% of all new HIV infections worldwide.
IV/10 What were the results of the first two Phase III VaxGen trials?
Preliminary results of a large-scale trial of a candidate AIDS vaccine were announced in February 2003 by VaxGen. The AIDSVAX Phase III trial was the first large-scale human trial of an HIV vaccine. The vaccine used in this trial was designed to reduce susceptibility to infection with HIV subtype B, which is prevalent in the Americas, Western Europe, Australia, and New Zealand.
The trial of the company's AIDSVAX vaccine appeared to show a protective effect among non-Caucasian populations, especially African Americans, although sample sizes were small. However, for the majority of the participants, who were Caucasians, the effect of the vaccine was minimal. Additional studies would be conducted to further clarify the data.
Although the trial vaccine was seen by some to mark a promising first step, an effective vaccine providing widespread protection is still not on the horizon. To date, eleven subtypes of HIV-1 have been identified. One of the major challenges in HIV vaccine development is to develop one or multiple vaccines effective against all major subtypes of HIV.
Results from the Phase III clinical trial in Thailand, released in November 2003, showed that the vaccine candidate did not show efficacy for either the primary or secondary endpoints. The primary endpoint for the trial was the prevention of infection by HIV, the virus that causes AIDS. The secondary endpoints concerned whether vaccination slowed the progression of the disease among those who received the vaccine but later became infected with HIV.
IV/11 What are some of the other vaccine initiatives that are underway?
At present, a whole new generation of candidate HIV vaccines are under development, in particular those based on globally prevalent HIV strains, which may be more appropriate for use in developing countries. These candidate vaccines are developed under frameworks of different national agencies in private and public sectors, including among others the US National Institute of Health (NIH), European research Institutions, the International AIDS Vaccine Initiative (IAVI) and the European Union (EU), as well as an increasing number of national HIV vaccine programmes and research institutions in developing countries. WHO, UNAIDS and the African AIDS Vaccine Programme (AAVP) are committed to supporting the developing countries in building capacity to conduct clinical trials at the highest scientific and ethical standards. The recently announced Global HIV Vaccine Enterprise sponsored by the Gates Foundation and endorsed by the G-8 countries also will provide a new and vital boost to help forge the strategic planning and global investment of resources by governments and industry that is commensurate with the intensive effort required to develop a globally accessible and affordable HIV vaccine.
IV/12 What is being done to ensure that trials are conducted with the appropriate scientific and ethical standards?
In 2000, UNAIDS issued a Guidance Document on 'Ethical considerations in HIV preventive vaccine research', which was developed through an intensive process of international consultation. UNAIDS and WHO are also conducting training workshops to strengthen the capacity of developing countries to conduct ethical reviewing.
IV/13 Would a successful vaccine mean we can abandon other prevention programmes?
No. A vaccine will not be a panacea, nor can it be an alternative to existing programmes for preventing HIV spread through sex, blood or drug use. Because an eventual vaccine is unlikely to be 100% effective, it will have to be used alongside wide-ranging and effective prevention programmes. In fact, once a vaccine is developed, awareness-raising and prevention efforts will need to be redoubled in order to counter the risk of complacency.
IV/14 What is the role of UNAIDS and WHO in the field of vaccine development?
UNAIDS and WHO have joined efforts, creating a WHO-UNAIDS HIV Vaccine Initiative. The joint initiative does not fund trials. Its role is to provide international coordination and to build up the capacity of developing countries to conduct such trials. It also plays a useful role in setting standards. Specifically, the Initiative:
• Advocates for HIV vaccines
• Helps developing countries prepare to conduct vaccine trials in a scientifically and ethically sound way
• Promotes and supports the development of HIV vaccines that would be appropriate for use in developing countries
• Supports the surveillance of different subtypes of HIV-1 in the world, particularly in developing countries
• Prepares for the availability of, and access to, future HIV vaccines.
One of the recent activities of the WHO-UNAIDS HIV Vaccine Initiative is the Africa AIDS Vaccine Programme (AAVP), an African Network to facilitate the development and evaluation of HIV vaccines for Africa, through capacity-building and regional and international collaboration. The AAVP was officially launched at a forum conducted in South Africa in June 2002.
IV/15 What is the Global HIV Vaccine Enterprise?
The Global HIV Vaccine Enterprise is expected to enhance coordination, information sharing and global collaboration amongst the world's HIV vaccine researchers in industrialized and developing countries in both private and public sectors. It will prioritize the scientific challenges that need to be addressed, coordinate product development efforts and encourage greater use of information sharing technologies. Existing resources would be better aligned and would be channeled more efficiently. Its work would also promote more effective synergies between research into new technologies and global efforts to scale up the preventive and therapeutic interventions for AIDS which already exist.
To achieve these goals, the Enterprise will develop a strategic plan for development, testing and production of HIV candidate vaccines in collaboration with major national and international partners, as well as vaccine manufacturers. Partners in the Enterprise include the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Centre at the US National Institutes of Health (NIH), the European Research Institutes, the International AIDS Vaccine Initiative (IAVI), European Union and national HIV vaccine programmes and research institutions from developing countries.
WHO and UNAIDS are committed to supporting the Enterprise, by contributing to capacity building in developing countries in conducting clinical trials at the highest scientific and ethical levels, addressing issues such as future access to HIV vaccines as part of HIV prevention, treatment and care programmes.
IV/16 What efforts are being made to make an HIV vaccine available once it is produced?
Usually, vaccines arrive in low- and middle-income countries many years after they have recouped their costs in high-income countries. This cannot be allowed to happen in the case of AIDS. Effective HIV vaccines need to be made rapidly available and affordable with simultaneous access in both low- and high-income countries. WHO, UNAIDS and the International AIDS Vaccine Initiative (IAVI) are already discussing strategies to ensure the rapid availability of future HIV vaccines. Many of the challenges are similar to those relating to expanding access to antiretroviral drugs. IAVI and others are proposing significant changes to existing approaches to vaccine production, licensing, pricing, purchasing and distribution.
Differential pricing, together with financial support from donors, will be necessary for low-income countries. Technical assistance and coordination by international agencies will be needed. Since vaccination will not immediately be available to everyone, costs and benefits have to be calculated to determine where the initial focus should be. Policy-makers must also decide what to do if the first available vaccines are only marginally effective or have significant side effects. WHO and UNAIDS, in collaboration with IAVI, conducted an international study to identify potential polices that will guide the introduction and use of future HIV vaccines, and obtained initial information on global and regional needs for future vaccines. This information is essential to industry, public health authorities and financial institutions.
IV/17 There seems to be a lack of economic incentive for the private sector to invest in vaccine development. How can this be changed?
In general, preventive vaccines are not as financially lucrative for the pharmaceutical industry as therapeutic products, particularly drugs that patients need to take repeatedly (as for the treatment of chronic disease). This has been a problem with the development of vaccines in the past. In addition, the costs for development, evaluation, and liability are much higher for vaccines than for most other products. Because of these obstacles, WHO and UNAIDS are encouraging the pharmaceutical industry's work in this area, and are facilitating partnerships—among governments, foundations, research institutions and industry—to share the risks, costs and benefits of vaccine development.
Section V: Microbicides
Microbicides are a form of "chemical condom" that can be self-administered and that can protect both partners from HIV infection during sexual intercourse.
The ideal product would be odourless and colourless, and therefore undetectable to a sex partner who refuses other forms of protection. As such, microbicides could increase the options for women and men who find it difficult or impossible to persuade their partners to use a condom.
Microbicides have been shown to be acceptable to women. In a recent trial, nonoxynol-9 was shown not to be effective against HIV. However, an estimated 56 new microbicide products are in various stages of development, and research efforts have been spurred by several grants from the Bill and Melinda Gates Foundation. It is difficult to say how long it will be before an effective product is available on the world market.
V/1 Why have microbicides been heralded as a potentially powerful tool in the fight against HIV?
Microbicides are chemical substances that kill viruses and bacteria when applied vaginally or rectally before sexual intercourse. Applied inside the vagina or rectum in the form of gel, cream, suppository or film, a microbicide for HIV would prevent infection with HIV and, possibly, other sexually transmitted infections. If spermicidal, it might also be useful for birth control. The ideal product would be odourless and colourless, and therefore undetectable to partners.
V/2 How would microbicides benefit women and others who cannot negotiate safe sex?
As a form of "chemical condom" that can be self-administered and might be undetectable to partners, microbicides could increase the options for women, men, and sex workers who find it difficult or impossible to persuade their spouses or other sex partners to use a condom. Acceptability studies in South Africa, Uganda and Zimbabwe suggest that women who seldom or never use condoms would reduce their overall risk of infection if an effective microbicide were available to them at low cost.
V/3 What is happening with microbicide research?
A UNAIDS-sponsored study found that nonoxynol-9 is not an effective microbicide for HIV. Similar results were also found in studies by the University of Washington in Kenya and Family Health International (FHI) in Cameroon. However, there are an estimated 56 other products in various stages of development, from pre-clinical stages to Phase III effectiveness trials. The US-based HIV Prevention Trials Network has decided to bring two new agents (Buffergel and Pro 2000) to Phase III clinical trials. Population council is conducting a Phase III trial of carrageenum in Southern Africa. In addition, a European Community-sponsored consortium is bringing new microbicide concepts in Phase II trials to developing countries after having confirmed their safety in Europe. Others are also initiating Phase II/III trials, and as a result of increased attention to microbicide development from the scientific community, public sector funding agencies and a few biotechnology companies, more compounds are entering Phase II, Phase I and preclinical stages of development. The Gates Foundation has recently provided International Partnership for Microbicides (IPM) with US$60 million and previous funded the the US-based NGO CONRAD with US$ 25 million to accelerate microbicide development. The International Working Group on Microbicides, which includes public agencies from across the world among its members, continues to promote and facilitate the development of microbicides. It is estimated that an effective product may be available on the world market in 5 to 10 years.
V/4 What is the International Partnership on Microbicides (IPM)?
This is a not-for-profit organization that was established recently to accelerate the discovery, development and accessibility of microbicides to prevent HIV transmission. Born out of a Rockefeller Foundation's Microbicide Initiative (), the IPM will initially be housed at FHI in Arlington, Virginia. Its main objective is to increase the efficiency of the development and delivery of a microbicide by expanding the level of public and private sector funding and by identifying critical gaps in research and development, access, and advocacy.
V/5 What is the WHO microbicide project?
The main objective of the project is to accelerate the development and deployment of safe and effective topical microbicides for prevention of HIV and other sexually transmitted infections.
Specific objectives include:
1) To conduct safety and acceptability trials of promising microbicide candidates in collaboration with other agencies. In conjunction with CONRAD, WHO is conducting a Phase I safety and acceptability study of 6% Cellulose sulfate in India, Nigeria, and Uganda. Expanded safety trials of other promising products will be initiated in 2004-5.
2) To strengthen institutional research capacity of clinical sites in developing countries for participation in microbicide research and development. Countries that are involved with WHO in microbicide research capacity strengthening include Ethiopia, India, Kenya, Nigeria and Uganda. Additional sites are being identified and assessed for future support.
3) To provide technical support to countries by facilitating discussions on scientific, regulatory, and ethics issues related to microbicide research and development leading to licensure and post marketing surveillance. WHO in conjunction with its partners has convened international and regional meetings on the scientific basis for regulation of microbicides. 4) To foster global advocacy and international collaboration for microbicide research and development by (a) providing sponsorship to international conferences, symposia, and workshops, and (b) strengthening collaboration with international agencies involved with microbicides. WHO continues to play a key role in the International Working Group on Microbicides and collaborates with the Alliance for Microbicide Development, International Partnership for Microbicides, CONRAD, and other agencies involved in microbicides.
Section VI: Condoms and safer sex
Prevention is the first line of defence against AIDS, and the correct and consistent use of condoms is a mainstay of HIV prevention approaches. Condom use to prevent HIV is most effective when it is part of a broader safer sexual behavior package that includes sexual abstinence, non-penetrative sexual practices, and reduced numbers of sexual partners.
But many people, especially young people and young girls, do not have sufficient information about the importance of using condoms, nor are there sufficient supplies of condoms. Cost is also a major issue. UNAIDS continues to make the promotion and availability of condoms, including the female condom, a key priority.
VI/1 Why is condom promotion and distribution absolutely essential in limiting the spread of HIV and AIDS?
The vast majority of HIV infections are sexually transmitted. There are only four ways to prevent sexual transmission of HIV. These are: (1) abstinence, (2) monogamous relations with an uninfected partner, (3) non-penetrative sex, and (4) consistent and correct use of male or female condoms. Studies consistently show that in every population above the age of sexual debut there are many people who are either unable or unwilling to practise abstinence, monogamy and non-penetrative sex. This leaves condoms for protecting these people and their partners.
VI/2 Are condoms really effective in preventing HIV transmission?
Quality-assured condoms are the only products currently available to protect against sexual infection by HIV and other sexually transmitted infections (STIs). When used properly, condoms are a proven and effective means for preventing HIV infection in women and men.
Based on research between discordant couples (one HIV-negative and one HIV-positive), condoms have been found to be 90% effective. The vast majority of condom failures result not from leakage or permeability of the latex material, but from improper use, breakage, or slippage.
It is important to emphasize that an effectiveness of 90% for condoms does not mean HIV transmission will take place in 10% of sexual acts in which condoms are used. This means that each time a person has sex using a condom, he or she reduces their risk to acquire HIV by 90%.
VI/3 What about other STIs?
The data are less complete for other STIs, but enough evidence exists to make condoms the recommended strategy for preventing gonorrhoea, chlamydia, trichomoniasis, and syphilis. Studies to establish reliably the effectiveness of condoms against specific STIs are difficult to conduct in a scientifically rigorous and ethical manner, but a number of studies are underway and more are planned. Studies have already proven the effectiveness of condoms in preventing gonorrhoea in men.
VI/4 Is there any evidence that condom use is effective in reducing HIV infections in generalized epidemics?
More data is now emerging that demonstrates the effectiveness of condoms in preventing HIV transmission in generalized epidemics. A study from South Africa, soon to be published in the journal “AIDS”, finds that when enough young men use condoms consistently, there is a clear protective effect for both the individual and the population at large.
VI/5 Can HIV pass through a condom?
Condoms provide an impermeable barrier to viruses and to sperm barrier that indeed blocks the passage of organisms much smaller than the HIV virus. Condoms are required to undergo demanding tests, including tests for holes, before they are distributed or sold. If any holes or perforations are found, the condoms are discarded.
VI/6 Don't condoms often "fail" during intercourse?
The evidence from valid studies conducted by reputable and reliable organizations is overwhelmingly that condoms provide effective protection from sexually transmitted HIV infection and other STIs, as well as unwanted pregnancy. Condom "failure" occurs on the rare occasion that a person contracts an infection or becomes pregnant despite the use of a condom. Such "failure" is very infrequent and is usually associated with condom breakage or slippage. Most slippage and breakage of condoms are caused by incorrect use, though there is an increased likelihood of breakage if the condom is past its expiry date or has been exposed to excessive heat. If condoms are to prevent HIV and STIs, they must be used correctly and consistently. Occasional use provides no more than occasional protection.
VI/7 Do condoms lead to increased promiscuity?
No, condoms do not lead to increased promiscuity. Since the early 1990s, extensive research has shown that education about sexuality and access to condoms do not lead young people to begin having sex, or to have more partners. In fact, condoms, when distributed with educational materials as part of a comprehensive prevention package, have been shown to significantly lower sexual risk and activity, both among those already sexually active and those who are not.
VI/8 What is the “ABC” prevention approach?
Just as combination treatment attacks HIV at different phases of virus replication, combination prevention includes various safer sex behaviour strategies that informed individuals who are in a position to decide for themselves can choose at different times in their lives to reduce their risk of exposing themselves or others to HIV (Global HIV Prevention Working Group, 2003). These are often referred to as the ABCs of combination prevention:
• A means abstinence—not engaging in sexual intercourse or delaying sexual initiation. Whether abstinence occurs by delaying sexual debut or by adopting a period of abstinence at a later stage, access to information and education about alternative safer sexual practices is critical to avoid HIV infection when sexual activity begins or is resumed.
• B means being safer—by being faithful to one’s partner or reducing the number of sexual partners. The lifetime number of sexual partners is a very important predictor of HIV infection. Thus, having fewer sexual partners reduces the risk of HIV exposure. However, strategies to promote faithfulness among couples do not necessarily lead to lower incidence of HIV unless neither partner has HIV infec-tion and both are consistently faithful.
• C means correct and consistent condom use—condoms reduce the risk of HIV transmission for sexually active young people, couples in which one person is HIV-positive, sex workers and their clients, and anyone engaging in sexual activity with partners who may have been at risk of HIV expo-sure. Research has found that if people do not have access to condoms, other prevention strategies lose much of their potential effectiveness.
A, B, and C interventions can be adapted and combined in a balanced approach that will vary by cultural context, the population addressed and the stage of the epidemic.
VI/9 Why does UNAIDS promote condom use if condoms are not fool-proof?
UNAIDS is a strong advocate for condom promotion and distribution because it is a proven fact that condoms can prevent HIV infection during vaginal, anal, or oral sex. And condoms are the only existing products that can do this.
VI/10 What is the "condom gap"?
UNFPA estimates that 8 billion condoms were needed in 2000 for HIV/STI prevention alone, and that, by 2015, at least 19 billion condoms will be needed. These figures exclude condoms needed for family planning purposes, and assume that the condoms would, in any case, not be used consistently.
VI/11 What is being done to overcome the condom gap?
Cost is a major issue. Costs will rise from an estimated US$ 239 million in 2000 to an estimated US$ 557 million in 2015. This cost does not include delivery, distribution, promotion or other services.
Resources to meet demand for condoms come from domestic government sources and out-of-pocket expenditures; multilateral agencies, including the United Nations Population Fund (UNFPA) and the World Bank Multi-Country AIDS Programme (MAP); the Global Fund to fight AIDS, TB, and Malaria; the private sector (foundations,employers, international nongovernmental organisations) and bilateral donors. Donors provided 3.574 billion condoms in 2002, at a cost of US$ 94.9 million. Condom funding peaked in 1996 when international funding of condoms was at US$ 68 million, but it subsequently declined to US$ 40 million annually in 1999 and 2000.
VI/12 Are condoms enough?
No. It is essential that all people, including young people and women and girls, have access to the information, education and life skills that enable them to have safe and responsible sexual relations and negotiate safer sex, including condom use. This is especially important with regard to changing harmful gender norms that make men less likely to use condoms, and make women and girls less able to insist on their use.
VI/13 What makes someone use a condom?
Knowledge about HIV/AIDS, easy accessibility and affordability, and social support to do so. Increasing condom accessibility and availability also increases condom use. In Brazil, there was a massive increase in the uptake of condoms when prices came down in the early 1990s. However, almost everywhere, sexually active young people (especially young women) are denied accurate information about condoms. Researchers in Kenya report that 54% of young people do not believe that condoms protect against HIV infection.
VI/14 What are the most effective ways for women to protect themselves against HIV infection during sexual intercourse?
Besides mutual fidelity between uninfected partners, correct use of a condom "from start to finish" continues to be the single most effective means for women and men to protect themselves from HIV infection through sexual intercourse. However, because of their social and cultural situations, women are often unable to insist on condom use by their male partners. This should be countered by the promotion of the following:
• Sexual health education, sexual responsibility and gender sensitivity for men/boys
• Negotiating and life-skills for women/girls
• Economic, social and political equality for women/girls
• Promotion and widespread distribution of female condoms
• Urgent development and distribution of microbicides.
VI/15 What has UNAIDS done to promote the female condom?
In 1996, UNAIDS and the sole manufacturer of female condoms established a special discount price of about US$ 0.60 per condom for use by the public sector and non-profit organizations, especially in developing countries, in order to make the female condom more easily available and affordable. As a strong advocate for the inclusion of female condoms in prevention programmes, UNAIDS, in collaboration with the manufacturer, has also made the female condom available to many developing countries to encourage its integration into existing condom programmes.
Ghana is one of the countries that has a national programme to boost female condom use, including high-level political commitment (notably, in the person of the former First Lady, Nana Konadu Agyeman Rawlings), social marketing, and distribution by both the public and private sectors. Technical assistance to country programmes is also provided by WHO and UNFPA. In addition, UNAIDS has produced and disseminated key documents and Best Practices on the introduction and integration of female condoms in countries, including the recent "The Female Condom: A Guide for Planning and Programming".
Section VII: Religious organizations and the response to HIV/AIDS
UNAIDS encourages religious organizations to support effective prevention and care programmes, including the use of condoms as part of these programmes. Many do support such programmes. Though abstinence and monogamy (involving two seronegative partners) do protect against HIV transmission, statistics in every region and age group (after sexual debut) indicate that large numbers of people, including young people, do not practise abstinence or monogamy.
UNAIDS believes it is every person's right, including young people, to have access to effective education on human sexuality, health and life skills to enable that person to make informed choices and follow through on them, including abstinence and monogamy. Research has shown that such education does not result in increased sexual relations.
VII/1 What is UNAIDS' position regarding religious organizations that prohibit the use of condoms?
UNAIDS provides factual, scientific information about condoms, and encourages religious organizations and leaders to support effective prevention and care programmes. UNAIDS encourages the use of condoms as part of these programmes, and encourages religious organizations to debate and consider the use of condoms.
VII/2 How does UNAIDS view abstinence and monogamy?
UNAIDS recognizes that abstinence and monogamy (involving two seronegative partners) protects against HIV transmission. UNAIDS can also provide scientific evidence that a delayed sexual debut is a prevention measure. However, UNAIDS also recognizes that statistics in every region and age group (after sexual debut) indicate that large numbers of people, including young people, do not practise abstinence or monogamy. UNAIDS believes that it is every person's right, including young people, to have access to effective education regarding human sexuality, health and life skills to enable that person to make informed choices and follow through on them, including abstinence and monogamy. In collaboration with various organizations, UNAIDS advocates that a call for abstinence and monogamy be done in conjunction with education on human sexuality in order for people to be able to practise these approaches successfully. Research has shown that sexual health and life skills education can be a support for abstinence, monogamy and delayed sexual debut. Many religious organizations provide such education.
VII/3 What have religious organizations done in the field of AIDS so far?
Religious organizations have for two decades cared for people living with HIV in various ways, both at hospitals and in the communities. Religious organizations are also part of coping mechanisms in hard-hit communities.
VII/4 Does UNAIDS collaborate with religious organizations that are proselytizing?
UNAIDS works with all organizations that have sound HIV policies and that perform effective and ethical work in the field of AIDS.
VII/5 What is the most important work religious organizations can do for the next two years?
Take a stand against stigma and discrimination against people living with HIV, help communities eradicate such stigma and discrimination, and mobilize communities in HIV prevention and care efforts. They can also de-emphasize labeling or blaming that lead to stigma and discrimination, and emphasize openness, acceptance, reconciliation, compassion and action: within individuals, between individuals, within communities and between communities.
VII/6 What can UNAIDS do to facilitate the work of religious organizations?
UNAIDS can broker partnerships with religious organizations and facilitate collaboration with governments and AIDS service organizations at all levels. UNAIDS can also give technical input to religious organizations as they create their action plans and strategies on HIV/AIDS.
Section VIII: Sexually Transmitted Infections
The prevention and treatment of STIs are key strategies in the fight against AIDS because the presence of STIs magnifies the risk of HIV transmission during unprotected sex tenfold. According to WHO estimates, over 300 million people are infected each year with an STI.
Most STIs can be cured relatively easily with antibiotic treatment, but people are often left untreated because of the lack of services, lack of drugs, limited access to diagnosis, and disparaging attitudes by health workers.
These problems are surmountable, and integrated STI and HIV services can go a long way in prevention and care. In addition, syndromic management (recognizing the 'syndrome' and prescribing treatment) can enable health workers without specialized skills or laboratories to provide effective treatment.
VIII/1 Is UNAIDS in favour of mass treatment for STIs such as syphilis, gonorrhoea and chancroid?
Mass treatment is not a strategy that is recommended for STI control in general, and recent studies suggest that intermittent mass treatment of the general population is not an effective means for the care and prevention of STIs. Nor does it have any impact on HIV transmission. However, evidence is accruing that shows that periodic presumptive treatment (treatment given on the evidence-based assumption that infection is present in the individual) of certain population groups, such as sex workers, reduces the prevalence of infection in this group as well as in their clients. This has been tried in settings where the sex workers and their clients are in a concentrated environment, for example a mining community. Operational research is ongoing to determine the ideal repeat frequency of the medication and how to tail off the treatment as the prevalence of infection diminishes within that community.
VIII/2 The Rakai Community Intervention study to determine whether reductions in STI prevalence and incidence would result in decreased HIV transmission seemed to have a negative outcome. What are the implications of these results compared with the Mwanza trial in Tanzania, which showed that controlling STIs was an effective approach to HIV prevention?
The Mwanza trial and the Rakai trial tested different STI interventions: continuous access to improved STI treatment services in Mwanza versus intermittent mass therapy administered every 10 months in Rakai. The trials used different STI measurement approaches and studied different populations in terms of HIV/STI epidemiology: HIV prevalence in Mwanza was 4% compared with 16% in Rakai. Another major difference was that the Mwanza trial focused on symptomatic STIs; while the Rakai trial focused on STIs in people with no symptoms (asymptomatic STI).
Given the differences in population characteristics, intervention design and measurement methodology, these landmark trials are not comparable. But they have highlighted the need to improve people-oriented services, rather than deliver mass treatment in the face of what is a complex epidemic. Based on available evidence, the treatment of symptomatic STIs (as in the Mwanza trial) remains a key strategy for HIV prevention. In areas with substantial STI rates, one of the basic HIV prevention strategies is to provide effective STI detection and treatment through existing primary health care services, as well as maternal and child health services.
VIII/3 Are STI care services useful even when patients present with an incurable infection?
Yes. Recent data point to the enormous potential for using STI care providers as an entry-point for AIDS and STI prevention, even when patients present with an incurable viral infection, such as genital herpes. All patients should receive prevention services (advice, condoms and referral for possibly-infected partners) that can help reduce their risk of acquiring and passing on HIV and having future episodes of STIs. Furthermore, as certain drugs for viral infections become available as generic products, it will be important to advise such patients on how to obtain these drugs and use them. One such drug is Aciclovir, whose role in herpes infections is particularly important in both controlling the disease and reducing HIV transmission and acquisition.
Section IX: Partner notification
Mandatory partner notification has not been shown to be an effective way to prevent the spread of STIs or HIV. UNAIDS encourages voluntary and ethical partner notification in which the HIV-positive person is strongly encouraged and supported to inform (or allow others to inform) his or her partners of exposure to infection.
In the rare cases where the person refuses, the health care worker should be authorized, but not required, to inform partners, based on whether there is a real, actual threat of infection and whether the HIV-positive person can be protected from discrimination and violence. Where there is strong support for the individuals involved, voluntary and ethical partner notification can be a way to prevent transmission, increase care and open up the epidemic.
IX/1 What is partner notification?
Partner notification or counselling involves the process of contacting sexual and/or injecting partners of the HIV-positive person (often called the "source" or "index" client or patient) in order to advise these partners that they may have been exposed to HIV and to encourage them to attend for HIV counselling, testing, and when applicable, treatment. The objectives of this kind of disclosure are to prevent the onward transmission of HIV and to improve care and support for people living with HIV/AIDS.
IX/2 What has been learned from partner notification for STIs?
Public health experience in the control of STIs has shown that partner notification is often conducted poorly, making it relatively ineffective in breaking the chain of transmission. This is especially the case when there is a delay in tracing the person's contacts, if the person has multiple sex partners, and if health services are inaccessible or unacceptable to clients. These lessons can be applied to HIV infection, which has a very long incubation period and is often associated with sex outside primary relationships.
IX/3 Does partner notification lead to behaviour change and risk reduction? Does it reduce the incidence of HIV?
There are no published studies to indicate that partner notification helps partners adopt safer sexual behaviour, or that it reduces incidence and prevalence of HIV. But it has been shown that partner notification has little effect on high-risk behaviour, unless it is accompanied by preventive services and intensive counselling.
IX/4 Should there be mandatory partner notification of HIV infection?
There have been calls for mandatory notification of HIV infection to sexual or drug-injecting partners. However, in the history of partner notification or counselling (for STIs and HIV), there are no clear data indicating that the mandatory counselling of partners is more effective in preventing transmission than voluntary counselling is. Mandatory notification has negative public health consequences because if people think they will be forced to notify their partners, or that their status will be revealed without their consent, they will stay away from STI testing, counselling or other prevention and care services. This has been true in the case of mandatory notification of syphilis and gonorrhoea—even though, unlike HIV, these are curable and have much less stigma and discrimination attached to them than HIV/AIDS.
Furthermore, it is not possible or practical to implement a large-scale scheme of mandatory partner notification. It is virtually impossible to force people to test mandatorily for HIV, to retest periodically, and to inform partners continually, as would be necessary. People do not always know or remember the name of their sexual partners. Nor is it possible to force them to reveal them. Finally, it is very costly to train and employ staff to trace and counsel all those whose names are given.
IX/5 Is there evidence that partner notification is more effective when voluntary rather mandatory?
There is some evidence that partner notification is more effective when carried out on a voluntary rather than mandatory basis. WHO and UNAIDS are currently involved in gathering more data on this matter.
IX/6 Isn't partner notification by the infected person a good way to protect uninfected partners?
On a voluntary basis, yes, it can be important—but not in isolation. Any sort of partner notification must be accompanied by counselling and medical support, and it must take place in a supportive environment. In many instances, particularly for women, the male partner is already infected—and indeed may have been the source of infection.
There are other ways of protecting uninfected partners than partner notification. These include the promotion of safer sex, including the use of condoms, reducing the number of partners, and abstinence. Many of these prevention interventions are tried and tested, and may be more cost-effective than partner notification.
IX/7 What can partner notification achieve in the context of HIV?
When an HIV-positive person has voluntarily agreed that his or her HIV status may be divulged to partner/s, such notification can help protect a partner who is still uninfected. It provides information that can help spur a person to take protective measures. Even when it is too late to break the chain of transmission, partner notification can help a partner who is already infected get early access to treatment and care. A programme involving voluntary partner notification can lead to 'opening up the epidemic' where it encourages people to get tested, share the results with partners and family, be protected from discrimination and stigma, and be supported to get treatment and care and live positively.
IX/8 Does UNAIDS recommend voluntary, confidential and ethical partner notification?
Yes, voluntary, confidential and ethical partner notification should be part of standard HIV/AIDS prevention and care, accompanied by psychosocial and medical care and support, including counselling. It should be provided in a supportive and confidential environment. HIV-positive people should be counselled about the importance of informing their partners and about their responsibility to protect the health of their partner or partners, as well as their own.
IX/9 What should be done when the HIV-positive person refuses to inform his/her partners?
Where the HIV-positive person refuses, after much counselling, to reveal his or her status to his/her partners, the health care worker should be authorized, but not required, to decide, on the basis of each individual case and ethical considerations, whether to inform the partners. Such a decision should only be made in accordance with carefully prescribed criteria—for example, has the HIV-positive person been thoroughly counselled, is there a real risk of transmission, and is follow-up essential to ensure support to those involved, if necessary. Because disclosure of HIV status to a partner could cause stigmatization, discrimination and violence against the person living with HIV (particularly women), legal, material and social protection from the adverse consequences of disclosure should be ensured.
Section X: UN peacekeepers
Recognizing that conflict and post-conflict areas are high-risk environments for the spread of HIV, UN Security Council Resolution 1308, July 2000, underscores the importance of HIV/AIDS awareness training and prevention initiatives for peacekeepers.
The UN has initiated a number of strategies to increase HIV/AIDS prevention and care interventions for UN peacekeepers, including technical assistance to peacekeeping operations, the promotion of training, civil and military cooperation, expanded medical services in the area of HIV/AIDS; and the development of an HIV/AIDS Awareness Card for Peacekeeping Operations. The UN recommends voluntary HIV counselling and testing as the most effective means of preventing the transmission of HIV, including among peacekeepers, host populations, and the spouses and partners of peacekeepers. This should be provided within a comprehensive package of integrated HIV prevention and care programmes.
X/1 What is the UN role in preventing HIV transmission among peacekeepers?
In January 2001, UNAIDS and the UN Department of Peacekeeping Operations (DPKO) signed a cooperation framework. UNAIDS provides technical and advisory support in the areas of training, code of conduct, VCCT, cooperation between peacekeepers, national militaries and civilian populations, in-mission care of affected personnel, information and education resources and best practices. UNAIDS has undertaken several joint missions to major peacekeeping operations, including UNAMSIL (Sierra Leone), UNMEE (Ethiopia and Eritrea), UNTAET (East Timor, now UNMISET), UNMIK (Kosovo) and UNMIBH (Bosnia and Herzegovina). These missions have resulted in the establishment of technical networks to address HIV/AIDS in the context of peacekeeping operations, notably through training, civil and military cooperation, and medical services.
As part of the global awareness strategy for uniformed services, UNAIDS and DPKO jointly developed an 'HIV/AIDS Awareness Card for Peacekeeping Operations'. This was officially introduced to the UN Security Council in June 2001. Such an HIV/AIDS awareness strategy is being used in MONUC, UNAMSIL, UNMEE and UNMISET and is being expanded to include all peacekeeping missions. The HIV/AIDS Awareness Card is currently available in the ten most common languages of troop contributing countries--Arabic, Bengali, English, French, Hindi, Kiswahili, Portuguese, Russian, Spanish and Urdu – and is being translated into Chinese.
DPKO has developed training modules on HIV and AIDS to form part of pre-deployment training for troop contributing countries. Further pre-deployment training is offered by DPKO on request. AIDS awareness is also included in induction upon arrival in the mission area. There are currently four mission HIV/AIDS policy advisers – in MONUC, UNAMSIL, UNMEE and UNMISET and a fifth is being recruited for UNMIL. Supported by UN Volunteers, they provide awareness training and collaborate with the medical services in setting up VCCT facilities; other peacekeeping missions have HIV/AIDS focal points. UNAIDS is funding the position of an HIV/AIDS policy adviser at DPKO headquarters to develop policy and coordinate and facilitate field initiatives.
DPKO has signed a memorandum of understanding with the UN Population Fund (UNFPA) to ensure a consistent and economical supply of reproductive health items to missions. Condoms are provided for peacekeepers and post-exposure prophylaxis kits are available for occupational exposure to HIV. DPKO ensures the safety of blood and blood products in field hospitals by using supplies from sources that meet WHO standards.
Using contributions raised by UNAIDS, DPKO has set up an HIV/AIDS Trust Fund. It will initially be used to strengthen voluntary confidential counselling and testing facilities in missions, to support collaborative local projects between peacekeepers and vulnerable groups, to collect baseline data through mission assessments and HIV/AIDS knowledge, attitude and practice surveys and to facilitate training for HIV/AIDS policy advisers and focal points.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) and representatives from the United Nations Department of Peacekeeping Operations (DPKO) have gone to Haiti to develop an HIV/AIDS programme for the newly established peacekeeping mission before the arrival of the main contingent of troops. This joint mission to Haiti was carried out under the auspices of the Cooperation Framework signed by UNAIDS and DPKO in 2001, who have agreed to work together to respond to the growing HIV/AIDS epidemic and to mitigate its impact on international peace and security. While all major peacekeeping missions have a HIV/AIDS policy advisor or focal point, this unprecedented joint effort to establish HIV/AIDS programmes at mission level from the outset of the mission will be repeated for all new UN peacekeeping missions.
X/2 What is the UN position on having peacekeepers tested for HIV?
In view of the complexity of issues relating to HIV testing in UN peacekeeping operations and in response to concerns expressed by Members of the UN Security Council, the UNAIDS Secretariat, in close consultation with DPKO, initiated a comprehensive review of United Nations policy in this area. In November 2001, UNAIDS convened an Expert Panel on HIV Testing in UN Peacekeeping Operations in Bangkok, Thailand. The panel unanimously recommended voluntary counselling and testing as the most effective means of preventing the transmission of HIV, including among peacekeepers, host populations, and the spouses and partners of peacekeepers. The panel stressed that VCT should be provided to peacekeeping personnel within a comprehensive package of integrated HIV prevention and care programmes. The panel also noted that VCT has been shown to be more effective than mandatory HIV testing in promoting safe sexual behaviour and reducing other risks involved in HIV transmission. The report from this panel was finalized and presented to the UNAIDS Executive Director in February 2002. Background papers commissioned for that meeting on testing, medical and legal issues in the context of peacekeeping can be found on the UNAIDS website. In accordance with current medical and human rights guidelines, the UN does not require that troops at any time be tested for HIV in relation to deployment as peacekeepers. In line with Resolution 1308 and the findings of the UNAIDS panel, DPKO encourages a policy of voluntary confidential counselling and testing for peacekeepers.
Section XI: Mother-to-Child Transmission
The internationally agreed approach to preventing MTCT includes: (1) primary prevention of HIV among prospective parents; (2) prevention of unwanted pregnancies among HIV-positive women; (3) prevention of transmission of HIV from mother to child; and (4) the care and treatment of HIV-positive mothers in the context of mother-to-child transmission.
Reduction in prices of antiretrovirals (ARVs), simpler regimens, donations of ARVs, and increased commitment and funding for the prevention of MTCT are resulting in significant expansion of these services.
As to infant feeding, an HIV-positive woman should be counselled on infant feeding and be allowed to choose the option most feasible and safe in her circumstances. If it is not feasible or safe to feed with formula, HIV-positive women should be counselled to practise exclusive breastfeeding for the first few months of the infant's life and discontinue this when an alternative form of feeding becomes feasible.
XI/1 What can be done to prevent babies from acquiring HIV from their infected mothers?
A three-fold strategy is needed in order to prevent MTCT:
• Protecting women and girls of child-bearing age and those lactating against HIV infection
• Avoiding unwanted pregnancies among HIV-positive women
• Preventing the transmission of HIV from an HIV-positive mother to her infant during pregnancy, labour, delivery, and breastfeeding by providing VCT, ARV therapy, safe delivery practices, and breast milk substitutes.
XI/2 What are the antiretroviral drugs used to prevent mother-to-child transmission and how do they work?
A number of regimens, long-term and short-term, involving zidovudine alone, zidovudine and lavumidine, and nevirapine, help to prevent MTCT by decreasing viral load in the mother and through prophylaxis of the infant during and after exposure to the virus.
XI/3 Do antiretroviral drugs also prevent MTCT during breastfeeding?
Not totally. Studies conducted in breastfeeding populations have shown that the protective efficacy of the various drug regimens is diminished when babies continue to be exposed to HIV through breastfeeding. In one such study (the PETRA study), the reduction in transmission seen at 6 weeks was no longer significant at 18 months of age. This underlines the substantial risk of HIV transmission during breastfeeding which can greatly erode the short-term benefit of drugs to prevent MTCT of HIV, and the urgent need for research to improve the safety of breastfeeding for infants born to HIV-positive women. Potential strategies include modifications to the pattern and duration of breastfeeding, ARV treatment for breastfeeding mothers, prevention treatment for the baby continued through the period of breastfeeding, or a combination of these.
XI/4 What effect do short-course regimens of antiretrovirals have on the mother and infant?
The safety of preventive treatments, including zidovudine alone, zidovudine and lamivudine, and nevirapine, has been studied extensively for both breastfeeding and non-breastfeeding populations worldwide. Information currently available does not suggest any adverse effects on the health of the mother, growth and development of infants, or the health and mortality of infants infected despite prophylaxis. The only possible risk for the mother is anaemia. However, pregnant women taking ARVs for HIV will be doing so under the supervision of the maternal health services, where screening for anaemia (and treatment, if necessary) should be routine procedures.
While resistant virus may develop quickly to antiretroviral drug regimens that do not fully suppress viral replication (such as those including lamivudine and nevirapine), evidence indicates that virus containing drug-resistant mutations decreases once the antiretroviral drugs are discontinued. Mutant virus may remain present in an individual in very low levels, which could reduce the effectiveness of future antiretroviral treatment for the mother.
XI/5 Are ARV drugs enough for successful prevention of MTCT?
No. The prevention of MTCT involves more than the provision of antiretroviral drugs. Voluntary counselling and testing are an essential part of any prevention of MTCT strategy, because VCT provides: (1) prevention information and support in order to avoid infection for childbearing women not infected; and (2) the knowledge of one's status, and referral so that positive women can access prevention of MTCT interventions. During prevention of MTCT regimens, there is further need for appropriate counselling and testing services, as well as support for mothers and infants in the taking of ARVs and on infant feeding options. Moreover, providing care and treatment for the HIV-positive mothers is not only ethically required, but also provides an incentive to access HIV prevention, care and VCT for themselves, their partners and families.
XI/6 How feasible is it to provide ARV drugs for MTCT in low-income countries?
The feasibility of providing ARVs to prevent MTCT has been increasing since 1994 when a long-course regimen using zidovudine was shown to reduce MTCT by about two-thirds in the absence of breastfeeding. At an average cost of US$ 1000 per pregnancy, this regimen was too expensive for use in poor countries. In early 1998, studies in Thailand showed that a relatively simple drug regimen, a short one-month course of zidovudine (AZT) given to HIV-infected mothers late in pregnancy, could halve the rate of HIV transmission to their infants as long as the women also avoided breastfeeding. In Côte d'Ivoire and Burkina Faso, it was shown that, even if the women breastfed their infants, the rate of MTCT was still cut by a third. Most significantly, a 1999 study in Uganda showed that one dose of nevirapine to the mother at the onset of labour followed by another dose given to the infant after delivery was highly effective in reducing MTCT. Further studies have shown the drug regimen to be safe as well. The regimen is easy to take because it comprises a total of two doses and costs about US$ 4. Other short-course regimens involving zidovudine, and a combination of zidovudine and another drug called lamivudine (the PETRA study), have also been shown to be effective.
XI/7 What does the UN Interagency Task Team on MTCT do?
A UN Interagency Task Team involving UNICEF, UNFPA, WHO, the World Bank and the UNAIDS Secretariat has been working with governments of several developing countries to set up MTCT programmes. It provides technical guidance and support to countries for implementation and scaling-up of MTCT programmes. It also reviews drug regimens for safety and provides guidance and support regarding implementation of MTCT programmes.
As part of the Task Team, UNICEF is currently supporting 226 programme sites in 16 countries for the prevention of MTCT of HIV. These are in: Botswana, Burundi (1 site), Côte d'Ivoire (6 sites), Honduras (40 sites), Kenya (7 sites), Rwanda (8 sites), Tanzania (5 sites), Uganda (23 sites), Zambia (9 sites), Zimbabwe (4 sites), India (102 sites), Cambodia (2 sites), Myanmar (12 sites), Malawi (7 siteS), Belarus (national) and Ukraine (national). In the first eleven countries, previously called pilot countries, the short course regimen of zidovudine and/or nevirapine are used.
During the pilot phase in Botswana and Rwanda, from April 1999 to July 2001, over 300,000 new antenatal clinic clients were reached and 220,000 people were counselled. Of those who were counselled, 138,000 were tested, out of whom 11,400 HIV-positive mothers were identified. About 4500 of them received antiretroviral regimens to reduce MTCT. Plans are underway to expand support to Cameroon, Central African Republic, Mozambique, Namibia, Nigeria and Viet Nam. In most of these countries, nevirapine will be the first option. While some projects are still in their early stages, the experience gained shows that MTCT prevention programmes can be and should be scaled up to achieve national coverage.
XI/8 What is the MTCT-Plus Initiative?
Leaders of philanthropic foundations from around the world met in December 2001 with the UN Secretary-General and announced large-scale funding for a five-year demonstration project in Africa, Asia and Latin America. Dubbed 'MTCT-Plus', the initiative expands services for HIV-positive women, including basic care for prevention and/or treatment of opportunistic infections and, when indicated, treatment with antiretrovirals. Eventually, MTCT-Plus aims to include HIV-positive family members of participating mothers and children. The initiative also includes information campaigns aimed at raising international awareness, the purchasing and distribution of drugs to prevent MTCT, advocacy for the elimination of laws and regulations that delay access to drugs, and education and training programmes. MTCT-Plus will start as an extension of existing MTCT prevention programmes and will initially be concentrated in sub-Saharan Africa.
XI/9 What is recommended regarding breastfeeding by HIV-positive mothers?
Up to 20% of infants born to HIV-positive mothers may acquire HIV through breastfeeding. But the use of infant formula is problematic. First, it poses risks because it means the baby is not receiving the special vitamins, nutrients and protective agents found in breast milk. Secondly the use of infant formula may not be feasible or safe. The cost of infant formula often puts it beyond the reach of poor families in developing countries, even when the products are widely available. Many women also lack access to the knowledge, potable water and fuel needed to prepare replacement feeds safely, or simply have no time to prepare them. If used incorrectly - mixed with unsafe water, for example, or over-diluted - a breast milk substitute can cause infections, malnutrition and even death. Furthermore, if a mother chooses not to breastfeed in settings where breastfeeding is the norm, this may draw attention to her HIV status and invite discrimination, violence or abandonment by her family and community. A further factor to be considered is that a mother who does not breastfeed loses the natural contraceptive effect of the practice and is at increased risk of becoming pregnant soon after having given birth.
Given these dilemmas, recent consultations held by the UN Interagency Task Team concluded that an HIV-positive mother should be counselled on the risks and benefits of different infant feeding options and should be guided in selecting the most suitable option for her situation. The ideal option is the one that is most acceptable, feasible, affordable, sustainable and safe in her particular context. If one of these conditions is not met with regard to formula feeding, the woman should be counselled to practise exclusive breastfeeding for the first few months. The final decision should be the woman's, and she should be supported in her choice.
For HIV-positive women who choose to breastfeed, exclusive breastfeeding (as opposed to "mixed feeding"-breastfeeding mixed with bottle feeding of water or formula, or providing other foods) is recommended for the first months of an infant's life, and should be discontinued once an alternative form of feeding becomes feasible. This is because mixed feeding may increase the risk of HIV infection. Indirect evidence suggests that keeping the period of transition from exclusive breastfeeding to alternative feeding as short as possible may reduce that risk. Unfortunately, the best duration for this is not yet known and may vary according to the infant's age and/or the environment.
XI/10 Is infant formula being provided as part of the UN Interagency Task Team programme? If so, is it free?
Only programmes that can afford to do so are providing free infant formula to women who choose to use it and who have been offered counselling about feeding options. In the early years of the programme, UNICEF was able to provide infant formula from a generic manufacturer. UNICEF has since discontinued this practice because of the many logistical problems in sustaining the supply and maintaining safe and effective use of the formula. UNICEF continues to support programmes in the areas of infant feeding counselling and ensuring that sustainable mechanisms are put in place to enable countries that provide formula in their programmes to do so without breaking the International Code of Marketing Breastmilk Substitutes.
XI/11 What is UNAIDS' position on the donation of infant formula from companies other than generics?
In principle, UNAIDS welcomes the involvement of all sectors in the expanded response to the epidemic, including manufacturers of infant formula. However, it is important that donations do not carry any restrictions or break the International Code of Marketing Breastmilk Substitutes - whether in relation to marketing in developing countries or to altering policies which emphasize the importance of breastfeeding for infants not infected with HIV.
Section XII: Human rights
Respect for human rights is vital to prevent the further spread of the epidemic; to provide better care, treatment and support for those infected; to alleviate the impact of HIV/AIDS; and to expand the response.
Human rights, ethics, and law and their promotion in the context of HIV/AIDS are cross-cutting themes in all UNAIDS activities and work plans. UNAIDS and the Office of the High Commissioner of Human Rights can provide technical assistance in the HIV-related areas of standard-setting, the UN human rights mechanisms, human rights and ethical best practice, legislation, training, litigation, research and support to governments. The UN Ethical Review Committee can advise on ethical issues in research involving human subjects.
XII/1 Why are human rights important in relation to AIDS?
There are at least three ways in which the promotion and protection of human rights are important in relation to HIV/AIDS. First, discrimination against people living with or thought to be living with HIV violates human rights. No one should be discriminated against on the basis of their health status, including HIV/AIDS. Protection of the rights of people living with HIV/AIDS, including the rights to health, care, treatment, employment and social services enable them to live longer and to support themselves and their families. Secondly, promoting and protecting human rights helps to remedy the underlying social and economic conditions - such as poverty or gender inequality - that make people vulnerable to HIV infection, or that compromise the quality of life of those who are already infected or affected. Thirdly, the promotion and protection of human rights can create a more supportive environment for AIDS prevention and care. The rights to education and information (including about HIV transmission) are crucial for effective prevention. Freedom from discrimination also makes people with HIV less fearful of disclosing their status to sex partners, providing opportunities to discuss safe sex and prevent onward transmission of the virus.
XII/2 What is the relationship between HIV/AIDS-related stigma, discrimination and human rights?
HIV/AIDS-related stigma derives from HIV/AIDS' association with sex, blood, disease and death and with behaviours that may be illegal or forbidden by religious or traditional teachings, such as pre- and extra-marital sex, sex work, men having sex with men, and injecting drug use. Such stigma builds upon and reinforces existing prejudices and social inequalities-especially those of gender, sexuality and race.
The right to non-discrimination is a fundamental human right and is also the basis for effective realization of all other rights. HIV-related discrimination is action that results from stigma. It occurs when a distinction is made against a person that results in their being treated unfairly and unjustly on the basis of their actual or presumed HIV status or their belonging, or being perceived to belong, to a particular group. HIV/AIDS-related stigmatization, discrimination and human rights abuses can originate from governments, private organizations and institutions and from communities, families and individuals.
XII/3 A number of countries have introduced restrictive laws to try to stop the spread of HIV. Is this a growing trend?
It is difficult to tell whether restrictive legislation is on the increase, as little comparative study has been undertaken. However, it is clear that many countries have realized the importance of a supportive and positive legal framework as a prerequisite for effective prevention, care and support programmes. Unfortunately, there are still countries where restrictive and discriminatory laws are being considered and sometimes introduced.
XII/4 What activities is UNAIDS undertaking in the area of human rights?
Human rights is a cross-cutting theme in all UNAIDS activities and work plan. UNAIDS human rights activities have been in the areas of standard setting, enhancing integration of HIV issues within the human rights machinery, providing technical support to governments and NGOs, conducting training, conducting research, and production of best practice material.
XII/5 What are some of the key sources that explain the relationship between human rights and HIV?
The Office of the High Commissioner for Human Rights and the UNAIDS Secretariat jointly published and launched the International Guidelines on HIV/AIDS and Human Rights which provide an overview of the critical rights, as well as concrete steps to take in the area of HIV and human rights. They are available in six UN languages. To guide parliamentarians on legislative matters, the UNAIDS Secretariat collaborated with the Inter-Parliamentary Union to publish and launch the Handbook for Legislators on HIV/AIDS and Human Rights.
XII/6 Are there many other useful publications on HIV and human rights?
Yes, see:
• A collection of twenty human rights case studies, titled Human Rights and HIV/AIDS: Effective Community Responses
• A Literature Review and Annotated Bibliography on Legal and Ethical Issues Raised by HIV/AIDS
• A Human Rights Approach to Employment: the Southern African Development Community's Code on HIV/AIDS and Employment
• HIV/AIDS and Human Rights: Young People in Action (UNESCO and UNAIDS)
• UNAIDS Compendium on Discrimination, Stigmatisation and Denial: Research studies from India and Uganda and Comparative analysis of the two studies
• Networks for Development: Lessons Learned from Supporting National and Regional Networks on Legal, Ethical and Human Rights Dimensions of HIV/AIDS (UNDP and UNAIDS).
XII/7 Are the UN human rights bodies involved in HIV/AIDS?
The UNAIDS Secretariat serves the UN human rights committees that monitor human rights violations and advocates for the integration of HIV-related human rights on subjects such as children, women and non-discrimination. The UNAIDS Secretariat published the Guide to the UN human rights machinery for AIDS service organizations, people living with HIV/AIDS and others working in the area of HIV/AIDS and human rights. It also supports the drafting of HIV-related resolutions adopted by the UN Commission on Human Rights.
XII/8 What about the right to health (health care, treatment, drugs)?
In April 2001, the UN Commission on Human Rights adopted Resolution 2001/33 on "Access to medication in the context of pandemics such as HIV/AIDS". It recognizes that access to medication is a fundamental element in achieving the full realization of the right of everyone to physical and mental health. The resolution calls upon States to pursue policies that promote the availability, accessibility, scientific appropriateness and quality of pharmaceuticals or medical technologies used to treat epidemics such as HIV/AIDS.
The Committee on Economic, Social and Cultural Rights has adopted General Recommendation 14 on the right to the highest attainable standard of health. The General Comment contains important guidance on the normative content of the right to health, including in the context of HIV/AIDS.
The Committee on Elimination of All Forms of Discrimination Against Women has adopted its General Recommendation 24 on women and health which highlights the centrality of issues of HIV/AIDS to the rights of women and adolescent girls to sexual health especially those belonging to vulnerable and disadvantaged groups, such as migrant women, refugee and internally displaced women, girls and older women, women in sex work, indigenous women and women with physical or mental disabilities. It draws attention to the lack of adequate access to information and services necessary to ensure sexual health, the impact of harmful traditional practices on the risk of HIV/AIDS infection for girls and women, and other factors that compound women and girls' vulnerability to HIV/AIDS.
XII/9 Does UNAIDS support regional human rights activities?
The UNAIDS Secretariat, in collaboration with various partners, is conducting human rights and HIV/AIDS activities in all regions. For example, it has supported activities concerning: the International Council of AIDS Service Organizations and its regional arms; parliamentarians in South Africa and the UK (see The All Party Parliamentary Group on HIV/AIDS: The UK, HIV and Human Rights); help in preparation of draft legislation, e.g. the AIDS Prevention and Control Act 1998 of the Philippines; and help in preparation of court cases involving human rights and HIV/AIDS, such as the India case on the right to marry and the South African case on unlawful dismissal based on HIV status.
XII/10 Does UNAIDS provide human rights training on the relationship between human rights and HIV/AIDS?
Yes, it has provided such training to AIDS-service NGOs, human rights NGOs, political leaders, national AIDS programme managers, people living with HIV/AIDS and staff of UN agencies. Training has taken place in Bangladesh, Canada, Ghana, India, Namibia, Russian Federation, South Africa and Switzerland.
XII/11 What about monitoring HIV-related human rights violations?
The UNAIDS Secretariat supports strengthened monitoring of HIV/AIDS-related human rights violations at community and national levels, as well as reporting violations and redressing them, in collaboration with national human rights commissions.
XII/12 Can UNAIDS help individuals whose rights have been violated?
UNAIDS cannot directly handle individual cases. UNAIDS refers such cases to more appropriate organizations, such as the courts or national human rights commissions. UNAIDS also promotes and supports networks of legal, ethical and human rights experts at the country level, who can help individuals whose rights have been violated.
XII/13 What is the UNAIDS Ethical Review Committee?
IN 1996, UNAIDS established the UNAIDS Ethical Review Committee. The Committee provides ethical assessments of research projects and proposals being considered by UNAIDS for financial and/or technical support, where the research involves human subjects. It also develops or reviews UNAIDS ethical guidelines for specific research issues, and participates in activities to build the capacity of regional, national and local institutions to undertake ethical review of research to be carried out at those levels. It has a balanced membership in terms of geographic regions, gender, HIV status and areas of expertise, including community experience.
XII/14 What else is being done to improve the quality of life of people living with HIV/AIDS?
UNAIDS is:
• Advocating for better and fairer employment policies and the implementation of those policies, starting within the UN system
• Collaborating with AIDS support organizations in their work to improve the quality of life of people with HIV or AIDS
• Increasing the availability of adequate information about HIV and AIDS
• Broadening the emphasis from clinical care to concern for psychosocial and economic well-being, acceptance and human rights in the community, and openness to confront the of silence surrounding HIV and AIDS
• Advocating for the social acceptance of people living with HIV, protection of human rights and openness to break the conspiracy of silence.
Section XIII: HIV Testing
XIII/1 What are the benefits of HIV Testing?
Knowledge of HIV status is the gateway to AIDS treatment and has documented prevention benefits; however, the current reach of HIV testing services is poor and uptake is often low, largely because of fear of stigma and discrimination. The cornerstones of HIV testing scale up include strengthened protection from stigma and discrimination as well as assured access to integrated prevention, treatment and care services. Public health strategies to increase knowledge of HIV status and human rights protection are mutually reinforcing and should be integrated for greatest effect in reducing HIV transmission and improving the quality of life of people living with HIV.
XIII/2 What is UNAIDS’ position on HIV Testing?
UNAIDS promotes expanded access to both client-initiated and provider-initiated voluntary, confidential HIV testing, conducted with informed consent and accompanied by counselling for both HIV-positive and HIV-negative individuals. With respect to provider-initiated testing, in all settings, individuals retain the right to refuse testing, i.e. to ‘opt out’ of a routine offer of testing. All testing needs to be accompanied by referral to medical and psychosocial services for those who receive a positive test result, and by community education and legal and policy reform to counter stigma and discrimination.
Section XIV: Care, treatment and support
Vastly increased access to comprehensive HIV care and support, including ARVs and treatment for HIV-related opportunistic infections, is a global priority. More affordable medicines will catalyze strengthened health care delivery systems. Better health care delivery systems will provide greater capacity to deliver affordable medical technology.
UNAIDS and its Cosponsors are working closely with governments, civil society, people living with HIV and the pharmaceutical industry, to expand dramatically the provision of HIV-related treatment in resource-poor settings. WHO and UNAIDS have set a target of placing three million people on HIV treatment by the end of 2005. WHO has declared that lack of HIV treatment in developing countries is a global public health emergency.
XIV/1 What is the current status of HIV therapy?
The use of ARVs in combinations of three or more drugs has dramatically reduced AIDS-related morbidity and mortality since 1996 in countries where they are widely accessible. While not a cure for AIDS, combination ARV therapy has enabled HIV-positive people to live longer, healthier, more productive lives by reducing viremia (the amount of HIV in the blood) and increasing the number of CD4+ cells (white blood cells that are central to the effective functioning of the immune system).
ARV treatment regimens must be adhered to closely. Dosing requirements, number of pills per dose, and dietary restrictions are some of the factors that may inhibit an individual's ability to take these medications regularly and as prescribed. Failure to maintain adherence can result in treatment failure and the emergence of drug-resistant HIV. Short-term toxicities, such as nausea, diarrhoea, central nervous system side effects and rash, must be closely monitored during the early stages of treatment. Long-term complications, such as body shape changes, elevations in blood lipids, peripheral neuropathy, diabetes, and kidney and liver function abnormalities may also occur.
Until recently, the high cost of the medicines, inadequate health care infrastructure and lack of financing has prevented wide use of combination ARV treatment in low- and middle-income countries. However, increased political and economic commitment in recent years, stimulated by people living with HIV, civil society and other partners, has opened the scope for dramatic expansion of access to HIV therapy.
Twelve ARV medicines have been included in the WHO Essential Medicines List following careful analysis of current evidence of ARV efficacy in developing countries which shows that these medicines can be used effectively and safely in poor settings. The long-sought inclusion of ARVs in WHO's Essential Medicines List will encourage governments in hard-hit countries to further expand the distribution of these vital drugs to those who need them.
XIV/2 How many people are estimated to be currently in need of antiretroviral (ARV) treatment? How is this figure calculated?
Approximately 38 million people are currently living with HIV throughout the world, of whom about 36.2 million, live in low- and middle-income countries. WHO estimates that some 6 million of these people are in need of ARV therapy now, based on the assumed number of people who have clinical symptoms of AIDS and/or a CD4+ cell count below 200 cells/mm3.
XIV/3 How many people were receiving ARV therapy at the end of 2003?
As of end 2003 only an estimated 400 000 people in the developing world had access to HIV-related medicines, just slightly up from the 300 000 who had such access at the end of 2002. (About one-third of these people live in one country, Brazil). This figure represents only about 7% of those in need in developing countries, while there is near universal access in the high-income countries. In the latter, it is estimated that some 500 000 people are receiving ARV therapy. Coverage in sub-Saharan Africa, where the burden is greatest, remains unacceptably low, at only 3%, while over 4 million people are in need.
XIV/4 What are the barriers to increased access to HIV-related treatments in low- and middle-income countries?
The primary barriers to increased access to ARV therapy and treatments for HIV-related opportunistic infections are high costs, lack of sufficient financing, weak health infrastructures, lack of diagnostics and monitoring equipment, and insufficient numbers and inappropriate distribution of trained health care providers.
XIV/5 What are the current targets for increasing access to ARV treatment in low- and middle-income countries?
UNAIDS and WHO launched the “3 by 5 Initiative” in 2003 to ensure that three million people in low-and middle-income countries are receiving ARV treatment by 2005. This would represent a thirteen-fold increase in the number of people now on therapy in low- and middle-income countries. This target is based on a consideration of the number of HIV-infected people worldwide that urgently need access to antiretroviral therapy (6 million) and the global coverage of functioning health systems (50%). The 3 by 5 initiative is an interim target, part of a global movement to scale up treatment access.
The target proposes that everyone with an urgent indication for antiretroviral treatment who has access to a functioning health service be offered such therapy. Reaching the target will require continued mobilization of sufficient political will, technical assistance, and financial resources. However, it should be possible to reach the target given: (1) the financial resources available through the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Bank; (2) the trend of declining prices of ARVs in developing countries; (3) the simplification of ARV therapy proposed by WHO; and (4) modest strengthening of health services in developing countries.
XIV /6 What are UNAIDS and others doing to increase access to HIV-related treatments in low- and middle-income countries?
The WHO, with support from UNAIDS, has declared lack of HIV treatment in developing countries to be a global public health emergency. WHO is the lead UNAIDS Cosponsoring agency for care and treatment. Since July 2003, WHO has embarked on an emergency response to support vastly expanded treatment access, including significant reallocation of additional staff and finances. The UNAIDS Secretariat is intensively involved in supporting the 3 by 5 Initiative, including by ensuring extensive support at the country level.
Since the XIV International AIDS Conference in 2001, treatment scale up efforts have increased dramatically:
• Global Fund to Fight AIDS, TB and Malaria has disbursed US$232 million dollars, 60% of it for AIDS programmes.
• World Bank’s MAP (Multi-country AIDS Programme) has provided US$1 billion for Africa and US$155 million for the Caribbean in the form of grants and loans to scale up both HIV treatment and prevention, and strengthen health infrastructure.
• The US President’s Emergency Plan for AIDS Relief (PEPFAR), aims to put 2 million people on ARVs by 2008. To date, US$2.4 billion of the US$15 billion emergency package have been allocated to 14 target countries.
• Several countries in the Caribbean and Latin America now offer universal coverage for antiretroviral treatment, including Argentina, Barbados, Brazil, Chile, Cuba, Mexico and Uruguay. Other countries that have made substantial progress in closing the treatment gap are Botswana, Senegal and Thailand.
• Many African countries intend to set up their own production facilities to manufacture AIDS drugs sometime during 2004 and 2005, including Ethiopia, Kenya, Mozambique, Nigeria, Tanzania, Uganda, Zambia and South Africa.
XIV/7 What is the Accelerating Access to Care, Support and Treatment Initiative?
The Accelerating Access Initiative is a public-private initiative established in 2000 by the UN (UNICEF, UNFPA, WHO, the World Bank and the UNAIDS Secretariat) and five major pharmaceutical companies with products, research and development portfolios in HIV/AIDS (Boehringer Ingelheim GmbH, Bristol-Myers Squibb, GlaxoSmithKline, Merck and Co., Inc. and F. Hoffmann-La-Roche Ltd.) to increase access to HIV-related treatment, care and support in resource-poor settings. (Abbott Laboratories Ltd has also subsequently joined). Accelerating Access has proceeded along two major tracks: the negotiation of price reductions on HIV-related drugs for low- and middle-income countries, and technical collaboration with countries to expand their capacity to deliver care, treatment and support.
Dramatic price reductions were achieved for ARV treatments in 2001. At the beginning of 2000, the average price of a three-drug ARV regimen was approximately US$ 10,000 per person per year. By December 2000, prices of between US$ 500 to US$ 800 were being negotiated by low- and middle-income countries for therapies based on patented and generic drugs. By 2003, certain brand name combinations were available in least developed countries for under US$ 675 per patient per year and certain generic combinations were being offered for under US$ 300 per person per year. In a separate development, The William J. Clinton Foundation announced that it had negotiated a price as low as US$ 140 per year with a few generic producers, under certain conditions, for countries in which the Foundation is working.
XIV/8 Are the UNAIDS secretariat and Cosponsors working with generic companies?
Yes, they are. WHO and the UNAIDS Secretariat promote the engagement of both generic and research-based pharmaceutical companies in the response to AIDS. WHO and UNAIDS co-hosted meetings in 2002 and 2003 with chief and senior executives of key generic manufacturers of HIV-related medicines to engage the generic pharmaceutical industry more intensively in the response to the epidemic. A number of generic companies, in addition to research and development-based pharmaceuticals, have submitted applications and have been reviewed by the quality assessment project (known as "pre-qualification") undertaken by WHO, with support from UNICEF and the UNAIDS Secretariat. Products from both branded and generic manufacturers have met the international standards used by WHO in its "prequalification" exercise (the results of the quality assessments are available at:
Generic drugs, diagnostics and other commodities have also been included in the published mapping of sources and prices of HIV-related medications undertaken by WHO, UNICEF, Médecins Sans Frontières and the UNAIDS Secretariat. Representatives of the generic pharmaceutical industry, along with research-based companies, have participated in the Contact Group on Accelerating Access to HIV/AIDS-related care.
XIV/9 What is UNAIDS's position regarding the exporting of generic drugs (including ARVs)?
UNAIDS supports the engagement of a broad range of partners in the response to the AIDS epidemic. Large volumes of antiretroviral medicines will be required to scale up access to treatment, and both research-based and generic manufacturers must be engaged. For this reason, UNAIDS welcomes the legislative reforms taking place in Canada to allow that country’s generic suppliers to export HIV medicines to developing countries that do not have their own manufacturing capacity. UNAIDS also supports generic competition as one way of reducing the cost of HIV-related medicines and of increasing access to HIV care and treatment.
The Declaration of Commitment unanimously endorsed by Member States at the UN General Assembly Special Session on HIV/AIDS emphasizes the importance of cooperation in strengthening pharmaceutical policies and practices, including those applicable to generic drugs. The WHO Medicines Strategy includes promotion of generic competition.
XIV/10 Does UNAIDS support FDC’s (Fixed Drug Combinations)?
Yes. Triple combination antiretroviral therapy has long been the standard for treating HIV infection. The pharmaceutical industry is contributing to simplifying treatment regimens through developing and manufacturing fixed-dose combination formulations. Fixed-dose combinations permit all three individual molecules to be taken in one tablet, capsule or, in the future, a solution which is of special importance to children.
Three fixed-dose combinations, one each from Indian generics producers Cipla and Ranbaxy, and one from GlaxoSmithKline, have been approved by the WHO pre-qualification quality assessment programme. The generic fixed-dose combinations provide a WHO recommended, first-line regimen. Patents for individual components are often held by different originator companies, and the research-based industry is exploring multi-company arrangements to allow their products under patent to be combined or packaged together in blister packs. Fixed-dose combination antiretrovirals offer a number of possible advantages. They can:
• increase patient adherence to treatment;
• delay the development of resistance;
• lower the total cost, including production, storage, transport, dispensing and other health system costs;
• reduce the risk of medication errors by prescribers, dispensers and patients them-selves;
• simplify supply-system functioning and increase security; and
• facilitate patient counselling and education, and reduce waiting time for patients.
XIV/11 Which countries have received cheap AIDS drugs as part of the Clinton Foundation Agreement with generic companies?
Countries that have received AIDS drugs as part of the Clinton Foundation Agreement with generic companies are: Mozambique, Rwanda, Bahamas, Haiti, Dominican Republic and the Eastern Caribbean States.
XIV/12 Which countries are now offering universal coverage for ARV treatment?
Many countries, including those with high HIV prevalence or with emerging epidemics in large populations, have already been mobilizing in response to the HIV treatment gap. Several countries in Latin America and the Caribbean now offer universal coverage for antiretroviral treatment, including Argentina, Barbados, Chile, Costa Rica, Cuba, Mexico and Uruguay. Bahamas and Guyana are advancing towards universal access. Brazil is engaged in a South-South cooperation programme with Bolivia and Paraguay to achieve universal access in those countries. Other countries that have made substantial progress include Botswana and Senegal. However, Brazil remains the only country with a large population to achieve universal access to AIDS treatment.
XIV/13 What is UNAIDS's position regarding the decisions of some pharmaceutical companies to relax certain drug patents in some regions of the world?
Decisions by some research-based pharmaceutical companies not to enforce their patent rights in some regions of the world should be commended as an example of the kind of flexibility that could foster greater access to affordable HIV medicines through imports and local production of less expensive medicines. Voluntary licensing is another traditional mechanism that can contribute to greater affordability of medicines of importance to people living with HIV.
XIV/I4 Why is it important to ensure the continuation of major research and development of HIV-related medicines?
Innovation of new and improved HIV-related treatments, diagnostics and monitoring technology is essential to the fight against AIDS. Currently available treatments are not a cure, and drug resistance is a threat to continued success with these treatments. Continuing development of simplified treatment regimens, as well as medicines with fewer instances of side effects, will improve patient adherence to the regimens and, in turn, reduce the development of drug resistance. In sub-Saharan Africa, many more countries say they intend to set up their own production facilities. These include Ethiopia, Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia. South Africa already launched its first antiretroviral drug in August 2003. All have plans to start manufacturing generics some-time during 2004–2005 (Dummett, 2003).
XIV/15 What is being done to facilitate technology transfer between low- and middle-income countries and to control the quality of drugs?
UNAIDS encourages 'South-to-South' cooperation to expand drug access. In October 2002, WHO and the UNAIDS Secretariat brought together generic manufacturers of HIV-related medicines based primarily in developing countries to exchange lessons and views on how they can contribute further to expanding access to these medicines in low-and middle-income countries. In April 2001, India and South Africa signed a declaration of intent to cooperate in a variety of health fields, including technology transfer and import of drugs. Thailand, with considerable experience in generics production, has signed a similar agreement with Ghana. Brazil also has supported technology transfers to other developing countries.
XIV/16 What is UNAIDS' position on intellectual property and compulsory licensing?
The UNAIDS Secretariat fully supports patent protection as an incentive for innovative research and development of new HIV/AIDS drugs and, hopefully, the discovery of HIV vaccines. In the absence of a cure and/or a vaccine, and in view of the serious risk of resistance to existing ARV therapies, innovation is crucial.
At the same time, intellectual property rights must be considered in the context of other social interests, such as the human right concerning health. Patents provide exclusive control over the protected product, which can impede affordability and access to medicines for people living with HIV in resource-limited countries or otherwise without the means to pay.
In 2001, UNAIDS called for a 'new deal' with industry to ensure that new forms of HIV treatment are made available on a far greater scale to HIV-positive people in low- and middle-income countries as to those in high-income countries. This requires multiple approaches, including differential pricing, regional procurement to secure price-reductions through large-volume purchases, licensing agreements between patent-holding companies and manufacturers in resource-limited countries, reinforcement of health safeguards in trade agreements (including compulsory licensing), and new private and public funding mechanisms to help pay for treatment in poor countries.
XIV/17 What is UNAIDS position regarding the debate on Thailand having to comply with free trade agreements with the US?
With some three million deaths annually from AIDS, most of which are in low and middle income countries and most of which could be prevented by antiretroviral treatment, countries need all the tools at their disposal to get life-saving HIV medicines to their people. Among the important tools that can help make medicines more affordable are the so-called public health “safeguards” and flexibilities in the international trade rules: the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Doha Declaration on Trips and Public Health, and 30 August 2003 paragraph 6 implementation agreement. Under these multilateral rules negotiated at the WTO, national authorities in Least Developed Countries, many of which are especially hard-hit by AIDS, do not have to issue any patents whatsoever for medicines until the year 2016. Developing countries may also avail themselves of flexibilities such as compulsory licensing of HIV medicines. Countries have only just begun to make use of these flexibilities, such as the compulsory licenses for certain HIV medicines announced in May 2004 by the Governments of Malaysia and Mozambique.
Although they vary in content, the bilateral and regional free trade agreements negotiated by the US with Central American countries (CAFTA), Chile and others contain some provisions that protect patent rights more strictly than necessary under the multilateral agreements negotiated at the WTO. Depending upon the particular agreement, these stricter-than-necessary provisions may include the use of public national drug regulatory agencies to enforce private patent rights (normally this is a judgment to be made by the judicial system), longer than necessary patent periods and the extension of patent periods for “new uses” of the product, limitations on compulsory licensing, and restrictions on pharmaceutical test data (“data exclusivity”). Free Trade Agreements that may contain such provisions reportedly may be negotiated with Thailand, as well as the Andean countries, the Southern African Customs Union and others.
UNAIDS advocates that the provisions that are in place in the multilateral WTO agreements can be used by national authorities to help expand access to affordable HIV medicines that can save the lives of people living with HIV and AIDS. While trade policies between countries fall within the sovereignty of the governments concerned, UNAIDS believes that public health interests must be primary in the application of trade policies and that governments should be aware of and recognize the importance of the flexibilities afforded to them under the multilateral trade rules. In view of the severity of the AIDS epidemic in so many developing countries, UNAIDS urges that governments preserve their rights under the multilateral WTO agreements and not trade away their flexibility to get affordable HIV medicines to those in need.
XIV/18 What is UNAIDS' position on international trade rules, compulsory licensing and access to HIV medicines?
International trade agreements and policies can affect access to goods and services that are crucial to HIV prevention, care and impact mitigation. These goods and services include condoms (male and female), HIV/AIDS drugs and other pharmaceutical products (such as HIV testing equipment, materials and services), and products and services to ensure the safety of blood transfusions. The most important international trade agreement concerning access to HIV-related medicines and products is the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). While setting out minimum norms (e.g., 20-year patent term) with which WTO members must comply, the TRIPS Agreement provides governments with flexibility (e.g., compulsory licensing) to protect the public health of their citizenry and improve access to affordable medicines. The WTO Ministerial Declaration on TRIPS and Public Health (the Doha Declaration of 2001) reaffirmed this flexibility.
XIV/19 Did the Doha meeting of the WTO clarify the public health implications of the TRIPS Agreement?
The interpretation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) with respect to public health and access to medicines was clarified at the WTO Ministerial Conference in Doha, Qatar in November 2001. All of the then 142 WTO Member States endorsed the Doha Declaration. UNAIDS welcomes and supports the WTO Doha Declaration. This declaration, while acknowledging the importance of intellectual property protection for the innovation of new medicines and technologies, stressed that, ‘The TRIPS agreement does not and should not prevent members (of the WTO) from taking measures to protect public health’, including access to medicine for all. It also provided a blanket extension of 10 years (from 2006 to 2016) for countries classified as ‘least-developed’ to comply with the patent requirements of TRIPS in the pharmaceutical sector. The Doha Declaration also states explicitly that ‘public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency’ for which governments can issue a compulsory license authorizing, under certain conditions, the manufacture and use of patented products without prior negotiation with the patent holder.
However, the Doha Declaration did not ensure that countries without sufficient pharmaceutical manufacturing capacity can make use of the compulsory licensing flexibility in the TRIPS Agreement in light of the current export limitation in TRIPS. The UN Secretary-General, as well as WHO and UNAIDS, had called for urgent resolution of the impact of the TRIPS exports limitation on the ability of poor countries that lack sufficient manufacturing capacity to benefit fully from the compulsory licensing flexibility in the TRIPS Agreement. UNAIDS supported a sustainable, simple and workable solution that allows poor countries without sufficient manufacturing capacity to source generic HIV medicines in exporting countries. In August 2003, just prior to the WTO Ministerial Conference in Cancun, WTO Member States agreed on a procedure that allows the granting of waivers of the TRIPS export limitation, so that medicines for HIV/AIDS and other public health problems could be exported under compulsory licenses to countries with insufficient manufacturing capacity.
XIV/20 Why does it make sense for countries to invest more in health care?
The impact of AIDS is devastating to the economies of low- and middle-income countries with high HIV prevalence. These countries, already suffering from heavy debt burdens, low productivity and weak infrastructures, are being further impoverished by the scourge of AIDS. There is strong evidence that investment in HIV-related treatment and care can reduce hospitalizations and other direct and indirect costs of HIV/AIDS. Brazil has completed a number of economic analyses demonstrating significant cost-savings and expenditures avoided since the introduction of universal coverage of HIV-related treatments, including ARV, in 1997. Other countries that are beginning to scale up HIV treatment are also documenting savings due to avoidance of hospitalizations and lower incidence of opportunistic infections. In addition to prolonging the lives of countless teachers, health workers, farmers, students, and other precious human capital in countries, it makes sense for countries to invest in health care in general, and HIV treatment in specific, because access to care and treatment is a human right.
XIV/21 What are some of the approaches countries are using to help fund access to care and treatment?
A number of different approaches are being used to help fund access to care and treatment in low- and middle-income countries. These include universal, free-of-charge access to treatment programmes through the public sector (the approach used by Brazil and a number of other Latin American countries), direct government subsidies to patients (the approach used by Chile, Côte d'Ivoire, Gabon, Mali, Romania, Senegal and Trinidad and Tobago), and out-of-pocket purchasing by patients after large-volume purchases at reduced prices by governments (the approach being used by Uganda). It is clear, however, that the vast majority of people living with HIV and in need of treatment will not be able to afford to cover the costs of their care. Countries that have maximised treatment access have done so through universal access. In the Brazilian model, for example, HIV treatment is free. HIV care will need to be provided at a price that is proportionate to local purchasing power – and for many people, in many communities, in many countries, that means HIV care and treatment must be free.
Section XV: Comprehensive care issues beyond ARV treatment
Drugs alone are not enough. ARV and medicines to treat opportunistic infections are an essential element of treatment, care and support for people living with HIV/AIDS, but they must be delivered within a continuum of care that includes peer support; home and community care; primary, secondary and tertiary health care; as well as income-generating programmes, protection of human rights and efforts to reduce the overall stigma of HIV/AIDS.
XV/1 What are the components of a comprehensive HIV care package?
Comprehensive care for people living with HIV/AIDS includes, but is not limited to, the following:
• Available, accessible voluntary counselling and testing services
• Antiretroviral therapy
• Prevention and treatment of tuberculosis and other infections
• Prevention and treatment of HIV-related illnesses, and palliative care
• Prevention and treatment of sexually transmitted infections
• Prevention of further HIV transmission, through existing technologies (e.g. male and female condoms, antiretrovirals for the prevention of mother-to-child transmission, clean needles and syringes) and investment in future technologies (e.g. vaccines and microbicides) as well as behaviour change
• Family planning
• Good nutrition
• Social, spiritual, psychological and peer support
• Respect for human rights
• Reduction of the stigma associated with HIV/AIDS
XV/2 Why is it essential to integrate HIV prevention programming and care, treatment and support?
The majority of people living with HIV in low- and middle-income countries are not aware of their HIV infection. Increased provision of treatment and care services will help motivate people to be tested. This, in turn, requires increased availability of voluntary counselling and testing services. VCT stands at the heart of prevention and treatment. Behavioural counselling and provision of condoms, clean needles and syringes must be made available to people, irresponsible of their HIV status. After testing positive, people living with HIV can be offered care, treatment and support services, including ARV if necessary. Counselling and other services aimed at prevention of secondary transmission, as well as the provision of ARV to prevent mother-to-child transmission, are an essential component of follow-up services for individuals who test positive. Effective prevention programming and treatment, care and support services therefore go hand-in-hand.
XV/3 What is UNAIDS' position on recently published suggestions that in hard-hit areas, HIV prevention should take priority over care?
Prevention is almost always cheaper than care irrespective of a country's development status, and particularly when therapeutic options are still dominated by first-generation drugs under patent. Prevention also has proven effective. This is why UNAIDS and its Cosponsors have always advocated for comprehensive prevention as a vital foundation for any national AIDS programme.
Prevention and treatment serve overlapping but not identical goals. No nation's health policy strictly enforces tradeoffs between prevention and care. Many millions are HIV infected and treatment is life-saving. This is reason enough to provide treatment without hesitation.
When highly active antiretroviral therapy (HAART) prices exceeded US$ 10,000 per patient-year and global resources for the epidemic remained paltry, treatment was flatly unaffordable. As prices fall and global funding increases, finances are rapidly ceasing to be the binding constraint. Low implementation capacity will soon be the limiting factor in many countries. There is no question that prevention efforts need to be scaled up dramatically. Cost estimates suggest that needs will increase over the years. Countries can expand prevention programmes quickly, but not instantaneously—the same applies to treatment and care programmes.
Prevention and care efforts should not be considered as separate "add-ons"; each reinforces the other. Further, prevention and treatment involve different sectors and constituencies. It is, therefore, possible and advisable to invest in both simultaneously to achieve more than would be accomplished by investing in either alone.
XV/4 What are some of the wider benefits of highly active antiretroviral therapy (HAART)?
HAART generates vast collateral benefits. The health system benefits directly and significantly. Each HIV-positive person who does not progress to AIDS is granted extra years of quality life (a priceless benefit) and saves the health system of even the poorest country several hundred dollars per patient-year in averted palliative and opportunistic infection care. It has been estimated that at an HIV prevalence of 5 percent, demand for medical care begins to increase faster than the public sector can meet it. This is already happening throughout Africa, where health sectors are overwhelmed by AIDS in their patients and their own staff. In the hardest-hit countries, it is therefore no exaggeration to say that providing HAART could not only save lives and the health system money, but save the health system itself. As an example, an analysis for Namibia, a country with one of the highest HIV rates in the world, has shown that the provision of HIV care including HAART for all in need, would increase per capita output above the per capita taxes required to fund such a programme.
The positive externalities of treatment on national development are also substantial. What makes AIDS uniquely destructive is that it targets adults in the prime of their lives as workers, parents, and caregivers. Treating HIV, therefore, saves children from orphan-hood, keeps households and businesses intact, maintains social cohesion, enhances the return on social investments in sectors such as education and rural development, boosts economic growth, enhances national security, and helps prevent the exacerbation of poverty which a mature epidemic is hypothesized to cause.
Prevention can help stave off such threats in the indeterminate future. But people, societies, economies, and nations are at risk today—and the risk stems primarily from the likely impact of millions of premature deaths within the next decade among those already infected. Only treatment can alter that trajectory. Moreover, those countries with the highest rates of infection are at disproportionately greater risk, which makes treatment there all the more important.
There is no arbitrary threshold value at which treatment can be valued. The decision to treat, cannot only be based upon narrow parameters of cost-effective analyses. Instead, decision-making must involve social, humanitarian, as well as impact and resource considerations; and evolve as factors – not least- prices and capacity change. Moreover, expanding treatment now may also help accelerate the reduction of costs, both by stimulating greater supply and competition, as well as by identifying less expensive ways of administering HAART in resource-limited settings.
The economic justification for HAART is not only its leverage effect on HIV prevention, but its potential to help secure the future against a host of disabling social and economic ills. This is not a matter of prioritizing lives today over lives tomorrow. The quality of future lives depends crucially on the quality of life today.
XV/5 How is TB linked to HIV care, treatment and support?
People infected both with TB and HIV face 30-50 times higher odds of developing active TB, due to HIV's gradual weakening of the immune system. In low- and middle-income countries, TB is the leading cause of death for people living with HIV/AIDS. The WHO estimates that more than 10 million people with HIV infection died of TB in the 1990s.
Treatment of HIV infection with ARV therapy has been demonstrated to reduce TB risk by 80-90% in both developing and industrialized countries. Wide access to ARV treatment is critical if morbidity and mortality from TB and other opportunistic diseases is to be reduced among people living with HIV.
Even with ARV treatment, TB preventive therapy is crucial. Progress towards controlling TB and HIV requires a dual strategy that targets both epidemics. Preventive and active TB therapy is equally effective in HIV-positive and HIV-negative people.
WHO's Pro-TEST Initiative aims to promote voluntary counselling and testing for HIV as a means of achieving a more coherent treatment, care and support strategy for HIV and TB in high-HIV-prevalence countries. UNAIDS is a partner in WHO's StopTB Initiative. The programme aims to expand and improve the detection and treatment of patients with active TB by means of DOTS (Directly Observed Treatment, Short-course). Another goal of the programme is to increase access to preventive TB therapy for people living with HIV/AIDS in settings with a high TB prevalence rate.
XV/6 Why is psychosocial support so essential to effective care, treatment and support?
Counselling, spiritual support, support for disclosing one's HIV-positive status and for engaging in safer sex and safer injecting drug use, end-of-life and bereavement support, peer support, and practical economic assistance are all part of psychosocial support for people living with HIV/AIDS. Psychosocial support helps to mitigate the devastating impact of AIDS on people's lives.
Psychosocial support is also essential to the success of ARV treatment. A number of studies have shown that psychological problems, such as depression, reduce people's ability to adhere to complex ARV regimens.
XV/7 Why is improved nutrition essential to effective care, treatment and support?
For much of the world's population living with HIV, the need for food remains an overwhelming priority. People living with HIV and AIDS need substantial nutritional inputs (up to 50% more protein) to fortify their compromised immune systems. Those suffering from hunger, famine and/or nutritional deficits are more likely to fall ill with opportunistic infections and less likely to be able to recover from them. Malnutrition is also one of the major clinical manifestations of HIV disease. Where drought conditions exist, access to clean water is reduced, further increasing the risk of infection for adults, children and infants, particularly those on formula feeding. Clean water supplies and adequate food must be part of an overall HIV treatment, care and support package.
XV/8 What is the role of traditional healers and pharmacists in HIV care, support and treatment?
Many people in resource-limited settings rely on traditional healers or pharmacists for their health care needs. Effective partnerships between formal health care systems and traditional healers and pharmacists have been shown to significantly improve HIV treatment, care and support. Collaboration with and education of traditional healers can also help dispel the many myths that prevail about the causes of HIV/AIDS, as well as counter spurious claims about "miracle AIDS cures".
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