SEA–AIDS–145 Distr..: General
Expanding Access to HIV/AIDS Treatment A Strategic Framework for Action at Country Level
WHO Project: ICP HIV 001
World Health Organization Regional Office for South-East Asia New Delhi 2004
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A Strategic Framework for Action at Country Level
Contents Foreword 1. Background 2. The “3 by 5” Initiative WHO Commitment to “3 by 5” 3. Scaling up Anteroviral Treatment in South-East Asia − A Strategic Framework for Action 3.1. Goal 3.2. Target 3.3 Three Guiding Principles 3.4. Five Strategic Elements 4. Scaling up Art in the South-East Asia Region 5. Progress Indicators 6. Conclusion 5 7 10 11
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An estimated 900 000 persons living with HIV/AIDS in the South-East Asia Region urgently require antiretroviral therapy. Only 64 000 are currently receiving it.
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Foreword With the development of life-saving antiretroviral drugs, persons living with HIV/AIDS can now live longer and more productively. In countries and societies that have easy access to antiretroviral therapy (ART), a dramatic shift in perceptions has already taken place. HIV/ AIDS has transferred its image from that of an inevitable, fatal condition to that of a manageable chronic illness. However, for the vast majority of people living with HIV/AIDS this has not happened. ART has remained largely inaccessible in resource-poor countries where HIV/AIDS continues to devastate families, communities and societies, especially the poor, the vulnerable and the socially marginalized. Estimates reveal that of the over six million people who currently need ART in developing countries, less than 8% have access to it. In the South-East Asia Region, approximately 900 000 are in immediate need of ART. However, only 64 000 (7%) patients were receiving it as of October 2004! In September 2003, WHO, UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria declared that lack of access to antiretroviral drugs is a global health emergency that must be tackled urgently. In response to this, WHO, UNAIDS and a wide range of partners launched the “3 by 5” Initiative, setting a global target of treating 3 million eligible people in developing countries with ART by the end of 2005. The time is now opportune for establishing a well designed regional strategy and plan that will scale up ART access to people who need it, without compromising on the basic prevention strategies. This document outlines a strategic framework within which the programme can be implemented in the South-East Asia Region. It
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underscores the important need to strengthen the capacities of health systems to identify individuals who need therapy, facilitate their entry into the ART programme, provide an uninterrupted supply of antiretroviral drugs and ensure treatment adherence. It also reiterates the need to collaborate with a number of partners from both the public and private sectors and especially with people living with HIV/AIDS who can play a critical role in advocacy, in reducing stigma and discrimination and in educating communities to come forward for HIV testing. Scaling up ART in the South-East Asia Region is a multidimensional challenge. It must be faced with commitment and determination to protect millions of lives that would be prematurely lost due to the epidemic in the years to come.
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Samlee Plianbangchang, M.D., Dr. P.H. Regional Director
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1. Background For over two decades, HIV/AIDS has continued to challenge public health all over the world. It is estimated that 37.8 million people are now living with HIV/AIDS. Of these, 95% are in developing countries. In 2003 alone, an estimated 4.8 million new infections occurred with nearly 2.9 million deaths. South-East Asia is the second most affected Region in the world after sub-Saharan Africa. By 2004, over six million people were living with HIV/AIDS in this Region. Against the backdrop of this bleak scenario, a new hope has emerged. Life-saving antiretroviral (ARV) drugs have dramatically reduced morbidity and mortality due to HIV/AIDS, adding many years of healthy life to the afflicted. There is still no cure for AIDS but ARVs successfully prevent HIV from replicating. This, in turn, reduces the amount of virus in the blood stream, which delays immune deterioration and thus prolongs and improves the quality of life. In countries where these drugs have been used, the results have been spectacular. Antiretroviral therapy (ART) has led to a 70% decline in deaths due to HIV/AIDS. HIV-infected individuals are now not only living much longer but also more productively. This has brought new hope to millions. It has also greatly helped to transform old perceptions of HIV/ AIDS, from that of a hopeless fatal disease to one of a manageable chronic illness – a dramatic shift that has effectively motivated people to seek their HIV status and to begin to treat it. Ironically, in those parts of the world which have the largest number of HIV infections, where HIV/AIDS is spreading rapidly, where individuals, families and communities continue to reel under the devastating health, social and economic impact of the disease; access to ART still remains severely restricted.
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In the South-East Asia Region, the second most affected Region in the world after sub-Saharan Africa, where thousands of people have died since the beginning of the epidemic, only around 7% of the HIVinfected population who need ART have access to it. Around 900 000 people living with HIV/AIDS in the Region are in immediate need of ART with the largest numbers in India, followed by Thailand, Myanmar and Indonesia. However, only approximately 64 000 are receiving it.
Estimated HIV prevalence and antiretroviral treatment needs in countries of the South-East Asia Region Country HIV prevalence Total number of people needing ART 1 950 0 n/a 16 500 765 000 0 51 000 9 150 85 500 525 0 929 625 Proposed WHO target by 2005 Treatment gap (number on treatment and WHO target) 970 0 n/a 6 900 368 500 0 24 300 4 475 -
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Number of people of ART in 2003 5 0 n/a 1 350 14 000 0 1 200 100 47 000 25 0 63 680
Bangladesh Bhutan DPR Korea Indonesia India Maldives Myanmar Nepal Thailand Sri Lanka Timor Leste Total
13 000 < 100 n/a 110 000 5 100 000 <100 340 000 61 000 570 000 3 500 100 6 197 500
975 0 n/a 8 250 382 500 0 25 500 4 575 42 750 263 0 464 813
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238 0 401 133
Source: National AIDS Programmes in SEAR.
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Antiretroviral treatment status in SEAR, October 2004 DPR Korea India “3 by 5” target* = 380 000 PHAs on ART** = 14 000 Nepal “3 by 5” target = 9 000 PHAs on ART = 100 Bhutan Myanmar “3 by 5” target = 25 000 PHAs on ART = 1200
Bangladesh
Thailand “3 by 5” target = 43 000 PHAs on ART = 47 000
Maldives
Sri Lanka Indonesia “3 by 5” target = 8 000 PHAs on ART = 1400
Timor-Leste Classification of HIV epidemics Generalized (HIV prevalence >1% in pregnant women) Concentrated (HIV prevalence >5% in high-risk groups but <1% in pregnant women) Low (HIV prevalence <5% in high-risk populations) * ”3 by 5” target: 50% of the People Living With HIV/AIDS(PLWHA) with advanced HIV infection who should receive antiretoviral treatment by 2005. ** PHAs on ART: Estimated number of people with HIV/AIDS on antiretroviral treatment in public and private health facilities.
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2. The “3 by 5” Initiative In 2003, WHO along with UNAIDS and other partners, declared the lack of access to ART to be a global emergency and launched the “3 by 5” Initiative. The “3 by 5” initiative targets 3 million eligible people in developing countries, with ART, by the end of 2005. The initiative conveys a new sense of urgency, demanding additional resources, streamlining of institutional procedures and goal-focused team work. The initiative will make special efforts to ensure access to ART to people who risk exclusion due to social, economic, geographical or other barriers. The rationale behind this initiative is evident in the following statements. There is a huge shortfall in ART for AIDS in many resource-poor countries. This inequity is unacceptable.
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Worldwide, six million people are urgently in need of ART in developing countries but fewer than 8% receive it. In the South-East Asia Region, the proportion is even lower (less than 7%), despite the fact that the much cheaper generic ARVs are manufactured in the Region. The delivery of ART in resource-poor countries once thought impossible is actually feasible.
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Successful programmes have been documented in Thailand, Haiti, Brazil and in some countries in Africa.
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ARVs are now more affordable The prices of ARVs have dropped sharply with India and Thailand
emerging as major manufacturers of affordable ARVs.
Many of those infected with HIV are unaware of their HIV status. In addition, denial, stigma, discrimination and other negative attitudes have seriously impeded HIV/AIDS prevention and care programmes in South-East Asia.
Making ARVs accessible raises new hope among people that the infection can be treated. This could encourage more and more people who want to know their HIV status, to come forward for testing, receive counselling and care and become knowledgeable about preventing the spread of HIV. ART will result in greater involvement of People Living With HIV/AIDS (PLWHAs) and more intensified efforts in overcoming attitudinal barriers like denial, stigma and discrimination that persist in accessing HIV/AIDS prevention and care programmes. Prevention strategies alone will not solve the present crisis.
WHO Commitment to “3 by 5” • WHO declares that failure to provide antiretroviral treatment for AIDS to millions of persons who need it is a global health emergency. • WHO identifies the “3 by 5” target as an institutional priority and realigns experts and activities across the Organization to achieve national targets set by Member States to scale up ART. • WHO commits additional resources to scaling up ART while maintaining full support for its overall HIV/AIDS programme, including prevention. • WHO and its partners take action by deploying teams in selected countries to conduct rapid assessment of barriers and opportunities for implementing “3 by 5”. • WHO establishes an AIDS Medicines and Diagnostics Service to assist countries in providing quality drugs at best prices.
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In addition to enhancing HIV/AIDS prevention services, access to ART programmes have a strong potential in strengthening and supporting an integrated HIV treatment, prevention and care service. An exceptional level of unprecedented resources are available for the fight against HIV/AIDS. There is growing worldwide political mobilization led by PLWHAs, affirming treatment as a human right. There is an increasing channelization of funds for HIV/AIDS, from the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Bank, bilateral agencies and other donors.
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3. Scaling up Antiretroviral Treatment in South-East Asia - A Strategic Framework for Action The scaling up of ART in the South-East Asia Region is a complex process, with multidimensional challenges. It demands the formulation of a carefully designed operational plan and sustained action by many partners within a well defined strategic framework for action. This must include clearly spelt-out goals, targets, guiding principles and actions needed for each of the strategic elements that comprise the framework.
3.1. Goal To prolong survival and restore quality of life for individuals with HIV/ AIDS by providing universal access to ART as a human right, within the context of a comprehensive response to HIV/AIDS.
3.2. Target 450 000 people in need of treatment will be on effective antiretroviral therapy by the end of 2005. Even though this target represents only 50% of all those needing ART, it is nevertheless a historic beginning of a feasible and doable strategy to mitigate the suffering of millions of HIV-infected individuals in the Region.
3 Guiding Principles 5 Strategic Elements
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3.3. Three Guiding Principles To accelerate HIV prevention activities and to strengthen health
systems, especially their managerial and operational capacities, to scale up ART.
To make ART an integral part of HIV prevention and care at all
levels of the health system.
To implement ART programmes that promote gender equality, are
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inclusive of children, intravenous drug users, the poor and other marginalized groups.
3.4. Five Strategic Elements The Regional Framework for scaling up ART at country level comprises the following five strategic elements: (1) Securing political and financial commitment. (2) Strengthening capacities of health systems (infrastructure for voluntary counselling and testing, laboratory diagnosis and monitoring, and training of health workers). (3) Ensuring uninterrupted supply of antiretroviral drugs and diagnostics. (4) Ensuring treatment adherence through partnerships including with PLWHAs. (5) Monitoring and evaluating performance including operational research. Each of the above elements requires urgent action. Element 1: Securing political and financial commitment It is imperative that political commitment is secured for a national ART policy and strategy as part of the overall national AIDS prevention and care programme. It is also essential that additional funds are mobilized to scale up ART.
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Develop effective advocacy approaches and materials to get policy makers to formulate a national policy on ART with well-defined targets. There is a special need for concerted advocacy to develop programmes that will encourage people to seek voluntary counselling and testing (VCT) services, to reduce stigma and discrimination that prevent people from seeking their HIV status and to ensure treatment adherence. Frame a national ART policy that will ensure ART for all eligible people especially the poor, vulnerable and marginalized, including women and children. Conduct situational assessment to identify available resources and gaps. Commit resources to ART without compromising on the support already being provided to the overall HIV/AIDS prevention and care programme. Formulate a national strategic plan setting realistic targets and ensuring that all the five strategic elements of the regional framework are included. Develop medium and long-term financing mechanisms and plans and mobilize additional financial resources for commodities, supplies and drugs as well as for strengthening the overall capacity of health services that will be sustainable. Build partnerships with various stakeholders including community representatives and PLWHAs for wider advocacy efforts in mobilizing political support and funds. Element 2: Strengthening capacities of health systems
Strengthening infrastructure and training of health care workers is especially needed to identify individuals in need of therapy, facilitate their entry into the ART programme, manage the side effects of drugs if any and ensure treatment adherence, both in the public and private sectors.
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Actions
Establish care teams at national and sub-national levels that would provide care and support as well as provide and manage ART services. Expand voluntary counselling and testing (VCT) services. Upgrade laboratory and clinical services. Strengthen referral systems for long-term support and management of persons on ART. Develop simplified guidelines for: – – HIV counselling and testing. Referral of individuals at high risk of HIV disease to VCT centres and better use of “entry points” such as VCT, TB clinics, medical clinics and programmes linked to prevention of mother-to-childtransmission, control of sexually transmitted infections and harm reduction. Identifying people who need ART. Drawing up HIV/AIDS clinical management guidelines including simplified standard, first- and second-line antiretroviral regimens. Ensuring treatment adherence through provision of adherence support for use by facilities and treatment monitors (community / peer), outreach workers and those on therapy.
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Develop materials for PLWHAs and their networks as well as for communities to facilitate their participation in ART programmes , and especially their involvement in reducing stigma and discrimination against HIV/AIDS, motivating people to come forward to seek their HIV status and ensuring treatment adherence.
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Develop operational models and mechanisms to get HIV-infected persons to come for treatment, for service delivery and for treatment adherence. Upgrade training: – Identify centres to train health cadres, outreach workers, PLWHAs, peer educators and NGOs on the various aspects of scaling up ART. Develop/adapt training tools and methods. Develop methods for accreditation of training centres and authorization of training providers to issue national certificates.
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Element 3: Ensuring uninterrupted supply of ARVs and diagnostics ART does not cure HIV infection. When administered correctly, it transforms AIDS into a chronic disease. Once started, ART must be continued throughout life. It is thus imperative that an uninterrupted supply of ARVs is always available to the HIVinfected. Discontinuing treatment will lead to a major setback in the well being, quality and lifespan of the HIV-infected. It will also lead to drug resistance. This has serious implications as the second-line drug regimens are not only more expensive but also carry more side effects.
Actions
Develop a national plan on drug procurement and distribution. Strengthen national regulations and procurement systems. Ensure that the National Essential Drug list is updated to include both first- and second-line ARV.
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Ensure procurement of quality HIV drugs and diagnostics at low cost to include at least all drugs required for the first- and second-line treatment regimens. Develop a supply chain management service to ensure availability of sufficient HIV test kits, CD 4 reagents, drug resistance assays and other related supplies and commodities. Establish an inventory system to monitor stocks of both drugs and diagnostics. Element 4: Ensuring treatment adherence through partnerships including with PLWHAs
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Ensuring more than 95% treatment adherence cannot be achieved by the public health sector alone. It will involve collaboration with a wide range of organizations, both government and nongovernment, community-based organizations, civil society, the private sector, religious groups and, most importantly, with activist groups and PLWHAs. PLWHAs and their networks have a very special role in treatment adherence and to provide peer support, as well as in educating communities, in advocacy, reducing stigma, motivating persons to come forward for testing and treatment.
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Identify key partners, both from the public and private sectors, delineate their roles and responsibilities as part of care / ART teams. Increase treatment literacy and knowledge in HIV prevention and care of people living with HIV/AIDS. Build capacities in partners to participate meaningfully in ensuring treatment adherence through orientation and training programmes. Mobilize communities including PLWHAs for their involvement in planning, encouraging people to seek their HIV status, reducing stigma and discrimination and overseeing enrolment, service delivery and treatment adherence.
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Element 5: Monitoring and evaluating performance including operational research It is important that performance of ART programmes are monitored and evaluated, including a focused operation research agenda to measure progress, identify obstacles and take necessary steps to ensure that the programme is on track.
Actions
Develop and use standard and easy to use monitoring and evaluation indicators. Develop a relevant operational research agenda that will analyze programme performance to study the impact of ART prevention, care and support programmes. Build capacities to monitor progress and evaluate outcomes of ART programmes and to conduct operational research to study its effectiveness and impact. Disseminate widely and utilize evaluation and research findings to improve ART performance and provide a sense of ownership to the programme among all stakeholders.
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4. Scaling up ART in the South-East Asia Region The Opportunities
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Several countries in the Region have included ART in their national policy for control of AIDS. Thailand has demonstrated that ART is not only implementable but also sustainable. ARVs for at least one of the WHO recommended first-line ARV combinations are available in Bangladesh, India, Indonesia, Myanmar, Nepal, Sri Lanka, and Thailand. Triple combination drugs now cost less than US$ 200 per year. The corporate sector, NGOs and PLWHAs networks are expanding significantly to collaborate with HIV/AIDS prevention, care and treatment programmes. There is unprecedented international commitment to assist and support countries in their endeavors to accelerate ART.
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The Challenges
The vast majority of HIV-infected individuals are not aware of their HIV status. This excludes them from ART programmes. Denial, stigma and discrimination are still formidable obstacles that prevent those infected, or at risk, to seek VCT services and treatment. HIV/AIDS treatment is a life-long therapeutic regimen demanding strict treatment adherence. Treatment interruptions have serious
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implications like the development of drug resistance. This calls for the use of the much more expensive second-line regimen of drugs, some of which are presently not available in the Region.
A Strategic Framework for Action at Country Level
Most public health systems in the Region are under-equipped to provide and manage an integrated HIV treatment, prevention and care service. Adequate resources are not available in countries to substantially scale up ART. Poverty and gender inequities are overriding constraints in implementing ART.
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5. Progress Indicators Development of indicators is crucial for monitoring progress and evaluating outcomes of scaled up ART programmes. Progress indicators must measure both coverage and quality of ART implementation as related to the action plan drawn up at national levels. Broadly, these would include: A. Process indicators B. Output/outcome indicators
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A. Process indicators (some examples) (1) Political commitment
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Commitment to ART as a national policy expressed in all relevant forums. National strategic plan formulated and targets set. Adequate financial resources mobilized and allocated for scaling up ART.
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(2) Strengthening capacities of health systems
Care/ART teams established at national and sub-national levels. Simplified national guidelines on VCT, treatment adherence and other relevant aspects of ART published and in use.
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Standards and accreditation criteria for laboratory, treatment and support services published and in use. Standardized training packages and communication materials developed and in use.
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(3) Ensuring uninterrupted supply of ARVs and diagnostics
National plan on drug procurement and distribution published and in use. Inventory systems to monitor drug stocks established and in use.
(4) Ensuring treatment adherence through partnerships including with PLWHAs
Number of PLWHAs networks actively engaged in increasing access to prevention, care and support services and assuring treatment adherence.
(5) Monitoring and evaluation including operational research
Standardized indicators for monitoring and evaluation developed and being collected, analyzed and disseminated. National operations research agenda developed and implemented by national research institutions and partners.
B. Output/Outcome indicators (some examples) (1) Number of professional and lay staff trained in ART according to national standards. (2) Numbers/per cent of designated health facilities adequately equipped and delivering quality ART. (3) Number/per cent of designated ART units reporting drug stockouts.
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(7) Per cent increase in VCT services at the treatment units delivering ART. (8) Number of PLWHAs with advanced HIV receiving ART according to national guidelines. (9) Number of PLWHAs remaining on treatment at 6, 12 and 24 months after start of treatment.
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6. Conclusion Lack of access to antiretroviral treatment for HIV/AIDS declared by WHO as a global health emergency is particularly relevant to the South-East Asia Region which is presently experiencing one of the most rapidly growing HIV/AIDS epidemics in the world. AIDS has claimed thousands of lives in the Region – mostly young people in their prime for whom opportunities to access ARVs have remained distant, elusive and impossible. A mere 64 000 (less than 7%) HIV-infected individuals today have access to ART; the rest live in fear and dread of impending death. Expanding access to ART for HIV/AIDS is a daunting challenge for the Region. The target is to scale up coverage − to get 450 000 persons on ART by the end of 2005. This requires major investments in the high-burden countries of the Region and the formulation of a well-designed strategy and plan that will form part of a comprehensive care package for people living with HIV/ AIDS, without compromising on the basic prevention strategies. It will also need a massive mobilization effort to secure political will, financial commitment and people’s involvement. The framework of a Regional strategy described in this document lists three guiding principles and five core elements for action at country level. The framework is based on the global strategy adopted by the “3 by 5” Initiative of WHO and its partners. The “3 by 5” target to treat 3 million people by 2005, is a key step in making it possible for those living with HIV/AIDS, particularly in resource-poor countries, to live longer and with dignity. The strategy, involving as it does, a multitude of actors and actions is complex; nevertheless, it is feasible and doable, when properly planned
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and executed, with strong political support, resource commitment and people’s involvement. Support is critically needed to build capacities of doctors, counsellors, nurses, laboratory technicians and pharmacists, to strengthen infrastructure by expanding VCT, clinical and laboratory capacity to deliver and monitor treatment and to ensure an uninterrupted supply of the required drugs. There is an unprecedented support from WHO, UNAIDS, UNICEF, UNDP, the World Bank, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Bilateral donors and other development partners are also contributing most significantly to scale up ART in the Region. The strategy outlined in this document provides directions to reach at least 50% of the Region’s HIV-infected. Eventually, everyone infected with HIV in the Region must gain access to ART. Documenting the experience gained and the lessons learned will go a long way in providing guidance for the years ahead.
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