V. Critical Interventions in the Focus Countries: Treatment

“There are whole countries in Africa where more than one-third of the adult population carries the infection. More than 4 million require immediate drug treatment. Yet across that continent, only 50,000 AIDS victims– only 50,000– are receiving the medicine they need.” President George W . Bush, January 28, 2003

In 2003 alone, AIDS claimed a staggering 3 million lives. The vast majority of these deaths – 2.4 million – occurred in developing nations. Access to anti-retroviral therapy (ART) and improved treatment of opportunistic infections have dramatically reduced AIDS morbidity and mortality in the industrialized world. But in developing countries, fewer than 8 percent of the 6 million people in immediate need of treatment receive it.

The United States has been a global leader in developing the tools – including ART and other treatment methodologies – that have enabled people in industrialized nations to live long and productive lives despite HIV. Driven by the President’s fundamental belief in the value and dignity of every human life, President Bush’s Emergency Plan for AIDS Relief expands this leadership role to dramatically increase access to treatment in some of the most affected and underserved countries in the world.

In the past, the provision of treatment in the developing world was considered too costly for under-resourced nations and too complicated for developing-country health infrastructures. These concerns are real but can no longer be barriers to providing treatment to the millions who need it. President Bush believes that moral duty alone is sufficient reason to act quickly to save lives. Providing treatment may be our best hope against the disease and its consequences.

In the absence of treatment, HIV is viewed as a death sentence. With no hope of survival, many refuse to be tested and thus lack information they need to protect themselves and others. Lack of hope contributes to fear of the disease and stigmatization of those who live with it, further hindering testing efforts. In contrast, the availability of treatment demystifies, and thus destigmatizes, AIDS and people who have it. The availability of treatment also provides an incen-tive to get tested. Treatment, then, can provide links to prevention efforts.

In addition, treatment provides a means to address the devastating consequences of AIDS-related mortality. It is the human toll of the disease that contributes to the loss of productivity, the dramatically increased poverty, the staggering numbers of orphans, and the population distortions that threaten not only the present but also the future. Treatment, in its basic ability to prolong life and reduce morbidity, allows parents to continue parenting, teachers to continue teaching, and civil servants, including health care workers, to continue serving their nations and fellow citizens for years to come. The hope for a future again appears on the horizon.

The President’s Emergency Plan establishes the aggressive goal of providing treatment over the next five years to at least 2 million people living with HIV/AIDS in countries bearing some of the greatest burdens of disease. Not everyone infected by HIV needs immediate ART, which starts when a person begins to experience symptoms or when their immune system has deteriorated. Once ART has begun, it continues for life.

Meeting this goal requires far more than providing a consistent supply of essential drugs, although this is a daunting challenge in itself. It requires addressing complex issues such as the lack of adequate infrastructure, staff, and technical capacity to provide safe, high-quality treatment programs that reach even rural communities. Further, many countries have yet to develop appropriate treatment protocols and policies to ensure safe and adequate drug supply and the equitable distribution of health resources. Other issues, such as drug resistance and patient adherence, are essential challenges that must be addressed.

The President’s Emergency Plan will capitalize on decades of U.S. Government expertise in biomedical research, delivery of HIV/AIDS care and treatment, and development to address these challenges and rapidly expand ARV treatment availability while building national and local health care capacity to sustain treatment programs over the long term. Reduced drug prices, proven treatment methodologies, committed host governments, and the involvement of FBOs, CBOs, and other private sector partners have proven that it is possible to deliver this life-extending intervention in resource-poor settings.

Priorities for the distribution of resources for treatment will ultimately be based upon the strategies, needs, and existing resources of the host countries. Activities funded under the Emergency Plan will collaborate closely with other donors to ensure complementary treatment efforts and the best use of treatment dollars.

The President’s Emergency Plan is fundamentally oriented to removing barriers to treatment and working to ensure that geography, gender, ethnicity, risk factors, and income no longer determine who lives and dies with AIDS. With the knowledge that 8,000 lives are lost daily to AIDS, there is no time to waste.

Treatment Objective:
Provide treatment to at least 2 million HIV-infected individuals in the focus countries

Treatment Strategies:

1. Rapidly scale up treatment availability through the network model

2. Build capacity for long-term sustainability of quality HIV/AIDS treatment programs

3. Advance policy initiatives that support treatment

4. Collect strategic information to monitor and evaluate progress and ensure compliance with Emergency Plan and national policies and strategies

1. Rapidly scale up treatment availability through the network model

The expansion of treatment services in the focus countries at the scale and scope envisioned by President Bush’s Emergency Plan is unprecedented. Pioneering new approaches are required to achieve the Emergency Plan’s ambitious treatment goal. Four operational strategies will guide the rapid scale-up of treatment availability:

• Assessing network capacity for treatment expansion;

• Building on established clinical programs;

• Rapidly training and mobilizing health care personnel to provide treatment services; and

• Enhancing the capacity of supply chain management systems to respond to rapid treatment scale-up.

Assessing network capacity for treatment expansion
The Emergency Plan will move quickly within each of the focus countries to help the host government and other in-country stakeholders assess the current capacity of the HIV/AIDS network by identifying key facilities, organizations, and health providers who deliver treatment at each level of the system. Using existing data to the greatest degree possible, the rapid assessment will document:

• Current capacity (human resources, infrastructure) of key units within the network to deliver and rapidly expand treatment and related services, including public facilities, private NGOs, FBOs, and private commercial facilities;

• The strengths and weaknesses of the systems that support the delivery of treatment, such as referral systems, logistics systems, management information systems, etc.;

• Organizations that currently deliver good health services – especially those with wide networks – that could be mobilized to expand their range of services to include HIV/AIDS treatment; and

• Policy issues and cultural practices that either support or inhibit the capacity to deliver treatment services.

The results of this rapid assessment will be used to guide Emergency Plan interventions to strengthen the capacity of the HIV/AIDS network to deliver treatment within each of the focus countries. Plans for technical assistance, training, and program interventions will be closely coordinated with host-country counterparts and will be consistent with their national AIDS strategies.

The Network Model The strategy to achieve President Bush’s Emergency Plan’s ambitious goals focuses on improving healthcare system capacity to deliver effective and expanded HIV/AIDS prevention, treatment, and care services. The focus on health care systems pro-vides a base from which to rapidly expand essential services. Health care systems in the target countries, and indeed in much of the world, are currently organized around the concept of a “network model” comprising central medical facilities,district-level hospitals, and local health clinics, supplemented by private, often faith-based,facilities. This network concept of public and private health care institutions currently pro-vides the backbone design of health care delivery systems, and many of the focus countries– Nigeria, Uganda, and Haiti, for example –have planned their HIV/AIDS strategies with net-worked health care systems as the foundation. The current capacity of these existing health systems to deliver HIV/AIDS prevention, treatment,and care services is limited, however, particularly in rural areas. The Emergency Plan, in accordance with national health and HIV/AIDS strategies and with the intent to build long-term sustainability, will strengthen linkages between central facilities and international and private support to build the capacity of different network components and strengthen network-wide linkages in order to more effectively deliver quality HIV/AIDS services to those who need them most.   The Emergency Plan, in support of national HIV/AIDS strategies, aspires to the goal of well-functioning, well-managed health care networks in which central medical centers and referral hospitals at the core of the network will have an adequate number of health care professionals highly trained in all aspects of HIV/AIDS clinical and program management. These facilities must also have adequate physical infrastructure and research capabilities. The central facilities will link through effective referral networks to a series of smaller regional hospitals and district facilities down to community-level satellite clinics, mobile units, and community-based services. To reach even the most rural areas, and to dramatically scale up access in the short term,community-based healthcare workers will deliver essential sup-plies, including medications,to patients in their communities, as currently practiced in Uganda. Nurses and community health care workers will be trained in routine care, symptom management, and monitoring for treatment adherence, while highly trained doctors– currently in scarce supply – will use their expertise in specialized and difficult cases. Doctors,for example, would periodically visit a community to evaluate patients identified for advanced care by nurses and community health care workers. The network ensures technical support and products flowing out from the center to facilities in the periphery that provide care. Facilities and health workers within the network, in turn, identify and refer patients for higher levels of care as needed.This might include HIV/AIDS patients exhibiting greater levels of complexity. Information systems link all levels of the network with regular feedback loops, enabling both providers and health policy-makers to make decisions based on solid data. Finally, the system will employ relatively uniform HIV/AIDS treatment and care protocols that are consistent with national strategies and guidelines.

Building on established clinical programs
Based on the results of the assessment, the Emergency Plan will mobilize immediately to scale up programs that already deliver ART or that have the necessary medical competence to do so quickly. Using existing programs (those already supported by the United States as well as those supported by others) as a platform for scale-up will allow for easier replication of best practices, more rapid mobilization of resources through institutions that already have functioning systems, and increased opportunities for twinning successful programs with those that show promise. President Bush’s Emergency Plan will support communication efforts to prepare communities for the introduction of ARV drugs. Such efforts should describe ARV treatment programs, including the nature of taking ARVs for life, and include messages to combat the possible misperception that a cure has arrived.

The second phase of scale-up will focus on those facilities that do not provide ART but do provide good health or HIV/AIDS prevention and care services and have networks of sites and personnel that allow for rapid expansion and mobilization to provide ARV treatment. Through targeted technical assistance and training, many public health facilities, private FBOs and CBOs, and private commercial facilities in the focus countries will be able to add ART to their services in a relatively short period of time. FBOs will play an important role, as in some countries in Africa nearly half of all medical services are provided through mission hospitals and health centers.

Other programs that offer the possibility for rapid scale-up and development of program synergies include:

Tuberculosis control programs. Tuberculosis (TB) is frequently the first manifestation of HIV/AIDS disease and the reason many people first present themselves for medical care. Since both tuberculosis treatment and HIV/AIDS treatment require longitudinal care and follow-up, successful TB programs may provide excellent platforms upon which to build capacity for HIV/AIDS treatment. The Emergency Plan will support TB treatment for those who are HIV-infected and develop HIV treatment capacity in TB programs. In addition, interventions that increase the number of persons diagnosed and treated for HIV/AIDS will increase the need for TB treatment and care services. Therefore, action is required to build or maintain necessary tuberculosis treatment capacity. Laboratories, clinical staff, community networks, and management structures used for TB control can be upgraded to accommodate HIV/AIDS treatment. Many of the techniques that have been found useful for TB control, such as directly observed therapy, may be applied to monitoring compliance with HIV/AIDS treatment. Because the prevalence of HIV infection is high among persons with tuberculosis, TB programs may be an important site for HIV testing in the focus countries.

Malaria control programs. Malaria infection during pregnancy increases the risk of mother-to-child HIV transmission. Therefore, the Emergency Plan will strengthen in-country program linkages between HIV/AIDS and malaria programs and provide technical assistance, training, and support to malaria prevention and control initiatives focusing particularly on HIV-positive pregnant women through PMTCT interventions. Bednets, an effective antimalarial intervention, will be incorporated into the Emergency Plan’s coordination strategy with malaria control programs.

Rapidly training and mobilizing health care personnel to provide treatment services
Expanding the human resources necessary to implement this bold new treatment program will require both short- and long-term strategies. In the short term, the immediate need for greater numbers of trained health workers to manage ARV treatment will be met by rapidly expanding the training of existing health workers and supplementing their capacity with foreign volunteer health professionals. At this stage, technical assistance and in-service training will be the primary vehicles for building the skills of current health workers, including physicians, nurses, community health workers, pharmacists, and laboratory technicians. Training will focus on building health worker skills to improve ART case management for both adults and children, including administering drugs, monitoring patients for side effects and treatment failure, and promoting treatment adherence.

In order to facilitate rapid expansion, President Bush’s Emergency Plan will support local and national efforts to broaden responsibility for patient treatment, care, and support to nurses, lay health workers and counselors, and health volunteers. Given the enormous human resource constraints, it will be critical to give greater responsibility, through training and supervision, to greater numbers of health workers in order to achieve treatment goals.

In addition to strengthening the skills of formally trained medical professionals, and as a way to extend services into the community, President Bush’s Emergency Plan will explore options to involve traditional healers, birth attendants, family members, and other lay persons in a more substantial way. Building on previous U.S. Government-funded work in this area, programs will focus on building skills to recognize HIV complications, provide basic home-based care, support patients and caregivers, increase adherence to treatment regimens, and refer patients to appropriate health care services. The Emergency Plan will also support efforts to forge relationships with associations of people living with HIV/AIDS to train their members to provide patient education, adherence counseling, and patient follow-up in order to free clinical staff to perform higher-level tasks.

Recruiting and deploying volunteer doctors, nurses, pharmacists, laboratory technicians, and other health professionals from the United States and other nations is another important strategy to meet the human capacity needs for HIV/AIDS treatment. Short-term training and technical assistance by experienced professionals, possibly as part of a twinning program, will help fill human resource gaps in key technical areas and provide opportunities for on-the-job training and mentoring of host-country counterparts. The U.S. Global AIDS Coordinator is exploring various mechanisms and options for facilitating U.S. professionals in this effort under the President’s Volunteers for Prosperity Initiative, including the Peace Corps’ Crisis Corps program, Freedom Corps, and other programs. Finally, telemedicine and distance education can be used to build the skills of health professionals in the focus countries and strengthen local, national, and international connections among medical institutions.

Volunteers for Prosperity President Bush’s Emergency Plan for AIDS Relief and many of its grantees will be participating in Volunteers for Prosperity, President Bush’s call to international service to engage the people of the United States as part of U.S. Government assistance programs that meet global prosperity needs. The Volunteers for Prosperity initiative is part of President Bush’s USA Freedom Corps volunteer service initiative that encourages highly skilled and trained individuals to volunteer with organizations promoting health and prosperity throughout the world. Volunteer service is a major component of the President’s ongoing effort to involve all Americans in sharing compassion and skills with others in their own communities and around the world.

The twinning of U.S.-based institutions with African or Caribbean institutions (or African with Caribbean or African) offers an important means of establishing these types of relationships. The twinning mechanism that is part of President Bush’s Emergency Plan will allow the creation and support of “centers of excellence” from which training, research, and talent can be diffused throughout the impacted regions. It is this ongoing sustained support for professional excellence that holds the key to increased capacity for care.

Enhancing the capacity of supply chain management systems to respond to rapid treatment scale-up
The development and implementation of logistics systems to manage the increased volume of products needed for an expanded treatment program will require both short- and long-term strategies. During rapid scale-up, the focus will be on procuring and delivering a continuous and secure supply of high-quality products to patients at all levels of the health system.

In most countries, the sharp increase in the volume of products provided through the Emergency Plan and other new sources such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria will likely challenge existing national supply systems. To facilitate rapid implementation of effective procurement and delivery systems, President Bush’s Emergency Plan will explore options to enhance the immediate performance of national logistics systems through:

• Centralized or pooled procurement mechanisms at global or regional levels, including collaboration with other donor-funded programs – e.g., the Global Fund, the World Bank’s Multi-Country HIV/AIDS Program for Africa (MAP), and WHO – and direct product donations;

• Outsourced transportation to secure courier services or purchase of dedicated vehicles for ARV drug delivery;

• Design of user-friendly, timely, and accurate methods of logistics data capture, collection, analysis, and feedback for resupply and forecasting;

• Product selection and packaging for better adherence;

• Provision of skilled people to perform logistics management functions;

• Strengthened collaboration between supply chain managers and program service managers to ensure coordination of patient enrollment and supply needs;

• Improvements in secure storage space and inventory management; and

• Facilitated development of national coordinating bodies to schedule donor financial and commodity commitments, develop medium-term procurement plans, and track actual funds and products received in order to avoid duplication of investment.

For more information on supply chain management issues, see chapter X, Supportive Interventions for U.S. Government Programs, Supply Chain Management.

Monitoring Resistance to Antiretroviral Drugs Careful monitoring of ARV treatment is essential to limit the development of resistant strains of the virus and ensure the long-term durability of treatment regimens. Currently, only a few countries have the sophisticated laboratory infrastructure, highly skilled laboratory staff, and rigorous health information systems necessary to support an ARV resistance monitoring program. President Bush’s Emergency Plan will help build the capacity of focus countries to monitor resistance to ARVs at the program level by providing technical assistance and training to upgrade laboratory capacity and strengthen monitoring and evaluation systems. The Emergency Plan will work with the U.S. Department of Health and Human Services and its constituent parts, the National Institutes of Health and the Centers for Disease Control and Prevention, and other research organizations to ensure that surveillance and research are supported to help detect viral resistance to ARVs and better understand the determinants of resistance in local settings. These studies will help inform decisions and policies related to clinical care, program management, and drug procurement. Clinical and operations research will identify and test appropriate alternative approaches to sophisticated laboratory monitoring of ARV therapy in resource-limited settings and increase understanding of ways to increase ARV regimen durability.

2. Build capacity for long-term sustainability of quality HIV/AIDS treatment programs

While mobilizing rapid scale-up for treatment availability, the Emergency Plan will also lay the foundation for sustainable high-quality treatment programs. This will be accomplished by:

• Strengthening national human resource capacity through health care worker recruitment and retention strategies, longer-term training, and technical assistance;

• Establishing, disseminating, and implementing treatment protocols;

• Developing the capacity of new partners; and

• Developing and strengthening health infrastructure.

Strengthening national human resource capacity through health care worker recruitment and retention strategies, longer-term training, and technical assistance
President Bush’s Emergency Plan will focus on building long-term human resource capacity through training and technical assistance that directly supports national strategic plans for scale-up of HIV/AIDS programs. Short- and long-term training is the backbone of this strategy, including the incorporation of PMTCT and ART content into the basic training programs for doctors, pharmacists, laboratory technologists, nurses, and midwives, including rotational practice. Activities include:

• Curriculum development to incorporate management of HIV-related illness into the basic package of care offered thorough routine health services, including methodologies for promoting treatment adherence;

• Technical assistance and training to improve ART case management, including promoting adherence and monitoring patients for side effects, treatment failure, toxicity, and contraindications;

• Technical assistance and training in improved supervision and quality assurance;

• Technical assistance in long-term planning for infrastructure and manpower requirements;

• Development of innovative training programs, including faculty and student exchange programsa and a practicum for health workers that allows trainees to gain experience in HIV/AIDS management by working under supervision in health clinics or hospitals providing high-quality treatment programs;

• Technical assistance to promote and improve treatment literacy for clients, through patient education, counseling, and community outreach to inform patients and their families about the drugs they are receiving, management of side effects, and the importance of adherence; and

• Promotion of policies to support the recruitment and retention of qualified health care professionals.

Establishing, disseminating, and implementing treatment protocols
It is important that every country have evidence-based national guidelines and protocols for managing ART and opportunistic infections. These guidelines and protocols must be constantly updated to reflect the nature of the epidemic and “state of the art” treatment, and they are an important tool for improving the quality of HIV/AIDS care. Thus, President Bush’s Emergency Plan will:

• Provide technical assistance and training to health ministries and professional organizations to strengthen the development, dissemination, and implementation of national guidelines and protocols for ART and treatment of opportunistic infections, based on evidence and experience gained in local settings and incorporating knowledge of the local health infrastructure and epidemiology of the epidemic in each country; and

• Provide technical assistance to develop clinical care guidelines and ARV regimens for children (which can significantly differ from those for adults), including methodologies for addressing treatment adherence and psychosocial support.

Developing and strengthening HIV/AIDS-related health infrastructure
A strong health infrastructure is the foundation that supports effective planning, delivery, and evaluation of HIV/AIDS treatment programs. Currently, health infrastructure within the focus countries is often not equipped to support the sustainable high-quality treatment services necessary to effectively address the epidemic. Thus, the President’s Emergency Plan will provide targeted technical assistance, training, and funding to improve and expand the infrastructure necessary to ensure optimal delivery of HIV/AIDS treatment services. By looking at the requirements at each level of care – and the linkages between them – support will be provided to:

• Equip health facilities and mobile units utilized for HIV/AIDS treatment services;

• Upgrade routine health information systems to improve treatment data management;

• Strengthen research and surveillance capacity;>

• Develop twinning mechanisms for the broad engagement of institutions across a full range of infrastructure-strengthening activities;

• Support effective product procurement, storage, and distribution;

• Strengthen financial and management systems; and

• Improve laboratory capacity to diagnose infection and monitor ARV treatment.

Developing the capacity of new partners
In order to achieve its ambitious treatment goals, the Emergency Plan must help focus countries link communities with treatment services on an enormous scale. To facilitate this, the President’s initiative seeks to leverage the comparative strengths of a wide range of different public and private sector partners to dramatically increase the number and reach of organizations providing treatment services. Activities to identify and engage new and innovative partners include outreach to and capacity building of:

Faith-based and community partners currently providing HIV/AIDS prevention and care services to add treatment support to their slate of services. Faith-based and other community partners have extensive reach and legitimacy in local communities and are among the most experienced organizations in providing HIV/AIDS prevention and care services. Expanding their services to treatment support will require training in both the technical aspects of treatment support services and building institutional capacity in program planning, financial and program management, and evaluation.

Corporate sector partners with resources and innovations to contribute. The corporate sector is a vibrant force for development worldwide. Partners from the corporate sector have enormous potential to bring significant new resources and innovative ideas to the fight against AIDS. The President’s Emergency Plan will provide technical assistance to help the corporate sector identify ways to support and expand treatment programs through improved workplace policies, delivery of services, the leveraging of commercial resources, and the application of new technologies. Business “champions” who provide effective HIV/AIDS treatment and care support services will be identified. President Bush’s Emergency Plan will also coordinate with private corporations to include treatment services for community members in their corporate health facilities.

Private sector networkssuch as unions and agricultural collectives to strengthen treatment programs through workplace-based HIV/AIDS programs, with support to employees and families where appropriate.

3. Advance policy initiatives that support treatment

President Bush’s Emergency Plan will provide support to governments to implement their national HIV/AIDS strategic plans and develop a comprehensive set of policies to support their implementation through a collaborative process involving stakeholders across multiple sectors. Most of the focus countries have committed to uphold the human rights of people living with HIV/AIDS and have begun to formulate policies in alignment with the 2001 United Nations General Assembly Special Session on HIV/AIDS (UNGASS) Declaration of Commitment on HIV/AIDS. Most have begun to consider how to address a wide range of HIV-related policies. President Bush’s Emergency Plan will help create a strong enabling environment that will support the expansion of high-quality treatment programs by:

• Providing technical assistance in policy development, and

• Building political commitment.

Providing technical assistance in policy development
As accessibility to treatment is a relatively new phenomenon in the focus countries, the policies and structures needed to support effective planning, implementation, and evaluation of treatment programs are generally not yet in place. Policy reform to support HIV/AIDS treatment must begin immediately to ensure successful expansion of treatment services under the Emergency Plan. Treatment-related policy issues that may need to be addressed through technical assistance include:

• Product registration;

• Development of standard treatment guidelines and essential drug lists;

• Drug procurement and financing;

• Compliance with the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other trade agreements;

• Regulations related to importation and taxation of drugs and medical supplies/equipment;

• Human resources policies, including broadened responsibilities for HIV treatment and opportunities for testing and diagnosis, so more nurses and community health workers can deliver care;

• Appropriate resource allocation and flow of national resources to HIV/AIDS programs;

• Barriers to treatment caused by stigma and discrimination;

• Insurance coverage of ART; and

• Administrative policy relating to health sector reform.

4. Collect strategic information to monitor and evaluate progress and ensure compliance with Emergency Plan and national policies and strategies

President Bush has insisted that his Emergency Plan place a high priority on maintaining program integrity, ensuring accountability, and assuring compliance with U.S. Government polices. A strategic information sys-tem to monitor treatment implementation and impact will be built upon:

• Surveillance information to track HIV incidence, prevalence, and mortality;

• Program monitoring information to measure provider capacity to treat clients, including individuals receiving ART and associated supply chain management and clinical care;

• Targeted evaluations to support evidence-based decisions regarding clinical programs; and

• Management information systems to increase data storage and flow.

An appropriate information technology framework has the potential to revolutionize the health information system supporting clinical care, program management, and international reporting. A strategic information system provides a vehicle for identifying those elements of a program that are most successful and highlighting those that could be more effective.

The Emergency Plan will help countries effectively collect and use appropriate data for decision-making and reporting on progress toward the achievement of results. A second critical activity is to harmonize indicators and reporting systems with international agencies such as UNAIDS and WHO and major international donors such as the Global Fund and the World Bank. Balance must be achieved between the need for immediate reports and results (e.g., timely demonstration of PMTCT core indicators) and the long-term objectives of building HIV country reporting capacity and institutionalizing locally useful and sustainable health information systems.  

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