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Presidential Advisory Council on HIV/AIDS
 

International Subcommittee Recommendations

PACHA Recommendations for Reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR)

Prepared by the PACHA International Subcommittee
16 October 2007

The Next Phase of PEPFAR (“PEPFARTHER”)

PEPFAR ... Time for Hope and Enhanced Response


Executive Summary and Recommendations

The President’s Emergency Plan for AIDS Relief (PEPFAR) is the largest commitment for an international health initiative dedicated to a single disease, by any nation. PEPFAR is currently in the fourth year of a 5-year, $15 billion program created to combat the disease in 15 focus countries around the world. The Presidential Advisory Council on HIV/AIDS (PACHA) believes that the PEPFAR program, to date, has had a very important impact on expanding global access to HIV prevention, care and treatment. In addition, the PEPFAR program is a powerful and unique demonstration of the commitment of the American people in addressing the most pressing global health challenges, in some of the most vulnerable populations of the world. Therefore, PACHA strongly recommends that the PEPFAR program be re-authorized for an additional 5 years. The goal of this report is to communicate PACHA’s support for PEPFAR re-authorization, as well as to provide specific recommendations for the next phase of the program. PACHA supports the following 14 recommendations to maximize the impact and sustainability of the next phase of PEPFAR:

1) The PEPFAR goals to provide HIV prevention, care and treatment should remain the focus of the next phase of this program.

2) All PEPFAR-supported prevention, care and treatment programs should be evaluated and supported, based on evidence-based criteria, including prevention of new HIV infections, as well as improvements in HIV-associated morbidity and mortality.

3) PEPFAR should continue to promote rational, evidence-based targeted prevention depending on age, circumstances, and risk profile. Therefore, abstinence and delay of sexual debut; mutual fidelity between partners; reduction in number of casual and concurrent partners; correct and consistent use of condoms (known as the ABC model) should remain the priorities for PEPFAR prevention programs in areas or regions with generalized epidemics, and as a strategy for general populations everywhere. Primary emphasis on condoms and other risk- and harm reduction interventions should remain the strategy for PEPFAR prevention programs in areas or regions with concentrated epidemics, and as a strategy for high-risk groups everywhere. In addition to primary emphasis, other available interventions should be considered as backup strategies.

4) The Office of Global Aids Coordinator (OGAC) should be encouraged to invest substantial annual funding to support operational research. This research should include additional monitoring and evaluation to obtain evidence-based data of the overall impact of the PEPFAR programs; and to support operational research targeted to optimize standard practice and PEPFAR programmatic impact. To maximize the benefits to PEPFAR programs, this monitoring and evaluation and operational research should be integrated into existing PEPFAR programs.

5) To further enhance the impact of HIV prevention, care and treatment programs, PEPFAR should increase its funding for training of health care workers, in resource-limited settings as well as increase target funding for the development, implementation and evaluation of novel approaches to sustainable human capacity development.

6) Local expertise needs to be increasingly reflected and engaged in the design and funding decisions of PEPFAR programs for their specific communities.

7) Interventions such as voluntary male circumcision, drug abuse treatment and relapse prevention as well as drug substitution programs, should also be considered for support by PEPFAR where supported by evidence based data and where appropriate, as additional components of comprehensive prevention strategies that also include ABC programs and interventions.

8) While HIV prevention and treatment programs are strengthened and optimized, the PEPFAR program should expand support for palliative care services, including end of life care.

9) To ensure optimal and uninterrupted access to services, administrative mechanisms to allow multi-year funding of PEPFAR programs should be considered.

10) To ensure the sustained availability of new drugs and formulations for pediatric patients, pregnant women, and adults living with HIV infection, OGAC should develop long-term strategies that fully engage the creativity, development, and market capacity of the pharmaceutical industry.

11) Request OGAC to prioritize the First Lady’s Initiative for pediatric patients of all ages.

12) OGAC should consider additional strategies to ensure long-term sustainability of successful PEPFAR programs, including integration with other United States government-sponsored public health programs.

13) OGAC should work to have all import fees on HIV-medications eliminated.

14) OGAC should be encouraged to enhance investment in HIV treatment, care and prevention program in the Caribbean region to include consideration of establishing the Caribbean region as a new focus area of PEPFAR investment.

15) In order to ensure long-term sustainability of the program and to address the growing strategic and public health impact the global HIV epidemic, we support the President’s recommendation to increase PEPFAR funding, to at least $30 billion over the next 5 years.

Introduction

In his January 2007 State of the Union speech, President Bush said, “American foreign policy is more than a matter of war and diplomacy. Our work in the world is also based on a timeless truth: To whom much is given, much is required. We hear the call to take on the challenges of hunger, poverty, and disease—and that is precisely what America is doing.” The President’s Emergency Plan for AIDS Relief (PEPFAR), the largest single international health initiative directed at a single disease, is a singularly unique and clear demonstration of this commitment of the American people to help our world’s most vulnerable populations. In addition, investments by the United States government in programs, like PEPFAR, that dramatically improve health in the developing world are important for long-term global economic development. As such, programs like PEPFAR contribute to stabilization of societies, to advancement of democracy and to strategic security of the United States.

In an age where global health problems are truly global, international health programs like PEPFAR are important to protect the American public’s health, through prevention and control of drug-resistant infections and emerging new pathogens, as well as to prevent re-introduction to the United States previously eradicated diseases from abroad. The PEPFAR program is far more than a targeted humanitarian program. The PEPFAR program is also a reflection of the United States government’s full embrace of global health, as a centerpiece of United States foreign policy and national security. Global health is the foreign policy and global development tool of our time. The PEPFAR program is the United States government’s flagship for the future of global health diplomacy and, as such, will provide a long-lasting and historic legacy.

The PEPFAR program, initiated in 2003 with an unprecedented committed of $15 billion over 5 years, has already provided HIV treatment to more than 800,000 patients, supported prevention of mother-to-child transmission services for more than 6 million pregnant women, and provided care for more than 2 million orphans and vulnerable children. Therefore, the Presidential Advisory Council on HIV/AIDS (PACHA) believes that the PEPFAR program, to date, has had a very important impact on expanding global access to HIV prevention, care and treatment. In this report, PACHA will outline the rationale for our strong support for PEPFAR re-authorization, as well as for specific recommendations for optimization and sustainability of the program for the future.

I. PEPFAR Goals, Accomplishments and Opportunities

  1. PEPFAR Goals

    The current PEPFAR program has three stated goals.

    1. Prevention of 7 million new HIV infections
    2. Antiretroviral treatment (ART) for 2 million HIV-infected people
    3. Care for 10 million people infected and affected by HIV/AIDS, including orphans and vulnerable children

  2. PEPFAR Accomplishments

    During the first 3 years, the PEPFAR program has achieved tremendous progress towards these goals. With programs in more than 120 countries, PEPFAR has committed $10 billion for 15 focus countries; $4 billion for other countries and for additional activities including HIV/AIDS research; and $1 billion over 5 years for the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Highlights of the PEPFAR program include:

    • Prevention

      • Outreach activities to over 42 million people to prevent sexual transmission of HIV
      • 3,000 service sites for prevention of mother-to-child transmission and blood safety
      • Mother-to-child transmission services for more than 6 million pregnant women
      • Antiretroviral prophylaxis for over 500,000 pregnant women, preventing an estimated 100,000 infant HIV infections
      • Training or retraining of over 300,000 people in provision of prevention services

    • Treatment

      • Antiretroviral therapy for more than 800,000 people; 60 percent are women and 10 percent are children
      • Support for 800 clinics delivering antiretroviral therapy.

    • Care

      • Care for nearly 4.5 million people with HIV to include treatment and prevention of opportunistic infection as well as symptomatic treatment and end of live care.
      • Care for more than 2 million orphans and vulnerable children

  3. PEPFAR Opportunities

    In light of the scale and scope of its programs and accomplishments, it is likely that PEPFAR has resulted in a number of additional important public health benefits that have not been sufficiently documented. While the initiation of the PEPFAR program required focus on rapidly expanding access to prevention, treatment and care services, a critically important opportunity and responsibility for the next phase of PEPFAR is to document that these services are having a direct public health impact. Despite the fact that many public health benefits have likely been achieved by the PEPFAR program, available data to demonstrate these outcomes are limited The support of the American people for the PEPFAR program, as well as the long-term sustainability and legacy of this program, would be greatly enhanced by evidence based data defining the specific public health benefits have been achieved.

    Therefore, demonstration of clear public health benefits is, therefore, critical for the next phase of the PEPFAR program. At the very least, all PEPFAR-supported prevention, care and treatment programs should be evaluated and supported, based on standard evidence-based criteria, including prevention of new HIV infections, as well as improvements in HIV-associated morbidity and mortality. The potential public health benefits of PEPFAR include, but are not limited to, the following:

    • Potential Benefits of PEPFAR’s Strengthening HIV Prevention Programs

      • Reduction in number and rates of new HIV infections and other sexually transmitted infections (STIs).
      • Improvement of STI prevention and treatment services
      • Enhancement of prenatal care and transfusion services
      • Reduction in maternal mortality rates
      • Reduction in neonatal mortality rates
      • Reduced transmission of other blood-born diseases (e.g., HBV, HCV, and malaria)
      • Reduced transmission of TB

    • Potential Benefits of PEPFAR’s Strengthening HIV Treatment and Care Programs

      • Reduction in HIV-associated morbidity and mortality
      • Strengthening of TB prevention and treatment services
      • Reduced community risk for TB, including multi-drug resistant TB (MDR-TB)
      • Reduction in incidence of other opportunistic infections
      • Reduction in the community risk for spread multi-drug resistant HIV virus
      • Enhancement of primary care for children, including immunization programs
      • Reduction in infant and child mortality rates
      • Reduction in “brain-drain” of nurses and doctors in PEPFAR countries

    PEPFAR has an opportunity to build on a strong foundation established during the initial 5 years and establish a permanent legacy of America’s support for addressing global health priorities. In addition to an unprecedented and important humanitarian program, PEPFAR can contribute significantly to even more important long-term United States foreign policy objectives, including global economic development, enhanced national security and protection of the health of United States citizens. Again, the support of the American people for the PEPFAR program, as well as the United States sustainability and legacy of this program, would be greatly enhanced by clear evidence that progress towards additional, United States public health and strategic benefits are being demonstrated.

    • Potential United States Public Health Benefits of PEPFAR

      • Reduced risk of global transmission of drug-resistant infections
      • Reduced risk of global transmission of emerging infections
      • Strengthening of United States-foreign public health partnerships and foreign capacity to more effectively address additional and future global health priorities, including pandemic flu, bioterrorism, etc.

    • Potential Strategic Benefits of PEPFAR

      • Creation and strengthening of in-country health care capacity, leading to increased demand for local government investment in and support for public health programs.
      • Recognition of PEPFAR’s improvements in public health outcomes, as a major contribution to global economic development and geo-political stabilization, leading to broader global support for other United States foreign policy objectives
      • Increase in life expectancy and GNP in PEPFAR countries, leading to less dependence on United States foreign aid and greater economic opportunities for United States businesses.

II. PEPFAR Challenges

  1. Optimization of HIV prevention, treatment and care programs for the future

    • Need for “Best Practice” guidelines for PEPFAR countries.

      As mentioned above, a critical challenge for the PEPFAR program is to measure and convincingly demonstrate its impact on key public health outcomes, particularly the reduction of new HIV infections, as well as reduction in HIV-associated morbidity and mortality. In addition, decisions about the design, implementation and funding of PEPFAR prevention, treatment and care programs should be guided primarily by available public health data and evidence of impact on public health outcomes. Current PEPFAR programs are guided by available data. Data from well-designed research studies to guide best practices for HIV prevention are generally limited. In addition, most of the data guiding best practices for HIV care and treatment come from studies limited to developing world settings, not from settings that adequately reflect the complexities and challenges of PEPFAR country settings. Therefore, to optimize the public health impact of PEPFAR, there is a critical need for additional HIV prevention and treatment research that is relevant to resource-limited settings. While awaiting the results of future research, to guide funding decisions and program evaluations, “Best practice guidelines” for PEPFAR settings are needed and these guidelines must be supported by the available, most reliable, most relevant and highest quality public health research data.

    • Need for new HIV prevention, care and treatment research

      The global HIV epidemic is highly diverse. Some countries are burdened with generalized epidemics and other countries must deal with epidemics focused in specific-high risk populations. The clinical characteristics of HIV-associated disease progression are also variable and affected by the prevalence of endemic disease co-pathogens such as TB and diarrheal diseases, as well as the impact of other factors such as nutrition, immunization practices, traditional therapies and available clinical care capacity. In light of this diversity and in order to optimize the cost-effectiveness and public health impact of the PEPFAR program for the future, it is important to continue and increase support for the very best peer-reviewed HIV prevention, treatment and care research. The future success and impact of the PEPFAR program is directly linked to the success and impact of HIV research. Additional operational research, designed to obtain evidence based data to optimize PEPFAR standards of practice and overall program impact is a critical need. Additional developmental research to design and evaluate new, optimized approaches to HIV prevention, care and treatment in PEPFAR countries is also advised. The DHHS has significant research capacity which when combined with the operational aspect of the PEPFAR Prevention, Care and Treatment program is poised to gather needed evidence based data in order to develop best practices and provide PEPFAR programs with the latest data and public health tools for their programs. Therefore, the utility and the long-term impact of the PEPFAR program should be directly supported by substantial annual funding to support additional peer-reviewed HIV prevention, treatment, and care operational research. To maximally benefit the PEPFAR program, these research resources should be utilized to support operational research, to obtain evidence based data to optimize PEPFAR standards of practice and impact. DHHS research resources should be utilized to support research to design and evaluate new, optimized approaches to HIV prevention, care and treatment in PEPFAR countries.

    • Need for additional human capacity building

      A major challenge for the PEPFAR program is human capacity development. Most PEPFAR countries have a limited number of qualified and trained health care workers, who are required to ensure that the public health impact of the considerable resources invested by PEPFAR are optimized. In many settings, PEPFAR programs are competing with other in-country programs for a limited pool of qualified clinicians and program managers. In some settings, other in-country programs such at TB and malaria control or immunization programs are losing their most experienced and qualified personnel to PEPFAR programs. As outlined below, greater integration of PEPFAR programs with other existing public health programs may help to address this issue. However, there remains a critical need to expand the pool of qualified and trained personnel in most PEPFAR countries. The success, cost effectiveness and sustainability of the PEPFAR programs is highly dependent on having sufficient and qualified local health care providers to deliver the programs. Therefore, to maximize the impact of HIV prevention, care and treatment programs, PEPFAR should increase it's funding for training of health care workers, in resource-limited settings as well as increase target funding for the development, implementation and evaluation of novel approaches to sustainable human capacity development.

    • Need for increasing antiretroviral (ARV) access for children with HIV infection.

      By the end of 2005, it was estimated that 2.3 million (1.7–3.5 million) children were living with HIV infection globally; 2.0 million of them reside in sub-Saharan Africa. 822,000 people were receiving PEPFAR-supported ARV treatment in the focus countries (as of September, 2007). Only, 9 percent of them were children. In contrast, children accounted for more than 13 percent of AIDS deaths in 2005. Thus, there is a need to increase the number of children receiving ARV treatment. One of the barriers to scaling up treatment in children is lack of availability of appropriate antiretroviral drug formulations that are easily usable and inexpensive. As of September, 2005, only 13 of the 21 ARV agents approved by the FDA were also approved for children and adolescents younger than 16 to 18 years of age. As a result, caregivers of pediatric HIV patients break or crush adult tablets which may lead to erratic and inappropriate doses. Even when liquid formulations are available, special requirements (e.g., refrigeration, potential harmful additives such as vitamin E, alcohol, propylene glycol and high concentrations of sugar) and problems with taste and large volumes limit a widespread global access to ARV treatment for children. Thus, there is an urgent need to develop formulations that are more acceptable to children and their families. Specifically, in addition to production of appropriate liquid formulations, development of the following should be considered: (1) smaller tablets; (2) tablets in which active drug is uniformly distributed and in shapes that can be easily and accurately divided into halves or quarters to administer smaller doses; (3) capsule sprinkle formulations that can be opened and mixed with food; or (4) tablets that can be crushed, dissolved in water, or chewed.

    • Need for expanded support of United States funded HIV prevention treatment and care efforts in the Western Hemisphere targeting the Caribbean

      During the next phase of PEPFAR, the global HIV epidemic will continue to have its greatest impact on the continent of Africa. However the HIV epidemic in the United States is impacted directly by the HIV epidemic in a number of Caribbean countries, with close economic and community ties to the United States. A number of Caribbean countries are disproportionally impacted by HIV infection and would benefit from enhanced support driven by inclusion as a focus area for PEPFAR support.

    • Need for expanded support for palliative care services, including end of life services

      The PEPFAR program has provided an unprecedented expansion in access to HAART for AIDS patients around the world. The program continues to expand and optimize access to HAART in order to meet the needs of many more patients who would benefit from these treatments. Many patients have yet to receive access to HAART and the PEPFAR program should expand support for palliative care services including end of life care to provide comfort and dignity to terminally ill patients and their families. OGAC should be encouraged to expand efforts to train local community institutions and their members in end of life care and support.

III. Optimization of PEPFAR funding and administrative procedures

  • Need for multi-year funding cycles

    The current administrative structure of the PEPFAR program operates on an annual funding cycle, where decisions are made by in-country United States government program leadership with approval by OGAC. Operationally, annualized funding commitments work against the ability of responsible groups to implement their full capacity because of uncertainty about available funds. For example, ARV procurement has a 3-6 month timeline, such that many programs only become fully operational at their funded levels, 6-8 months into each fiscal year. PEPFAR is a unique program for United States government foreign aid, in that it provides care and treatment for a chronic illness in which provision of ARV’s and other medications is key to survival. Treatment and care interruptions limit the public health benefits of the program. Therefore, an alternative multi-year funding mechanism is necessary, that would maximize the efficient use of available funding and minimize interruption of services.

  • Need for more local decision making and flexibility of community-specific programs.

    As mentioned above, the global HIV epidemic is highly diverse. Some communities face generalized HIV epidemics and other communities face more concentrated epidemics. It is becoming increasingly clear that most epidemics, including the fast-growing epidemics of Eastern Europe and the central Asian republics, are not generalized. Even in Africa, not all countries and regions follow the pattern of a generalized epidemic. Most of the West African epidemics—such as those in Senegal, the Gambia, Mali, Niger, Guinea, and even Ghana—are not really turning out to be generalized epidemics. Population-based surveys are showing that prevalence in all of these countries ranges from under 1 percent to just over 2 percent, and most HIV infections occur among vulnerable groups such as sex workers and their clients. These transmission dynamics resemble the epidemics of most parts of the world, where transmission also occurs mainly within vulnerable groups.

    Interventions for what have been called the universally vulnerable groups—sex workers (usually female), injecting drug users, and men who have sex with men—remain an essential part of AIDS prevention. Interventions for these vulnerable groups can include risk reduction measures such as condom supply and promotion and needle exchange, as well as interventions that help to eliminate high-risk behaviors. Encouraging men who have sex with men to practice faithfulness, helping girls and women leave sex work, preventing drug addiction in the general population, and helping addicts break patterns of addiction and avoid relapse are all needed interventions that have been tried in various settings. Promoting fidelity and abstinence to the general population should always be part of an overall prevention strategy, whatever the type of epidemic. In addition, the clinical diversity of HIV-associated diseases necessitate that optimal approaches for prevention, treatment and care of HIV infection must be flexible and account for this epidemiologic diversity. Local expertise needs to be reflected and engaged in the design and funding decisions of programs for their specific communities. One size may not fit all. Recent data support the implementation of programs that provide voluntary male circumcision as an effective HIV prevention intervention in some settings. However, while flexibility and local input are necessary, a common emphasized throughout this report, is that all PEPFAR-supported HIV prevention, treatment and care programs should be based on evidence based data and should utilize similar public health metrics for monitoring and evaluation, particularly demonstration of prevention of new HIV infections for prevention programs, as well as reduced morbidity and mortality for treatment and care programs.

IV. Sustainability

  • Need to demonstrate clear public health outcomes

    To ensure that PEPFAR's accomplishments are long-lasting and continue to contribute to improvements in global health, the program must be sustained. In order to be sustained, support for the infrastructure and programs established by PEPFAR must be shared by other donors and host governments. As mentioned above, central to securing shared support and local ownership of the programs over time is the clear demonstration of public health and other benefits. Programs without clearly demonstrated value to improving health outcomes, including reduction in new HIV transmissions, as well as reduction in HIV-associated morbidity and mortality, should not be supported by PEPFAR, will not be supported by other donors and will not be sustained. In addition, in order to optimally inform programmatic funding decisions and programmatic designs, all future PEPFAR programs should include plans for similar assessments of impact that include measurement of these public health outcomes.

  • Need to engage the long-term support of the pharmaceutical industry

    Central to the PEPFAR HIV treatment programs is the ability to provide efficacious ARV therapy. It should be anticipated that the standard of care and the recommended medication will change to include medications developed in the future, in the course of sustaining treatment benefits. For PEPFAR to meet the rapidly changing demands for new less costly, less toxic and more effective drugs, there is the need for a long-term strategy that fully engages the creativity, development, and market capacity of the pharmaceutical industry. This recognition is important to future success. It is not prudent, for PEPFAR to assume this will evolve passively or that current medication will continue as the backbone for therapy. Programs that provide incentives for the pharmaceutical industry to create new drugs and formulations, particularly to treat HIVIAIDS patients in PEPFAR country settings are critically important. PEPFAR should require that pediatric formulations (liquids and/or appropriate tablet dosage forms and sizes) be available at the time of country approval of the use of the drug in adults unless there is a biological imperative not to develop the drug use in children. PEPFAR and FDA should work with the pharmaceutical industry to maximize the use of existing pediatric testing incentives and ensure that required pediatric testing and formulation development be completed as early as is medically and ethically possible.

  • Need to engage shared support of local governments and other donors

    The United States government alone cannot indefinitely support the PEPFAR program. However, for the next phase of the program, substantial additional United States investment will be required. During the next phase, more effort focused on establishment of additional local and international partners to share the long-term cost of the programs is imperative. A critical requirement for sustainability and to encourage such partnerships is to implement cost-effective programs that demonstrated clear public health benefit. These benefits need to be reliably measured and clearly communicated to the public and private partners, in order to engage them in discussions about long-term strategies to support these programs.

  • Need to enhance and maintain United States taxpayer support for PEPFAR

    PEPFAR sustainability will require long term United States tax payer support. It is important for United States taxpayers to understand that PEPFAR is much more than humanitarian aid. This is in light of current budget constraints, as well as concerns for the cost of health care and uninsured citizens in the United States. The nation’s taxpayers will support PEPFAR in a sustainable fashion, if they can see and understand it in terms of a long term foreign policy and national security strategy to make the world safer and healthier for them, their children, and their grand children. This will only occur with strong, clear national leadership outlining the path and principle, and anticipated consequences of the linkage between global health and domestic health and global health, foreign policy and national security.

  • Need for more integration of PEPFAR with other existing health programs.

    In order to operationalize the infrastructure and procedures to launch PEPFAR in resource-limited settings, many programs were implemented from the ground up. For the sustainability of PEPFAR programs, greater integration with other existing public health programs, such at TB control, maternal and child health programs, and rural health primary care programs, is required. These other public health priorities are closely tied to and impacted by the HIV epidemic. Program integration is also necessary to maximize PEPFAR’s cost effectiveness and public health impact, as well as to minimize PEPFAR’s competition with other important health programs for resources, trained staff and infrastructure. In many cases, PEPFAR has created a new public health infrastructure, where none had existed. This provides a unique opportunity for PEPFAR to maximize the public health impact of the United States government investment, by building on PEPFAR infrastructure and staff to integrate and strengthen these other related health services.

  • Need to remove import fees on essential drugs and reduce cost of drug distribution

    A significant percentage of the PEPFAR budget is allocated for the purchase and distribution of antiretroviral drugs and other pharmaceuticals required for the care of HIV patients. In some cases, host countries have imposed high fees for the importation of these medications. PEPFAR must not allow high import fees and high local costs of drug distribution to limit the number of patients who can receive these life saving drugs. The United States Government should work to have import fees on HIV medications eliminated and utilize the resources that are now being diverted to those fees to providing more HIV prevention, treatment and care services to more people who need them.

Goals for the Next Phase of "PEPFAR-THER"

  1. HIV Prevention

    Effective HIV prevention programs are absolutely essential to controlling the global HIV epidemic. Every year, more than 4 million new HIV infections occur. Therefore, it is clear that we cannot treat our way out of this epidemic. HIV treatment and care is expensive and the costs of providing care will only continue to rise without a reduction in the numbers of new HIV infections. Comprehensive country-specific, community prevention approaches are necessary. Scaling up mother-to-child transmission prevention programs by making them part of all care sites and networks is just one example. These approaches should all be assessed by similar public health outcomes, including the number of new HIV infection prevented in the communities these programs serve. Current PEPFAR accomplishments have focused primarily on measuring the number of persons who have received prevention services. For the next phase of PEPFAR, it will be important to increase our efforts and demonstrate, with reliable epidemiological data, that PEPFAR prevents more than 2 million new HIV infections in each year of the program.

  2. HIV Treatment

    PEPFAR has provided ART to more than 800,000 patients, since 2003. This is a remarkable and unprecedented public health achievement. However, it is now important to build on this initial success and demonstrate clearly that this expanded access to care has resulted in measurable reductions in HIV associated morbidity and mortality. Given the experience gained over the initial 5 years of the program, scaling up to care should be more cost-effective and efficient. Therefore, the next phase of PEPFAR should aim to provide ART to 5 million HIV-infected patients and demonstrate increased life expectancy and reduced morbidity among those receiving ART through PEPFAR programs.

  3. HIV Care

    The accomplishments of the current PEPFAR HIV care programs are measured in numbers of patients, orphans and vulnerable children who are offered HIV care services. The goal of the next phase of PEPFAR HIV care programs should be to provide care that demonstrated clear public health benefits for the people they serve. Direct evidence of reduced morbidity and mortality among the people receiving care should be a goal of all HIV care programs. In addition, the current PEPFAR HIV care infrastructure that has been put into place should now be able to demonstrate a more cost-effective scale up of services. Therefore, the next phase of PEPFAR should be expanded to provide care for 5 million people every year, who are HIV infected and affected by HIV/AIDS, including orphans and vulnerable children.

  4. Additional PEPFAR Focus Countries

    During the next phase of PEPFAR, the global HIV epidemic will continue to have its greatest impact on the continent of Africa. However, the epidemic is increasing rapidly in Asia. In addition, a number of strategically important areas of the world are threatened by rapidly increasing HIV epidemics, primarily driven by intravenous drug use. These include Russia, Ukraine, Vietnam, and a number of other Eurasian countries. Finally, the HIV epidemic in the United States is impacted directly by the HIV epidemic in a number of Caribbean and Latin American countries, with close economic and community ties to the United States. Therefore, the next phase of PEPFAR should consider additional focus countries to increase the resources provided for HIV prevention, treatment and care to countries in Asia, the Caribbean, Eurasia, and Latin America.

  5. Additional PEPFAR Resources

    To meet the goals of the next phase of PEPFAR and to ensure that the United States government initial investment in PEPFAR optimizes its public health and strategic benefits, additional resources will be needed. Therefore, as recently recommended by President Bush, funding for the next phase of PEPFAR should increase to at least $6 billion per year. This is a substantial investment by the American people, during a time of limited resources and increasing fiscal responsibilities to support our national security. However, significantly improving global health is an important opportunity for the United States to contribute to our national security for generations to come. Global health diplomacy could be the most effective United States foreign policy tool for this century. The next 5-year phase of PEPFAR could provide a long-term legacy of global economic development, good will and strategic security for the United States.

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