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Testimony, Rear Admiral Tim Ziemer
Coordinator, President's Malaria Initiative
U.S. Agency for International Development
Subcommittee on Africa and Global Health
Committee on Foreign Affairs
April 25, 2007

Introduction and Summary:

Each year, an estimated 300 to 500 million people become ill with malaria worldwide and more than one million die. Of these deaths, 85 percent occur in sub-Saharan Africa. Recognizing the critical need for greater international efforts to reduce the burden of malaria across Africa, President George W. Bush, in June 2005, announced the President's Malaria Initiative (PMI). The PMI is a U.S. Government initiative led by the U.S. Agency for International Development (USAID) with the Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC) as its major partner. The Initiative represents an historic five-year expansion of U.S. Government resources to fight malaria in the region most affected by the disease. The President committed an additional $1.2 billion in malaria funding to this Initiative and set the ambitious goal of reducing malaria mortality by 50 percent in the 15 PMI focus countries. Working to mitigate diseases, such as malaria, that threaten the human and economic capacity of countries to progress on their own is a key aspect of the goal of transformational diplomacy.

Since the announcement of the PMI in June 2005, the Initiative has advanced rapidly to achieve results in all three Year 1 countries: Angola, Uganda, and Tanzania. The PMI supported highly successful indoor residual spraying (IRS) campaigns in all first-year countries. These campaigns protected more than two million people and were the first wide-scale spraying programs in these countries in decades. In all Year 1 countries, PMI significantly expanded insecticide-treated net (ITN) programs, procuring and supporting the distribution of approximately one million long-lasting ITNs. Artemisinin-based combination therapies (ACTs) were procured and delivered to all three countries, making this highly effective treatment available to more than 1.2 million people. PMI also supported training for health workers on proper ACT use. To improve the accuracy of malaria diagnosis and ensure the rational use of ACTs, the PMI is procuring microscopes and more than 1 million rapid diagnostic tests. To prevent malaria in pregnant women and reduce the incidence of life-threatening low birth weight among newborns, PMI supported training for 1,900 health providers on intermittent preventive treatment during pregnancy (IPTp). In total, over 6 million persons were reached in Angola, Tanzania, and Uganda during the first year of operations.

In Year 2, beginning in January 2007, the PMI expects to reach an additional 30 million persons with lifesaving interventions in seven focus countries (the initial three countries plus the new focus countries of Malawi, Mozambique, Rwanda, and Senegal). Already in 2007, the PMI is supporting indoor residual spraying programs in Tanzania, Angola, Uganda, Zambia and Madagascar (the latter two as "jump start" activities for new 2008 focus countries), which are benefiting over 5 million persons. Other early 2007 activities include the procurement and distribution of long-lasting ITNs in Malawi, the retreatment of regular nets in Mozambique and Senegal, and the support of malaria in pregnancy activities in Rwanda.

The PMI, in partnership with African ministries of health, The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), The World Bank, the Gates Foundation, and other international efforts, are helping to change attitudes toward malaria control. No more a "fact of life" or an "intractable problem" in sub-Saharan Africa, malaria can be beaten back with a concerted effort from all partners.

The Burden of Malaria:

Each year, an estimated 300 to 500 million people become ill with malaria worldwide and more than one million die. Of these deaths, 85 percent occur in sub-Saharan Africa. For children under age five in Africa, malaria is a leading cause of death, accounting for approximately 18 percent of all deaths in children under five.

Malaria and poverty are closely linked. Economists estimate that malaria accounts for approximately 40 percent of public health expenditures in Africa and is estimated to cause an annual loss of $12 billion from the continent's gross domestic product. Although malaria eradication efforts during the 1950s and 1960s successfully eliminated or controlled the disease in many other areas of the world, malaria remains a major killer in Africa due to a combination of biologic, economic, and political factors. The sub-Saharan climate provides ideal conditions for the malaria parasite and mosquito vector, while poverty and political instability have repeatedly created obstacles to successful malaria control in many African countries.

Malaria Transmission and Infection

Malaria is a blood-borne infection transmitted to human beings by the bite of female Anopheles mosquitoes that carry the malaria parasite. The initial symptoms of a malaria infection include fever, chills, and flu-like illness. The malaria parasite infects and destroys red blood cells, and if not promptly treated, can rapidly progress to severe anemia, lung and kidney failure, coma, and death.

Malaria is typically found in warmer regions of the world, such as sub-Saharan Africa, because both the mosquito and the malaria parasite it carries thrive in tropical and subtropical climates. Four types of malaria parasites infect humans. In sub-Saharan Africa, the majority of infections are caused by Plasmodium falciparum. This species of parasite is responsible for the most severe form of the disease and for the majority of deaths worldwide.

The President's Malaria Initiative

In spite of these grim statistics, malaria is a preventable and treatable disease. In June 2005, President George W. Bush, recognizing the critical need for greater international efforts to reduce the burden of malaria across Africa, announced the President's Malaria Initiative. The PMI represents an historic five-year expansion of U.S. Government resources to fight malaria in the region most affected by the disease. The President committed an additional $1.2 billion in malaria funding to this Initiative and set an ambitious goal for PMI focus countries to reduce the estimated deaths caused by malaria by 50 percent.

Prevention and Treatment Interventions

Malaria is both preventable and treatable. Although a malaria vaccine is not yet available, several proven and cost-effective prevention and treatment measures exist. These include:

• Indoor residual spraying of insecticides in homes;
• Insecticide-treated mosquito nets;
• Prompt use of artemisinin-based combination therapies for those who have malaria; and
• Intermittent preventive treatment of pregnant women with an antimalarial drug.

Specific PMI Targets

The PMI has a single set of country-level targets for the four major control measures. These targets are the same for each focus country and they apply to the populations most vulnerable to malaria-children under age five and pregnant women. These include:

• More than 90% of households with a pregnant woman and/or children under five will own at least one ITN;
• 85% of children under five will have slept under an ITN the previous night;
• 85% of pregnant women will have slept under an ITN the previous night;
• 85% of houses in geographic areas targeted for IRS will have been sprayed;
• 85% of pregnant women and children under five will have slept under an ITN the previous night or in a house that has been protected by IRS;
• 85% of women who have completed a pregnancy in the last two years will have received two or more doses of IPTp during that pregnancy; and
• 85% of children under five with suspected malaria will have received treatment with an ACT within 24 hours of onset of their symptoms.

PMI and Previous USG Malaria Control Programs

The PMI builds upon two decades of USG activities and experience in malaria control. Research supported by USAID and HHS/CDC provided the scientific basis for intermittent preventive treatment in pregnant women, and helped establish the safety and efficacy of ACTs in treating malaria and the value of ITNs in reducing malaria-related mortality and illness in African children. Together with the World Health Organization (WHO), USAID and HHS/CDC played key roles in working with ministries of health in Africa to promote policy change and adoption of ACTs and IPTp. Finally, USAID supported the cultivation in East Africa of the plant from which artemisinin drugs are extracted to increase global supplies of ACTs, provided technical assistance in good manufacturing practice and quality control to Chinese and Vietnamese manufacturers of ACTs, and assisted African textile manufacturers to enter the ITN market.

Scaling up to achieve PMI Targets

The PMI began with a budget of $30 million in Fiscal Year (FY) 2006, which was supplemented by $4.25 million in reprogrammed FY 2005 funds. With Congressional approval, the PMI budget will grow to $500 million in FY 2010.

Country Selection

Focus countries were selected and approved by the Interagency Steering Group using the following criteria:

• High malaria disease burden;
• National malaria control policies consistent with the internationally accepted standards of the WHO;
• Capacity to implement such policies;
• Willingness to partner with the United States to fight malaria; and
• Involvement of other international donors and partners in national malaria control efforts such as the GFATM and the World Bank.

The PMI Approach

The PMI is organized around the following operational principles:

• Commitment to strengthen national malaria control programs (NMCPs) and to build capacity for eventual country ownership of malaria control efforts;
• Close coordination with international and in-country partners, and
• Coherence with the overall strategy and plan of the host country's NMCP.

Malaria Control Interventions

Insecticide Treated Mosquito Nets: In Africa, malaria-carrying mosquitoes typically bite late at night or in the early morning hours. A net hung over the bed acts as a physical barrier to prevent mosquitoes from biting. When that net is treated with insecticide, it provides much greater protection by repelling and killing any mosquitoes that land on it. ITNs come in a variety of shapes, colors, and sizes to suit local tastes and needs. The insecticides used to treat the nets have been approved for safety and efficacy by the WHO.

ITNs have been shown to reduce all-cause mortality in children under five by about 20 percent and malarial illnesses among children under five and pregnant women by up to 50 percent. When a high percentage of residents in a village use an ITN, even those not sleeping under a net benefit from the community protective effect. First generation ITNs required re-treatment with insecticide every 6-12 months to remain effective. However newer ITNs retain effective amounts of insecticides for 3 years (the life of the net) and do not require re-treatment.

Indoor Residual Spraying: Indoor residual spraying is a proven and highly effective malaria control measure. During the 1950s and 1960s, IRS, together with improved standards of living, helped eliminate or control malaria in many areas outside Africa. IRS involves the coordinated, timely spraying of the interior walls of a home with small amounts of insecticides, which kill mosquitoes when they enter the home and rest on walls. The protection provided by spraying lasts from about four to ten months, depending on the insecticide used and the wall surface. The decision to use IRS as a control strategy takes into account such factors as the logistics of spray teams being able to regularly access communities, household construction and housing density, and the epidemiology of local malaria transmission.

WHO has approved 12 insecticides it considers effective and safe for use in IRS, including DDT (see below). The choice of insecticide depends on whether it is registered for use in the country, the type of wall surfaces to be sprayed, the duration of the transmission season, and resistance levels of the local species of mosquitoes that transmit malaria. The choice of insecticide will also depend on whether or not the national malaria control program plans to apply different insecticides in a rotation scheme to slow the emergence of resistance. For IRS to be effective, at least 80 percent of the homes in the targeted geographical area must be sprayed.

The PMI supports IRS with DDT as an effective malaria prevention strategy in tropical Africa in those situations where it is judged to be the best insecticide from the standpoint of local transmission of the disease and where use is permitted by host-country policy. The use of DDT for IRS to prevent malaria is allowable under the Stockholm Convention - also known as the Persistent Organic Pollutants or POPs Treaty - when used in accordance with WHO guidelines. Some countries do not carry out IRS or have not registered DDT for use in their malaria control programs. The reasons may include insecticide resistance, the epidemiological situation of the country, the organizational capacity of the program, or in some cases, concerns related to their agricultural export market.

DDT is more effective and less expensive than many other insecticides in some situations; as a result, it is a very competitive choice for IRS programs. DDT specifically has an advantage over other insecticides when long persistence is needed on porous surfaces, such as unpainted mud walls, which are found in many African communities, particularly in rural or semi-urban areas. In Zambia, as in the other countries receiving IRS support, USAID provided training and materials for improving national capacity for the safe and judicious use of pesticides in accordance with WHO standards and as stipulated by international agreements, such as the Stockholm Convention.

Intermittent Preventative Treatment in Pregnancy: Malaria infection during pregnancy poses serious health risks for both the mother and her unborn child. Malaria may be transmitted from mother to fetus before or during labor and delivery. If a pregnant woman contracts malaria, she is at much greater risk of anemia, premature delivery, and death. In addition, because malaria parasites sequester in the placenta and impair the delivery of nutrients to the growing fetus, a mother's newborn child is at higher risk of low birth weight - a leading cause of poor infant survival in Africa. The prevention and treatment of malaria during pregnancy depends on a combination of malaria control measures, including the use of ITNs, laboratory diagnosis for prompt and effective treatment, and intermittent preventive treatment.

Intermittent preventive treatment of pregnant women is a highly effective means of reducing the risk of malaria in pregnant woman and the adverse consequences to her unborn child. It involves the administration of at least two treatment doses of an antimalarial drug, sulfadoxine-pyrimethamine, to the woman during the second and third trimesters of her pregnancy with at least a one-month interval between doses. IPTp reduces the frequency of maternal anemia, malaria infection of the placenta, and the delivery of low birth weight babies. Because in most African countries more than 70 percent of pregnant women attend antenatal clinics, these clinics serve as an attractive platform for delivering preventive treatments. The wide-scale use of IPTp could prevent up to 75,000-200,000 infant deaths each year in Africa.

Diagnosis and Treatment: Artemisinin is an antimalarial drug derived from a plant, Artemisia annua, or sweet wormwood, which has been used as a fever remedy in China for more than 1,000 years. The artemisinin family of drugs are the most rapidly-acting and effective antimalarial drugs currently available. Combined with a second effective antimalarial, they have become the standard of care for malaria in most parts of the world where resistance to traditional single drug therapies, such as chloroquine, has become common. This is termed artemisinin-based combination therapy, or ACT.

Since ACTs cost 10-20 times more than chloroquine and have a shelf life of just 18-24 months, good pharmaceutical management is critical to their effective use. Unfortunately, many ministries of health in Africa have weak drug management and logistics systems. In addition, ACTs are relatively new to most African countries, so large-scale in-service training of health workers and education of patients will be needed.

The high cost of ACTs heightens the need for accurate diagnosis of malaria, which, because of its nonspecific symptoms, may be quite difficult to distinguish from other causes of fever. Microscopic examination of blood smears from patients with suspected malaria is considered the gold standard for diagnosis, but it requires considerable supervisory and logistic support to sustain high quality performance. In recent years, the development and refinement of rapid diagnostic tests for malaria has offered a potentially simpler solution to malaria diagnosis in settings where microscopy is not feasible or sustainable. RDTs are simple to use; however, they do have limitations, including problems with quality control during production, sensitivity to high temperature and humidity.

PMI Results in Year 1

The PMI is off to a very rapid start. Within six weeks of the President's announcement, PMI had fielded needs assessment teams to all three first-year countries. Within six months, high-impact activities were underway in Angola and Tanzania, and a month later in Uganda.

During the first year of the Initiative, PMI supported highly-successful indoor residual spraying campaigns in all first-year countries. These campaigns protected more than two million people and were the first wide-scale spraying programs in these countries in decades. In all three countries, PMI has significantly expanded ITN programs and is working to accelerate the transition from regular ITNs to long-lasting nets, which do not require periodic re-treatment. In both Angola and Uganda, private sector providers of ITNs have been supported and strengthened, contributing to sales of more than 600,000 ITNs to those who can afford to pay. In Uganda, PMI supported a campaign that resulted in free re-treatment with insecticide of more than 500,000 existing nets. In total, PMI has procured and supported the distribution of approximately one million ITNs in its first year. In addition, PMI's support for an integrated campaign in Angola that linked measles vaccination with free ITN distribution, helped attract contributions of about 400,000 additional ITNs from other donors.

Artemisinin-based combination therapies have already been procured and delivered to all three countries, making this highly effective treatment more widely available to vulnerable populations. The PMI is providing both microscopes and rapid diagnostic tests in all countries to improve the accuracy of malaria diagnosis. To prevent malaria in pregnant women and reduce the incidence of life-threatening low birth weight among newborns, PMI has supported IPTp. In total, more than 10,000 health providers have already been trained in these critical interventions with PMI support.

Highlights of the activities carried out during the first year of PMI in the three countries include:

Angola: Beginning in December 2005 in Angola, the PMI supported a spraying campaign in epidemic-prone southern provinces, which included training 350 locally-hired spray personnel and protected more than 590,000 people. In addition, PMI provided assistance to a complementary GFATM-supported spraying program that covered an additional 176,000 people. In July 2006, PMI, in conjunction with the Government of Angola, the GFATM, the Measles partnership, ExxonMobil Foundation and other donors supported the free distribution of 826,000 long-lasting ITNs (420,000 contributed by PMI) in seven provinces at high risk of malaria. An additional 120,000 long-lasting nets were sold at subsidized prices to urban residents who had the ability to pay. With support from both the GFATM and PMI, ACTs are now used for the treatment of malaria in health facilities in two provinces, with rapid, country-wide scale-up planned in the coming year.

Tanzania: In Tanzania, beginning in mid-December 2005, PMI distributed 130,000 free long-lasting ITNs (233,000 total with contributions by the GFATM) through local health clinics, more than doubling existing ITN ownership rates among pregnant women and children under age five on Zanzibar and Pemba Islands. Also in Zanzibar, PMI supported an indoor residual spraying campaign that benefited more than one million people. On the mainland, larviciding of mosquito breeding sites in Dar es Salaam is benefiting an estimated 128,000 people and more than $650,000 of ACTs have been procured and have arrived in-country.

Uganda: In Uganda, to address the alarming rates of malaria mortality in internally-displaced person camps in northern Uganda, PMI distributed over 300,000 free long-lasting ITNs to children and pregnant women. In addition, PMI is helping private net producers expand their markets and more than 500,000 ITNs have been sold to those who can afford to pay. The PMI also procured and began distributing 261,870 pediatric ACT treatments as part of community-based distribution in northern Uganda. In August 2006, PMI completed a spraying campaign in southwestern Uganda that benefited 488,000 people and trained more than 400 sprayers and supervisors who will be capable of implementing future programs. Finally, PMI completed a program that re-treated over 500,000 conventional nets with insecticide.

Plans for Year Two

In Year 2, beginning in January 2007, the PMI expects to reach an additional 30 million persons with lifesaving interventions in seven focus countries (the initial three countries plus the new focus countries of Malawi, Mozambique, Rwanda, and Senegal). Already in 2007, the PMI is supporting indoor residual spraying programs in Tanzania, Angola, Uganda, Zambia and Madagascar (the latter two as "jump start" activities for new 2008 focus countries), which are benefiting over 5 million persons. Other early 2007 activities included the procurement and distribution of long-lasting ITNs in Malawi, the mass re-treatment of nets with insecticide in Senegal and Mozambique, and malaria in pregnancy activities in Rwanda.

Early Impact

After just 15 months of implementation, we are already beginning to see significant progress towards national-level coverage with major malaria control interventions. In the past year, Zambia, as part of a PMI jump-start activity in collaboration with the World Bank and others, was able to more than double the population protected from IRS using DDT and pyrethroid insecticides. The number of households sprayed increased from approximately 250,000 to more than 600,000 houses, protecting roughly three and a half million persons. In the seven Angolan provinces that benefited from the Measles/Malaria ITN Campaign in July 2006, the percentage of children who slept under an ITN has increased from less than 5 percent to more than 69 percent. In these areas 94 percent of households now own an ITN. Since 2006, household ITN ownership in Uganda will have risen from 14 percent to an estimated 50 percent due to the net contributions of PMI and other partners. In Madagascar, PMI, in partnership with Malaria No More and the Measles/Malaria Coalition will fill a gap in ITN stocks to reach 80 percent coverage of vulnerable populations this year. In Zambia, the combined efforts of PMI, PEPFAR, and Global Business Coalition will provide 505,000 long-lasting ITNs to extremely vulnerable populations. With this and other donations, the country will reach its goal of 80 percent of households owning at least three ITNs this year.

Finally, in Zanzibar, where the PMI partnered with the Zanzibar Malaria Control Program, and the GFATM to distribute 230,000 ITNs, a health impact is already apparent. Between 2005 and 2006 there has been an 87 percent drop (from 12,531 to 1,570) in the number of laboratory-confirmed malaria cases on Pemba Island according to local health reports.

PMI and Partnerships

Partnerships are at the heart of PMI's strategy. Given the enormous burden of malaria and the ambitious target of reducing malaria deaths by half by 2010, effective partnerships, particularly at country level, are essential to reach the maximum number of people. For this reason, PMI closely coordinates its activities with host country governments, other U.S. Government agencies, international organizations, other bilateral, multilateral, and private donors, and non-governmental (NGO) and faith-based organizations.

Multilateral Organizations: The PMI seeks to identify and fill gaps in funding from other global partners engaged in the fight against malaria. In each of the Year 1 PMI countries, the Initiative coordinated its efforts with existing grants of the GFATM. For example, in Angola, where a major portion of the drugs needed for the initial phase of ACT implementation are provided through a three-year $40 million GFATM grant, PMI has focused on training health workers and health education to support the scale up of ACTs.

In Uganda, 3.8 million ACT treatments purchased by the GFATM were distributed nationwide with technical assistance from PMI in developing a plan for storing, distributing, reporting, and monitoring of these drugs at the national and district level. In Tanzania, PMI complements GFATM activities by training health care workers in 54 of 121 districts nationwide, while the GFATM trains health workers in other areas. The PMI also coordinates its activities with The World Bank's Malaria Booster Program in countries where both institutions are working. At the global level, PMI partners with both WHO and the United Nations Children's Fund (UNICEF) to ensure a steady world supply of high-quality ACTs, ITNs, and rapid diagnostic tests at reduced prices. The PMI and WHO are working together to support increased use of residual spraying with insecticides (including DDT) in Africa. The PMI also works with UNICEF at the country level to coordinate the implementation of activities, such as the joint implementation, in mid-2006, of the MoH-led ITN distribution-measles vaccination campaign in Angola.

Private Sector Partners:

When PMI was launched in June 2005, President Bush urged other donors, including the private sector, to join in a broad campaign to reduce malaria mortality by 50 percent in Africa. The President reiterated this challenge at the White House Summit on Malaria in December 2006. Several donors in the private sector are already making major contributions to the fight against malaria, including the Bill and Melinda Gates Foundation, one of the largest funders of health activities in the world today, and Marathon Oil Corporation with Noble Energy, Inc., which are supporting a highly successful malaria control project in Equatorial Guinea. The PMI also supports technology transfer to Tanzanian net manufacturers to ensure in-country capacity to produce high-quality ITNs.

In FY 2006, the largest direct financial contribution to PMI from an external source was a $1 million donation from ExxonMobil Foundation for activities in Angola. This funding helped support the nationwide Malaria Indicator Survey that will serve as a baseline against which to measure progress towards targets. This funding also supported promotion and health education activities for ITNs, and strengthening of the Ministry of Health pharmaceutical management system. In addition, ExxonMobil contributed 70,000 nets to the integrated measles vaccination-ITN distribution campaign. In FY 2007, ExxonMobil has again donated $1 million in support of PMI's activities in Angola.

In Uganda, PMI is partnering with the nonprofit organization Malaria No More to procure and distribute 550,000 free long-lasting ITNs through a national mass campaign targeting districts with low net coverage (350,000 long-lasting ITNs from Malaria No More, 200,000 long-lasting ITNs from PMI).

In Zambia, PMI and PEPFAR have joined forces with the Global Business Coalition and an NGO coalition (led by World Vision) to distribute more than 505,000 long-lasting ITNs to particularly vulnerable groups such as the poorest of the poor and households affected by HIV/AIDS.

In Madagascar, the American Red Cross, Malaria No More, and PMI will contribute 110,000 long-lasting ITNs and $1.3 million in distribution costs to an integrated measles-malaria campaign, which will benefit more than 1.4 million children.

Malaria Communities Program:

On December 14, 2006, President and Mrs. Bush hosted a White House Summit on Malaria in Washington, D.C., to raise awareness about malaria and mobilize a grassroots effort to save millions of lives from the disease in Africa. This event brought together international experts, corporations and foundations, African civic leaders, and voluntary, faith-based, and non-profit organizations. At the Summit, the President and First Lady launched the Malaria Communities Program - a $30 million initiative to build new and sustainable malaria control projects in Africa by providing grants to indigenous non-governmental organizations and faith-based organizations to implement community-based malaria prevention and control activities in PMI countries. The PMI just released its initial Request for Applications for the program.

Monitoring and Evaluation

The PMI has established a single set of targets for its four primary interventions: ITNs, IRS, IPTp, and ACTs. These targets establish the levels of coverage to be achieved by the end of PMI and are the same for each focus country. The targets support the achievement of PMI's goal to reduce estimated malaria-related deaths by 50 percent. The PMI's evaluation framework is aligned with the standard methodology for malaria program evaluation adopted and promoted by the Roll Back Malaria Partnership. Coverage indicators will be estimated at baseline, midpoint, and at the end of PMI. The impact of PMI-supported efforts on deaths in children under five years of age will be estimated at the end of PMI compared with baseline information collected in each country.

The evaluation strategy includes:

• Measurement of coverage with ITNs, IPTp, ACT's, and IRS at baseline, midpoint, and the end of PMI to see if coverage at the national level has increased as expected.
• National estimates of deaths from all causes for children under five at baseline and at the end of PMI. Deaths from all causes among children under five is a routine health indicator collected through nationally representative surveys, such as Demographic and Health Surveys and Multiple Indicator Cluster Surveys, in countries where routine registration of deaths is not available;
• Collection of data on deaths attributed to malaria from selected demographic surveillance system sites and, in some cases, national surveys. This information, along with information on deaths from all causes for children under five, coverage of malaria interventions, and other relevant factors, will be analyzed together to estimate reductions in malaria-associated deaths; and
• Collection of data on the frequency of anemia and malaria infection among children under five to assess impact on malaria-related morbidity.

The PMI as a Catalyst for Improving Maternal and Child Health (MCH) and Health Systems

The high impact malaria prevention and treatment interventions of the PMI are implemented in target countries in a way that benefits and improves broader MCH efforts and strengthens health systems. For example:

• PMI support of IPTp and the distribution of long-lasting ITNs will help improve the scope of antenatal care (ANC) services provided at first line health facilities and may help increase early use and frequency of use of ANC services. To further support ANC, in many countries PMI will support the purchase of iron and folate supplements, the printing of ANC cards, information, education, and communication activities to promote ANC attendance, and other actions to improve the overall quality of antenatal care;
• We are supporting the expansion of community based services, outreach, and community volunteer programs that can deliver malaria as well as other high priority MCH services (e.g., pneumonia and diarrhea treatment). The availability of ACTs in community programs has the potential to increase utilization of community-based services and the effectiveness of local health agents;
• The PMI supports the strengthening of pharmaceutical management systems that will improve the management of not only malaria commodities but all essential medicines that are needed for public health programs;
• PMI supports strengthening of laboratory services for malaria diagnosis, and in so doing strengthen the overall quality and quantity of laboratory services;
• While training of health care workers is essential, on-the-job supervision is equally critical. The PMI supports ministry of health efforts to improve the quality and quantity of health care worker supervisory visits in a manner that integrates malaria with other MCH services;
• PMI provision of ACTs and long-lasting ITNs to health facilities should increase the population's utilization of these facilities. Preliminary evidence from an operational research project in Mali shows an increase in attendance at health clinics and care-seeking from community health workers following provision of free ACTs;
• In all countries we are supporting improvements in the health management information system; and
• PMI is collaborating with other major health initiatives, such as PEPFAR, to strengthen and integrate MCH services.

We will be closely monitoring the impact of the PMI on public health programs, including improvements in access of the population to services, the quality of services, and the utilization of public and private facilities.

PMI and PEPFAR Collaboration

The President's Malaria Initiative (PMI) continues to partner with the President's Emergency Plan for AIDS Relief (Emergency Plan/PEPFAR) in countries that are targeted by both programs. By 2008, five countries will be jointly covered by the two Presidential initiatives. The collaboration of PMI and PEPFAR has already enabled countries to provide comprehensive services for some of the most vulnerable groups for both diseases, including pregnant women, people living with HIV/AIDS (PLWHA) and orphans and vulnerable children (OVCs) under age five. PMI and PEPFAR are actively collaborating to ensure integration of health care worker training and supervision, strengthening of laboratory services, and integration of interventions, especially in the context of antenatal care.

Because of technical and programmatic overlap between PMI and PEPFAR, the two programs are developing a framework for cooperating and sharing resources. This collaborative framework will allow both initiatives to avoid duplication, ensure safety, facilitate maintenance of appropriate and efficient funding streams and result in an overall increase of coverage of key interventions.

PEPFAR and PMI have asked its country teams to work together to ensure that USG resources are maximized and leveraged to mobilize host government resources to address the problem. For example, PMI is leveraging resources with PEPFAR in programs that expand the use of cotrimoxazole and insecticide treated nets.

Capacity Building

One of the guiding principles of the PMI is to build the capacities of national malaria control programs, district and health facility workers, and private sector providers. The PMI launched IRS programs in all three first-year countries, building the capacity of national programs to implement these high impact activities. For example, in Uganda, the NMCP introduced IRS to Kabale district, which is prone to epidemics, and protected over 500,000 persons. As a result of the experience, the NMCP strengthened their IRS policies to include spraying in high transmission and internally displaced person settings, in addition to IRS for epidemic control. The NMCP also improved planning, reporting, and environmental and human health safety requirements related to IRS as well as hired additional entomologists to manage the program. In total, over 1,300 persons were trained as part of the IRS programs supported in Uganda, Tanzania, and Angola.

In Tanzania, the PMI provided assistance to the NMCP to improve the procurement, storage, inventory management, and distribution of ACTs as well as established a commodity tracking system. This support included the training of trainers for 32 regional pharmacists and 150 district-level pharmaceutical personnel.

During its first year, the PMI trained over 10,000 health workers and spray personnel in the initial three countries and built capacities of national programs to plan, conduct, and supervise high quality prevention and treatment activities. In Uganda, Senegal, Rwanda and other countries, the PMI is expanding community health programs by helping to train, supervise, and support community health agents who have the potential for delivering a broader range of essential services.

Sustainability

Sustainability of malaria control programs is a critical goal of the PMI. To this end, the PMI aims to promote:

• Increased funding by host governments of NMCPs;
• Increased diversification and long-term funding of malaria control activities by donors and international organizations;
• Improved quality of national malaria control activities, including the training of critical masses of health workers in malaria interventions;
• High and sustained national coverage rates for malaria prevention and treatment interventions and the full integration of these interventions into other health programs such as MCH and HIV/AIDS;
• Involvement of community, voluntary and private sector organizations in malaria control activities at national, district and community levels; and
• Increased knowledge of malaria at the community level and demand for high quality preventive and curative services at all levels of the health care system.

With progress on each of these elements, NMCPs in Africa will become more effective, sustainable, and accountable. More importantly, national leaders, health managers, and persons living in malaria endemic areas will expect and demand effective, nationwide malaria control activities and will help to make this happen. As with child vaccines, there should be an international mandate that no malaria endemic country will suffer stock-outs of essential malaria commodities. Finally, national governments and international donors and organizations will be judged by the quality and coverage of their national malaria programs.

There is now evidence that the PMI, the GFATM and other malaria donors are helping to make important progress on all these key elements of sustainability. For example:

• There is clearly increased international and national level funding for malaria control activities. In PMI countries, national governments are hiring additional staff and providing increased operational costs for malaria prevention and treatment.
• National coverage rates for malaria interventions are increasing rapidly. For example, ITN household ownership rates are now approaching 50 percent for all three first-year PMI countries, compared with household ownership levels of less than 10 percent only a few years ago; and
• More community and private sector organizations are being mobilized as evidenced by the partnerships established by the PMI.

Accountability and Transparency of PMI

Providing information to the public on funding allocations, procurements, program activities, milestones, and results in a timely and accurate manner is a high priority for PMI. The PMI communication strategy calls for information about PMI and its operations to be made available through multiple communication channels, including PMI newsletters, public announcements, press releases, various international events, and the PMI Web site (www.fightingmalaria.gov). Latest news and updates on PMI activities from the field are continuously collected and shared through these channels. Key items that will be posted to the PMI Web site include:

• Contracts/grants. (As of December 31, 2006, more than 90 percent of all contracts and agreements related to Fiscal Year 2006 PMI activities were posted on the PMI web site);
• Annual reports from PMI implementers;
• Program audits; and
• Annual country PMI operational plans that describe the strategies, activities, implementing mechanisms, and funding for the coming year.

USAID Malaria Programs outside of the PMI

Country and Regional Programs: In FY 2007, USAID will be supporting comprehensive malaria prevention and treatment programs in 11 African countries. Eight of these have been selected to become PMI countries beginning in FY 2008. All programs are directly supporting NMCPs to fill critical gaps in programming. Focus is on scaling up the high priority interventions mentioned above.

Outside of Africa, USAID supports two regional malaria activities in areas with severe problems related to multi-drug resistance: the Amazon Malaria Initiative in South America and the Mekong Malaria Program in Southeast Asia. As a result of these USAID-supported efforts, all 8 countries making up the Amazon Basin of South America and all 5 countries in the Mekong Delta Region have updated their national treatment policies and are now using ACTs as recommended by WHO. Support is now being provided to ensure that the new treatment policies are being effectively and safely implemented. In addition, because of the growing problem with fake or substandard antimalarial drugs, particularly in Southeast Asia, these two programs are helping ministries of health strengthen their capabilities for monitoring the quality of antimalarial drugs circulating in their countries.

Malaria Vaccine Development: USAID continues its commitment to development of a malaria vaccine to complement other malaria control measures. USAID actively collaborates with the other major groups involved in malaria vaccine development world wide, including the Department of Defense, the National Institutes of Health, CDC within HHS, the Food and Drug Administration, WHO, the European Commission, the European Malaria Vaccine Initiative, the Wellcome Trust, the Bill and Melinda Gates Foundation, the Malaria Vaccine Initiative, and GlaxoSmithKline. Focus is on translating research findings into vaccines that can be tested in human volunteers as quickly as possible.

Field testing has accelerated in recent years with one vaccine with moderate efficacy scheduled for licensure within five years, supported by other partners. In the meantime, USAID's support is focused on developing other vaccine options. A vaccine candidate will begin Phase 2 efficacy trials in the field this year, supported by USAID with other partners. These research and development efforts form a necessary and important part of the worldwide thrust to combat this disease.

Other Research: USAID's support to Medicines for Malaria Venture, a public-private partnership for new drug discovery and development, is contributing to the development of a pediatric formulation of artemether-lumefantrine and several new and very promising combination antimalarial drugs, which should be registered within the next 2-3 years. In collaboration with WHO, USAID is funding research on the safety of ACTs in pregnant women, community-based use of ACTs, and the integrated management of malaria and acute respiratory illnesses in children under five.

Conclusion:

The PMI is helping to change attitudes toward malaria control. No more a "fact of life" or an "intractable problem" in sub-Saharan Africa, malaria can be beaten back with a concerted effort from all partners.