OVERVIEW: An estimated 800,000 to 900,000 Americans are believed to be living with HIV, the virus that causes AIDS. Since the epidemic began in 1981, more than 700,000 Americans have been diagnosed with AIDS, and more than 420,000 men, women, and children have lost their lives to this disease.
The Clinton Administration has responded aggressively to the significant threat posed by HIV/AIDS with increased attention to research, prevention, and treatment. Overall funding for AIDS-related programs within HHS has increased by 150 percent under the Clinton Administration, with funding for HIV/AIDS care under the Health Resources and Services Administration's Ryan White CARE Act increasing by 358 percent. The proposed FY 2001 budget includes $9.2 billion in total HIV/AIDS funding within HHS.
At the same time, the Administration has sharpened the focus of its AIDS programs, establishing a new Office of National AIDS Policy at the White House, and signed legislation creating a permanent Office of AIDS Research at the National Institutes of Health (NIH). The Administration also convened the first-ever White House Conference on HIV and AIDS in December 1995, released the first National AIDS Strategy in December 1996, and prepared the first federal biomedical research plan for HIV/AIDS in 1997. In May 1997, President Clinton announced a comprehensive AIDS vaccine research initiative designed to lead to the development of an AIDS vaccine within 10 years, and in 1998, the Food and Drug Administration approved the nation's first large-scale trial of an AIDS prevention vaccine. In addition, the President announced the Millenium Vaccine Initiative on May 31, 2000 which calls for sharp increases in vaccine research at the National Institutes of Health, new investments for the purchase and delivery of existing vaccines and a substantial tax credit for the private sector to speed the development of new vaccines.
Today, HIV research efforts are making real inroads. New drugs are providing vast improvements in the treatment of HIV and AIDS, and new treatment guidelines released by HHS are giving health professionals much needed guidance to help standardize the care of individuals living with HIV/AIDS. As a result, the National Center for Health Statistics announced on October 5, 1999, that HIV/AIDS mortality has declined more than 70 percent since 1995, and that AIDS cases are no longer among the top 15 causes of death in national statistics, a fall from eighth place in 1996. Overall, the age-adjusted death rate from HIV infection is the lowest since 1987. This reflects the impact of powerful new anti-HIV drugs, and increased access to health care for those living with HIV/AIDS. However, transmission of the disease continues, and effective prevention efforts are still crucially important, as is the search for a vaccine.
The trends in AIDS death rates are uneven across racial and ethnic groups. In October 1998, President Clinton declared HIV/AIDS to be a severe and ongoing health crisis in racial and ethnic minority communities and announced a comprehensive new initiative in collaboration with the Congressional Black Caucus to improve the nation's effectiveness in preventing and treating HIV/AIDS in the African-American, Hispanic and other minority communities. Through the Minority AIDS Initiative, targeted funding and technical assistance helps minority organizations and coalitions become stable, ongoing sources of HIV prevention, HIV care and treatment services, and substance abuse and mental health services within their communities. In June 1999, the Administration also announced that Crisis Response Teams would provide special technical assistance to 11 U.S. metropolitan areas to combat the spread of HIV/AIDS among racial and ethnic minority populations. The Crisis Response Teams are meeting with local officials, public health personnel and community-based organizations that work with racial/ethnic minority persons living with HIV/AIDS to help them develop targeted strategies to curb the rapid spread of HIV/AIDS among minority populations in their communities and to encourage those affected to enter care.
HHS SPENDING ON HIV/AIDS
Under the Clinton Administration, discretionary spending for HIV/AIDS research, prevention, and treatment has increased dramatically. Altogether, discretionary AIDS-related spending by HHS in FY 2000 totaled $4.6 billion, up from $2.1 billion in FY 1993. In addition, at least $3.9 billion is estimated to have been expended in FY 2000 for AIDS care under Medicaid and Medicare, up from $1.6 billion in FY 1993. It is estimated that more than 50 percent of Americans living with AIDS rely on Medicaid for their health coverage.
The President's FY 2001 budget proposes an increase of $66 million, for a total of $795 million, for programs focused in two areas -- domestic HIV prevention and global AIDS. This increase in funding for HIV activities at the Centers for Disease Control and Prevention (CDC) will be used to encourage individuals at risk to avoid behaviors that can result in the transmission of the disease. Funding for CDC HIV prevention efforts in the U.S. have increased by $297 million, or 60 percent during the Clinton Administration. Internationally, the President's budget includes $61 million for CDC, an increase of $26 million, or 74 percent, to continue efforts to prevent the spread of HIV in developing nations. It is estimated that currently there are 22 million adults and 1 million children living with HIV/AIDS in the sub-Saharan region of Africa, and 34 million persons living with HIV infection globally.
The FY 2001 budget will also invest an additional $125 million, for a total of $1.72 billion, in the Ryan White CARE Act Program, an increase of almost 8 percent over last year's funding level, to provide primary medical care and other crucial support services for people living with HIV and AIDS among increasingly vulnerable populations. This increase will allow an additional 2,900 persons to receive drug therapy through the AIDS Drug Assistance Program (ADAP). These drugs have helped to decrease the progression of HIV to AIDS as well as to improve the quality of life for people living with HIV/AIDS. During the Clinton Administration, the funding for the Ryan White CARE Act has increased 358 percent from $348 million in FY 1993 to $1.595 billion in FY 2000.
The FY 2001 budget also requests a total of $2.1 billion for AIDS-related research at the NIH. This is an increase of $105 million, or 5.2 percent over the FY 2000 level. It represents a 97 percent increase in funding for NIH AIDS-related research since FY 1993.
Further, the FY 2001 budget requests $128.4 million for the Substance Abuse and Mental Health Services Administration (SAMHSA) to address substance abuse and mental illness specifically as they relate to HIV/AIDS. This is an increase of $14.8 million, or 13 percent, over the FY 2000 level. The majority of this funding will be used for the HIV set-aside of the Substance Abuse Block Grant and Targeted Capacity Expansion programs for substance abuse treatment, prevention, and HIV/AIDS services focused on building infrastructure in racial and ethnic minority communities highly impacted by the HIV/AIDS epidemic.
STEPPING UP HIV PREVENTION
HIV prevention efforts in the United States have significantly reduced the incidence of HIV infections. Prevention initiatives have helped slow the rate of new HIV infections in the U.S. from more than 150,000 per year in the late 1980's to approximately 40,000 per year today. Specifically, the number of U.S infants who acquire AIDS from mother-to-child transmission dropped by 75 percent from 1992 to 1998. In 1996, for the first time in the history of the AIDS epidemic, the number of Americans diagnosed with AIDS, a late manifestation of HIV disease, also declined. AIDS deaths dropped 42 percent between 1996 and 1997 and the rate of decline was 20 percent from 1997 to 1998.
· HIV Prevention - Helping Communities: CDC provides local communities with extensive financial support and technical guidance to implement effective strategies to prevent HIV transmission. Each year, CDC delivers more than $450 million in financial support for HIV prevention activities to 65 state, territorial and local health departments, multiple national and regional minority organizations, and more than 100 local community-based organizations. Altogether, this assistance accounts for 76 percent of CDC's spending on HIV prevention for high-risk communities.
In 1993, CDC revised the way funds were distributed from health departments, adopting "community planning" to improve the effectiveness of its prevention funding to local communities. Under this approach, special committees, including health department and community representatives, collaborate to determine local priorities for HIV prevention based on data on the local epidemic, existing community resources, and science on the most effective prevention interventions.
In addition to community-based prevention programs, CDC's grants to health departments also support the public HIV counseling and testing programs that serve as a gateway to HIV prevention and treatment for both at-risk and infected individuals. CDC also funds and provides technical assistance to state and city education departments throughout the country to help them provide HIV prevention education for young people.
· Publication of Compendium of HIV Prevention Interventions with Evidence of Effectiveness: CDC developed the Compendium of HIV Prevention Interventions with Evidence of Effectiveness to help prevention service providers, planners, and others to implement science-based interventions that work. The Compendium provides state-of-the-science information about interventions with evidence of reducing sex- and/or drug-related risks, and the rate of HIV/STD infections. These interventions have been effective with a variety of populations, including heterosexual men and women, high-risk youth, incarcerated populations, injection drug users, and men who have sex with men. All interventions included in the Compendium came from behavioral or social studies that had both intervention and control or comparison groups and had positive results for behavioral or health outcomes.
· Implementation of Know Now! Campaign: Of the estimated 800,000- 900,000 people living with HIV in the United States, as many as one-third don't know it. Experience with, and formal evaluations of previous public health social marketing and communication campaigns consistently demonstrate the value of communication approaches in increasing awareness and promoting specific behaviors, such as HIV testing. In addition, campaigns can play a significant role in addressing HIV related stigma. For these reasons, CDC has developed "Know Now!," a social marketing campaign that will utilize various communication channels in multiple targeted efforts to reach those at greatest risk of HIV with HIV testing and referral messages.
· Surveillance: CDC works with state and local health departments to track the number of HIV and AIDS cases in different areas. In December 1999, after extensive work with state health departments and community HIV/AIDS organizations, CDC released guidelines to assist states in designing and implementing effective HIV surveillance systems. These guidelines include specific standards for both quality and confidentiality, reflecting CDC's responsibility to balance the need for better data with legitimate concerns about confidentiality and security. They also stress the continued importance of anonymous testing as an essential component of any surveillance system.
· Collaboration for Incarcerated Populations: The prevalence rates for AIDS are significantly higher among inmates and releases, especially women and adolescents, than in the total U.S. population. Of the estimated 229,000 persons living with AIDS in 1996, almost 39,000 (17% ) passed through a correctional facility that year. The confirmed AIDS case rate among prisoners (0.51%) was more than 5 times the US rate. Racial and ethnic minorities are disproportionally represented in incarcerated populations, and approximately 80% of prisoners have a history of substance abuse, including alcohol use. To begin to address these issues, in FY 99, CDC and the Health Resource and Services Administration (HRSA) jointly developed and funded a corrections demonstration project with 7 State health departments to design and implement innovative HIV prevention, care, and continuity of care programs for inmates in jails, prisons, or juvenile detention centers. Projects were also funded to provide technical support for these demonstrations and help highly impacted communities develop capacity to address HIV/AIDS prevention in correctional settings.
· New Testing Technologies: CDC developed a cutting-edge laboratory tool, the detuned assay, which allows identification of recent HIV infections. This new technology has enhanced our ability to characterize the epidemic and allows us to ensure prevention programs are directed to those most in need.
· Progress with Associated Conditions: Syphilis infections increase the risk of HIV transmission among adults at least 3 to 5-fold. Since 1990, syphilis rates have declined 88 percent. In 1999, CDC launched the National Plan to Eliminate Syphilis in the United States and initiated new efforts targeting 33 States and cities with either a heavy burden of syphilis or a high potential for re-emergence of syphilis. CDC has also increased tuberculosis (TB) prevention and control activities and subsequently reported a 34 percent decrease in new TB cases in the U.S. from 1992 to 1999. Persons with weakened immune systems, especially those infected with HIV, are at higher risk of developing active TB once infected with TB.
· Engaging States in Prevention: The Substance Abuse and Mental Health Services Administration (SAMHSA) has encouraged state and community efforts to link and coordinate substance abuse treatment, mental health services, and HIV/AIDS prevention and treatment efforts. SAMHSA surveys, conducted with the three national state mental health, alcohol and substance abuse organizations identified gaps in service coordination and ways to enhance service integration at the State level. These data are informing States on ways to bridge the three communities to improve outcomes for people with or at risk for substance abuse, mental illness and/or HIV/AIDS.
· Reducing Risk-Taking Behavior: The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Mental Health Services funds Project Shield, the HIV/AIDS High-Risk Behavior Prevention/Intervention Model for Adolescents/Young Adults and Women Program. Project Shield is a four-year, multi-site effort, which is developing, implementing and evaluating a community-focused intervention to reduce high-risk behaviors among individuals at high risk for HIV infection.
· Syringe and Needle Exchange: Scientific research supported by NIH has shown that needle exchange programs can be an effective component of a comprehensive strategy to prevent HIV and other bloodborne infectious diseases in communities that choose to include them, and do not encourage the use of illegal drugs. The Clinton Administration has communicated what has been learned from the science so that communities can construct the most successful programs possible to reduce the transmission of HIV, while not encouraging illegal drug use.
· Substance Abuse Treatment Services to Reduce HIV/AIDS Risk: More than one third of all AIDS cases are directly or indirectly attributable to substance abuse. Current evidence indicates that substance abuse treatment greatly reduces risk behaviors associated with the transmission of HIV. Beginning in 1994, SAMHSA's Center for Substance Abuse Treatment (CSAT) has supported the AIDS Outreach Program (now called the Community-based Substance Abuse and HIV/AIDS Outreach Program) targeting high risk injecting drug users, designed to both increase the number of clients entering treatment and to reduce their risk for contracting HIV and other infectious diseases. In FY 1999, SAMHSA initiated a Targeted Capacity Expansion Program for Substance Abuse Treatment and HIV/AIDS Services in racial and ethnic communities with high AIDS case rates, expanding this effort to include a second group of grantees in FY 2000 with a total investment of $32 million. In addition, SAMHSA's Substance Abuse Prevention and Treatment Block Grant HIV set-aside provides funds for HIV counseling and testing in states with high AIDS case rates.
INCREASING ACCESS TO CARE AND TREATMENT
· Ryan White CARE Act: The Health Resources and Services Administration's (HRSA) HIV/AIDS Bureau administers the Ryan White CARE (Comprehensive AIDS Resources Emergency) Act, first enacted in 1990 to provide primary care and supportive services for low-income, uninsured and underinsured individuals and families affected by HIV/AIDS. Since FY 1991, $8.0 billion has been appropriated for CARE Act programs, with a 358 percent in funding during the Clinton Administration FY 1993-FY 2000. In 2000, the CARE Act is serving some 500,000 people, providing care for individuals affected by HIV/AIDS in every state, the District of Columbia, Puerto Rico, Guam and the Virgin Islands. The CARE Act also funds services to individuals in 51 major metropolitan areas hardest hit by the AIDS epidemic. More than 2,500 organizations are now receiving funding to provide care to individuals living with HIV disease in their communities.
The CARE Act has saved many lives by speeding delivery of new HIV/AIDS treatments to the many Americans who otherwise lacked access to these therapies and quality health care. In 1995, AIDS was the leading cause of death for Americans between the ages of 25 and 44. In 1996, highly effective new HIV/AIDS medications were introduced and the AIDS Drug Assistance Program (ADAP) began to assist the states in paying for the expensive new medications. The benefits of these therapies were seen in 1997, when a sharp drop in the AIDS mortality rate was reported. The President's FY 2001 budget proposal includes $554 million for the ADAP program, which serves thousands of Americans who would otherwise go without life-sustaining HIV/AIDS medications.
On May 26, 1996, and again on October 20, 2000, President Clinton signed legislation reauthorizing the Ryan White CARE Act for another five years. In addition to the health care and pharmaceutical assistance provided through states and municipalities described above, the CARE Act supports 260 programs that provide community-based HIV early intervention services, including HIV testing and counseling, and treatment for HIV disease. Over 700,000 AIDS care providers have received state-of-the-art education and training through the AIDS Education and Training Centers Program.
By widely distributing the results of the 076 AZT Perinatal Transmission Study to CARE Act providers, HRSA has facilitated a dramatic nationwide reduction of mother-to-infant transmission of HIV, with the incidence of mother-to-child transmission dropping to nearly zero at many treatment centers funded by the CARE Act. Through the Special Projects of National Significance Program, more than 200 research and demonstration projects nationwide have been supported to develop and evaluate new and more effective ways to delivery HIV/AIDS care and services to hard-to-reach populations.
· Mental Health Services: Attention to the mental health needs of persons living with HIV, or those with high-risk behaviors for HIV infection, is critical to HIV prevention and treatment efforts. SAMHSA's Center for Mental Health Services (CMHS) funded the Mental Health Services Demonstration Program from FY 1994 - FY 1998 to provide mental health services to people living with or affected by HIV, generate new knowledge about the role of mental health services in primary medical treatment for people living with or affected by HIV, and to identify characteristics of clients served and the types of services utilized. The CMHS now sponsors a collaborative effort with CSAT, HRSA and three NIH Institutes, known as the HIV Cost Study Grant Program, to determine the effectiveness of treatment adherence models, health outcomes, and costs associated with the provision of integrated mental health, substance abuse, and HIV/AIDS primary care services for people living with HIV/AIDS who have both a mental disorder and a substance abuse disorder.
· Treatment Guidelines: HHS regularly updates and releases clinical guidelines for treating HIV disease using antiretroviral drugs among adults and adolescents, women during pregnancy, and children and infants, and guidelines for the reduction of mother-to-child transmission of HIV. The guidelines, developed by panels of expert AIDS clinicians and researchers, reflect the current state of knowledge about HIV disease and antiretroviral drugs, and help to improve and standardize the quality of care for HIV-infected persons in the United States.
· Maine Medicaid Demonstration Plan: On February 24, 2000, HHS approved Maine's Medicaid demonstration plan to launch an early intervention and treatment program for individuals in need who are HIV-positive but do not yet have AIDS and who are not already eligible for Medicaid. Maine is the first state to offer a plan to enroll low-income HIV-positive individuals in the Medicaid program before they become disabled or impoverished. Recent research has shown that early intervention with AIDS-fighting drugs, including antiretroviral therapies, can slow the progress of the disease and increase life expectancy for many HIV-positive individuals. However, many people with HIV generally do not qualify for Medicaid -- the state/federal partnership that provides health insurance to low-income young, aged, blind and disabled Americans -- until they are considered disabled. This demonstration program will make drug therapies and treatment services available to HIV-positive people earlier in the course of their disease, helping them live longer, healthier lives.
· Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA): On October 25, 1999 HHS announced two new initiatives to enable people with disabilities to become and stay competitively employed. One of the grant programs will fund cutting-edge demonstrations that enable people with chronic, disabling conditions to get medical benefits without having to quit their jobs to obtain needed care. The other will assist states to increase services and supports to those who work, as well as help others return to work without the fear of losing health coverage. Both the grants and the demonstrations help advance the goals of the Ticket to Work and Work Incentives Improvement Act of 1999, a law passed by the Congress and strongly supported by the Clinton Administration to encourage people with disabilities to work without fear of losing their Medicare, Medicaid or similar health benefits. For example, Mississippi is using its $27.5 million grant award with additional state funds to cover 500 persons with a diagnosis of HIV/AIDS, who work or who plan to return to work. The state's program will mirror the full Medicaid benefits and services. The project is being implemented in nine counties in the Mississippi Delta where there is a relatively high rate of HIV/AIDS and limited health care resources for people with HIV/AIDS.
· Accelerating AIDS Drug Approvals: Since 1993, the Food and Drug Administration (FDA) has approved eleven AIDS drugs and twenty-two new drugs for AIDS-related conditions, and accelerated approval to record times. Included in those approvals were the new class of drugs known as protease inhibitors, which have proven to be dramatically effective in the treatment of HIV disease. In March 1997 the FDA approved the first protease inhibitor with labeling for use in children. Also in 1997, the President signed into law the FDA Modernization Act that included important measures to modernize and streamline the regulation of biological products; increase patient access to experimental drugs and medical devices; and accelerate review of important new medications. These reforms build on the Administration's reinventing government initiatives which led U.S. drug approvals to be as fast, or faster than any other industrialized nation. Average drug approval times have dropped from almost three years at the beginning of the Clinton Administration to just over one year.
· Ricky Ray Hemophilia Relief Fund: In August 2000, HHS began notifying the first eligible families approved to receive payments from the Ricky Ray Hemophilia Relief Fund. The fund was authorized by Congress in 1998 to provide compensation payments of $100,000 to individuals with blood-clotting disorders, such as hemophilia, who contracted HIV from contaminated anti-hemophilic blood products between July 1, 1982 and Dec. 31, 1987. Spouses and children who contracted HIV from these individuals and certain survivors may also be eligible. In 1999, the Clinton Administration worked with Congress to achieve a $75 million appropriation for FY 2000.
ACCELERATING RESEARCH ON HIV/AIDS
The National Institutes of Health (NIH) represents the largest single public investment in AIDS research in the world. NIH funding for AIDS research has nearly doubled during the Clinton Administration, increasing from $1.1 billion in FY 93 to $2.3 billion in FY 2000. The NIH supports a comprehensive program of basic, clinical, and behavioral research on HIV infection and its associated opportunistic infections and malignancies, including a growing portfolio of research conducted in collaboration with investigators in developing countries. This research aims to better understand the basic biology of HIV, develop effective therapies to treat it, and design interventions to prevent new infections from occurring.
· NIH Office of AIDS Research: In one of his first acts in office, President Clinton signed the National Institutes of Health Revitalization Act of 1993, placing full responsibility for planning, budgeting and evaluation of the AIDS research program at NIH in the Office of AIDS Research (OAR). Since 1993, the OAR has developed an annual comprehensive AIDS research plan and budget, based on the most compelling scientific priorities that will lead to better therapies and prevention for HIV infection and AIDS. These priorities are determined through a unique and collaborative process involving the 25 NIH Institutes and Centers and non-government experts from academia and industry, with the full participation of AIDS community representatives.
The OAR initiated a major evaluation of the entire trans-NIH program in 1996, to assure that the most promising areas of science were being supported, that critical scientific questions were being addressed, and that the most effective use was being made of federal AIDS research resources. The review was of unprecedented scope and breadth across all the NIH Institutes and Centers. The "Levine Report", as it was known, provided a blueprint for restructuring the NIH AIDS science program to streamline research, strengthen high-quality programs, eliminate inadequate programs, and ensure that the American people reap the full benefits of their substantial investment in AIDS research.
· AIDS Vaccine Initiative: A safe and effective HIV preventive vaccine is essential for the global control of the AIDS pandemic. NIH has the largest single AIDS vaccine research program in the world. On May 18, 1997, President Clinton challenged the nation to commit itself to the goal of developing an AIDS vaccine within the next ten years. The President also announced a number of important initiatives to help fill this commitment, including high-level international collaboration, a dedicated research center for AIDS vaccine research at NIH, and outreach to scientists, pharmaceutical companies, and patient advocates to maximize the involvement of both private and public sectors in the development of an AIDS vaccine. As of May 2000, NIAID-supported researchers had evaluated 28 vaccine candidates and 12 adjuvants (substances incorporated into a vaccine that boost specific immune responses to vaccine) in more than 3,400 volunteers in Phase I/II clinical trials. On June 3, 1998, the FDA granted permission to VaxGen Inc. for the nation's first phase III clinical trial for an AIDS prevention vaccine. The trial of the vaccine, called AIDSVAX, will include at least 5,000 volunteers from the U.S., Canada and Europe and will last up to five years. A separate Phase III trial of AIDSVAX in Thailand will enroll 2,500 volunteers. In February 1999, NIH-supported investigators initiated the first AIDS vaccine trial in Africa.
CDC will play an important role in the AIDSVAX trials in the U.S., and continue to provide technical support to the Thailand trials. CDC's role in HIV vaccine research is to work to determine the behavioral approaches necessary to maintain prevention progress during vaccine trials and ultimately during implementation of a vaccine program, if an effective and safe HIV vaccine is identified.
Consistent with the President's challenge, NIH funding for HIV vaccine research increased by more than 100 percent between FY 1997 and FY 2000, resulting in the award of new grants to foster innovative research on HIV vaccines, including vaccine design and development, and the invigoration and reorganization of the NIH vaccine clinical trials effort. Construction of the new intramural Vaccine Research Center is complete, and world-renown scientists have been recruited. The AIDS Vaccine Research Committee, chaired by Nobel laureate Dr. David Baltimore, continues to provide critical advice on all aspects of the NIH AIDS vaccine development program. To establish a global infrastructure for HIV vaccine trials, the NIAID has established a new comprehensive, clinically-based research and development network, the HIV Vaccine Trials Network (HVTN) with an expanded, integrated clinical research agenda that has both domestic and international components.
· Topical Microbicides Research: The vulnerability of women to acquiring HIV infection demands the development of effective and acceptable female-controlled chemical and physical barrier methods, such as topical microbicides, to reduce HIV transmission. To enhance and stimulate research in this area, the OAR co-sponsored the first international conference devoted to all aspects of microbicide research and development, including more than 600 participants from 45 nations. NIH is supporting Phase I, Phase II, and Phase III trials of various topical microbicides. NIH also supports behavioral and social research on the acceptability and use of microbicides among different populations. NIH has recently completed a strategic plan for microbicide research.
· Mother-to-Child Transmission: In the United States, regimens of antiretroviral drugs resulting from NIH-supported research have dramatically reduced HIV transmission from infected mother to infant. NIH researchers first demonstrated the benefits of zidovudine (AZT) therapy for preventing mother-to-child transmission of HIV in 1994. However, the complexity of administration and high cost make this option impractical for much of the developing world.
In 1998, researchers from CDC and the Ministry of Public Health in Thailand found that a short course of AZT given late in pregnancy and during delivery reduced the rate of HIV transmission to infants of infected mothers by half in non breast-feeding settings and is safe for use in the developing world. Studies in west Africa found that using this or a similar short course AZT regimen resulted in about a one-third reduction in the risk of perinatal transmission among breast-feeding women. Another important study in Africa using a AZT/3TC combination found a similar reduction in risk.
Most recently, in the summer of 1999, results from a NIH-supported clinical trial in Uganda showed that use of a single dose of another antiretroviral drug, Nevirapine, given to the mother at the onset of labor and another dose given to her baby reduced the risk of transmission by about 50% when compared to a very short course of AZT given only at labor and for one week to the infant.
The UNICEF/WHO/UNAIDS, with technical assistance from CDC, are now working with public health agencies around the globe to help make these short-course regimens available for as many women as possible and to continue to identify practical solutions for reducing the toll of the HIV epidemic on women and children worldwide.
Behavioral and Social Science Research
Both the CDC and the NIH conduct prevention research to assure that prevention efforts are based on sound behavioral and biomedical science. Studies have demonstrated that behavioral change can successfully prevent or reduce the spread of HIV infection in both domestic and international settings. Prevention programs resulting from such studies have reduced the risk of transmission in many communities and subgroups. NIH supports research to further understanding of how to change the behaviors that lead to HIV transmission-including preventing their initiation-and how to maintain protective behaviors once they are adopted in all populations at risk.
CDC's research focuses on identifying the factors that influence risky behavior and transmission in different communities, and evaluating various approaches to reducing risk. For example, CDC researchers have recently examined the important role parental communication can play in reducing risk behavior among young African-American and Latino youth. Research also has focused on developing and evaluating new approaches to counseling and testing for women at high risk. Other behavioral research initiatives include examining the effectiveness of peer interventions for gay men, street outreach for injection drug users, community-level interventions for young Latino men who have sex with men, HIV education for youth, and faith-based programs for African-American communities.
In June, 1998, the National Institute of Mental Health (NIMH) at the NIH announced that the NIMH Multisite HIV Prevention Trial found that even among persons considered hardest to reach, educational sessions that motivate and offer specific strategies to reduce high-risk sexual behaviors can cut those behaviors in half. The National Institute on Drug Abuse (NIDA) at the NIH has also conducted research on understanding the trends in HIV transmission among drug users and their sexual partners, as well as ways to reduce viral spread. As a result, innovative models of outreach have been developed to help stem the spread of HIV among this at-risk population.
Advances in understanding HIV and how it causes AIDS have helped scientists to develop an effective arsenal of drugs that, when used in combination, can help many people with HIV disease live longer and healthier lives. These achievements highlight the pivotal contributions of both NIH-supported basic research and NIH collaborations with academia and industry to develop effective anti-HIV therapies. For example, NIH-supported research was pivotal to discovering and defining the importance of the HIV protease enzyme. NIH-supported scientists helped determine the precise three-dimensional structure of HIV protease, a crucial step in designing drugs that block the action of the enzyme. NIH also supported researchers who helped drug-screening efforts by developing simple rapid tests to measure the inhibition of protease activity. These accomplishments set the stage for NIH collaboration with the pharmaceutical industry in developing the new class of anti-HIV drugs known as protease inhibitors. NIH worked closely with industry as they designed, produced, and clinically tested protease inhibitors. This collaboration helped speed product development.
NIH-supported investigators conclusively demonstrated that triple-drug combination therapy with a protease inhibitor and two other anti-HIV drugs was more effective than one- or two- drug regimens for long-term suppression of HIV. Basic researchers at NIH laboratories have helped explain why HIV can rebound in patients who discontinue combination therapy, and continue to open new avenues for drug development.
NIH clinical trials continue to study new anti-retroviral drugs and combinations of therapies to prevent disease progression and HIV-associated opportunistic infections and malignancies. NIH has also implemented guidelines requiring the inclusion of women and minorities in clinical trials.
Of paramount importance is maintaining a strong commitment to basic research. Tremendous progress has been made through groundbreaking research on basic HIV biology and AIDS pathogenesis, revolutionizing the design of drugs, the methodologies for diagnosis, and the monitoring for efficacy of antiviral therapies. Recently, NIH researchers identified a new genetic risk factor for HIV infection. A recently published study shows that a tiny variation in an immune system gene called RANTES can be a double-edged sword, substantially increasing one's susceptibility to HIV infection, but subsequently slowing down the disease's progress.
Women and AIDS
The NIH supports a number of epidemiologic cohort studies specifically focused on women and adolescents. These studies are designed to elucidate the pathogenic mechanisms more commonly observed in women, children and adolescents with HIV infection, and represent an important scientific link between epidemiology and basic research. Women also experience certain clinical manifestations of HIV infection that are unique and more prevalent than in men. The Women's Interagency HIV Study (WIHS), a major study conducted in collaboration with other PHS agencies, is identifying the nature and rate of HIV disease progression in women, characterizing clinical manifestations of HIV important to women, assessing the effects of therapeutic regimens, and identifying sociocultural and health care access factors that affect disease outcomes in women.
ELIMINATING RACIAL AND ETHNIC DISPARITIES IN HIV/AIDS
Although racial and ethnic minority groups account for only about 25 percent of the U.S. population, they account for more than 50 percent of all AIDS cases. While overall AIDS deaths are down, AIDS remained the leading killer of African-Americans ages 25-44 in 1998. In October 1998, President Clinton declared HIV/AIDS to be a severe and ongoing health crisis in racial and ethnic minority communities, and announced a comprehensive new initiative in collaboration with the Congressional Black Caucus to improve the nation's effectiveness in preventing and treating HIV/AIDS in African-American, Hispanic, and other minority communities.
In FY 99, $165.7 million in new targeted funding was provided for the Minority AIDS Initiative, increasing to $250.9 million in FY 2000. The HHS Crisis Response Team initiative has also provided intensive technical assistance to large metropolitan areas with high numbers of HIV/AIDS cases among racial and ethnic minority populations.
In October 2000, CDC awarded $19 million to community coalitions in 15 states to help address racial and ethnic disparities in health in the United States. In addition, NIH contributed $5 million dollars, for a total of $24 million, and has pledged to sustain that level of support for 4 additional years. This is the second year that CDC has awarded the funds as part of its "Racial and Ethnic Approaches to Community Health (REACH 2010)" initiative, a demonstration project that targets HIV/AIDS and five other health priority areas.
In addition to appropriated funds directly targeted to HIV prevention, care and treatment, and substance abuse and mental health prevention and treatment in minority communities, the FY 1999 and FY 2000 Public Health and Social Services Emergency Fund provided $50 million to address high priority HIV prevention and treatment needs of minority communities heavily impacted by HIV/AIDS. These resources were directed across three broad categories: technical assistance and infrastructure support; increasing access to prevention and care; and building stronger linkages to address the needs of specific populations. The Office of Minority Health and the Office of HIV/AIDS Policy have taken an active role in increasing the availability and effectiveness of technical assistance and capacity development initiatives to strengthen the community-based response to HIV/AIDS in minority communities. The Office of HIV/AIDS Policy has also conducted the Surgeon General's Leadership Campaign on AIDS to raise awareness and involvement of minority leaders and decrease the stigma associated with HIV/AIDS.
Research to address the disproportionate impact of the HIV/AIDS epidemic on U.S. racial and ethnic minority communities continues to be a high priority. The OAR at NIH has established the Ad Hoc Working Group on Minority Research to advise NIH on the scientific priorities, and NIH is directing increased resources towards new interventions that will have the greatest impact on these groups. The NIH is also making significant investments to improve research infrastructure and training opportunities for minorities. The NIH has provided additional funds to projects aimed at: increasing the number of minority investigators conducting behavioral and clinical research; increasing outreach education programs targeting minority physicians and at-risk populations; targeting the links between substance abuse, sexual behaviors and HIV infection; and expanding the portfolio of population-based research. The Training and Career Development Workshops for racial and ethnic minority investigators provide minority investigators with an opportunity to learn about available NIH funding mechanisms and to meet and network with senior minority investigators who receive significant levels of NIH funding.
The NIH has implemented a series of guidelines, policies, and programs to ensure that HIV-infected individuals from the most at-risk populations for HIV/AIDS are enrolled and accrued into federally-sponsored AIDS studies. In 1994, the NIH implemented revised Guidelines on the Inclusion of Women and Minorities in Clinical Research, requiring applicants to address the appropriate inclusion of women and minorities in clinical research. Applications that fail to meet these requirements, as evaluated by peer review, are barred from funding.
Care and Treatment
The Ryan White CARE Act is reaching minorities living with HIV disease B more than 60 percent of clients served are minority. The proportion of minority CARE Act clients mirrors the proportion of total AIDS cases that are among minorities. Minority women and children are the most heavily impacted groups; three out of five women newly diagnosed with HIV/AIDS are African-American, and one out of five is Hispanic; over 80 percent of AIDS cases among children are among racial and ethnic minorities. As part of the Minority AIDS Initiative, over 100 new planning grants have been awarded to help community-based organizations to develop primary health care services for HIV/AIDS in minority communities. The Targeted Provider Education Program has also directed new outreach efforts to minority providers of health and social services to increase their knowledge about HIV/AIDS.
Substance Abuse and Mental Health Services
SAMHSA has made both new and enhanced investments in substance abuse treatment services as part of the Minority AIDS Initiative, totaling $73.6 million over the Fiscal Years 1999 and 2000. These include $32 million for Targeted Capacity Expansion Programs for Substance Abuse Treatment and HIV/AIDS Services, $13.5 million for Targeted Capacity Expansion for Substance Abuse Prevention and HIV Prevention, $9.5 million for the Community-based Substance Abuse and HIV/AIDS Outreach Program, and other resources for integrated services planning grants, and developmental technical assistance for minority community-based organizations. SAMHSA has placed a special emphasis on addressing the needs of minority women around substance abuse treatment and prevention issues. In 1999, SAMHSA sponsored two policy forums focusing on Coordination of HIV/AIDS, Substance Abuse and Mental Health Services for African American and Latina women. An interagency working group has also been established to address potential gaps in care and services for women infected and affected by HIV/AIDS.
HIV Prevention for People of Color
The most effective prevention programs are targeted to specific needs of communities at risk for HIV transmission. CDC funding enables local community organizations to mount targeted prevention programs that are based on sound science. CDC's efforts to ensure that prevention programs are effectively directed toward those in greatest need have resulted in a substantial increase in HIV prevention funding targeted to African Americans and Latinos. The implementation of community planning has dramatically increased funds targeted to African-American and Latino communities, resulting in an increase from approximately $17 million in 1993 to more than $67 million in 1999. Additionally, recognizing the critical role of the faith community in mobilizing community leaders and reaching and serving those at risk, CDC established a collaboration with the faith community in 1987. By partnering with a small group of national faith organizations and schools of public health, CDC leverages relatively modest resources into remarkable programs for HIV prevention with communities of faith nationally.
· Implementation of LIFE Initiative: In collaboration with USAID, HRSA, OPHS and other federal agencies, CDC has begun to work to combat the AIDS epidemic in India and 14 countries in Africa. CDC works in these countries to: (1) Provide technical assistance for primary HIV prevention activities (voluntary HIV counseling and testing, blood safety, behavior change and mother-to-child transmission); (2) Help countries develop surveillance programs to target prevention resources and assess the effects of HIV prevention interventions; and (3) Provide technical assistance for the care and treatment of opportunistic infections and STDs and for the provision of palliative care and psychosocial support to persons living with AIDS and their families.
· International Research Priorities: The exploding nature of the HIV pandemic globally, particularly in the poorest parts of the world, has escalated the urgency of improved intervention strategies. The NIH supports a growing portfolio of research conducted in collaboration with investigators in developing countries. For example, NIH collaborates with UNAIDS, host country governments, and in-country scientists for vaccine development and in preparation for efficacy trials. NIH-sponsored programs target studies on factors related to HIV transmission and the pathogenic mechanisms associated with HIV disease progression through a number of studies in Africa, Asia, and Latin America. NIH also supports international training programs and initiatives that help to build infrastructure and laboratory capacity in developing countries where the research is conducted. Funding for international HIV/AIDS research has increased from $34.6 million in FY 1993 to an estimated $90.3 million in FY 2000.
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