OVERVIEW: The HIV/AIDS epidemic remains an urgent public health issue in the United States, as it does in the global community. According to the Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC), 800,000 to 900,000 people are currently living with HIV and up to one-third do not know they are infected. More than 438,000 persons have lost their lives since the epidemic began in 1981. CDC estimates that 40,000 individuals in the United States become infected each year. People of color, particularly African Americans and Latinos, are disproportionately affected by HIV/AIDS and have some of the highest infection rates. Gay and bisexual men, injection drug users and women represent other populations at greatest risk of infection.
Significant progress has been made in the first two decades of the HIV/AIDS epidemic. By the early 1990s, infections had been reduced from a high of roughly 150,000 per year to an estimated 40,000. AIDS related deaths began to decline significantly in the mid 1990s. In the U.S. alone, mother-to-child HIV transmission has consistently decreased from 2,500 perinatal HIV infections in 1992, to an estimated 300 to 400 annual infections in recent years. Community mobilization, scientifically proven prevention interventions, new combination drug therapies and increased access to care have all contributed to these significant reductions in morbidity and mortality associated with HIV/AIDS in the U.S.
HHS has pursued a vigorous, broad-based public health response to HIV/AIDS through extensive research, HIV prevention initiatives and expanding access to quality HIV care and treatment. The increasing impact of the epidemic on racial and ethnic minority populations has also triggered an intensive effort to target needed resources to these communities to assist them in building strong, community-based responses for prevention and care.
The National Institutes of Health (NIH) represents the largest single public investment in AIDS research in the world. Total proposed spending for HIV/AIDS in fiscal year 2002 is $2.5 billion, more than an 11.5 percent increase than total AIDS spending in fiscal year 2001.
The CDC provides national leadership to prevent the spread of HIV/AIDS. A newly released comprehensive blueprint outlining strategic efforts to reduce HIV/AIDS calls for a reduction by half of new HIV infection cases by the year 2005. The Health Resources and Services Administration (HRSA) administers the landmark Ryan White CARE Act program, which delivers health care and support service to individuals with HIV/AIDS, and supports training of health care practitioners in the delivery of quality care. In addition, the Health Care Financing Administration, Substance Abuse and Mental Health Services Administration, and the Food and Drug Administration each support critical components of the comprehensive HIV/AIDS response through reimbursement for health services, specialized substance abuse and mental health services, outreach and referral, and review and licensing of new therapeutics for HIV/AIDS.
The human immunodeficiency virus (HIV) is the virus that causes AIDS, or acquired immunodeficiency syndrome. This virus is passed from one person to another through blood-to-blood and sexual contact. Pregnant women with HIV infection can pass the virus to their baby during pregnancy or delivery, as well as through breast feeding. Other bodily fluids proven to spread HIV are semen, vaginal fluid, amniotic fluid, and fluids surrounding the brain, spinal cord and bone joints. An HIV-infected person receives a diagnosis of AIDS only after developing one of the CDC-defined AIDS indicator illnesses. An HIV-positive person who has not had any serious illnesses can also receive an AIDS diagnosis on the basis of certain blood tests.
HIV destroys certain kind of blood cells--CD4+ T cells (helper cells)--which are crucial to the normal function of the human immune system. In fact, loss of these cells in people with HIV is an extremely powerful predictor of the development of AIDS. Studies of thousands of people have revealed that most people infected with HIV carry the virus for years before enough damage is done to the immune system for AIDS to develop. However, recently developed sensitive tests have shown a strong connection between the amount of HIV in the blood and the decline in CD4+ T cell numbers and the development of AIDS. Reducing the amount of virus in the body with anti-HIV drugs can slow this immune destruction.
The CDC estimates that 40,000 people living in the U.S. are infected with HIV each year. In 1999, more African Americans were reported as new AIDS cases than any other racial or ethnic group - 63 percent of all reported women and 42 percent of all reported men. Hispanics accounted for 19 percent of the total number of new AIDS cases in 1999. To address the disproportionate effect of AIDS in minority communities, HHS has implemented several broad initiatives targeting at-risk populations.
· HIV Prevention Strategic Plan Through 2005 (CDC): In January 2001, CDC's National Center for HIV, STD and TB Prevention released its HIV strategic plan, a blueprint for protecting the nation's health against HIV infection. The plan's overarching national goal is to reduce the number of new HIV infections in the U.S. from an estimated 40,000 to 20,000 per year by 2005, with a particular focus on eliminating racial and ethnic disparities in new HIV infections. CDC also strives to assist in reducing HIV transmission and improving HIV/AIDS care and support in partnership with resource-constrained countries. For more information, visit http://www.cdc.gov/hiv/dhap.htm.
· Healthy People 2010: Healthy People 2010 is the nation's health prevention agenda for the decade. It is a statement of national health objectives designed to identify the most significant preventable threats to health and to establish national goals to reduce these threats. Preventing HIV infection and its related illnesses is one of the focus areas of Healthy People 2010. For more information, visit http://www.health.gov/healthypeople/default.htm.
· HHS Initiative to Eliminate Racial and Ethnic Disparities in Health: As part of the 1997 President's Initiative on Race and parallel to Healthy People 2010 goals, the Initiative to Eliminate Racial and Ethnic Disparities in Health was established in February 1998 to reduce disparities in six key areas: infant mortality, diabetes, cardiovascular disease, cancer screening and management, HIV/AIDS, and childhood and adult immunizations. For more information, visit http://www.raceandhealth.hhs.gov.
· Minority HIV/AIDS Initiative: An outgrowth of the department's initiative to eliminate racial health disparities, the Minority HIV/AIDS Initiative provides special focus on communities of color. Since 1998, HHS, the Congressional Black Caucus and the Congressional Hispanic Caucus have collaborated on a special package of programs to reduce the disproportionate HIV/AIDS impact in these communities. Congress appropriated $251 million for fiscal year 2000 and $358 million in 2001. For more information, visit http://www.hiv.omhrc.gov.
Promoting Safety in the Blood Supply
· FDA ensures the safety of the nation's blood supply by minimizing the risk of infectious disease transmission and other hazards. This is accomplished primarily through FDA's registration and inspection of numerous entities: blood banks, plasma centers, other blood processing facilities, and establishments engaged in interstate distribution of blood and blood products. FDA also oversees licensing and inspection of plasma centers, evaluating and licensing biologics manufacturing firms who make blood derivative products, such as clotting factor, and develops necessary regulations, compliance programs, and guidelines for the blood industry. For more information, visit http://www.fda.gov/cber/blood.htm.
· CDC assists the U.S. Public Health Service, state and local health departments, hospitals, and professional organizations worldwide in the prevention and control of HIV infection acquired in hospitals and other health care settings. While the risk of occupational HIV transmission is low, CDC maintains programs to further reduce occupational HIV transmission. Health care workers are at highest risk of occupational HIV transmission. The primary emphasis of prevention efforts is implementation of universal precautions. With universal precautions, the health care worker treats blood and other body fluids from all patients as potentially infectious. In addition, CDC and other organizations and private companies are working to develop safer medical devices that will further reduce the risk of exposure to HIV and other infectious agents. For more information, visit http://www.cdc.gov/hiv/dhap.htm.
TREATMENT AND SERVICES
HHS agencies are dedicated to providing comprehensive HIV/AIDS treatment and services to all individuals in need. To ensure this process, the department has core programs in place to enhance access and improve the delivery of quality care.
· Ryan White CARE Act Program, (HRSA): HRSA is the department's lead agency for providing HIV care and treatment services for individuals living with HIV/AIDS. Each year the agency distributes grants under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act to fund HIV/AIDS primary health care and support services for low-income individuals in 51 eligible metropolitan areas. The funds help support essential services, such as physician visits, case management, assistance in obtaining medications, home-based hospice care, substance abuse and mental health services, and other related services. The CARE Act targets services to vulnerable populations, such as rural communities, women, minorities, adolescents, the homeless, incarcerated individuals transitioning to society, and those with substance abuse and mental health challenges. It is estimated that more than 500,000 individuals access CARE Act programs every year. In fiscal year 2002, anticipated HIV/AIDS spending for HRSA will reach $1.8 billion. For more information, visit http://www.hab.hrsa.gov/.
· Medicaid and Medicare Programs (HCFA): HCFA, which administers Medicaid and Medicare, is the largest payer of care provided to persons living with AIDS in the U.S. HCFA estimates that Medicaid alone pays for more than 50 percent of care to persons with AIDS, and provides care to 90 percent of children with AIDS. The estimated total federal share of Medicaid spending on HIV/AIDS for fiscal year 2002 is $2.6 billion, with Medicare spending totaling $2.1 billion. In total, proposed spending for HCFA will be $4.7 billion for HIV/AIDS services in 2002, an increase of $400 million from fiscal year 2001. For more information, visit http://www.hcfa.gov.
· Targeted Capacity Expansion Program, (SAMHSA): In 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 and third group of grantees in fiscal year 2000 and 2001. 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 rates of AIDS cases. SAMHSA also receives funds from the Congressional Black Caucus for their HIV/AIDS substance abuse treatment initiative for minorities. Proposed spending for SAMHSA in fiscal year 2002 is $158 million, an increase of $4 million from fiscal year 2001. For more information, visit http://www.samhsa.gov/centers/cmhs/cmhs.html.
· HIV Center of Excellence, Indian Health Service (IHS): HIV/AIDS needs of American Indians and Alaska Natives are addressed through direct health services provided by the IHS, IHS services contracted by tribes, and urban Indian health programs receiving IHS funds. The HIV Center of Excellence was established to provide the highest quality of culturally competent HIV services for American Indians and Alaska Natives, including clinically based prevention, intervention and medically appropriate HIV care and treatment. In addition, IHS funds cooperative agreements with the CDC to improve HIV/AIDS, STDs and Hepatitis C surveillance activities, and also school health education and training activities. The IHS also funds ongoing efforts with HRSA to develop training for IHS, tribal and urban Indian health center providers on prevention and treatment of HIV/AIDS and STDs. The IHS and HRSA also collaborated in the development of the Ryan White CARE Act Guidelines for American Indians and Alaska Natives now in use and which also makes available to Indian people living off-reservation and away from IHS health care services, and the AIDS Drugs Assistance Program from HRSA funded facilities. For more information, visit http://www.ihs.gov/MedicalPrograms/AIDS/.
· Medicaid Eligibility Expansion Demonstrations, (HCFA): Under the Secretary's demonstration authority, HCFA to date has granted three states (the District of Columbia, Maine and Massachusetts) waivers to expand Medicaid eligibility to non-disabled persons with HIV disease who are not otherwise Medicaid eligible. The waivers were granted to determine if early access to treatment could result in savings to the Medicaid program over time. HCFA is reviewing requests from other states to implement similar demonstrations. For more information, visit http://www.hcfa.gov/medicaid/obs11.htm.
EDUCATION AND AWARENESS
According to the CDC, half of all new HIV infections are among young people under age 25, most infected sexually. To combat these unacceptably high incidence rates, HHS is dedicated to informing the public through strategic education and awareness activities.
· Surgeon General's Leadership Campaign on AIDS: Administered by the Surgeon General and the director of the department's Office of HIV/AIDS Policy, the Leadership Campaign on AIDS arranges community forums and encourages public/private partnerships in minority communities to increase HIV/AIDS knowledge, awareness and action. The campaign works to combat the negative attitudes towards those living with HIV and the groups at highest risk for contracting the disease, which impede prevention and treatment goals. This is particularly important to reaching and engaging groups at high risk for HIV, including injection drug users, gay and bisexual men, women and youth. For more information, visit http://www.surgeongeneral.gov/aids/tlcapage1.html.
· Crisis Response Teams Initiative: A key element in the Minority AIDS Initiative are the Crisis Response Teams (CRTs), which provide technical assistance to eligible communities to quickly assess their HIV/AIDS needs and identify specific programs. Cities eligible for CRTs include areas with at least 500,000 residents, at least 1,500 documented AIDS cases among African Americans and Hispanic Americans, and at least 50 percent of their AIDS cases among these groups. Programs build on the leadership of local officials and community members, and are tailored to encourage HIV-infected individuals to enter and remain in care and treatment services, as well as target prevention efforts most effectively. For more information, visit http://www.surgeongeneral.gov/aids/crtpage1.html.
· Maternal HIV Consumer Information Project, (HCFA): In an effort to help reduce perinatal transmission of HIV disease, HCFA conducts its Maternal HIV Consumer Information Project designed to inform women of child-bearing age and their health care providers of the importance of being tested for HIV when pregnant. HCFA makes informational brochures and posters available in 14 languages to state Medicaid agencies and their partners free of charge. In addition, an informational video featuring HIV-positive women telling their own true stories about their pregnancy and childbirth is available in Spanish and English. For more information, visit http://www.hcfa.gov/medicaid/obs11.htm.
· National AIDS Hotline (CDC): The CDC operates a toll free national hotline which provides anonymous, confidential HIV/AIDS information 24 hours a day, 7 days a week. Specialists can offer referrals to hospitals, clinics, testing and counseling sites, legal services, educational and support groups, and service agencies. Information is provided in English (1-800-342-AIDS) and Spanish (1-800-344-7432). The CDC also supports state education agencies to provide locally-directed HIV education to adolescents and young adults. For more information, visit http://www.cdc.gov/hiv/hivinfo/nah.htm.
· HHS' Office of Minority Health (OMH): The OMH was established as Resource Center in 1987 to meet the public's need for reliable, accurate and timely health information. The Resource Center is now one of the nation's largest sources of minority health information, with a special focus on HIV/AIDS, and has an HIV services team that provides technical assistance to community-based and AIDS service organizations working in minority communities. OMH also administers grants and cooperative agreements that support HIV/AIDS programs for at-risk minority populations. These include projects organized by states and territories, technical assistance and capacity development in highly impacted minority communities, and demonstration projects for bilingual/bicultural services, community health, and the elimination of health disparities. For more information, visit http://www.omhrc.gov.
· HIV/AIDS Treatment Information Service and AIDS Clinical Trials Information Service (NIH): NIH's National Library of Medicine is home to two networks of HIV/AIDS information - the HIV/AIDS Treatment Information Service (ATIS) and the AIDS Clinical Trials Information Service (ACTIS). Spearheaded by the department's U.S. Public Health Service (PHS), ATIS is a central resource for information on federally approved treatment guidelines for HIV and AIDS. The confidential hotline (1-800-HIV-0440) is staffed by multilingual health specialists who provide answers to a broad array of questions concerning HIV treatment options. ACTIS (1-800-TRIALS-A), also directed by the PHS, is a comprehensive resource for information on HIV/AIDS clinical trials, including open and closed trials, new vaccine trials, trial recruitment, drug therapies and other information. For more information, visit http://www.hivatis.org.
· Clinical Guideline for the Care of Women with HIV, (HRSA): This manual, developed by HRSA, is believed to be the first resource specifically written for the medical treatment of women with HIV. It provides practical, experience-based advice and authoritative treatment guidelines for clinicians treating women with HIV. The guide includes suggestions, comments and revisions to the preliminary version that HRSA first distributed during the 13th International AIDS Conference in South Africa. Copies are available online at http://hab.hrsa.gov/womencare.htm.
· AIDS Education and Training Centers Program, (HRSA): An extension of HRSA's Ryan White CARE Act program, the AETCs comprise 14 regional centers that are responsible for conducting multidisciplinary education and training programs for practitioners treating persons with HIV/AIDS. The AETCs serve all 50 states, the Virgin Islands, Puerto Rico and the six U.S. Pacific jurisdictions. For more information, visit http://hab.hrsa.gov.
· Treatment Improvement Protocols (SAMHSA): SAMHSA's Center for Substance Abuse Treatment has published two protocols designed to acquaint clinicians and practitioners in all disciplines with the need to screen and treat for both substance abuse and HIV/AIDS. Protocol 37, published in 2000, is a comprehensive document providing an overview of how substance abuse treatment centers in areas with high HIV exposure should attend to the multiple needs of their patients, and includes effective counseling techniques for use with HIV-infected substance abusing patients. For more information, visit http://www.samhsa.gov.
NIH supports cutting-edge research to advance HIV/AIDS related priorities, including vaccine development, drug therapies, and prevention measures. The NIH's Office of AIDS Research (OAR) was established in 1988 to coordinate all AIDS research efforts across NIH, and to serve as a focal point for AIDS policy and budget development. Each year, OAR develops a comprehensive AIDS research agenda, which is divided into five Scientific Areas of Emphasis and four Areas of Special Interest. Scientific Areas of Emphasis include natural history and epidemiology; etiology and pathogenesis; therapeutics; vaccines; and behavioral and social science. Areas of Special Interest include racial and ethnic minorities; international research priorities; training, infrastructure and capacity building; and information dissemination. For fiscal year 2002, the research plan highlights:
· prevention research to reduce HIV transmission in the U.S. and worldwide;
· therapeutic research to treat those who are infected;
· international research priorities to address needs in developing countries; and
· research targeting the disproportionate impact of AIDS on minority populations in the U.S.
For more information on the plan, visit http://www.nih.gov/od/oar.
Vaccine and Drug Development
NIH funding for HIV vaccine research has increased by more than 170 percent since fiscal year 1997. As of May 2000, researchers from NIH's National Institute for Allergy and Infectious Diseases (NIAID) 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 and II clinical trials. In June 1998, FDA granted permission to Vax Gen Inc. for the nation's first Phase III clinical trial for an AIDS prevention vaccine. The vaccine trial, 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 the AIDSVAX in Thailand will enroll 2,500 volunteers. In February 1999, NIH investigators initiated the first AIDS vaccine trial in Africa.
The FDA reports that 19 antiretroviral drugs have been approved for use in combination therapy for the treatment of HIV/AIDS. The average review time for approval of these products has been under six months. Twenty-nine drugs have been approved for 37 indicated conditions associated with AIDS.
In addition, CDC collaborates with scientists and researchers on HIV vaccines by providing expertise in the areas of site selection and virologic and immunologic investigations. CDC also provides representation for data safety and monitoring boards to oversee the conduct and evaluations of vaccine trials. CDC is working with other organizations to develop links between communities and scientists related to the field of vaccines and other research.
As reported by NIAID, an estimated 36.1 million people worldwide were living with HIV/AIDS at the end of 2000, with more than 6,500 young people aged 15 to 24 becoming HIV infected every day. More than 70 percent of these people live in Sub-Saharan Africa; another 16 percent live in South and Southeast Asia.
To address the increasing urgency of the global AIDS pandemic, the Office of AIDS Research established the Global AIDS Initiative and released the first strategic plan for international AIDS research on December 1, 2000. The initiative and plan reaffirm the long-standing commitment of NIH to international AIDS research and significantly increases research efforts to benefit poor nations.
Since the early days the epidemic, NIH has supported research efforts in countries impacted by AIDS. Beginning in 1984 with a research project in Haiti and the establishment of Project SIDA in 1985, in what was then Zaire, NIH has maintained a strong international research portfolio. NIH has expanded this effort to encompass more than 50 countries in Africa, Asia, Europe and Latin America. For more information, visit http://www.nih.gov/od/oar.
Since the epidemic was first identified in 1981, CDC's National AIDS Surveillance System has tracked the progression of AIDS. In addition, CDC has numerous surveillance programs and studies to monitor the occurrence of HIV infection, disease, and death; behaviors that place people at risk; and HIV-related knowledge and testing behaviors. This information is designed to provide communities the most complete and timely information possible about ongoing and emerging trends.
On Jan.1, 2000, new HIV/AIDS surveillance guidelines developed by the CDC and the Council of State and Territorial Epidemiologists went into effect. Among the recommendations were:
· a new HIV surveillance case definition for adults and children to reflect the change and increased sensitivity of new diagnostic tests;
· updated state and local HIV/AIDS surveillance practice standards regarding reporting criteria, coded identifier systems, rare and unusual cases of HIV transmission, data collection processes, published surveillance data and surveillance assessments;
· updated minimum performance standards surrounding accuracy, timeliness and quality of HIV/AIDS case surveillance; and
· revised security and confidentiality practices pertaining to periodic reviews of data, storage and retention, security enhancement systems, and assessment of security practices.
For more information on the guidelines, visit http://www.cdc.gov/.
Tracking the Costs Associated with HIV and AIDS
In March 2001, the Agency for Healthcare Research and Quality's HIV Cost And Services Utilization Study (HCSUS) indicated that expenditures for hospital inpatient care for HIV fell more than 40 percent by mid 1997 in the wake of the introduction of highly active combination antiretroviral therapy in early 1996. The decrease in demand for hospital care, along with a more modest reduction in the use of outpatient care, helped drive down overall treatment expenditures for HIV patients by one-sixth between early 1996 and 1998. For more information, visit http://www.ahrq.gov/data/hcsus.htm.
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.