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A Partnership for Health: Minorities & Biomedical Research National Institute of Allergy and Infectious Diseases National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2003–2004

Minorities & Biomedical Research - CORE · Minorities & Biomedical Research National Institute of Allergy and Infectious Diseases ... its Strategic Plan for Addressing Health Disparities,

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Page 1: Minorities & Biomedical Research - CORE · Minorities & Biomedical Research National Institute of Allergy and Infectious Diseases ... its Strategic Plan for Addressing Health Disparities,

A Partnership for Health:

Minorities &Biomed i ca lR e s e a r c h

National Institute of Allergy and Infectious Diseases

National Institutes of Health

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

2003–2004

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A Partnership for Health:Minorities and Biomedical Research

National Institute of Allergy and Infectious Diseases

National Institutes of Health

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

2003–2004

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Contents

Executive Summary ....................................................................................................................iii

I. Minority Health Initiatives .....................................................................................................1Allergy, Immunology and Transplantation.............................................................................1

Asthma and Allergic Diseases ...................................................................................1Autoimmune Diseases..............................................................................................2Transplantation ........................................................................................................4Immune-Mediated Graft Rejection ..........................................................................5Histocompatibility and Immunogenetics .................................................................6Donor Organ Shortage ............................................................................................6

Microbiology and Infectious Diseases ...................................................................................7Tuberculosis .............................................................................................................7Sexually Transmitted Infections................................................................................9Hepatitis C ............................................................................................................12Pneumonia.............................................................................................................13

Acquired Immunodeficiency Syndrome ..............................................................................14Vaccine Development ............................................................................................16Prevention..............................................................................................................18

NIAID Outreach Activities .................................................................................................19

II. Minority Researchers’ Training and Enhancement Programs..............................................21NIH-Wide Programs ..........................................................................................................21

Minority Biomedical Research Support Program ...................................................21Minority Access to Research Careers ......................................................................22Research Supplements for Underrepresented Minorities Program ..........................22Research Centers in Minority Institutions..............................................................23

NIAID Programs ................................................................................................................24Office of Special Populations and Research Training..............................................24Bridging the Career Gap ........................................................................................24Centers for AIDS Research ...................................................................................24NIAID Enhancement Award .................................................................................25NIAID/Mali Medical School Minority Training Initiative .....................................25Introduction to Biomedical Research Program.......................................................26Richard M. Asofsky Scholars In Research ..............................................................26Intramural NIAID Research Opportunities Program .............................................26Temple University Longitudinal Program ..............................................................26Partnership Program ..............................................................................................27Biomedical Research After School Scholars ............................................................27

Collaborative Efforts ...........................................................................................................27 Native American Research Centers for Health .......................................................27Interamerican College of Physicians and Scientists.................................................28Association of American Indian Physicians National Native

American Youth Initiative.................................................................................28

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III. Future Plans .......................................................................................................................29Allergy, Immunology and Transplantation...........................................................................29Microbiology and Infectious Diseases .................................................................................29Acquired Immunodeficiency Syndrome ..............................................................................30Training ..............................................................................................................................30Outreach Activities..............................................................................................................31

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Minorities and Biomedical Research

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The National Institute of Allergy and InfectiousDiseases (NIAID) has long recognized that minoritypopulations bear a disproportionate burden ofsickness and disease in the United States.Differences in racial and ethnic backgrounds canaffect susceptibility to infectious and immunologicdiseases, including acquired immunodeficiencysyndrome (AIDS), asthma, sexually transmittedinfections, and kidney disease. Moreover, minoritypopulations often do not fully benefit from researchadvances that have helped improve the health ofother Americans.

For more than 50 years, NIAID has progressed inunderstanding, treating, and preventing infectiousand immunologic diseases known to occurdisparately in minority populations. As outlined inits Strategic Plan for Addressing Health Disparities,NIAID continues to prioritize basic, clinical, andepidemiological research in addressing the healthdisparities in minority populations. Specifically,NIAID supports efforts to increase the participationof minority scientists in its research, increase theparticipation of the minority community in clinicalresearch, and design targeted outreach activities forminority communities that communicate researchdevelopments and health risk.

Asthma and Allergic Diseases

Asthma morbidity and mortality have beenincreasing in the United States for the past 15 yearsand are particularly high among poor, AfricanAmerican, inner-city residents. For more than adecade, improving the management of asthma inchildren has remained a high priority for NIAID.Preliminary results from the Inner-City AsthmaStudy (1996–2001), co-sponsored by the NationalInstitute of Environmental Health Sciences, indicatethat physician education and an extensiveenvironmental intervention can successfully reduceasthma symptoms among inner-city children andcan continue to reduce symptoms 1 year afterintervention. The Inner-City Asthma Consortium

(ICAC), established by NIAID in 2002, was createdto evaluate the safety and effectiveness of promisingimmune-based asthma treatments developed toreduce asthma severity and prevent disease onset ininner-city children. ICAC will conduct research todetermine the mechanisms of action of immune-based therapies; develop and validate biomarkers tomeasure disease stage, progression, and therapeuticeffect; and understand the immunopathogenesis ofasthma in inner-city children.

NIAID’s Asthma and Allergic Diseases ResearchCenters program is the cornerstone of thepathobiology component of NIAID asthma andallergy research. This national network of centersconducts basic and clinical research on themechanisms, diagnosis, treatment, and prevention ofasthma and allergic diseases. In 2003, NIAIDfunded 4 Asthma and Allergic Diseases ResearchCenters, bringing the total number of centers to 13.

In 2003, NIAID requested applications for researchprojects aimed at understanding the early lifechanges in immune function that led to thedevelopment of asthma (RFA-AI-03-041 “ImmuneSystem Development and the Genesis of Asthma”).The Immune System Development and the Genesisof Asthma program will be launched in 2004 andwill be co-funded by the National Heart, Lung, andBlood Institute (NHLBI). In response to provisionsin the Children’s Health Act of 2000 (P.L. 106-310),NIAID participates in the Federal Liaison Group forAsthma, a subcommittee of the National AsthmaEducation and Prevention Program.

Autoimmune Diseases

Collectively, autoimmune diseases afflict more than5 percent of the U.S. population, and women aremore likely to suffer from an autoimmune diseasethan men. Several autoimmune diseases, such assystemic lupus erythematosus (SLE) andscleroderma, disproportionately affect minoritypopulations. NIAID supports a broad portfolio of

Executive Summary

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basic, preclinical, and clinical research aimed atunderstanding the pathogenesis of autoimmunediseases. Research programs include theAutoimmunity Centers of Excellence (ACE), theAutoimmune Disease Prevention Centers, andmultidisciplinary research targeting theidentification, characterization, and definition ofgender-based differences in the immune response.In 2003, ACE was renewed and expanded toinclude nine separate institutions. Trials for newimmunomodulatory interventions and studies ofmechanisms of action are being developed. Centersare co-sponsored by the National Institute ofDiabetes and Digestive and Kidney Diseases(NIDDK) and the NIH Office of Research onWomen’s Health (ORWH). In fiscal year (FY)2003, Autoimmune Disease Prevention Centerssupported 14 pilot projects to test innovativeapproaches that may lead to the development ofnovel targets for disease prevention or assays forbiomarkers of disease progression. The preventioncenters are co-sponsored by NIDDK, the NationalInstitute of Child Health and HumanDevelopment, ORWH, and the Juvenile DiabetesResearch Foundation International (JDRF).

NIAID continues to support the Immune ToleranceNetwork (ITN). Co-sponsored by the NIDDK andJDRF, ITN is an international consortium of morethan 80 investigators throughout the United States,Canada, and Europe dedicated to the clinicalevaluation of novel, tolerance-inducing therapies forautoimmune diseases, asthma and allergic diseases,as well as the development of tolerance-inducingtherapies to prevent the rejection of transplantedorgans, tissues, and cells. NIAID supports theMultiple Autoimmune Disease GeneticsConsortium (MADGC), a repository of genetic andclinical data and materials from families in whichtwo or more individuals are affected by two or moredistinct autoimmune diseases. MADGC hasenrolled more than 150 families since May 2000.Established in FY 1998, NIAID continues to chairthe Autoimmune Diseases Coordinating Committee(ADCC). The ADCC Autoimmune DiseasesResearch Plan was presented to Congress in 2002.

Transplantation

Organ transplantation represents a health disparityfor African Americans and other minorities, whoreceive fewer transplants than would be expectedfrom their representation on the transplant waitinglist. NIAID supports a broad portfolio of researchto address immune-mediated graft rejection,including basic research in transplantationimmunology, preclinical evaluation of newtherapies, and clinical trials of promisingtherapeutic approaches to improve short- and long-term graft survival. In 2003, NIAID renewed theCooperative Clinical Trial in PediatricTransplantation (CCTPT) program. CCTPTsupports multicenter clinical trials of novelapproaches to prevent acute and chronic graftrejection in pediatric kidney transplantation,evaluates modifications of immunosuppressive drugregimens to mitigate unwanted side effects ofimmunosuppression, and assesses pretransplantimmunotherapy to improve transplantationoutcomes. NIAID’s Division of Allergy,Immunology and Transplantation and NIAID’sDivision of AIDS launched a study on theoutcomes of kidney and liver transplantation forHIV-positive (HIV+) patients in 2003. Theprimary aim of this prospective, multicenter cohortstudy is to evaluate the safety and efficacy of solidorgan transplantation in HIV+ patients whoundergo kidney or liver transplantation.

In 2001, NIAID and NHLBI renewed theImmunopathogenesis of Chronic Graft RejectionProgram, designed to enhance knowledge of chronicgraft failure. NIAID, in collaboration withNIDDK, supports the Non-Human PrimateImmune Tolerance Cooperative Study Group toevaluate the safety and efficacy of novel tolerogenicregimens in preclinical animal models of kidney andislet transplantation. The study group was renewedin 2002, adding several new research centers.

NIAID, along with several NIH Institutes andCenters, and JDRF, continues to support theInternational Histocompatibility Working Group

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(IHWG). IHWG, a network of more than 200laboratories in 44 countries, collects and shares dataon the human leukocyte antigen (HLA) genecomplex.

Recently, IHWG investigators joined forces withHematopoietic Stem Cell Transplant Centers todevelop an international database of transplantationoutcomes and donor-recipient HLA genotypes.NIAID, with the National Center for MinorityHealth and Health Disparities, continues to supportthe demonstration and education research projectsaimed at increasing minority involvement in organdonor registries. The Louisiana Legacy DonorRegistry is working to increase organ donations byusing new and nontraditional approaches to donorrecruitment, improving the consent process, andfacilitating the medical community’s access to donorregistry information. NIAID continues to supportthe Minority Community Outreach Program onOrgan Donation and Transplantation at the HopeHeart Institute in Seattle, Washington. A secondresearch project at the Hope Heart Institute seeks toincrease organ donation among rural AmericanIndians and Alaska Natives.

Tuberculosis

During 2000, approximately 78 percent of activetuberculosis (TB) cases were reported among racialand ethnic minorities. Problems of urban poverty,high HIV infection rates, and the effects ofhousehold overcrowding may contribute to thedisproportionate impact of TB on minorities.

Over the past decade, NIAID has dramaticallyboosted funding for TB research, which has allowedthe Institute to support a number of initiatives anda markedly expanded community of TB researchers.NIAID’s extramural TB research program currentlysupports more than 231 grants for basic, applied,and clinical research, including awards to supportthe genomic sequencing of Mycobacteriumtuberculosis (M.tb) and other strains of thebacterium that cause TB.

NIAID continues to support the TuberculosisResearch Unit at Case Western Reserve University,

established to conduct clinical trials of potentiallynew TB therapeutic, preventive, and diagnosticstrategies. NIAID’s Blueprint for TB VaccineDevelopment, presented at the 1998 InternationalSymposium for Tuberculosis Vaccine Developmentand Evaluation, outlines the specific steps needed todevelop improved TB vaccines. A task force willoversee the implementation of the blueprint.NIAID’s Vaccine Treatment and Evaluation Unit inSt. Louis, Missouri, will work with the GlobalVaccine Foundation to conduct a phase I safety andimmunogenicity trial on a new anti-TB vaccine(recombinant bacille Calmette-Guerin vaccine),expected to begin in early spring 2004.

Through the Tuberculosis Research Materials andVaccine Testing contract at Colorado StateUniversity, NIAID provides TB research reagents toqualified investigators throughout the world.During 2003, 121 individual vaccines or adjuvantcandidates have been tested, with 15 vaccine testingexperiments completed, 16 experiments in process,and 7 under development. The Southern ResearchInstitute in Birmingham, Alabama, maintains anNIAID-supported Tuberculosis AntimicrobialAcquisition and Coordinating Facility (TAACF).TAACF has contacted more than 3,500 chemiststhroughout the world seeking candidate anti-TBcompounds. More than 60,000 candidate anti-TBcompounds have been received from academic andprivate-sector investigators, principally in the UnitedStates and Europe, with growing involvement ofscientists from Africa, Asia, Australia, SouthAmerica, and other geographic sites.

Sexually Transmitted Infections

Sexually transmitted infections (STIs) are criticalglobal and national health priorities because of theirdevastating impact on women and infants and theircausal association with HIV infection. Reportedrates of some STIs, such as gonorrhea and syphilis,are as much as 30 times higher for AfricanAmericans than for whites. This disparity is due tomany factors, including differences in thedistribution of poverty, health-seeking behaviors,and access to quality health care. NIAID supportsindividual investigator-initiated research grants and

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a variety of research programs for the developmentof more effective prevention and treatmentapproaches for STIs. Research efforts includedeveloping and licensing vaccines, topicalmicrobicides, and treatments for microbes thatcause STIs; understanding the long-term healthimpact of sexually transmitted pathogens in variouspopulations; stimulating basic research on thepathogenesis, immunity, and structural biology ofthese pathogens; and developing better and fasterdiagnostics.

NIAID’s ongoing efforts include the STDCooperative Research Centers, the STD ClinicalTrials Unit, and the Topical Microbicides ProgramProjects. NIAID recently intensified efforts insyphilis research, especially in the development ofnew, improved biomedical tools to complement andsustain CDC’s Syphilis Elimination Program. Inaddition, NIAID continues to initiate and support avariety of other STI research projects, including thedevelopment and evaluation of STI diagnosticsdesigned for point-of-care use through the SmallBusiness Innovation Research mechanism, grants forthe development of vaccines to prevent chlamydialand gonorrheal infections, and a herpes vaccineefficacy trial.

Hepatitis C

Hepatitis C virus (HCV) infection is the mostcommon chronic blood-borne viral infection in theUnited States. Various surveys indicate that HCVdisproportionately affects minority populations. Atthe same time, available HCV treatments are lesseffective for African Americans than otherpopulations.

NIAID has aggressively pursued the expansion ofHCV research through its development of the“Hepatitis C Framework for Progress.” With theaid of participating Institutes and Centers, an NIH-wide framework was drafted that incorporatesvarying individual missions into a cohesive globalplan. NIAID is investigating clinical manifestationsto develop noninvasive methods to evaluate currentdisease state, to predict outcomes, and to prevent orreverse disease progression.

Currently, NIAID provides funding support tosix hepatitis C Cooperative Research Centers, oneof the cornerstones of NIAID’s HCV research.Other NIAID HCV research activities includepartial support for the ancillary studies of theNIDDK-sponsored trial “Hepatitis C AntiviralLong-term Treatment against Cirrhosis (HALT-C)”;the development of robust and economical cellculture and animal models; support for twoantiviral screening tools via its in vitro screeningcontract programs; activities to broaden HCVresearch and development; the “Liver and PancreaticDisease in HIV Infection” program announcementsponsored jointly with NIDDK to stimulateresearch on the pathogenesis and therapeutics ofliver and pancreatic disease associated with theco-infections (e.g., hepatitis B, hepatitis C) thatoccur in patients with HIV infection; and researchinvestigating the relationships between hepatitis Cvirus replication, evolution, and disease progressionin American Indians and Alaska Natives.

Pneumonia

Pneumococcal pneumonia is an infection in thelungs caused by the Streptococcus pneumoniae. Ratesof invasive infection increase with age and aredisproportionately higher among certain minoritypopulations. NIAID supports an efficacy and safetyphase III randomized trial in 8,292 Navajo andWhite Mountain Apache children using the licensed7-valent pneumococcal conjugate vaccine, Prevnar.This study shows that Prevnar is capable ofpreventing disease in the general U.S. population.

Acquired Immunodeficiency Syndrome

Although AIDS affects all racial groups, the diseasecontinues to disproportionately affect minoritypopulations. African Americans and Hispanicsconstitute 61 percent of the AIDS cases in theUnited States. Of the new AIDS cases reported in2002, 55 percent were African American,13 percent Hispanic, 32 percent white, and lessthan 1 percent American Indian, Alaska Native, andAsian-Pacific Islander. Among women, AfricanAmericans and Hispanics account for 81 percent ofAIDS cases. Among men, African Americans and

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Hispanics account for 64 percent of cases. Minoritychildren also are disproportionately affected byAIDS.

As the HIV/AIDS epidemic continues to expand inminority communities, enrolling minority patientsin HIV/AIDS clinical trials is particularly urgent.People of minority backgrounds face unique social,economic, and medical issues when coping with thechallenges associated with HIV/AIDS infection,and, therefore, one of the greatest challenges facingHIV/AIDS researchers today is the recruitment andretention of minority patients for clinical trials. Anadditional challenge is the recruitment ofunderrepresented minority investigators to AIDSand AIDS-related clinical and basic researchdisciplines. Consequently, NIAID supports acomprehensive portfolio of biomedical andbehavioral research aimed at preventing and treatingHIV disease in minority communities, trainingminority investigators, and fostering infrastructuredevelopment.

NIAID directs a large therapeutic clinical trialsprogram consisting of three groups: the Adult AIDSClinical Trials Group (AACTG), the Pediatric AIDSClinical Trials Group (PACTG), and the TerryBeirn Community Programs for Clinical Researchon AIDS (CPCRA). AACTG, PACTG, andCPCRA strive to ensure that a sufficient proportionof minority individuals is enrolled in clinical trials.

NIAID’s HIV/AIDS clinical research networksprovide opportunities for communityrepresentatives to participate in the research processthrough local, national, and internationalCommunity Advisory Boards. In addition, NIAIDrecently released the “Enrolling Women andMinorities in HIV/AIDS Research Trials” programannouncement to fund innovative approaches toaccess, enroll, and retain women and racial/ethnicminorities in HIV/AIDS research trials in theUnited States.

NIAID’s epidemiologic research explores the clinicalcourse and factors contributing to the transmissionof HIV/AIDS infection in a variety of populations.NIAID supports several studies including the

Women and Infants Transmission Study, whichtargets inner-city women and their children; theWomen’s Interagency HIV/AIDS Study, whichexplores the clinical course of HIV/AIDS infectionin women with a focus on minority women; andthe Multicenter AIDS Cohort Study, a prospective,longitudinal study of HIV/AIDS disease inhomosexual and bisexual men.

NIAID continues to support efforts to develop aneffective HIV vaccine. Established in 2000, theHIV Vaccine Trials Network (HVTN) is acollaboration of domestic and international clinicalsites dedicated to developing a preventive HIVvaccine. HVTN tests and evaluates candidatevaccines in clinical trials. There are 18 sites in theUnited States and 13 sites overseas, including sitesin Africa, Asia, South America, and the Caribbean.HVTN’s global capacity will allow for rapidexpansion and the ability to perform large-scalestudies of suitable vaccines as more vaccinecandidates enter the pipeline for testing anddevelopment. Currently, HVTN is conducting sixphase I and two phase II clinical trials of candidateHIV vaccines. In addition to conducting clinicalstudies, HVTN develops community outreachprograms to educate people about HIV/AIDS andvaccine research.

NIAID is currently in the second year of its HIVVaccine Communications Campaign. Targeting at-risk populations, the HIV VaccineCommunications Campaign is developing andimplementing a national education campaign toincrease awareness and support for HIV vaccineresearch, especially in at-risk populations. This pastyear, a national survey was completed that evaluatedthe attitudes toward and knowledge of HIV vaccineresearch in the general population, as well as insegmented groups of African Americans, Hispanics,and men who have sex with men. TheCommunications Campaign is working to correctthe misperceptions that exist regarding HIV vaccinetrials and, at the same time, provide generalinformation about HIV vaccine research tominority communities.

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NIAID established the HIV Prevention TrialsNetwork (HPTN) in 2000 in an effort to reducethe worldwide spread of HIV. HPTN is a globalnetwork of clinical trial sites with 9 sites in theUnited States and 16 international sites in Africa,Asia, Europe, and South America. The networkexplores a variety of nonvaccine preventionstrategies to reduce HIV/AIDS transmission, suchas testing and developing biomedical and behavioralintervention programs. Additional preventionefforts include research to prevent mother-to-childtransmission of HIV; evaluation of simpler and lesscostly prevention regimens suitable for global use;support for the Centers for AIDS Research, whichaddress problems in the enrollment and retention ofwomen and minority groups in AIDS clinical trials;and promotion of the development of minorityscientists in AIDS research.

NIAID Outreach Activities

Disseminating research results to the media, healthprofessionals, and the public is an important aspectof NIAID’s mission. Outreach activities includeproducing and publicizing print, audiovisual, andWeb-based materials; distributing materials atprofessional and community meetings; andsponsoring workshops and conferences forcommunity health care providers and the public.Materials such as press releases, information sheets,and booklets are distributed worldwide in responseto more than 10,000 requests from people whocontact NIAID each year. The NIAID Web site isvisited 1.5 million times each month. Hundreds ofthousands of inquirers request materials ordownload information from the NIAID Web siteeach year. Periodic e-mails provide NIAID researchnews and information on advances that specificallyrelate to an organization’s research interests.

Minority Researchers’ Training andEnhancement Programs

Through innovative programs and outreach efforts,NIH continually works to increase the number ofminority researchers in the field of biomedicalresearch. In addition to supporting NIH-wideprograms, NIAID supports a variety of minority

programs for biomedical research, from high schoolthrough postdoctoral training. NIAID’s Office ofSpecial Populations and Research Training(OSPRT) is engaged in an extensive outreachcampaign targeting colleges, universities, medicalcenters, and professional organizations to encouragethe participation of minority investigators inNIAID research activities. OSPRT programsinclude the Introduction to Biomedical ResearchProgram (IBRP) and the Bridging the Career Gapfor Underrepresented Minority Scientists workshop.In addition, OSPRT plays a key role in reportingdata about women and minority inclusion in phaseIII clinical trials and serves as NIAID’s coordinatorand liaison for the Institute’s Strategic Plan forAddressing Health Disparities.

IBRP seeks to encourage academically talentedmembers of minority groups to pursue careers inlife sciences and biomedical research through itsextramural and intramural research arms. TheRichard M. Asofsky Scholars In Research (ASIR) isthe IBRP extramural arm and is administeredthrough OSPRT. The intramural arm of IBRP isknown as the Introduction to NIAID ResearchOpportunities (INRO) and is administered throughthe Division of Intramural Research’s Office ofSpecial Emphasis.

The ASIR program provides opportunities forunderrepresented minority students to work withextramural principal investigators in a mentorshiprelationship.

In FY 2003, INRO provided qualified minoritystudents with a 3-day program that introducedthem to research opportunities at NIAID andincluded scientific lectures and tours of some of theNIAID laboratories.

NIAID also collaborates with minorityorganizations to disseminate information aboutbiomedical research careers to members ofunderrepresented groups. The Research Centers inMinority Institutions (RCMI) program providesgrant support to predominantly minority healthprofessional schools and graduate institutions thatoffer a doctorate in the health professions or health-

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related sciences for the purpose of strengtheningand augmenting their human and physical resourcesfor conducting biomedical or behavioral research.Currently, 17 institutions participate in the RCMIprogram.

The Interamerican College of Physicians andScientists (ICPS) is one outreach activity supportedby OSPRT that targets a specific underrepresentedcommunity. Founded in 1979, ICPS promotescooperation among U.S. Hispanic physicians andseeks to advance their professional and educationaldevelopment. ICPS is the only nationalorganization representing Hispanic physicians.

Targeting individuals who receive NIAID minoritytraining and research supplemental awards, theBridging the Career Gap program seeks to provideyoung, minority investigators with the tools andinformation needed for a successful career inbiomedical research. The initiative consists of a2-day seminar addressing career choices,networking, the importance of selecting the rightmentor, and the NIH grant system andcomponents.

NIAID continues to work with schools on severalprograms that foster an interest in science andresearch careers among younger students. TheInstitute supports the Partners in EducationProgram that provides students in the Washington,DC, area with a scientific environment in whichthey can nurture their interest in the sciences. InFY 2001, NIAID co-funded the Temple UniversityMinority Access to Biomedical Research Careerspartnership program. The goal of the program is toprovide additional math and science instruction tooutstanding minority middle school students andencourage them to pursue graduate degrees inbiomedical research. NIAID’s Rocky MountainLaboratories teamed with local middle and highschools in Montana to present a program thatintroduces students to biomedical research.

NIAID continues to strengthen its research oninfectious and immunologic diseases that contributeto health disparities experienced by minoritypopulations, as well as programs designed to build anew cadre of minority researchers. These efforts,coupled with the Institute’s increased outreach tominority groups, will help ensure that NIAIDresearch benefits all individuals in the United States.

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Allergy, Immunology and Transplantation

NIAID’s Strategic Plan for Addressing HealthDisparities outlines two main objectives with respectto minority health in the areas of allergy,immunology, and transplantation:

• Support basic and clinical research on immune-mediated diseases, including asthma and allergicdiseases, autoimmune diseases, and rejection oftransplanted organs, tissues, and cells, that willlead to a better understanding of these diseases andimproved prevention and treatment strategies.

• Increase the number of minority biomedicalscientists through individual and institutionalsupport for undergraduate, graduate, andpostgraduate research training in a variety ofdisciplines related to immune-mediated diseases.

Asthma and Allergic Diseases

Asthma and allergic diseases are among the majorcauses of illness and disability in the United States.Approximately 50 percent of Americans havepositive skin tests to at least 1 of 10 allergens thatcontribute to allergic illness (NHANES III, the1987–1994 National Health and NutritionExamination Survey. J Allergy Clin Immunol2002;110:381-7). Chronic allergic conditions cansignificantly decrease personal quality of life, patientwell-being, employee productivity, and schoolperformance and attendance. Compared with whitechildren of the same age, African American childrenhave a higher prevalence of allergy to cockroaches,house dust mites, and molds (Alternaria). Similarly,Mexican American children have a higher prevalenceof allergy to cockroaches and house dust mites(NHANES III. J Allergy Clin Immunol2001;108:747-52).

Asthma affects more than 17 million Americans,resulting in more than 500,000 hospitalizations and5,000 deaths annually. African Americans aredisproportionately affected by asthma. In 2001, the

current asthma prevalence among non-HispanicAfrican Americans was approximately 10 percenthigher than among non-Hispanic whites andapproximately 40 percent higher than amongHispanics. Non-Hispanic African Americans had anasthma attack prevalence about 20 percent higherthan among non-Hispanic whites and almost60 percent higher than among Hispanics (Centersfor Disease Control and Prevention [CDC], “AsthmaPrevalence, Health Care Use and Mortality, 2000-2001,” National Center for Health Statistics,January 28, 2003. www.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm). Thedisparity in asthma prevalence was also greateramong African American children: asthma was moreprevalent among African American children youngerthan 18 years (7.4 percent) than among whitechildren (5.0 percent) of the same age (Pediatrics2002;110:317). In 1998, asthma accounted for anestimated $12.7 billion in expenditures, with$7.4 billion in direct medical expenditures and$5.3 billion in indirect costs (J Allergy Clin Immunol2001;107:3-8).

Asthma is a long-term, generally progressive lungdisease characterized by episodes of obstructedairways. The cellular infiltrates and inflammatorymediators of asthma are thought to be similar tothose of other allergic diseases, but asthma mediatorsalso appear to cause airway hyperreactivity. Chronicinflammation of the airways is recognized widely as akey factor in the development of asthma, and, as aresult, anti-inflammatory medications have become amainstay of asthma therapy. Many immune-basedtherapies are in the early stages of development orare being studied as investigational agents. However,much needs to be learned before the more promisingimmune-based approaches can be developed intolicensed therapies.

Although allergic reactions are an important cause ofasthma, nonimmunologic factors (e.g., viralinfections, exposure to environmental tobacco smokeand pollutants) also contribute to thepathophysiology of this disease. Recent studies

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suggest that the development of asthma beginsaround the first months of gestation. These andother promising findings offer new opportunities toinitiate basic and clinical research aimed at clearlydefining the early-life perturbations of the immunesystem that lead to the development of asthma.

For more than a decade, improving themanagement of asthma in children has remained ahigh priority for NIAID. Preliminary results fromthe Inner-City Asthma Study (1996-2001), co-sponsored by the National Institute ofEnvironmental Health Sciences, indicate thatphysician education and an extensive environmentalintervention can successfully reduce asthmasymptoms among inner-city children and cancontinue to reduce symptoms 1 year afterintervention. The environmental interventioninvolved home-based education to reduce exposureto environmental triggers, including environmentaltobacco smoke, cockroaches, house dust mites,mold, furry pets, and rodents. Data show that theenvironmental intervention resulted in 2 to 4 weeksof additional symptom-free days, a reduction inunscheduled medical visits, and improvements inasthma symptoms. The physician feedbackintervention provided physicians with up-to-dateinformation on patients’ asthma symptoms,medication, and health care utilization. Data showthat the physician feedback intervention resulted ina 20 percent decrease in unscheduled visits forpoorly controlled asthma. The final results of theInner-City Asthma Study should reveal significantlyimproved health for inner-city children withasthma, as well as an overall reduction of the highmedical, economic, and social costs associated withthis disease. The Inner-City Asthma Consortium(ICAC), established by NIAID in 2002, willevaluate the safety and efficacy of promisingimmune-based asthma treatments developed toreduce asthma severity and prevent disease onset ininner-city children. ICAC will conduct research todetermine the mechanisms of action of immune-based therapies; develop and validate biomarkers tomeasure disease stage, progression, and therapeuticeffect; and conduct research to understand theimmunopathogenesis of asthma in inner-citychildren.

NIAID’s Asthma and Allergic Diseases ResearchCenters program is the cornerstone of thepathobiology component of NIAID asthma andallergy research. This national network of centersconducts basic and clinical research on themechanisms, diagnosis, treatment, and preventionof asthma and allergic diseases. In 2003, NIAIDfunded 4 new Asthma and Allergic DiseasesResearch Centers, bringing the total number ofcenters to 13.

In 2003, NIAID requested applications for researchprojects aimed at understanding the early lifechanges in immune function that lead to thedevelopment of asthma (RFA-AI-03-041 “ImmuneSystem Development and the Genesis of Asthma”).Identifying the cellular and molecular processesinvolved in the onset of asthma provides the basisfor devising novel and effective immune-basedstrategies for the treatment and prevention of thisdisease. This approach will allow researchers todevelop strategies that do not compromise immunesystem integrity and are not hampered by thelimitations inherent in current therapies. TheImmune System Development and the Genesis ofAsthma program will be launched in 2004 and willbe co-funded by the National Heart, Lung, andBlood Institute (NHLBI).

In response to provisions in the Children’s HealthAct of 2000 (P.L. 106-310), NIAID participates inthe Federal Liaison Group for Asthma, asubcommittee of the National Asthma Educationand Prevention Program.

Autoimmune Diseases

Autoimmune diseases are caused by themisdirection of an immune response toward thebody’s own tissues, causing the immune systemmistakenly to attack the body’s own cells, tissues,and organs. People suffering from autoimmunediseases often endure loss of function, disability,hospitalizations, outpatient visits, decreasedproductivity, and impaired quality of life.Autoimmune diseases include systemic lupuserythematosus (SLE), type 1 diabetes, scleroderma,multiple sclerosis, Crohn’s disease, Graves disease,and rheumatoid arthritis. Collectively, autoimmune

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diseases afflict more than 5 percent of the U.S.population, and women are more likely to sufferfrom an autoimmune disease than men. Severalautoimmune diseases, such as systemic lupuserythematosus and scleroderma, disproportionatelyaffect minority populations.

SLE, or “lupus,” is a chronic, inflammatory,multisystem disorder of the immune system inwhich the body produces antibodies that target thebody’s healthy cells and tissues. SLE occurs in 1 of2,000 Americans with varying severity. SLE is morecommon and more severe in African Americanwomen, occurring in as many as 1 in 250 youngAfrican American women. SLE is twice as prevalentamong African American men as among white men.Reports also indicate an increased prevalence of SLEand rheumatoid arthritis among many AmericanIndian and Alaska Native tribes.

Scleroderma is an autoimmune disease involving theabnormal growth of connective tissues supportingthe skin and internal organs. There are two mainclasses of scleroderma: localized and systemic.Localized scleroderma affects the skin andmusculoskeletal system. Systemic sclerodermaaffects the skin and musculoskeletal system and canalso affect blood vessels and damage the heart,lungs, and kidneys. The number of Americansaffected by systemic scleroderma is estimated torange from 40,000 to 165,000. Systemicscleroderma affects more African American womenthan women of European descent.

NIAID supports a broad portfolio of basic,preclinical, and clinical research aimed atunderstanding the pathogenesis of autoimmunediseases. Researchers investigate new ways tomodify the immune system and will apply thisknowledge to the identification and evaluation ofpromising approaches to treat and preventautoimmune diseases. Research programs includeAutoimmunity Centers of Excellence (ACEs);Autoimmune Disease Prevention Centers; andmultidisciplinary research targeting theidentification, characterization, and definition ofgender-based differences in the immune response.

The ACEs support collaborative basic and clinicalresearch on autoimmune diseases, including pilotclinical trials of immunomodulatory therapies. In2003, the ACEs were renewed and expanded toinclude nine separate institutions. The centersbring together subspecialists (e.g., neurologists,gastroenterologists, rheumatologists) and basicscientists to increase clinical and researchcollaborations on autoimmunity. These centersconduct clinical trials to evaluate therapeuticinterventions for several autoimmune diseases,including SLE. Trials for new immunomodulatoryinterventions and studies of mechanisms of actionare being developed. The ACEs are co-sponsoredby the National Institute of Diabetes and Digestiveand Kidney Diseases (NIDDK) and the NIH Officeof Research on Women’s Health (ORWH).

The Autoimmune Disease Prevention Centersconduct basic research on the development of newtargets and approaches to prevent autoimmunediseases. In fiscal year (FY) 2003, AutoimmuneDisease Prevention Centers supported 14 pilotprojects to test innovative approaches that may leadto the development of novel targets for diseaseprevention or assays for biomarkers of diseaseprogression. The centers continue to evaluatesupported projects through pilot and clinicalstudies. The prevention centers are co-sponsored byNIDDK, the National Institute of Child Healthand Human Development (NICHD), ORWH, andthe Juvenile Diabetes Research FoundationInternational (JDRF).

NIAID established the “Sex-Based Differences inthe Immune Response” (RFA-AI-01-005) researchinitiative in 2001 to better understand differences inimmune response between males and females.Research supported under this initiative willidentify, characterize, and define sex- and gender-based differences in immune responses. Studiesinclude basic and clinical investigations of sexdifferences regulated by hormonal andnonhormonal mechanisms in response to exogenousantigens, the innate and adaptive immune response,and systemic and mucosal immunity. This initiativeis co-sponsored by the National Institute ofNeurological Disorders and Stroke, the National

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Institute of Arthritis and Musculoskeletal and SkinDiseases, ORWH, and the National MultipleSclerosis Society.

NIAID continues to support the Immune ToleranceNetwork (ITN). Co-sponsored by NIDDK andJDRF, ITN is an international consortium of morethan 80 investigators throughout the United States,Canada, and Europe. Investigators are dedicated tothe clinical evaluation of novel, tolerance-inducingtherapies for autoimmune diseases, asthma andallergic diseases; and the development of tolerance-inducing therapies to prevent the rejection oftransplanted organs, tissues, and cells. The goal oftolerance-inducing therapies is to “re-educate” theimmune system to eliminate injurious immuneresponses and graft rejection, while preservingprotective immunity against infectious agents. ITNconducts integrated studies on the underlyingmechanisms of approaches and develops andevaluates markers and assays to measure theinduction, maintenance, and loss of tolerance inhumans. More information about ITN is availableat www.immunetolerance.org.

The NIAID Clinical Trials Network for Stem CellTransplantation for Autoimmune Diseases willevaluate the safety and efficacy of hematopoieticstem cell transplantation for treating severeautoimmune diseases, including SLE andscleroderma.

NIAID supports the Multiple Autoimmune DiseaseGenetics Consortium (MADGC), a repository ofgenetic and clinical data and materials from familiesin which two or more individuals are affected bytwo or more distinct autoimmune diseases.MADGC provides materials to advance researchaimed at discovering the human immune responsegenes involved in autoimmunity. MADGC hasenrolled more than 150 families since May 2000.More information can be found at www.madgc.org.

NIAID chairs the NIH Autoimmune DiseasesCoordinating Committee (ADCC), established inFY 1998 at the request of Congress to increasecollaboration and facilitate coordination of research

among NIH Institutes and Centers, other Federalagencies, and private groups interested in thesediseases. The ADCC Autoimmune DiseasesResearch Plan was presented to Congress in 2002.The research plan can be found at www.niaid.nih.gov/dait/pdf/ADCC_Report.pdf.

Transplantation

The principal goal of transplantation is the physicaland functional replacement of failing organs andtissues. The most striking advances intransplantation have come in the past 30 years, withimprovements in surgical techniques and thedevelopment of immunosuppressive agents toinhibit a recipient’s immune responses againstgrafts. These advances have made transplantationthe preferred treatment for many end-stage organdiseases. Today, transplantation procedures areperformed using more than 25 different organs andtissues with first-year graft survival rates oftenexceeding 80 percent. Despite these successes, twomajor impediments remain: immune-mediatedgraft rejection and the critical shortage of donororgans. The primary reason for graft failure is arecipient’s vigorous immune response to the graft.Improvements in immunosuppressive therapy havedramatically increased graft survival for all organsduring the first year after transplantation. However,long-term graft survival has not improvedsignificantly in the past two decades because ofchronic graft failure. The mechanisms of chronicgraft failure differ from those of acute rejection andare less well understood.

Organ transplantation represents a health disparityfor African Americans. It has been shown thatAfrican Americans are less likely to be identified ascandidates for renal transplantation, often lacksuitable donors, and tend to remain longer ontransplant waiting lists than other groups.Although African Americans compriseapproximately 35 percent of patients on the renaltransplant waiting list, the organ donation rateamong African Americans is lower than that ofother racial groups.

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Immune-Mediated Graft Rejection

Although advances in surgical procedures andimmunosuppressive therapies have greatly increased,1-year graft survival rates for all organs and tissuesand long-term graft survival is relatively unchanged.NIAID supports a broad portfolio of research toaddress immune-mediated graft rejection, includingbasic research in transplantation immunology,preclinical evaluation of new therapies, and clinicaltrials of promising therapeutic approaches toimprove short- and long-term graft survival. Themajor goals of transplantation research are tounderstand the pathways whereby the immunesystem recognizes transplanted organs, tissues, andcells; characterize the cellular and molecularcomponents of acute rejection and chronic graftfailure; evaluate novel therapies for treating rejectionand prolonging graft survival in preclinical models;develop and implement strategies for immunetolerance induction; and conduct clinical trials ofnew therapies to improve graft survival whileminimizing the toxic side effects ofimmunosuppressive drugs.

Kidney transplantation accounts for 59 percent ofall solid-organ transplant procedures and is thepreferred therapy for end-stage renal disease (OrganProcurement and Transplantation Network.www.optn.org). In 2003, NIAID renewed theCooperative Clinical Trials in PediatricTransplantation (CCTPT) program. The programsupports multicenter clinical trials of novelapproaches to prevent acute and chronic graftrejection in pediatric kidney transplantation,evaluates modifications of immunosuppressive drugregimens to mitigate unwanted side effects ofimmunosuppression, and assesses pretransplantimmunotherapy to improve transplantationoutcomes. Clinical trials that continue to accruesubjects include a study comparing theimmunosuppressive drug sirolimus to the standardtreatment for chronic graft failure, a study of theeffects of steroid withdrawal in pediatric transplantrecipients, an evaluation of intravenousimmunoglobulin as an agent to reduce existingimmunity to potential donor organs, and the studyof transplantation for high-risk kidney transplantcandidates. CCTPT conducts mechanistic studies

to determine the effect of these interventionalapproaches on the immune system. Themechanistic studies have led to novel approaches fornoninvasive diagnosis of acute rejection as well asinnovative approaches for detecting T cells that mayregulate the immune response to grafts.

Patients infected with HIV/AIDS are at significantrisk for end-stage organ disease. Before the adventof highly active antiretroviral therapy (HAART),HIV-positive (HIV+) patients often were notconsidered for transplants on the basis of poorprognosis. HAART has significantly increased thenumber of HIV+ patients with end-stage kidney orliver disease as potential candidates fortransplantation. NIAID’s Division of Allergy,Immunology and Transplantation and NIAID’sDivision of AIDS launched a study on theoutcomes of kidney or liver transplantation forHIV+ patients in 2003. The primary aim of thisprospective, multicenter cohort study is to evaluatethe safety and efficacy of solid organ transplantationin HIV+ patients who undergo kidney or livertransplantation.

Despite substantial improvements in short-termgraft survival, long-term graft survival remains poor,primarily because of chronic graft failure. In 2001,NIAID and NHLBI renewed theImmunopathogenesis of Chronic Graft RejectionProgram, designed to enhance knowledge of chronicgraft failure. Little is known about the etiology ofchronic graft failure, including the factors thatdetermine onset and severity, the targets of immunereactivity, and the factors that control the degree ofvariability in the rejection process between patients.The Immunopathogenesis of Chronic GraftRejection Program will enhance understanding ofboth the immunologic and nonimmunologicmechanisms that underlie chronic graft failurerejection of solid organs, improve diagnostic criteriato predict graft failure, and identify novelapproaches for clinical intervention.

Improvements in immunosuppressive therapy havedramatically reduced acute graft rejection and haveincreased the 1-year graft survival rate for all organtransplants. However, many serious side effects

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such as infections and malignancies are associatedwith the use of systemic immunosuppressive drugsto prevent graft rejection. Reducing the risk ofserious side effects while improving graft andpatient survival is a priority in transplantationimmunology. One promising alternative toimmunosuppression is to interrupt or modify theimmune response to establish specific tolerance tothe graft. NIAID, in collaboration with NIDDK,supports the Non-Human Primate ImmuneTolerance Cooperative Study Group. The goal ofthis program is to evaluate the safety and efficacy ofnovel tolerogenic regimens in animal models ofkidney and islet transplantation. The study grouphas demonstrated long-term graft acceptance usingtolerogenic regimens in both kidney and isletallograft recipients. The study group was renewedin 2002, adding several new research centers. Thenew research centers will allow a larger number oftolerance-induction strategies to be rigorouslyevaluated. NIAID supports breeding colonies ofrhesus and cynomolgus macaques to accelerate theresearch conducted through this program.

Histocompatibility and Immunogenetics

NIAID, along with several NIH Institutes andCenters, and JDRF, continues to support theInternational Histocompatibility Working Group(IHWG). IHWG, a network of more than 200laboratories in 44 countries, collects and shares dataon the human leukocyte antigen (HLA) genecomplex. Researchers seek to (1) advancehistocompatibility testing by discovering new HLAalleles and developing new tissue-typing reagentsand methods, (2) elucidate HLA associations withautoimmune diseases, and (3) improve theoutcomes of hematopoietic stem cell (HSC)transplantation through better donor-recipientmatching. Recently, IHWG investigators joinedforces with HSC transplant centers to develop aninternational database of transplantation outcomesand donor-recipient HLA genotypes. Theinternational database will help determine optimalmatching criteria for HSC transplants betweenunrelated individuals and increase transplantationaccess for ethnically diverse populations. In

addition, IHWG researchers are working to identifysingle nucleotide polymorphisms (SNPs) inimmune-response genes. SNPs may account for theincreased susceptibility of certain individuals orgroups to immune-mediated diseases. SNP datahave been gathered for more than 100 immune-response-related genes. More information about theIHWG can be found at www.ihwg.org.

Donor Organ Shortage

In 2001, a total of 24,897 organ transplants wereperformed in the United States, including 14,774kidneys, 5,328 livers, 2,154 hearts, 554 pancreata,1,042 lungs, 107 intestines, 33 heart-lungcombinations, and 905 kidney-pancreascombinations. For the second consecutive year,living donors exceeded deceased donors (6,617versus 6,183) (Organ Procurement andTransplantation Network, September 5, 2003.www.optn.org). However, the limited availability ofdonor organs is the main factor that restricts thenumber of transplantation procedures performedeach year in the United States. The waiting list fortransplants has quadrupled in size since 1988 tomore than 80,000 patients, and, as a result, 6,482patients died in 2002 while awaiting transplants.NIAID supports efforts to increase organ donationby improving donor registries and developing andtesting educational interventions. Efforts toincrease organ donation emphasize the involvementof African Americans and other underrepresentedminority populations that are at greater risk of end-stage renal disease.

NIAID, with the National Center for MinorityHealth and Health Disparities, continues to supportdemonstration and education research projectsaimed at increasing minority involvement in organdonor registries. The Legacy Donor Registry inLouisiana is working to increase organ donation byusing new and nontraditional approaches to organdonor recruitment, improving the consent processto enhance organ donations, and facilitating themedical community’s access to donor registryinformation. The program’s Corporate DonorProgram began in 2000 and has conducted organ

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donation awareness events that reach majorLouisiana corporations and employers. Moreinformation about the Legacy Donor Registry canbe found at www.lopa.org/about_leg_rg.php.

NIAID continues to support the MinorityCommunity Outreach Program on OrganDonation and Transplantation at the Hope HeartInstitute in Seattle, Washington. This uniquecommunity-based outreach network is dedicated toincreasing organ donation among minoritypopulations in Seattle and Tacoma, Washington.Projects supported by the program involve (1) thedevelopment and distribution of educationalmaterials in African American and Asiancommunities, (2) public service announcements atDepartment of Motor Vehicles offices, and (3) thedevelopment of a computerized database ofcommunity residents to record donationpreferences, educational levels, and medicalhistories. A second research project developed bythe Hope Heart Institute includes an educationalvideo, “New Traditions of Sharing: Alaska NativeStories of Organ Donation and Transplantation”and other culturally sensitive educational materialsthat seek to increase organ donation among ruralAlaska Natives.

Microbiology and Infectious Diseases

The microbiology and infectious diseases segmentof NIAID’s scientific agenda includes intramuraland extramural research to control and preventdiseases in humans caused by virtually everyinfectious agent except HIV. NIAID supports awide spectrum of projects ranging from basicbiomedical research (e.g., studies of microbialphysiology and antigenic structure) to appliedresearch (e.g., developing diagnostic tests andclinical trials to evaluate potential drugs andvaccines).

Tuberculosis

A century ago, tuberculosis (TB) was a leadingcause of death in the United States. Through theefforts of physicians, researchers, public health

officials, improvements in living conditions, and theintroduction of effective drug therapies, the numberof TB cases and deaths in the United States declinedsteadily from the early 20th century until 1985.

Because of the HIV epidemic, new cases of TB inthe United States increased unexpectedly between1985 and 1992. Starting in 1992, however, a largeinflux of Federal funds and a renewed emphasis onTB therapy, prevention, and control have led todeclining TB cases and death rates in the UnitedStates. During 2002, a total of 15,078 TB caseswere reported to the CDC. This number representsa 5.7-percent decline in the number of reported TBcases from 2001, a 43.5-percent decline in reportedTB cases from the 1992 peak of the TB resurgence,and the lowest recorded TB rate in the UnitedStates since reporting began in 1953 (CDC.MMWR March 21, 2003).

The continued downward trend in reported TBcases is thought to reflect at least six factors:

• Improved laboratory methods for promptidentification of Mycobacterium tuberculosis (M.tb)

• Broader use of drug susceptibility testing

• Expanded use of preventive therapy in high-riskgroups

• Implementation of measures to limit transmissionof M.tb in congregate settings (e.g., hospitals,homeless shelters, and HIV/AIDS treatmentfacilities)

• Improved follow-up of diagnosed cases

• Increased Federal resources

Despite progress in TB reduction over the past 10years, TB remains a matter of grave concern.Overall, national declines in TB incidence masksubstantial disparities between rates in the majorityof U.S. residents and rates in two specificpopulations. Foreign-born minorities and U.S.-born non-Hispanic African Americans now

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account for approximately three-fourths of the TBcases in the United States (CDC. MMWRMarch 21, 2003). A combination of factors isresponsible for the disproportionate impact of TBon minorities. Foreign-born minorities emigratingfrom TB-endemic countries may harbor TBinfection or already have active TB disease whenthey move to the United States. In addition, urbanpoverty, high HIV infection rates, and the effects ofhousehold overcrowding may contribute to thedisproportionately high number of TB cases inminority populations.

The link between HIV/AIDS and TB is thought tobe a significant factor in the spread of TB.Worldwide, TB is the leading cause of death inindividuals with HIV/AIDS infection because TBaccelerates the progression of AIDS by increasingthe replication rate of HIV (Goletti D et al.J Immunol 157:1271-8, 1996). At the same time,persons co-infected with HIV and TB show rapidprogression from infection to active TB disease,indicating that HIV infection accelerates thepathogenicity of TB (World Health Organization[WHO], Tuberculosis Strategy and Operations[TB-HIV], Jan 2001). For M.tb-infected personsnot infected with HIV, 1 in 10 individuals maydevelop TB over his or her lifetime; in HIVco-infected individuals with weakened immunesystems, 1 in 10 persons may develop TB duringthe next year. Furthermore, infection with M.tbaccelerates the progression of AIDS, increasing thereplication rate of HIV in M.tb co-infectedindividuals (Goletti D et al. J Immunol 157:1271-8, 1996).

The TB crisis is intensified by the emergence of TBcaused by multidrug-resistant M.tb. The longduration and associated side effects of standard TBdrug treatment often result in patients notcompleting their full course of therapy. Whenindividuals do not complete their full course oftherapy, single- and multidrug-resistant strains ofTB may emerge that are more difficult and moreexpensive to treat. Patients with drug-resistantstrains may require up to 2 years of treatment andmay remain infectious for longer periods of timecompared with patients with non-multidrug-

resistant organisms (CDC. Fact Sheet: Treatment ofDrug-Resistant Tuberculosis, June 20, 2000. www.cdc.gov/nchstp/tb/pubs/tbfactsheets/250112.htm).

Drug-resistant TB represents a small percentage ofthe total cases of TB in the United States, with themost common form being M.tb strains resistant tothe commonly prescribed TB drug isoniazid. Forthe more than 85 percent of culture-positive casesin which data on drug resistance were available,resistance to at least isoniazid was between 7 percentand 8 percent in 2002. Among the tested M.tbstrains, resistance to two of the most commonlyprescribed drugs (isoniazid and rifampin) hasincreased from 116 cases (1.0 percent) in 2001 to121 cases (1.2 percent) in 2002 in patients whohave no prior history of drug-resistant TB (CDC.Surveillance Slides, 2002. www.cdc.gov/nchstp/tb/pubs/slidesets/surv/default.htm).

Over the past decade, NIAID has dramaticallyboosted funding for TB research. This increasedfunding has allowed the Institute to support anumber of initiatives and a markedly expandedcommunity of TB researchers. Higher levels offunding enabled NIAID to establish theTuberculosis Research Unit (TBRU) at CaseWestern Reserve University in 1994(www.tbresearchunit.org). TBRU conducts clinicaltrials of potentially new TB therapeutic, preventive,and diagnostic strategies. At the same time, TBRUcontinues to make progress in developing surrogatemarkers of disease and human protective immunity.A newly established repository will distribute well-characterized clinical samples to TBRUinvestigators and their collaborators. TBRUactivities are coordinated with major organizationsinvolved in TB research, including CDC, the Foodand Drug Administration, the United States Agencyfor International Development, WHO, GlobalAlliance for TB Drug Development, and theInternational Union Against Tuberculosis and LungDisease, and with interested industrial partners.

NIAID’s extramural TB research program currentlysupports more than 230 grants for basic, applied,and clinical research. Among the projectssupported by NIAID is an award to The Institute

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for Genomic Research (TIGR) in Rockville,Maryland, to sequence and annotate Mycobacteriumsmegmatis (strain MC2 155), an important modelsystem used in TB research. M. smegmatismicroarrays also will be produced as part of thisgrant and are expected to be distributed through thePathogen Functional Genomics Resource Center inFY 2004. For additional information on genomedata, see www.tigr.org/tdb/mdb/mdbinprogress.html.

One of NIAID’s high priorities is the developmentof improved TB vaccines, which are crucial to thelong-term control of TB worldwide. NIAID’sBlueprint for TB Vaccine Development, presented atthe 1998 International Symposium for TuberculosisVaccine Development and Evaluation, outlines thespecific steps needed to develop improved TBvaccines (www.niaid.nih.gov/publications/blueprint). A task force with representatives fromNIAID and several Department of Health andHuman Services (DHHS) agencies, will oversee theimplementation of the report. NIAID’s VaccineTreatment and Evaluation Unit in St. Louis,Missouri, will work with the Global VaccineFoundation to conduct a phase I safety andimmunogenicity trial on a new anti-TB vaccine(recombinant bacille Calmette-Guerin vaccine).This candidate vaccine was originally developedwith NIAID grant support. Enrollment in thephase I safety and immunogenicity trial is expectedto begin in early spring 2004.

Through the Tuberculosis Research Materials andVaccine Testing contract at Colorado StateUniversity, NIAID provides TB research reagents toqualified investigators throughout the world. TheTB research reagents provided by NIAID enableresearchers to work with consistent, high-qualityreagents prepared from the highly contagious andtechnically demanding causative M.tb pathogen.This contract also screens potential TB vaccinecandidates in appropriate animal models. During2003, 121 individual vaccines or adjuvantcandidates have been tested, with 15 vaccine-testingexperiments completed, 16 experiments in process,and 7 under development.

The Southern Research Institute in Birmingham,Alabama, maintains an NIAID-supportedTuberculosis Antimicrobial Acquisition andCoordinating Facility (TAACF). TAACF acquirescompounds for screening against virulent M.tb,maintains a computerized chemical database ofcompound structures, coordinates and distributescompounds for evaluation in vitro and in animalmodels, and reports data to suppliers. TAACF hascontacted more than 3,500 chemists throughout theworld seeking candidate anti-TB compounds.More than 60,000 candidate anti-TB compoundshave been received from academic and private sectorinvestigators principally in the United States andEurope, with growing involvement of scientistsfrom Africa, Asia, Australia, South America, andother geographic sites. For more information,please visit www.taacf.org.

NIAID’s Division of Intramural Research has asubstantial intramural program that integratesgenomics and combinatorial chemistry to speed thedevelopment of new antibiotics for the control oftuberculosis. At present, intramural scientists areworking on a number of approaches to improvecurrent anti-TB chemotherapeutics.

Sexually Transmitted Infections

Because of their devastating impact on women andinfants and their causal association with HIV/AIDS,sexually transmitted infections (STIs) are criticalglobal and national health priorities. STIs oftenhave severe sequelae such as infertility, tubalpregnancy, cervical cancer, fetal wastage, lowbirthweight, congenital or perinatal infection, andHIV/AIDS infection. Recent studies indicate thatnonulcerative STIs (e.g., chlamydia, gonorrhea, andtrichomoniasis) and ulcerative STIs (e.g., genitalherpes, syphilis, and chancroid) increase the risk ofHIV/AIDS transmission by at least twofold tofivefold. Because HIV/AIDS infection ischaracterized by a weakened or nonfunctioningimmune system, it can alter the natural history ofsome STIs (e.g., pelvic inflammatory disease andhuman papillomavirus infection).

Individuals with STIs are at least 2 to 5 times morelikely than uninfected individuals to acquire HIV if

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they are exposed to the virus through sexualcontact. In addition, if an HIV-infected individualalso is infected with another STI, that person ismore likely to transmit HIV through sexual contactthan other HIV-infected persons (CDC. The Roleof STD Detection and Treatment in HIV Prevention.www.cdc.gov/nchstp/dstd/fact_sheets/facts_std_testing_and_treatment.htm).

Even though rates of some STIs (e.g., syphilis) sawan overall U.S.-wide decline in 2001, a recentreport by CDC indicates that STI rates tend to behigher among African Americans than amongwhites. In 2001, the rate of primary and secondarysyphilis reported in African Americans (11.0 casesper 100,000 population) was 16 times greater thanthe rate reported in whites (0.7 cases per 100,000).This differential was substantially less than that in1997, when the rate of primary and secondarysyphilis among African Americans was 44 timesgreater than the rate reported among whites.Although STI rates tend to be higher amongAfrican Americans than whites, the differential ratesbetween the two groups declined between 1997 and2001. Declining differences are due to consistentdecreases in STI rates in African Americans togetherwith an increase in STI rates in whites (U.S. Trendsin Sexually Transmitted Diseases. [all from STDSurveillance, 2001. DHHS, CDC, September2002 unless otherwise cited])

NIAID supports individual investigator-initiatedresearch grants and a variety of research programsfor the development of more effective preventionand treatment approaches to control STIs(www.niaid.nih.gov/dmid/STDs). Research effortsinclude developing and licensing vaccines, topicalmicrobicides, and treatments for the microbes thatcause STIs; understanding the long-term healthimpact of sexually transmitted pathogens in variouspopulations; stimulating basic research on thepathogenesis, immunity, and structural biology ofthese pathogens; and developing better and morerapid diagnostics. Specific programs supported byNIAID include the Sexually Transmitted Disease(STD) Cooperative Research Centers (CRCs),which bridge basic biomedical, clinical, behavioral,and epidemiologic research; promote productive

collaborations among academic researchers; andfacilitate the development of intervention-orientedresearch. Another program, the STD Clinical TrialsUnit, conducts clinical trials to test the safety andefficacy of biomedical and behavioral interventionsaimed at the prevention and control of STIs.Finally, the Topical Microbicides Program Projectsconduct basic research, product development, andclinical evaluation activities aimed at developingfemale-controlled barrier methods for theprevention of STIs and HIV/AIDS infection.

As part of the Public Health Service’s effort toeliminate syphilis in the United States by 2005,NIAID’s efforts focus on providing betterbiomedical tools to prevent and control this disease.These efforts include (1) diagnostic testdevelopment, which is intended to create a rapid,inexpensive, easy-to-use test that would not requirea blood sample; (2) a clinical research study of oraltherapy to treat early-stage syphilis; and (3)development of a syphilis vaccine that would targetand prevent systemic infection (including congenitalsyphilis) and could potentially ameliorate diseaseprogression.

NIAID currently is supporting a clinical researchprotocol examining a single oral dose of therapy forearly syphilis. The goal of the study is to determinewhether treating syphilis with azithromycin is aseffective as the current recommended treatment,benzathine penicillin G. Azithromycin offers manyadvantages over benzathine penicillin.Azithromycin is taken orally; benzathine penicillinis administered by often-painful injections that candiscourage patients from seeking treatment.In addition, the penicillin injections requirerefrigeration and needles, which can hamperadministration in “field” settings. The azithromycinregimen proposed in this study could beadministered as direct observed therapy in the field,using strategies modeled after those used to treattuberculosis.

The long-term goals of all NIAID’s syphilisactivities are to (1) complement CDC’s syphiliselimination program, (2) provide improvedbiomedical and behavioral tools to achieve and

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sustain syphilis elimination in the United States,and (3) provide improved tools for prevention andcontrol of syphilis in developing countries.NIAID’s research takes into account the limitedresources of areas where syphilis is endemic, thesocial and cultural barriers to accessing effectivehealth care in some of those endemic areas, and theneed for sustainable interventions.

In addition, NIAID continues to initiate andsupport a variety of other STI research projects,including the following:

• Developing and evaluating STI diagnosticsdesigned for point-of-care use through the SmallBusiness Innovation Research mechanism

• Continuing to support grants for the developmentof vaccines to prevent chlamydial and gonorrhealinfections

• Supporting a herpes vaccine efficacy trial

• Supporting an STD CRC focused on preventingSTIs. Through this center, two studies willexamine strategies for preventing bacterialvaginosis, herpes, and chlamydial infections

• Supporting an STD CRC focused onmultidisciplinary research on sexual behavior,clinical epidemiology, immunobiology, and thepathogenesis of gonococcal and chlamydialinfections

• Supporting an STD CRC that emphasizesresearch exploring more effective interventions forpreventing STI morbidity in adolescents

• Supporting a longitudinal study to examine socialand sexual networks of Hispanic adolescents inSan Francisco

NIAID also supports the sequencing of thegenomes of sexually transmitted pathogens,including Chlamydia trachomatis, Treponemapallidum, and Ureaplasma urealyticum. Completed

genome sequences have provided new insights intothe pathogenesis of their associated diseases andpave the way for new opportunities to developdiagnostics, drugs, vaccines, and microbicides.

Additional activities include the following:

• Opened in November 2002, the Herpevac Trialfor Women is a pivotal phase III double-blindclinical efficacy trial of an investigational vaccinefor the prevention of genital herpes. The study,conducted as a public-private partnership withGlaxoSmithKline, will enroll 7,550 women atapproximately 25 sites across the United States.The trial will require an estimated 4 years tocomplete.

• This past year, the STDs Prevention Primate Unitfor preclinical evaluation of topical microbicidesand vaccines at the University of Washingtonevaluated several candidate microbicides for safetyby examining the effects on surface tissues and theimpact on the microenvironment of the cervixand vagina in pig-tailed macaques. Results fromthe testing contract are supported by the Divisionof Microbiology and Infectious Diseases (DMID).Coordination and testing are conducted inassociation with the Division of AcquiredImmunodeficiency Syndrome (DAIDS). DMIDand DAIDS will facilitate product developmentand ensure safety and efficacy testing in clinicaltrials.

• The Topical Microbicides Development andEvaluation Workshop, held on March 18–20,2003, was the first joint meeting of DMID-,DAIDS-, and NICHD-supported investigatorsconducting research on topical microbicides.The workshop addressed issues ranging from basicresearch through formulation and applicatordesign and served as a forum for establishingcollaborative work among STI and HIV/AIDSinvestigators in the microbicide arena.

• The STD Clinical Trials Unit is conducting arandomized phase III trial to evaluate the

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equivalency of oral azithromycin versus injectablebenzathine penicillin for the treatment of primarysyphilis. If successful, this trial may provide anadditional antimicrobial strategy for treatingprimary syphilis.

• Collaborating with STD CRCs, NIAID continuesto support a research program with second-yearmedical students from Howard University inWashington, DC. This program providesstudents with a 10-week STI research experienceat the STD CRCs, with the long-term objective ofencouraging young minority physicians to pursuecareers in STI research.

Hepatitis C

Hepatitis C virus (HCV) infection is the mostcommon chronic blood-borne viral infection in theUnited States. HCV infects approximately 2 percentof the U.S. population, or approximately 4 millionpersons. New infections in the United Statescontinue at the rate of 25,000 cases per year(www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm).According to CDC, HCV infection occurs amongpersons of all ages, but the highest incidence rate ofacute hepatitis C is found among persons betweenages 20 and 40 years, and males predominate.African Americans and whites have similarincidence rates of acute disease. Persons ofHispanic ethnicity have higher rates of acutedisease. In the general population, the highestprevalence rates of HCV infection are found amongpersons in the 30-to-50 age range, and again malespredominate. Unlike the rates of acute disease,African Americans have a substantially higherprevalence of HCV infection than do whites.

NIAID has aggressively pursued the expansion ofHCV research through its development of theHepatitis C Framework for Progress. With the aid ofparticipating Institutes and Centers, an NIH-wideframework was drafted that incorporates varyingindividual missions into a cohesive global plan. Thefinal plan underwent external review and has beenapproved by the NIH Director as well as NIH

Institute and Center Directors. The followingresearch goals were identified in the framework:

• Understanding HCV transmission modes todevelop effective intervention strategies

• Understanding HCV pathogenic mechanisms anddisease progression to develop effective treatments

• Characterizing hosts’ immune responses to HCVinfection to develop vaccines, prophylacticmeasures, and therapeutic measures

• Defining viral replication and recovery withtherapy develop new therapeutic strategies

• Investigating clinical manifestations to developnoninvasive methods to evaluate current diseasestate, to predict outcomes, and to prevent orreverse disease progression

• Defining effective prevention and interventionstrategies to improve health

One of the cornerstones of NIAID’s HCV effort isthe Hepatitis C Cooperative Research Centers (HCCRCs), which were launched in 1996 as basic andclinical research units devoted to understandingHCV infection and disease processes. Currently,NIAID provides funding support to six HC CRCs.The goals of NIAID’s six HC CRCs are to identifycomponents of HCV, isolate the body’s immuneresponse to HCV, determine the individual geneticfactors that have a crucial impact on recovery frominitial and chronic infection, track diseaseprogression and severity, and determine howcofactors influence HCV disease. Clinical researchemphasizes studies in special populations (e.g.,African Americans) heavily affected by HCV thatrespond poorly to standard therapies. Specifically,one of the HCV CRCs is conducting a therapeuticclinical trial examining the use of pegylatedinterferon and ribavirin in parallel cohorts ofAfrican Americans and whites. The goal of thisclinical trial is to determine what causes disparitiesbetween African Americans and whites in responseto standard therapy.

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Other NIAID HCV research activities include thefollowing:

• NIAID continues to provide partial support forthe ancillary studies of the NIDDK-sponsoredtrial, “Hepatitis C Antiviral Long-term Treatmentagainst Cirrhosis (HALT-C).” The trial isevaluating the impact of long-term therapy ondisease progression, including virologic andimmunologic responses and their association withrecovery.

• NIAID supports HCV epidemiological researchand treatment trials within its HIV clinical trialnetworks.

• NIAID research efforts toward the development ofvaccines have been and remain primarily focusedon developing a better understanding of themolecular biology of HCV and the immuneresponse to HCV infection. These investigationsare providing an in-depth analysis of immuneresponses to HCV infection, the role of cytokinesand other immune regulatory molecules in thecontrol of HCV infections, and the evolution ofvirus in response to the immune responsemounted by the host.

• The development of antivirals for HCV has beenhindered by the lack of robust and economicalcell culture and animal models. NIAID granteeshave recently developed a novel enzymaticreporter system for the detection and quantitationof HCV ribonucleic acid in intact cells. This cell-based system was optimized for a high-throughputscreening program and is being used to identifynew antiviral compounds for HCV.

• Extramural investigators developed HCV cell linesthat are now validated as in vitro antiviralscreening tools. NIAID supports two of thesesystems via its in vitro screening contractprograms. These systems are used by academicand corporate scientists (www.niaid.nih.gov/dmid/viral).

• NIAID’s extramural program has initiated twoactivities to broaden HCV research and

development. The first activity involves theacquisition and provision of HCV researchreagents. These reagents are obtainable throughthe AIDS Research and Reference ReagentProgram (www.aidsreagent.org). Other reagentsare available through www.niaid.nih.gov/reposit/tetramer/index.html and www.bratonbiotech.com/braton11.htm. The second activity involves thedevelopment of an annotated HCV sequencedatabase by Los Alamos National Laboratories(http://hcv.lanl.gov/content/hcv-db/index).

• NIAID released the “Liver and Pancreatic Diseasein HIV Infection” program announcement (PA),sponsored jointly with NIDDK. This program isintended to stimulate research on the pathogenesisand therapeutics of liver and pancreatic diseaseassociated with the co-infections (e.g., hepatitis B,hepatitis C) that occur in patients with HIVinfection. This PA also seeks to stimulate researchin the metabolic complications associated withtreating HIV infection. Metabolic complicationsinclude hepatic drug toxicity, hepatic lipidmetabolism, nonalcoholic steatohepatitis, andpancreatitis.

• Researchers supported by NIAID are investigatingthe relationships between HCV replication,evolution, and disease progression in AlaskaNatives. To date, more than 900 HCV-positivepatients have been enrolled in the study.Complete patient histories, including theestimated date of infection and alcohol history, arebeing obtained. Blood and liver specimens arebeing collected both retrospectively andprospectively. Specimens will be examined todetermine the levels and variation of HCV virusand will be compared with the disease progressionin patients. This well-defined Alaska Nativepopulation may provide many key answersregarding the natural history of hepatitis C andmay affect the future worldwide treatment ofhepatitis C.

Pneumonia

Pneumococcal pneumonia is an infection in thelungs caused by the Streptococcus pneumoniae(S. pneumoniae or pneumococcus). Pneumococcus

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can infect the upper respiratory tracts of adults andchildren and can spread to the blood, lungs, middleear, or nervous system. More than 60,000 cases andmore than 6,000 deaths from invasivepneumococcal disease (e.g., bacteremia andmeningitis) are estimated to occur annually in theUnited States. Rates of invasive infection increasewith age and are disproportionately higher amongcertain minority populations. For example,children of Alaska Native ethnicity, those fromcertain American Indian groups, and children ofAfrican American origin have increased rates ofpneumococcal pneumonia. Pneumococci accountfor up to 36 percent of adult community-acquiredpneumonia and 50 percent of hospital-acquiredpneumonia. Pneumonia is a common bacterialcomplication of influenza and measles. Thepneumonia case-fatality rate is 5 percent to7 percent and may be much higher in elderlypersons (www.cdc.gov/nip/publications/pink/pneumo2.pdf ).

NIAID has supported an efficacy and safetyphase III randomized trial in 8,292 Navajo andWhite Mountain Apache children using thelicensed 7-valent pneumococcal conjugate vaccinePrevnar. Results of the trial demonstrate that thevaccine is highly efficacious (76.8 percent) againstvaccine serotype invasive pneumococcal disease inthis high-risk population. The data clearlydemonstrate that the vaccine is capable ofpreventing disease, not only in the general U.S.population, but also in a setting wherepneumococcal colonization frequency is 50 percentat 2 months of age.

Acquired Immunodeficiency Syndrome

Since the emergence of HIV/AIDS as a deadlyglobal infectious disease in 1981, considerableprogress has been made in understanding theimpact of HIV/AIDS on the immune system andhow to intervene therapeutically. Researchers havedeveloped new techniques to detect HIV/AIDS inblood and tissue and have also identified powerfulnew antiviral therapies. These therapies, referred toas HAART, suppress the virus to undetectable levelsin the blood and delay disease progression and

death. Since the widespread introduction ofHAART, deaths in persons with HIV/AIDS havedropped dramatically in the United States and otherdeveloped countries. HIV-infected individuals livelonger as a result of HAART, but many experience ahost of complications from the complex therapeuticregimen. These complications include thedevelopment of drug resistance, metabolicabnormalities and toxicities, and patientnoncompliance. Despite the scientific advances,AIDS continues to rage around the world.

According to the Joint United Nations Programmeon HIV/AIDS, 42 million people were estimated tobe living with HIV/AIDS, and 3.1 million peopledied from AIDS worldwide in 2002. In addition,5 million people became infected with HIV in2002, including 2 million women and 800,000children aged 15 years and younger.

More than 830,000 cases of AIDS have been reportedin the United States since the epidemic began in1981, with an estimated 384,906 persons known tocurrently be living with AIDS. One-quarter of theapproximately 950,000 Americans who currently maybe infected with HIV are unaware of their infection.Although AIDS affects all groups, the diseasecontinues to disproportionately affect racial andethnic minority populations. African Americansand Hispanics constitute 61 percent of the AIDScases in the United States. Although AfricanAmericans comprise only 12 percent of the U.S.population, they make up almost 41 percent of allAIDS cases reported in the United States. Similarly,Hispanics comprise 13 percent of the U.S.population and represent 19 percent of all AIDScases. Of the new AIDS cases reported in 2002,55 percent were among African Americans,13 percent among Hispanics, and 32 percentamong whites; less than 1 percent were amongAmerican Indians, Alaska Natives, and Asian-Pacific Islanders. Among women, AfricanAmericans and Hispanics account for 81 percent ofAIDS cases. Among men, African Americans andHispanics account for 64 percent of cases. Minoritychildren also are disproportionately affected byAIDS. Of the 92 pediatric AIDS cases reported in2002, 89 percent (82) were in African Americanand Hispanic children. CDC reported 16,371

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deaths from AIDS in the United States in 2002, ofwhich 52.3 percent were African Americans,18.7 percent were Hispanics, 27.8 percent werewhites, 0.6 percent were Asian-Pacific Islanders, and0.4 percent were American Indians and AlaskaNatives (CDC. HIV/AIDS Surveillance Report,Vol.14, 2002. www.cdc.gov/hiv/stats/hasr1402.htm).

The disproportionate impact of the HIV/AIDSepidemic is seen more clearly by comparing therates of infection between specific groups. Rates ofinfection are defined as the number of cases per100,000 people. The rate of HIV/AIDS infectionis 5.9 among whites, 58.7 among AfricanAmericans, 19.2 among Hispanics, 4.0 amongAsian-Pacific Islanders, and 8.5 among AmericanIndians and Alaska Natives.

The estimated number of people living with AIDSat the end of 2002 in 30 areas with confidentialname-based reporting show that HIV transmissiondue to substance abuse continues to be a significantfactor in contributing to the spread of HIV/AIDSin minority communities. Data show that24 percent of African American males and23 percent of Hispanic males reported injectiondrug use as a potential exposure route forHIV/AIDS. In contrast, only 10 percent of whitesreported injection drug use as a potential forexposure. Among women, injection drug use wasreported as a potential exposure route forHIV/AIDS by approximately 24 percent of AfricanAmericans, 26 percent of Hispanics, 17 percent ofAsian-Pacific Islanders, 36 percent of AmericanIndians and Alaska Natives, and 34 percent ofwhites. A large proportion of women becomeinfected with HIV/AIDS through sexual contactwith an injection drug user. Of the HIV+ womenin the United States, more than 75 percent wereinfected through heterosexual contact. Anotherfactor contributing to the spread of HIV/AIDS inminority communities is men having sex with men(MSMs). For both African American and Hispanicmales, MSM continues to be the leading exposuremethod (CDC. HIV/AIDS Surveillance Report,Vol.14, 2002). For the most up-to-date U.S.HIV/AIDS statistics, please visitwww.cdc.gov/hiv/stats/ hasr1402.htm.

As the HIV/AIDS epidemic continues to expand inminority communities, enrolling minority patientsin HIV/AIDS clinical trials is particularly urgent sothat research results are applicable to all populationsaffected by the disease. People of minoritybackgrounds face unique social, economic, andmedical issues when coping with the challengesassociated with HIV/AIDS infection, and therefore,one of the greatest challenges facing HIV/AIDSresearchers today is the recruitment and retention ofminority patients for clinical trials. To ensure thatenrollment reflects the national epidemic, NIAIDhas taken strong steps to encourage minorityparticipation in clinical trials, natural historystudies, and prevention studies. NIAID works withcommunities to identify and overcome barriers toparticipating in clinical trials. Outreach isaccomplished by developing culturally sensitiveeducation materials and providing additionalresources (e.g., childcare, transportation) that arenecessary for enhancing participation by allcommunities in NIAID-sponsored trials. NIAIDalso has taken a leadership role in involvingcommunity representatives in local, national, andinternational research activities. Encouragingcommunity members to play an active role in allaspects of research facilitates communication andhelps ensure that new HIV/AIDS treatment andprevention strategies address areas of utmostconcern to those affected by the disease. NIAID’sHIV/AIDS clinical research networks provideopportunities for community representatives toparticipate in the research process through local,national, and international Community AdvisoryBoards. In addition, NIAID recently released the“Enrolling Women and Minorities in HIV/AIDSResearch Trials” program announcement. Thisprogram will fund innovative approaches to reach,enroll, and retain women and racial/ethnicminorities in HIV/AIDS research trials in theUnited States. Research trials will be conducted toadvance the body of scientific knowledge that willimprove the diagnosis, treatment, and developmentof preventive strategies for women and minorities.

NIAID directs a large therapeutic clinical trialsprogram consisting of three groups: the Adult AIDSClinical Trials Group (AACTG), the Pediatric AIDSClinical Trials Group (PACTG), and the Terry

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Beirn Community Programs for Clinical Researchon AIDS (CPCRA). AACTG investigatestherapeutic interventions for HIV infection, AIDS,and complications of HIV-associated immunedeficiency in adults (http://aactg.s-3.com). PACTGevaluates clinical interventions for treating HIVinfection and HIV-associated illnesses in neonates,infants, children, adolescents, and pregnant women.PACTG also researches approaches to preventmother-to-child transmission (MTCT) of HIV(http://pactg.s-3.com). CPCRA is a network ofcommunity-based health centers and clinics thatsupport clinical research in community settings.CPCRA conducts large, comparative studies thatevaluate therapies and treatment strategies for HIVinfection and HIV-associated illnesses (www.cpcra.org). AACTG, PACTG, and CPCRA strive toensure that a sufficient proportion of minorityindividuals is enrolled in clinical trials. In 2003,7,699 and 2,984 participants were enrolled inAACTG and PACTG studies, respectively. In theAACTG, 29 percent were African American,18 percent Hispanic, 2 percent Asian-PacificIslander, and less than 1 percent American Indianand Alaska Native. In the PACTG, 57 percent wereAfrican American, 28 percent Hispanic, and lessthan 1 percent Asian-Pacific Islander, AmericanIndian, or Alaska Native. Of the 3,513 patientswho were enrolled in CPCRA studies duringFY 2003, 46 percent were African American,16 percent were Hispanic, 0.7 percent were Asian-Pacific Islanders, and 0.5 percent were AmericanIndians and Alaska Natives (NIAID. HIVInfections in Minority Populations, August, 2003.www.thebody.com/niaid/2003/minorities_hiv.html).

NIAID’s epidemiologic research explores the clinicalcourse and factors contributing to the transmissionof HIV/AIDS infection in a variety of populations.NIAID supports several studies, including theWomen and Infants Transmission Study (WITS),which targets inner-city women and their children;the Women’s Interagency HIV/AIDS Study(WIHS), which explores the clinical course ofHIV/AIDS infection in women with a focus onminority women (http://statepiaps.jhsph.edu/wihs);and the Multicenter AIDS Cohort Study (MACS),a prospective, longitudinal study of HIV/AIDS

disease in homosexual and bisexual men(http://statepi.jhsph.edu/macs/macs). WIHS andMACS are the two largest observational studies ofHIV/AIDS in women and homosexual or bisexualmen in the United States. These studies have mademajor contributions in understanding how HIV isspread, understanding HIV disease and progressionto AIDS, and developing the most effectivemethods for treating HIV/AIDS. As of thecompletion of the enrollment period, WIHS andMACS have increased the study group size by60 percent and added to the total number ofminority participants. The expanded groups willfocus on contemporary questions regarding HIVinfection and treatment. This year, MACS isentering its 20th year of research while WIHS hasjust completed its 10th year of research. In 2003,the enrollment of individuals from minoritycommunities in NIAID-supported epidemiologycohorts was 23.3 percent in MACS, 85.1 percent inWIHS, and 85.4 percent in WITS. MACS isco-funded by the National Cancer Institute (NCI)and the National Heart Lung and Blood Institute.WIHS is co-funded by NCI, NICHD, the NationalInstitute of Dental and Craniofacial Research, andthe National Institute on Drug Abuse (NIDA).

Vaccine Development

NIAID continues to support efforts to develop aneffective HIV vaccine for use around the world.Established in 2000, the HIV Vaccine TrialsNetwork (HVTN) is a collaboration of domesticand international clinical sites dedicated todeveloping a preventive HIV vaccine. Building onthe previous accomplishments of NIAID’s AIDSVaccine Evaluation Group and the HIV Networkfor Prevention Trials (HIVNET), HVTN tests andevaluates candidate vaccines in clinical trials. Thereare 18 sites in the United States and 13 sitesoverseas, including sites in Africa, Asia, SouthAmerica, and the Caribbean. HVTN’s globalcapacity will allow for rapid expansion and theability to perform large-scale studies of suitablevaccines as more vaccine candidates enter thepipeline for testing and development. In 2003,13 percent of participants in U.S. HVTN studieswere African American, 4.2 percent were Hispanic,

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1.8 percent were Asian-Pacific Islander, and1.0 percent were American Indian and AlaskaNative.

Currently, HVTN is conducting six phase I andtwo phase II clinical trials of candidate HIVvaccines. For more information about these trials,please visit www.hvtn.org or www.aidsinfo.nih.gov.

The participation of international sites and theinvolvement of ethnically diverse populations inHVTN studies are critical components of NIAID’sHIV/AIDS vaccine effort. HVTN’s broadparticipation allows researchers to design studiesthat examine factors crucial to developing aneffective vaccine for use around the world. Thesefactors include genetic background, nutritionalstatus, effects of co-infection, and access to healthcare. HVTN’s international capacity also facilitatesstudies of the HIV/AIDS subtypes, which affect aminority of the global population. StudyingHIV/AIDS subtypes is an important aspect ofdeveloping a vaccine that will protect individualsfrom the various circulating strains of HIV/AIDS.

In addition to conducting clinical studies, HVTNdevelops community outreach programs to educatepeople about HIV/AIDS and vaccine research.Through outreach, HVTN seeks to encourageparticipation in clinical trials and enroll a diversepopulation, emphasizing the recruitment ofminorities and women.

NIAID also is actively involved in educating thepublic about HIV vaccine research and is currentlyin year two of its HIV Vaccine CommunicationsCampaign. Targeting at-risk populations, inparticular African Americans, Hispanics, andMSMs, the NIAID HIV Vaccine CommunicationsCampaign is developing and implementing anational education campaign to increase awarenessof and support for HIV vaccine research, especiallyin at-risk populations. To ensure that communityneeds are considered, NIAID receives input andguidance from the HIV Vaccine CommunicationsSteering Group, a group of representatives from thecommunity, Federal agencies, pharmaceuticalcompanies, and HIV vaccine advocacy groups. A

key component of the campaign’s first year was toengage individuals and organizations representingtarget audiences and currently involved inHIV/AIDS prevention and treatment efforts.Roundtable discussions were held with leaders inthe African American and Hispanic communities torefine strategies and engage participants in materialsdevelopment, outreach, and other activities. As partof the campaign, a qualitative, comprehensiveresearch effort was conducted including primaryresearch (e.g., 28 focus groups) and secondaryresearch. This past year, a national survey wascompleted that evaluated the attitudes andknowledge of HIV vaccine research in the generalpopulation, as well as in segmented groups ofAfrican Americans, Hispanics, and MSMs. Keyfindings of the survey indicate that large numbers ofAfrican Americans and Hispanics believe that asecret HIV vaccine already exists. The survey alsoreveals that many African Americans and Hispanicsdo not know that all vaccine trial volunteers areHIV negative and there is no risk of contractingHIV from the vaccines being tested. The HIVVaccine Communications Campaign is working tocorrect the misperceptions that exist regarding HIVvaccine trials and, at the same time, provide generalinformation about HIV vaccine research tominority communities. In early 2003, funding willbe provided to community-based and nationalorganizations with strong ties to racial and ethnicminority communities to support local and nationalHIV vaccine research awareness activities, includingactivities related to HIV Vaccine Awareness Day,which is designated May 18 of each year. Inaddition, the campaign is conducting an ongoingprogram aimed at educating minority media aboutHIV vaccine research so that they can be betterprepared to report on key research findings. Formore general information about HIV vaccineresearch, please visit www.niaid.nih.gov/newsroom/mayday/default.htm.

NIAID established the Dale and Betty BumpersVaccine Research Center (VRC) at NIH in 2000.This unique venture within the NIH intramuralresearch program uses national and internationalcollaborations with scientists in academic, clinical,and industrial laboratories to conduct researchfacilitating the rigorous pursuit of effective vaccines

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for AIDS and other human diseases. DevelopingAIDS vaccines is the highest priority of the center.VRC employs a multidisciplinary approach,integrating research from basic and clinicalimmunology and virology into vaccine design andproduction. VRC activities target three mainpriorities: (1) basic research to establishmechanisms of inducing long-lasting protectiveimmunity against HIV and other pathogens thatpresent special challenges to vaccine development;(2) the conception, design, and preparation ofvaccine candidates for HIV and related viruses; and(3) laboratory analysis, animal testing, and clinicaltrials of vaccine candidates.

VRC actively recruits volunteers to participate inphase I clinical trials. VRC seeks to increaseminority participation through a process ofoutreach and education. Recruiting participantsfrom diverse ethnic backgrounds will ensure that allpotential stakeholders are included in developing asuccessful vaccine.

In November 2002, VRC launched a phase Iclinical study of a novel DNA vaccine directed atthe three most globally prevalent HIV subtypes, orclades. The vaccine incorporates HIV geneticmaterial from clades A, B and C, which cause about90 percent of all HIV infections around the world.This first multigene, multiclade HIV vaccine toenter human trials marks an important milestone inthe search for a single vaccine targeting the U.S.subtypes of HIV and for the clades causing theglobal epidemic. During the year-long first phase ofthe trial, conducted at the NIH campus inBethesda, Maryland, VRC scientists will assess thevaccine’s safety and determine whether the vaccineinduces any immune response. Expanded testsconducted through HVTN are planned for severaldomestic sites, as well as sites in Haiti and SouthAfrica.

Prevention

Preventing the transmission of HIV/AIDS is animportant aspect of HIV/AIDS research activities.In an effort to reduce the worldwide spread of HIV,NIAID established the HIV Prevention Trials

Network (HPTN) in 2000. HPTN is a globalnetwork of clinical trial sites with 9 sites in theUnited States and 16 international sites in Africa,Asia, Europe, and South America. The networkexplores a variety of nonvaccine preventionstrategies to reduce HIV/AIDS transmission, suchas testing and developing biomedical and behavioralintervention programs. Because HIV/AIDS istransmitted through different routes in variouspopulations, developing a variety of HIV/AIDSprevention strategies will have a significant impacton reducing transmission rates and slowing theworldwide spread of HIV/AIDS. In 2003,9.5 percent of participants in U.S. HPTN studieswere African American, 15 percent were Hispanic,2.6 percent were Asian-Pacific Islander, and0.7 percent were American Indian or Alaska Native.Besides being sponsored by NIAID, HPTN isco-sponsored by NICHD, NIDA, and the NationalInstitute of Mental Health.

HPTN evolved from HIVNET, a program thatconducted phase I, II, and III clinical trials at U.S.and international sites. Building on HIVNET’smany accomplishments, HPTN continues toexpand the multidisciplinary research agendaestablished by HIVNET. HIVNET’saccomplishments include the discovery ofnevirapine as an effective, affordable drug forpreventing MTCT of HIV/AIDS in developingcountries, and the establishment of the initial safetyand acceptability of two new nondetergentmicrobicides.

The HPTN scientific agenda is divided into thefollowing six main areas of research:

• Evaluating biomedical approaches to preventMTCT of HIV

• Developing and evaluating topical microbicides toprevent transmission of HIV

• Developing behavioral interventions to helppeople reduce their risk of exposure to HIV

• Developing interventions to reduce HIV infectionresulting from substance use

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• Evaluating programs to control or reduce STIs asa means of decreasing the risk of acquiring andtransmitting HIV infection

• Evaluating the impact of antiretroviral therapies inreducing the infectiousness of individuals infectedwith HIV

Educating communities about HIV/AIDSprevention trials and building community trust hasbeen an important and crucial aspect of HPTN andHVTN outreach. HPTN invites communitymembers to participate in developing its scientificagenda to promote information exchange andensure that social, cultural, and political values arerespected. Community members discuss studydesigns, recruitment plans, volunteer incentives,informed consent requirements, risk-reductionstrategies, and research findings. Each HPTN sitealso has a community educator who assistscommunity members in understanding the scienceof HIV/AIDS, research methods that will be used,and the clinical trial process. Community educatorsbuild community trust by creating open forumsallowing for candid conversations about communityfears and concerns related to Government-sponsored research. For information regardingHPTN studies, please visit www.hptn.org orwww.aidsinfo.nih.gov.

For more information on HIV/AIDS clinicaltrials, please visit www.aidsinfo.nih.gov or call 1-800-448-0440.

NIAID Outreach Activities

Disseminating research results to the media, healthprofessionals, and the public is an important aspectof NIAID’s mission. Outreach activities includeproducing and publicizing print, audiovisual, andWeb-based materials; distributing materials atprofessional and community meetings; andsponsoring workshops and conferences forcommunity health care providers and the public.

NIAID produces materials on allergic andimmunologic diseases, AIDS/HIV, sexuallytransmitted infections, and potential illnesses

caused by agents of bioterrorism. Press releases,information sheets, and booklets are distributedworldwide in response to more than 10,000requests from people who contact NIAID each year.For example, the TB educational booklets LearnAbout Tuberculosis/Aprenda Sobre la Tuberculosis andLearn About Tuberculosis Infection/Aprenda Sobre laInfeccion de laTuberculosis remain popular and aredistributed in English and Spanish each year. Inaddition, the NIAID Web site is visited 1.5 milliontimes each month. Hundreds of thousands ofinquirers request materials or downloadinformation from the NIAID Web site each year(www.niaid.nih.gov).

Expanding its outreach efforts, NIAID keeps morethan 400 voluntary and scientific organizationsupdated about Institute activities. Periodic e-mailsprovide NIAID research news and information onadvances that specifically relate to an organization’sresearch interests. In addition, workshops on HIVvaccine research were featured at the AIDS Vaccine2002 conference, the Conference on Retrovirusesand Opportunistic Infections, the U.S. Conferenceon AIDS, the National AIDS Treatment AdvocatesForum, the National Association of People WithAIDS Conference, and many other scientific andcommunity-oriented conferences. NIAID providesexhibit booths at scientific, health-related, andstudent scientific organization meetings andconferences where staff distribute materials aboutallergic, immunologic, and infectious diseases. Staffmembers working in the booths also answerquestions about NIAID research and jobopportunities. NIAID performs outreach atconferences sponsored by the followingorganizations: the American Academy of Allergy,Asthma and Immunology; American Society forMicrobiology; American Indian Science andEngineering Society; Hispanic Association ofColleges and Universities; American Public HealthAssociation; Society for Advancement of Chicanosand Native Americans; and Congressional BlackCaucus. NIAID has also provided outreach at theAnnual Black Family Reunion, the AnnualBiomedical Research Conference for MinorityStudents, and the National Conference on Blacks inHigher Education.

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NIAID has been involved extensively in theoutreach efforts of the Dale and Betty BumpersVRC. As VRC prepares for its second HIV vaccinetrial, NIAID is helping to construct communitypartnerships by targeting local news media, visitinglocal churches and other community organizations,and attending HIV/AIDS-related conferences andmeetings.

Working directly with the public is one aspect ofNIAID’s outreach campaign. NIAID offers apublic-speaking component consisting of researcherswho will speak on request to community groupsand at public schools. NIAID also has participatedin a community awareness program addressingcancer awareness, self-management techniques forasthma sufferers, and the silent damage done to thebody by hypertension. Staff members haveparticipated as judges in science fair projects at localschools. Working in local schools provides NIAIDstaff with the opportunity to interact with teachers,parents, and budding scientists.

In FY 2003, NIAID held its first Health DisparitiesSymposium titled “Increasing Diversity in ClinicalTrials: Best Practices.” The symposium objectiveswere the following:

• Examine cultural issues that affect the recruitmentand retention of minority participants in clinicaltrials

• Provide researchers, outreach workers, andcommunity educators with effective strategies foroutreach, recruiting, and retaining participantsfrom minority populations

• Demonstrate best practices for using electronicresources to identify applicable clinical trials,human subjects policies, and funding sources andmechanisms

The 200 symposium attendees included NIAIDgrantees, members of advocacy groups, communityphysicians, nurse practitioners, and researchclinicians. The proceedings of the symposium willbe posted on the NIAID Web site at a future date.

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NIH-Wide Programs

Minority Biomedical Research Support Program

Through innovative programs and outreach efforts,NIH continually works to increase the number ofminority researchers in the field of biomedicalresearch. The Minority Biomedical ResearchSupport Program (MBRS) is one of the largest NIHprograms working toward this goal. MBRS awardsgrants to educational institutions with substantialminority enrollment. Grants are given to supportfaculty research, strengthen an institution’sbiomedical research capabilities, and increase theinterest, skills, and competitiveness of students andfaculty in the pursuit of careers in biomedicalresearch. NIH Institutes contribute money to theNational Institute of General Medical Sciences(NIGMS), which administers MBRS through itsDivision of Minority Opportunities in Research(www.nigms.nih.gov/about_nigms/more.html#mbrs).

A recent reorganization of MBRS raised the numberof institutions that are eligible for research andinstitutional development support because of theirsubstantial minority student enrollment. Alongwith this increase, there also has been a rise in theaverage size of requested grant awards, making thesegrants comparable in size to other NIH researchgrants. There are three subcomponents of MBRS:the Support of Continuous Research Excellence(SCORE) initiative, the Research Initiative forScientific Enhancement (RISE), and the Initiativefor Minority Student Development (IMSD).

Collectively, SCORE, RISE, and IMSD providesupport from the undergraduate level to thepostdoctoral level in institutional development,student and faculty training, and student andfaculty career development. Overall program goalsfor SCORE, RISE, and IMSD are to enhance thescience curricula and faculty research capabilities atinstitutions with significant underrepresented

minority enrollment, encourage minority studentsto pursue training for scientific careers, andstrengthen the research skills of minority studentsand faculty. The opportunities provided by theseprograms encourage participation from institutionsranging from 2-year colleges to research-intensiveinstitutions with doctoral programs.

SCORE provides financial assistance to competitiveresearch programs in all areas of biomedical andbehavioral research. Funding is provided to developbiomedical research faculty committed to improvingcompetitive research programs and increasing thenumber of underrepresented minoritiesprofessionally engaged in biomedical research. Theprogram supports faculty-initiated, scientificallymeritorious research projects, including pilotresearch projects (http://grants1.nih.gov/grants/guide/pa-files/PAR-04-001.html).

RISE seeks to enhance the research environment atminority-serving institutions through faculty andstudent development by increasing the interests,skills, and competitiveness of students and facultywho are pursuing biomedical research careers. RISEoffers support for faculty and student developmentactivities such as on-campus workshops, off-campusworkshops, specialty courses, travel to scientificmeetings, and research experiences at on-campus oroff-campus laboratories. Support also is availablefor evaluation activities and limited institutionaldevelopment (e.g., equipment purchases, thedevelopment of research courses, the renovation orremodeling of existing facilities to provide space foran investigator to conduct developmental activities)(http://grants.nih.gov/grants/guide/pa-files/PAR-99-151.html).

IMSD encourages domestic private and publiceducational institutions with fully developed andfunded research programs to initiate and/or expandinnovative programs to target underrepresentedminority students. Institutions that receive thefunding are expected to improve the academic and

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II. Minority Researchers’ Training andEnhancement Programs

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research capabilities of underrepresented minoritystudents and to facilitate their progress towardcareers in biomedical research. Funding also maybe directed toward developing underrepresentedminority scientists who are in any phase of theircareer development, from the undergraduate levelthrough the Ph.D. level. IMSD awards use theinstitutional education project grant mechanism(http://grants1.nih.gov/grants/guide/pa-files/PAR-02-084.html).

Minority Access to Research Careers

The Minority Access to Research Careers (MARC)Undergraduate Student Training in AcademicResearch (U*STAR) program provides support forstudents who are members of minority groups thatare underrepresented in the biomedical sciences atinstitutions with significant minority studentenrollments. U*STAR seeks to improve students’preparation for graduate training in biomedicalresearch through faculty development,strengthening of science course curricula,development of biomedical research trainingprograms, and infrastructure development.Additional information about this program isavailable online at http://grants1.nih.gov/grants/guide/pa-files/PAR-02-033.html.

MARC predoctoral fellowships provide funding forgraduates of the U*STAR program. The programprovides outstanding U*STAR students with up to5 years of support for research training leading to aPh.D., M.D./Ph.D., or other combined professionaldegree/Ph.D. in the biomedical or behavioralsciences, including mathematics. Support isavailable only for individuals enrolled in acombined professional degree/Ph.D. program in thebiomedical or behavioral sciences. The MARCpredoctoral fellowship program encourages studentsfrom minority groups underrepresented in thebiomedical and behavioral sciences to seek graduatedegrees. This program furthers the NIH goal ofincreasing the number of underrepresented minorityscientists who are competitively trained to pursuecareers in biomedical or behavioral research. Formore details on these fellowships, visithttp://grants2.nih.gov/grants/guide/pa-files/PAR-03-114.html.

MARC faculty predoctoral fellowships are awardedto faculty members of colleges or universities withsignificant minority enrollment. Awards provideeligible faculty lacking a Ph.D. degree or Ph.D.equivalent the opportunity to obtain a researchdoctorate. Applicants must be full-time, permanentfaculty in a biomedical science or mathematicsprogram and must have been at the minorityinstitution for at least 3 years at the time ofapplication. Candidates must be enrolled in orhave been accepted into a Ph.D. or combinedM.D./Ph.D. training program in the biomedical orbehavioral sciences at the time of application.Applicants also must state their intention to returnto the minority institution at the end of theirtraining period. Additional information on facultypredoctoral fellowships is available at http://grants2.nih.gov/grants/guide/pa-files/PAR-03-048.html.

MARC faculty senior fellowships are awarded toeligible faculty members of colleges or universitieswith significant minority enrollment. The goal ofthe fellowship is to provide eligible faculty membersa yearlong period of intensive research in a state-of-the-art research environment to update theirresearch skills or move into new areas of research.Applicants must be full-time faculty members in abiomedical science or mathematics program for atleast 3 years at the time of application. Moreover,candidates must have received a Ph.D. or Ph.D.equivalent at least 7 years before the date ofapplication. Candidates must state their intentionto return to the minority institution at the end oftheir training period. Applicants must requestsupport ranging from 1 academic year (e.g.,9 months) to 2 years. Additional information isavailable online at http://grants1.nih.gov/grants/guide/pa-files/PAR-02-145.html.

Research Supplements for UnderrepresentedMinorities Program

In 1989, NIH launched an initiative to providefunding for underrepresented minorities inbiomedical research at all levels of careerdevelopment. The Research Supplements forUnderrepresented Minorities (RSUM) programseeks to increase the number of underrepresentedminorities in biomedical research. RSUM

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accomplishes its mission by supplementing researchgrants currently funded by NIH Institutes andCenters. Investigators with an existing NIH grantmay apply for supplemental funds from RSUM tosupport minority high school, college, postgraduate,postdoctoral, or junior faculty researchers to workin an area closely allied to the funded research.Awards may be tied to the length of the parentgrant and are limited to a total award period not toexceed 4 years.

RSUM defines underrepresented minorities asAfrican Americans, Hispanics, American Indiansand Alaska Natives, and Asian-Pacific Islanders.Funds are provided for salary, tuition, fees,expendable supplies, travel, and other incidentals.Award levels are determined by the targetededucational strata, with smaller awards made tohigh school students. Salary stipends depend onthe level of experience and are consistent with thesalary scales provided to investigators at the samelevel of experience in the grantee institution.

In fiscal year (FY) 2003, NIAID funded 41 newand continuing RSUM applications for a total of6 million dollars. Awardees included minorityinvestigators at the junior faculty, postdoctoral,predoctoral, undergraduate, and high school levels.RSUM promises to be a continued success inincreasing the total number of underrepresentedminorities in biomedical research in areas of sciencerelevant to NIAID’s mission. For moreinformation, please visit www.niaid.nih.gov/facts/mwhhp5.htm#C.

Research Centers in Minority Institutions

NIAID continues to work toward its goal to expandthe national capability for health sciences researchthrough the Research Centers in MinorityInstitutions (RCMI) program. RCMI providesgrant support to predominantly minority healthprofessional schools and graduate institutions thatoffer a doctorate in the health professions or health-related sciences. The program assistsinstitutions in strengthening and augmenting their

human and physical resources for conductingbiomedical or behavioral research. RCMI alsofosters faculty expansion and development,infrastructure improvement, and the support ofresearch-related activities, including laboratoryrenovation and equipment replacement. ThroughRCMI, institutions become more competitive inseeking funding for biomedical or behavioralresearch. Institutions that qualify to receive RCMIsupport must have more than 50-percent minoritystudent enrollment and be chartered to awardM.D., D.V.M., D.D.S., or Ph.D. health sciencedegrees. Currently, 17 institutions participate in theRCMI program.

RCMI’s HIV/AIDS Infrastructure Initiative seeks toensure that minority institutions have the physicalfacilities and faculty competence to participate inmainstream HIV/AIDS research. Support isawarded to expand physical infrastructure andimprove faculty competence in virology,immunology, molecular biology, and theneurosciences. Participating institutions are locatedin communities in which the HIV/AIDS epidemichas hit the hardest. As a result, these institutionsare uniquely suited to treat and recruit patients inclinical trials. Nine minority medical schools areeligible to participate in the HIV/AIDSInfrastructure Initiative: Howard University,Meharry Medical College, Morehouse School ofMedicine, University of Puerto Rico MedicalSciences, Morgan State University, UniversidadCentral del Caribe, Ponce School of Medicine,Charles R. Drew School of Medicine and Science,Texas Southern University, University of Hawaii,and City University of New York.

RCMI is co-funded by NIAID and the NationalCenter for Research Resources. NIAID providessupport for RCMI HIV/AIDS research pilotprojects, as well as support for infrastructuredevelopment. In FY 2003, NIAID awarded pilotprojects for clinical research, molecular vaccinedevelopment, opportunistic infections, andimmunologic research to seven institutions.

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NIAID Programs

Office of Special Populations and ResearchTraining

The Office of Special Populations and ResearchTraining (OSPRT) was established by NIAID’sdirector in 1998 to combine the functions formerlyhoused in the Office of Research on Minority andWomen’s Health (ORMWH) and the Office ofScience Training and Manpower Development(OSTMD). Combining the functions of OSTMDand ORMWH under one entity has led to greaterefficiency in developing research and traininginitiatives. OSPRT administers the Introduction toBiomedical Research Program (IBRP) and theBridging the Career Gap for UnderrepresentedMinority Scientists workshop and serves as NIAID’scoordinator and liaison for the Institute’s StrategicPlan for Addressing Health Disparities. In addition,OSPRT plays a key role in reporting data aboutwomen and minority inclusion in phase III clinicaltrials.

OSPRT’s director has been instrumental inoverseeing collaborative funding efforts betweenNIAID, the Center for Minority Health and HealthDisparities, and the Office of Research on Women’sHealth. OSPRT supports innovative programs,such as the Inter-American College of Physiciansand Scientists, National Hispanic Youth Initiative,and the Temple University Longitudinal Program.

Bridging the Career Gap

To increase the number of underrepresentedminority investigators in biomedical research, theBridging the Career Gap for UnderrepresentedMinority Students initiative was established in1993. Targeting individuals who receive NIAIDminority training and research supplemental awards,Bridging the Career Gap seeks to provide young,minority investigators with the tools andinformation needed for a successful career inbiomedical research. The initiative consists of a 2-day seminar addressing career choices,networking, the importance of selecting the rightmentor, and the NIH grant system and

components. The seminar also providesparticipants with the opportunity to network withNIAID intramural and extramural staff. NIAIDstaff continue to work closely with many studentsthroughout various phases of their careers. TheBridging the Career Gap program demonstratesNIAID’s interest in the academic future of itsminority training and research supplementalfunding awardees. NIAID continues to developinnovative programs that will attractunderrepresented minority scientists to theInstitute’s research agenda.

Results from NIAID’s 1996 evaluation of the firsttwo Bridging the Career Gap program cohortsillustrate the program’s success. Survey results showthat the seminar has many benefits includinghelping participants understand what to expectfrom careers in biomedical research and assistingindividuals to determine what adjustments areneeded in their current career direction to pursuefutures in biomedical research; it also providesparticipants with the opportunity to establishimportant NIAID contacts. The success ofNIAID’s Bridging the Career Gap program also hasbeen validated through its replication in other NIHInstitutes. The program is administered by OSPRTand is conducted with the assistance of NIAIDscientific review, program, and grants managementstaff and with scientific and administrative expertsfrom academia and industry aligned with NIAID.The sixth Bridging the Career Gap symposium washeld in November 2003 and was attended by 70individuals.

Centers for AIDS Research

NIAID promotes the development of minorityscientists in HIV/AIDS research through Centersfor AIDS Research (CFARs). CFARs support amultidisciplinary environment promoting basic,clinical, behavioral, and translational research in theprevention, detection, and treatment of HIV/AIDSinfections. CFARs accomplish their missionthrough outreach, fostering scientificcommunication, training, and sponsoringeducation. NIAID-sponsored CFARs arecommitted to educating and training minority

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investigators, as well as providing outreach tominority communities.

NIAID Enhancement Award

Historically, NIAID has supported a variety ofprograms seeking to encourage underrepresentedminority investigators to pursue careers inbiomedical research. Programs have targetedstudents ranging in age from high school topostdoctoral levels, and, although these programshave demonstrated success in specific areas, only afew underrepresented minority investigators havebecome well established in biomedical research.The NIAID Enhancement Award forUnderrepresented Minorities was established inFY 2003 to recruit talented underrepresentedminority investigators in the early stages of theirscientific careers (e.g., assistant professor or junior-level faculty) for basic or clinical research programsin the areas of allergy, immunology, transplantation,microbiology, and infectious diseases, includingAIDS. The present Request for Applications isintended to increase the number ofunderrepresented minority investigators capable ofperforming independent competitive research andto enhance the long-term research skills andpotential of these individuals in all of NIAID’sscientific research areas. For more information,please look on the Web at http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-03-045.html.

NIAID/Mali Medical School Minority TrainingInitiative

In early 1997, the NIAID Division of IntramuralResearch (DIR), the University of Mali MedicalSchool, and the University of Maryland School ofMedicine created a program to provide trainingopportunities for minority students and youngfaculty in Africa. NIAID/Mali Medical SchoolMinority Training initiative seeks to provideopportunities that will attract minority students andyoung faculty to careers in tropical medicine. As apart of the program, American students train inmalarial research under Malian researchers at theMalaria Research and Training Center (MRTC) inBamako, Mali. In turn, Malian researchers are

given sabbaticals to learn new research techniques atNIAID.

In December 1998, the Guest House, located onthe campus of the National School of Medicine ofMali and immediately adjacent to MRTClaboratories and the National Medical Library ofMali, was completed. Consisting of a living room,dining, room, kitchen, computer room/library, andeight bedrooms, the Guest House serves as the baseof operations for the training program. Eachbedroom is equipped with its own computer whilethe computer room/library has two computerslinked to the medical school local area network andthe Internet. To ensure student safety, the GuestHouse is situated within the medical schoolcomplex and surrounded by an additional wallstaffed by a night guard. Although Mali is generallyconsidered one of the safest countries in Africa, theroutine safety precautions are in place to reassureparents and students.

MRTC provides an intricate training program thatcan accommodate the various educational levels ofstudent participants (e.g., advanced undergraduatestudents, graduate students, postdoctoral fellows,junior faculty, midcareer faculty) with a potentialinterest in tropical medicine research. Medicalstudents, recent medical graduates, junior medicalfaculty, and midcareer faculty are given theopportunity to participate in medical school fieldtraining programs, laboratory work, and field work.

The training program emphasizes field research andprovides opportunities for all students to work inlocal villages. As NIH prepares Mali to be a majortest site for malaria vaccines, MRTC programparticipants will have an opportunity to take part inthis important and exciting initiative.

In May 1998, the University of Maryland School ofMedicine received funding through the FogartyInternational Center to manage the promotion,recruitment, selection, and posting of students andfellows in Mali. In FY 2003, a total of 10 studentswere enrolled in the program, including 2 AfricanAmericans, 5 whites, and 3 Asian-Pacific Islanders.

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Introduction to Biomedical Research Program

The NIAID IBRP was established in 1979 toinform academically talented college juniors,graduating seniors, and first-year graduate ormedical students from underrepresented minoritygroups about career opportunities in the broad fieldof biomedical research. This initiative grew out ofthe need to increase the number of minorityscientific researchers in this country. While thenumbers of underrepresented minorities in the lifesciences has increased, their numbers are still small;to meet the continuing challenge of attracting thispopulation, the program was divided into twodistinct programs in 2003. The Richard M.Asofsky Scholars In Research (ASIR) is the IBRPextramural arm and is administered throughOSPRT. The intramural arm of IBRP is known asthe Introduction to NIAID Research Opportunities(INRO) and is administered through the Divisionof Intramural Research’s Office of Special Emphasis.For more information, please visitwww.niaid.nih.gov/ibrp.

Richard M. Asofsky Scholars In Research For 37 years, Dr. Richard M. Asofsky served NIHand NIAID in improving research trainingprograms. The ASIR program was created in honorof Dr. Asofsky to bring underrepresented minoritiesinto the biomedical sciences. ASIR providessupplemental funding to NIAID extramuralprincipal investigators to conduct laboratoryresearch with underrepresented minority highschool and college students. Students gain amentoring relationship and are exposed to researchcareer opportunities in the areas of allergy,immunology, transplantation, microbiology, andinfectious diseases, including AIDS. In FY 2003,19 students were supported by five NIAID grantees.

Intramural NIAID Research OpportunitiesProgram

Recently, NIAID’s Office of Special EmphasisPrograms launched the INRO program toencourage committed and talentedunderrepresented minority students to considercareers in allergy, immunology, and infectiousdisease research. Undergraduate and first-year

graduate students with a GPA of 3.5 or better wereselected to participate in the program based on theirinterest in NIAID research and their desire toconduct research at the NIH. To qualify for theprogram, applicants also must be American citizensor legal U.S. residents. In FY 2003, 12 studentsattended the 3-day intramural program representingcolleges and universities from across the UnitedStates, Puerto Rico, and the U.S. Virgin Islands.The 3-day program focused on the breadth ofresearch conducted at NIAID and includedscientific lectures by intramural researchers,discussions with scientists, and tours of thelaboratories in the Research Technology Branch andthe Vaccine Research Center. Students alsodiscussed training opportunities with scientists whoconduct research in Rockville, Maryland, and theRocky Mountain Laboratories in Hamilton,Montana. For more information, please visitwww.niaid.nih.gov/dir/inro/default.htm.

Temple University Longitudinal Program

In FY 2001, NIAID collaborated with the NationalInstitute of Diabetes and Digestive and KidneyDiseases and the National Institute of Arthritis andMusculoskeletal and Skin Diseases to establish theTemple University Minority Access to BiomedicalResearch Careers initiative at Temple University inPhiladelphia. The initiative is a longitudinalprogram that recruits outstanding middle schoolstudents and provides them with additionalinstruction in mathematics and the sciences. Thegoal of this initiative is to increase the pool ofM.D./Ph.D. program applicants by ensuring thatstudents succeed in high school and continue intheir education to obtain graduate degrees.Participating students are extremely motivated,have research experience, and have very strongacademic records. During the summer of theirjunior and senior years of high school, participantsare placed in NIAID intramural laboratories for an8-week rotation. When participants enter college,the 9-week summer experiences are rotated amongFederal, private, and academic institutions.

Participating students assist in research projects, andmany of them have been cited in researchpublications. In FY 2002, 207 students were

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participating: 148 African Americans, 32 Asians-Pacific Islanders, and 27 Hispanics. NIAID willcontinue to support this initiative through FY 2005.

Partnership Program

The Partnership Program continues to benefitNIAID and participating schools. As part of thePartners in Education Program, students areexposed to a scientific environment and are giventhe opportunity to see science in action, meet andconsult with working scientists, gain practicalexperience by participating in laboratory work, andreceive supplemental instruction. Students’ interestsin the sciences are nurtured through the educationprogram as they improve their understanding andknowledge of biomedical research. Additionalresources include monthly lectures, mentoring, rolemodels, tutorial matching, library resources,incentive awards, workplace tours, facultyenrichment, and advisory services. Participatingschools also have received NIAID-donatedcomputers, fax machines, microscopes, andnumerous laboratory supplies for their scienceclassrooms.

Six schools participated in the Partnership Programin FY 2003. NIAID has partnership agreementswith three high schools and three elementaryschools: Dunbar High, Friendly High, CrosslandHigh, Ideal Academy, St. Thomas More, andCarmody Hills.

Biomedical Research After School Scholars

Since 1998, scientists from NIAID’s RockyMountain Laboratories (RML) in Hamilton,Montana, have teamed up with local middle andhigh schools to present the Biomedical ResearchAfter School Scholars (BRASS) program. BRASSintroduces 7th- through 12th-grade students to thefundamentals and relevance of biomedical researchto stimulate student interest in science andencourage students to pursue careers in biomedicalresearch. The program encourages a broad range ofstudent participation, from minorities, youngwomen, economically disadvantaged, and at-riskstudents.

BRASS consists of five 2-hour laboratory sessionscovering hematology, genetics, cancer, infectiousdiseases, and animal research. Each 2-hour sessionis highly interactive, with scientists providingbackground on topics using the scientific method.The program concludes with a commencementceremony featuring a guest speaker and laboratorydemonstrations conducted by the students.

More than 60 scientists and 350 students haveparticipated BRASS. RML scientists have workedwith middle schools in Montana, includingHamilton, Corvallis, Victor, Darby, Stevensville,and Lone Rock middle schools. A March 2003regional newspaper article, written by students fromLone Rock middle school, can be found atwww.missoulian.com/articles/2003/03/17/export3781.txt.

In 2000, RML expanded BRASS to schools locatedin American Indian and Alaska Nativecommunities. During the past 3 summers, 45scientists have participated in the Pathways toAcademic Excellence (PACE), a mini-BRASSprogram at an American Indian and Alaska Nativesummer math and science camp. More than 150American Indian and Alaska Native students haveparticipated in the minicourse.

Collaborative Efforts

Native American Research Centers for Health

In FY 2001, NIGMS and the Indian Health Servicedeveloped the Native American Research Centersfor Health (NARCH) program. NARCH supportsthe development of partnerships composed ofAmerican Indian and Alaska Native tribes ortribal-based organizations (e.g., the National IndianHealth Board, Local Area Health Boards) andinstitutions conducting intensive, academic-level,biomedical and behavioral research. The purpose ofNARCH is to (1) encourage competitive researchlinked to reducing health disparities, (2) develop acadre of American Indian and Alaska Nativescientists and health professionals engaged inbiomedical, clinical, and behavioral research whowill be able to compete for NIH funding,(3) increase the collaborative efforts of research-

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intensive institutions and American Indian andAlaska Native organizations and (4) reduceAmerican Indian and Alaska Native communityskepticism toward Government-funded research.NARCH continues to support research, studentdevelopment, and faculty development projects.

As a part of NARCH, NIAID supports two studiesthat will investigate adult pneumococcal infectionsin Alaska Natives and White Mountain Apaches.Support for these two studies will continue throughFY 2005 and is anticipated to continue throughFY 2006.

Interamerican College of Physicians andScientists

Increasing the participation of underrepresentedminority investigators in virtually all fields ofbiomedical research is a continuing NIH andNIAID priority. NIAID supports a variety ofminority programs for biomedical research, fromhigh school through postdoctoral training.NIAID’s OSPRT is engaged in an extensiveoutreach campaign targeting colleges, universities,medical centers, and professional organizations toencourage the participation of minorityinvestigators in NIAID research activities. TheInteramerican College of Physicians and Scientists(ICPS) is one outreach activity supported byOSPRT that targets a specific underrepresentedcommunity. Founded in 1979, OSPRT promotescooperation among U.S. Hispanic physicians andseeks to advance their professional and educationaldevelopment. ICPS is the only nationalorganization representing Hispanic physicians.

The official ICPS journal, MEDICO Interamericano,is distributed monthly to 39,000 physicians in theUnited States. MEDICO Interamericano providesinformation on grants and contracts, as well asinformation on professional opportunities forHispanics in academia, Government agencies, andthe private sector. ICPS outreach capabilities helpincrease Hispanic student participation in biomedicalresearch, educate communities regarding minorityhealth issues, and explain NIAID’s role in addressingminority health issues through research and other

activities. NIAID continues to provide funding tothe ICPS National Hispanic Youth Initiative inHealth (NHYI) summer program. NHYI introducesHispanic youth to careers in biomedical researchthrough scientific seminars and field trips. NHYImotivates, prepares, and encourages Hispanic highschool juniors and seniors to pursue careers in healthsciences.

Association of American Indian PhysiciansNational Native American Youth Initiative

Through its cooperative agreement with the Officeof Minority Health, the Department of Health andHuman Services’ Association of American IndianPhysicians (AAIP) offers a health, biomedicalresearch, and policy development program forAmerican Indian and Alaska Native studentsbetween ages 16 and 18 years. AAIP seeks tomotivate American Indian and Alaska Nativestudents to remain in school and pursue careers inhealth professions and/or biomedical research. TheNational Native American Youth Initiative (NNAYI)prepares American Indian and Alaska Nativestudents for admission to college and professionalschools by empowering students with effectiveleadership skills, analytical skills, and academicproficiency. Promoting self-awareness, NNAYIeducates students regarding health status, health careresearch issues, and policies and legislation that affectAmerican Indian and Alaska Native communities.NNAYI is an intense academic enrichment andreinforcement program consisting of mini-blockcourses addressing leadership, communication, studyskills, testing skills, assertiveness, networking,professional behavior, interactive learning, and timemanagement. Courses are designed to increasestudents’ skills so they are better prepared to remainin school and pursue a career in the healthprofessions and/or biomedical research. The summerprogram introduces students to the variety of healthcareers available to American Indian and AlaskaNative youth. AAIP members, health professionals,and traditional healers provide a personal perspectivefor students by relating their experiences in healthcareers to their familiarity with collaborative effortsbetween Western and traditional medicine.

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Allergy, Immunology andTransplantation

NIAID will continue to work toward meeting itsgoals of increasing efforts in the areas of allergy,immunology, and transplantation that targetminority populations and their health care. Theseplans include the following:

• Through the Immune Tolerance Network and theAutoimmunity Centers of Excellence, NIAID willcontinue to support clinical trials and assaydevelopment for promising tolerance inductionand immunomodulatory strategies to treat asthmaand allergic diseases; autoimmune diseases,including systemic lupus erythematosus andscleroderma; and rejection of transplanted organs,tissues, and cells.

• The NIAID Inner-City Asthma Consortium willlaunch three protocols in 2004, including acockroach allergen standardization protocol, astudy to evaluate the usefulness of measuringexhaled nitric oxide in the clinical management ofasthma in children, and a birth cohort toinvestigate factors that contribute to thedevelopment of asthma in inner-city children.

• NIAID will sponsor a workshop at the 2004annual meeting of the American Academy ofAsthma, Allergy and Immunology focusing on theinfluence of allergens on asthma severity andasthma interventions in inner-city children.

• NIAID plans to sponsor a symposium at the 2004annual meeting of the American Thoracic Societyhighlighting recent results of the NIAID NationalInstitute of Environmental Health Sciences’Inner-City Asthma Study.

• In 2004, NIAID will launch the Clinical Trials inOrgan Transplantation program. The newprogram will support a cooperative, multisiteconsortium for interventional or observationalclinical studies, accompanied by mechanistic

studies, to research the immune-mediatedpathologic processes in organ transplantation.The consortium will work toward understandingimmune-mediated morbidity and mortality oforgan transplantation and will seek to developstrategies that will reduce organ transplantationmorbidity and mortality.

• In 2004, NIAID will launch the Genomics ofTransplantation Program. The new program willestablish cooperative interdisciplinary researchprograms for large-scale, broad-scope genomicstudies in clinical transplantation, including solidorgan, tissue, and cell transplantation. The goalsof this program are to identify and characterizegene polymorphisms and gene expression patternsin immune responses relating to the onset andseverity of acute and chronic graft rejection,responses to immunosuppressive therapeutics, andvariability in graft survival among populations.

Microbiology and Infectious Diseases

NIAID plans to continue its multidisciplinarymicrobiology and infectious disease strategiesthrough basic research, targeted studies, anddeveloping innovative vaccine delivery techniquesfor diseases and infections that disproportionatelyaffect minority populations. Support forinvestigator-initiated research in areas related tominority health will remain a priority. Plansinclude the following:

• Support for investigator-initiated, tuberculosis(TB) basic and applied Mycobacterium tuberculosis(M.tb) research will remain a priority. NIAIDseeks to add to the fundamental base ofknowledge about M.Tb and the pathogenesis ofTB to develop improved diagnostic, therapeutic,and intervention strategies for combating TB.NIAID’s Division of Microbiology and InfectiousDiseases considers the development of improvedTB vaccines, drugs, and diagnostics a highpriority.

III. Future Plans

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• NIAID’s Division of AIDS will continue tosupport research to discover new, more effective,selective therapeutic agents to treat and preventTB through screening contracts, investigator-initiated grants, the National Cooperative DrugDiscovery Groups for the Treatment ofOpportunistic Infections Associated with AIDSprogram, and Small Business InnovationResearch/Small Business Technology Transfermechanisms.

• NIAID will continue funding basic and clinicalresearch studies on mechanisms of pathogenesisand immunology of bacterial and viral sexuallytransmitted infections.

• NIAID will continue to support investigator-initiated basic and clinical research for hepatitis Cvirus. Multidisciplinary research approaches willbe encouraged.

• NIAID is exploring the possibility of developingdiagnostic assays that can quickly differentiatebetween bacterial and viral respiratory infections.NIAID also is exploring the possibility ofidentifying the virulence genes associated withlung tissue that can specifically recognizepneumococcal infections using sputum samples.

• NIAID continues to support efforts to examinenew, alternative approaches for improving thediagnosis of community-acquired pneumonia.

Acquired Immunodeficiency Syndrome

NIAID will continue developing innovativestrategies to augment minority participation inHIV/AIDS clinical trials and epidemiologic studies.Encouraging the participation of minorityinvestigators in all facets of basic and clinicalHIV/AIDS research remains a high priority forNIAID. Specific plans include the following:

• NIAID will continue to co-fund meritorious,peer-reviewed HIV/AIDS projects through theHIV/AIDS Infrastructure Initiative of theResearch Centers in Minority Institutions(RCMI) program.

• NIAID will continue to support grantsupplements to attract underrepresented minorityinvestigators into biomedical and behavioralresearch through the Research Supplements forUnderrepresented Minorities (RSUM) program.

• NIAID will continue to support the Adult andPediatric AIDS Clinical Trials Group, Terry BeirnCommunity Programs for Clinical Research onAIDS, HIV Vaccine Trials Network (HVTN) andHIV Prevention Trials Network (HPTN). Effortswill continue to increase the participation ofwomen and underrepresented minorities inHIV/AIDS clinical trials.

• NIAID will continue to develop and implementthe HIV Vaccine Communications Campaign. Inaddition, NIAID will continue to coordinateactivities surrounding the observance of HIVVaccine Awareness Day on May 18. Please visitwww.niaid.nih.gov/newsroom/mayday/default.htm for more information.

• NIAID will continue to fund the Centers forAIDS Research program.

• NIAID will study the scope and relevance of viraland human genetic variation in relation to vaccinedevelopment through HVTN and collaborativeefforts with other scientists.

• NIAID will continue to fund the MulticenterAIDS Cohort Study and the Women’s InteragencyHIV Study epidemiologic cohorts.

Training

NIAID will continue supporting training effortsthat encourage underrepresented minorityinvestigators to pursue careers in biomedicalresearch. Specific plans include the following:

• NIAID will continue to support the minoritytraining programs administered through NationalInstitute of General Medical Sciences.

A Partnership for Health

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Minorities and Biomedical Research

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• NIAID will continue to fund the AIDS projectsconducted in the National Center for ResearchResources’ RCMI program.

• NIAID will continue to provide support for theRichard M. Asofsky Scholars in Researchinitiative. NIAID expects to exceed 2003successes in future years.

• The Intramural NIAID Research Opportunities(INRO) program will be expanded to 5 days in2004.

• NIAID continues to support the EnhancementAward for Underrepresented Minorities. TheEnhancement Award initiative is expected tomake several additional awards in FY 2004.

• NIAID will continue efforts to increase thenumber of minority researchers supported byRSUM. A Bridging the Career Gap seminar willbe conducted in October 2005.

• NIAID will explore new concepts and ideas toimprove outreach efforts to precollege studentsand will continue to support educational efforts atthe middle and high school levels including theTemple Longitudinal Program, the Partners inEducation Program, and Biomedical ResearchAfter School Scholars.

• NIAID will continue to actively recruitunderrepresented minority researchers.

Outreach Activities

NIAID will continue its efforts to disseminateresearch results to the media, health professionals,and the public. Specific outreach activities includethe following:

• NIAID will continue to implement innovativeactivities designed to improve awareness ofbiomedical research issues, awareness of clinicaltrials, and interest in biomedical research inunderrepresented minority communities.

• NIAID will continue to support programs thatincrease the numbers of underrepresentedminority individuals who pursue careers inbiomedical research.

• NIAID will continue its efforts to increase publicawareness of HIV vaccine and research and torecruit diverse volunteers for future clinicalstudies.

• NIAID will continue its outreach activitiesincluding producing and publicizing print,audiovisual, and Web-based materials; distributingmaterials at professional and communitymeetings; and sponsoring workshops andconferences for community health care providersand the public.

• NIAID will continue informing more than 400voluntary and scientific organizations aboutInstitute activities.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

National Institute of Allergy and Infectious Diseases

NIH Publication No. 04-4698February 2004www.niaid.nih.gov