1. NIH HIV/AIDS Research Priorities
Gina M. Brown, M.D.
Office of AIDS Research
National Institutes of Health

2. National Institutes of Health
Office of the Director
Office of AIDS
Research
National Institute
of Child Health
and Human
Development
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Institute of
Biomedical Imaging
and Bioengineering
National Center
for Complementary
and Integrative Health
John E. Fogarty
International
Center
National Center
for Research
Resources
National Library
of Medicine
National Center on
Minority Health and
Health Disparities
Warren Grant
Magnuson
Clinical Center
Center for
Information
Technology
Center for
Scientific Review
DHHS/NIH/OD/OAR

3. NIH HIV/AIDS Research Portfolio
Largest public investment in AIDS research in the world ($3.0 Billion in FY 2016)
Encompasses nearly all 27 NIH ICs
Transcends every area of clinical medicine and basic scientific investigation
Multi-IC, multidisciplinary, global
Comprehensive program of basic, clinical, and behavioral research and training on HIV infection, associated co-infections (TB, malaria), comorbidities, and other complications

6. Guidelines for High-, Medium-, and Low-Priorities for Use of AIDS Funds
Developed based on OAR Advisory Council HIV/AIDS Research Portfolio Review Working Group Report (May 2014)
FY 2015 Trans-NIH Plan for HIV-Related Research – reflecting input from scientific and academic community, scientific foundations, and community constituency groups
NIH Leadership

7. Overarching High Priority Areas
BSSR

8. NIH Overarching AIDS Research Priorities
Critical to ensure that NIH AIDS funds are supporting the highest priorities for next 3-5 years:
Reduced incidence, including vaccines, microbicides, PrEP, TasP
Next generation of HIV therapies with better safety and ease of use
Research toward a cure
HIV-associated comorbidities and co- infections
Cross cutting areas: Basic research, health disparities, BSSR, and training

10. Reducing the Incidence
Basic Sciences
Viral pathogenesis/mechanisms of infection—genital injury, immunology, microbiome, other infections, hormonal environment, age, other exposures—partner, cleansing practices, STIs, New testing modalities, sex differences
BSSR
Interventions to reduce risk, acceptability and desireability of biomedical prevention- modality and delivery method, risk beliefs, factors that affect risk—violence, sexual practices, risk assessment, risk recognition, positive reinforcement, societal factors that impact adherence and risk,
Clinical
PK/PD, safety, efficacy, biomarkers of effectiveness and adherence, side effects,
Disparities
Sex, race, gender, geography, SES,

11. Next Generation Therapies
Basic Sciences
PK/PD, Mechanisms of action, drug interactions (hormones, other), genomics, biomarkers
BSSR
Adherence, social norms, care continuum, health beliefs, delivery mechanisms
Clinical
Efficacy/effectiveness side effects, safety, PK, biomarkers, pregnancy, drug interactions, care continuum comorbidity/coinfections
Disparities
Age, race, sex, gender, geography, SES, access to care

12. Research Towards a Cure
Basic Sciences
Sex differences, hormone effects
BSSR
Desirability, acceptability, health beliefs, ethics
Clinical
Safety, side effects, efficacy/effectiveness
Disparities
Access to research, sex, gender, race, SES

13. Comorbidities and Coinfections
Basic Sciences
Biomarkers, pathogenesis
BSSR
Adherence, exposure, access to care, continuum of care
Clinical
Disease acquisition and outcomes, treatment response —HIV vs. other illnesses, care continuum, NCDs
Disparities
Age, sex, race, gender, SES, access to care

14. Training

15. Low-Priority Research Areas
Low-priority projects will not be supported with AIDS dollars:
Natural history and epidemiology focused on a co-morbidity and does not have any focus on or inclusion of HIV (e.g., malaria, TB, and drug abuse alone)
Basic virology on pathogens that are co-infecting, not in the context of HIV infection; and basic immunology studies of general relevance, but not specific to HIV
Basic virology and neurobiology research of co-infecting pathogens not in the context of HIV infection (e.g., HPV, TB, Malaria, hepatitis C and B, syphilis, Cryptococcus, flaviviruses, JC virus, etc.)
Basic cancer-related immunology studies not in the context of HIV infection
Studies of co-morbidities of general relevance, but not in the context of HIV (e.g., diabetes, lipid defects, endocrinology)

16. Low-Priority Areas (continued)
Data analysis and systems tools that are not HIV-related, e.g., genomics studies of little or no relevance to HIV
Studies of behaviors (e.g., sexual activities, drug use activities) or social conditions (e.g., economic distress) that have multiple negative outcomes where HIV/AIDS is only one of many outcomes being studied without a focus on how HIV/AIDS is unique in that context (i.e., it is just mentioned as potentially relevant)

17. https://www. federalregister

18. NIH…
Turning Discovery Into Health

19. High Priority Research Areas For Use of AIDS Funds
Reducing incidence of HIV/AIDS including:
Developing/testing promising vaccines candidates,
Developing/testing microbicide and PrEP candidates
Developing and testing innovative delivery methods to mitigate adherence issues
Developing, testing, and implementing strategies to improve HIV testing, entry into prevention services, and entry into treatment

20. High Priority Research Areas For Use of AIDS Funds (continued)
Next generation of HIV therapies
Treatment regimens that are less toxic with fewer side effects and complications
Longer acting
Easier to take and adhere to than current regimens
Implementation research to ensure
Initiation of treatment as soon as diagnosis has been made
Retention and engagement in services
Achievement and maintenance of optimal prevention and treatment responses

21. High Priority Research Areas For Use of AIDS Funds (continued)
Research toward a cure including: 
Developing novel approaches and strategies to identify and eliminate viral reservoirs
Toward a cure
Lifelong remission of HIV infection
Studies of viral persistence, latency, reactivation, and eradication
HIV-associated comorbidities, coinfections, and complications including
Impact of HIV-associated comorbidities, including TB, malignancies; cardiovascular, neurological, and metabolic complications
Premature aging associated with long-term HIV disease and antiretroviral therapy

22. High Priority Cross-Cutting Areas
Basic research on HIV transmission, pathogenesis, and immune dysfunction
Research to reduce health disparities in incidence and treatment
Training to conduct high priority research

23. Medium-Priority Research Areas for Use of AIDS Funds
HIV/AIDS is a meaningful component of the project and/or knowledge about HIV is enhanced by the project
Project includes people/biological specimens from people
Living with HIV
HIV exposed
At elevated risk for HIV infection as part of a broader sample or as a comparative cohort

24. Medium-Priority Research Areas for Use of AIDS Funds
HIV/AIDS is a meaningful component of the project and/or knowledge about HIV is enhanced by the project
Project addresses health and social issues clearly linked with HIV
Transmission, acquisition, pathogenesis
Morbidity and mortality
Stigma
Examines issues in the context of HIV
Other infectious pathogens and diseases
Non-infectious pathogens and diseases
Substance use/addiction
Mental health disorders

25. Medium Priority Research Areas (continued)
Project meaningfully includes HIV/AIDS (or SIV) outcomes/endpoints
Results will advance HIV treatment or prevention
Results provide tools/techniques and/or capacity beneficial to HIV research
Includes training and infrastructure development