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Jacques Normand, Ph.D.
Director, AIDS Research Program
NIDA
The Johns Hopkins University
Baltimore, Maryland
November 5, 2014
Objectives
2
3
NIDA HIV/AIDS FY13 Program Profile
17%
16%
1%
55%
3% 4% 2%
Behavioral and
Social Science
Natural History &
Epidemiology
Etiology &
Pathogenesis
Vaccines
Therapeutics
Training Other
NIDA HIV/AIDS Budget by Research Area
Natural History and Epidemiology-------------- $44M
Etiology and Pathogenesis----------------------- $41M
Microbicides----------------------------------------- $0
Vaccines---------------------------------------------- $4M
Behavioral and Social Science----------------- $188M
Therapeutics----------------------------------------- $8M
Training, Infrastructure, and
Capacity Building------------------------------ $13M
Information Dissemination----------------------- $2M
4
On Nov. 2013, Dr. Collins charge to OAR’s Advisory
Council “Produce a report that outlines the highest
priority AIDS research in 3 areas”
• Prevention - including vaccines, microbicides, ARV-based
prevention, behavioral research focused on risk reduction,
stigma, and adherence
• Treatment - including advances in therapeutic interventions
and research toward a cure
• Co-morbidities - neurologic, cardiovascular, oncologic, and
accelerated aging
The document should also identify priorities that cut across the
above mentioned areas with regard to basic science, training,
and information dissemination.
OAR Priority Report (June, 2014)
• Prevention
Vaccines, microbicides, PrEP,
Integrated Strategies (combination)
• Treatment: Anti-retroviral
Therapy
More efficient Tx
• The Prevention and Care
Continua
STTR
• Cure Animal models, latency, reservoirs
• Co-infection, Co-morbidities, &
complications TB, HCV, cardio, kidney,
neuro, & aging (in presence of HIV)
• Basic Science
System Bio, Animal models
• Behavioral & Social Sciences
Innovative methods, comparative
effectiveness
• Implementation Science
Access, uptake, retention, scale-up,
Sustainability
• Training, infrastructure, and
Capacity-building
• Information Dissemination
Managing NIH HIV/AIDS Program
Proactively
• OAR approval of all FOAs
• Review of HIV/AIDS relatedness of
Applications (CSR)
• Develop Trans-NIH definition of what is
HIV/AIDS research
• Develop trans-NIH policy for proportional
funding (Prorate)
Next step: Portfolio review to identify low priority grants
FY15 & FY16 Priorities
 Promoting Retention in HIV Care
 HIV Prevention in Vulnerable Populations in the U.S.—Emphasis on youth, the
Homeless and Black/African American Women and Young Black/African
American Men
 Developing Comprehensive Interventions for Substance Using MSM
 Implementation Science Research
 Transformative Research
 Prevention and Treatment of HCV in those with and at Risk for HIV
 Enhancing Treatment as Prevention through Use of Incentives and Technology
 Training, Infrastructure, and Capacity Building
FY15 Initiatives
 Avant-Garde RFA (DP1)
 A-START PAR (R03/$100K)
 NIDA/ANRS Fellowship ($75K)
 Advancing exceptional HIV/AIDS Research RFA (R01)
 Extracellular Vesicles in HIV/AIDS and Substance Abuse RFA (R21, R01)
 NIDA Drug Abuse and HIV Cohorts PAR (U01)
 Technology-Based Interventions to Promote Engagement in Care & Tx
Adherence & For Substance Abusing Populations with HIV PA (R01,R34)
 HIV, Drugs, & Vulnerable Pop PA (R21, R01)
 AVENIR (AIDS) RFA (DP2)
FY15 Initiatives (Cont.)
 Substance Use & Abuse, Risky Decision Making & HIV/AIDS PA (R03, R21, R01)
 Centers for AIDS Research & Developmental Centers for AIDS Research PA (P30)
 Drug Abuse Aspects of HIV/AIDS PA (R03, R21, R01)
 Prevention & Tx of HCV in Those with and at Risk for HIV PAR (R21, R01, R34)
 Long-Term Retention in Care for US Substance Using Pops PA (R01, R21, R34)
 International Research Collaboration on Drug Abuse & Addiction Research (R21,
R01)
 Development and Testing of Novel Interventions to Improve HIV Prevention, Care,
and Program Implementation PA (R34)
Note: NIDA has also joined many other ICS’ FOAs
FY16 Initiatives
 Avant-Garde RFA (DP1)
 A-START PAR (R03/$100K)
 NIDA/ANRS Fellowship ($75K)
 Advancing exceptional HIV/AIDS Research RFA (R01)
 AVENIR (AIDS) RFA (DP2)
 Substance Use & Abuse, Risky Decision Making & HIV/AIDS PA
(R03, R21, R01)
 Centers for AIDS Research & Developmental Centers for AIDS
Research PA (P30)
FY16 Initiatives (Cont.)
 Drug Abuse Aspects of HIV/AIDS PA (R03, R21, R01)
 Prevention & Tx of HCV in Those with and at Risk for HIV PAR
(R21, R01, R34)
 Long-Term Retention in Care for US Substance Using Pops PA
(R01, R21, R34)
 International Research Collaboration on Drug Abuse & Addiction
Research (R21, R01)
 Development and Testing of Novel Interventions to Improve HIV
Prevention, Care, and Program Implementation PA (R34)
Note: NIDA has also joined many other ICS’ FOAs
New FY16 Initiatives
Role of Polysubstance use in HIV Cure/Remission
Research: Novel Approaches RFA (R03, R21, R01)
Integration of Infectious Diseases and Substance Abuse
Treatment for HIV Positive Patients RFA (R01 & R34)
Enhancing Seek, Test, Treat, & Retain Strategies for
Substance Using Adolescents and Young Adults RFA (R01)
Role of Polysubstance use in HIV
Cure/Remission Research: Novel Approaches
• Goals: Provide basic/clinical research
evidence on specific role of polySU that
may be most critical in HIV pathophysiology
• NIH Towards the cure—emphasis on virus
in primary peripheral sites (CD4+ and other
immune cells)
• This RFA will emphasize two critical areas:
– 1) Towards a cure in brain (in vivo
emphasis with in vitro components)
– 2) Towards a cure in substance using
populations (periphery)
• Critical research on reservoirs within
macrophage, microglia, and astrocytes
Integration of Infectious Diseases and
Substance Abuse Treatment for HIV Positive
Patients
Goals
 To develop and evaluate comprehensive integrated treatment
services for HIV and co-infections among substance abusers
 Support implementation research to determine how to best
provide comprehensive, integrated effective preventive and
treatment interventions that are scalable, sustainable, and
cost-effective in diverse populations
Note: This initiative can provide data on the beneficial health effects of drug
treatment on other than HIV outcomes
• Target US youth age 14-25
• Prioritize intervention studies that
recruit highest risk youth &
address developmental, legal
and service delivery issues
– Lead to improvements in
serostatus knowledge, linkage to
care/retention, & achievement of
undetectable viral loads.
Enhancing Seek, Test, Treat, & Retain Strategies for
Substance Using Adolescents and Young Adults
Estimated Cascade of Care among
HIV+ Youth
in the US (age 13-29)
Topics Under Consideration
 Cascade of Care Retention Gap
 Combination HIV Prevention Strategy
 Alcohol, drug abuse, and HIV
 Functional collaboration with NIAAA
 STTR/TasP
17
18
WWW.DRUGABUSE.GOV/AIDS

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NIDA’s AIDS Research Program

  • 1. Jacques Normand, Ph.D. Director, AIDS Research Program NIDA The Johns Hopkins University Baltimore, Maryland November 5, 2014
  • 3. 3 NIDA HIV/AIDS FY13 Program Profile 17% 16% 1% 55% 3% 4% 2% Behavioral and Social Science Natural History & Epidemiology Etiology & Pathogenesis Vaccines Therapeutics Training Other
  • 4. NIDA HIV/AIDS Budget by Research Area Natural History and Epidemiology-------------- $44M Etiology and Pathogenesis----------------------- $41M Microbicides----------------------------------------- $0 Vaccines---------------------------------------------- $4M Behavioral and Social Science----------------- $188M Therapeutics----------------------------------------- $8M Training, Infrastructure, and Capacity Building------------------------------ $13M Information Dissemination----------------------- $2M 4
  • 5. On Nov. 2013, Dr. Collins charge to OAR’s Advisory Council “Produce a report that outlines the highest priority AIDS research in 3 areas” • Prevention - including vaccines, microbicides, ARV-based prevention, behavioral research focused on risk reduction, stigma, and adherence • Treatment - including advances in therapeutic interventions and research toward a cure • Co-morbidities - neurologic, cardiovascular, oncologic, and accelerated aging The document should also identify priorities that cut across the above mentioned areas with regard to basic science, training, and information dissemination.
  • 6. OAR Priority Report (June, 2014) • Prevention Vaccines, microbicides, PrEP, Integrated Strategies (combination) • Treatment: Anti-retroviral Therapy More efficient Tx • The Prevention and Care Continua STTR • Cure Animal models, latency, reservoirs • Co-infection, Co-morbidities, & complications TB, HCV, cardio, kidney, neuro, & aging (in presence of HIV) • Basic Science System Bio, Animal models • Behavioral & Social Sciences Innovative methods, comparative effectiveness • Implementation Science Access, uptake, retention, scale-up, Sustainability • Training, infrastructure, and Capacity-building • Information Dissemination
  • 7. Managing NIH HIV/AIDS Program Proactively • OAR approval of all FOAs • Review of HIV/AIDS relatedness of Applications (CSR) • Develop Trans-NIH definition of what is HIV/AIDS research • Develop trans-NIH policy for proportional funding (Prorate) Next step: Portfolio review to identify low priority grants
  • 8. FY15 & FY16 Priorities  Promoting Retention in HIV Care  HIV Prevention in Vulnerable Populations in the U.S.—Emphasis on youth, the Homeless and Black/African American Women and Young Black/African American Men  Developing Comprehensive Interventions for Substance Using MSM  Implementation Science Research  Transformative Research  Prevention and Treatment of HCV in those with and at Risk for HIV  Enhancing Treatment as Prevention through Use of Incentives and Technology  Training, Infrastructure, and Capacity Building
  • 9. FY15 Initiatives  Avant-Garde RFA (DP1)  A-START PAR (R03/$100K)  NIDA/ANRS Fellowship ($75K)  Advancing exceptional HIV/AIDS Research RFA (R01)  Extracellular Vesicles in HIV/AIDS and Substance Abuse RFA (R21, R01)  NIDA Drug Abuse and HIV Cohorts PAR (U01)  Technology-Based Interventions to Promote Engagement in Care & Tx Adherence & For Substance Abusing Populations with HIV PA (R01,R34)  HIV, Drugs, & Vulnerable Pop PA (R21, R01)  AVENIR (AIDS) RFA (DP2)
  • 10. FY15 Initiatives (Cont.)  Substance Use & Abuse, Risky Decision Making & HIV/AIDS PA (R03, R21, R01)  Centers for AIDS Research & Developmental Centers for AIDS Research PA (P30)  Drug Abuse Aspects of HIV/AIDS PA (R03, R21, R01)  Prevention & Tx of HCV in Those with and at Risk for HIV PAR (R21, R01, R34)  Long-Term Retention in Care for US Substance Using Pops PA (R01, R21, R34)  International Research Collaboration on Drug Abuse & Addiction Research (R21, R01)  Development and Testing of Novel Interventions to Improve HIV Prevention, Care, and Program Implementation PA (R34) Note: NIDA has also joined many other ICS’ FOAs
  • 11. FY16 Initiatives  Avant-Garde RFA (DP1)  A-START PAR (R03/$100K)  NIDA/ANRS Fellowship ($75K)  Advancing exceptional HIV/AIDS Research RFA (R01)  AVENIR (AIDS) RFA (DP2)  Substance Use & Abuse, Risky Decision Making & HIV/AIDS PA (R03, R21, R01)  Centers for AIDS Research & Developmental Centers for AIDS Research PA (P30)
  • 12. FY16 Initiatives (Cont.)  Drug Abuse Aspects of HIV/AIDS PA (R03, R21, R01)  Prevention & Tx of HCV in Those with and at Risk for HIV PAR (R21, R01, R34)  Long-Term Retention in Care for US Substance Using Pops PA (R01, R21, R34)  International Research Collaboration on Drug Abuse & Addiction Research (R21, R01)  Development and Testing of Novel Interventions to Improve HIV Prevention, Care, and Program Implementation PA (R34) Note: NIDA has also joined many other ICS’ FOAs
  • 13. New FY16 Initiatives Role of Polysubstance use in HIV Cure/Remission Research: Novel Approaches RFA (R03, R21, R01) Integration of Infectious Diseases and Substance Abuse Treatment for HIV Positive Patients RFA (R01 & R34) Enhancing Seek, Test, Treat, & Retain Strategies for Substance Using Adolescents and Young Adults RFA (R01)
  • 14. Role of Polysubstance use in HIV Cure/Remission Research: Novel Approaches • Goals: Provide basic/clinical research evidence on specific role of polySU that may be most critical in HIV pathophysiology • NIH Towards the cure—emphasis on virus in primary peripheral sites (CD4+ and other immune cells) • This RFA will emphasize two critical areas: – 1) Towards a cure in brain (in vivo emphasis with in vitro components) – 2) Towards a cure in substance using populations (periphery) • Critical research on reservoirs within macrophage, microglia, and astrocytes
  • 15. Integration of Infectious Diseases and Substance Abuse Treatment for HIV Positive Patients Goals  To develop and evaluate comprehensive integrated treatment services for HIV and co-infections among substance abusers  Support implementation research to determine how to best provide comprehensive, integrated effective preventive and treatment interventions that are scalable, sustainable, and cost-effective in diverse populations Note: This initiative can provide data on the beneficial health effects of drug treatment on other than HIV outcomes
  • 16. • Target US youth age 14-25 • Prioritize intervention studies that recruit highest risk youth & address developmental, legal and service delivery issues – Lead to improvements in serostatus knowledge, linkage to care/retention, & achievement of undetectable viral loads. Enhancing Seek, Test, Treat, & Retain Strategies for Substance Using Adolescents and Young Adults Estimated Cascade of Care among HIV+ Youth in the US (age 13-29)
  • 17. Topics Under Consideration  Cascade of Care Retention Gap  Combination HIV Prevention Strategy  Alcohol, drug abuse, and HIV  Functional collaboration with NIAAA  STTR/TasP 17