UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding

Notice Number: NOT-OD-20-018

Key Dates
Release Date: December 31, 2019

Related Announcements

NOT-DK-20-011

NOT-DK-20-010

NOT-OD-15-137

NOT-OD-19-078

NOT-AR-21-005

Issued by
Office of AIDS Research (OAR)

Purpose

The Notice informs the scientific community about the NIH HIV/AIDS research priorities and guidelines for allocation of HIV funding for fiscal years (FY) 2021-2025. This Notice maintains the NIH HIV/AIDS Research Priorities and updates the Guidelines for Determining AIDS Funding as defined previously in NOT-OD-15-137. To capture the dynamic and evolving scientific discovery from HIV/AIDS research anticipated for FY 2021 and beyond, the guidelines for classifying a research project as high-, medium-, or low-priority for receiving HIV/AIDS-designated funds described in NOT-OD-15-137 are replaced with ALIGNED or NOT ALIGNED with the priorities.

Background

The NIH is a part of the U.S. Department of Health and Human Services and the nation’s medical research agency making important discoveries to improve health and save lives. The NIH HIV/AIDS research program supports a comprehensive portfolio of evolving research representing a broad range of basic, translational, clinical, behavioral, social sciences, and implementation science research relevant to HIV/AIDS and its associated coinfections, comorbidities, and other complications. Building on the most recent scientific progress and anticipated new scientific discoveries that could support ending the AIDS pandemic and achieve an AIDS-free generation, NIH will continue to use the HIV/AIDS research priorities to ensure that resources will fund research with the highest potential to impact the HIV epidemic.

The update of the NIH HIV research priorities was informed by stakeholder input via a 2019 request for information NOT-OD-19-078, Listening Sessions hosted by OAR at sites in different locations, the OAR Advisory Council and the NIH AIDS Executive Committee, the NIH Plan for HIV and HIV-Related Research, and input from NIH leadership. Implementation of the updated priorities will begin with FY 2021 funding of HIV/AIDS research.

HIV/AIDS Research Priorities

The highest overarching priorities for HIV/AIDS research and guidelines for determining the use of HIV/AIDS-designated funds effective FY 2021 to FY 2025 are: 1) reduce the incidence of HIV/AIDS, including the development of safe and effective HIV/AIDS vaccines and microbicides; 2) develop the next generation of HIV therapies with improved safety and ease of use; 3) discover a cure for HIV/AIDS; and 4) reduce HIV-associated comorbidities and coinfections. Basic research, health disparities, behavioral and social sciences research, epidemiology, information dissemination, implementation sciences, and training that cut across the four priority areas are also supported.

Guidelines for Determining HIV/AIDS Funding

Refer also to the FY 2021-2025 NIH Strategic Plan for HIV and HIV-Related Research for descriptions of priority areas for new research. The NIH will use the following guidelines to determine if a research project is ALIGNED with NIH priorities and eligible to receive support with HIV/AIDS-designated funds. The guidelines are not used to assess the scientific or technical merit of a research project.

Examples of research ALIGNED with the priority areas are listed below. The list is not ranked and is not all inclusive.

  • Reduce incidence of HIV/AIDS, including develop safe, effective, practical, and affordable HIV vaccines, microbicide and pre-exposure prophylaxis candidates and methods of delivery, especially those that improve adherence; and develop, test, and implement strategies to improve HIV testing and entry into prevention services.
  • Research focused at fundamental scientific questions with a clear or credible link to HIV/AIDS to understand the mechanisms of HIV transmission and acquisition, virus/host cell interactions and pathogenesis, and the structure and dynamics of HIV proteins to prevent ART drug resistance; immune dysfunction and persistent inflammation; host microbiome and genetic determinants; and other fundamental issues that underpin the development of high priority HIV prevention, cure, co-morbidities, and treatment strategies.
  • Next generation HIV therapies with better safety and ease of use including develop and test HIV treatments that are less toxic with fewer side effects and complications, longer acting, easier to take and adhere to than current regimens.
  • Long-term treatment or prevention strategies for HIV-relevant coinfections and comorbid conditions across the lifespan
  • Effective socio-behavioral interventions to achieve uptake of HIV prevention and treatment strategies and reduce health disparities.
  • Implementation research designed to ensure biomedical and other prevention and treatment strategies, are initiated as soon as possible, increased retention and engagement in treatment services, and maintenance of optimal prevention and treatment responses are achieved.
  • Research toward a cure including development of novel approaches and strategies to study viral persistence, latency, reactivation, and eradication; identify and eliminate viral reservoirs that could lead toward a cure or long-term remission.
  • Research training of the multidisciplinary workforce required to conduct High Priority HIV/AIDS or HIV/AIDS-related research.
  • Research that includes people (or biological specimens from people) who with HIV, are HIV exposed, and/or are at elevated risk for HIV infection as part of a broader sample or as a comparative cohort.
  • Research that examines health and social issues, such as other infectious or non-infectious conditions and substance use or mental health disorders, clearly linked with HIV. (transmission/acquisition, pathogenesis, morbidity and mortality, stigma) in populations or settings with high HIV prevalence or incidence.
  • Research that meaningfully includes HIV/AIDS (or SIV) outcomes/endpoints.
  • Development of innovative technologies, such as sensitive assays, biomarkers, and imaging methods, coupled with cutting-edge studies of biology, virology, pharmacology, and immunology to advance durable and scalable prevention, treatment and cure in people with HIV.

Examples of research NOT ALIGNED* with the priority areas are listed below. The list is not ranked and is not all inclusive.

  • Research on natural history and epidemiology that is entirely focused on a co-morbidity and does not have any focus on or inclusion of HIV.
  • Research on co-infecting pathogens, but not in the context of HIV infection, basic immunology studies of general relevance, but not specific to HIV; basic cancer-related immunology studies not in the context of HIV infection; or studies on co-morbidities of general relevance, but not in the context of HIV.
  • Data analysis and systems tools that are not HIV-related, e.g., genomics and other omics studies with little or no relevance to HIV.
  • Studies of behaviors (e.g., sexual activities, drug use activities) or social conditions where HIV/AIDS is only one of many outcomes without a focus on how HIV/AIDS is unique in that context.

*Highly meritorious research could be eligible for support by an NIH Institute, Center or Office using non-HIV/AIDS funds.

Inquiries

Please direct all inquiries to:

Maureen M. Goodenow, Ph.D.
Office of AIDS Research (OAR)
Telephone: 301-496-0357
Email: OARInfo@nih.gov