NIH – High Priority HIV and Substance Use Research (R01 Clinical Trial Optional)

September 17, 2021 by


The purpose of this Funding Opportunity Announcement (FOA) is to support high priority research at the intersection of HIV and substance use. This FOA invites innovative research projects with the potential to open new areas of HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use drugs (PWUD). Applications submitted under this FOA are required to have a detailed research plan, preliminary data, and a clear description of the nexus with substance use. This FOA is open to both individual researchers and research teams and includes all areas of research from basic science to clinical and implementation research. All studies must focus on NIH HIV/AIDS Research Priorities: NOT-OD-20-018: UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.


This FOA is designed to attract exceptionally talented investigators to conduct innovative, potentially groundbreaking investigations at the intersection of HIV and substance use. Examples of relevant studies include but are not limited to:

  • Innovative strategies and interventions at the individual, provider, and community level to reduce stigma that impedes the provision and utilization of services for substance use and HIV prevention and/or care.
  • Innovative approaches to assess and/or address social determinants related to substance use and HIV with attention to longstanding structural issues such as racism and community resources.
  • Studies developing and testing the use of media and communication campaigns to address stigma and build demand for evidence-based practices addressing substance use and HIV prevention and/or treatment.
  • Innovative approaches to model HIV risk and predict future hotspots in the context of changing drug use epidemics (domestic or international)
  • Novel modeling approaches to estimate population-level effects of epidemic dynamics and/or intervention strategies on HIV incidence and HIV clinical outcomes.
  • Novel biomedical, behavioral and/or integrated strategies to improve prevention and treatment outcomes for people living with or at risk for HIV and SUDs.
  • Implementation research that develops and tests strategies to increase the availability, uptake, and sustainability of evidence-based HIV and substance use prevention and/or treatment interventions, emphasizing jurisdictions with high HIV/substance use burden.
  • Demonstrations of how to aggregate data from different settings to understand population needs, resources and infrastructure within jurisdictions to promote effective community-based approaches to address HIV and substance use prevention and/or treatment.
  • Novel approaches to address HIV prevention and/or treatment and substance use in the context of infectious disease and/or psychiatric comorbidities.
  • Applications of optimization and/or adaptive trial strategies to increase delivery of evidence-based practices and improve outcomes, particularly complex patient/client populations.
  • Studies developing and testing cutting-edge technologies to deliver HIV and SUD therapeutics to PLWH
  • Innovative strategies to optimize immune responses to HIV and HIV vaccine candidates in the presence of substance use
  • Creative strategies to monitor HIV infection or latency in the CNS and/or determine the size and nature of the viral reservoir under the influences of substance use and/or therapies for SUD and HIV.
  • Research to identify the underlying molecular mechanisms by which HIV latency is initiated, established, and maintained in the CNS, lymphoid and myeloid tissues and how substance use might influence these processes.
  • Innovative approaches to achieve sustained ART-free remission and/or eradication of HIV among PWUD who experience ART interruptions and delays, and relapse in drug use.
  • Explore and develop potential biomarkers or therapeutic targets to prevent, treat, and/or eliminate CNS HIV reservoirs in people with SUD
  • Application of spatial genomics and other related state-of-the art strategies to address questions at the intersection of HIV and SUD
  • Novel approaches to unravel the roles of addictive substances in epigenomic or transcriptional regulation, or other molecular processes critical to HIV replication, persistence and reactivation.
  • Research to decipher the contributions of addictive substances and inflammatory stimuli on HIV infection, latency or pathogenesis
  • In vivo analysis of HIV infection, latency and immunity as a result of addictive substance use using longitudinal patient studies or primate models.

Key Dates:

Open Date (Earliest Submission Date): January 15, 2022
Letter of Intent Due Date(s): 30 days prior to the application due date
First Application due date: February 15, 2022

URL for more information:

Filed Under: Funding Opportunities