The National Institute on Drug Abuse (NIDA) is soliciting applications under the R01 grant mechanism for studies aimed at uncovering the biochemical mechanisms by which sex hormones influence the effects of HIV and substance use disorders (SUD). This funding opportunity seeks to improve understanding of how sex hormones like estrogen, progesterone, and testosterone interact with HIV infection and addiction to substances such as opioids, stimulants, and cannabinoids. Research outcomes are expected to identify novel biological targets and therapeutic mechanisms to address the unique challenges posed by HIV-SUD comorbidity. This R01 is appropriate for applicants with preliminary data; those proposing high-risk projects without preliminary data may consider the companion R21 (RFA-DA-26-008).

The scope of this research includes investigating how sex hormones influence HIV replication, viral latency, and drug-seeking behaviors in HIV-positive individuals. Specific areas of focus may include hormonal effects on HIV reservoirs, interactions between HIV proteins and addictive substances, and hormonal pathways that can potentially be targeted to improve HIV and SUD outcomes. This NOFO excludes studies focused solely on social, behavioral, or environmental factors, as well as studies examining alcohol use as the primary addictive substance.

This NOFO requires applicants to include a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity in research teams and methodologies. The PEDP should outline actionable strategies to integrate diverse scientific perspectives, and it will be evaluated as part of the application’s scientific merit. Examples of inclusivity efforts may include establishing partnerships with minority-serving institutions, recruiting underrepresented groups for study participation, and creating career development opportunities within the project framework.

NIDA anticipates awarding $3 million in FY 2026 across this and the companion R21 opportunity, with an expected 4–6 awards. For R01 applications, budgets are limited to $400,000 in direct costs annually, with a maximum project duration of five years. Proposals should present budgets commensurate with project needs and expected outcomes. Eligibility is open to a wide range of applicants, including higher education institutions, nonprofits, for-profit organizations, and state and local governments. Foreign institutions and foreign components of U.S. entities are also eligible.

Applications are due by March 13, 2025, with letters of intent encouraged by February 12, 2025. All applications must be submitted electronically through NIH ASSIST, Grants.gov, or an institutional system-to-system solution. Applications that do not adhere to submission requirements, including the PEDP attachment, will be considered incomplete and will not proceed to review. Key review criteria include the significance of the proposed research, rigor and feasibility of the approach, and qualifications of the research team and environment.