Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required)

The Development & Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required) grant, issued by the National Institute on Drug Abuse (NIDA) within the National Institutes of Health (NIH), supports pilot research that aims to address the intersecting public health challenges of substance use and HIV. This funding opportunity is part of a reissue of PA-21-205 and carries the funding opportunity number PAR-24-329. The initiative reflects evolving agency priorities, with updates as of March 31, 2025, and aligns with national efforts such as the Ending the HIV Epidemic initiative and PEPFAR. This Notice of Funding Opportunity (NOFO) seeks to support research at the formative stages of intervention development. Projects should focus on assessing the feasibility, acceptability, and safety of novel or adapted interventions aimed at HIV prevention, treatment, or service delivery improvements among populations that use drugs. Eligible interventions may be behavioral, social, structural, or combined biomedical and behavioral in nature. Examples include new methods for enhancing pre-exposure prophylaxis (PrEP) uptake, linkage to care, viral suppression, or addressing stigma and co-morbidities. Both domestic and international studies are welcome, particularly those involving key populations disproportionately affected by HIV. Applicants may request up to $450,000 in direct costs over a three-year period, with no more than $225,000 in any single year. The grant mechanism requires a clinical trial, and funds may be used for pilot or feasibility studies that inform future efficacy or implementation research. Intervention development projects must show a clear theory of change or logic model and describe how sustainability and scalability will be considered from the outset. Applicants are encouraged to incorporate end users—including policymakers, practitioners, and community members—into study design, implementation, and evaluation processes. Use of the NIDA Clinical Trials Network is encouraged where applicable. Eligibility is broad and includes public and private institutions of higher education, non-profit and for-profit organizations, local and state governments, independent school districts, tribal organizations, faith-based and community-based organizations, and foreign entities. There are no stated geographic restrictions for eligibility; therefore, the opportunity is open to U.S.-based and international applicants. All applicants must complete registrations in SAM.gov, Grants.gov, and eRA Commons, and obtain a Unique Entity Identifier (UEI). Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Key components include a research strategy that outlines theoretical underpinnings, significance, and approach; documentation of partnerships with community stakeholders; and a strong plan for eventual dissemination and adoption. While preliminary data is not required, applications must demonstrate scientific rigor and investigator capability. The evaluation process will weigh importance, innovation, rigor, feasibility, and the expertise of the research team. The NOFO supports recurring AIDS-related application due dates, with upcoming submission deadlines on May 7, 2025; September 7, 2025; January 7, 2026; May 7, 2026; and subsequent cycles through at least February 16, 2027. Reviews and award decisions follow a standard NIH timeline, with the earliest potential start dates occurring approximately 6–9 months after submission. The current expiration date for the NOFO is March 17, 2027, reflecting a recent extension. For scientific inquiries, contacts include Dr. Richard A. Jenkins, Candace Webb, and Dr. Raul N. Mandler of NIDA.

Include a clear theory of change and strong end-user engagement; plan for sustainability and scalability.