Research to Address Systemic and Structural Barriers and Facilitators to Improve the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum for People Who Use Substances (R01 Clinical Trials Required)

The National Institutes of Health (NIH) is soliciting applications for research addressing systemic and structural barriers and facilitators to improve the **HIV Pre-Exposure Prophylaxis (PrEP) care continuum for people who use substances**. This funding opportunity, supported by the **National Institute on Drug Abuse (NIDA)**, **Office of AIDS Research (OAR)**, and **National Institute on Minority Health and Health Disparities (NIMHD)**, aims to develop, implement, and evaluate strategies to increase PrEP uptake and persistence among marginalized and underserved populations disproportionately affected by substance use and HIV. The grant, classified under the **R01 Research Project Grant**, requires a clinical trial and emphasizes systemic approaches to address socio-structural determinants of health, reduce stigma, and enhance the accessibility of PrEP. Research should particularly focus on populations such as women, transgender individuals, men who have sex with men, people with criminal legal involvement, and sex workers. Projects must integrate community partnerships and emphasize equitable, scalable, and sustainable approaches, employing an **intersectional perspective**. Applicants can request budgets based on project needs, though the recommendation is to limit direct costs to **$500,000 per year**, unless well-justified. Up to **eight awards** may be funded under a total budget of **$5,000,000** for fiscal year 2026, contingent upon available funds and meritorious applications. Eligible applicants include higher education institutions, nonprofits, for-profits, local governments, and international entities. Projects can span a maximum of **five years**. Applications must include a **Plan for Enhancing Diverse Perspectives (PEDP)**, demonstrating actionable strategies for inclusivity in research teams, community engagement, and equitable partnerships. Without a PEDP, applications will not be reviewed. Other required components include a detailed research strategy addressing socio-structural factors, community engagement plans, and sustainability considerations. The **application deadline is March 12, 2025**, with the earliest start date anticipated in December 2025. A **letter of intent** is encouraged by February 12, 2025, though it is not mandatory. Applicants must complete all necessary registrations, including **SAM.gov**, **eRA Commons**, and **Grants.gov**. Key contacts for scientific, financial, and peer review inquiries are listed in the announcement. For detailed guidance and submission instructions, applicants are directed to consult the NIH **How to Apply – Application Guide** and the specific funding opportunity announcement.