Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional)

The National Institute of Mental Health (NIMH), a component of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, invites applications for the “Innovations to Optimize HIV Prevention and Care Continuum Outcomes” under funding opportunity number PAR-23-062. This initiative supports research projects (R01) that aim to advance understanding and develop effective strategies to enhance outcomes across the HIV prevention and treatment continuum. The opportunity aligns with both national and global priorities, including the U.S. National HIV/AIDS Strategy and the UNAIDS 95-95-95 goals. It seeks to address ongoing disparities and barriers in HIV prevention and care through innovative scientific approaches and implementation research. The funding opportunity focuses on supporting projects that examine behavioral, social, structural, and implementation science-based solutions. Studies may include formative research to identify barriers, large-scale trials to test innovative interventions, or the development of data science methods to understand and forecast outcomes. Areas of particular interest include improving adherence and persistence to antiretroviral treatments, promoting uptake and sustained use of pre-exposure prophylaxis (PrEP), and enhancing engagement and retention in care. A strong emphasis is placed on the inclusion of community stakeholders, interdisciplinary approaches, and strategic partnerships with public health agencies and community-based organizations. Eligible applicants include a wide range of U.S. and foreign institutions such as higher education institutions, nonprofit and for-profit organizations, government agencies, tribal entities, public housing authorities, and others. All applicants must be registered with appropriate federal systems including SAM, eRA Commons, and Grants.gov. The grant allows for clinical trial inclusion but also supports projects that do not propose clinical trials. Applications must adhere strictly to SF424 (R&R) Application Guide instructions, with conformance required for eligibility and review. Applications are due multiple times annually through January 2026, with the next due date for AIDS-related applications on May 9, 2025. Awards will be granted based on NIH appropriations and the scientific merit of applications. There is no set budget limit; however, budgets should be justified and aligned with project needs. Projects may span up to five years. A cost-sharing match is not required for this grant opportunity. All applications will undergo a rigorous NIH peer-review process. Key review criteria include significance, innovation, approach, investigator qualifications, and the proposed research environment. Specific attention is paid to the adequacy of protections for human subjects, adherence to data sharing requirements, and inclusion of marginalized populations. Detailed contact information is provided for program-specific NIH scientific staff, including specialists in adherence, prevention, data science, and health equity.