Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional)

The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH) within the Department of Health and Human Services, is offering the “Innovations to Optimize HIV Prevention and Care Continuum Outcomes” grant under funding opportunity number PAR-23-061. This opportunity uses the R21 exploratory/developmental grant mechanism and allows for the optional inclusion of clinical trials. The initiative aims to support innovative research designed to advance HIV prevention and care. The NIMH emphasizes the importance of novel basic or applied behavioral and social science research that enhances understanding or intervention development across steps in the HIV care and prevention continuum. This funding opportunity was updated on March 31, 2025, to better reflect current agency priorities, and applicants are advised to carefully reread the full announcement before submitting. The overarching goal is to develop or enhance HIV intervention strategies and understand the social, behavioral, and structural factors influencing HIV outcomes. The research is expected to align with national and international strategic plans such as the U.S. National HIV/AIDS Strategy 2022–2025 and the global UNAIDS 95-95-95 goals. A wide range of topics are of interest, including those targeting intervention design, implementation strategies, disparities in care, biomedical and behavioral factors, as well as novel methods for data analysis and strategic health communication. Funding is available for up to two years, with a total direct cost cap of $275,000, and no more than $200,000 in a single year. Projects with more advanced data or broader implementation aims should consider related opportunities under the R01 (PAR-23-062) or R34 (PAR-23-060) mechanisms. The number of awards depends on the availability of funds and the merit of applications. Clinical trials are optional, and preliminary data are not mandatory for submission. Eligibility spans a wide array of applicant organizations, including higher education institutions, nonprofits, for-profit entities, and various levels of U.S. and non-U.S. governments. Individuals with the appropriate background and resources are invited to apply. Foreign entities and components are also eligible, provided they meet NIH policies. There are no cost-sharing requirements. Applicants must complete several registrations, including SAM, eRA Commons, and Grants.gov, which can take up to six weeks. The application must be submitted by 5:00 PM local time on one of the listed AIDS-related due dates. For 2025, these are January 9, May 9, and September 9. The FOA officially expires on May 24, 2025, as updated in NOT-OD-25-113. Evaluation criteria include significance, innovation, investigators, approach, and environment, among others. The NIH peer review system will assess applications, and funding decisions will be based on scientific merit, relevance to program priorities, and availability of funds. Contact information for inquiries is provided for both scientific and administrative matters. Multiple NIMH program officers are listed, each specializing in specific HIV-related research domains. Applicants are encouraged to consult these contacts early in their application process. Submissions must comply with all instructions detailed in the SF424 (R&R) Application Guide and additional requirements specific to this FOA. Plans for data sharing, especially through the NIMH Data Archive, are essential, and CDE collection is strongly recommended.