Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes (R34 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 "Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes" under Funding Opportunity Announcement (FOA) number PAR-23-060. This initiative uses the R34 Planning Grant mechanism and is a reissue of PA-20-141. It supports early-stage research projects that develop, adapt, or pilot-test interventions and implementation strategies aiming to improve HIV prevention and treatment outcomes. This FOA is aligned with the goals of the NIMH Division of AIDS Research and should be informed by recent Notices of Special Interest and the NIH Strategic Plan for HIV and HIV-Related Research. The FOA aims to support studies that assess feasibility, acceptability, and safety of behavioral, social, structural, or combination interventions that enhance HIV prevention or care. Applications may include intervention development, formative implementation research, or pilot testing of implementation strategies. Examples include leveraging technology for intervention delivery, testing novel behavioral change mechanisms, or adapting proven interventions to new settings. Projects should include communities and organizations affected by HIV in the conceptualization and conduct of the research, and are encouraged to collaborate with local health departments or Ministries of Health. Eligible applicants include institutions of higher education (both public and private), nonprofits, for-profit organizations (including small businesses), various government entities (local, state, tribal), public housing authorities, Native American tribal organizations, and foreign institutions. Applications proposing NIH-defined clinical trials are acceptable under this opportunity. Registration requirements include SAM, eRA Commons, and Grants.gov. Applications must follow the SF424 (R&R) guidelines and include a detailed Data Management and Sharing Plan. Submissions can be made through the NIH ASSIST system, Grants.gov Workspace, or institutional S2S systems. The FOA allows for new, renewal, resubmission, and revision applications. Deadlines for AIDS-related research occur three times annually, with the next submission due May 9, 2025. The grant closes on May 24, 2025. Review criteria include significance, innovation, approach, investigators, and environment. Projects will be scored on their potential to make a sustained impact in HIV prevention and treatment research. Applications must address human subjects protection, inclusion plans, and data safety. Award decisions will consider scientific merit, availability of funds, and alignment with program priorities. For application or program inquiries, several NIH contacts are provided, including Drs. Gregory Greenwood, Susannah Allison, and Chris Gordon.