Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)

The Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research opportunity is issued by the National Institutes of Health within the U.S. Department of Health and Human Services. This program is administered through the Office of Research Infrastructure Programs and reflects NIH’s ongoing investment in advancing biomedical research infrastructure. The initiative aligns with federal priorities to modernize research methodologies, improve translational relevance, and enhance ethical standards by reducing reliance on animal models where scientifically appropriate. The primary purpose of this funding opportunity is to support two integrated priorities in HIV/AIDS research. First, it seeks to implement a framework that incorporates human new approach methodologies, referred to as NAMs, into research workflows. These methodologies include in vitro and human tissue-based approaches that can reduce or replace the use of specific pathogen free in vivo models. Second, the program continues to support high-quality SPF colony resources for studies where animal models remain necessary, ensuring that such resources are well-characterized, rigorously maintained, and used efficiently. Funding under this cooperative agreement supports a wide range of activities. For the NAMs-enabled component, applicants are required to integrate triage and consultation services to evaluate whether proposed studies can transition to NAM-based approaches. They must also establish referral pathways to NAM centers and human-based research resources. Optional activities include developing standardized procedures for HIV-related in vitro testing, such as viral load quantification and drug resistance analysis, and conducting pilot benchmarking studies to define performance standards. For the SPF component, funding supports colony management, disease surveillance, immunogenetic characterization, and transparent allocation processes to ensure equitable and scientifically justified use of limited in vivo resources. Eligibility for this opportunity is broad and inclusive, encompassing public and private institutions of higher education, nonprofit organizations with and without 501(c)(3) status, for-profit entities, small businesses, and various levels of government including state, local, and tribal organizations. Additional eligible entities include federal agencies, U.S. territories, foreign institutions, and faith-based or community organizations. There is no cost-sharing or matching requirement, which lowers financial barriers to participation and encourages a wide range of applicants to apply. The submission process follows standard NIH cooperative agreement procedures. While specific application components are not fully detailed in the forecast notice, applicants can expect to prepare comprehensive proposals outlining research infrastructure plans, methodological integration strategies, and operational frameworks for both NAM and SPF components. Applications are expected to undergo peer review based on scientific merit, feasibility, and alignment with program priorities, including rigor, reproducibility, and translational relevance. The timeline for this opportunity indicates that it is currently in a forecast stage. The estimated posting date is November 24, 2026, with an application due date of January 25, 2027. Awards are anticipated to be made by February 1, 2028, with project start dates aligned to the same timeframe. The program is expected to support four awards. No recurring cycle is explicitly stated, suggesting that this may be a one-time or periodically reissued initiative depending on federal priorities and funding availability. For additional information, applicants may contact the Division of Comparative Medicine within the Office of Research Infrastructure Programs. The program provides both a phone number and an email contact for inquiries, ensuring that prospective applicants can obtain clarification on requirements and expectations as the opportunity moves from forecast to active status.