HIV/AIDS Scholars Using Nonhuman Primate (NHP) Models Program (K01 Independent Clinical Trial Not Allowed) | PAR 23 225

Opportunity Information: Apply for PAR 23 225

The HIV/AIDS Scholars Using Nonhuman Primate (NHP) Models Program is an NIH Mentored Research Scientist Development Award (K01) opportunity intended to help early-stage investigators build a strong, independent research career focused on HIV/AIDS translational science. It targets researchers who are within 10 years of completing a terminal professional degree (such as a PhD or MD) or finishing residency training, and it provides a structured, mentored pathway to develop the skills, publication record, and preliminary data needed to compete for major independent funding later on, such as an NIH R01. The award is designed to support an intensive period of career development, combining protected time, salary support, and research resources so recipients can focus deeply on a well-justified research plan and a formal training and mentoring strategy.

A defining feature of this program is its scientific scope: the research and mentorship must center on HIV/AIDS translational studies that use nonhuman primates as preclinical models. In practice, that means proposed projects should leverage NHP models in ways that clearly connect mechanistic or preclinical findings to human health and clinical relevance, rather than stopping at basic observations. NIH expects awardees to be guided by an experienced mentorship team with complementary expertise, specifically including both (1) deep knowledge of NHP HIV/AIDS model systems and their preclinical application and (2) demonstrated ability to translate findings toward clinical application in humans. The overall goal is that, after three years of mentored and well-supported research career development, awardees are positioned to transition into independent investigator roles and secure subsequent grant support.

The program aligns with the NIH Strategic Plan for HIV and HIV-Related Research for FY 2021-2025. Research framed under this K01 is expected to speak to major HIV priorities such as reducing HIV incidence, developing next-generation HIV therapies, advancing research toward an HIV cure, and addressing HIV-associated comorbidities, coinfections, and complications. While applicants have flexibility in the specific scientific questions they propose, the emphasis is on translational impact and on using NHP models in ways that directly strengthen the pipeline from preclinical discovery to interventions, strategies, or insights relevant to humans.

This particular announcement is the version of the K01 that does not allow the candidate to lead an independent clinical trial. Applicants cannot propose to serve as the lead investigator for an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial under this FOA. However, the FOA does allow candidates to gain clinical trial experience when the clinical trial is led by a mentor or co-mentor, which can be useful for building translational skills without taking on the responsibilities and review expectations associated with leading a trial. Applicants who intend to lead a clinical trial or lead an ancillary clinical trial are directed to apply under the companion FOA designed for that purpose.

Eligibility is broad at the organizational level and includes many types of domestic U.S. institutions and entities such as public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and a wide range of governmental bodies (state, county, city or township, special district), as well as independent school districts and public housing/Indian housing authorities. The announcement also explicitly highlights a range of mission-driven and capacity-building eligible organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with tribal governments and tribal organizations, faith-based or community-based organizations, and U.S. territories or possessions. At the same time, there are clear restrictions related to foreign involvement: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed under this FOA.

Administratively, this opportunity is offered by the National Institutes of Health as a discretionary grant under Funding Opportunity Number PAR-23-225, associated with CFDA numbers 93.242, 93.351, and 93.855. The listing indicates an original closing date of 2025-09-07. The program is fundamentally a career development mechanism: the core deliverable NIH is looking for is not only high-quality NHP-based translational HIV/AIDS science, but also a clear, credible plan showing how three years of mentored training and research productivity will culminate in the applicant becoming an independent investigator who is ready to compete successfully for future NIH research project grants.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "HIV/AIDS Scholars Using Nonhuman Primate (NHP) Models Program (K01 Independent Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.351, 93.855.
• This funding opportunity was created on 2023-06-28.
• Applicants must submit their applications by 2025-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 23 225

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