HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required) | RFA AI 19 045

Opportunity Information: Apply for RFA AI 19 045

This funding opportunity, titled "HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)" (RFA AI 19 045), is a National Institutes of Health (NIH) cooperative agreement designed to support the operations of Clinical Trials Units (CTUs) that can run HIV/AIDS clinical studies developed by NIH-supported HIV/AIDS Clinical Trials Networks. The central idea is to fund organizations that already have, or can build and maintain, the real-world infrastructure needed to carry out complex clinical research in people, not just plan it on paper. Because the award mechanism is a cooperative agreement, recipients should expect substantial NIH program involvement in oversight and coordination, reflecting a partnership model rather than a fully independent grant.

The CTUs funded under this announcement are expected to provide both scientific and administrative expertise and the on-the-ground capacity to execute network-developed protocols. In practical terms, this means a CTU must be able to participate in the development and implementation of clinical trials and supply the core operational components required to run studies reliably and safely. Key expectations include providing clinical sites capable of enrolling and following participants, maintaining local laboratory capacity to support study testing and specimen handling, and ensuring pharmacy support appropriate for investigational products and protocol-driven medication management. The announcement also emphasizes that CTUs should support two or more HIV/AIDS Clinical Trials Networks, signaling that NIH is looking for units that can operate at a scale and level of flexibility sufficient to contribute across multiple network portfolios rather than serving only a single program.

The opportunity falls under the health activity category and is associated with CFDA number 93.855. It is listed as a discretionary funding opportunity and uses the UM1 activity code, which typically supports multi-component, milestone-driven or programmatically coordinated efforts and often aligns with large clinical research operations. While the listing does not provide an award ceiling or the expected number of awards in the provided excerpt, the operational scope described suggests substantial responsibilities related to staffing, regulatory compliance, data and safety processes, laboratory and pharmacy operations, and consistent coordination with NIH network leadership and other sites.

Eligibility is broad and includes a wide range of domestic and certain non-domestic entities. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also specifically highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) organizations. This wide eligibility reflects the reality that HIV/AIDS clinical research often requires diverse clinical settings and partnerships, including community-based sites and international locations where the epidemic burden and research needs may be substantial.

Important dates in the provided record include a creation date of 2019-05-01 and an original closing date of 2019-11-18. In summary, the FOA aims to strengthen and sustain the clinical trial infrastructure that NIH HIV/AIDS networks rely on by funding CTUs that can deliver high-quality, compliant, and coordinated trial operations, including clinics, laboratories, and pharmacies, while contributing to protocol development and supporting multiple networks at once.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2019-05-01.
• Applicants must submit their applications by 2019-11-18. (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.

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