HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required) | RFA AI 19 003

Opportunity Information: Apply for RFA AI 19 003

The National Institutes of Health (NIH) released this discretionary funding opportunity, RFA-AI-19-003, to support a single central hub called the HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center (LOC). The LOC is meant to serve as the main coordinating and leadership body for the HIV/AIDS Adult Therapeutics Clinical Trials Network, providing both the administrative backbone and the scientific direction needed to run a large, multi-site clinical trials enterprise focused on adult HIV therapeutics. The award mechanism is a cooperative agreement (UM1), which typically means NIH will have substantial programmatic involvement in how the network is led and how major activities are carried out, and the opportunity explicitly requires clinical trials as part of the supported work.

Functionally, this LOC role is about running the network day to day while also shaping its scientific agenda. On the operations side, that generally implies coordinating network governance, supporting protocol development and prioritization, aligning multiple participating sites and partners, overseeing timelines and deliverables, and ensuring consistent procedures across studies. On the scientific leadership side, the LOC is expected to guide the network toward high-impact adult HIV therapeutic research questions, help drive trial concepts into full protocols, and support the conduct of those trials within the network structure. Because this is positioned as the overall leadership and operations center, the LOC is not simply a participating site; it is the coordinating core that organizes and integrates the network's activities so trials can be launched and executed efficiently and consistently.

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city or township governments; 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; and Native American tribal organizations that are not federally recognized tribal governments. The FOA also allows a wide range of nonprofit entities (both 501(c)(3) and non-501(c)(3), as long as they are not institutions of higher education in the category listed), for-profit organizations other than small businesses, and small businesses, plus an "other" category. The announcement also calls out additional eligible applicant types 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, and U.S. territories or possessions.

There are important restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, the FOA states that foreign components, as defined by the NIH Grants Policy Statement, are allowed. In practical terms, that usually means a U.S. applicant organization can include certain foreign activities or collaborators as part of the project if they meet NIH's definition and requirements for a foreign component, but the applicant organization itself must be U.S.-based and cannot be a foreign institution.

The opportunity is categorized under education and health and is associated with multiple CFDA numbers (93.242, 93.279, 93.853, 93.855), reflecting NIH program authorities that can support HIV-related clinical research and training/related activities depending on the specific institute and funding stream. The original posting date (creation date) is January 24, 2019, and the original application due date is August 1, 2019. The award ceiling and expected number of awards are not specified in the provided data, which is sometimes the case in NIH FOAs when budgets are guided by detailed instructions in the full announcement rather than a single fixed ceiling in summary tables.

Overall, the grant is aimed at establishing and running the central leadership and operations function for a national adult HIV therapeutics clinical trials network, with NIH involvement typical of a cooperative agreement and with an emphasis on coordinating and delivering multi-site clinical trials through strong administrative infrastructure and clear scientific direction.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center (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): 93.242, 93.279, 93.853, 93.855.
• This funding opportunity was created on 2019-01-24.
• Applicants must submit their applications by 2019-08-01. (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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