HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required) | RFA AI 19 005

Opportunity Information: Apply for RFA AI 19 005

The funding opportunity titled "HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)" (RFA AI 19 005) is a National Institutes of Health (NIH) cooperative agreement solicitation for an organization to serve as the Leadership and Operations Center (LOC) for the HIV Prevention Clinical Trials Network. Through the UM1 mechanism, NIH is looking for an applicant that can provide both high-level scientific direction and day-to-day operational management for a large, multi-site HIV prevention clinical trials network. The emphasis on "Clinical Trial Required" signals that the awardee is expected to be directly involved in the planning, coordination, and execution of clinical trials work, consistent with NIH expectations for networks that actively conduct and oversee clinical research rather than only providing support services.

As the network’s LOC, the successful applicant would function as the central hub responsible for overall administrative leadership and scientific leadership across the HIV Prevention Clinical Trials Network. In practical terms, this typically means coordinating network governance and decision-making structures, aligning scientific priorities with feasible trial concepts, and ensuring that multi-site studies are implemented consistently and efficiently. The LOC role generally includes developing and maintaining operational systems for trial start-up and conduct (such as protocol development workflows, site coordination, training and communications, and performance monitoring), and supporting network-wide collaboration so that trials can be launched and managed on reliable timelines. Because it is a cooperative agreement, the award is expected to involve substantial NIH programmatic involvement, meaning the NIH will be an active partner in shaping priorities and oversight rather than acting solely as a passive funder.

Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities. Eligible applicants listed 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; other Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other entities that meet NIH requirements. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. This reflects NIH’s intent to allow a wide range of institutions with the capacity to lead complex clinical research networks to compete.

Foreign eligibility is specifically limited. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply as part of the applicant organization. At the same time, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, which generally means a U.S.-based applicant can include certain international elements of the research when they are scientifically justified and structured in compliance with NIH policy, even though a foreign organization cannot serve as the prime applicant.

This opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument, reflecting the collaborative nature of NIH-run clinical trial networks. The activity area spans education, health, income security, and social services, and it is associated with CFDA numbers 93.242, 93.279, 93.855, and 93.865. The original closing date was August 1, 2019, and the FOA was created on January 24, 2019. The public summary does not specify an award ceiling or the expected number of awards in the provided source text, but the core objective is clear: NIH sought a single, capable Leadership and Operations Center to guide and run the administrative and scientific backbone of the HIV Prevention Clinical Trials Network under an active, trial-conducting UM1 cooperative agreement structure.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HIV Prevention 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, 93.855, 93.865.
• 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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