U.S. and Low- and Middle-Income Country (LMIC) HIV-Associated Malignancy Research Centers (U54 Clinical Trial Optional) | RFA CA 22 011

Opportunity Information: Apply for RFA CA 22 011

The National Institutes of Health (NIH) announced this funding opportunity (RFA-CA-22-011) to build and support HIV-Associated Malignancy Research Centers (HAMRCs) that focus on cancers linked to HIV in low- and middle-income countries (LMICs). The main goal is to strengthen long-term, collaborative research partnerships that connect investigators and institutions in the United States with investigators and institutions in LMICs, recognizing that HIV-associated cancers remain a major cause of illness and death in many resource-limited settings and that progress depends on shared expertise, shared infrastructure, and research that is grounded in local realities.

Awards are made through a U54 Specialized Center Cooperative Agreement mechanism, which generally means NIH will have an active role in the program beyond standard grant oversight. In practice, applicants should expect close coordination with NIH program staff, center-style governance expectations, and an emphasis on collaboration, harmonization, and accountability across multiple projects and cores. The FOA is labeled "Clinical Trial Optional," meaning applicants may include certain types of clinical research that meet the NIH definition of a clinical trial, but doing so is not required. Importantly, the FOA specifies that mechanistic clinical studies that meet the NIH clinical trial definition are allowed, signaling that the program is open to clinical investigations designed to understand biological mechanisms, immune responses, viral oncology, or related pathways in people, as long as the studies fit the overall center theme and goals.

Each HAMRC must be built around a formal partnership that includes at least one U.S. institution and institutions from at least two or more LMICs. That structure is a central requirement, not a preference. The intent is to create multi-country networks rather than isolated bilateral collaborations, enabling comparisons across settings, larger and more diverse participant populations, and shared approaches to data, biospecimens, and implementation challenges. The program is designed to support research that is relevant both to LMIC contexts and, where appropriate, to the United States, particularly where scientific insights about HIV-associated malignancies can translate across regions.

Applications must propose two to three research projects that fit under a single, coherent scientific theme related to HIV-associated malignancies. The FOA gives "viral-associated cancers" as an example theme, which reflects the reality that several HIV-associated cancers have strong viral drivers, and that HIV-related immune suppression can interact with oncogenic viruses to increase cancer risk and worsen outcomes. Within that single theme, the center can support a range of study types spanning basic research, translational research, and population or implementation science. This breadth is intentional: the FOA supports work that can move from understanding mechanisms, to improving diagnostics and prevention, to testing strategies for delivering effective interventions in real-world health systems.

Beyond the research projects, each U54 HAMRC must include two required cores: an Administrative Core and a Developmental Core. The Administrative Core is typically where the center organizes leadership, governance, project management, communication across countries, regulatory and ethics coordination, budgeting, reporting, and shared policies for things like data sharing and specimen handling. The Developmental Core is meant to build capacity and keep the center innovative over time, often by supporting pilot studies, developing early-stage ideas into fundable projects, strengthening local research infrastructure, and cultivating investigator development, including for early-career scientists and LMIC-based researchers. Taken together, these cores are meant to ensure the center operates as an integrated program rather than as unrelated projects housed under one award.

Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants listed include U.S. state and local governments, public and private institutions of higher education, tribal governments and tribal organizations, public housing authorities, nonprofits with or without 501(c)(3) status, for-profit organizations (including entities other than small businesses), and small businesses, among others. The FOA also explicitly highlights a range of institution types and community-facing organizations that may apply or participate, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This broad eligibility aligns with the center model, where success often depends on bringing together academic researchers, clinical sites, public health programs, and community partners across multiple countries.

From the source details provided, the opportunity is categorized as discretionary funding, uses the cooperative agreement instrument, and falls under education and health activity categories. It is administered by NIH and is associated with multiple CFDA numbers (93.393, 93.394, 93.395, 93.396, 93.989), reflecting NIH's organizational structure and the potential involvement of multiple NIH components. The original closing date listed is March 30, 2022, and while an award ceiling and expected number of awards are not specified in the provided text, applicants generally would be expected to propose budgets that match the scale of a multi-project, multi-country research center with the required cores and the operational demands of collaborative science.

Overall, this FOA is designed for teams that can demonstrate a clear, unified research vision on HIV-associated cancers, the ability to run two to three tightly connected projects under one theme, and the organizational strength to manage an international center with shared governance, harmonized methods, and meaningful LMIC engagement. The emphasis is not just on producing research findings, but on building durable research centers that can generate high-impact science, strengthen capacity in LMIC settings, and accelerate improvements in prevention, diagnosis, and care for HIV-associated malignancies.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "U.S. and Low- and Middle-Income Country (LMIC) HIV-Associated Malignancy Research Centers (U54 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.396, 93.989.
• This funding opportunity was created on 2022-01-03.
• Applicants must submit their applications by 2022-03-30. (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 RFA CA 22 011

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