U.S. and Low- and Middle-Income Country (LMIC) HIV-Associated Malignancy Research Centers (U54 Clinical Trials Optional) | RFA CA 20 001

Frequently Asked Questions (FAQs)

1) What is the purpose of this grant opportunity?

This funding opportunity supports the creation and operation of international research centers focused on HIV-associated malignancies (cancers linked to HIV). The intent is to build collaborative networks that connect U.S.-based researchers and institutions with partners in low- and middle-income countries (LMICs), where HIV-associated cancers often pose a major clinical burden and where local conditions can shape scientific and implementation challenges.

2) What is the official title of the opportunity?

The opportunity is titled: "U.S. and Low- and Middle-Income Country (LMIC) HIV-Associated Malignancy Research Centers (U54 Clinical Trials Optional)."

3) Which federal agency is offering this funding?

The funding is offered by the National Institutes of Health (NIH).

4) What kind of NIH award mechanism is this?

This is a U54 cooperative agreement. That structure indicates a center-style program with substantial coordination and interaction between awardees and NIH, rather than a set of independent, disconnected projects.

5) What does "cooperative agreement" imply for how the program is run?

Based on the description provided, a cooperative agreement is intended to be coordinated with meaningful NIH involvement and ongoing interaction. The work is framed as a network/center effort with governance and coordination across partners, rather than isolated investigator-initiated studies.

6) What is meant by an "international research center" in this FOA?

Applicants are expected to form a research center that functions as a collaborative network linking U.S. institutions with LMIC partners. The center is organized around integrated projects and shared cores, designed to tackle HIV-associated cancer questions that are relevant in LMIC settings and also meaningful to the United States.

7) Do applications have to include both U.S. and LMIC partners?

Yes. The central concept of the FOA is to fund collaborative networks that join U.S. researchers and institutions with partners in LMIC settings.

8) How many research projects can be included under the center?

Each proposed center is expected to include one to three integrated research projects.

9) Do the projects need to be connected to each other?

Yes. The projects are expected to be integrated and organized around a single unifying theme. This thematic approach is intended to keep the center cohesive.

10) What kinds of research topics are appropriate?

The scientific scope is described as intentionally broad. Examples of themes and questions mentioned include understanding cancer biology in the context of HIV, improving early detection, strengthening prevention strategies, and optimizing treatment and care delivery in resource-limited environments.

11) What types of research approaches are allowed?

The FOA allows a wide range of approaches, including basic laboratory research, translational studies, population-level research, and implementation science.

12) Are clinical trials allowed in this program?

Yes. The opportunity states that mechanistic clinical studies that meet the NIH definition of a clinical trial are allowed. The title also signals this as "Clinical Trials Optional," meaning clinical trial activities may be included when appropriate to the center's core scientific questions.

13) What are the required cores for the center?

Each proposed network must include two mandatory cores: (1) an Administrative Core and (2) a Developmental Core.

14) What is the role of the Administrative Core?

The Administrative Core is described as the operational backbone of the center. Typical functions include governance, coordination across U.S. and LMIC partners, regulatory and compliance planning, communications, budgeting, reporting, and overall program management.

15) What is the role of the Developmental Core?

The Developmental Core is intended to stimulate growth and sustainability of the research program. Activities often include supporting pilot projects, building research capacity, mentoring early-stage investigators, and strengthening infrastructure and expertise across the collaboration.

16) Can applicants propose additional cores beyond the required ones?

Yes. Applicants may propose additional cores if they are justified by the needs of the research projects.

17) What is an example of an optional core that may be included?

An example noted is a Shared Resource Core. This type of core could provide centralized services such as biostatistics, data management, pathology review, specimen banking, specialized laboratory assays, or other shared resources used by multiple projects.

18) Who is eligible to apply?

Eligibility is broad and includes many types of entities, such as government organizations (state, county, city/township, and special districts), public and private institutions of higher education, independent school districts, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, and nonprofit and for-profit organizations (including small businesses).

19) Are non-U.S. entities and foreign organizations eligible?

Yes. The opportunity explicitly highlights inclusion of non-U.S. entities and foreign organizations, consistent with the LMIC partnership focus.

20) Are U.S. territories and possessions eligible applicants?

Yes. U.S. territories and possessions are listed as eligible.

21) Does the FOA encourage participation by specific institution types?

Yes. The eligibility language specifically includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions.

22) Are faith-based or community-based organizations eligible?

Yes. Faith-based and community-based organizations are listed among eligible applicant types, reflecting the importance of community engagement and local partnerships in LMIC research settings.

23) What is the funding opportunity number?

The funding opportunity number is RFA CA 20 001.

24) What are the CFDA numbers associated with this opportunity?

The opportunity is associated with multiple CFDA numbers: 93.393, 93.394, 93.395, and 93.396.

25) What is the listed application closing date and creation date?

The original closing date listed is January 10, 2020, and the creation date is October 17, 2019.

26) What is the award ceiling listed for this grant?

An award ceiling of $800,000 is shown. This suggests an upper bound on the budget level (for example, annual direct costs or total costs depending on NIH budget rules referenced in the full announcement), and applicants are expected to design projects and cores that fit within that limit while still forming a coherent center program.

27) How is this funding categorized?

It is identified as discretionary funding and is categorized under education and health-related activities.

28) What is the overall program emphasis of the FOA?

The program emphasizes center-building and network-building to produce impactful, context-aware research on HIV-associated malignancies. It prioritizes integrated projects under a unifying theme, requires strong coordination and development functions through mandatory cores, allows a broad range of research approaches (including certain clinical trials), and encourages broad participation across organizational types to support both scientific discovery and practical translation in LMIC settings and beyond.