A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT; U01 Clinical Trial Optional) | RFA CA 21 063

Opportunity Information: Apply for RFA CA 21 063

The National Cancer Institute (NCI) funding opportunity titled "A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT; U01 Clinical Trial Optional)" supports projects designed to increase participation of underrepresented racial and ethnic minority populations in NCI-supported cancer clinical trials. The central goal is practical and measurable: improve culturally tailored outreach and education in ways that raise referral to trials and, ultimately, increase accrual (enrollment) of these populations into trials conducted through major NCI clinical trial networks, including the National Clinical Trial Network (NCTN), the NCI Community Oncology Research Program (NCORP), and the Experimental Therapeutics Clinical Trials Network (ETCTN). The program is positioned explicitly as a cancer health disparities effort, focused on reducing inequities in access to cutting-edge cancer research and treatment options that are often available through clinical trials.

This FOA uses a cooperative agreement mechanism (U01), which generally means NCI expects an active partnership role during the project, not just a standard grant where the awardee operates independently. Applicants are expected to implement and evaluate multilevel interventions, meaning strategies should work across more than one layer of influence such as the clinical trial site itself (how trials are presented, navigated, and supported), healthcare providers (knowledge, referral behavior, communication practices, and awareness of underrepresented participation), and patients or community members (awareness, trust, practical navigation, and decision support). The emphasis is on interventions that are culturally tailored, grounded in relevant theories, frameworks, or models, and informed by preliminary data and/or strong existing infrastructure and local expertise. In other words, proposed projects should not be generic awareness campaigns; they should be tied to a clear understanding of local barriers and facilitators that shape whether eligible patients are identified, referred, and supported through enrollment.

A defining feature of the program is its expectation of strong, integrated local partnerships. Applicants are expected to build or leverage networks that include community health educators and lay health advisors, along with community members, healthcare providers, and researchers who can coordinate efforts end-to-end. This partnership model reflects the reality that low trial participation is rarely caused by a single issue; it often stems from interacting factors such as limited awareness of trials, lack of provider referral pathways, logistical burdens (transportation, time off work, caregiving responsibilities), language barriers, medical mistrust based on historical and present-day experiences, limited trial availability at local sites, and complicated eligibility and consent processes. CUSP2CT projects are meant to address these kinds of barriers in a coordinated way so that community-facing education connects directly to clinical workflows that can translate interest into actual referrals and enrollment.

The FOA also anticipates coordination with a companion award that funds a Data, Evaluation and Coordinating Center (DECC) through a separate U24 opportunity (RFA-CA-21-058). The DECC is intended to provide experienced support for evaluation and coordination, which signals that NCI expects consistent measurement, shared learning, and comparable evaluation approaches across sites. For applicants, this typically implies that projects must be designed with clear outcomes and evaluation plans, likely including metrics related to awareness, referral rates, navigation success, and accrual outcomes for underrepresented racial and ethnic minority populations into NCI-supported trials.

Eligibility for this opportunity is broad across U.S.-based organizations and includes many types of government entities (state, county, city/township, special districts), public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as tribal governments and tribal organizations. The FOA also highlights additional eligible applicants that are especially relevant to the underrepresented focus and community partnership approach, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based and community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, the program is limited to domestic applicants: non-U.S. (foreign) institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

Key administrative details included in the posting are that the opportunity number is RFA-CA-21-063, it is categorized as discretionary funding and uses the cooperative agreement instrument, and it is associated with CFDA number 93.395. The posting lists an award ceiling of $450,000 and an original closing date of 2021-12-10, with a creation date of 2021-10-19. Overall, the opportunity is aimed at building real-world, community-engaged systems that can reliably connect underrepresented racial and ethnic minority patients to appropriate NCI-supported cancer clinical trials, while also generating evidence about which multilevel strategies work best in specific local contexts.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT; U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
• This funding opportunity was created on 2021-10-19.
• Applicants must submit their applications by 2021-12-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $450,000.00 in funding.
• 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 21 063

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