A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT U01 Clinical Trial Not Allowed) | RFA CA 21 057

Opportunity Information: Apply for RFA CA 21 057

The National Cancer Institute (NCI) funding opportunity titled "A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT U01 Clinical Trial Not Allowed)" supports projects that are designed to increase both referral to, and eventual enrollment (accrual) of underrepresented racial and ethnic minority populations into NCI-supported cancer clinical trials. The program is centered on reducing cancer health disparities by improving how communities and healthcare systems connect eligible patients to trials available through major NCI trial infrastructures, including the National Clinical Trial Network (NCTN), the NCI Community Oncology Research Program (NCORP), and the Experimental Therapeutics Clinical Trials Network (ETCTN). Rather than funding clinical trials themselves, this announcement focuses on outreach, education, and referral strategies that make trial participation more accessible and more likely for groups that have historically been left out.

A defining feature of CUSP2CT is its expectation of multilevel, culturally tailored interventions. Applicants are expected to build and test interventions that operate at more than one level, such as the clinical trial site level (how trials are presented, navigated, and supported), the provider level (how clinicians identify, discuss, and refer patients to trials), and the patient or community level (how people learn about trials, address concerns, and get help navigating eligibility and logistics). The interventions should be responsive to local context and should directly address barriers and facilitators that affect referral and participation among underrepresented racial and ethnic minority populations. The approach is meant to be practical and implementation-focused, not just descriptive, with a strong emphasis on evaluating whether the chosen strategies actually improve referrals and enrollment.

The FOA emphasizes building strong local networks that integrate community and healthcare partners. Projects should involve multidisciplinary teams that may include community health educators (CHEs), lay health advisors (LHAs), community members, healthcare providers, and researchers, working in a coordinated way. The intent is to combine community trust and cultural knowledge with clinical and research expertise so that outreach and education are credible, accessible, and aligned with real-world clinical workflows. Applicants are also expected to partner with primary care providers and other relevant stakeholders to better identify referral barriers (for example, lack of awareness, logistical obstacles, mistrust, language needs, eligibility misconceptions, or workflow issues) and to put workable solutions into place.

From a design standpoint, NCI expects proposed interventions to be grounded in established theories, frameworks, or models, and to be justified by preliminary data and/or a demonstrated ability to carry out the work because the necessary infrastructure and expertise already exist. In other words, applicants should show they understand the local environment, have a rationale for why their strategy should work, and can realistically implement and evaluate it within the community and healthcare settings where underrepresented populations receive care. Evaluation is not an add-on; it is a core requirement, because the overall program goal is to learn what works, for whom, and under what conditions when trying to improve referral and accrual of underrepresented populations to NCI-supported trials.

This opportunity uses a U01 cooperative agreement mechanism, which typically means substantial scientific or programmatic involvement by NCI staff during the project. The FOA also notes that a companion award (a separate U24 funding opportunity, RFA-CA-21-058) will support a Data, Evaluation and Coordinating Center (DECC). That DECC is intended to provide coordinated support across projects, particularly around evaluation and cross-site coordination, helping ensure that outcomes are measured rigorously and in a way that can be compared or synthesized across different funded teams.

Eligibility is broad and includes many types of U.S.-based organizations, such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofits (with or without 501(c)(3) status); and for-profit organizations (other than small businesses), as well as small businesses. The FOA also highlights additional eligible applicant categories that align with the program focus on underserved communities, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and certain regional organizations and U.S. territories or possessions. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not allowed; foreign components as defined by NIH policy are explicitly not permitted.

Administrative details in the source listing include the funding opportunity number RFA-CA-21-057, classification as a discretionary opportunity, and a cooperative agreement funding instrument. The activity category is listed under education and health, with CFDA number 93.395. The original closing date shown is September 22, 2021, and an award ceiling of $450,000 is listed. Overall, the program is aimed at producing actionable, evaluated outreach and referral models that can measurably improve underrepresented racial and ethnic minority participation in NCI-supported cancer clinical trials by aligning community engagement with healthcare system processes.

• 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 Not Allowed)" 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 2021-09-01.
• Applicants must submit their applications by 2021-09-22. (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 21 057

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