Coordinating Center for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (U24 Clinical Trial Required) | RFA CA 21 045

Opportunity Information: Apply for RFA CA 21 045

The NIH funding opportunity RFA-CA-21-045 supports the creation and operation of a Network Coordinating Center for the HIV/Cervical Cancer Prevention "CASCADE" Clinical Trials Network under a U24 cooperative agreement (clinical trial required). The central purpose of the CASCADE Network is to generate practical, real-world evidence on how to reduce breakdowns in the cervical cancer prevention pathway for women living with HIV, a group that faces elevated cervical cancer risk and often experiences gaps in screening follow-up and timely treatment. Rather than testing brand-new experimental therapies in idealized settings, the network is designed to run pragmatic clinical trials that evaluate proven interventions as they are delivered in routine, intended-use health care environments, with an emphasis on implementation and measurable improvements across the prevention continuum.

The clinical focus is the secondary prevention "cascade" for cervical cancer, meaning the full set of steps that begin with getting people screened and continue through appropriate management and treatment. Trials are expected to address key failure points such as low screening uptake, delays or losses to follow-up among individuals with positive screens, barriers to accessing precancer treatment, and challenges in delivering and optimizing precancer treatments once patients enter care. The intention is to test strategies that can be adopted widely in real systems of care, producing evidence that is immediately actionable for programs and clinics serving women with HIV.

A core deliverable of the network is evidence that can refine clinical practice guidelines and inform public health policy. By comparing the effectiveness of different approaches to improving screening, follow-up, and treatment completion, the network aims to strengthen cervical cancer prevention implementation programs and improve outcomes at scale. In other words, the trials are meant to do more than show that an intervention works; they are meant to show what works best in everyday clinical settings, for whom, and under what conditions, so health systems and policymakers can make better decisions.

The U24-funded Network Coordinating Center plays the backbone role for the entire multicenter network. Its responsibilities include coordinating network-wide activities and governance; managing concept development and protocol review processes so that proposed studies are methodologically sound, feasible, and aligned with network goals; and providing centralized data management support to ensure consistent data collection, high-quality datasets, and efficient analysis across sites. The Coordinating Center is also responsible for independent clinical trials auditing across the network, which supports participant safety, regulatory compliance, and data integrity. In addition, it interfaces closely with network grantees to strengthen study training, reporting, and quality assurance activities, helping ensure that sites implement protocols consistently and meet monitoring and performance expectations.

The opportunity uses the NIH cooperative agreement model, which typically involves substantial programmatic involvement from NIH staff compared with standard research grants. That structure is well-suited to a networked clinical trials program where harmonization, shared infrastructure, and coordinated oversight are necessary to produce comparable results across multiple studies and locations.

Eligibility is broad across U.S.-based organizations, spanning state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), tribal governments and tribal organizations, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The announcement also highlights inclusion of a wide range of community- and minority-serving institutions and organizations, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, as well as faith-based or community-based organizations and U.S. territories or possessions. Non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply, but foreign components are allowed as defined by the NIH Grants Policy Statement, which can enable specific, justified international collaborations while keeping the applicant organization domestic.

Key administrative details include the agency (National Institutes of Health), funding instrument (cooperative agreement), activity category (Education and Health), and associated CFDA numbers (93.393, 93.395, 93.399). The original closing date listed for this opportunity was 2021-12-28, and the award ceiling shown is $750,000. Overall, the grant is aimed at building the coordinating infrastructure that makes a pragmatic, multicenter clinical trials network possible, with the end goal of improving the real-world delivery of cervical cancer screening, follow-up, and precancer care for women living with HIV.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Coordinating Center for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (U24 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.395, 93.399.
• This funding opportunity was created on 2021-10-26.
• Applicants must submit their applications by 2021-12-28. (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 $750,000.00 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 21 045

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