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

Frequently Asked Questions (FAQs)

What is RFA-CA-21-045?

RFA-CA-21-045 is a National Institutes of Health (NIH) funding opportunity to support the creation and operation of a Network Coordinating Center for the HIV/Cervical Cancer Prevention "CASCADE" Clinical Trials Network. The award mechanism is a U24 cooperative agreement, and the announcement specifies that a clinical trial is required.

What is the main purpose of the CASCADE Clinical Trials Network?

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. The network is designed to address gaps such as screening follow-up and timely treatment, with an emphasis on measurable improvements across the prevention continuum.

What type of research does this opportunity support?

This opportunity supports pragmatic clinical trials that evaluate proven interventions as they are delivered in routine, intended-use health care environments. The focus is on implementation and on producing evidence that is actionable for real systems of care, rather than testing brand-new experimental therapies in idealized settings.

What does "secondary prevention cascade" mean in this context?

In this announcement, the "secondary prevention cascade" refers to the full set of steps in cervical cancer prevention that begins with screening and continues through appropriate management and treatment. It includes moving people from screening to follow-up after abnormal results, and then to precancer treatment and optimization of that treatment once patients enter care.

What kinds of failure points or breakdowns are trials expected to address?

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.

Who is the priority population for the network's work?

The network is focused on women living with HIV, a group that faces elevated cervical cancer risk and often experiences gaps in screening follow-up and timely treatment.

What is the intended impact of the evidence generated by the network?

A core deliverable is evidence that can refine clinical practice guidelines and inform public health policy. By comparing 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.

What does the announcement mean by "real-world evidence" and "pragmatic clinical trials"?

As described, the trials are meant to determine what works best in everyday clinical settings, for whom, and under what conditions. The intent is to produce results that health systems, programs, and policymakers can use immediately, including strategies that can be adopted widely in real systems of care.

What is being funded under the U24 award?

The U24 award funds a Network Coordinating Center that serves as the backbone for a multicenter clinical trials network. The funding is intended to build and operate the coordinating infrastructure needed to run pragmatic, multicenter clinical trials and support consistent implementation across sites.

What are the main responsibilities of the Network Coordinating Center?

The Coordinating Center responsibilities described include coordinating network-wide activities and governance; managing concept development and protocol review processes; providing centralized data management support; conducting independent clinical trials auditing across the network; and interfacing closely with network grantees to strengthen training, reporting, and quality assurance activities.

What does "concept development and protocol review" involve for this network?

Based on the description, the Coordinating Center is expected to manage processes that help ensure proposed studies are methodologically sound, feasible, and aligned with the network's goals before protocols move forward across the multicenter network.

What does "centralized data management support" mean here?

The opportunity calls for centralized data management to ensure consistent data collection, high-quality datasets, and efficient analysis across multiple sites. This is intended to enable comparable results across studies and locations within the network.

What is meant by "independent clinical trials auditing"?

The Coordinating Center is responsible for independent clinical trials auditing across the network, supporting participant safety, regulatory compliance, and data integrity.

How does the Coordinating Center support study quality across different sites?

The Coordinating Center is expected to work closely with network grantees to strengthen study training, reporting, and quality assurance, helping ensure sites implement protocols consistently and meet monitoring and performance expectations.

What does it mean that this is a cooperative agreement?

This opportunity uses the NIH cooperative agreement model, which typically involves substantial programmatic involvement from NIH staff compared with standard research grants. The announcement notes that this structure is well-suited to a networked clinical trials program where harmonization, shared infrastructure, and coordinated oversight are needed.

Which federal agency is sponsoring this opportunity?

The sponsoring agency listed is the National Institutes of Health (NIH).

What is the funding instrument and activity type?

The funding instrument is a cooperative agreement, and the activity category is listed as Education and Health.

What are the associated CFDA numbers for this opportunity?

The associated CFDA numbers provided are 93.393, 93.395, and 93.399.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations, including 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.

Are minority-serving institutions and community-based organizations included in eligible applicants?

Yes. The announcement highlights inclusion of a wide range of community- and minority-serving institutions and organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, and faith-based or community-based organizations, as well as U.S. territories or possessions.

Can non-U.S. (non-domestic) organizations apply?

No. Non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply.

Are foreign components allowed at all?

Yes. The announcement states that 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.

Is a clinical trial required under this funding opportunity?

Yes. The opportunity is described as a U24 cooperative agreement with "clinical trial required."

What is the award ceiling listed for this opportunity?

The award ceiling shown in the provided information is $750,000.

What was the original closing date for this opportunity?

The original closing date listed is 2021-12-28.

What is the overall goal of funding the Coordinating Center?

The overall goal is to build and operate the coordinating infrastructure needed for a pragmatic, multicenter clinical trials network, with the end goal of improving real-world delivery of cervical cancer screening, follow-up, and precancer care for women living with HIV.