Opportunity Information: Apply for RFA CA 21 046
The National Institutes of Health (NIH) funding opportunity RFA-CA-21-046 supports the creation of a multicenter clinical trials network focused on improving secondary cervical cancer prevention for women living with HIV. The network is called the HIV/Cervical Cancer Prevention "CASCADE" Clinical Trials Network, and its central purpose is to address real-world breakdowns in the cervical cancer prevention pathway, from screening through follow-up care and treatment of cervical precancer. The emphasis is on pragmatic clinical trials, meaning studies designed to test interventions under typical, intended-use conditions in clinics and health systems rather than under tightly controlled laboratory-style environments. The overall goal is to generate practical evidence that can directly improve how screening and treatment programs are implemented and, in turn, reduce cervical cancer risk in this high-priority population.
A key theme of the opportunity is the "cascade" concept: many women may be screened but never receive results, or may receive abnormal results but face delays or barriers to confirmatory evaluation, referral, or treatment. CASCADE aims to evaluate innovative, implementation-focused approaches to prevent these drop-offs and failures. The trials supported through the network are expected to concentrate on the full continuum of care for secondary prevention, including increasing screening uptake, improving timely and appropriate management of positive screening results, reducing loss to follow-up, expanding access to precancer treatment services, and optimizing the treatments themselves. Importantly, the trials are meant to test clinically proven interventions (things that already work clinically) and evaluate how best to deliver them effectively, efficiently, and equitably in the settings where women living with HIV actually receive care.
The evidence produced by these studies is intended to have direct downstream impact on guidelines and policy. NIH is looking for results that can refine clinical practice guidance and inform public health decision-making, especially around how cervical cancer screening and precancer treatment programs should be structured for women living with HIV. In other words, the opportunity is not just about showing that an intervention can work, but about generating actionable findings that can improve real-world prevention programs at scale, including clearer best practices for implementation across diverse health systems and resource settings.
The award mechanism is a UG1 cooperative agreement, which signals substantial scientific and programmatic involvement by NIH compared with a standard research grant. Under this structure, awardees are expected to operate as part of a coordinated network, collaborating on multi-institutional trial development and execution. The opportunity specifically funds two to three "Research Bases" that will serve as the scientific backbone of the network. Each Research Base is envisioned as a self-organized consortium of investigators with complementary expertise, brought together to provide leadership in trial concept development, protocol design, and analysis planning across multiple institutions and sites. This includes strong statistical leadership, since pragmatic multi-site trials typically require robust design, power calculations, and analytic approaches that account for clustered data, variable clinical workflows, and implementation heterogeneity.
Beyond scientific leadership, the Research Bases are responsible for ensuring compliance with regulatory requirements and human subjects protections across the network. This includes coordinating or supporting Institutional Review Board (IRB) processes, data and safety monitoring expectations, participant protection standards, and other policy requirements that are especially important in clinical trials involving potentially vulnerable populations. The network structure also includes an explicit workforce development component: the Research Bases are expected to help create training and mentorship opportunities for emerging investigators, building future capacity in HIV-associated cervical cancer prevention research and implementation science.
Eligibility is broad and includes many types of U.S. governmental and non-governmental entities, as well as certain non-U.S. organizations. Eligible applicants listed in the source information include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other organizations. The announcement also highlights additional eligible applicant categories 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 or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and non-domestic (non-U.S.) entities.
From the funding details provided, this is a discretionary NIH opportunity using the cooperative agreement funding instrument, with activity categories spanning education and health and CFDA numbers 93.393, 93.395, and 93.399. The original closing date was 2021-12-28, and the listed award ceiling is $400,000. Taken together, the opportunity is designed to build a small number of strong coordinating research hubs that can drive rigorous, real-world clinical trials to strengthen every step of the cervical cancer screening and treatment cascade for women living with HIV, producing evidence that can be translated into improved practice and policy.Apply for RFA CA 21 046
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Research Bases for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (UG1 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 $400,000.00 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.
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Frequently Asked Questions (FAQs): NIH RFA-CA-21-046 (CASCADE Clinical Trials Network)
1. What is the NIH funding opportunity RFA-CA-21-046?
RFA-CA-21-046 is a National Institutes of Health (NIH) funding opportunity that supports the creation of a multicenter clinical trials network focused on improving secondary cervical cancer prevention for women living with HIV. The network is named the HIV/Cervical Cancer Prevention "CASCADE" Clinical Trials Network.
2. What is the main purpose of the CASCADE Clinical Trials Network?
The purpose of CASCADE is to address real-world breakdowns in the cervical cancer prevention pathway for women living with HIV, spanning screening through follow-up care and treatment of cervical precancer. The network is intended to generate practical evidence that can improve implementation of screening and treatment programs and reduce cervical cancer risk in this high-priority population.
3. What does the "cascade" concept mean in this opportunity?
"Cascade" refers to the step-by-step prevention pathway where drop-offs can occur. For example, women may be screened but never receive results, or may receive abnormal results but experience delays or barriers to confirmatory evaluation, referral, or treatment. CASCADE aims to test approaches designed to prevent these failures across the continuum of care.
4. What types of studies does NIH want supported through this network?
The emphasis is on pragmatic clinical trials, meaning trials designed to test interventions under typical, intended-use conditions in clinics and health systems (not tightly controlled laboratory-style environments). The network is expected to evaluate implementation-focused approaches that strengthen real-world delivery of proven prevention services.
5. What is meant by a "pragmatic clinical trial" in the context of this program?
In this program, pragmatic clinical trials are studies that evaluate how interventions work when delivered through routine clinical workflows and real health systems. These trials are meant to produce findings that can be applied directly to everyday practice across diverse sites and settings.
6. What parts of cervical cancer secondary prevention are expected to be addressed?
Trials are expected to focus on the full continuum of secondary prevention, including improving screening uptake, ensuring timely and appropriate management of positive screening results, reducing loss to follow-up, expanding access to precancer treatment services, and optimizing treatment approaches for cervical precancer.
7. Is the network focused on discovering new clinical interventions?
No. The trials are meant to test clinically proven interventions and evaluate how best to deliver them effectively, efficiently, and equitably in the real-world settings where women living with HIV receive care.
8. What is the intended impact of the evidence produced by CASCADE trials?
The evidence is intended to have downstream impact on guidelines and policy. NIH is looking for actionable results that can refine clinical practice guidance and inform public health decision-making about how cervical cancer screening and precancer treatment programs should be structured for women living with HIV.
9. What does it mean that this award uses a UG1 cooperative agreement mechanism?
A UG1 cooperative agreement signals substantial NIH scientific and programmatic involvement compared with a standard research grant. Awardees are expected to function as part of a coordinated network and collaborate on multi-institutional trial development and execution with NIH involvement.
10. How many awards are expected and what is being funded?
The opportunity specifically funds two to three "Research Bases" that will serve as the scientific backbone of the CASCADE network. Each Research Base is expected to provide leadership and coordination for network clinical trials work across multiple institutions and sites.
11. What is a "Research Base" in the CASCADE network?
A Research Base is envisioned as a self-organized consortium of investigators with complementary expertise. Research Bases are responsible for scientific leadership in trial concept development, protocol design, and analysis planning across multiple institutions and sites.
12. What expertise is expected within a Research Base?
Research Bases are expected to bring together investigators with complementary expertise and provide strong statistical leadership. This is important because pragmatic multi-site trials often require robust design, power calculations, and analytic approaches suited to clustered data, variable clinical workflows, and implementation heterogeneity.
13. What are the regulatory and human subjects responsibilities under this opportunity?
Research Bases are responsible for ensuring compliance with regulatory requirements and human subjects protections across the network. This includes coordinating or supporting Institutional Review Board (IRB) processes, data and safety monitoring expectations, participant protection standards, and related policy requirements relevant to clinical trials, including those involving potentially vulnerable populations.
14. Does the opportunity include training or workforce development expectations?
Yes. The network includes an explicit workforce development component. Research Bases are expected to help create training and mentorship opportunities for emerging investigators to build future capacity in HIV-associated cervical cancer prevention research and implementation science.
15. Who is eligible to apply for RFA-CA-21-046?
Eligibility is broad and includes many U.S. governmental and non-governmental entities, as well as certain non-U.S. organizations. The listed eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other organizations.
16. Are specific institution types explicitly highlighted as eligible?
Yes. Additional highlighted eligible categories include 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 or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and non-domestic (non-U.S.) entities.
17. Is this opportunity limited to U.S.-based applicants?
No. The eligibility information provided explicitly includes non-domestic (non-U.S.) entities among eligible applicant categories.
18. What is the subject area or program focus for this NIH opportunity?
The program focus is secondary cervical cancer prevention for women living with HIV, with an emphasis on pragmatic clinical trials and implementation-focused approaches that reduce breakdowns across the screening-to-treatment pathway.
19. What are the activity categories and CFDA numbers listed for this opportunity?
The opportunity is described as spanning education and health activity categories. The CFDA numbers listed are 93.393, 93.395, and 93.399.
20. What is the award ceiling listed for this funding opportunity?
The listed award ceiling is $400,000.
21. What was the original closing date for this funding opportunity?
The original closing date listed is 2021-12-28.
22. What makes this opportunity different from a typical single-site clinical trial grant?
Based on the provided description, this opportunity is designed to build a coordinated multicenter network via two to three Research Bases, with NIH having substantial involvement (UG1 cooperative agreement). The focus is on pragmatic, real-world trials and implementation strategies that can translate into guideline and policy impact.
23. What kinds of "real-world breakdowns" is CASCADE trying to fix?
The opportunity highlights common problems such as screening without results being received, abnormal results not leading to confirmatory evaluation, delays in referral pathways, barriers to accessing treatment, and loss to follow-up. CASCADE-supported trials are expected to test approaches that reduce these drop-offs across the continuum.
24. What is NIH looking for in terms of outcomes or deliverables?
NIH is looking for practical, actionable evidence from pragmatic clinical trials that can directly improve how screening and treatment programs are implemented, with results that can refine clinical guidance and inform public health policy decisions for women living with HIV.
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