Clinical Sites for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (UG1 Clinical Trial Required) | RFA CA 21 047

Opportunity Information: Apply for RFA CA 21 047

The National Institutes of Health (NIH) funding opportunity RFA-CA-21-047 supports the creation of clinical trial sites for the HIV/Cervical Cancer Prevention "CASCADE" Clinical Trials Network using the UG1 cooperative agreement mechanism (clinical trial required). The central purpose of the program is to strengthen and test real-world, clinic-ready strategies that reduce breakdowns in the cervical cancer prevention pathway for women living with HIV, a population that faces elevated risk for persistent HPV infection, cervical precancer, and cervical cancer, and that often experiences gaps in screening follow-through and access to timely treatment. Rather than focusing on experimental interventions in highly controlled settings, the network is designed to run pragmatic clinical trials in intended-use environments (for example, HIV clinics, integrated health systems, safety-net settings, and other routine care contexts) to determine what actually works at scale and under typical operational constraints.

The CASCADE trials are aimed at the secondary prevention "cascade" for cervical cancer, meaning the sequence of steps that must happen reliably to prevent cancer: getting eligible patients screened, ensuring positive screening results are managed correctly and promptly, linking patients to diagnostic evaluation when needed, enabling access to precancer treatment, and improving the effectiveness and completion of precancer treatment itself. In practical terms, the trials will examine approaches to increase screening uptake (such as workflow changes, reminders, self-sampling pathways where appropriate, or integration of services), improve management of screen-positive results (such as navigation, tracking systems, standardized triage protocols, or point-of-care strategies), reduce delays and losses to follow-up between screening and treatment (such as referral coordination, telehealth-enabled follow-up, or same-day services), and optimize precancer treatments (including how treatments are delivered, monitored, and supported so that completion and outcomes improve). The end goal is to generate actionable evidence that can directly refine clinical practice guidelines and inform public health policy, with an emphasis on implementation-quality data that health systems and programs can realistically use.

This announcement specifically solicits six to eight UG1-funded Clinical Sites that will serve as the network's on-the-ground infrastructure for conducting multiple prevention-focused clinical trials over time. These sites are expected to be led by clinical investigators and/or practicing clinicians and to provide a flexible, "pluripotent" platform capable of supporting different study concepts and protocols as the network evolves. A key expectation is active engagement with other network awardees during the concept and protocol development phases, offering practical input on clinical significance, feasibility, patient flow, staffing realities, and operational barriers that could affect recruitment, adherence, follow-up, and data capture. Because this is a cooperative agreement, NIH will have substantial scientific and programmatic involvement compared with a standard grant, and awardees should expect close collaboration, shared decision-making structures, and coordination across sites to ensure harmonized operations and comparable outcomes across diverse settings.

Eligibility is broad and includes many domestic U.S. organization types that could credibly host pragmatic clinical trials, such as state, county, city, and special district governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; independent school districts; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other domestic entities. The opportunity explicitly notes additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, the program clearly restricts foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. The activity focus is in education and health, and it is associated with CFDA numbers 93.393, 93.395, and 93.399. The source information lists an award ceiling of $200,000 and an original closing date of 2021-12-28, with a creation date of 2021-10-26. Overall, the funding is intended to build a coordinated set of clinical sites that can rapidly stand up, execute, and learn from pragmatic trials that strengthen the screening-to-treatment continuum for women living with HIV, producing evidence that can be translated into updated guidance and better-performing prevention programs in real health care settings.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Clinical Sites 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 $200,000.00 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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