Prevention of HPV-related Cancers in HIV-infected individuals: United States-Latin American-Caribbean Clinical Trials Network: Partnership Centers (U54 Clinical Trial Required) | RFA CA 18 018

Opportunity Information: Apply for RFA CA 18 018

This NIH funding opportunity (RFA-CA-18-018) supports the creation of U54 Partnership Centers designed to run a coordinated set of clinical trials aimed at reducing HPV-related cancers among people living with HIV. The core idea is to strengthen prevention in populations where HPV-driven disease burdens are high and where HIV infection increases the risk of persistent HPV infection, precancer, and cancer. Through a cooperative agreement mechanism, NIH intends to actively partner with awardees to help move well-designed prevention trials from planning to completion, with an emphasis on producing evidence that can realistically shape clinical practice and guideline recommendations.

A defining feature of the program is that each Partnership Center must be an international collaboration anchored by a United States research institution as the applicant, working closely with one or more partner institutions located in low- and middle-income countries across the Latin American and Caribbean region. The network structure is meant to support real-world trial implementation in the LAC region, building durable clinical research capacity while also generating results that are directly relevant to local health systems and patient populations. Although the research is international, the applicant organization must be US-based; foreign institutions themselves cannot apply as the prime recipient, and non-US components of US organizations are not eligible. At the same time, foreign components (as defined by NIH policy) are allowed, which is how the LAC partners and in-country trial operations are expected to be integrated into the work.

Scientifically, the trials are required to focus on improving clinical prevention interventions for HPV-related cancers specifically in HIV-infected individuals. The FOA highlights several priority areas: immunoprevention such as HPV vaccination strategies, improved screening and triage approaches (for example, better ways to identify which screen-positive patients truly need further evaluation or treatment), and management of precancer, including treatment strategies that prevent progression to invasive cancer. In other words, the program is not about basic biology or observational work; it is explicitly about testing interventions in prevention-oriented clinical trials that can be translated into clinical services and public health programs.

Operationally, each application must propose a Clinical Trials Program that will develop and conduct three prevention clinical trials during the five-year project period. This requirement drives the overall center design: applicants need to show they can recruit and retain HIV-infected participants, deliver the prevention interventions safely and consistently, and measure clinically meaningful outcomes across multiple trials within a tight timeframe. Because these are prevention trials, the program expects rigorous design, appropriate ethical and regulatory oversight, and strong plans for monitoring, quality assurance, and harmonized data collection across participating sites.

To make that possible, the U54 Partnership Center structure must include three core infrastructure components. First is an Administrative and Coordinating Core, which typically handles leadership, governance, trial coordination, regulatory processes, site management, communications, and overall integration across US and LAC partners. Second is a Data Management and Statistical Core, responsible for building and maintaining data systems, ensuring data quality, developing and executing statistical analysis plans, and supporting interim and final analyses in a way that meets clinical trial standards. Third is a Central Laboratory Core, which is critical for standardized HPV and related testing, specimen handling, assay quality control, and cross-site comparability of laboratory endpoints. Together, these cores are intended to reduce fragmentation and ensure that the trials produce credible, reproducible findings.

The intended impact is practical and policy-relevant. NIH expects that the results generated by these Partnership Centers will inform clinical practice guidelines and improve preventive care for HIV-infected individuals, ultimately lowering the burden of HPV-related cancers that are considered highly preventable with the right combination of vaccination, screening, triage, and timely treatment of precancer. The emphasis on guideline influence signals that trials should address questions clinicians and health systems actually face, such as which prevention strategy works best in HIV-infected populations, what implementation pathway is feasible in LAC settings, and how to allocate limited resources to achieve the greatest reduction in cancer risk.

In terms of who can apply, eligibility is broad on the US side and includes many government entities and academic organizations, along with nonprofit and for-profit organizations (other than small businesses), small businesses, and various types of higher education institutions. The FOA explicitly mentions eligibility for organizations such as Historically Black Colleges and Universities, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions, as well as faith-based and community-based organizations and eligible federal agencies. Even with this broad applicant pool, the main structural requirement remains that the prime applicant is a US institution that has meaningful, well-justified partnerships with LMIC institutions in Latin America and the Caribbean where the clinical trials will be carried out.

Administratively, the opportunity is categorized as discretionary funding and uses a cooperative agreement funding instrument, reflecting NIH involvement in program stewardship. It is associated with CFDA numbers 93.393 and 93.395 and was published by the National Institutes of Health with an original closing date of November 15, 2018. The listed award ceiling is $1,500,000. The FOA describes “ExpectedAwards” but does not specify a number in the provided text, implying that applicants would need to consult the full announcement for details on anticipated funding levels, number of awards, and any additional budget constraints or expectations.

Overall, the grant is best understood as a center-based, trial-driven program to build a US-LAC clinical trials network focused on preventing HPV-related cancers in people living with HIV. Applicants are expected to bring together strong international partnerships, the infrastructure to run multiple high-quality prevention trials, and a clear plan for generating results that can change how prevention is delivered in clinical settings, especially across Latin America and the Caribbean.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Prevention of HPV-related Cancers in HIV-infected individuals: United States-Latin American-Caribbean Clinical Trials Network: Partnership Centers (U54 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.
• This funding opportunity was created on 2018-08-28.
• Applicants must submit their applications by 2018-11-15. (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 $1,500,000.00 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 18 018

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