Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01 Clinical Trial Optional) | PA 18 753

Opportunity Information: Apply for PA 18 753

The National Institutes of Health (NIH) announced this discretionary grant opportunity, PA 18-753, titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01 Clinical Trial Optional)." It uses the R01 Research Project Grant mechanism to fund research aimed at improving how HIV incidence is measured, specifically by supporting the discovery and development of new biomarkers and the creation or refinement of laboratory assays and analytic algorithms that can more accurately tell whether an HIV infection is recent (generally within the first 12 months after infection) or long-standing (chronic). The central emphasis is on increasing specificity, meaning reducing the chance that someone with a chronic infection is incorrectly classified as recently infected, which is a key limitation of many existing incidence assays.

The scientific goal of the FOA is to strengthen the tools used for HIV surveillance, public health planning, and evaluation of prevention programs by improving "incidence assays" and related multi-assay algorithms. In practice, incidence estimates often rely on identifying a subset of infections that appear "recent" based on immunologic or virologic signals, then using those classifications to infer how many new infections are occurring in a population. If an assay misclassifies chronic infections as recent, incidence can be substantially overestimated, especially in populations where many people have long-standing infection, are on antiretroviral therapy, or have atypical immune responses. This FOA is designed to push the field toward biomarkers and testing strategies that remain reliable across diverse real-world conditions, including different HIV subtypes, treatment exposure, and host factors that can distort standard serologic measurements.

Applicants are invited to propose projects that identify novel markers of time-since-infection, validate those markers, and translate them into improved assays or algorithmic approaches that better separate recent from chronic infection. "Biomarkers" in this context can include immune response characteristics (for example, antibody maturation patterns or antibody avidity dynamics), viral markers (such as measures related to viral diversity or evolution over time), host response signals, or combinations of signals that, when integrated, produce a more dependable classification. The mention of "assays and algorithms" signals that NIH is interested not only in a single lab test, but also in multi-marker strategies that may combine results from multiple assays, clinical data, or statistical models to improve classification performance and reduce false-recent results. The "Clinical Trial Optional" designation means an application may include a clinical trial component if it is scientifically justified, but it is not required for submission.

Eligibility is broad and is intended to encourage participation from a wide range of institutions and organizational types involved in HIV research, diagnostics, epidemiology, and public health. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations. This wide eligibility reflects the global and community-linked nature of HIV research and the practical need to validate incidence tools across settings and populations.

From an administrative standpoint, the opportunity is categorized as a grant within the health funding activity category and is associated with CFDA number 93.855. The FOA was created on 2018-04-11, and the original closing date listed in the source information is 2021-05-07. The provided source data does not specify an award ceiling or the expected number of awards, which typically means applicants would need to consult the full FOA text and NIH budgeting norms for R01s to understand likely funding ranges, project periods, and institute-specific expectations.

Overall, this FOA is aimed at researchers who can advance HIV incidence science beyond current limitations by delivering better-performing biomarkers and practical assay or algorithm solutions that public health and research programs can use to produce more accurate, more defensible estimates of recent infection and HIV incidence.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2018-04-11.
• Applicants must submit their applications by 2021-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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