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

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

What is the title and identifier of this funding opportunity?

The opportunity is NIH discretionary grant opportunity PA 18-753, titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01 Clinical Trial Optional)."

What funding mechanism does this opportunity use?

This opportunity uses the R01 Research Project Grant mechanism.

What is the main purpose of this FOA?

The main purpose is to support research that improves how HIV incidence is measured by discovering and developing novel biomarkers and by creating or refining laboratory assays and analytic algorithms that more accurately distinguish recent HIV infection from long-standing (chronic) infection.

What does "HIV incidence assay" mean in the context of this FOA?

In this context, an HIV incidence assay is a laboratory-based approach (sometimes combined with other tests or data) used to classify infections as "recent" versus "chronic" so that researchers and public health programs can estimate how many new infections are occurring in a population.

What is meant by "recent" versus "chronic" HIV infection here?

The FOA describes "recent" infection as generally within the first 12 months after infection, while "chronic" refers to long-standing infection beyond that period.

What is the central scientific emphasis of the FOA?

The central emphasis is improving specificity, meaning reducing the chance that a person with chronic HIV infection is incorrectly classified as recently infected (a "false-recent" result).

Why is improving specificity so important for HIV incidence estimation?

If an assay misclassifies chronic infections as recent, incidence can be substantially overestimated. This can be especially problematic in populations where many people have long-standing infection, are on antiretroviral therapy, or have atypical immune responses that affect standard serologic measurements.

What kinds of projects is NIH inviting under this FOA?

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.

What types of biomarkers are relevant to this FOA?

The FOA describes biomarkers broadly and includes immune response characteristics (such as antibody maturation patterns or antibody avidity dynamics), viral markers (including measures related to viral diversity or evolution over time), host response signals, or combinations of signals.

Does this FOA focus only on a single laboratory test?

No. The FOA explicitly highlights interest in both assays and analytic algorithms, including multi-marker strategies that may combine results from multiple assays, clinical data, or statistical models to improve classification performance and reduce false-recent results.

What are "multi-assay algorithms" in the context of this opportunity?

Multi-assay algorithms are approaches that integrate results from multiple laboratory assays and potentially additional information (such as clinical data or statistical modeling outputs) to improve the ability to classify infections as recent versus chronic.

How does this FOA relate to public health surveillance and prevention programs?

The FOA aims to strengthen tools used for HIV surveillance, public health planning, and evaluation of prevention programs by improving incidence assays and related multi-assay algorithms that support more accurate estimates of recent infection and incidence.

What real-world conditions does NIH want improved incidence tools to handle?

The FOA emphasizes reliability across diverse real-world conditions, including different HIV subtypes, treatment exposure (including antiretroviral therapy), and host factors that can distort standard serologic measurements.

Are clinical trials required under this FOA?

No. The FOA is designated "Clinical Trial Optional," meaning an application may include a clinical trial component if scientifically justified, but a clinical trial is not required for submission.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include a wide range of government entities, educational institutions, nonprofits, for-profit organizations, small businesses, and other entities, including non-U.S. entities (foreign organizations) and regional organizations.

What types of government entities are eligible?

Eligible government applicants include state, county, city or township governments, special district governments, and independent school districts.

Are public and private universities eligible?

Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are eligible.

Are tribal governments and tribal organizations eligible?

Yes. Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments) are listed as eligible applicants.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. Nonprofits with or without 501(c)(3) status (other than institutions of higher education) are included as eligible applicants.

Are for-profit organizations and small businesses eligible?

Yes. For-profit organizations (other than small businesses) and small businesses are both listed as eligible applicants.

Are community-based and faith-based organizations eligible?

Yes. The FOA explicitly highlights faith-based or community-based organizations among additional eligible applicants.

Are U.S. territories and possessions eligible?

Yes. U.S. territories or possessions are included among the additional eligible applicants highlighted in the FOA.

Are non-U.S. (foreign) organizations eligible?

Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) and regional organizations as eligible applicants.

Which serving institutions are specifically highlighted as eligible?

The FOA highlights 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), and related categories as additional eligible applicants.

Is this opportunity categorized within a particular funding activity area?

Yes. It is categorized as a grant within the health funding activity category.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA number 93.855.

When was the FOA created?

The FOA was created on 2018-04-11.

What closing date is listed in the provided information?

The original closing date listed in the source information is 2021-05-07.

Does the provided information state the award ceiling or number of awards?

No. The provided source data does not specify an award ceiling or the expected number of awards.

What should applicants infer from the lack of a stated award ceiling or expected number of awards in the provided text?

Based on the provided information alone, it means those details are not included here; applicants would typically need to consult the full FOA text and NIH budgeting norms for R01s to understand likely funding ranges, project periods, and institute-specific expectations.

What kind of impact is NIH aiming for with this funding?

The FOA aims to advance HIV incidence science by delivering better-performing biomarkers and practical assay or algorithm solutions that can be used by public health and research programs to produce more accurate and defensible estimates of recent infection and HIV incidence.