Opportunity Information: Apply for PA 18 754
The grant opportunity titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R21 Clinical Trials Not Allowed)" is a discretionary NIH funding announcement (PA 18-754) that supports early-stage, exploratory research aimed at improving how researchers and public health programs determine whether an HIV infection is recent or long-standing. The central goal is to develop new biomarkers and to advance HIV incidence assays and related algorithms that can more accurately distinguish infections acquired within roughly the past 12 months from chronic infections. In practical terms, the opportunity focuses on improving "specificity," meaning it is designed to reduce misclassification where long-term infections are mistakenly labeled as recent, a problem that can distort incidence estimates and undermine surveillance and prevention planning.
This program uses the NIH R21 Exploratory/Developmental Grant mechanism, which is generally intended for high-impact, innovative projects that may still be in the proof-of-concept or early validation phase rather than fully mature, large-scale programs. The announcement explicitly states that clinical trials are not allowed, signaling that proposed work should not involve prospective interventional studies designed to evaluate clinical outcomes. Instead, applicants would typically pursue work such as discovering or refining candidate biomarkers, developing or optimizing assay platforms, testing analytical performance, and improving multi-marker algorithms using existing specimens, observational resources, or laboratory-based studies consistent with the non-clinical-trial requirement.
The scientific emphasis is on identifying "novel biomarkers" and translating them into better-performing incidence tools. Biomarkers in this context can include measurable biological signals that change in a predictable way after HIV infection, such as features of the immune response, antibody maturation patterns, viral characteristics, or other host or pathogen signatures. The "incidence assays and algorithms" language also highlights that NIH is interested not only in single laboratory tests, but also in combinations of tests and statistical or computational approaches that improve classification accuracy. Many incidence approaches rely on integrating multiple signals (for example, an assay result plus viral load information and treatment history) to improve specificity and to reduce false-recent rates across diverse populations and viral subtypes.
From an eligibility standpoint, the opportunity is broadly open. Eligible applicants include many types of U.S. governmental entities (state, county, city or township governments, and special district governments), federally recognized Native American tribal governments, and public housing authorities/Indian housing authorities. A wide range of academic institutions can apply, including public and state-controlled institutions of higher education and private institutions of higher education. The announcement also allows nonprofit organizations with or without 501(c)(3) status, as well as for-profit organizations (other than small businesses) and small businesses. In addition, the FOA highlights an expanded set of eligible applicant categories, including 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, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This breadth reflects the global and community-relevant nature of HIV surveillance and the value of including diverse institutional and geographic perspectives in assay development.
The funding details included in the source information indicate an award ceiling of $200,000, and the activity is categorized under health (CFDA number 93.855). The sponsoring agency is the National Institutes of Health. The FOA was created on 2018-04-11, and the original closing date listed in the source data is 2021-05-07. While the number of expected awards is not specified in the provided text, the structure and budget ceiling suggest relatively small, targeted projects intended to generate key data, demonstrate feasibility, and position investigators for subsequent, larger-scale development or validation efforts through other mechanisms.
Overall, this opportunity is best understood as NIH support for sharpening the tools used to measure HIV incidence by improving the biological signals and decision rules behind "recent vs. chronic" infection classification. By funding biomarker discovery, assay refinement, and algorithm development (without clinical trials), the program aims to strengthen the accuracy of incidence estimation, which is critical for tracking epidemic trends, evaluating prevention strategies, and directing resources to the communities and regions where new infections are occurring.Apply for PA 18 754
- 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 (R21 Clinical Trials Not Allowed)" 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.)
- 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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| Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed) Apply for PAR 18 761 Funding Number: PAR 18 761 Agency: National Institutes of Health Category: Health Funding Amount: $499,000 |
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| Advancing HIV Therapeutic Vaccine Science (U01 Clinical Trial Required) Apply for RFA AI 18 015 Funding Number: RFA AI 18 015 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| T32 Training Program for Institutions That Promote Diversity (T32 Clinical Trial Not Allowed) Apply for RFA HL 19 023 Funding Number: RFA HL 19 023 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Improving the Reach and Quality of Cancer Care in Rural Populations (R01 Clinical Trial Required) Apply for RFA CA 18 026 Funding Number: RFA CA 18 026 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| AHRQ Health Services Research Dissertation Program (R36) Apply for PA 18 765 Funding Number: PA 18 765 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $40,000 |
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