Advancing Biomarker Discovery and Novel Point-of-Care Diagnostics for Active TB Disease Detection in HIV-1 Infected and Exposed Children (R01 Clinical Trial Optional) | RFA AI 19 036

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This NIH grant opportunity (RFA-AI-19-036) supports research aimed at improving how active tuberculosis (TB) disease is detected in children who are HIV-1 infected as well as children who were exposed to HIV-1 but are uninfected (often referred to as HEU). The core problem the funding addresses is that many existing pediatric TB tests rely on sputum, yet young children frequently cannot produce sputum reliably, and even when samples are obtained, the bacterial burden can be low, making confirmation difficult. In settings where HIV is common, diagnosing TB in children is even more challenging because symptoms can overlap with other infections and immune suppression can complicate clinical presentation. The FOA is designed to push the field toward non-sputum-based diagnostic approaches that work faster, are simpler to run, and can be deployed closer to where children receive care, including decentralized and point-of-care settings.

The scientific focus is twofold. First, it funds the discovery and validation of novel biomarkers that could indicate active TB disease in these pediatric populations using non-sputum specimens. Biomarkers could come from host responses (for example, immune or inflammatory signatures) or pathogen-derived components detectable in alternative sample types. Second, it supports the development, optimization, and early validation of new diagnostic technologies that can translate those biomarkers (or other detection strategies) into practical tests. The emphasis on point-of-care or near-patient diagnostics signals an interest in tools that reduce reliance on sophisticated laboratories, shorten time-to-result, and improve decision-making during clinical visits, which is particularly important in resource-limited areas where pediatric HIV and TB burdens are high.

The mechanism is an R01 research project grant, and the funding announcement states that clinical trials are optional, meaning applicants may propose studies that include clinical trial elements if appropriate, but they are not required to do so. The activity category is health (CFDA 93.855), and the issuing agency is the National Institutes of Health. While the listing does not provide an award ceiling or expected number of awards in the provided source data, the overall intent is clear: to generate evidence and early-stage validation that can move promising biomarker signatures and prototype diagnostic platforms closer to real-world pediatric use.

Eligibility is broad and includes many types of U.S. organizations and governmental units, such as state, county, and city governments; special districts; independent school districts; public and state-controlled universities; private institutions of higher education; and public housing authorities/Indian housing authorities. It also includes federally recognized tribal governments and other tribal organizations, nonprofits with or without 501(c)(3) status, for-profit entities (other than small businesses), small businesses, and other organizations. The FOA also explicitly notes additional eligible applicant categories that NIH highlights for inclusivity and capacity building, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, U.S. territories or possessions, and non-U.S. (foreign) entities and regional organizations. This wide eligibility is consistent with the global and community-facing nature of pediatric TB/HIV diagnostic needs, where collaborations between academic centers, clinical sites, and regional partners are often essential.

Key administrative details from the source listing include the funding instrument type (grant), opportunity category (discretionary), and the original closing date of July 30, 2019, with a creation date of March 29, 2019. In practical terms, the announcement reflects NIH interest in accelerating the pipeline from biomarker discovery through early validation and technology optimization, specifically for child-friendly, non-sputum diagnostic solutions that can be used quickly and reliably in the settings where HIV-affected and HIV-exposed children are evaluated for TB.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Biomarker Discovery and Novel Point-of-Care Diagnostics for Active TB Disease Detection in HIV-1 Infected and Exposed Children (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 2019-03-29.
• Applicants must submit their applications by 2019-07-30. (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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