Identification of Biomarkers of HIV-1 Pathogenesis and Substance Abuse Comorbidity (R01- Clinical Trial Not Allowed) | RFA DA 18 023

Opportunity Information: Apply for RFA DA 18 023

This funding opportunity, titled "Identification of Biomarkers of HIV-1 Pathogenesis and Substance Abuse Comorbidity (R01 - Clinical Trial Not Allowed)" (RFA-DA-18-023), is a National Institutes of Health (NIH) research grant announcement from the U.S. Department of Health and Human Services. It supports investigator-driven R01 projects focused on HIV-1 disease biology in the context of substance use disorders (SUDs), with a specific emphasis on discovering and validating molecular biomarkers or broader biosignatures that help explain why HIV progresses differently in people who use substances and how substance use may worsen or alter HIV-related immune and physiological decline.

The central scientific aim is to define measurable biological indicators that reflect either (1) loss of functional reserve, meaning a reduced capacity of key systems (especially immune and host-defense pathways) to respond to stressors over time, or (2) resilience, meaning protective or compensatory mechanisms that preserve host defense despite HIV infection and substance exposure. The FOA is interested in biomarkers that can distinguish or track different phases of HIV-1 pathogenesis, so the work should be relevant to staging disease processes over time rather than capturing a single static snapshot. In practical terms, this could include research that identifies panels of markers tied to immune dysfunction, inflammation, viral persistence, neuroimmune changes, metabolic or endocrine dysregulation, tissue injury, or other molecular pathways that plausibly connect substance use with HIV-related morbidity.

A key feature of the announcement is that it is "Clinical Trial Not Allowed," indicating applications should not propose clinical trials as defined by NIH, such as prospective assignment of human participants to interventions to evaluate health-related outcomes. The research can still involve human samples, observational cohorts, secondary analyses of existing datasets, laboratory-based work using clinical specimens, or preclinical models, as long as it does not cross into interventional clinical trial territory. The goal is biomarker and biosignature definition and validation, which often involves assay development, multi-omic profiling, computational modeling, and replication in independent sample sets or cohorts.

The opportunity uses the R01 mechanism (a standard NIH research project grant). It is categorized as a discretionary grant in the Education/Health activity area and is associated with CFDA number 93.279. The anticipated number of awards listed is six, and the award ceiling is shown as 0, which typically means a specific dollar cap is not provided in the summary record and applicants should follow standard NIH R01 budget rules and any FOA-specific budget guidance in the full announcement.

Eligibility is broad and includes many types of domestic institutions and organizations that commonly apply for NIH funding. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; 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 as allowed under the FOA's additional eligibility language. The sponsoring agency is NIH within HHS, and the FOA was created on December 21, 2017, with an original closing date of April 17, 2018.

Overall, the program is aimed at strengthening the biological foundation for understanding HIV-1 pathogenesis when complicated by substance use, by producing validated molecular indicators that can stratify risk, capture disease phase-related changes, and quantify resilience versus decline in host defense mechanisms. The expected outcome is a more precise set of biological tools and signatures that researchers can use to study mechanisms, compare subgroups, and potentially guide future non-trial translational work, especially for populations experiencing both HIV infection and substance use disorders.

• The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Identification of Biomarkers of HIV-1 Pathogenesis and Substance Abuse Comorbidity (R01- Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on Dec 21, 2017.
• Applicants must submit their applications by Apr 17, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 6 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA DA 18 023

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: