Exploratory studies to investigate mechanisms of HIV infection, replication, latency, and/or pathogenesis in the context of substance use disorders (R61/R33 - Clinical Trial Not Allowed) | RFA DA 22 004

Opportunity Information: Apply for RFA DA 22 004

This National Institutes of Health (NIH) funding opportunity, RFA-DA-22-004, supports exploratory, mechanism-focused research on how substance use disorders (SUDs) influence HIV infection, viral replication, viral persistence and latency, and HIV-related disease processes (pathogenesis). The scientific emphasis is on understanding biological and mechanistic links between substance use and HIV outcomes, including effects on the central nervous system such as HIV-associated neurocognitive disorders (HAND). The program is framed as a broad initiative intended to stimulate early-stage, high-value studies that can clarify how substances, substance-related behaviors, or SUD-associated physiological changes shape HIV biology and disease progression.

The grant uses an R61/R33 phased innovation mechanism and is explicitly labeled “Clinical Trial Not Allowed,” meaning applicants must propose research that does not meet NIH’s definition of a clinical trial (for example, not prospectively assigning human participants to an intervention to study effects on health-related outcomes). In practice, this mechanism is often used to let investigators pursue a milestone-driven exploratory phase (R61) to establish feasibility or generate critical preliminary mechanistic evidence, with the possibility of transitioning to a second phase (R33) to expand or deepen the work once predefined milestones are met. The intent is to reduce risk while still pushing forward promising mechanistic ideas quickly and efficiently.

The activity category is listed under Education and Health, and the CFDA number is 93.279. The funding instrument is a grant, and the opportunity is categorized as discretionary. The listing does not provide an award ceiling or an expected number of awards in the provided source details, so applicants typically need to consult the full announcement and NIH institute guidance for budget expectations, allowable costs, and any limits tied to the R61/R33 structure.

Eligibility is broad and includes many types of organizations that commonly apply to NIH, spanning government entities (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and a range of nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education institutions in those nonprofit categories as specified). It also includes public housing authorities/Indian housing authorities, federally recognized Native American tribal governments, and Native American tribal organizations that are not federally recognized tribal governments. For-profit organizations (other than small businesses) and small businesses are eligible as well, and the opportunity allows for additional applicant types under the “Others” category.

The announcement also highlights a wide set of “other eligible applicants,” signaling an explicit interest in participation from diverse institution types and communities. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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; Indian/Native American tribal governments that are not federally recognized; non-domestic (non-U.S.) entities (foreign organizations); and U.S. territories or possessions. This breadth suggests NIH is encouraging research capacity and partnerships across a wide range of settings, including those that may be closely connected to populations disproportionately affected by HIV and SUDs.

Key administrative details from the source include an original closing date of 2022-08-10 and a creation date of 2021-02-02. While those dates indicate the initial posting and a specific deadline at that time, NIH opportunities sometimes have multiple receipt dates or may be reissued in updated forms, so anyone planning to apply would need to verify the current status and any active submission windows through NIH and grants.gov listings tied to the opportunity number.

Overall, the opportunity is designed for investigators aiming to uncover how SUDs intersect with HIV at a mechanistic level, including persistence/latency and neurologic complications, using an exploratory, milestone-based phased approach that does not involve clinical trials. The broad eligibility and inclusion of domestic and foreign organizations, community-based entities, and minority-serving institutions point to an intent to draw in multidisciplinary teams and varied research environments to address complex, real-world drivers of HIV outcomes in the context of substance use.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Exploratory studies to investigate mechanisms of HIV infection, replication, latency, and/or pathogenesis in the context of substance use disorders (R61/R33 - 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 2021-02-02.
• Applicants must submit their applications by 2022-08-10. (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.

Apply for RFA DA 22 004

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