Multi-Level HIV Prevention Interventions for Individuals at the Highest Risk of HIV Infection (R01 Clinical Trial Optional) | RFA MD 21 001

Opportunity Information: Apply for RFA MD 21 001

The National Institutes of Health (NIH) funding opportunity titled "Multi-Level HIV Prevention Interventions for Individuals at the Highest Risk of HIV Infection (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-MD-21-001) supports research projects that aim to prevent HIV infections among people who face the greatest risk, particularly within health disparity populations. The central focus is on testing the effectiveness of multi-level HIV prevention interventions, meaning approaches that operate across more than one layer of influence such as individual behavior and knowledge, interpersonal relationships, community settings, healthcare systems, or broader structural and policy conditions. Projects are expected to target one or more geographic areas experiencing high rates of new HIV infections, with an emphasis on subgroups that are often underserved or disproportionately affected.

This opportunity uses the NIH R01 grant mechanism, which is commonly used for substantial, multi-year research studies. The "Clinical Trial Optional" designation indicates that applicants may propose a clinical trial if it fits the aims of the project, but a clinical trial is not required. In practical terms, that flexibility allows teams to propose designs ranging from community-based implementation studies and pragmatic trials to rigorous comparative effectiveness evaluations, depending on what is most appropriate for the intervention and the population being served.

Eligibility is broad and includes many types of organizations that might be positioned to run HIV prevention research in real-world settings. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments that are federally recognized; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. In addition, the announcement highlights "other eligible applicants" such as 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, and U.S. territories or possessions. Taken together, this list signals NIH interest in engaging a wide range of research, education, healthcare, and community partners, especially those deeply connected to populations experiencing the highest HIV burden.

There are important restrictions related to non-U.S. participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means a U.S.-based applicant can include certain international elements when justified and compliant with NIH policy, even though a foreign institution cannot serve as the primary applicant.

From an administrative standpoint, this is a discretionary grant opportunity in the health category, associated with CFDA numbers 93.242 and 93.307. The funding agency is NIH. The opportunity was created on 2020-11-05 and had an original closing date of 2021-01-15. The public posting does not provide an award ceiling or the expected number of awards in the provided text, so applicants would typically consult the full announcement or NIH guidance for budget expectations, project period norms, and review considerations.

Overall, the opportunity is designed to move beyond single-focus prevention programs by encouraging interventions that address multiple drivers of HIV risk simultaneously, particularly in locations with high incidence and among groups most affected by disparities. The intent is to generate evidence about what actually works in reducing new infections when interventions are designed and delivered in ways that reflect the layered realities of risk, access, and inequity.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Multi-Level HIV Prevention Interventions for Individuals at the Highest Risk of HIV Infection (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): 93.242, 93.307.
• This funding opportunity was created on 2020-11-05.
• Applicants must submit their applications by 2021-01-15. (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 MD 21 001

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