Prevention Strategies to End the HIV Epidemic (R01 Clinical Trial Optional) | RFA AI 21 025

Opportunity Information: Apply for RFA AI 21 025

The National Institutes of Health (NIH) funding opportunity announcement (FOA) titled "Prevention Strategies to End the HIV Epidemic (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-AI-21-025) is a discretionary grant program using the R01 research project grant mechanism. Its central aim is to fund research projects that strengthen the real-world use and uptake of evidence-based HIV prevention interventions, especially for people and communities living in jurisdictions that are considered highly impacted by HIV. In practical terms, this opportunity is about closing the gap between what is already known to prevent HIV and what is actually being delivered, accessed, and sustained in the places and populations where new infections remain concentrated.

The FOA is explicitly aligned with the federal Ending the HIV Epidemic: A Plan for America (EHE) initiative, with an emphasis on advancing the DIAGNOSE and PREVENT pillars. That framing signals a focus on improving prevention alongside efforts that identify and respond to HIV more effectively, with the overall objective of reducing HIV incidence. The announcement also underscores that progress will require creative, multidisciplinary approaches tailored to local realities, meaning applicants are expected to consider the unique needs of specific communities, settings, and health systems rather than offering one-size-fits-all approaches.

From a research scope standpoint, the FOA is geared toward implementation-focused work that improves the delivery, adoption, and sustained use of proven prevention tools. While the announcement does not list specific interventions in the provided excerpt, "evidence-based HIV prevention interventions" typically refers to strategies with strong scientific support, and the spirit of the FOA is to improve how such strategies are put into practice, particularly in communities facing higher HIV burden. The "Clinical Trial Optional" designation means applicants may propose studies that include a clinical trial component, but a clinical trial is not required; non-trial research designs that still rigorously test prevention implementation strategies are also within scope.

Eligibility is broad and intentionally inclusive across government, education, health, nonprofit, and private-sector entities. Eligible applicants include state, county, city or township, 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; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA further highlights additional applicant types that are explicitly welcomed, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, and U.S. territories or possessions. This emphasis reflects the program's intent to reach and support organizations that are deeply connected to affected communities and are positioned to implement and study prevention strategies in high-impact settings.

At the same time, the FOA places clear limits on foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible, and foreign components, as defined in the NIH Grants Policy Statement, are not allowed. These restrictions indicate the work is intended to be conducted entirely within eligible U.S.-based organizational structures and locations, consistent with the focus on jurisdictions in the United States most affected by HIV under the EHE initiative.

Administratively, the funding is issued by NIH and is associated with CFDA numbers 93.242, 93.279, and 93.855, reflecting NIH program areas that can support HIV-related research. The original closing date listed for this opportunity is July 30, 2021, and the FOA creation date is March 30, 2021. The excerpt does not provide an award ceiling or expected number of awards, so those details would normally need to be confirmed in the full FOA text or NIH funding pages if planning or benchmarking budgets.

Overall, this grant opportunity is best understood as an NIH-supported push to make proven HIV prevention strategies work better on the ground in the communities carrying the greatest HIV burden, using rigorous research approaches that can identify what improves access, uptake, quality, and sustained prevention impact in real-world settings.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Prevention Strategies to End the HIV Epidemic (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, 93.279, 93.855.
• This funding opportunity was created on 2021-03-30.
• Applicants must submit their applications by 2021-07-30. (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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