Addressing HIV in Highest Risk Sexual and Gender Minorities (R01 Clinical Trial Optional) | RFA DA 25 001

Opportunity Information: Apply for RFA DA 25 001

The National Institutes of Health (NIH) is soliciting R01 grant applications under the funding opportunity "Addressing HIV in Highest Risk Sexual and Gender Minorities (R01 Clinical Trial Optional)" (RFA-DA-25-001). The goal is to advance research that improves HIV prevention and care outcomes among sexual and gender minority populations at highest risk, with a particular emphasis on closing persistent gaps in engagement, retention, and overall effectiveness of services. A central theme is that HIV risk and treatment outcomes in these communities are often shaped by overlapping conditions and pressures, so proposed research is expected to reflect a syndemic perspective that considers HIV alongside co-occurring issues such as substance use, sexually transmitted infections (STIs), hepatitis C virus (HCV), and psychiatric disorders.

A major focus of the initiative is the integration of substance use considerations into HIV-related interventions. NIH is highlighting that substance use is frequently not addressed robustly enough within prevention and care strategies for sexual minority persons, even though it can strongly influence adherence, continuity of care, and vulnerability to HIV acquisition. Applicants are encouraged to design and test approaches that better incorporate substance use screening, treatment linkage, harm reduction, and ongoing support within HIV prevention and treatment settings. The announcement also points to emerging biomedical prevention tools, specifically long-acting pre-exposure prophylaxis (PrEP), signaling interest in research that evaluates how these newer options can be implemented effectively for individuals facing barriers related to substance use, instability, or mistrust of healthcare systems.

The opportunity also emphasizes social determinants of health that disproportionately affect sexual and gender minorities and can worsen both HIV outcomes and problematic substance use. Examples specifically named include homelessness and criminal justice involvement, both of which can interrupt prevention access, destabilize care, and increase exposure to high-risk contexts. Competitive applications will likely be those that do more than simply measure these factors and instead incorporate them into the core design of epidemiologic studies, intervention development, or implementation strategies. In practice, that could mean testing service delivery models that better reach people with unstable housing, building continuity of prevention or treatment during and after incarceration, or developing partnerships with community organizations that are already positioned to serve people in these circumstances.

Another gap area NIH highlights is the changing way individuals self-define sexual minority status over time and the implications that has for outreach, measurement, and provider interactions. Because identity labels, disclosure patterns, and community affiliations can shift, NIH is pointing applicants toward research that improves how programs identify and engage those at risk without relying on outdated or overly rigid categories. This also ties directly to provider stigma and the need for interventions that reduce bias, improve cultural responsiveness, and create clinical and prevention environments where people feel safe accessing services and staying engaged over time.

From a research scope standpoint, NIH indicates interest in multiple types of studies, including epidemiologic research (to better characterize risk patterns, service gaps, and syndemic relationships), intervention research (to develop and test strategies to improve prevention and care engagement and outcomes), and implementation research (to understand how to deliver effective approaches in real-world settings and scale them). The "clinical trial optional" designation means applicants may propose studies that include a clinical trial component, but doing so is not required; non-trial research that directly addresses the initiative goals is also responsive.

In terms of eligibility, the applicant pool is broad and includes state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; and tribal organizations other than federally recognized tribal governments. Public housing authorities and Indian housing authorities may apply, as can nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, and small businesses. NIH also explicitly calls out additional eligible applicants such as 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities applying directly) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning certain collaborations or project elements conducted abroad may be permissible if they meet NIH policy requirements.

Key administrative details provided include that this is a discretionary grant mechanism within the education and health activity category (CFDA 93.279). The original closing date listed is August 14, 2024. The award ceiling is stated as $500,000, indicating an upper limit on the amount that can be requested or awarded under the opportunity (applicants would still need to follow NIH budget rules and the specific instructions in the full announcement). The sponsoring agency is the National Institutes of Health, and the funding opportunity was created on July 31, 2023.

Overall, this opportunity is aimed at strengthening the evidence base for how to prevent HIV and improve care outcomes in sexual and gender minorities facing the highest levels of risk, especially where substance use, social disadvantage, and comorbid health conditions interact. Projects that directly address these interlocking challenges, incorporate newer prevention modalities like long-acting PrEP, and produce practical knowledge about real-world delivery and sustained engagement are well aligned with the intent of the initiative.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Addressing HIV in Highest Risk Sexual and Gender Minorities (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): 93.279.
• This funding opportunity was created on 2023-07-31.
• Applicants must submit their applications by 2024-08-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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