Addressing HIV in highest risk sexual and gender minorities (R34 Clinical Trial Required) | RFA DA 25 002

Opportunity Information: Apply for RFA DA 25 002

This NIH funding opportunity, RFA-DA-25-002, supports planning and pilot work to strengthen HIV prevention and care approaches for sexual and gender minorities who face the highest risk, with a specific emphasis on how substance use affects engagement, retention, and outcomes across the HIV continuum. The central idea is that many existing HIV interventions do not adequately account for problematic substance use, even though it is tightly linked to missed prevention opportunities, inconsistent PrEP uptake, lower retention in care, and worse clinical outcomes. A major priority is integrating substance use considerations into HIV-focused strategies, including newer and rapidly evolving prevention tools such as long-acting PrEP, where the practical realities of follow-up visits, adherence to injection schedules, and ongoing engagement may be especially challenging for people experiencing substance use disorders or unstable living situations.

A key feature of the opportunity is its focus on the broader context shaping HIV vulnerability and care, particularly social determinants of health that disproportionately affect sexual and gender minorities. The announcement highlights homelessness and criminal justice involvement as two especially important factors that can disrupt prevention access, continuity of care, and the ability to maintain consistent contact with providers or clinics. Applicants are encouraged to address these real-world barriers directly, rather than treating them as background variables, by designing epidemiologic, intervention, and implementation studies that build in practical supports, systems navigation, or service models that can function in complex community settings.

The opportunity also calls attention to the way sexual minority identity can be fluid or change over time, and how that has concrete implications for outreach, measurement, trust, and stigma in healthcare environments. Because self-definition and disclosure are shaped by safety, culture, setting, and experiences with discrimination, the funding announcement signals interest in research that improves how programs identify, reach, and serve people without forcing rigid categories. This includes work that reduces provider stigma, improves cultural responsiveness, and adapts interventions so they remain effective when identity labels, community norms, and patterns of disclosure shift across time or context.

Another major theme is treating HIV as part of a syndemic, meaning HIV risk and outcomes are often driven by interacting, mutually reinforcing problems rather than a single issue in isolation. The announcement specifically points to co-occurring conditions such as sexually transmitted infections, hepatitis C, and psychiatric disorders, which frequently overlap with substance use and can complicate prevention and treatment efforts. In practice, the initiative is seeking projects that recognize these intertwined burdens and test integrated or coordinated approaches, whether through combined screening and treatment pathways, models that link HIV services with mental health and substance use care, or implementation strategies that make integrated care feasible in the settings where people actually receive services.

The mechanism is an R34, which is typically used for clinical trial planning, feasibility, and early-stage testing to prepare for a larger, later-phase clinical trial or definitive study. The title indicates "Clinical Trial Required," meaning the proposed work is expected to include a clinical trial component consistent with NIH definitions, such as testing an intervention or service delivery strategy. The award ceiling listed is $225,000, and the original closing date provided is August 14, 2024. The funding activity category is listed under education and health, and the CFDA number is 93.279, reflecting the NIH program area associated with drug abuse and related research priorities, which aligns with the emphasis on substance use.

Eligibility is broad and includes many types of U.S.-based organizations and governments, such as state, county, city, and special district governments; public housing authorities; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The notice also explicitly names additional applicant types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it draws clear limits around foreign participation: non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply as applicants, though foreign components are allowed when they meet the NIH Grants Policy Statement definition and are appropriately justified within an otherwise eligible application.

Overall, the opportunity is aimed at advancing practical, evidence-based HIV prevention and care solutions for sexual and gender minorities at highest risk by directly confronting substance use, structural barriers like housing instability and justice involvement, evolving identity and stigma dynamics, and the clustering of HIV with other infections and mental health conditions. The expected output is research that not only tests promising interventions but also generates the real-world knowledge needed to implement and scale them effectively in communities where these overlapping challenges are most acute.

• 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 (R34 Clinical Trial Required)" 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 $225,000.00 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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