Research to Address Systemic and Structural Barriers and Facilitators to Improve the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum for People Who Use Substances (R01 Clinical Trials Required) | RFA DA 26 003

Opportunity Information: Apply for RFA DA 26 003

This funding opportunity, titled "Research to Address Systemic and Structural Barriers and Facilitators to Improve the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum for People Who Use Substances (R01 Clinical Trials Required)," is a National Institutes of Health (NIH) discretionary grant program (Funding Opportunity Number RFA-DA-26-003) that aims to improve how well PrEP works in the real world for people who use substances. PrEP is a highly effective medication for preventing HIV transmission through sex or injection drug use, but many people who could benefit from it still do not know about it, do not start it, or have difficulty staying on it. The central focus of this opportunity is not simply on individual behavior change, but on identifying and tackling the bigger systemic and structural conditions that shape PrEP access and outcomes for people who use substances.

The opportunity is designed to support research that examines the full PrEP "care continuum" for this population, meaning the series of steps from awareness of PrEP, to initiation and uptake, to adherence and persistence over time. Applicants are expected to study the real barriers and facilitators that sit above the individual level, such as how healthcare systems are organized, how services are financed, how policies are implemented, and how stigma and discrimination operate in clinical and community settings. In practice, this can include issues like limited PrEP prescribing capacity in safety-net settings, fragmented care between substance use services and sexual health services, insurance and prior authorization hurdles, pharmacy access challenges, criminalization and policing environments that discourage healthcare engagement, housing instability, and clinic practices that unintentionally exclude or alienate people who use drugs.

A major expectation is that projects will move beyond describing problems and will develop, implement, and rigorously evaluate strategies that address those systemic and structural drivers. The strategies should be tailored to the needs and lived realities of people who use substances, and should be tested in ways that produce actionable evidence for improving PrEP delivery. Because this is an R01 and explicitly states "Clinical Trials Required," applicants should be prepared to conduct clinical trials or trial-like evaluations of interventions. In other words, the program is looking for research that can demonstrate whether specific approaches actually improve PrEP awareness, uptake, and adherence for people who use substances, not just whether those approaches are feasible or acceptable.

From an administrative standpoint, this is a grant funding mechanism (R01) under NIH, with activity areas listed under education and health and associated CFDA numbers 93.279, 93.307, 93.310, and 93.313. The application deadline provided is March 12, 2025, and the listed award ceiling is $500,000. While the source data does not specify the number of expected awards, the program is clearly positioned to fund high-impact, well-designed projects that can generate strong evidence and inform practice and policy changes.

Eligibility is broad and includes a wide range of organizations that might be positioned to conduct intervention research with clinical trial components. Eligible applicants include state, county, and 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 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; for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types that are often central to community-engaged and equity-focused HIV and substance use work, 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 and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, tribal governments that are not federally recognized, and non-U.S. entities (foreign organizations).

Overall, the opportunity is aimed at closing the gap between PrEP's proven effectiveness and the uneven reality of who is able to access and benefit from it. It prioritizes research that takes seriously the structural context of HIV prevention among people who use substances and funds projects that can test concrete, scalable solutions to improve PrEP delivery, continuity, and outcomes across the entire care continuum.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Research to Address Systemic and Structural Barriers and Facilitators to Improve the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum for People Who Use Substances (R01 Clinical Trials Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279, 93.307, 93.310, 93.313.
• This funding opportunity was created on 2024-12-02.
• Applicants must submit their applications by 2025-03-12. (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.

Apply for RFA DA 26 003

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