Novel Approaches to Decrease Stigma of Substance Use Disorders in order to Facilitate Prevention, Treatment, and Support During Recovery (R43/R44 - Clinical Trials Optional) | RFA DA 21 016

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The grant opportunity titled "Novel Approaches to Decrease Stigma of Substance Use Disorders in order to Facilitate Prevention, Treatment, and Support During Recovery (R43/R44 - Clinical Trials Optional)" is a National Institutes of Health (NIH) small business funding announcement designed to push practical, market-ready solutions that can reduce stigma related to substance use disorders (SUD). The core idea is that stigma remains a major barrier that keeps people from seeking help, staying in care, and receiving supportive services during recovery, and that new tools and approaches are needed to change attitudes and behaviors in real-world settings. This program is structured under the SBIR mechanism (R43/R44), meaning it is specifically aimed at small businesses developing commercializable products rather than purely academic research projects.

The funding opportunity emphasizes the development of interventions that can be deployed in places where stigma actively shapes care decisions and patient experiences. That includes general clinical care environments as well as HIV prevention and HIV care settings, where SUD stigma can intersect with HIV-related stigma and contribute to worse health outcomes. Beyond patient-facing environments, the announcement also highlights clinical training and other relevant professional settings, reflecting the recognition that stigma is often reinforced through institutional culture, provider beliefs, and standard practices. Applicants are expected to address stigma in a way that is measurable and meaningful, not just through awareness messaging but through tools, services, or interventions that can plausibly change how people are treated and how they engage with prevention, treatment, and recovery support.

Phase I (R43) is positioned as the early development and feasibility stage. In this phase, the NIH is inviting small businesses to build and pilot novel digital technologies, services, or other intervention concepts aimed at reducing SUD stigma. The goal at this stage is to demonstrate that the proposed approach is workable in the intended setting and that it has a credible path toward reducing stigma. A notable element is the encouragement to establish or refine methods for measuring stigma reduction, since stigma can be difficult to quantify and may require carefully designed instruments, workflows, or outcome measures. Phase I is essentially about proving that the idea can be implemented, that end users will engage with it, and that there is a defensible way to evaluate whether it is actually reducing stigma.

Phase II (R44) is framed as the stage where applicants move beyond feasibility and show real efficacy, while also demonstrating commercialization potential. The NIH is looking for evidence that the product or service can decrease stigma toward SUD in the target environment and that it can realistically be adopted, scaled, and sustained as a commercial offering. Phase II projects can focus on clinical care settings, training environments, and other relevant contexts, including organizations delivering HIV prevention and care, with the broader aim of removing barriers that block SUD prevention, treatment engagement, and recovery support. For Phase II applications that specifically focus on HIV prevention and care settings, the opportunity goes a step further by inviting applicants to demonstrate not only stigma reduction but also improved health outcomes for people living with both HIV and SUD. In other words, the program is especially interested in solutions that connect stigma reduction to concrete downstream benefits, such as better care retention, improved adherence, increased uptake of services, or other measurable health improvements.

This announcement is listed as "Clinical Trials Optional," which signals flexibility rather than a requirement to run a clinical trial. Applicants can propose clinical trials if that is the appropriate way to test the intervention, but they can also pursue rigorous non-trial study designs when those are better aligned with the product and setting. That matters for digital or service-based stigma interventions, where evaluation might involve pragmatic studies, implementation research approaches, training evaluations, or other designs that still generate strong evidence.

Eligibility is limited to small businesses, consistent with the SBIR focus on commercialization. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined under NIH Grants Policy, may be allowed in certain cases, which usually means discrete parts of the project may be conducted abroad if there is a strong justification and it aligns with NIH policy, even though the applicant organization itself must be U.S.-based and eligible.

From an administrative standpoint, the opportunity is identified as RFA-DA-21-016, categorized as a discretionary grant in the health and education activity area, and tied to CFDA number 93.279. The original closing date was February 26, 2021, and the listed award ceiling is $256,580. Overall, the opportunity is best understood as a targeted SBIR push to generate deployable, scalable products that can reduce SUD stigma in healthcare and training environments, including high-priority HIV-related settings, with a clear expectation that Phase I establishes feasibility and measurement strategy while Phase II proves efficacy and market readiness.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Novel Approaches to Decrease Stigma of Substance Use Disorders in order to Facilitate Prevention, Treatment, and Support During Recovery (R43/R44 - Clinical Trials 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 2020-12-23.
• Applicants must submit their applications by 2021-02-26. (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 $256,580.00 in funding.
• Eligible applicants include: Small businesses.

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