HEAL Initiative: Pragmatic and Implementation Studies for the Management of Sickle Cell Disease Pain (UG3/UH3, Clinical Trials Optional) | RFA AT 23 001

Opportunity Information: Apply for RFA AT 23 001

The National Institutes of Health (NIH) released this funding opportunity under the HEAL (Helping to End Addiction Long-term) Initiative to support real-world research that improves how acute and chronic pain from sickle cell disease (SCD) is managed in the health care settings where people with SCD actually receive care. The FOA is designed for multisite studies that are embedded in health care systems, meaning the research should fit into routine clinical workflows and generate evidence that can be adopted quickly and broadly. Rather than focusing on tightly controlled explanatory trials, the emphasis is on pragmatic and implementation-focused trials that test how to increase the use, quality, and consistency of effective pain management approaches for SCD across different clinics, hospitals, and community care environments.

The program specifically encourages studies that evaluate pharmacologic approaches, nonpharmacologic approaches, and multicomponent care models, including combinations of treatments and care processes. Opioids can be part of care when clinically necessary, and a study can allow continued opioid use; however, the FOA makes it clear that opioid medication alone should not be the only intervention being studied. Instead, projects should examine broader strategies for SCD pain management such as improving guideline-concordant care, increasing adherence to evidence-based protocols, integrating non-opioid medications and behavioral or supportive therapies, and building coordinated models that address both pain episodes and longer-term pain management needs.

A major theme of this opportunity is implementation: applicants can propose trials that test methods to implement or scale pain management guidelines, strengthen clinician and patient adherence, and measure effectiveness in diverse health care settings. The expectation is that funded projects will generate practical evidence about what works, for whom, and under what conditions, including information that helps health systems adopt effective approaches with fewer barriers. Importantly, the FOA also recognizes that SCD pain care is often affected by social and structural factors, and it explicitly allows studies to address barriers like stigma, racial bias, and other systemic issues that can lead to undertreatment, delays in care, mistrust, and uneven quality across sites. In other words, interventions can target not only medications and therapies, but also care delivery practices and the patient experience within health systems.

Mechanistically, this opportunity uses a cooperative agreement (UG3/UH3) structure. In NIH terms, that means NIH staff are expected to have substantial involvement during the project, and the award is typically organized in phases: an initial planning, feasibility, and start-up period (UG3) followed by an implementation/expansion period (UH3) if predefined milestones are met. This structure is commonly used for complex multisite research where early-stage work (site readiness, workflow integration, recruitment plans, data systems, and stakeholder engagement) needs to be demonstrated before moving into full-scale execution.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

On the foreign eligibility side, the rules are restrictive in a way that is typical for many NIH opportunities of this kind. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply as components. However, foreign components are allowed if they meet the NIH definition in the NIH Grants Policy Statement, meaning a U.S. applicant may be able to include certain foreign activities or collaborations when justified and compliant with NIH policy.

From the administrative details provided, the FOA is listed as discretionary funding, with the funding instrument type being a cooperative agreement and the activity category centered on education and health. It is associated with multiple CFDA listings (93.213, 93.233, 93.307, 93.313, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.867), reflecting NIH’s cross-cutting program structure and participating institutes/centers. The opportunity number is RFA AT 23 001, it was created on 2022-07-13, and the original closing date was 2022-11-21. The source data notes an award ceiling of $500,000, though the practical budget and scope for a multisite UG3/UH3 project typically depend on NIH guidance in the full FOA and on the proposed milestones, number of sites, and trial complexity.

Overall, the grant is aimed at closing the gap between what is known (or recommended) about SCD pain management and what is consistently delivered in real-world care. Competitive projects under this FOA would be expected to partner closely with health systems serving the SCD community, test scalable interventions beyond opioids alone, measure outcomes that matter to patients and providers, and produce implementation-ready findings that can be adopted broadly while also confronting the stigma and structural inequities that shape SCD pain treatment in practice.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Pragmatic and Implementation Studies for the Management of Sickle Cell Disease Pain (UG3/UH3, Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.233, 93.307, 93.313, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.867.
• This funding opportunity was created on 2022-07-13.
• Applicants must submit their applications by 2022-11-21. (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 AT 23 001

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