HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required) | RFA AT 23 002

Opportunity Information: Apply for RFA AT 23 002

This NIH HEAL Initiative funding opportunity (RFA-AT-23-002) supports multisite clinical trials focused on improving pain management for people with sickle cell disease (SCD). It uses a cooperative agreement mechanism (UG3/UH3), meaning awardees should expect substantial NIH scientific and programmatic involvement during planning and execution. The intent is to fund well-controlled efficacy or effectiveness trials that test pharmacologic, nonpharmacologic, and/or multicomponent strategies for managing acute pain episodes, chronic pain, or both in SCD. Opioids may continue to be used as part of usual care or as a component of an intervention when clinically needed, but applications cannot propose opioid medication use alone as the sole intervention under study. The overall emphasis is consistent with HEAL goals: advancing evidence-based approaches that reduce pain burden, improve functioning, and strengthen quality of life while supporting safer, more comprehensive pain care.

The FOA is broad in the types of interventions that can be evaluated, as long as they fit within NIH HEAL Initiative priorities and are tested in rigorous trials in SCD populations. Examples of acceptable intervention categories include medications and biologics, procedures, medical or assistive devices and technologies, behavioral interventions, rehabilitation strategies, complementary approaches, integrated care models, and health care delivery system strategies. The trials are expected to be multisite, which is important for generalizability and for capturing variability across clinical settings and patient populations. Beyond pain intensity or frequency alone, studies may also measure psychological and functional outcomes tied to daily life, such as mood, sleep, coping, physical function, school or work participation, and other indicators of well-being that reflect the real-world impact of SCD pain.

A distinctive feature of this opportunity is its explicit interest in the broader context that shapes pain care for SCD. Applications that address stigma, structural factors within health care systems, and social influences that can interfere with timely, high-quality, comprehensive pain management are encouraged. This can include examining barriers to accessing care, biases in treatment, inequities in pain assessment and response, and system-level challenges that contribute to undertreatment or inconsistent care. In parallel, investigators are encouraged to include biological markers or psychological processes when they are well-justified and have evidence suggesting they may mediate pain outcomes, helping move the field beyond simple symptom tracking toward understanding mechanisms of improvement.

The FOA also stresses the importance of robust participant characterization (phenotyping) so that trial findings are interpretable and applicable to different SCD pain presentations. Applicants are expected to collect sufficient measures to clinically characterize participants, including the type of pain (for example, acute vaso-occlusive pain versus chronic pain syndromes), pain variability over time, relevant co-occurring conditions, and social determinants of health. This level of detail is meant to clarify who benefits from which approaches, identify subgroups with distinct needs, and support more personalized and equitable pain management strategies.

Eligibility is broad and includes many domestic organization types: state, county, city, township, and 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 (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights interest in applications from organizations that serve communities disproportionately affected by SCD and related inequities, including 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 (AANAPISI), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. While foreign components (as defined by NIH policy) may be allowed, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible.

Administratively, the opportunity is run by the National Institutes of Health and is categorized as a discretionary, health-related cooperative agreement program. The original closing date listed is November 21, 2022, with an award ceiling of $500,000 shown in the provided source data. The FOA is associated with multiple CFDA numbers (now commonly referenced under assistance listing numbers), reflecting participation across NIH institutes and centers. Overall, the grant aims to accelerate practical, evidence-based pain management solutions for SCD by funding multisite trials that test comprehensive interventions, measure outcomes that matter to patients, and address the clinical, psychological, and structural factors that shape pain care and quality of life.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.233, 93.307, 93.313, 93.350, 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 23 002

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