HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required) | RFA AT 22 005

Opportunity Information: Apply for RFA AT 22 005

The NIH HEAL Initiative funding opportunity RFA-AT-22-005 supports multisite, real-world effectiveness clinical trials aimed at improving how acute and/or chronic pain is managed in people living with sickle cell disease (SCD). It uses a cooperative agreement mechanism (UG3/UH3), which generally means funded teams work closely with NIH staff and the program is structured in phases, typically with an initial planning and start-up period followed by an implementation phase if specific milestones are met. The trials must be clinical trials and are intended to generate practical evidence about what works best for SCD pain in routine care settings, not just under ideal, tightly controlled circumstances.

A central emphasis of the FOA is testing pharmacologic, nonpharmacologic, or multicomponent strategies for SCD pain management. Opioids may remain part of a participant's pain care when clinically needed, but the application cannot propose opioid medication use alone as the sole intervention being studied. In other words, the research can accommodate ongoing opioid therapy, but the scientific question has to evaluate additional or alternative approaches such as medications beyond opioids, biologics, procedures, medical or assistive devices and technologies, behavioral and psychological interventions, rehabilitation strategies, complementary health approaches, integrated multimodal care models, or delivery-system strategies that change how pain care is organized and delivered.

The FOA also signals strong interest in outcomes that matter to patients beyond pain intensity alone. Applicants are encouraged to examine how pain management strategies affect psychological and functional outcomes, overall well-being, and quality of life. This includes outcomes like daily functioning, sleep, mood, anxiety and depression symptoms, school or work participation, and broader measures of health-related quality of life. The opportunity also recognizes that pain care for SCD does not occur in a vacuum, so it welcomes studies that address stigma and the structural and social factors that can block access to high-quality, comprehensive pain treatment. Examples of these barriers can include biased clinical decision-making, policies that restrict appropriate analgesia, fragmented care between emergency and outpatient settings, lack of access to multidisciplinary services, transportation or financial barriers, and other social determinants that shape the pain experience and the care patients receive.

On the measurement side, the FOA encourages investigators to collect biological markers and/or measures of psychological processes when there is a strong rationale that these factors could help explain how or why an intervention changes pain outcomes. Just as important, it asks teams to collect enough information to meaningfully phenotype participants. That includes characterizing pain type (for example, acute vaso-occlusive episodes versus chronic pain), pain variability over time, co-occurring conditions, and social determinants of health. The goal is to make trial findings more interpretable and actionable, including understanding which approaches work best for which subgroups of patients and under what circumstances.

Projects must fit the NIH HEAL Initiative mission and research priorities, which focus on improving pain management and reducing the harms associated with pain treatment through better evidence and better care strategies. The research is expected to be conducted in well-controlled trials in SCD populations and to evaluate preventive or treatment strategies for pain management, whether those strategies are clinical interventions, combinations of interventions, or systems-level approaches to delivering care.

Eligibility is broad across U.S.-based organizations and includes state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; independent school districts; special district governments; public housing authorities/Indian housing authorities; and federally recognized tribal governments and certain tribal organizations. The FOA explicitly highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

Administratively, the opportunity is listed as a discretionary NIH funding program using a cooperative agreement award instrument, with an original application due date of December 15, 2021, and a posting date in late October 2021. Multiple CFDA program numbers are associated with the announcement, reflecting the cross-cutting NIH institute and center participation typical of HEAL-related initiatives.

• 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, 93.279, 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 2021-10-29.
• Applicants must submit their applications by 2021-12-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 22 005

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