Heal Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required) | RFA AT 19 005

Opportunity Information: Apply for RFA AT 19 005

The grant opportunity "HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)" is an NIH cooperative agreement designed to fund a large, real-world clinical study (or an implementation science study) that tests both the impact of acupuncture for chronic low back pain in older adults and the practical details of how to integrate acupuncture into routine health care delivery. The emphasis is on pragmatic research, meaning the study is expected to operate under conditions that look like everyday care rather than a tightly controlled laboratory-style trial. The goal is not only to determine whether acupuncture helps in this population, but also to figure out how health systems can deliver it effectively, consistently, and at scale as part of pain management strategies aligned with the broader HEAL (Helping to End Addiction Long-term) initiative.

This FOA uses a phased UG3/UH3 structure. The first phase (UG3) is a one-year, milestone-driven planning period focused on proving feasibility and getting all major study components ready for rapid execution. During UG3, applicants are expected to finalize protocols, confirm operational readiness across participating sites, establish recruitment and workflow processes, align data collection methods, and meet specific predefined milestones. Only projects that successfully meet the UG3 milestones and feasibility benchmarks are eligible to transition to the second phase (UH3), which supports the full implementation of the trial or implementation study. Importantly, applicants must submit the UG3 and UH3 phases together as a single combined application, with the understanding that funding beyond the planning phase is contingent on performance.

A key requirement is that the research must be conducted across two or more health care systems (HCS). This multi-system design is meant to ensure the findings are broadly applicable and to test implementation across different real-world delivery settings. Another central requirement is that the trial must be carried out as part of the NIH Health Care Systems Research Collaboratory, a Common Fund-supported program focused on improving how large-scale pragmatic clinical trials are designed and run within health care delivery systems. Awardees will work closely with the Collaboratory Coordinating Center (CCC), which provides technical support, infrastructure guidance, and methodological expertise for conducting embedded research in health systems. After awards are made, NIH and the CCC are expected to partner with funded teams to speed planning and execution, troubleshoot common barriers, and help produce high-impact results that can be used by health systems and policymakers.

The funding instrument is a cooperative agreement, which signals substantial NIH program involvement compared with a standard research grant. In practice, that usually means NIH staff and the CCC will have an active role in coordination, oversight, and ensuring the project stays aligned with Collaboratory expectations and UG3/UH3 milestones. The opportunity falls under the broad activity category of health and is associated with CFDA numbers 93.213, 93.273, and 93.866. The listed award ceiling is $750,000 (as provided in the source information), and the original closing date for applications was March 15, 2019. The sponsoring agency is the National Institutes of Health, and the FOA number is RFA-AT-19-005, reflecting the focus area that includes complementary and integrative health approaches such as acupuncture.

Eligibility is broad across U.S.-based organizations and government entities, including state, county, and city governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, certain tribal governments that are not federally recognized, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-U.S. entities and non-U.S. institutional components of U.S. organizations are not eligible to apply, and foreign components are not allowed under NIH policy as referenced in the announcement.

Overall, this opportunity is aimed at producing actionable evidence about acupuncture as a non-pharmacologic option for chronic low back pain in older adults, while also generating practical implementation knowledge that health care systems can use to adopt or scale acupuncture services. The structure, requirements, and Collaboratory partnership are set up to support a rigorous but operationally realistic trial that can be executed efficiently across multiple health systems and translate more directly into routine care decisions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Heal Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (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, 93.273, 93.866.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-03-15. (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 $750,000.00 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 19 005

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