HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional) | RFA MH 21 145

Opportunity Information: Apply for RFA MH 21 145

The HEAL Initiative funding opportunity titled "Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)" (RFA-MH-21-145) is a National Institutes of Health (NIH) research grant focused on improving how real-world care is delivered to people with opioid use disorder (OUD) who also face additional clinical risks and needs, including co-occurring mental health or medical conditions and suicide risk. The central idea is that many service delivery approaches for OUD are delivered as bundled, multi-part packages, but it is often unclear which specific elements of those packages are actually responsible for better outcomes. This program supports research that breaks those bundled interventions down, tests them in practical healthcare settings, and identifies which components matter most so that systems can deliver leaner, more effective, and easier-to-implement care.

The purpose of the RFA is twofold. First, it supports studies that test the overall effectiveness of multi-component service delivery interventions aimed at improving outcomes for people with OUD and co-occurring conditions, explicitly including suicide risk. Second, it supports studies that examine the relative contribution of the individual components inside those multi-component interventions. In other words, applicants are expected to evaluate not only whether the package works, but also which parts of the package are driving improvements and which parts may be unnecessary, redundant, too costly, or too difficult to deliver at scale. The long-term goal is to streamline service packages so that programs focus on the components that produce meaningful clinical improvements for people with complex, overlapping needs.

A key emphasis is pragmatism and practice relevance. The research is expected to be designed so that results can be translated into routine care quickly, balancing methodological rigor with the urgency of getting effective models into practice. Rather than highly controlled trials that are difficult to replicate in community settings, the RFA calls for studies that fit within real treatment systems and service environments, where patients often have multiple comorbidities, variable engagement, and complex social needs. The interventions of interest are service delivery interventions, meaning approaches that change how care is organized, coordinated, accessed, or sustained over time (for example, care coordination, integration of services, follow-up and continuity strategies, linkage models, collaborative care elements, recovery support structures, or other system-level and program-level components), rather than focusing only on a single medication or a single psychotherapy protocol.

The RFA highlights two main categories of projects. One category is for interventions that have already shown effectiveness as a bundled package; these studies should identify which constituent components are responsible for improvements in areas such as access to care, continuity of care, quality, value, and patient outcomes. The other category is for service delivery packages that are popular and widely implemented in the field but do not yet have strong evidence of overall effectiveness; in those cases, projects should simultaneously test the overall effectiveness of the package while also testing the effectiveness of its subcomponents. This creates a direct pathway to answer practical implementation questions like: if a program is widely used, does it actually work as delivered, and if it does, what is the minimal combination of elements needed to preserve benefit?

The funding mechanism is an R01 research project grant, with clinical trials listed as optional, which signals that applicants may propose clinical trial designs when appropriate but are not required to do so. The opportunity sits under the broader NIH HEAL (Helping to End Addiction Long Term) Initiative, which is an NIH-wide effort to accelerate scientific solutions to the opioid crisis, including improving prevention, treatment, recovery, and related outcomes. The funding activity category is listed under education and health, and the CFDA numbers associated with the announcement include 93.213, 93.242, and 93.279.

In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly notes additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American tribal governments other than federally recognized entities, and U.S. territories or possessions. At the same time, it clearly excludes non-domestic applicants: 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 NIH defines them in its Grants Policy Statement) are not allowed.

Administrative details provided in the source indicate the opportunity was created on January 11, 2021, with an original closing date of March 18, 2021. The award ceiling is listed as $2,000,000. The agency is NIH, and the opportunity category is discretionary with the instrument type listed as a grant. Overall, the opportunity is aimed at producing actionable evidence about what parts of complex OUD service delivery models actually improve engagement, retention, clinical outcomes, and safety (including suicide-related risk), so that healthcare systems can focus resources on the most effective components and move evidence-based service models into routine practice faster.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 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, 93.242, 93.279.
• This funding opportunity was created on 2021-01-11.
• Applicants must submit their applications by 2021-03-18. (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 $2,000,000.00 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 MH 21 145

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