Emergency Award HEAL Initiative: Optimizing Existing Evidence-Based Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional) | RFA MH 22 175

Opportunity Information: Apply for RFA MH 22 175

The Emergency Award HEAL Initiative funding opportunity (RFA-MH-22-175) is an NIH R01 grant competition under the Helping to End Addiction Long-Term (HEAL) Initiative focused on improving how real-world service delivery systems care for people with opioid use disorder (OUD) who also have other serious, complicating needs. The core idea is that many effective programs for OUD are not single treatments; they are bundled, multi-component service packages that might include medication treatment, care coordination, peer support, behavioral health services, case management, housing or employment supports, overdose prevention, and other wraparound elements. This RFA aims to make those packages more efficient and more impactful by figuring out what actually drives improvements, what is redundant, and what can be streamlined without losing benefit. A central emphasis is on people with OUD and co-occurring conditions, explicitly including suicide risk, which is often intertwined with substance use, mental health disorders, and gaps in care.

The research purpose is two-fold. First, NIH is looking for studies that test the overall effectiveness of multi-component interventions for OUD and co-occurring conditions in pragmatic, practice-relevant settings. Second, NIH wants investigators to examine the relative contribution of the individual components that make up those interventions, rather than only evaluating the bundle as a black box. In practical terms, the goal is to move beyond asking "Does this big program work?" to also asking "Which pieces of this program are responsible for the improvement, and which pieces are not pulling their weight?" That kind of component-level evidence can help health systems and community providers deploy service models that are easier to implement, less costly, and more scalable, while still improving outcomes for complex, high-risk populations.

The opportunity supports studies that are designed to be highly pragmatic and responsive to time-to-practice urgency. That means NIH is signaling that applicants should prioritize designs that can produce actionable results under real-world constraints, while still maintaining scientific rigor. The announcement highlights outcomes and performance domains that matter to service systems, including access to care, continuity and retention, quality of care, value (including efficiency and resource use), and patient-centered clinical outcomes. Because suicide risk is explicitly included, competitive proposals would typically be expected to address identification of suicide risk, linkage to appropriate interventions, and measurement of suicide-related outcomes or validated proxies, in ways that fit routine care workflows.

The RFA describes two main research directions. One direction is to take a service delivery intervention that has already demonstrated effectiveness as a bundled package and then identify which constituent components are driving improvements in the targeted outcomes. This "optimization" approach is meant to clarify the active ingredients so that service packages can be simplified and still remain effective. The second direction applies to popular or widely implemented service delivery packages that do not yet have strong evidence of effectiveness as a whole. In that case, the RFA encourages studies that simultaneously test the overall effectiveness of the full package and the effectiveness of its subcomponents. This is essentially an invitation to generate evidence that can either validate common practice models or help redesign them based on which elements contribute meaningful benefit.

Administratively, this is a discretionary NIH grant using the R01 mechanism, with clinical trials listed as optional, meaning applicants may propose clinical trials if appropriate but are not required to do so. The opportunity lists an award ceiling of $12,500,000, signaling that NIH anticipates some large, complex projects, potentially including multi-site pragmatic evaluations or optimization designs that can isolate component effects. The original closing date listed for the opportunity was March 18, 2022, and it was created January 21, 2022. Multiple CFDA numbers are associated with the announcement (93.213, 93.242, 93.273, 93.279, 93.846, 93.865, 93.866), reflecting NIH institutes and program areas that commonly contribute to HEAL-related funding across substance use, mental health, and health services research portfolios.

Eligibility is broad and includes many types of domestic organizations that commonly implement or study service delivery interventions. 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; Native American tribal governments (federally recognized); tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and 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 mentions additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions. At the same time, the RFA is clear about foreign involvement restrictions: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply; non-domestic components of U.S. organizations are not eligible; and foreign components as defined by the NIH Grants Policy Statement are not allowed.

Taken together, the opportunity is essentially a call for pragmatic optimization research that can sharpen and modernize the service delivery "playbook" for OUD in the real world, especially for people whose recovery is complicated by co-occurring mental and physical conditions and by suicide risk. The expected payoff is clearer guidance for clinics, health systems, community programs, and policymakers about which components of multi-part care models are worth the time, staffing, and cost because they actually improve access, continuity, quality, value, and patient outcomes, and which components can be removed or redesigned to make high-quality care easier to deliver at scale.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Emergency Award HEAL Initiative: Optimizing Existing Evidence-Based 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, 93.273, 93.279, 93.846, 93.865, 93.866.
• This funding opportunity was created on 2022-01-21.
• Applicants must submit their applications by 2022-03-18. (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 $12,500,000.00 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 MH 22 175

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