HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required) | RFA MH 19 525

Opportunity Information: Apply for RFA MH 19 525

This NIH funding opportunity (RFA-MH-19-525) sits under the HEAL (Helping to End Addiction Long-term) Initiative, a cross-NIH effort launched in 2018 to accelerate research-driven solutions to the opioid public health crisis. Led by the National Institute of Mental Health (NIMH) in collaboration with other NIH Institutes, the goal is to generate real-world evidence on how to adapt and strengthen the Collaborative Care Model in primary care so it better serves people with opioid use disorder (OUD) who also have co-occurring mental health conditions. The emphasis is on practical, clinic-ready approaches that can be deployed in everyday healthcare settings, not just tightly controlled research environments.

The scientific focus is on effectiveness trials that develop, optimize, implement, scale, and sustain collaborative care programs that integrate Medication Assisted Treatment (often referred to as medication treatment for OUD, such as buprenorphine, methadone, or naltrexone, depending on the setting) with evidence-based care for common co-occurring mental health conditions that can be treated in primary care. In other words, applicants are expected to test integrated service delivery models where OUD care and mental health care are delivered together through a structured team-based approach. Collaborative care generally relies on a coordinated team that may include a primary care provider, a care manager, and psychiatric/behavioral health consultation, supported by measurement-based care and systematic follow-up. This opportunity is looking for adaptations of that framework that specifically address the clinical and operational realities of treating OUD alongside conditions such as depression, anxiety, PTSD, or other behavioral health needs that frequently accompany OUD.

The award mechanism is a U01 cooperative agreement, which typically means NIH will have substantial scientific and programmatic involvement during the project rather than operating purely as a hands-off funder. The funding instrument also explicitly requires a clinical trial, so proposed work needs to include a prospective study design that evaluates the effectiveness of the adapted collaborative care approach in real-world conditions. While the notice highlights optimization, implementation, scaling, and sustainability, the unifying theme is building models that can actually be adopted and maintained by primary care and community-facing systems, including workflow integration, staffing models, fidelity and flexibility balance, and strategies to support longer-term continuation after the research period.

A broad range of organizations are eligible to apply, reflecting the intention to test and implement these approaches in diverse systems and communities. Eligible applicants include state, county, and local governments; public and private institutions of higher education; independent school districts and special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and additional categories such as faith-based or community-based organizations. The opportunity also calls out eligibility for institutions serving specific populations, 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 (AANAPISIs), as well as U.S. territories or possessions and certain regional organizations.

Foreign eligibility is limited in a way that is common for NIH opportunities: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply as the primary applicant. However, non-domestic components of U.S. organizations are eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are allowed, meaning a U.S.-based applicant can include certain international elements if they are justified and compliant with NIH policy. The opportunity is categorized as discretionary funding and is aligned with education and health-related federal assistance, with CFDA listings spanning multiple NIH-related program numbers (93.213, 93.242, 93.273, 93.279, 93.307, 93.313, 93.361, 93.866).

Key administrative details provided include the sponsoring agency (NIH), the creation date of the opportunity (December 10, 2018), and an original closing date of April 1, 2019. Some fields such as the award ceiling and the expected number of awards are not specified in the provided source data. Overall, the opportunity is designed for applicants who can run pragmatic clinical effectiveness trials and simultaneously address the real implementation barriers that determine whether integrated OUD and mental health collaborative care can be adopted broadly, scaled across settings, and sustained over time.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 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, 93.242, 93.273, 93.279, 93.307, 93.313, 93.361, 93.866.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-04-01. (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 MH 19 525

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