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National Institutes of Health · United States

Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)

Open

Applications close on 15 Oct 2027. Eligible applicant types include state governments, private institutions of higher education, nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education and 12 more.

About this call

Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This NOFO is a key element of NIMHs set of NOFOs to support clinical trials research across the intervention development and testing pipeline. The NOFO supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This NOFO is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).

Who can apply

• State governments
• Private institutions of higher education
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Special district governments
• Public housing authorities/Indian housing authorities
• Independent school districts
• Native American tribal organizations (other than Federally recognized tribal governments)
• Public and State controlled institutions of higher education
• Small businesses
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• For profit organizations other than small businesses
• County governments
• City or township governments
• Native American tribal governments (Federally recognized)
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

Other Eligible Applicants include the following:

Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Applicant categories are a starting point. The official call decides eligibility.

Topics

Health

How to apply

1. Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
2. Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
3. For NIH: the organisation and the principal investigator also need eRA Commons accounts; applications are usually submitted through Grants.gov (for example with ASSIST).
4. Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
5. Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply

Not stated in the call text we hold — check the official page

Company stage

Not stated in the call text we hold — check the official page

Single applicant or consortium

Not stated in the call text we hold — check the official page

Where applicants must be based

Not stated in the call text we hold — check the official page

Where to apply

Not stated in the call text we hold — check the official page

Contact

National Institutes of Health · grantsinfo@nih.gov · 301-402-2541

Where these facts come from

Official sources

Official call page · Funder's programme page

Facts on this page come from the funder’s official data, taken on 13 Nov 2026. The funder's own documents, including later amendments, always take precedence.

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