Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R34 Clinical Trial Required) | PAR 21 211

Opportunity Information: Apply for PAR 21 211

Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R34 Clinical Trial Required) is a National Institute of Mental Health (NIMH) funding opportunity (PAR-21-211; reissue of PAR-18-431) that supports pilot-stage effectiveness clinical trials focused on the post-acute phase of mental health conditions. The central idea is to test interventions and service delivery approaches that come after an initial or acute course of care, when people may have improved but still face residual symptoms, functional impairment, relapse risk, or challenges staying engaged in appropriate services. The opportunity is aimed at interventions that are thoughtfully matched to the stage of illness, meaning they should fit the realities of the post-acute period in both what they target (for example, maintaining gains from earlier treatment, preventing relapse, improving adherence, supporting recovery and functioning, and promoting appropriate service use) and the intensity or burden placed on patients, families, clinicians, and systems.

This announcement is specifically for an R34 mechanism, which is designed to generate the kind of practical, real-world evidence needed to justify and shape a later, fully powered effectiveness trial. The expectation is not to run a definitive, large-scale study at this stage, but to carry out a rigorous pilot effectiveness trial that can answer key early questions: whether the intervention can be implemented as planned, whether participants will enroll and stay involved, whether the approach is acceptable and tolerable, whether there are any safety issues, and whether there are preliminary signals that outcomes are moving in the desired direction. A major emphasis is on showing that the intervention actually engages the presumed targets or mechanisms that are believed to drive clinical benefit, and on producing the operational details and estimates (recruitment rates, adherence, retention, implementation fidelity, outcome variability, and other planning parameters) that are needed to design a later comparative effectiveness study or practical trial.

The scope includes both therapeutic interventions and service delivery models intended to improve longer-term outcomes after the acute phase of treatment. In practice, this could mean structured relapse-prevention supports, stepped-care or maintenance strategies, care coordination approaches, adherence and engagement supports, technology-assisted follow-up, strategies to manage residual symptoms, or models that help people use the right level of care at the right time. What matters is that the intervention addresses post-acute needs and is realistic for the settings and populations in which it is intended to be used. Because the FOA requires a clinical trial, applicants should be prepared to describe the trial design, outcomes, safety monitoring, and how feasibility and acceptability will be measured, along with a clear path from pilot findings to a subsequent definitive trial.

This FOA also draws a clear boundary between pilot work and definitive effectiveness testing. It supports early effectiveness research meant to inform and de-risk a larger study, while fully powered, definitive effectiveness trials for post-acute phase interventions are expected to be pursued through a separate R01 pathway (noted in the description as TEMP-11234). In other words, the R34 should build the evidence base and the implementation know-how necessary to make an R01-scale effectiveness trial feasible and well-designed, rather than attempting to answer the final effectiveness question on its own.

Eligible applicants are broad and include many types of organizations that can carry out clinical research and partner with service systems. Domestic eligibility includes state, county, city, township, and 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; other Native American tribal organizations; public housing and Indian housing authorities; nonprofits with and without 501(c)(3) status (when not an institution of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations), reflecting an intent to encourage diverse institutional participation and research settings.

Administrative details in the source information place this opportunity under the NIH, with a health-related funding activity category and CFDA number 93.242. The funding instrument is a grant under a discretionary program. The opportunity was created on April 1, 2021, and the listed original closing date is January 25, 2025. The public description does not specify an award ceiling or the expected number of awards in the provided fields, so applicants would typically confirm budget structure, project period expectations, and any institute-specific limits in the full FOA and related NIH policy guidance.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R34 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2021-04-01.
• Applicants must submit their applications by 2025-01-25. (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.

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