NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) | PAR 18 656

Opportunity Information: Apply for PAR 18 656

The NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3; Clinical Trial Required) is a National Institutes of Health funding opportunity designed to support the full arc of behavioral and social intervention clinical trials focused on dental, oral, and craniofacial health. The core idea is to fund investigators who are developing and testing behavior change interventions that can prevent or treat oral health conditions, as well as trials where an intervention is used as a research tool to better understand how behavior change works (for example, identifying mechanisms that explain why an intervention succeeds or fails). The award uses a phased structure so that applicants can do the necessary groundwork before launching a larger, more expensive clinical trial.

The mechanism is a cooperative agreement, which typically means NIH program staff are expected to have substantial involvement during the project compared with a standard grant. Applications must be submitted as a single, combined UG3/UH3 application that lays out both phases from the start, including clear plans for what will be accomplished during the planning phase and how the study will move into the implementation phase. The funding is milestone-driven: the project begins with a UG3 planning period of up to 2 years, and only projects that meet the predefined scientific milestones and feasibility benchmarks during UG3 are eligible to transition to the UH3 implementation phase, which can last up to 5 additional years. If those milestones are not met, the project may not advance to the implementation portion.

The UG3 phase is specifically meant to reduce risk and strengthen the eventual clinical trial by allowing both scientific planning and operational planning. On the scientific side, investigators can do small-scale data collection and preparatory work to check whether the intervention and study approach are feasible and acceptable in the target population. This can include testing whether participants find the content appropriate and usable, whether the delivery method (in-person, digital, community-based, etc.) is workable, and whether proposed outcome measures and data collection procedures can be executed reliably. It also supports preliminary testing of intervention training methods and fidelity monitoring, so the research team can demonstrate that the intervention can be delivered consistently and as intended across staff and sites. The overall expectation is that by the end of UG3, the team has evidence that recruitment, retention, intervention delivery, and measurement plans are realistic and that the trial can be run with adequate quality control.

The operational planning during UG3 is equally emphasized and is expected to result in the key infrastructure needed for a successful trial. At a minimum, this includes developing a final clinical protocol and an intervention manual (or an equivalent standardized set of materials), building out the data management system and the broader toolset for data and quality management, and establishing safety and operational oversight plans appropriate to the intervention and population. The planning phase also covers practical strategies for recruitment and retention, as well as other essential documents used to run multi-step clinical trials, such as a Manual of Procedures that details workflows, staff responsibilities, training, and monitoring. The goal is that the UH3 phase begins with a trial that is fully specified and ready to execute rather than still being designed.

The UH3 phase supports the actual implementation of the clinical trial, meaning the award can fund the conduct of the investigator-initiated behavioral or social intervention study once feasibility has been demonstrated and the operational foundation is in place. In this phase, the study moves from planning and pilot testing into full execution, including enrollment, intervention delivery, ongoing fidelity checks, data capture and management, and the oversight procedures laid out in UG3. The FOA is structured to accommodate intervention research at different stages, from earlier mechanistic work aimed at understanding behavior change processes through more traditional efficacy or effectiveness-oriented trials, as long as the project fits within NIDCR's mission related to dental, oral, and craniofacial conditions and meets the clinical trial requirement.

Eligibility is broad across many U.S.-based organization types, reflecting an interest in engaging academic, clinical, community, governmental, and private-sector partners who can carry out rigorous behavioral trials. Eligible applicants include state, county, and local governments; special districts; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; and a range of nonprofit organizations both with and without 501(c)(3) status. For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with other applicant types. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, eligible federal government agencies, regional organizations, and U.S. territories or possessions. At the same time, it places firm limits on foreign involvement: non-U.S. (foreign) institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

In the source listing, the opportunity is identified as PAR-18-656, categorized as a discretionary funding opportunity using a cooperative agreement funding instrument, and aligned with the health activity category under CFDA 93.121. The original closing date shown is 2021-04-02, and the posting date is 2018-02-13. Overall, the opportunity is built for teams that can demonstrate a clear behavioral or social intervention concept relevant to oral health, a credible clinical trial design, and a realistic set of milestones that prove readiness to move from careful planning into full-scale trial implementation.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
• This funding opportunity was created on 2018-02-13.
• Applicants must submit their applications by 2021-04-02. (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 PAR 18 656

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