The National Institutes of Health is accepting applications for its Harnessing Technologies to Support Oral Health Promotion and Management Outside the Dental Setting (UG3/UH3 Clinical Trial Required).
Donor Name: National Institutes of Health
State: All States
County: All Counties
Type of Grant: Grant
Deadline: 11/10/2022
Grant Duration: 5 years
Details:
The purpose of this Funding Opportunity Announcement (FOA) is to encourage research that develops and/or adapts and tests technology-facilitated behavioral, social, and organizational tools for use in oral health promotion and management outside the dental setting. Of particular interest are tools that harness mobile, web, sensor, or other technology-based platforms with the potential to improve oral care at home or in the community; to facilitate needs assessment, treatment planning, and engagement; and to expand access to quality care for those who are under-served.
Oral Health Promotion
Recommendations to maintain good oral health typically advise regular toothbrushing with fluoridated toothpaste, flossing or cleaning between teeth daily, eating a healthy diet that limits sugary foods and beverages, and visiting a dental care provider regularly for prevention and treatment services.
Use of Technology for Oral Health Promotion
Some oral health promotion programs are already making use of technology, with exponential growth in smartphone- and web-based health promotion programs in recent years. In addition, oral-health related sensor and remote communication technologies are increasingly available, potentially allowing for skill-building, patient self-monitoring, and use by clinicians for tailored recall and treatment planning. Efforts to develop integrated electronic health record systems add to the promise of technology-facilitated oral health promotion, empowering patients to direct their own health care, for example by having access to their health records, scheduling, and other resources.
- Clinical Trial Planning Phase (UG3): The UG3 award will provide up to 2 years of support for scientific and operational planning activities necessary to conduct the clinical trial. The UG3 planning phase should incorporate all activities required—and not yet completed–to prepare for conduct of a subsequent clinical trial.
- When not yet already completed, at a minimum, UG3 planning activities should include the following activities, included as UG3 milestones:
- Adherence to good technology design and behavioral/social/organizational intervention principles
- Oral health disparities and/or inequities
- Measurement of target engagement
- Acceptability and feasibility of the study intervention(s) and procedures
- Finalization of agreements for use of resources available within CTSAs, practice-based research networks, patient registries, etc., as applicable.
- Finalization of the clinical protocol and other required study documentation
- Development of fidelity monitoring procedures
- Completion of the data management system
- Near-final drafts of all materials required for regulatory approvals (IRB and applicable oversight committees) and any other documents necessary to implement the trial.
- When not yet already completed, at a minimum, UG3 planning activities should include the following activities, included as UG3 milestones:
- Clinical Trial Implementation Phase (UH3): The UH3 award will provide up to 5 years of support to conduct the clinical trial in accordance with activities planned in the UG3 phase, and is contingent upon successful completion of the UG3 milestones. The NIDCR expects clinical trials supported during the UH3 phase to be hypothesis driven, milestone-defined, and to contribute meaningfully to a cumulative science of behavior change and public health research within the research mission of the NIDCR. The clinical trial must meet all applicable NIH, and Office of Human Research Protections (OHRP) policy requirements.
- At a minimum, UH3 activities should include the following operational activities, expressed as UH3 milestones:
- Completion of regulatory approvals and site activation
- Registration of clinical trial in ClinicalTrials.gov
- Enrollment of the first subject
- Regular clinical and data quality management activities, including ongoing confirmation of intervention fidelity
- If applicable, enrollment and randomization of 25%, 50%, 75%, and 100% of the projected study sample
- Completion of data collection
- Completion of primary study analyses
- Completion of the final study report.
- At a minimum, UH3 activities should include the following operational activities, expressed as UH3 milestones:
Grant Period
The UG3 phase may be up to 2 years, and the UH3 phase may be up to 5 years.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.
