Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for investigator-initiated clinical trials testing complementary and integrative health interventions delivered remotely or via mHealth. Eligible applicants include research institutions, HBCUs, tribal colleges, faith-based and community organizations, and federal agencies. The trial must be fully powered, remotely conducted with no in-person contact, and assess interventions in NCCIH priority research areas. Non-U.S. entities are ineligible, though foreign components of U.S. organizations are allowed.
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Program description
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH- designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- SF-424 (R&R) blocks
- Project Narrative (per page limits)
- Specific Aims
- Research Strategy
- Budget Justification
- Biographical Sketches
- Research Plan with Preliminary Data
- Letters of Support (as applicable)
- IRB Documentation
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.213 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$22,367,527
-
$21,646,919
-
$19,236,131
-
$17,730,528
-
$15,036,701
-
$14,473,882
-
$12,748,932
-
$11,956,053
-
$11,225,697
-
$10,919,780
Top States by Funding
- CA 13 awards $83.5M
- MA 13 awards $80.2M
- WA 8 awards $69.9M
- NC 7 awards $53.8M
- NY 6 awards $40.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.213). How funding has trended year over year.
| 2024 | $240,178,154 | |
| 2025 | $232,899,116 | |
| 2026 est. | $2,655,626 |
FAQ
Who can apply for this grant?
Research institutions, HBCUs, tribal colleges, faith-based organizations, and federal agencies can apply. Non-U.S. entities cannot apply directly.
What type of study is required?
Applications must propose a fully powered, remotely conducted clinical trial with no in-person participant contact. The trial should test complementary and integrative health interventions.
Can I include in-person visits?
No. This grant requires fully remote delivery and conduct with no in-person contact between research staff and study participants.
What preliminary work is needed?
You must provide preliminary data on feasibility and safety of the remote approach, plus evidence the intervention shows promise of clinical benefit.
Should I contact NCCIH before applying?
Yes. Contact the appropriate NCCIH scientific contact for your research area before submitting your application.
💡 Tips for applicants
- Contact NCCIH program staff early to confirm your research area aligns with their priorities and to get feedback on feasibility.
- Provide robust preliminary data demonstrating the remote delivery method is safe and feasible for your target population.
- Clearly justify why a fully remote approach is appropriate for your specific intervention and population.
- Plan for mHealth tools or technologies that enhance remote delivery and participant engagement.
- Ensure your trial is adequately powered and uses rigorous designs to assess efficacy or effectiveness.
⚠️ Common mistakes
Proposals lacking adequate preliminary data on remote delivery feasibility and safety. Insufficient justification for why the intervention cannot include any in-person contact. Weak evidence that the intervention has promise of clinical benefit.
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