Notice of Intent to Publish a Funding Opportunity Announcement for HIV Pediatric, Adolescent and Maternal Clinical Trials
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for research institutions and organizations conducting clinical trials focused on HIV in pediatric, adolescent, and maternal populations. Eligible applicants typically include accredited universities, medical schools, teaching hospitals, research institutes, and nonprofit research organizations with established research infrastructure and IRB approval capabilities. The program supports domestic and international research sites participating in NIH-sponsored clinical trials. Applicants must have the capacity to enroll and manage study participants, maintain regulatory compliance, and contribute to HIV treatment and prevention knowledge for vulnerable populations. Geographic scope includes U.S.-based institutions and eligible international sites, with funding supporting trial-related activities including participant recruitment, clinical assessment, laboratory services, and data management.
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Key dates
- Jun 25, 2025 Applications open
- Mar 25, 2026 Application deadline
- Dec 1, 2026 Award announced
- Dec 1, 2026 Project start
Program description
The Eunice Kennedy Shriver National Institute of Child Health and Human Development intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research focused on high-priority HIV studies for infants, children, youth and young adults (AYA), and maternal populations. An HIV clinical trials network focused exclusively on pediatric and maternal populations will innovate and conduct rigorously designed, collaborative clinical trials in partnership with site consortia to address high-priority research areas in HIV and related comorbidities and coinfections. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the UM2 activity code. Investigators with expertise and insights into this area of HIV are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise in chronic and infectious diseases, pediatrics, adolescent medicine, laboratory innovation, and cost-effectiveness will be encouraged and these investigators should also begin considering applying for this application.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- County Government
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) and SF-424 (R&R) Cover Page Supplement
- Project/Research Narrative (typically 15 pages, describing trial rationale, design, participant population, site capabilities)
- Detailed Budget and Budget Justification (Form 424)
- Biographical Sketches (NIH Form Page 5) for key personnel (limit 5 pages each)
- Institutional Certifications (IRB approval or pending approval, CLIA certification if applicable, Federal-wide Assurance documentation)
- Letters of Institutional Support and Commitment
- Facilities and Administrative Resources documentation
- Appendices (recruitment/retention plans, community partnership letters, curricula vitae)
Program contact
- 👤 Sonia Lee, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 📧 Sonia.lee@nih.gov
- 📞 301-594-4783
Funding track record
Recent awards under CFDA 93.865 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$1,073,967,938
-
$719,372,575
-
$276,059,721
-
$155,556,396
-
$155,482,198
-
$103,665,364
-
$74,151,078
-
$72,701,366
-
$52,238,426
-
$47,450,377
Top States by Funding
- WA 1 awards $1,074.0M
- NC 7 awards $925.9M
- MD 4 awards $501.6M
- MA 3 awards $190.0M
- PA 3 awards $145.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.865). How funding has trended year over year.
| 2024 | $1,282,226,682 | |
| 2025 | $1,333,391,690 | |
| 2026 est. | $184,920,723 |
FAQ
Who is eligible to apply for this HIV pediatric and maternal clinical trials funding?
Research institutions, medical centers, universities, and organizations with established clinical trial infrastructure and IRB oversight capabilities. Applicants must demonstrate experience or capacity in conducting clinical research with pediatric, adolescent, or maternal populations.
What types of activities does this funding support?
Funding supports clinical trial operations including patient recruitment, clinical assessments, laboratory testing, data collection and management, study coordination, and regulatory compliance activities for HIV-related trials in pediatric, adolescent, and maternal cohorts.
When is the application deadline?
The Notice of Intent indicates a future Funding Opportunity Announcement will be published. Check NIH.gov and Grants.gov regularly for the full FOA with specific submission deadlines once released.
What makes an HIV clinical trials application competitive?
Strong applications demonstrate experienced research staff, robust institutional support, proven ability to recruit and retain study participants from target populations, appropriate clinical facilities, strong IRB and regulatory processes, and clear commitment to research integrity and participant safety.
What is the typical funding range for these awards?
NIH clinical trials awards vary widely depending on trial scope, participant population, and site requirements. Direct costs typically range from $250,000 to $2 million annually, but specific amounts depend on the final FOA and your proposed trial involvement.
💡 Tips for applicants
- Begin preparing now by reviewing the NIH Division of AIDS and NICHD websites for similar recently-funded trials to understand funding priorities, study designs, and site requirements.
- Ensure your institution has current institutional certifications (IRB registration, federal-wide assurance, CLIA certification for any lab components) and strong clinical research infrastructure—these are prerequisites NIH reviewers will verify.
- Develop detailed recruitment and retention strategies specific to pediatric, adolescent, or maternal populations, including community partnerships, staff expertise, and cultural competency plans that directly address potential enrollment challenges.
- Coordinate early with your NIH Program Officer once the full FOA is released; they can clarify scope, participant population priorities, and whether your site is best suited as a lead site, participating site, or both.
- Build a clear, realistic budget narrative that itemizes direct costs (personnel, equipment, participant incentives, lab work) and justifies each line item relative to trial scope—vague or inflated budgets significantly reduce competitiveness.
⚠️ Common mistakes
Many applications underestimate the complexity of enrolling and retaining pediatric, adolescent, and maternal populations and fail to articulate specific strategies that address unique barriers (e.g., parental consent, medical mistrust, logistical challenges). Additionally, applicants often submit generic clinical research experience without clearly demonstrating prior success in HIV-related trials or with the specific population cohorts mentioned in the funding opportunity.
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