Notice of Intent to Publish a Funding Opportunity Announcement for the Pediatric HIV AIDS Cohort Study Program Project Grant Applications (P01 Clinical Trial Not Allowed)

Notice Number: NOT-HD-19-024

Key Dates

Release Date: September 04, 2019
Estimated Publication Date of Funding Opportunity Announcement: September 10, 2019
First Estimated Application Due Date: December 06, 2019
Earliest Estimated Award Date: July 01, 2020
Earliest Estimated Start Date: July 01, 2020

Related Announcements
None

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for the Pediatric HIV AIDS Cohort Study Program Project Grant Applications (P01 Clinical Trial l Not Allowed).

This Notice is being provided to allow potential applicants enough time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in September 2019 with an expected application due date in December 2019.

This FOA will utilize the P01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages applicants with the appropriate scientific backgrounds to apply for the Pediatric HIV/AIDS Cohort Study (PHACS), which addresses critical scientific questions on the clinical course of perinatally acquired HIV infection in adolescents and young adults and the oral and systemic health consequences of in utero and infant exposure to antiretroviral therapy in representative cohorts of children in the United States. The findings from this domestically based initiative have great relevance internationally since millions of HIV-infected children in resource-constrained settings receive treatment and survive into adolescence and adulthood and many pregnant women with HIV have access to and use combination antiretroviral therapy to prevent infant HIV infection and preserve their own health.

Collaborative, synergistic Program Projects (P01) Grants comprised of at least three component projects and associated cores are planned. The proposed research should integrate basic, translational, and/or clinical approaches. The component projects must share a common central theme and research focus.

At least two groups will be studied in the PHACS: HIV exposed uninfected (HEU) and youth with perinatal HIV(PHIV). New HEU enrollments will continue to capture the evolving type and timing of antiretrovirals during pregnancy. Timing of antiretroviral initiation continues to evolve, and more women are on treatment at the time of conception or earlier in pregnancy. PHACS will support ongoing evaluations of in utero and postnatal exposures to new antiretroviral drugs in the HEU cohort and identify specific adverse events and potential etiologic factors.

The transition to adulthood of youth with PHIV treated with ART provides an important opportunity for PHACS to examine a host of health outcomes, including reproduction, oral, cognitive, neurodevelopmental, mental health, substance use, behavioral, emotional, social, academic and vocational outcomes. Since this cohort includes youth who received very early treatment and have had nearly lifelong HIV suppression, there is also a unique opportunity to glean insights that may inform HIV cure research. Collaborations will continue to be encouraged with other cohorts in both resource-rich and resource-constrained settings.

A pre-application webinar is planned for fall 2019.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.865

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Bill G. Kapogiannis, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
301-402-0698
kapogiannisb@mail.nih.gov