NIAID is among several NIH institutes and centers (ICs) participating in the notice of funding opportunity (NOFO) Pediatric HIV/AIDS Cohort Study (PHACS) (U19, Clinical Trial Not Allowed), which is led by the National Institute of Child Health and Human Development (NICHD). The NOFO is designed to support cohorts of the Pediatric HIV/AIDS Cohort Study (PHACS)—a streamlined and agile grant program that addresses developmental and clinical issues that affect individuals with HIV.
According to the World Health Organization, in 2022, there were approximately 1.2 million pregnant women and 1.5 million children living with HIV. While the increased availability of antiretrovirals for HIV treatment and prevention has allowed for more HIV-infected kids to age into adulthood globally, there is limited clinical data on the long-term impact of HIV and its treatments on this population as they enter reproductive age and have children of their own.
Scope and Cohorts of Interest
The cohorts of interest for this NOFO include groups of 500 to 1,000 people, including youth and women of reproductive age, who are at risk for or living with HIV, whether acquired at birth or through behavior. We encourage researchers to recruit both pregnant and non-pregnant individuals at high risk or living with HIV, along with their children. New enrollments will help track changes in antiretroviral treatment (ART) as they grow up or during pregnancy, guiding future HIV treatment and prevention strategies. Each year, at least 200 new individuals will be added to these groups.
As part of this effort, investigators will be expected to collect basic information in areas of interest such as the effects of lifelong ART on reproductive system pathology, nutrition, growth, endocrine, and bone development. Refer to the NOFO for more examples of basic information that will be collected as part of this effort.
This NOFO encourages participation of researchers with experience using efficient scientific and administrative methods to help enhance the function and scientific vision of PHACS. This includes development of a centralized data storage system for site data, the creation and roll-out of a searchable web-based platform to enrich data sharing and broader integration, development of methodologies to support the interoperability of PHACS data with other datasets, and other related activities. Refer to the NOFO for more examples of activities that will be supported and encouraged.
Award Structure
The expectations that this NOFO sets for how you will arrange your proposed research program are complicated. Under this structure, a Scientific Administrative Core and a Data Management Analysis Core are both required. In addition, each U19 research project must include a minimum of two research projects and a maximum of three. Research projects should focus on the effects of ART on either HIV during reproductive years, or the developmental and clinical course of people living with HIV that was acquired at birth, or both.
Applicants can propose up to two optional cores to support their research projects. They should plan to attend annual programmatic meetings that will either be in person at an NICHD-approved site or online, as well as identify an independent external advisory group that will meet twice a year to review ongoing progress of the research project. Applicants will also be expected to include a Data Management and Sharing Plan, which NIH staff will review and approve prior to the award. Finally, given the nature of Cooperative Agreements, investigators can anticipate substantial involvement from NIH program or scientific staff.
Application and Budget Information
The application deadline is December 11, 2024, and the award project period is 5 years. While application budgets are capped at $5.5 million direct costs per year, they will need to reflect the actual needs of the proposed project.
Note that a Plan for Enhancing Diverse Perspectives is required as part of the application.
Foreign organizations are not eligible to apply.
Contact
For NIAID-related questions, reach out to Tia Morton at 240-627-3073 or frazierti@niaid.nih.gov.