Notice of Intent to Publish a Funding Opportunity Announcement for HIV Pediatric, Adolescent and Maternal Clinical Trials

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH), has announced its intention to publish a Notice of Funding Opportunity (NOFO) for the development and implementation of clinical trials focused on HIV among pediatric, adolescent, and maternal populations. This forthcoming funding opportunity aims to support high-priority studies targeting HIV and its related comorbidities and coinfections within these specific demographic groups. The NOFO is not yet active, as this is a forecasted opportunity meant to give prospective applicants sufficient time to plan and form necessary collaborations. This initiative will fund research conducted through a clinical trials network that concentrates exclusively on pediatric and maternal HIV-related conditions. The program is expected to promote innovation and collaborative trial designs developed in partnership with site consortia. Investigators are encouraged to engage in early planning, particularly those with expertise in pediatric and adolescent medicine, maternal health, chronic and infectious diseases, laboratory innovation, and cost-effectiveness research. The notice encourages integrated, multidisciplinary approaches to the trial designs. The opportunity is expected to utilize the UM2 cooperative agreement funding mechanism, which implies a substantial level of involvement from NIH program staff throughout the project. While specific budget ceilings and floors have not been published, the estimated total program funding is $30,000,000, and two awards are anticipated. Applicants should monitor grants.gov for the official NOFO publication, which is estimated to be released on November 21, 2025. The estimated application due date for this opportunity is March 25, 2026. Projects awarded under this opportunity are expected to start on December 1, 2026. The forecasted opportunity aligns with NIH’s broader strategy to support impactful, scientifically rigorous interventions aimed at vulnerable populations affected by HIV. Although specific application components are not detailed in the notice, standard NIH grant submission requirements are expected to apply, including detailed research plans, budget justifications, and documentation of consortium agreements, where applicable. Eligibility for this opportunity is broad. It includes state and local governments, independent school districts, nonprofits (excluding institutions of higher education), for-profit organizations (including small businesses), tribal governments and organizations, public and private institutions of higher education, and public housing authorities. Matching funds are not required for this program, making it more accessible to a wider array of applicants, particularly those from under-resourced institutions or communities. For additional information or questions regarding this funding forecast, interested parties should contact Dr. Sonia Lee at the Eunice Kennedy Shriver NICHD. She can be reached at 301-594-4783 or via email at Sonia.lee@nih.gov. Potential applicants are advised to begin conceptualizing their proposals and identifying suitable collaborators well in advance of the NOFO’s publication date to maximize responsiveness and alignment with program objectives.