Notice of Intent to Publish a Funding Opportunity Announcement for Adolescent Medicine Trials Network for HIV/AIDS Intervention (ATN) Scientific Leadership Center (UM2 Clinical Trial Required), and Operations and Collaborations Center (UM1 Clinical Trial)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with other NIH Institutes and Centers (ICs), the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for a research program cooperative agreement to support the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) to develop and conduct innovative behavioral, community-based, translational, therapeutic, microbicide and vaccine trials in youth ages 13-24 years at-risk for HIV and living with HIV, with a focus on the inclusion of minors. This FOA will encourage a more focused, clinical research agenda, with increased emphasis on registrational trials of biomedical interventions. The ATN is the sole HIV clinical trials network focused exclusively on youth, and will continue to design, develop and conduct clinical trials as well as pertinent formative and implementation science research studies, and enroll youth participants into rigorously designed, collaborative protocols to address high-priority HIV research areas. The ATN will include a UM2 Scientific Leadership Center (SLC) to include a Scientific Leadership Group, a Statistical and Data Management Core, and 5-8 Research Projects. . The ATN will also include a UM2 Operations and Collaborations Center (OCC) to include at least 8 Site Consortiums made up of established collaborations among clinics, academic universities, community-based organizations, health departments and other partners. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in Fall 2021, with an expected application due date in Winter 2022. This FOA will utilize the UM2 activity code. Details of the planned FOA are provided below.