ABSTRACT – OVERALL Adolescents and young adults (AYA) ages 13-24 accounted for 21% of new HIV diagnoses in the United States in 2019. New infections in AYA disproportionately affect Black, Latino, multiracial, and American Indian/Alaska Native men who have sex with men. Geographic areas of the United States are also disproportionately affected by new infections: Northeast > South > West followed by the Midwest. The specific aim of the applicant is to serve as the Operations and Collaborations Center (OCC) of the Adolescent Trials Network (ATN). Westat is in an ideal position to expertly perform the ATN OCC scope of work (SOW) as outlined in RFA-HD-23-021 due to our prior and current successful experience supporting HIV pediatric and adolescent research programs. The newly designed ATN network will be made up of a Scientific Leadership Center (SLC) and OCC. As the OCC, Westat will work collaboratively with the ATN SLC and provide operational and logistical infrastructure to support the ATN Executive Committee (EC). This is critical to the EC's success in achieving its scientific leadership agenda and in its collaborations with the ATN External Scientific Panel (ESP), National Institutes of Health (NIH) program staff, and external research networks and investigators. The overall aims of the ATN OCC are to: (1) Provide administrative management and coordinate Network external collaborations; (2) Provide operational support for cross-network protocols, collaborations, and other projects (e.g., conduct trainings, develop manuals of operation, Network public support relations, provide Network website maintenance, support communications and conference calls, convening committees and meetings); (3)Train Network participants on a breadth of research-related topics; (4) Manage resources and execute performance-based subcontracts with site consortiums, vendors, and collaborators; (5) Provide regulatory infrastructure for cross-network protocols, collaborations, and emerging projects (e.g., site performance monitoring, quality assurance procedures, and protocol registration); (6) Provide mechanisms and metrics to monitor subject screening, recruitment, retention, and dropout, and procedures for adjustment if enrollment targets are not being met; (7) Provide detailed systems for tracking study progress and performance of site consortia and reporting to the EC (e.g., support of a study progress and performance monitoring committee). Routine tracking and reporting will include defined metrics, milestones, timelines, and quality-control measures to ensure studies stay on track and within budget. Relevance: Westat will provide the appropriate technical, organizational, administrative expertise, and resources to efficiently design, implement, and simultaneously manage a broad portfolio of therapeutic, behavioral, and community studies. Study findings will be used to develop interventions for reducing HIV transmission and acquisition among AYA, safe and effective forms of long-acting HIV pre-exposure prophylaxis (PrEP), and long-acting antiretroviral therapies (ARTs) for improving adherence and long-term health outcomes of AYA living with HIV (LHIV).

PROJECT NARRATIVE – OVERALL The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) will develop and conduct innovative behavioral, community-based, translational, therapeutic, microbicide, and vaccine trials in youth ages 13-24 at risk for HIV and living with HIV, with a focus on the inclusion of minors. This initiative will center on collaboratively conducted interventional research aimed at reducing new HIV infections and investigating HIV treatments in this disproportionately medically underserved, gender and racial/ethnic minority, and/or substance abusing youth population. The ATN OCC will facilitate transdisciplinary research through organizational leadership and collaboration support for the ATN-specific agenda that will address substantial and disproportionate gaps in health outcomes across the HIV prevention and care continuum for youth.