SCIENTIFIC ADMINISTRATIVE CORE (SAC)

– Scientific Administrative Core (SAC) Despite advancements in HIV prevention, treatment, and care in the context of modern antiretroviral therapy (ART), reproductive age women are uniquely affected by HIV yet remain under-represented in HIV research. During its inaugural funding, the Study of Treatment And Reproductive outcomes (STAR) sought to address this gap by establishing a large, comprehensive, diverse cohort of reproductive age women with HIV and demographically similar women without HIV across six Southern US sites representative of the HIV epidemic in this high burden region, with longitudinal data collection on sociodemographic, psychosocial, and clinical measures (including during pregnancy and for infants) along with laboratory tests and biospecimen repositing. Building on its successful track record during its inaugural funding of efficient and collaborative leadership, establishing the cohort, promoting science, and fostering mentorship, the STAR Scientific and Administrative Core (SAC) is uniquely positioned to provide overall management, coordination, and supervision of this proposed U19 program project award to continue STAR. Led by MPIs Drs. Maria Alcaide and Anandi Sheth, the SAC will be the hub for all STAR activities proposed in this program project application and will collaboratively develop, implement, and monitor STAR recruitment, retention, data collection along with its scientific agenda and support for ESIs. The SAC will also provide administrative, regulatory, and fiscal coordination of STAR initiatives, its Cores, and its Research Projects, by first (Aim 1), continuing and expanding the STAR cohort by enrolling reproductive age women (ages 18-45 years) with HIV and demographically similar women without HIV across six Southern US sites to longitudinally collect data and biospecimens from a total of 1,400 participants (pregnant and non-pregnant women and their infants); second (Aim 2), providing effective and efficient scientific, programmatic, regulatory and fiscal leadership through a governance structure that supports the operational (via the Executive Committee) and scientific (via the Scientific Leadership Group) goals of the program project; and third (Aim 3) catalyze scientific collaborations by engaging established and early stage scientists through the SLG and Emerging Research Pilot (ERP) program, advised by STAR’s advisory boards and groups. Building on the prior progress of the cohort and its established leadership structure, coupled with robust institutional support and resources across all STAR- affiliated institutions, the SAC will be ideally positioned to serve as the administrative and leadership hub to continue and expand the cohort through its sites, provide effective regulatory and fiscal oversight, and develop programmatic support for early stage investigators and other scientists, to ultimately advance science and address health inequities across the reproductive life course. Project Number: 1U19HD119884-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: MARIA ALCAIDE | Institution: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE, CORAL GABLES, FL | Award Amount: $6,247,926 | Activity Code: U19 | Study Section: Special Emphasis Panel[ZHD1 DSR-H (55)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1U19HD11988401