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IMPAACT 2028 is an observational study to characterize a cohort of children who may participate in future research related to HIV remission or cure. Children in this study will have previously received early or very early treatment for HIV in other IMPAACT studies or other studies sponsored by the United States National Institutes of Health. Children in this study will complete study visits approximately every six months at which key clinical, immunologic, and virologic outcomes will be assessed for a period of up to seven years.
Site selection was completed in March 2021. IMPAACT- and protocol-specific sites that had previously enrolled or plan to enroll participants in IMPAACT P1115, IMPAACT 2008, Children with HIV Early antiretroviral (CHER), Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial (LEOPARD), and the Treating Infants Early Study (TIES) were invited to participate. Sites are located in Botswana, Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, the United States, and Zimbabwe.