The HIV Centers for Underrepresented Populations in Research Clinical Trials Unit (CURE CTU) will be comprised of five highly experienced and successful Clinical Research Sites (CRS) within the continental U.S. and a sixth new CRS located at Children’s National Medical Center in Washington, DC. Each of the CRSs has >20 years of experience conducting clinical research in pregnant women, infants, children, adolescents and young adults with and at-risk for HIV infection. Each of the HIV CURE CRSs is located in one of 48 counties or in Washington DC, geographic locations that have been targeted by the U.S. President’s initiative to end the HIV epidemic. The CURE CTU management is located at the University of California San Diego; Dr. Stephen A. Spector will serve as the Principal Investigator. The six CRSs are located at Baylor College of Medicine/Texas Children’s Hospital in Houston, TX, Ann & Robert H. Lurie Children’s Hospital of Chicago, IL, Northwestern University, St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center in Memphis, TN, University of Miami, Holtz Children’s Hospital, Miami, FL, Children’s National Medical Center in Washington, DC, and the University of California, San Diego, CA. The CURE CTU is the only unit specifically focused on research in pregnant women, women, children, adolescents and young adults less than 25 years in the continental U.S. funded through NIAID. The Specific Aims address many of the targeted high priority areas of the four NIAID proposed Networks. Aim 1: Identify novel and durable interventions to reduce reservoirs and control HIV replication in the absence of ART (ART- free remission) (ACTG Aim 1 and IMPAACT Aim 2). Aim 2: Advance ART of pregnant and postpartum women with HIV, to optimize maternal and infant health outcomes, and accelerate the evaluation (PK, safety, antiviral efficacy), licensure and optimal use of potent and durable ARVs for pregnant women, infants, children and adolescents with HIV (IMPAACT Aim 1). Aim 3: Design and conduct studies of broadly neutralizing antibodies (bnAbs), alone and in combination, and long-acting antiretroviral agents and delivery systems for pre-exposure prophylaxis (PrEP) (ACTG Aim 2, HPTN Aim 1, IMPAACT Aim 1). Aim 4: To investigate vaccination of HIV- exposed and unexposed infants to induce broad immune responses including broadly neutralizing antibody (HVTN Aim 4). Specific Aim 5: Design and conduct studies to evaluate multipurpose prevention technologies that concurrently prevent HIV and pregnancy, sexually transmitted infections or opioid dependence (HPTN Aim 2). Aim 6: Determine optimal and feasible methods for the prevention and management of complications and co-infections of HIV infection and their treatment in infants, children, adolescents and pregnant and postpartum women (IMPAACT Aim 4). Aim 7: Prevent or improve the treatment of HIV-related non-infectious co- morbidities and evaluate strategies to cure hepatitis B virus infection in people with/without HIV (ACTG Aim 4, HVTN Aim 1).

The HIV Centers for Underrepresented Populations in Research Clinical Trials Unit (CURE CTU) will be comprised of six highly experienced research sites located at Texas Children’s Hospital, Baylor College of Medicine in Houston, TX, Ann & Robert H. Lurie Children’s Hospital of Chicago, IL, Northwestern University, St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center in Memphis, TN, University of Miami, Holtz Children’s Hospital, Miami, FL, Children’s National Medical Center in Washington, DC, and the University of California, San Diego, CA; each located in an area targeted by the U.S. initiative to end the HIV epidemic. The CURE CTU is the only unit specifically focused on research in pregnant women, women, children, adolescents and young adults less than 25 years in the continental U.S. funded through NIAID. The Specific Aims of the CURE CTU address many of the targeted high priority areas of the 4 NIAID proposed Networks.