JHUBI PROJECT SUMMARY The proposed Johns Hopkins University Baltimore-India Clinical Trials Unit (JHUBI CTU) will combine three highly productive Clinical Research Sites (CRSs): the Johns Hopkins University (JHU) CRS at the JHU School of Medicine in Baltimore, the Byramji Jeejeebhoy Government Medical College-Johns Hopkins University (BJGMC-JHU) CRS in Pune, India, and the Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE) CRS in Chennai, India, committed to ending the HIV, TB and comorbidities epidemics. These sites include the largest HIV care provider in Baltimore, the largest HIV and TB care and clinical research provider in Pune, India, and the largest HIV prevention and treatment care and clinical research center in Chennai, India. Two of these sites are currently affiliated with existing NIAID Networks (JHU site 201 and BJGMC-JHU site 31441), while YRG CARE is applying as a new site but has most of its staff and infrastructure that was previously part of Network site 11701. All three of these sites have extensive, ongoing NIH-funded research portfolios, and are affiliated with the Division of Infectious Diseases at the JHU School of Medicine in Baltimore, which will serve as the CTU home. Over the past 25 years, these three sites have contributed significantly to the science, populations, and management of studies sponsored by all of the existing DAIDS Networks: 1) the AIDS Clinical Trials Group (ACTG); 2) the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT); 3) the HIV Prevention Trials Network (HPTN); 4) the Microbicides Trials Network (MTN); and 5) the HIV Vaccine Trials Network (HVTN). Since December 2013, JHUBI CTU investigators have led 10 ACTG, 7 IMPAACT, and 2 HPTN scientific and administrative committees; led 27 ACTG, 11 IMPAACT, 7 HPTN and 1 HVTN protocols; and authored 2,167 HIV, TB, hepatitis, and related scientific publications, including 150 Network-related publications. In addition, the JHUBI CTU has enrolled and followed 2,702 participants with >90% retention into ACTG, IMPAACT, and HPTN trials, and >30,000 participants into non-Network studies relevant to the next 7 years of DAIDS Network science. The JHUBI CTU proposes to affiliate with all four DAIDS Networks: HIV Adult Therapeutics, Maternal Adolescent and Pediatric Therapeutics, HIV Prevention, and HIV Vaccine. The JHUBI CTU will engage in the highest quality human subjects research based on implementation of our Mission Statement: "To serve our communities in Baltimore and India, the Johns Hopkins University Baltimore-India Clinical Trials Unit (JHUBI CTU) will develop and provide access to the highest priority HIV prevention and treatment research. To support NIAID networks, the JHUBI CTU will provide scientific leadership, access to key populations, and the most efficient and responsible management of our clinical trials activities."

NARRATIVE Research on HIV and related infections has improved the treatment and prevention of disease, but much more needs to be done to control the epidemic. The proposed Clinical Trials Unit will join together the most active HIV clinical research sites in Baltimore, Maryland, Pune, and Chennai, India, to optimize patient-oriented research and to access key populations affected by this epidemic for participation in clinical trials.