Document text
Principal Investigator: Charles W. Flexner
Organization: JOHNS HOPKINS UNIVERSITY
Fiscal Year: 2024
Award: $2,176,002
Funding agency: National Institute of Allergy and Infectious Diseases
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."
Terms: <0-11 years old><21+ years old><AACTG><ACTG><AIDS><AIDS Virus><AIDS clinical trial group><AIDS prevention><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Adolescent><Adolescent Youth><Adult><Adult Human><Affect><African American group><African American individual><African American people><African American population><African Americans><Android App><Android Application><Area><Baltimore><Caring><Cell Phone Application><Cell phone App><Cellular Phone App><Cellular Phone Application><Child><Child Youth><Childhood><Children (0-21)><Clinical Pharmacology><Clinical Research><Clinical Research Protocols><Clinical Study><Clinical Trials><Clinical Trials Network><Clinical Trials Unit><Color><Communicable Diseases><Communication><Communities><Distance Learning><Education><Educational aspects><Enrollment><Epidemic><Funding><Government><HIV><HIV Prevention><HIV Vaccine Trials Network><HIV prevention trials network><HIV vaccine><HIV/AIDS Vaccines><HIV/AIDS prevention><HIV/Mtb><HIV/TB><HIV/mycobacterium tuberculosis><HIV/tuberculosis><HVTN><Health><Hepatitis><History><Home><Human Immunodeficiency Viruses><Human Subject Research><IMPAACT><IRB><IRBs><Immunology><Impoverished><India><Infant><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Infrastructure><Institution><Institutional Review Boards><International><International Maternal Pediatric Adolescent AIDS Clinical Trials><International Maternal Pediatric Adolescent HIV/AIDS Clinical Trials><Investigators><LAV-HTLV-III><Latine><Latinx><Leadership><Lymphadenopathy-Associated Virus><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M. tuberculosis/HIV><M.tb infection><M.tuberculosis infection><MSM><MTB infection><MTB vaccine><Maryland><Media Campaign><Mentorship><Microbicide Treatment Network><Microbicide Trials Network><Mission><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Participant><Population><Poverty><Pregnant Women><Prevention Research><Process><Productivity><Protocol><Protocols documentation><Provider><Publications><Recording of previous events><Research><Research Personnel><Research Resources><Researchers><Resource Sharing><Resources><Science><Scientific Advances and Accomplishments><Scientific Publication><Scientist><Site><Smart Phone App><Smart Phone Application><Smartphone App><Structure><Substance abuse problem><System><TB infection><TB vaccine><Therapeutic><Training><Tuberculosis><Tuberculosis Vaccines><Underrepresented Groups><Underrepresented Populations><United States National Institutes of Health><Universities><Vaccine for TB><Vaccine for Tuberculosis><Viral hepatitis><Virus-HIV><abuse of substances><acquired immunodeficiency syndrome clinical trial group><adulthood><anti-TB vaccine><care providers><cell phone based app><cis-female><cis-gender woman><cis-woman><cisgender woman><clinical care><clinical research site><clinical site><co-morbid><co-morbidity><cohesion><community advisory board><community advisory committee><community advisory panel><comorbidity><disease prevention><disorder prevention><disseminated TB><disseminated tuberculosis><enroll><epidemic containment><epidemic control><epidemic mitigation><epidemic response><expectant mother><expecting mother><experience><hepatitis virus infection><high risk><histories><homes><human immunodeficiency virus vaccine><iOS app><iOS application><iPhone App><iPhone Application><improved><infection due to Mycobacterium tuberculosis><innovate><innovation><innovative><internet portal><intravenous drug use><juvenile><juvenile human><kids><medical college><medical schools><men having sex with men><men who have sex with men><men who have sex with other men><mobile phone app><on-line portal><online portal><operation><operations><patient oriented research><patient oriented study><pediatric><pregnant mothers><programs><recruit><remote learning><research facility><research study><school of medicine><scientific accomplishments><scientific advances><sexually active><smartphone application><smartphone based app><smartphone based application><social media><substance abuse><substance user><synergism><trans*><trans-women><transgender><transgender women><transwoman><transwomen><treatment research><tuberculosis infection><tuberculous spondyloarthropathy><under representation of groups><under represented groups><under represented people><under represented populations><underrepresentation of groups><underrepresented people><vaccine against M. tuberculosis><vaccine against Mtb><vaccine against Mycobacterium tuberculosis><vaccine against TB><vaccine against tuberculosis><vaccine candidates against tuberculosis><web portal><web-based portal><youngster>