title: Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): protocol for a multicentric prospective observational study.
abstract: BACKGROUND
  Tuberculosis disease (TB) remains an important global health threat. An evidence-based response, tailored to local disease epidemiology in high-burden countries, is key to controlling the global TB epidemic. Reliable surrogate biomarkers that predict key active disease and latent TB infection outcomes are vital to advancing clinical research necessary to 'End TB'. Well executed longitudinal studies strengthening local research capacity for addressing TB research priorities and advancing biomarker discovery are urgently needed.
  
  
  METHODS
  The Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH) study conducted in Byramjee Jeejeebhoy Government Medical College (BJGMC), Pune and National Institute for Research in Tuberculosis (NIRT), Chennai, India, will establish and maintain three prospective cohorts: (1) an Active TB Cohort comprising 800 adults with pulmonary TB, 200 adults with extrapulmonary TB and 200 children with TB; (2) a Household Contact Cohort of 3200 adults and children at risk of developing active disease; and (3) a Control Cohort consisting of 300 adults and 200 children with no known exposure to TB. Relevant clinical, sociodemographic and psychosocial data will be collected and a strategic specimen repository established at multiple time points over 24 months of follow-up to measure host and microbial factors associated with (1) TB treatment outcomes; (2) progression from infection to active TB disease; and (3) Mycobacterium tuberculosis transmission among Indian adults and children. We anticipate CTRIUMPH to serve as a research platform necessary to characterise some relevant aspects of the TB epidemic in India, generate evidence to inform local and global TB control strategies and support novel TB biomarker discovery.
  
  
  BACKGROUND
  This study is approved by the Institutional Review Boards of NIRT, BJGMC and Johns Hopkins University, USA. Study results will be disseminated through peer-reviewed journals and research conferences.
  
  
  BACKGROUND
  NIH/DBT Indo-US Vaccine Action Programme and the Indian Council of Medical Research.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Akshay
authors.initials: A
authors.lastname: Gupte
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
authors.forename: Chandrasekaran
authors.initials: C
authors.lastname: Padmapriyadarsini
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Johns Hopkins Clinical Trials Unit, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Vidya
authors.initials: V
authors.lastname: Mave
authors.affiliation: Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Dileep
authors.initials: D
authors.lastname: Kadam
authors.affiliation: Johns Hopkins Clinical Trials Unit, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Nishi
authors.initials: N
authors.lastname: Suryavanshi
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
authors.forename: Shri Vijay Bala Yogendra
authors.initials: SV
authors.lastname: Shivakumar
authors.affiliation: Johns Hopkins Clinical Trials Unit, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Rewa
authors.initials: R
authors.lastname: Kohli
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Johns Hopkins Clinical Trials Unit, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Nikhil
authors.initials: N
authors.lastname: Gupte
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
authors.forename: Kannan
authors.initials: K
authors.lastname: Thiruvengadam
authors.affiliation: Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Anju
authors.initials: A
authors.lastname: Kagal
authors.affiliation: Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Sushant
authors.initials: S
authors.lastname: Meshram
authors.affiliation: Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Renu
authors.initials: R
authors.lastname: Bharadwaj
authors.affiliation: Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Sandhya
authors.initials: S
authors.lastname: Khadse
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
authors.forename: Geetha
authors.initials: G
authors.lastname: Ramachandran
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
authors.forename: Luke Elizabeth
authors.initials: LE
authors.lastname: Hanna
authors.affiliation: Johns Hopkins Clinical Trials Unit, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
authors.forename: Neeta
authors.initials: N
authors.lastname: Pradhan
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
authors.forename: N S
authors.initials: NS
authors.lastname: Gomathy
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: DeLuca
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Amita
authors.initials: A
authors.lastname: Gupta
authors.affiliation: Indian Council of Medical Research, New Delhi, India.
authors.forename: Soumya
authors.initials: S
authors.lastname: Swaminathan
mesh_terms: D000328:Adult; D035843:Biomedical Research; D002648:Child; D015331:Cohort Studies; D003299:Cooperative Behavior; D006801:Humans; D007194:India / Q000453:epidemiology; D038622:Internationality; D011446:Prospective Studies; D012107:Research Design; D014376:Tuberculosis / Q000453:epidemiology*; D014481:United States / Q000453:epidemiology
keywords: EPIDEMIOLOGY