India

With a population of more than one billion, India is the second largest country in the world, represents 16% of the global population, and the national average for life expectancy is only 65 years. India leads the world in the largest absolute burden of TB, ranks third for HIV (behind South Africa and Nigeria), and ranks second for diabetes. The country receives funding to support HIV/AIDS prevention, treatment and care programs under the US President's Emergency Plan for AIDS Relief (PEPFAR).

Our Indo-JHU Clinical Research Partnership is dedicated to reversing poor patient outcomes. With operations based in Pune, our extensive research portfolio is directed by Dr. Amita Gupta (Baltimore, MD), with onsite direction from Dr. Vidya Mave, Dr. Nishi Suryavanshi, and Dr. Nikhil Gupte (Pune). The Indo-JHU Partnership employs more than 200 people and, in addition to our memberships in consortia with many esteemed Indian research institutions, we have formal agreements with:

Byramjee Jeejeebhoy Government Medical College, and Sassoon General Hospital (BJGMC). Pune, India
DY Patil Medical College, Hospital and Research Center. Pune, India
National Institute for Research in Tuberculosis. Chennai, India
PD Hinduja Hospital and Medical Group. Mumbai, India
Medanta The Medicity. Gurgaon, India
KEM Hospital. Pune, India
Bharati Vidyapeeth Medical College. Pune, India

CCGHE WORK IN INDIA

Studies/Projects
Publications

Characterization of TB-specific T Cell Responses in Highly-exposed, but Uninfected Health Care Workers in India

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2018-10-25

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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. PIs are Robert Bollinger, MD, MPH; Jyothi Rengarajan, MD, Emory University. Primary Research Question Do health care workers who remain TST...

Vaginal Microbiota in HIV Infected and Uninfected Pregnant Women (Stand Alone)

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2018-10-16

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Amita Gupta, MD, MHS, and Shilpa Naik, MD, are PIs for this study; Rupak Shivakoti, PhD, MSPH, is Co-Investigator The makeup of vaginal microbiota is dynamic and may play a role in the birth outcomes of pregnant women. While HIV and pregnancy both uniquely impact vaginal microbiota, the impact of...

Validating a Novel Functional Correlate of Immune Protection of Tuberculosis

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2018-10-03

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This C-TRIUMPH study is a longitudinal assessment of PBMC samples of progressors and non-progressors among adult household contacts of active TB patients. The purpose of the study is to probe the functional diversity of T cell responses to several of the antigens encoded by Mtb simultaneously in...

Validation of Sputum as Direct DNA Source for Whole Genome Sequencing of Mycobacterium Tuberculosis

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2018-09-20

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Hinduja Hospital

This study was terminated on September 27, 2021 Dr. Jeffrey Tornheim is Principal Investigator for this study. There are limited studies available from India on whole genome sequencing (WGS). This is a first-of-its-kind wherein WGS for MTB will be carried out utilizing direct sputum DNA and...

Assessing the Impact of Psychosocial Involvement in Health Care Workers with and without Active Tuberculosis at the Byramjee Jeejeebhoy Government Medical College, Pune, India

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2018-09-13

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This study was terminated effective 9/13/2021 This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. The overall goal is to understand the psychosocial involvement in health care workers with and...

Assessment of Depression and Anxiety among HIV-infected Adolescents in Pune, India

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2018-07-22

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This study is conducted under the TREAT Asia Network and funded by amfAR. PURPOSE The purpose of this study is to estimate the prevalence of depression and anxiety among adolescents living with HIV in India and their determinants. DESIGN...

Evaluating the Source of Neonatal Bloodstream Infections due to Classically Hospital Acquired Pathogens in the Neonatal Intensive Care Unit in Pune, India

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2018-07-12

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Bharati Vidyapeeth Medical College

This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. The PIs for this study are Dr. Julia Johnson of Johns Hopkins and Dr. Shilpa Naik of BJGMC. CoPIs...

Molecular Signatures of Tuberculosis-Diabetes Interaction: Metabolomics Study

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2018-06-15

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This study is using stored samples from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Type 2 diabetes mellitus (DM...

Molecular Signatures of Tuberculosis-Diabetes Interaction: Transcriptomics Study

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2018-06-15

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This study is using stored samples from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Type 2 diabetes is an...

Gut Microbiota of HIV Infected Pregnant Women

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2018-06-14

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Birth Outcomes in HIV Both antiretroviral-therapy (ART)-naïve and ART-experienced HIV-infected pregnant women have higher incidences of pre-term birth (PTB) compared to HIV-uninfected women. For example, the global prevalence of PTB is around 8%, while the rates in in HIV-infected...

Assessing Tuberculosis Transmission Dynamics, Drug Resistance and Recurrence Using Whole Genome Sequencing in Pune, India

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2018-06-12

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Indo-JHU researchers are using combined geospatial and genotyping methods to describe TB transmission dynamics in a hyperlocal region of Pune City in Western India.

Optimal Approach for TB Screening among HIV Infected Indian Children

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2018-06-11

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This study was terminated May 20, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Determining TB status (ie, uninfected, latent, and active TB disease) is more difficult among children, particularly HIV-infected children...

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

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2018-06-07

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New study will characterize the pharmacokinetics of delamanid using a model-based approach, and evaluate safety and tolerability of over 24 weeks of study treatment in HIV infected and uninfected children.

Implementing the Comprehensive Unit-based Safety Program to Reduce Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

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2018-04-19

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This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. Dr. Aaron Milstone is the PI, and Dr. Amita Gupta and Yuka Manabe are Co-PIs. The Study...

Predictors of Resistance Emergence Evaluation in Multidrug Resistant-Tuberculosis Patients on Treatment (PREEMPT Pilot Study)

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2018-03-20

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Hinduja Hospital

Indo-JHU Clinical Resarch Partnership is participating with Brazilian colleagues in a 3-year effort led by Boston University to identify what contributes to TB drug resistance.

A Multicenter Phase II/II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of VPM1002 in the Prevention of Tuberculosis (TB) Recurrence in Pulmonary TB Patients After Successful TB Treatment in India

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2018-01-23

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Dr. Vidya Mave is leading this clinical trial evaluating the safety and efficacy of a new recombinant BCG vaccine.

Assessing the Impact of the Fogarty HIV-TB Training Program at the Byramjee Jeejeebhoy Government Medical College, Pune, India

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2018-01-19

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This study was terminated in January 2021. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Johns Hopkins University was funded in 2013 to establish a new post-doctoral training program in HIV-TB epidemiology, clinical and...

Perceptions of HCWs on Barriers and Opportunities to Airborne Infection Control Guideline Implementation

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2017-12-07

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This study was terminated in December 2020 It was funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. Led by Dr. Nishi Suryavanshi, this qualitative, cross-sectional study is assessing healthcare worker (HCW) perceptions about...

A5302: BioBank for Surrogate Marker Research for TB (B-SMART)

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2017-11-21

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This study was terminated September 1, 2021. This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. A5302 is a multi-center trial of the AIDS Clinical Trials Group (ACTG) in collaboration...

The Role of GeneXpert in Bacterial Diagnosis of Spinal Tuberculosis

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2017-10-26

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This study was teriminated June 19, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. India has the maximum burden of tuberculosis (TB) in the world. In 2014, there were an estimated 9.6 million incident...

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Heightened microbial translocation is a prognostic biomarker of recurrent tuberculosis

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2022-03-30

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Clinical Infectious Diseases

Background Microbial translocation is a known characteristic of pulmonary tuberculosis (PTB). Whether microbial translocation is also a biomarker of recurrence in PTB is not known. Methods We examined the presence of microbial translocation in a cohort of newly diagnosed, sputum smear, and culture...

Cycloserine did not increase depression incidence or severity at standard dosing for MDR-TB

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2022-03-24

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European Respitory Journal

In 2018 cycloserine was elevated to World Health Organization (WHO) group B status for multidrug-resistant tuberculosis (MDR-TB), and is recommended in longer MDR-TB treatment regimens [ 1 ]. Inclusion of cycloserine is associated with improved MDR-TB treatment success and reduced mortality, but is...

Shorter treatment for non-severe tuberculosis in African and Indian children

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2022-03-10

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New England Medical Journal

BACKGROUND Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen. METHODS We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-...

Pharmacokinetics and Safety of Three Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women

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2022-03-05

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Clinical Infectious Diseases

Background Pregnancy increases the risk of tuberculosis and its complications. A 3-month regimen of weekly isoniazid and rifapentine (3HP) is safe and effective for tuberculosis prevention in adults and children, including those with HIV, but 3HP has not been evaluated in pregnancy. Methods IMPAACT...

Burden of COVID-19 and Case Fatality Rate in Pune India: An Analysis of First and Second Wave of the Pandemic

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2022-01-22

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IJID Regions

Objective To assess trends in case incidence and fatality rate between the first and second waves, we analyzed programmatic COVID-19 data from Pune city, an epicenter of COVID-19 cases in India. Method The trends of cases incidence, time-to-death and case fatality rate (CFR) were analyzed. Poisson...

Tuberculosis Pathways to Care and Transmission of Multidrug Resistance in India

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2022-01-15

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American Journal of Respiratory Critical Care Medicine

Abstract Rationale: India is experiencing a regional increase in cases of multidrug-resistant tuberculosis (MDR-TB). Objectives: Given the complexity of MDR-TB diagnosis and care, we sought to address key knowledge gaps in MDR risk factors, care delays, and drivers of delay to help guide disease...

Host lipidome and tuberculosis treatment failure

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2022-01-06

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European Respiratory Journal

Introduction: Host lipids play important roles in tuberculosis (TB) pathogenesis. Whether host lipids at TB treatment initiation (baseline) affect subsequent treatment outcomes has not been well characterised. We used unbiased lipidomics to study the prospective association of host lipids with TB...

Implementation of the Comprehensive Unit-based Safety Program to Improve Infection Prevention and Control Practices in Four Neonatal Intensive Care Units in Pune, India

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2022-01-06

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Frontiers in Pediatrics

Objective: To implement the Comprehensive Unit-based Safety Program (CUSP) in four neonatal intensive care units (NICUs) in Pune, India, to improve infection prevention and control (IPC) practices. Design: In this quasi-experimental study, we implemented CUSP in four NICUs in Pune, India, to...

Increased Moxifloxacin Dosing among MDR-TB Patients with Low-Level Resistance to Moxifloxacin did not Improve Treatment Outcomes in a Tertiary Care Center in Mumbai, India

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2021-12-23

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Open Forum Infectious Diseases

Background Mycobacterium tuberculosis (Mtb) strains resistant to isoniazid and rifampin (multidrug-resistant tuberculosis [MDR-TB]) are increasingly reported worldwide, requiring renewed focus on the nuances of drug resistance. Patients with low-level moxifloxacin resistance may benefit from higher...

Impact of HIV status on systemic inflammation during pregnancy

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2021-11-15

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AIDS London

Objective: There are limited studies on the association of HIV infection with systemic inflammation during pregnancy. Design: A cohort study (N = 220) of pregnant women with HIV (N = 70) (all on antiretroviral therapy) and without HIV (N = 150) were enrolled from an...

Validation of New Interactive Nutrition Assistant - Diet in India Study of Health (NINA-DISH) FFQ with multiple 24-h dietary recalls among pregnant women in Pune, India

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2021-11-02

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The British Journal of Nutrition

Adequate dietary intake is critical to prevent adverse pregnancy outcomes. India has a high burden of maternal and child morbidity and mortality, but there is a lack of adequate tools to assess dietary intake. We validate an FFQ, New Interactive Nutrition Assistant - Diet in India Study of Health (NINA-DISH), among pregnant women living with and without HIV in Pune, India.

Tuberculosis Pathways to Care and Transmission of Multidrug-Resistance in India

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2021-11-01

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American Journal of Respiratory and Critical Care Medicine

Rationale: India is experiencing a regional increase in cases of multidrug-resistant tuberculosis (MDR-TB). Given the complexity of MDR-TB diagnosis and care, we sought to address key knowledge gaps in MDR risk factors, care delays, and drivers of delay to help guide disease control. Methods: From...

Outbreak of Mucormycosis in Coronavirus Disease Patients, Pune, India

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2021-09-29

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Emerging Infectious Diseases

Abstract We provide an overview of the epidemiology and clinical course of mucormycosis in the coronavirus disease (COVID-19) pandemic era. We conducted a retrospective chart review of 178 patients with clinical or diagnostic, endoscopically or histopathologically confirmed rhino-sino-orbital or...

Health Systems and Tuberculosis Control

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2021-09-20

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Essential Tuberculosis

This chapter discusses the relationship between health systems and organization of tuberculosis (TB) control, which is generally a part and parcel of a health system. It juxtaposes the six building blocks of a health system identified by the World Health Organization (WHO) on WHO’s End TB...

Modern lineages of Mycobacterium tuberculosis were recently introduced in western India and demonstrate increased transmissibility

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2021-08-21

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Open Forum Infectious Diseases

Background Mycobacterium tuberculosis (Mtb) transmissibility may vary between lineages (or variants) and this may contribute to the slow decline of tuberculosis (TB) incidence. The objective of our study was to compare transmissibility across four major lineages (L1-4) of Mtb among participants...

A Case Study of Intra-Family Clustering of COVID-19 in India

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2021-08-18

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European Journal of Pharmaceutical and Medical Research

Background: With unprecedented COVID-19 disease-related morbidity and mortality globally, understanding the transmission dynamics of this disease is of paramount importance for disease control efforts. Despite the lockdown in India, there has been reported an ever-increasing number of infected...

Urine LAM Testing in Advanced HIV-Infected Adults in a Trial of Empiric TB Therapy

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2021-08-15

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Clinical Infectious Diseases

Background The urine lipoarabinomannan (LAM) antigen test is a tuberculosis (TB) diagnostic test with highest sensitivity in individuals with advanced human immunodeficiency virus (HIV). Its role in TB diagnostic algorithms for HIV-positive outpatients remains unclear. Methods The AIDS Clinical...

Utility of the interferon-gamma release assay for latent tuberculosis infection screening among indian health-care workers

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2021-07-13

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Indian Journal of Community Medicine

Background: The utility of interferon-gamma release assays (IGRAs) for latent tuberculosis infection (LTBI) screening among health-care workers (HCWs) in low- and middle-income countries (LMICs) remains unclear. Methods: This was a prospective cohort study among HCW trainees...

The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial

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2021-07-13

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PLoS One

Background: Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes. Methods: HIV+ breastfeeding (BF) and Formula Feeding (FF)...

Targeted next generation sequencing directly from sputum for comprehensive genetic information on drug resistant Mycobacterium tuberculosis

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2021-07-13

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Tuberculosis

Background: Timely drug resistance detection is essential to global tuberculosis management. Unfortunately, rapid molecular tests assess resistance to only a few drugs, with culture required for comprehensive susceptibility test results. Methods: We evaluated targeted next generation sequencing (...

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