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

Risk of Tuberculosis among Health Care Workers and Trainees in a Tertiary-care Hospital in Pune, India

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2015-04-15

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This study was terminated April 24, 2018. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. A retrospective study of health care workers (HCWs) was conducted by investigators of the Byramjee Jeejeebhoy Medical and...

Predictive Value of TB-symptom Screen in HIV-infected and HIV-uninfected Pregnant Women in Pune, India

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2014-10-28

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This study was terminated July 17, 2017. This is a cross sectional observational study will be conducted at BJGMC to establish what the predictive value of the WHO TB symptom screen is in pregnant women in India. We hypothesize that the WHO TB symptom...

Inflammation in HIV-infected Pregnant Women: Relationship with Diet, Gut Microbiome and Preterm Birth

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2014-10-28

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This study was terminated May 7, 2018. P regnancy is a state of relative immunosuppression in order to protect the fetus from being rejected. It has also been shown that the Th-1 helper cell response, which is normally necessary for overcoming TB infection...

Diagnosis of Tuberculosis Infection and Th1 Immune Response in Pregnant Women in India

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2014-09-01

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This study was terminated April 16, 2018. Tuberculosis (TB) disease is a major cause of mortality among Indian women of reproductive age; approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune...

Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis

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2014-09-01

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This is the Parent Study for CCGHE’s PRACHITI (PRegnancy And CHanges In TuberculosIs) effort. It's supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the U.S. National Institutes of Health. Purpose: TB is a...

A5279: Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-infected Individuals with Latent Tuberculosis Infection

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2014-06-30

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This study ended April 27, 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. Dr. Amita Gupta was Protocol Co-Vice Chair for this multinational clinical trial being conducted in Botswana, Brazil, Haiti,...

Evaluation of Longitudinal Blood Culture Isolates from BJ Medical College in Pune, India, 2003-2013

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2014-06-16

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This study was terminated July 31, 2014. Antibiotic resistance is a serious global problem and is caused by multiple factors which have led to difficulty in the management of life-threatening, multi-drug resistant (MDR) bacterial bloodstream infections. The knowledge of antibiotic resistance...

ART Study 1: Database: Epidemiology of HIV/AIDS and Associated Comorbidities in a Public Antiretroviral Treatment (ART) Clinic at BJGMC in Pune

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2014-06-14

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Hinduja Hospital

Since 2004, the National AIDS Control Program of India has been rolling out free antiretroviral therapy. Byramjee Jeejeebhoy Government Medical College (BJGMC), located in Pune, India, is now the largest HIV clinic in India, with over 26,000 adult and pediatric patients registered since 2005...

Optimizing Treatment to Improve TBM Outcomes in Children

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2014-05-01

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This study, known as TBM Kids, is being conducted in India and Malawi. Primary Objectives To characterize the pharmacokinetics (PK) (plasma and cerebrospinal fluid (CSF)) of rifampicin given at model-derived optimal daily doses and...

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

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2014-04-01

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This is a clinical trial conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Dr. Amita Gupta is Protocol Chair for this multinational clinical trial being conducted in...

Screening for Gender Based-violence (GBV) and Feasibility and Acceptability of mHealth GBV Screening and Support Tools

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2014-03-26

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This study was terminated February 14, 2017. Gender-based violence (GBV) is a significant public health issue in India, with estimates that over a third of women and girls are impacted at some point in their lifetime. This pilot qualitative study examined the feasibility of enhancing GBV prevention...

Evaluation of HIV Disease Burden in Hospitalized Patients at Sassoon General Hospital in Pune, India

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2013-11-18

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This study was terminated September 13, 2005. The goal of this project was to conduct both a retrospective and prospective epidemiological study of the burden of HIV disease at Sassoon General Hospital. The specific objectives of the study were to establish the proportion of...

Tuberculosis Noon Conference

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2013-10-24

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Hinduja Hospital

This effort ended in 2015. As part of the BJGMC-Johns Hopkins India Fogarty Training Program, from 2013-2015 CCGHE hosted the live Tuberculosis Noon Conference webcast. Led by Drs. Maunank Shah, Jonathan Golub, and Richard Chaisson, these webcast meetings brought together Johns Hopkins TB...

Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH)

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2013-09-28

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Collaboratively funded by the US NIH, India’s Department of Biotechnology [DBT], and Indian Council of Medical Research, the Cohort for TB Research by the Indo-US Medical Partnership (C-TRIUMPH) is an Indo-US research consortium that is part of RePORT India, a countrywide consortium for TB...

Assessing the Association of Indoor Air Pollution with Tuberculosis in Adult Women and Children under 5 Years of Age

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2013-09-15

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This study is conducted 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. Addressing social and...

Community Home Based India Prevention of Mother to Child Transmission of HIV (COMBIND)

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2013-09-02

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This study ended May 14, 2019. CCGHE is assessing whether equipping Community Health Workers with mobile health technology and involving them in technology training and personal empowerment seminars can help prevent mother-to-child...

Epidemiological Assessment of Pediatric Tuberculosis in Pune, India, through Contact Tracing

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2013-06-10

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This study ended in June 2016. Approximately 1 million new cases of Tuberculosis occur among children each year around the world, with a large number of these cases occurring among indigent populations without access to adequate healthcare facilities (World Health Organization). Due to their high...

Impact of Diabetes on TB Treatment Outcomes

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2013-02-01

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CCGHE, the JHU Center for TB Research and BJGMC have been awarded a $2.5 million dollar NIH grant (2013-2018) to conduct a study to evaluate treatment outcomes among Indian patients with both diabetes mellitus and active TB. This study is assessing the prevalence of impaired glucose or frank...

Bacterial Antimicrobial Resistance Patterns in Pune, India

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2013-01-10

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This study was terminated September 24, 2019. Evaluate etiology of acute fever and bacterial drug resistance patterns among adults and children in India.

ONCOGRID: An mHealth Approach to Prevention and Early Diagnosis of Oral Cancer in Rural South India

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2012-11-01

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This study ended February 7, 2017. The Indian sub-continent is burdened with 80% of the world’s patients with oral cancer, and delay in oral cancer diagnosis is one of the major problems that leads to poor treatment outcomes (V. Shanta, R. Swaminathan, R...

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Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

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2019-10-03

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New England Journal of Medicine

New England Journal of Medicine: Dr. Amita Gupta and colleagues found that the current standard of care given to HIV+ pregnant women to prevent TB should wait until 12 weeks after delivery. The study underscores the need to include pregnant women in clinical trials.

Challenges in conducting trials for pediatric tuberculosis meningitis: lessons learned in the field

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2019-10-01

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International Journal of Tuberculosis and Lung Disease

International Journal of Tuberculosis and Lung Disease: Researchers describe the challenges associated with conducting the first randomized clinical trial of antimicrobial agents in pediatric tuberculosis meningitis.

Re: A Shorter Regimen for Rifampin-Resistant Tuberculosis

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2019-09-12

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Hinduja Hospital

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New England Journal of Medicine

Dr. Jeff Tornheim and colleagues respond to an NEJM article about shorter course TB treatment.

Use of smartphone-based video Directly Observed Therapy (vDOT) in tuberculosis care: Single-arm, prospective feasibility study

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2019-08-30

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Journal of Medical Internet Research

Video-based monitoring is increasingly used as an efficient and low cost alternative to in-person observation and monitoring of TB patients. It showed promise in the high TB setting of India, too.

Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons

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2019-08-15

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PLOS Medicine

PLOS Medicine: Dr. Amita Gupta and colleagues discuss the scientific and ethical basis for including pregnant and lactation women, children, and HIV+ patients in tuberculosis therapeutic clinical trials.

Smoking, alcohol use disorder and tuberculosis treatment outcomes: A dual co-morbidity burden that cannot be ignored

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2019-07-31

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PLoS One

BACKGROUND: More than 20% of tuberculosis (TB) disease worldwide may be attributable to smoking and alcohol abuse. India is the second largest consumer of tobacco products, a major consumer of alcohol particularly among males, and has the highest burden of TB globally. The impact of...

Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study

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2019-07-29

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Lancet HIV

BACKGROUND: Antiretroviral therapy (ART) management is challenging for individuals in resource-limited settings presenting for third-line treatment because of complex resistance patterns, partly due to reduced access to viral load monitoring. We aimed to evaluate use of newer...

Infection free "resisters" among household contacts of adult pulmonary tuberculosis

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2019-07-18

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PLoS One

Despite substantial exposure to infectious pulmonary tuberculosis (TB) cases, some household contacts (HHC) never acquire latent TB infection (LTBI). Characterizing these "resisters" can inform who to study immunologically for the development of TB vaccines. We enrolled HHCs of culture-confirmed...

Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology

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2019-07-15

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PLoS Medicine

Summary points Translational and clinical pharmacology are the state-of-the-art tools used by drug developers to efficiently move compounds and regimens through all drug development phases. Tuberculosis drug and regimen development, though, has traditionally underutilized these modern, model-based...

High risk for latent tuberculosis infection among medical residents and nursing students in India

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2019-07-08

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PLoS One

PLoS ONE: Self-reported TB exposure is underreported, and uptake of LTBI prevention therapy remains low

Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology

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2019-07-05

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PLOS

Application of clinical pharmacology best practices is essential to the efficient and rational development of drugs. In general, knowledge gained about exposure–response relationships in preclinical models aids drug and dose selection in human studies, and biomarkers and pharmacokinetic (PK) data...

Mobile phone access and comfort: implications for HIV and tuberculosis care in India and South Africa.

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2019-07-01

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International Journal of Tuberculosis and Lung Disease

SETTING: India and South Africa shoulder the greatest burden of tuberculosis (TB) and human immunodeficiency virus (HIV) infection respectively, but care retention is suboptimal. OBJECTIVE: We conducted a study in Pune, India, and Matlosana, South Africa ...

Age-specific prevalence of TB infection among household contacts of pulmonary tuberculosis: Is it time for TB preventive therapy?

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2019-06-21

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Transactions of the Royal Society of Tropical Medicine and Hygiene

BACKGROUND: Household contacts (HHCs) of TB patients are at high risk of developing evidence of latent TB infection (LTBI) and active disease from the index patient. We estimated the age-specific prevalence of LTBI and the force of infection (FI), as a measure of recent transmission, among HHCs of...

Assessment of lung function in successfully treated tuberculosis reveals high burden of ventilatory defects and COPD

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2019-05-23

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PLoS One

New in PLoS One: We found a high burden of lung function defects and COPD in tuberculosis cases who successfully completed treatment, suggesting a need for lung function screening as part of patient management.

High prevalence of insulin resistance and occurrence prior to hyperinsulinemia threshold among people living with HIV in Pune, India

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2019-05-21

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Diabetes Metabolic Syndrome: Clinical Research & Reviews

BACKGROUND Diabetes prevalence in HIV is not well characterized for India, despite the high burden of both individual diseases. Epidemiology of insulin resistance (IR): a precursor to diabetes, and its associated risk factors are also poorly understood in Asian Indian people living with HIV (PLHIV...

Subtherapeutic rifampicin concentration is associated with unfavourable tuberculosis treatment outcomes

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2019-05-10

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Clinical Infectious Diseases

Rifampicin concentrations were sub-therapeutic in most Indian patients taking a thrice-weekly TB regimen

Respiratory health status is associated with treatment outcomes in pulmonary tuberculosis

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2019-04-19

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The International Journal of Tuberculosis and Lung Disease

BACKGROUND: The association between respiratory impairment and tuberculosis (TB) treatment outcomes is not clear. METHODS: We prospectively evaluated respiratory health status, measured using the Saint George's Respiratory Questionnaire (SGRQ), in a cohort of new adult pulmonary TB cases during and...

The burden of diabetes in India

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2019-04-01

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The Lancet Global Health

The India State-Level Disease Burden Initiative Diabetes Collaborators (December, 2018)1 provide a comprehensive overview of the diabetes burden in India. The authors point out some limitations in estimates due to inadequacies in the data. Nevertheless, on the basis of my field experience in India...

Feasibility of identifying household contacts of rifampin- and multidrug-resistant tuberculosis cases at high risk of progression to tuberculosis disease

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2019-03-28

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Clinical Infectious Diseases

We assessed multidrug-resistant tuberculosis (MDR-TB) cases and their household contacts (HHCs) to inform the development of an interventional clinical trial.

Willingness to take multidrug-resistant tuberculosis (MDR-TB) preventive therapy among adult and adolescent household contacts of MDR-TB index cases: an international multi-site cross-sectional study

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2019-03-28

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Clinical Infectious Diseases

Abstract BACKGROUND: Household contacts (HHCs) of individuals with multidrug-resistant tuberculosis (MDR-TB) are at high risk of infection and subsequent disease. There is limited evidence on the willingness of MDR-TB HHCs to take MDR-TB preventive therapy (TPT) to decrease their risk of TB disease...

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