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 MaveDr. 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:

CCGHE WORK IN INDIA

Assessing Psychological Distress among Tuberculosis Patients and Their Household Members

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2018-07-17
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By assessing psychological distress, Indo-JHU researchers hope to better understand the correlation between depression and TB severity.

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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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 are Dr...

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 populations are...

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. Diagnosis of TB disease is...

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 Investigator is...

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

Post Date: 
2018-03-20
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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

Post Date: 
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 laboratory research, for junior...

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 barriers and facilitators...

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 with the Tuberculosis Trials Consortium (...

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 cases of TB (range, 9.1 million–10.0 million)...

Assessment of Cardiovascular Health Knowledge, Preventive Practices and Cardio-protective Behavior among HIV-infected Individuals in Pune, India

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2017-10-12
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This study is conducted under the TREAT Asia Network and funded by amfAR. Cardiovascular Diseases (CVD) have become one of the leading causes of death among PLWH (People Living with HIV) across the globe. The burden that CVD will pose in the imminent future for the 2.1...

Characteristics Associated with Mobile Phone Usage among TB Populations in Pune, India

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2017-10-02
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With 8.6 million people affected worldwide in 2012, the control and prevention of tuberculosis (TB) has become an international priority. In order to reduce burdens and achieve global goals for TB control, new and innovative tools are necessary. With a growing number of mobile phone subscriptions...

Lipid Mediators of Inflammation in TB and TB-Diabetes

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2017-10-02
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This study was terminated August 1, 2019. It was funded and conducted under the U.S. National Institutes of Health and is nested within Impact of Diabetes on TB Treatment Outcomes. Dr. Jonathan Golub was the PI. Studies have shown that individuals with Tuberculosis (TB) and diabetes (TB-DM) have a...

Targeting Mycobacterium Tuberculosis Persisters by Enhancing Stringent Response-specific Cellular Immunity

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2017-09-11
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C-TRIUMPH nested study begins to see if stringent response antigen is enhanced while treating drug-susceptible TB using the first-line anti-TB regimen.

Zika Surveillance among Antenatal Clinic Outpatients in BJ Government Medical College and Sassoon General Hospitals, Pune, India

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2017-08-31
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This study was terminated July 21, 2020. Zika virus is a vector-borne disease carried by the mosquito Aedes aegypti . Pregnant women infected with Zika may pass the virus to the fetus, which may cause microcephaly and other severe brain defects. It is also linked to miscarriage, stillbirth, and...

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HIV, Pregnancy, and Isoniazid Preventive Therapy. Reply

Post Date: 
2020-03-19
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The New England Journal of Medicine
Gupta et al. (Oct. 3 issue)1 report a higher incidence of adverse pregnancy outcomes among women with human immunodeficiency virus (HIV) infection who were exposed to isoniazid preventive therapy (IPT) during the second and third trimesters than among those not exposed to IPT during pregnancy. From...

High prevalence of late presentation of ART-naïve perinatally infected children for care in Pune, India

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2020-02-19
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AIDS Care
AIDS Care : There is an urgent need to identify strategies that improve linkage of perinatally infected ART-naïve children to care, and earlier than what is currently observed.

Evaluating the Concordance of Clinician Antiretroviral Prescribing Practices and HIV-ASSIST, an Online Clinical Decision Support Tool

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2019-12-02
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Journal of General Internal Medicine
Recent studies have shown that more than half of HIV care is provided by primary care practitioners.However, clinicians with experience and expertise in HIV medicine are declining.

MAL adaptor (TIRAP) S180L polymorphism and severity of disease among tuberculosis patients

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2019-10-31
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Infection, Genetics, and Evolution
Infection, Genetics, and Evolution : We investigated the association of TIRAP variants with severity of TB disease and IP-10 production in humans, which may be useful in predicting poor clinical outcome

Incidence of tuberculosis in HIV-infected adults on first- and second-line antiretroviral therapy in India

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2019-10-29
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BMC Infectious Diseases
In this study among people living with HIV, Akshay Gupte and colleagues found that the risk of acquiring tuberculosis was higher in those receiving first-line antiretrovial therapy versus those receiving second-line medications.

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

Post Date: 
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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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...

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