Nikhil Gupte, PhD

Pune, India

Role:

Staff

Deputy Director, BJGMC Clinical Research Site

Dr. Gupte is Deputy Director of the BJGMC-JHU Clinical Research Site, a collaborative research partnership associated with the world’s largest HIV therapeutic trials networks, the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric and Adolescent AIDS Clinical Trial Network (IMPAACT). He is also the Director of Data Management and Biostatistics for the center.

Dr. Gupte has more than 20 years of experience in public health research in developing countries and is a recognized leader in biostatistics education in India. Based in Pune, India, Dr. Gupte is the lead statistician for the BJGMC-JHU CRS, which conducts Phase I, II and III clinical trials of therapeutic drug interventions for HIV and co-morbid infections, such as tuberculosis and hepatitis, in adults (including pregnant women) and children. An experienced educator, Dr. Gupte has developed and taught biostatistics courses in India, including a number of University courses and NIH-supported training courses, and he currently leads the Biostatistics training for the BJGMC-JHU Fogarty HIV-TB Training Program.

A recipient of the Hopkins Fogarty fellowship, Dr. Gupte received a PhD in biostatistics from the Johns Hopkins Bloomberg School of Public Health.

Studies/Projects
Publications

Host RNA Expression for Diagnosis and Monitoring of Pediatric TB in Africa and India

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2018-12-13

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We are leveraging the RePORT platform by including a cohort of Indian children together with South African children in a large validation study to study on changes in gene expression profiles during treatment for TB

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...

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...

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...

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...

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...

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...

Association of Lipid Mediators of Inflammation with TB Treatment Outcomes

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2017-08-03

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This study was terminated July 22, 2019. This study used 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...

Understanding Quality of Life during and Loss to Follow-up from Drug-Resistant Tuberculosis Treatment in Pune, India

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2017-05-15

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This study will examine a) risk factors for loss to follow-up from DR-TB treatment, b) actively trace DR-TB patients lost to follow-up from treatment and c) establish a prospective observational cohort of MDR-TB, XDR-TB and DS-TB patients as well as healthy controls nested within ongoing...

Risk Factors for Unfavourable Treatment Outcomes among Multidrug-Resistant Tuberculosis Patients in Public Sector Treatment in Pune

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2017-03-29

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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. This study seeks to identify risk factors associated with unfavourable treatment outcomes (death, treatment failure, default, XDR-TB) among multidrug-resistant...

Biomarkers for Tuberculosis Diagnosis and Treatment Response

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2017-03-24

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This study is conducted by 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. Aims: ...

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Integrative multi-omics reveals serum markers of tuberculosis in advanced HIV

Post Date:

2021-06-08

Publication:

Frontiers in Immunology

Tuberculosis (TB) accounts for disproportionate morbidity and mortality among persons living with HIV (PLWH). Conventional methods of TB diagnosis, including smear microscopy and Xpert MTB/RIF, have lower sensitivity in PLWH. Novel high-throughput approaches, such as miRNAomics and metabolomics,...

Diabetes Mellitus and Tuberculosis Treatment Outcomes in Pune, India

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2021-04-01

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Open Forum Infectious Diseases

Background Diabetes mellitus (DM) increases the risk of tuberculosis (TB) disease. Knowledge of the impact of DM on TB treatment outcomes is primarily based on retrospective studies. Methods We conducted a prospective cohort study of new pulmonary TB patients with and without DM (TB-DM and TB only...

Unhealthy alcohol use independently associated with unfavorable TB treatment outcomes among Indian men

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2021-03-10

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International Journal of Tuberculosis and Lung Disease

This study by Samyra Cox and colleagues highlights the need for integrating effective alcohol interventions into TB care.

Stages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium Tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort study in Pune, India

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2021-01-11

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IJID

Background Accurate tuberculosis infection (TBI) tests are critical for pregnant women, especially those with HIV, who have a high risk of TB disease. Methods We enrolled interferon gamma release assay (IGRA)+ pregnant women with and without HIV in a longitudinal study, followed up at delivery and...

Measuring TB drug levels in the hair in adults and children to monitor drug exposure and outcomes

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2021-01-01

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International Journal of Tuberculosis and Lung Disease

INTRODUCTION: Testing for anti-TB drugs in small hair samples may serve as a non-invasive tool to measure cumulative drug exposure and/or adherence, as these determine treatment success. We aimed to assess how well hair assays of TB drugs predict TB treatment outcomes.METHODS: A small thatch of...

Integration of metabolomics and transcriptomics reveals novel biomarkers in the blood for tuberculosis diagnosis in children

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2020-11-11

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Scientific Reports

Pediatric tuberculosis (TB) remains a major global health problem. Improved pediatric diagnostics using readily available biosources are urgently needed. We used liquid chromatography-mass spectrometry to analyze plasma metabolite profiles of Indian children with active TB (n = 16) and age- and sex...

Assessment of persistent depression among TB patients

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2020-11-01

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International Journal of Tuberculosis and Lung Disease

(No abstract available)

Mental health and quality of life among healthcare professionals during the COVID-19 pandemic in India

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2020-09-11

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Brain and Behavior

Background: The COVID-19 pandemic has placed healthcare professionals (HCP) in stressful circumstances with increased patient loads and a high risk of exposure. We sought to assess the mental health and quality of life (QoL) of Indian HCPs, the fourth highest-burden country for COVID-19. Method:...

Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India

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2020-07-29

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PLoS One

PLoS One: Dr. Mandar Paradkar and colleagues conducted a CTRIUMPH study that supports TB preventive therapy for all household contacts of pulmonary TB patients in India

Impact of the Fogarty Training Program on Trainee and Institutional Research Capacity Building at a Government Medical College in India

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2020-07-28

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Annals of Global Health

Gauri Dumal and colleagues assess the impact of the 5-year HIV-TB research training program on building individual research capacity at BJGMC.

Mullen Scales of Early Learning Adaptation for Assessment of Indian Children and Application to Tuberculous Meningitis

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2020-07-04

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Journal of Tropical Pediatrics

Introduction: Tuberculous meningitis (TBM) results in significant morbidity and mortality among children worldwide. Associated neurocognitive complications are common but not well characterized. The Mullen Scales of Early Learning (MSEL), a well-established measure for assessment of...

A mobile health-facilitated behavioral intervention for community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India: A cluster randomized trial

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2020-07-03

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Journal of the International AIDS Society

When community health workers used a mobile health intervention with HIV+ women to deliver care, there was a higher uptake of exclusive breastfeeding at two months and early infant HIV diagnosis at six weeks

Impact of Nationwide and Regional Lockdowns on Incident COVID-19 Cases in Pune City, India

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2020-06-16

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Scientific Reports

Assessing the impact of lockdowns on COVID-19 incidence may provide important lessons for management of pandemic in resource-limited settings. We examined growth of incident confirmed COVID-19 patients before, during and after lockdowns during the first wave in Pune city that reported the largest...

Acceptability and Feasibility of a Behavioral and Mobile Health Intervention (COMBIND) Shown to Increase Uptake of Prevention of Mother to Child Transmission (PMTCT) Care in India

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2020-05-24

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BMC Public Health

A cluster-randomized trial recently demonstrated that an integrated behavioral and mobile technology intervention improved uptake of key components of a Prevention of Mother to Child Transmission (PMTCT) Option B+ program, among HIV- infected pregnant/breastfeeding women in India.

Assessment of the Xpert assay among new pulmonary tuberculosis suspects with and without diabetes mellitus

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2020-01-01

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International Journal of Tuberculosis and Lung Disease

IJTLD: Deshmukh and colleagues: High sensitivity and specificity of Xpert underscores need for rapid scale up for early detection of TB in settings with a high dual burden of TB and DM

Transcriptomic profiles of confirmed pediatric tuberculosis patients and household contacts identifies active tuberculosis, infection, and treatment response among Indian children

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2019-12-04

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Journal of Infectious Diseases

Journal of Infectious Diseases: Gene expression profiles among Indian children with confirmed TB were distinct from those of adults, highlighting the importance of including distinct populations in differential gene expression models

A parsimonious host inflammatory biomarker signature predicts incident TB and mortality in advanced HIV

Post Date:

2019-11-25

Publication:

Clinical Infectious Diseases

BACKGROUND: People with advanced HIV (CD4<50) remain at high risk of TB or death despite the initiation of antiretroviral therapy. We aimed to identify immunological profiles that were most predictive of incident TB disease and death. METHODS: The REMEMBER randomized clinical trial enrolled 850...

Lipid mediators of inflammation and resolution in individuals with tuberculosis and tuberculosis-diabetes

Post Date:

2019-11-11

Publication:

Prostaglandins and Other Lipid Mediators

Individuals with concurrent tuberculosis (TB) and Type 2 diabetes (DM) have a higher risk of adverse outcomes. To better understand potential immunological differences, we utilized a comprehensive panel to characterize pro-inflammatory and pro-resolving (i.e., mediators involved in the resolution...

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.

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