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

Cost-effectiveness of Xpert MTB/RIF for Diagnosing Pulmonary Tuberculosis in HIV-positive Patients

Post Date:

2016-12-01

|

Countries:

|

Clinical Sites:

This study was terminated October 8, 2019. This is a prospective cross-sectional study which will be conducted at BJGMC in Pune, India. The aim of this study is to see whether Xpert MTB/RIF is useful for early detection of pulmonary tuberculosis, and therefore cost-effective, as compared with...

The Evaluation of Clinical Profile and Mortality of Children Admitted with Tuberculosis in Pediatric Intensive-Care Unit at Sassoon General Hospitals, Pune

Post Date:

2016-10-27

|

Countries:

|

Clinical Sites:

This study was terminated October 27, 2019. Tuberculosis (TB) is one of the most common causes of infection-related death globally. TB was declared global public health emergency in 1993 by World HealthOrganization (WHO). Mortality due to TB is increasing due to emergence of multidrug resistant (...

Transcriptomic and Metabolomic Analysis of Microbiologically Confirmed Pediatric Tuberculosis Patients and Uninfected Household Contacts

Post Date:

2016-09-01

|

Countries:

|

Clinical Sites:

This study was terminated in June 2020. 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...

Establishing an Observational Cohort Database for Patient Care and Research at the Hinduja Hospital Chest Clinic

Post Date:

2016-08-30

|

Countries:

|

Clinical Sites:

Hinduja Hospital

India has the largest burden of global tuberculosis (TB), accounting for one quarter of the total number of cases reported. Together with South Africa, India sees one-third of the total number of deaths from TB. Drug-resistant strains of the disease are also on the rise, with India having one...

Measuring TB Drugs in Hair as a Tool to Monitor Adherence, Exposure and Response in Patients with HIV

Post Date:

2016-08-16

|

Countries:

|

Clinical Sites:

Our study will examine whether hair levels of two key first line tuberculosis drugs will be useful markers to identify individuals at highest risk of treatment failure in active tuberculosis. Our study aims to provide a lowcost clinical tool using hair that can be noninvasively...

Adherence to Indian National Guidelines for Isoniazid Chemoprophylaxis among Pediatric Contacts of Pulmonary Tuberculosis Cases

Post Date:

2016-07-06

|

Countries:

|

Clinical Sites:

This study was terminated June 19, 2019. The primary objective of the study was to assess the implementation of the Indian Revised National Tuberculosis Programme's (RNTCP) guidelines regarding isoniazid preventive treatment (IPT) for children under 6 years of age who had been in contact with...

TB and Pregnancy Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis: Nested Study on Temporal Dynamics of Gut Microbiota in HIV Infected Pregnant Women

Post Date:

2016-07-05

|

Countries:

|

Clinical Sites:

This is a nested prospective longitudinal cohort study of 35 HIV-infected and 35 HIV-noninfected pregnant women who are part of the parent study “Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis." The objectives are to: Determine the association...

A Randomized Therapeutic Interventional Comparative Study between Three Different Modalities of Paediatric Antitubercular Treatment

Post Date:

2016-06-13

|

Countries:

|

Clinical Sites:

This study was terminated July 6, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. This study evaluated three different TB treatment regimens in children attending Sassoon General Hospital in Pune, India. A...

Optimal Algorithmic Diagnosis of Genital TB among HIV-infected and Uninfected Infertile Women

Post Date:

2016-05-26

|

Countries:

|

Clinical Sites:

This study was terminated March 2020. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. There is a lack of a set protocol universally for diagnosis of genital TB, and for Indian hospitals, India's Revised National...

Whole Genome Sequencing and Trek Sensititre Testing of Stored Isolates of Drug-resistant Tuberculosis from a Clinical Cohort at Hinduja Hospital, Mumbai

Post Date:

2016-05-02

|

Countries:

|

Clinical Sites:

Hinduja Hospital

Among HIV-positive TB patients presenting to Médecins San Frontières (MSF) clinics in Mumbai, 78% carried MDR-TB strains, with nearly half also found to have additional drug resistance. A previously published cohort of 202 patients cared for at these MSF clinics have enrolled in a...

Barriers to Early Treatment Initiation in Childhood Tuberculosis in High Incidence Setting

Post Date:

2016-04-21

|

Countries:

|

Clinical Sites:

This study was terminated October 25, 2019. Funded by the Fogarty International Center and led by PI Dr. Chhaya Tukaram Valvi, the aim of this study is to evaluate the time to treatment initiation and barriers to early treatment initiation in childhood tuberculosis. TB...

Barriers to Implementation of Isoniazid Preventive Treatment (IPT) in Pediatric Contacts of Sputum Positive Adults with Tuberculosis

Post Date:

2016-03-24

|

Countries:

|

Clinical Sites:

This study was terminated January 3, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Young children infected with M.tuberculosis can rapidly progress to pulmonary and extrapulmonary disease with high rates of mortality and...

The Human Virome in Health and Disease

Post Date:

2016-02-21

|

Countries:

|

Clinical Sites:

This study was terminated in September 2020. This study is part of the Antimicrobial Resistance study referenced below, Some samples were used from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional...

Whole Genome Sequencing of Clinical Isolates from Patients with Multidrug Resistant Tuberculosis in India

Post Date:

2015-11-12

|

Countries:

|

Clinical Sites:

This study was terminated August 9, 2019. Comparative genomic analysis using whole genome sequencing (WGS) offers an opportunity to understand the specific mutations associated with drug resistance and the phenotypic behavior of TB. As treatment programs incorporate more...

Residual Respiratory Impairment Following Pulmonary Tuberculosis

Post Date:

2015-09-13

|

Countries:

|

Clinical Sites:

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. Many TB patients have...

A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Post Date:

2015-09-01

|

Countries:

|

Clinical Sites:

This clinical trial was terminated July 18, 2017. It was a study conducted under both the AIDS Clinical Trial Group (ACTG) and the the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and funded by the U.S. National Institutes of Health. Dr...

Prevalence Survey of Risk Factors for Tuberculosis and Non-communicable Diseases in an HIV-positive Population in Pune, India

Post Date:

2015-08-17

|

Countries:

|

Clinical Sites:

This study is conducted under the TREAT Asia Network and funded by amfAR. The primary objective of this study is to assess the prevalence of risk factors for tuberculosis and non-communicable diseases (NCDs)--coronary artery disease and diabetes mellitus--...

A5290: A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis...

Post Date:

2015-07-07

|

Countries:

|

Clinical Sites:

This study was terminated February 23, 2016; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health.. Full Title: A5290, A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen...

Bacterial Antimicrobial Resistance Patterns in Pune, India: Substudy on Community Health-Seeking Behavior Among Patients Admitted with Acute Febrile Illness

Post Date:

2015-05-28

|

Countries:

|

Clinical Sites:

Objectives: To describe the patterns of health-care seeking behavior and prior outpatient care among patients admitted with acute febrile illness to Sassoon Hospital To determine the effects of outpatient behaviors and prior treatments on the antimicrobial...

Barriers for Intervention to Prevent Occupationally Acquired Tuberculosis in Healthcare Workers

Post Date:

2015-05-21

|

Countries:

|

Clinical Sites:

This study was terminated April 20, 2017; it was funded by the Fogarty International Center at the U.S. National Institutes of Health. Observational study to assess the current status of implementation of interventions for preventing occupationally acquired...

Pages

The Impact of Hypertension and Use of Calcium Channel Blockers on Tuberculosis Treatment Outcomes

Post Date:

2020-09-24

|

Countries:

Publication:

Clinical Infectious Diseases

Background: Hypertension induces systemic inflammation, but its impact on the outcome of infectious diseases like tuberculosis (TB) is unknown. Calcium channel blockers (CCB) improve TB treatment outcomes in pre-clinical models, but their effect in patients with TB remain unclear. Methods: This...

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

Post Date:

2020-09-11

|

Countries:

Publication:

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:...

Pharmacokinetics and drug-drug interactions of isoniazid and efavirenz in pregnant women living with HIV in high TB incidence settings: importance of genotyping

Post Date:

2020-09-09

|

Countries:

Publication:

Clinical Pharmacology and Therapeutics

World Health Organization guidelines recommend that individuals living with HIV receive ≥6 months of isoniazid preventive therapy, including pregnant women.

The effect of TB treatment on health-related quality of life for people with advanced HIV

Post Date:

2020-09-01

|

Countries:

Publication:

International Journal of Tuberculosis and Lung Disease

BACKGROUND: Study A5274 was an open-label trial of people with HIV (PLHIV) with CD4 cell count <50 cells/µL who were randomized to empirical TB treatment vs. isoniazid preventive therapy (IPT) in addition to antiretroviral therapy (ART). We evaluated health-related quality of life (HRQoL) by...

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

Post Date:

2020-07-29

|

Countries:

|

Clinical Sites:

Publication:

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

Post Date:

2020-07-28

|

Countries:

|

Clinical Sites:

Publication:

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.

Effects of Pregnancy and Isoniazid Preventive Therapy on M. tuberculosis Interferon Gamma Response Assays in Women with HIV

Post Date:

2020-07-28

|

Countries:

Publication:

Clinical Infectious Diseases

944 women with HIV participating in a randomized, double-blind, placebo-controlled study comparing 28 weeks of IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST) at delivery and postpartum.

Clinical features associated with linezolid resistance among multidrug resistant tuberculosis patients at a tertiary care hospital in Mumbai, India

Post Date:

2020-07-24

|

Countries:

Publication:

Journal of Clinical Tuberculosis and other Mycobacterial Diseases

Background: Multidrug-resistant tuberculosis (MDR-TB) is an increasing problem worldwide, and 24% occurs in India. Linezolid is associated with improved MDR-TB treatment outcomes but causes significant side-effects and drug susceptibility testing (DST) is rarely available. This study assessed...

Drug resistant TB spine in a two year old child: A case report

Post Date:

2020-07-14

|

Countries:

Publication:

Indian Journal of Tuberculosis

Spinal tuberculosis (TB) is a disease of high morbidity that is associated with deformity and neurological sequelae, especially in growing children. Children diagnosed with spinal TB need to be monitored closely for clinical improvements. Previous history of antituberculous therapy (ATT), poor...

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

Post Date:

2020-07-04

|

Countries:

Publication:

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

Post Date:

2020-07-03

|

Countries:

|

Clinical Sites:

Publication:

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

Trends and gender differences in access to HIV care with scale up of national HIV treatment guidelines in India

Post Date:

2020-06-24

|

Countries:

Publication:

Journal of the International Association of Providers of AIDS Care

Test and treat is the current global standard, yet sex differences persist in access to HIV care. We assessed the differences in presentation and antiretroviral therapy (ART) uptake by sex and ART-eligibility period among ART-naive adults registered at a public ART center in India. Four ART...

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

Post Date:

2020-06-16

|

Countries:

|

Clinical Sites:

Publication:

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

Post Date:

2020-05-24

|

Countries:

Publication:

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.

Intensified short symptom screening program for Dengue infection during pregnancy, India

Post Date:

2020-04-15

|

Countries:

|

Clinical Sites:

Publication:

Emerging Infectious Diseases

Mosquitoborne diseases (e.g., malaria, dengue, and chikungunya) are endemic to India and pose diagnostic challenges during pregnancy. We evaluated an intensified short symptom screening program in India to diagnose dengue during pregnancy. During October 2017-January 2018, we screened pregnant...

HIV, Pregnancy, and Isoniazid Preventive Therapy. Reply

Post Date:

2020-03-19

|

Countries:

Publication:

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

Post Date:

2020-02-19

|

Countries:

|

Clinical Sites:

Publication:

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

Post Date:

2019-12-02

|

Countries:

Publication:

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

Post Date:

2019-10-31

|

Countries:

|

Clinical Sites:

Publication:

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

Post Date:

2019-10-29

|

Countries:

|

Clinical Sites:

Publication:

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.

Pages