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

ACCELERATE

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2022-09-08

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Under the directives of PEPFAR, with support from USAID, and in collaboration with NACO, the ACCELERATE program provides HIV/AIDS services for high-risk populations including key populations affected by HIV throughout India and technical assistance (TA) to the national, state, and district HIV/AIDS...

Kidaba Thawai (Fearless Souls) Documentary

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2022-09-08

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The documentary Kidaba Thawai is based on ACCELERATE's intervention - an Adolescent Friendly Health Center (AFHC) in Imphal, Manipur. The documentary discusses AFHC's comprehensive health care delivery model (HIV and non-HIV services) which contributes to the holistic development of adolescents. A...

Prevalence of gestational diabetes (GDM) and postpartum diabetes (DM) and their risk factors at Sassoon General Hospital and Byramjee Jeejeebhoy Government Medical College in Pune, India

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2021-12-19

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Primary objective: To determine the prevalence of GDM in a population of women in our hospital To identify the risk factors for GDM and determine the prevalence of GDM risk factors in a population of women screened for GDM and their association with GDM To determine the incidence and time course of...

Creating a Hope: A Mixed-Method Approach to Identify Most Acceptable Evidence-Based Psycho-Social Intervention to Improve the Retention in Care among Indian Youth Diagnosed with Multi-Drug Resistant TB (MDR-TB)

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2021-11-02

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PURPOSE: Adolescents and youths with MDR/RR tuberculosis reported social isolation, stigmatization, depression, and poor self-esteem highlighting the importance of psychosocial support during tuberculosis treatment phase. Addressing the psycho-social need of youths, by identifying youth friendly...

“Bridging the Gaps”: Understanding the Barriers and Facilitators in the Tuberculosis Prevention Care Cascade for Optimizing Isoniazid Preventive Therapy Uptake among Adults Living with HIV in India, a Mixed-Method Approach

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2021-11-02

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PURPOSE: The isoniazid preventive therapy policy has achieved limited success in low and middle-income countries. With limited empirical research exploring the barriers to suboptimal IPT uptake, it is important to understand this knowledge gap. Also, limited programmatic strategies exist to address...

Childhood ‘Omics’ and Mycobacterium tuberculosis-derived BiOsignatures (COMBO) for TB diagnosis

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2021-10-18

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The overall objective of the project is to identify Mtb- and/or host-derived biosignatures in children that can achieve World Health Organization (WHO) target product profile (TPP) accuracy thresholds for a non-sputum biomarker-based triage or diagnostic test for childhood TB. We hypothesize that...

Epidemiologic Factors Associated with TB Treatment Outcomes Across Report International Consortia

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2021-08-12

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Rationale: RePORT International was designed to enable cross-consortium data analysis. Now that a large number of consortium sites have completed participant enrollment in Common Protocol Cohort A, we can proceed with large-scale analysis of aligned RePORT data. The current study will harmonize and...

A5362: A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

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2021-06-15

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Primary Hypothesis A 3-month regimen of rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) with clofazimine (CFZ) dosed as 100 mg daily with a 2-week 300 mg daily loading dose (Arm 1) will demonstrate early efficacy (time to 12-week liquid culture conversion) relative to standard of care (SOC) (...

P2026: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum

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2021-05-18

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IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women, studied the PK of more than 25 HIV and TB drugs in these women and published 27 manuscripts presenting these data. P1026s data was cited in 32% of the 76 perinatal...

The Pharmacokinetics, Safety and Acceptability of New Child-Friendly Formulations of Clofazimine and Moxifloxacin in Children Routinely Treated for Rifampicin-Resistant Tuberculosis (CATALYST)

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2021-04-26

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PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of moxifloxacin and clofazimine in children are urgently needed to inform their current and future use in children with Rifampicin-Resistant TB (RR-TB). Both medications have a key...

Dynamics and immune mechanisms of QFT response in close contacts of TB cases

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2021-04-05

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Rationale: A vaccine that prevents infection with Mycobacterium tuberculosis (Mtb) (POI vaccine) is an ideal approach to TB control. As Mtb infection (MTBI) is measured indirectly (positive tuberculin skin test (TST) or interferon gamma release assay (IGRA), prevention of IGRA conversion is the...

A Nanopore Biosensor for Leveling MTB Antigens in Blood

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2021-04-01

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Purpose of the study: The inability to obtain diagnostically useful sputum specimens, or the inability to analyze non-sputum specimens, is a significant contributor to poor diagnostic sensitivity of current TB assays, leading to the WHO to call for the development of non-sputum-based biomarker or...

Effect of Neighborhoods and Peer Networks on substance use and violence among adolescents living with and without HIV in India

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2021-01-28

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Purpose of the study: A strong bidirectional association exists between substance use, various forms of violence and HIV. Substance use accounts for 0.8% of the burden of disease measured in disability adjusted life years (DALYs) among adolescents in South Asia. Violence among adolescents living...

Impact of Tuberculosis Infection on HIV-1 Antibody Response (NWCS501)

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2020-12-05

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Study Objective: Compare longitudinal HIV-1 antibody responses among HIV-1 infected participants that either did or did not develop active TB enrolled in ACTG 5274 and ACTG 5279 Study Design: Longitudinal antibody responses will be examined among select participants in A5274 who have plasma samples...

Pharmacokinetic Assessment of MDR-TB Drugs in the Treatment of TB Meningitis

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2020-08-23

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Hinduja Hospital

Rationale: MDR-TBM is a devastating disease with high mortality and severe neurologic sequelae among survivors. We recognize the importance of sufficient drug concentrations at the site of infection for efficacy of anti-TB drugs and believe it is likely that drug distribution into brain and CSF...

Identification of Biomarkers That Can Predict Progression from Latent Tuberculosis Infection to Active Tuberculosis Disease

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2020-08-23

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Purpose: The C-TRIUMPH study has identified 20 household contacts (HHC), who have progressed to active TB from its HHCs cohort (Cohort B). Immunological profiling of TB antigen induced biosignatures, profiling of transcriptional and proteomic biosignatures should provide novel insights into the...

Epidemiology and Clinical Outcomes of COVID-19 in India (ECO-19)

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2020-07-09

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This study was terminated May 25, 2021 This is a prospective cohort study of adults with suspected COVID-19 to address key knowledge gaps in the epidemiology of disease severity and poor clinical outcomes in India. Results from this study may help clinicians in India focus limited health resources...

Tuberculosis (TB) Aftermath

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2020-06-05

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Drs. Vidya Mave and Jonathan Golub are co-PIs and Dr. Barthwal from DY Patil Medical College is local site PI for this study. TB Aftermath seeks to provide evidence for an effective and scalable strategy targeting HHs of treated TB cases, a high priority of the NTEP. Purpose To compare the...

Mental Health Outcomes among Health Care Professionals Involved in the Treatment and Care of COVID 19 Patients in India

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2020-06-01

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Drs. Nikhil Gupta and Nishi Suryavanshi are leading this survey project. This study is investigating the immediate impact of the COVID-19 pandemic on mental health outcomes and overall quality of life and what are the factors associated with it among Indian Health care workers. Among health care...

Prevalence of Risk Factors for Lung Cancer and Facilitators and Barriers for Tobacco Cessation among People Living with HIV

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2020-04-01

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India has the world’s third largest HIV epidemic, with 2.1 million people currently living with HIV and an additional 90,000 new infections each year.[29] At the same time, expansion of the HIV response under India’s premier governmental agency - the National AIDS Control Organization (NACO), has...

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Characterising cause of death among people treated for drug-susceptible TB in India

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2023-01-12

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The International Journal of Tuberculosis and Lung Disease

Annually, 1.5 million people die of TB.1 India has thehighest burden of TB,1 and in 2020, the case fatality ratio (CFR) among people with drug-susceptible TB was 4.3%.2 Even after treatment, mortality is more than two-fold higher among people with prior TB compared to the general population.3...

Drug use stigma, antiretroviral therapy use, and HIV viral suppression in a community-based sample of people with HIV who inject drugs

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2022-10-06

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AIDS

Drug use stigma may be a barrier to HIV viral suppression among people with HIV who inject drugs, thereby hindering efforts to achieve HIV control.

Whole Genome Sequencing Assessing Impact of Diabetes Mellitus on Tuberculosis Mutations and Type of Recurrence in India

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2022-10-06

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Clinical Infectious Diseases

Dr. Vidya Mave and colleagues concluded considerable intrahost mycobacterium tuberculosis mutation rates were present at recurrence among patients with diabetes mellitus.

Clinical and Immunological Markers of Pulmonary Impairment Among People With HIV in India

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2022-10-06

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Open Form Infectious Diseases

Dr. Akshay Gupte and team found females were 7 times more likely to have restrictive spirometry pattern and 22 times more likely to have preserved ratio impaired spirometry, compared with men.

Changes in HIV care continuum indicators among community-based samples of HIV-infected people who inject drugs and men who have sex with men across 21 cities in India

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2022-10-06

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AIDS Care

The findings by Drs. Shruti Mehta, Gregory Lucas and colleagues show population-specific interventions and routine surveillance are need to facilitate HIV elimination.

Concomitant pulmonary disease is common among patients with extrapulmonary TB

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2022-08-12

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International Journal of Tuberculosis and Lung Disease

Dr. Shivakumar and his group discovered that a high proportion of patients classified as EPTB in India have concomitant PTB. Their results support the need for improved symptom and CXR screening, and recommends routine sputum TB microbiology screening of all Indian patients with EPTB.

Clinical and Immunological Markers of Pulmonary Impairment among People with HIV(PWH) in India

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2022-05-12

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Open Forum Infectious Diseases

Background Despite anti-retroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods 210 adult PWH receiving antiretroviral...

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...

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...

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...

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 (...

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...

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.

Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection

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2021-01-27

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Frontiers in Immunology

Background: Recent studies in adults have characterized differences in systemic inflammation between adults with and without latent tuberculosis infection (LTBI+ vs. LTBI-). Potential differences in systemic inflammation by LTBI status has not been assess in pregnant women. Methods: We conducted a...

Higher interleukin-6 levels and changes in transforming growth factor-β are associated with lung impairment in pulmonary tuberculosis

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2021-01-18

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ERJ Open Resource

Higher levels of IL-6 and slow-to-resolve TGF-β are associated with lung impairment in treated tuberculosis. These results have important implications for clinical trials of immunomodulatory therapies to prevent tuberculosis-associated lung disease. http://openres.ersjournals.com/lookup/doi/...

Pharmacogenetic interactions of rifapentine plus isoniazid with efavirenz or nevirapine

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2021-01-15

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Pharmacogenetics and Genomics

Objectives: The effect of rifapentine plus isoniazid on efavirenz pharmacokinetics was characterized in AIDS Clinical Trials Group protocol A5279 (NCT01404312). The present analyses characterize pharmacogenetic interactions between these drugs, and with nevirapine. Methods: A subset of HIV-positive...

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