BJGMC

Byramjee Jeejeebhoy Government Medical College (BJGMC), and Sassoon General Hospitals (SGH)
Jai Prakash Narayan Road, Near Pune Railway Station
Pune, India 411001
www.bjmcpune.org    

 

About:

  • Among the top medical schools in India
  • 200 medical students, 130 residents per year; 50 nursing students per year
  • SGH: State-funded 1500-bed tertiary-care public hospital, 21 outpatient clinics, and links to multiple NGOs in the community
  • JHU partnership established in 1999 for HIV studies; now investigates other infectious diseases, such as tuberculosis, antimicrobial resistance, noncommunicable diseases, and comorbidities 
  • In 2008, JHU field office established at BJGMC Clinical Research Site: 3 full time Hopkins faculty and 20 staff; 150 BJGMC clinical research staff.
  • Clinical research as well as leadership and oversight for clinical rotations and field studies

 

Field Study Administrators:

  • Dr. Vidya Mave, Clinical Research Site Director
  • Dr. Sandesh Patil, Student Coordinator
  • Komal Arora, Senior Financial Administrator
  • Manisha Mhaske, HR Manager

ACTIV-2d/A5407 - A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 (SCORPIO-HR)

Post Date: 
2023-04-11
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
COVID-19 is a disease caused by infection with a coronavirus called SARS-CoV-2. COVID-19 affects people in different ways. Infected people have had a wide range of symptoms reported – from no symptoms or mild symptoms to severe illness needing hospitalization and sometimes death. Severe illness is...

HIV, Gestational Diabetes and TB in Pregnancy (PraGaTHi)

Post Date: 
2023-02-27
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
The purpose of this study is to learn about how diabetes, TB, and HIV affect pregnant women and whether pregnancy, HIV and diabetes increase the risk of acquiring TB during pregnancy and postpartum. During pregnancy, some women will develop a form of diabetes (high blood sugar) called gestational...

Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non contrast CT among PLHIV in Pune, India

Post Date: 
2022-11-25
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Primary objective Determine the prevalence of pulmonary nodules, including lung cancer using NCCT. Determine the risk of pulmonary nodules, including lung cancer using NCCT. Evaluate the association of smoking, immune suppression, ART, and TB with the prevalence and risk of NCCT-diagnosed pulmonary...

A multicenter Phase II/ III 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: 
2022-05-08
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
To evaluate the efficacy of VPM1002 in prevention of TB recurrence in former pulmonary TB patients who have successfully completed ATT and were declared cured. Secondary Objective To evaluate the safety of VPM1002 in former TB patients who have successfully completed ATT and were declared as cured...

The Regional Prospective Observational Research In Tuberculosis (Report) India Phase II Common Protocol

Post Date: 
2022-01-10
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Hinduja Hospital
NIRT
Purpose and Scientific Aims The purpose of the RePORT India Phase II Common Protocol is to collect and utilize data and specimens for tuberculosis (TB) research, leveraging the existing infrastructure, processes, and scientific partnerships established under RePORT India consortium. The RePORT...

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

Post Date: 
2021-12-19
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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)

Post Date: 
2021-11-02
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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

Post Date: 
2021-11-02
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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

Post Date: 
2021-10-18
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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...

Biomarkers of Hepatotoxicity in Pregnant and Postpartum Women Living With HIV and Latent TB

Post Date: 
2021-06-21
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Primary objectives: 1. Quantify INH metabolite PK in pregnant and postpartum WLWH receiving IPT, and compare INH metabolites exposures between cases and controls. 1. Identify biomarkers of hepatotoxicity in pregnant and postpartum WLWH receiving IPT. 2. Model relationships between drug metabolite...

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

Post Date: 
2021-06-15
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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

Post Date: 
2021-05-18
   |   
Countries: 
Brazil
India
Malawi
South Africa
Thailand
Uganda
United States
Zimbabwe
   |   
Clinical Sites: 
BJGMC
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)

Post Date: 
2021-04-26
   |   
Countries: 
India
Philippines
South Africa
   |   
Clinical Sites: 
BJGMC
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

Post Date: 
2021-04-05
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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

Post Date: 
2021-04-01
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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

Post Date: 
2021-01-28
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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)

Post Date: 
2020-12-05
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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...

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

Post Date: 
2020-08-23
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
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)

Post Date: 
2020-07-09
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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...

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

Post Date: 
2020-06-01
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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...

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Challenges with the use of Xpert HPV as a screening tool for oral HPV among people living with HIV (PLHIV): experiences from Pune, India

Post Date: 
2023-05-04
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
BMC Infectious Diseases
Background: People living with HIV (PLHIV) are at higher risk for human papillomavirus (HPV)-related oropharyngeal cancers compared to the general population. Xpert HPV test is a polymerase chain reaction (PCR) assay capable of rapid HPV detection. Performing the assay requires minimal intervention...

Operational challenges undermine the WHO TB symptom screen in pregnant women in India

Post Date: 
2023-04-26
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Open Forum Infectious Diseases
Background. Pregnancy increases both a woman's risk of developing tuberculosis (TB) and her likelihood to seek health care. A symptom screen that is effective during pregnancy would therefore be valuable. We assessed a World Health Organization (WHO)-recommended TB symptom screen in an antenatal...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV (PLWH)

Post Date: 
2023-04-21
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Diabetes & Metabolic Syndrome
Background People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

Impact of undernutrition on tuberculosis treatment outcomes in India: A multicenter prospective cohort analysis by Dr. Pranay Sinha

Post Date: 
2023-04-17
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Publication: 
Clinical Infectious Diseases
Abstract Background Undernutrition is the leading risk factor for tuberculosis (TB) globally. Its impact on treatment outcomes is poorly defined. Methods We conducted a prospective cohort analysis of adults with drug-sensitive pulmonary TB at 5 sites from 2015–2019. Using multivariable Poisson...

Virological Failure among People living with HIV Receiving Second-Line Antiretroviral Therapy in Pune, India

Post Date: 
2022-12-17
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
BMC Infectious Diseases
Background The number of people receiving second-line antiretroviral therapy (ART) has increased as global access to ART has expanded. Data on the burden and factors associated with second-line ART virologic failure (VF) from India remain limited. Methods We conducted cross-sectional viral load (VL...

Willingness of Caregivers to Give Preventive Therapy to Children Living in Households of Patients with Rifampin-resistant Tuberculosis

Post Date: 
2022-10-26
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
The International Journal of Tuberculosis and Lung Disease
BACKGROUND Pediatric household contacts (HHCs) of patients with multidrug-resistant TB (MDR-TB) are at high risk of infection and active disease. Evidence of caregiver willingness to give MDR-TB preventive therapy (TPT) to children is limited. METHODS This was a cross-sectional study of HHCs of...

Concomitant pulmonary disease is common among patients with extrapulmonary TB

Post Date: 
2022-08-12
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
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.

Development of shortened HIV-related stigma scales for young people living with HIV and young people affected by HIV in India

Post Date: 
2022-07-31
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
BMC Health and Quality of Life Outcomes
Background: HIV-related stigma is associated with poor quality of life and poor healthcare-seeking behaviours in young people living with HIV (YPLHIV) and young people affected by HIV (YPAHIV). India has an estimated 120,000 YPLHIV and 4 million YPAHIV, but efforts to measure HIV-related stigma in...

Comparative immune responses to M. tuberculosis in individuals with latent infection or sterile protection against infection

Post Date: 
2022-07-13
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
bioRxiv
Summary To identify immunologic targets for tuberculosis vaccines more efficacious than BCG, we investigated the immune responses that differentiate individuals with sterile protection against M. tuberculosis (Mtb) infection (TB-resisters) from those who develop latent tuberculosis infection (LTBI-...

Smokeless tobacco use and oral potentially malignant disorders among people living with HIV (PLHIV) in Pune, India: Implications for oral cancer screening in PLHIV

Post Date: 
2022-07-13
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
PLOS ONE
Introduction In India, smokeless tobacco (SLT) is a predominant form of tobacco used among people living with HIV (PLHIV). Despite SLT being a risk factor for oral potentially malignant disorders (OPMDs), no prior studies have quantified the association of OPMDs with SLT use among PLHIV. This...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV in Pune, Western India

Post Date: 
2022-07-01
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Diabetes & Metabolic Syndrome: Clinical Research & Reviews
Background: People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

A Novel Computer-Based Virtual Counselor-Delivered Alcohol Reduction Intervention : Acceptability, Adaptability and Feasibility among Adults with HIV or TB in Indian Clinical Settings

Post Date: 
2022-05-27
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
JMIR Formative Research
Background: Unhealthy alcohol use is associated with increased morbidity and mortality among persons with HIV and tuberculosis (TB). Computer-based interventions (CBIs) can reduce unhealthy alcohol use, are scalable, and may improve outcomes among patients with HIV or TB. Objective: We assessed the...

Clinical and Immunological Markers of Pulmonary Impairment among People Living with HIV in India

Post Date: 
2022-05-11
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Open Forum Infectious Diseases
Background Despite antiretroviral 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 Two hundred ten adult PWH receiving...

TB-related Knowledge and Stigma Among Pregnant Women in Low Resource Settings of Pune, India

Post Date: 
2022-02-01
   |   
Countries: 
Haiti
   |   
Clinical Sites: 
BJGMC
Publication: 
The International Journal of Tuberculosis and Lung Disease,
TB is an important cause of maternal morbidity.1 Studies among adults with TB in several countries have consistently demonstrated that a lack of TB-related knowledge and increased stigma can be a barrier to early diagnosis, seeking treatment and treatment adherence.2–6 India has the highest number...

Burden of COVID-19 and Case Fatality Rate in Pune India: An Analysis of First and Second Wave of the Pandemic

Post Date: 
2022-01-22
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
IJID Regions
Objective To assess trends in case incidence and fatality rate between the first and second waves, we analyzed programmatic COVID-19 data from Pune city, an epicenter of COVID-19 cases in India. Method The trends of cases incidence, time-to-death and case fatality rate (CFR) were analyzed. Poisson...

Implementation of the Comprehensive Unit-based Safety Program to Improve Infection Prevention and Control Practices in Four Neonatal Intensive Care Units in Pune, India

Post Date: 
2022-01-06
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Frontiers in Pediatrics
Objective: To implement the Comprehensive Unit-based Safety Program (CUSP) in four neonatal intensive care units (NICUs) in Pune, India, to improve infection prevention and control (IPC) practices. Design: In this quasi-experimental study, we implemented CUSP in four NICUs in Pune, India, to...

Outbreak of Mucormycosis in Coronavirus Disease Patients, Pune, India

Post Date: 
2021-09-29
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
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...

Diabetes Mellitus and Tuberculosis Treatment Outcomes in Pune, India

Post Date: 
2021-04-01
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
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

Post Date: 
2021-03-10
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Publication: 
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.

Detection of genital tuberculosis among women with infertility using best clinical practices in India: An implementation study

Post Date: 
2021-01-15
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Indian Journal of Tuberculosis
Background Diagnosis of genital tuberculosis (TB) as a cause of infertility still remains a diagnostic dilemma for clinicians, as no standard guidelines exist. The recently proposed best practices for genital TB diagnosis have not been evaluated yet in India. Objectives To implement best practices...

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