Research News

November 22, 2022

To determine the mechanisms that mediate resistance to Mycobacterium tuberculosis (M. tuberculosis) infection in household contacts (HHCs) of patients with tuberculosis (TB), we followed 452 latent TB infection-negative (LTBI-) HHCs for 2 years.

Clinical Research


Leadership



Our Indo-JHU Clinical Research Partnership is located in Pune and 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:

 




 

1 to 3 HP

Post Date: 
2023-01-24
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Protocol Title: A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The “One...

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
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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
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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...

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
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Countries: 
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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)

Post Date: 
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...

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

Post Date: 
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

Post Date: 
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...

Project COVID-19 Test At Home

Post Date: 
2021-06-28
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Countries: 
This study to test the accuracy of a COVID-19 test for use at home. This test has been authorized by the FDA to be done in a health care setting by a health care provider, but the study is evaluating diagnostic accuracy of tests administered at home

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

Post Date: 
2021-06-21
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Clinical Sites: 
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
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Clinical Sites: 
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
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Clinical Sites: 
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
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Clinical Sites: 
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
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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

Post Date: 
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

Post Date: 
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...

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

Post Date: 
2020-08-23
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Clinical Sites: 
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

Post Date: 
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...

RADx Tech COVID-19 Test US Study

Post Date: 
2020-08-05
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Countries: 
Rationale: Scalable, inexpensive point-of-care (PoC) technologies that enable detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus are desperately needed. However, understanding the accuracy and usability of novel PoC technologies for SARS-CoV-2 is critical. Each PoC...

RADx Tech COVID-19 Test Us Bank

Post Date: 
2020-08-05
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Countries: 
This study is collecting and storing lab samples of COVID-19 diagnostic tests among both people who have tested positive for COVID and those who haven’t to evaluate new COVID test and study how COVID-19 and related viruses cause disease in people.

RADx Tech COVID-19 Test Us Study

Post Date: 
2020-07-27
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Countries: 
Scalable, inexpensive novel technologies that enable detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus are desperately needed. However, understanding the accuracy and usability of novel technologies for SARS-CoV-2 is critical. Each novel test needs to be evaluated...

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Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial

Post Date: 
2023-09-13
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Countries: 
Publication: 
Lancet Child Adolescent Health
Deferral of maternal isoniazid preventive therapy to early postpartum had no effect on infant tuberculosis acquisition in our trial population, regardless of the diagnostic test used.

Mycobacterium tuberculosis disease associates with higher HIV-1-specific antibody responses

Post Date: 
2023-05-19
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Publication: 
Science Direct
Mycobacterium tuberculosis (Mtb) is the most common infection among people with HIV (PWH). Mtb disease-associated inflammation could affect HIV-directed immune responses in PWH. We show that HIV antibodies are broader and more potent in PWH in the presence as compared to the absence of Mtb disease...

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
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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
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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
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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
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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...

Integration of a geospatially targeted community-based testing approach with respondent-driven sampling to identify people who inject drugs living with HIV and HCV in Patti and Gorakhpur, India

Post Date: 
2023-04-14
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Countries: 
Publication: 
Drug Alcohol Dependency
Background: Respondent-driven sampling (RDS), a network recruitment approach, is effective at reaching people who inject drugs (PWID), but other strategies may be needed to reach PWID at risk or living with HIV and/or Hepatitis C (HCV). We examined the impact of integrating geospatially targeted...

Sex Differences in TB Clinical Presentation, Drug Exposure, and Treatment Outcomes in India

Post Date: 
2023-04-01
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Countries: 
Publication: 
CHEST
Background: The role of sex differences in clinical presentation, TB drug pharmacokinetic variables, and treatment outcomes is unclear. Research question: What is the effect of sex on TB disease severity, drug exposure, and treatment outcome? Study design and methods: This study was a prospective...

Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household

Post Date: 
2023-03-17
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Countries: 
Publication: 
PLOS ONE
Background: Understanding factors associated with prevalent Mycobacterium tuberculosis infection and prevalent TB disease in household contacts of patients with drug-resistant tuberculosis (TB) may be useful for TB program staff conducting contact investigations. Methods: Using data from a cross-...

Pro-inflammatory and pro-resolving lipid mediators of inflammation in HIV: effect of aspirin intervention

Post Date: 
2023-03-01
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Countries: 
Publication: 
eBioMedicine
Background: Persons with HIV (PWH) have an increased risk of cardiovascular disease (CVD) compared to HIV-seronegative individuals (SN). Inflammation contributes to this risk but the role of lipid mediators, with central roles in inflammation, in HIV infection remain to be established; further...

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

Post Date: 
2023-01-12
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Publication: 
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...

Predictive performance of interferon-gamma release assays and the tuberculin skin test for incident tuberculosis: an individual participant data meta-analysis

Post Date: 
2023-01-05
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Countries: 
Publication: 
EClinicalMedicine
Background: Evidence on the comparative performance of purified protein derivative tuberculin skin tests (TST) and interferon-gamma release assays (IGRA) for predicting incident active tuberculosis (TB) remains conflicting. We conducted an individual participant data meta-analysis to directly...

Pharmacokinetic analysis of linezolid for multidrug resistant tuberculosis at a tertiary care centre in Mumbai, India

Post Date: 
2023-01-04
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Countries: 
Publication: 
Frontiers in Pharmacology
Linezolid is an oxazolidinone used to treat multidrug-resistant tuberculosis (MDR-TB), including in the recently-endorsed shorter 6-month treatment regimens. Due to its narrow therapeutic index, linezolid is often either dose-adjusted or discontinued due to intolerance or toxicity during treatment...

Self-Reported Antiretroviral Adherence: Association with Maternal Viral Load Suppression in Postpartum Women Living with HIV-1 from Promoting Maternal and Infant Survival Everywhere (PROMISE), a Randomized Controlled Trial in Sub-Saharan Africa and India

Post Date: 
2023-01-01
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Countries: 
Publication: 
Journal of Acquired Immune Deficiency Syndrome
Introduction: Optimal adherence to antiretroviral therapy (ART) is crucial to promoting maternal–infant health. Setting: Fourteen sites in 7 countries within sub-Saharan Africa and India. Methods: The multicomponent, open-label strategy PROMISE trial enrolled breastfeeding mother–infant pairs not...

The Kynurenine / Tryptophan Ratio is a Sensitive Biomarker for the Diagnosis of Pediatric Tuberculosis among Indian Children

Post Date: 
2022-12-22
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Countries: 
Publication: 
Frontiers in Immunology
Objectives: Pediatric tuberculosis (TB) remains difficult to diagnose. The plasma kynurenine to tryptophan ratio (K/T ratio) is a potential biomarker for TB diagnosis and treatment response but has not been assessed in children. Methods: We performed a targeted diagnostic accuracy analysis of four...

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

Post Date: 
2022-12-17
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Countries: 
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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...

Metabolites enhance innate resistance to human Mycobacterium tuberculosis infection

Post Date: 
2022-11-22
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Countries: 
Publication: 
JCI Insight
To determine the mechanisms that mediate resistance to Mycobacterium tuberculosis (M. tuberculosis) infection in household contacts (HHCs) of patients with tuberculosis (TB), we followed 452 latent TB infection-negative (LTBI-) HHCs for 2 years. Those who remained LTBI- throughout the study were...

Developing TB Vaccines for People with HIV: A Roadmap: Meeting Consensus Report

Post Date: 
2022-11-09
Publication: 
Lancet HIV
New tuberculosis vaccine candidates that are in the development pipeline need to be studied in people with HIV, who are at high risk of acquiring Mycobacterium tuberculosis infection and tuberculosis disease and tend to develop less robust vaccine-induced immune responses. To address the gaps in...

Impact of pregnancy and HIV on LTBI diagnostics and MTB-induced immune response: a cohort study in Pune, India

Post Date: 
2022-11-01
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Countries: 
Publication: 
International Journal of Infectious Diseases
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...

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

Post Date: 
2022-10-26
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Countries: 
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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...

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Experts say COVID-19 mutations are normal

Post Date: 
2021-01-15
Dr. Robert Bollinger: “... As with any virus, changes are something to be watched, to ensure that testing and vaccines are still effective.

Pune : HIV infected people will get TB treatment from six months to a month

Post Date: 
2023-12-16
Source: 
Pune Mirror
Team photo
Director Dr. Nishi Suryavanshi, said, “One to Three HP' trial will generate scientific evidence for ultra-short-term TB preventive regimens. This may improve the TB prevention guideline system and policy in India. In turn, this study will help expand medical research on TB-HIV.

World AIDS Day 2023

Post Date: 
2023-12-14
Pune Team
For World AIDS Day, BJGMC CRS), Pune, hosted a discussion on six major HIV related studies.

NIH clinical trial of tuberculous meningitis drug regimen begins

Post Date: 
2023-12-07
Source: 
NIH
Tuberculosis bacteria
The Improved Management with Antimicrobial Agents Isoniazid Rifampicin Linezolid for TBM (IMAGINE-TBM) trial will compare a six-month regimen of four drugs with the nine-month, standard-of-care regimen for TBM.

Photo from the Union Conference 2023

Post Date: 
2023-11-21
CIDI team at a table
Check out the photo gallery from CIDI at the 2023 Union Conference on Lung Health.

Common antibiotic can prevent drug-resistant TB in exposed kids, says study. But is it safe?

Post Date: 
2023-11-20
Source: 
Indian Express
Vidya Mave with text quote
Two clinical trials show how Levofloxacin, given once daily to children over six months, prevented infection in five-year-olds exposed to MDR-TB by 56 per cent and in adolescents by 45 per cent.

New study aims for best strategy to find recurrent cases of Tuberculosis

Post Date: 
2023-09-15
Source: 
Indian Express
Counsellors visit patients ' homes
A novel trial is underway in Pune to provide evidence on how best to find people with recurrent Tuberculosis (TB) , so that they can be quickly linked to care.

Pune study shows ‘promising results’ in bid to prevent TB among those at most risk

Post Date: 
2023-08-01
Source: 
Indian Express
Woman showing a diagram to a patient
Interim results are “promising” and show that a short treatment regimen called “3HP” could pave the way in preventing TB.

How a Pune trial SHINEs light on shorter TB treatment for children

Post Date: 
2023-06-26
Source: 
The Indian Express
TB OPD at Sassoon hospital
Last year, based on SHINE research, the WHO strongly recommended shortening the TB treatment duration in non-severe paediatric TB cases from six-four months.

BJ Government Medical College launches new study to assess TB, HIV, diabetes among pregnant women

Post Date: 
2023-03-23
Source: 
The Indian Express
Team photo
The launch of the study coincides with the World TB week. “Titled `PraGaTHi’, this study will explore how the changes in immunity due to pregnancy and GDM increase the risk of TB in pregnant and postpartum women.”

Johns Hopkins Medicine-Led Consortium to Receive Up to $200 Million to Fight TB Globally

Post Date: 
2022-08-04
Chaisson headshot; USAID Awards Johns Hopkins Medicine, Partners, Up to $200 Million for Global TB R
To address the global burden of TB, an international collaboration led by Johns Hopkins Medicine has today been awarded up to $200 million in research funding over five years by USAID for the SMART4TB project.

CDC Launches Two Global Networks, Awards $22 Million to Combat Antimicrobial Resistance and Infectious Diseases

Post Date: 
2021-12-07
Dr. Matt Robinson
Dr. Matt Robinson’s collaboration with Indian partners on this CDC-funded effort builds on years of work on antimicrobial resistance.

Study identifies need to improve patient retention in the National TB Elimination Programme, highlights patients’ trust relationship with private providers

Post Date: 
2021-11-02
Source: 
indianexpress.com
Study identifies need to improve patient retention
The study identified the need to improve patient retention in the NTEP and highlight patients' trust relationship with private providers

CURE ID Moves to Automated Data Collection in Light of COVID Pandemic

Post Date: 
2021-07-13
Dr. Matt Robinson
Drs. Matt Robinson is leading JHU efforts in this FDA program, and Robert Bollinger and Jane McKenzie-White helped launch it before COVID.

Hopkins Tool Predicts How Hospitalized COVID Patients Will Fare

Post Date: 
2021-03-31
Source: 
Fox 45 News (Baltimore)
Dr. Matthew Robinson
Fox New 45 (Baltimore): Dr. Matt Robinson discusses the SCARP tool, which can predict patients' risk of severe COVID disease and death.

Innovation During Times of Change  |  2020 Annual Report

Post Date: 
2021-03-30
2020 Annual Report
2020 was a year like no other. Learn what CCGHE discovered in our Annual Report.

World Renowned Infectious Disease Expert on CDC's New School Guidelines.

Post Date: 
2021-02-16
Source: 
Leslie Marshall Show
Dr. Robert Bollinger
Leslie Marshall interviews Dr. Robert Bollinger on CDC's New School Guidelines.

Will the New COVID-19 Variants Increase Reinfection Rates?

Post Date: 
2021-02-16
Source: 
VeryWellHealth
Dr. Robert Bollinger
"While the mutations don’t mean much in terms of how the virus functions, if the mutations lead to a change in how the virus works, then we pay more attention to it."

COVID-19 Strain Variants, Ramping Up Vaccinations to Get to Herd Immunity

Post Date: 
2021-01-27
Source: 
Leslie Marshall Show
Dr. Robert Bollinger
Leslie and Dr. Bollinger discuss the latest news surrounding COVID-19, including: Moderna announcing that its COVID-19 vaccine is effective against new...

Doctors Explain The Risks If You Miss Your Second Vaccine Appointment

Post Date: 
2021-01-27
Source: 
Bustle
Dr. Robert Bollinger
Dr. Robert Bollinger: "You could be less protected against COVID, for a shorter period, or it could also give the virus time and space to mutate."

New strains of COVID swiftly moving through the US need careful watch, scientists say

Post Date: 
2021-01-25
Source: 
USATODAY
Dr. Robert Bollinger
Instead of perfectly copying its 29,811 bases, the four-letter alphabet used to describe its genetic code, a wrong letter sneaks in.

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