Clinical Research

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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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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

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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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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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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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...

COVID-19 Viral Dynamics

Post Date:

2020-12-20

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Purpose of the study: This study aims to quantitatively define the relationships between (a) testing results obtained via multiple distinct platforms (antigen vs. RT-qPCR), (b) shedding of infectious virus, and (c) self-reported disease symptoms over the course of SARS-CoV-2 infection.

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

Post Date:

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

Post Date:

2020-08-23

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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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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...

RADx Tech COVID-19 Test US Study

Post Date:

2020-08-05

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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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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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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...

Tuberculosis (TB) Aftermath

Post Date:

2020-06-05

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DY Patil

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

Post Date:

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...

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...

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

Post Date:

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

Post Date:

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.

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

Post Date:

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

Post Date:

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.

Concomitant pulmonary disease is common among patients with extrapulmonary TB

Post Date:

2022-08-12

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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.

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

Post Date:

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

Post Date:

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...

Baseline IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes: a multi-site discovery and validation study

Post Date:

2021-11-08

Publication:

The European Respiratory Journal

Dr. Akshay Gupte and colleagues discovered that elevated IL-6 can predict poor treatment outcomes, showcasing a need for including IL-6 in clinical screenings.

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

Post Date:

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

Post Date:

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

Post Date:

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

Post Date:

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...

Sex and gender differences in COVID testing, hospital admission, presentation, and drivers of severe outcomes in the DC/Maryland region

Post Date:

2021-08-31

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medRxiv

Rates of severe illness and mortality from SARS-CoV-2 are greater for males, but the mechanisms for this difference are unclear.

Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19

Post Date:

2021-03-24

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JAMA Network Open

Just Published in JAMA Network Open: In this retrospective analysis, remdesivir was associated with faster clinical improvement of COVID-19 in a cohort of predominantly non-White patients

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

Post Date:

2021-03-10

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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.

Development of Severe COVID-19 Adaptive Risk Predictor (SCARP), a Calculator to Predict Severe Disease or Death in Hospitalized Patients With COVID-19

Post Date:

2021-03-02

Publication:

Annals of Internal Medicine

Dr. Matt Robinson and colleagues developed a real-time tool that can predict severe disease or death among COVID patients

Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection

Post Date:

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

Post Date:

2021-01-18

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Publication:

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/...

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

Post Date:

2021-01-15

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