Study/Projects by Year (2021)

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...

Innovative modelling for predicting TB treatment outcomes in global cohorts

Post Date: 
2021-12-19
Our overarching hypothesis is that clinical and laboratory risk factors for the adversity be treatment outcomes of failure, recurrence and mortality are heterogeneous and time-dependent. Precision medicine approaches supported by Machine learning techniques that overcome the limitations 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...

Epidemiologic Factors Associated with TB Treatment Outcomes Across Report International Consortia

Post Date: 
2021-08-12
   |   
Countries: 
Brazil
China
India
Indonesia
Philippines
South Africa
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...

ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients with COVID-19 (Adapt Out COVID)

Post Date: 
2021-07-21
   |   
Countries: 
India
United States
   |   
Clinical Sites: 
BJGMC
This study was terminated effective 4/18/2022 Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease progression, and reduce serious complications of COVID-19 and transmission [10]. ACTIV-2/A5401 is a phase II/III randomized,...

Project COVID-19 Test At Home

Post Date: 
2021-06-28
   |   
Countries: 
United States
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
   |   
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...