Clinical Research

Clinical Sites:

This is a prospective, double-blind, randomized, placebo-controlled, multicenter efficacy study in 6500 subjects, with individual subjects to be followed for up to 72 months. The purpose is to study the efficacy of statins to reduce the risk of cardiovascular disease in HIV-infected patients. HIV-...

A5349: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial

Post Date:

2017-06-05

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This is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 non-inferiority trial. Primary Objectives: To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to...

Understanding Quality of Life during and Loss to Follow-up from Drug-Resistant Tuberculosis Treatment in Pune, India

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2017-05-15

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This study will examine a) risk factors for loss to follow-up from DR-TB treatment, b) actively trace DR-TB patients lost to follow-up from treatment and c) establish a prospective observational cohort of MDR-TB, XDR-TB and DS-TB patients as well as healthy controls nested within ongoing RNTCP...

Risk Factors for Unfavourable Treatment Outcomes among Multidrug-Resistant Tuberculosis Patients in Public Sector Treatment in Pune

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2017-03-29

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This Fogarty funded study seeks to identify risk factors associated with unfavourable treatment outcomes (death, treatment failure, default, XDR-TB) among multidrug-resistant tuberculosis (MDR-TB) patients under public sector Directly Observed Treatment Short-course (DOTS) Plus in Pune, India...

MDR-TB Free: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy

Post Date:

2017-03-24

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This study is also known as MDR-TB MUKT: M onitoring Adverse Effects, U tilizing Resources Optimally, K nowing Resistance Patterns, and T reatment Strategy. Purpose: To establish an observational cohort of MDR-TB cases and household contacts with accompanying biorepository at PD Hinduja National...

RePORT: C-TRIUMPH: Biomarkers for Tuberculosis Diagnosis and Treatment Response

Post Date:

2017-03-24

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Aims: To develop non-sputum, blood-based tools for TB diagnosis and treatment, we urgently need biomarkers that identify active TB (ATB) cases and accurately distinguish them from latent TB infection (LTBI). Such biomarkers, when validated in diverse populations, can be developed into improved...

Impact of HIV and Diabetes Mellitus on TB Drug Resistance and Recurrence

Post Date:

2017-03-02

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Tuberculosis (TB) is the leading cause of mortality globally. With increasing burden of HIV and diabetes mellitus (DM), there is a critical need to understand the microbial response and ensuing disease dynamics of TB in the HIV-infected and diabetic host to optimally control TB globally. Among...

Multicenter Study of the Accuracy of the BD MAX MDR-TB Assay for Detection of M. tuberculosis Complex and Mutations Associated with Resistance to Rifampin or Isoniazid

Post Date:

2017-03-01

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In a multi-country study, we are assessing the accuracy of the BD MAX rapid MDR-TB assay to detect rifampin and isoniazid resistance.

TREAT Asia: Pediatric HIV Observational Database

Post Date:

2017-02-09

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TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study of infants, children, and adolescents living with HIV. TApHOD study participants are enrolled and followed at selected TREAT Asia Network clinical sites in the Asia-Pacific region. Participating...

TREAT Asia Observational Database

Post Date:

2017-02-09

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The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and disease progression; short- and long-term responses to ART; impact of co-infections; HIV drug resistance patterns; and toxicity of...

Shorter Treatment for Minimal TB in Children (SHINE)

Post Date:

2017-01-17

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This is a multicountry study being conducted in India, South Africa, Uganda, and Zambia. The principal objective is to determine whether the standard 6 month regimen (8 weeks HRZ(E) followed by 16 weeks HR) can be reduced with similar efficacy, to 4 months (8 weeks HRZ(E) followed by 8 weeks HR),...

Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

Post Date:

2017-01-17

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DY Patil

This study is part of CDC's Safe healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Domain 7: International. Johns Hopkins neonatologist Dr. Julia Johnson is lead investigator for a systematic study of the epidemiology of neonatal sepsis in the Neonatal Intensive Care Unit in...

Bacterial Antimicrobial Resistance Patterns in Pune, India: Substudy on the Introduction of Triage to a Triage Naïve Emergency Department in Pune, India, and the Effects on Patient Flow

Post Date:

2017-01-01

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Despite state-of-the-art inpatient facilities, Sassoon General Hospital (SGH) in Pune, India, does not currently have a method of triaging the large volume of patients they care for on a daily basis. Based on prior studies in low to middle income countries with underdeveloped emergency medical...

LaMocha: A Mobile Technology to Promote HIV Testing among Immigrant Latino Men

Post Date:

2016-12-15

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Foreign-born Latino males have a high risk of late HIV diagnosis and presentation to care, which can lead to poor clinical outcomes and ongoing HIV transmission in the community. We propose to evaluate if tailored videos delivered through a tablet by a Latino Health Worker and regular SMS text...

TREAT Asia: Prevalence and Risk Factors for Oral Cancer among HIV-Infected Adults

Post Date:

2016-12-13

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The study is designed as a cross-sectional, single time point study for opportunistic oral cancer screening of HIV-infected and non- HIV adults 21 years or older in an urban hospital. All participants will undergo screening for oral cancer and oral potentially malignant disorders (OPMD) by visual...

Cost-effectiveness of Xpert MTB/RIF for Diagnosing Pulmonary Tuberculosis in HIV-positive Patients

Post Date:

2016-12-01

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This is a prospective cross-sectional study which will be conducted at BJGMC in Pune, India. The aim of this study is to see whether Xpert MTB/RIF is useful for early detection of pulmonary tuberculosis, and therefore cost-effective, as compared with sputum microscopy and the gold standard tests...

The Evaluation of Clinical Profile and Mortality of Children Admitted with Tuberculosis in Pediatric Intensive-Care Unit at Sassoon General Hospitals, Pune

Post Date:

2016-10-27

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Tuberculosis (TB) is one of the most common causes of infection-related death globally. TB was declared global public health emergency in 1993 by World HealthOrganization (WHO). Mortality due to TB is increasing due to emergence of multidrug resistant (MDR) strains and HIV-TB co-infection,...

ART Study 1: Database: Epidemiology of HIV/AIDS and Associated Comorbidities in a Public Antiretroviral Treatment (ART) Clinic at BJGMC in Pune

Post Date:

2016-09-19

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Since 2004, the National AIDS Control Program of India has been rolling out free antiretroviral therapy. Byramjee Jeejeebhoy Government Medical College (BJGMC), located in Pune, India, is now the largest HIV clinic in India, with over 26,000 adult and pediatric patients registered since 2005. We...

RePORT: C-TRIUMPH: Substudy on Transcriptomic and Metabolomic Analysis of Microbiologically Confirmed Pediatric Tuberculosis Patients and Uninfected Household Contacts

Post Date:

2016-09-01

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The objectives for this study are to: Assess the RNAseq, microRNA, and metabolic signature differences between confirmed pediatric TB patients and age- and sex-matched controls who are all household contacts of known cases but have remained TST and IGRA negative. Determine which of the published...

Addressing knowledge gaps and prevention for tuberculosis-infected Indian adults: a vital part of elimination

Post Date:

2018-05-02

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BMC Infectious Diseases

BMC Infectious Diseases : Our survey among TB patients' household contacts with evidence of recent exposure found that knowledge is poor and families are confused about disease transmission.

Hepatotoxicity during isoniazid preventive therapy and antiretroviral therapy in people living with HIV with severe immunosuppression: a secondary analysis of a multi-country open-label randomized controlled clinical trial

Post Date:

2018-05-01

Publication:

Journal of Acquired Immune Deficiency Syndromes

BACKGROUND: Hepatotoxicity associated with isoniazid preventive therapy (IPT) and antiretroviral therapy (ART) has not been well studied in severely immunosuppressed people with HIV. Our objective was to determine risk factors for hepatotoxicity in severely immunosuppressed individuals taking IPT...

MDR-TB in children: back to the basics

Post Date:

2018-05-01

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The International Journal of Tuberculosis and Lung Disease

IJTLD: Summary of the Pediatric Multidrug-Resistant Tuberculosis Clinical Trials Landscape Meeting: a primer of current directions.

Advancing patient-centered care in tuberculosis management: A mixed-methods appraisal of video directly observed therapy

Post Date:

2018-04-26

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Open Forum Infectious Diseases

BACKGROUND: Directly observed therapy (DOT) remains an integral component of treatment support and adherence monitoring in tuberculosis care. In-person DOT is resource intensive and often burdensome for patients. Video DOT (vDOT) has been proposed as an alternative to increase treatment flexibility...

Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

Post Date:

2018-04-19

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Trials

Trials: Evidence for TB treatment in kids is largely based on adult studies. The SHINE study aims to fix this

Migration and risk of HIV acquisition in Rakai, Uganda: a population-based cohort study

Post Date:

2018-04-15

Countries:

Uganda

Publication:

Lancet HIV

BACKGROUND: In sub-Saharan Africa, migrants typically have higher HIV prevalence than non-migrants; however, whether HIV acquisition typically precedes or follows migration is unknown. We aimed to investigate the risk of HIV after migration in Rakai District, Uganda. METHODS: In a prospective...

Prevention of HIV-1 transmission through breastfeeding:efficacy of safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE)

Post Date:

2018-04-01

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Journal of Acquired Immune Deficiency Syndromes

BACKGROUND: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. SETTING: Fourteen sites in Sub-Saharan Africa and India...

HIV viral suppression and geospatial patterns of HIV antiretroviral therapy treatment facility use in Rakai, Uganda

Post Date:

2018-03-27

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Uganda

Publication:

AIDS

OBJECTIVE: To assess geospatial patterns of HIV antiretroviral therapy (ART) treatment facility use and whether they were impacted by viral load suppression. METHODS: We extracted data on the location and type of care services utilized by HIV-positive persons accessing ART between February 2015 and...

Pyrosequencing to resolve discrepant Xpert MTB/RIF and Mycobacterial Growth Indicator Tube 960

Post Date:

2018-03-26

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Lung India

Lung India: Indo-JHU researchers find that pyrosequencing can clear up discrepancies about drug resistance in TB.

Screening and diagnosis of gestational diabetes in India: A systematic review and meta analysis

Post Date:

2018-03-26

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Acta Diabetologica

Review article on prevalence and screening and diagnostic methods for gestational diabetes in India.

Intestinal barrier dysfunction and microbial translocation in HIV-infected pregnant women is associated with preterm birth

Post Date:

2018-03-24

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Clinical Infectious Diseases

Our results show select immune markers can identify women at higher risk for PTB in HIV-1-infected populations and suggest modulating gut barrier integrity and microbial translocation may affect PTB.

Mobile phone incentives for childhood immunizations in rural India

Post Date:

2018-03-19

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Pediatrics

In Pediatrics: Incentives and technology can improve immunization coverage in young children in resource-poor settings.

How feasible is pharmaceutical regulation in India?

Post Date:

2018-01-29

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The Lancet Global Health

Lancet Global Health: Dr. Sachin Atre outlines factors that complicate pharmaceutical regulation in India, which is a component of WHO's Global Antimicrobial Resistance Action Plan.

The validity of self-reported antiretroviral use in persons living with HIV: a population-based study

Post Date:

2018-01-28

Countries:

Uganda

Publication:

AIDS

OBJECTIVE: To assess the validity of self-reported antiretroviral therapy use (ART) using population-based cohort data. METHODS: Self-reported ART use and nonuse was compared with a validated laboratory assay in 557 HIV-positive participants in the Rakai Community Cohort Study surveyed between...

¡Vive!: Designing an intervention to improve timely HIV diagnosis among Latino immigrant men

Post Date:

2018-01-23

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Progress in Community Health Partnerships

Background: Latinos, particularly immigrant men, are more likely to present late to care for human immunodeficiency virus (HIV) infection. Objectives: This manuscript describes the development of ¡Sólo Se Vive Una Vez! (¡Vive!) (You Only Live Once), a multilevel (individual and community)...

Gender-based violence screening methods preferred by women visiting a public hospital in Pune, India

Post Date:

2018-01-22

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BMC Womens Health

BMC Womens Health : In our study, 23% of women reported experiencing gender based violence, and 90% reported they had never been asked about it in the healthcare setting.

Secondhand smoke exposure and validity of self-report in low-income women and children in India

Post Date:

2018-01-10

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Pediatrics

Pediatrics: Dr. Jessica Elf and colleagues evaluated the validity of standard self-reported measures for secondhand smoke (SHS) exposure among women and children in urban India.

What will it take to reduce HIV incidence in the United States: A mathematical modeling analysis

Post Date:

2018-01-06

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Open Forum Infectious Diseases

Modeling and simulations suggest that cutting HIV incidence in half by 2025 will require 95% of people living with HIV to be engaged in care.

Suboptimal antituberculosis drug concentrations and outcomes in small and HIV‐coinfected children in India: Recommendations for dose modifications

Post Date:

2017-12-16

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Clinical Pharmacology and Therapeutics

This work aimed to evaluate the once-daily antituberculosis treatment as recommended by the new Indian pediatric guidelines. Isoniazid, rifampin, and pyrazinamide concentration-time profiles and treatment outcome were obtained from 161 Indian children with drug-sensitive tuberculosis undergoing...

Isoniazid concentrations in hair and plasma area-under-the-curve exposure among children with tuberculosis

Post Date:

2017-12-07

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PLOS One

PLOS One: Mave and colleagues compared TB drug exposure in plasma and hair samples among a small cohort of children.

Biological Differences in Tuberculosis Diagnosis and Disease in Women

Post Date:

2017-10-12

Clinical Sites:

Mathad J. Biological Differences in Tuberculosis Diagnosis and Disease in Women. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Symposium: From Bench to Bassinet: Scientific Innovations: The Fight against Maternal-Infant TB

Post Date:

2017-10-12

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Gupta A. Symposium: From Bench to Bassinet: Scientific Innovations: The Fight against Maternal-Infant TB. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Barriers to Contact Screening and Isoniazid Preventive Therapy among Pediatric Contacts of Adults with Smear-positive Tuberculosis

Post Date:

2017-10-12

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Belgaumkar V , Chandanwale A, Valvi C, Khadse S, Jain D, Dhumal G, Bollinger RC, Deluca A. Barriers to Contact Screening and Isoniazid Preventive Therapy among Pediatric Contacts of Adults with Smear-positive Tuberculosis. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Drug Susceptibility of Rifampin-resistant Tuberculosis using Whole Genome Sequencing to Identify Genes of Interest in Pune, India

Post Date:

2017-10-12

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Tornheim JA , Madugundu AK, Pradhan N, Bharadwaj R, Mave V, Golub J, Pandey A, Gupta A. Drug Susceptibility of Rifampin-resistant Tuberculosis using Whole Genome Sequencing to Identify Genes of Interest in Pune, India. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Linezolid Experience among MDRTB Patients in Mumbai

Post Date:

2017-09-13

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Tornheim J, Ganatra S, Deluca A, Banka R, Rodrigues C, Gupta A, Udwadia Z. Poster Presentation. Linezolid Experience among MDRTB Patients in Mumbai. ERS International Congress. European Respiratory Society. Milan, Italy.

Trends in Glycated Hemoglobin Levels and Implications for Diabetes Screening among Pulmonary Tuberculosis Cases Undergoing Treatment in India

Post Date:

2017-09-13

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DY Patil

Gupte AN , Mave V, Meshram S, Lokhande R, Kadam D, Dharmshale S, Bharadwaj R, Kagal A, Pradhan N, Deshmukh S, Atre S, Sahasrabudhe T, Barthwal M, Meshram S, Kakrani A, Kulkarni V, Raskar S, Suryavanshi S, Shivakoti R, Chon S, Selvin E, Gupte N, Gupta A, Golub JE. Trends in Glycated Hemoglobin...

High Burden of Diabetes and Prediabetes among Adult Household Contacts of India

Post Date:

2017-09-13

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Shivakumar SVBY , Chandrasekaran P, Kumar AJMV, Paradkar M, Dhanasekaran K, Suryavanshi N, Thomas B, Kohli R, Thiruvengadam K, Kulkarni V, Hannah LE, Sivaramakrishnan GN, Pradhan N, Dolla C, Gupte A, Ramachandran G, DeLuca A, Meshram S, Bhardawaj R, Bollinger RC, Golub J, Selvaraj K, Gupte N,...

Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India

Post Date:

2017-09-13

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Tornheim JA , Paradkar M, Madugundu A, Gupte N, Kulkarni V, Sreenivasamurthy S, Raja R, Pradhan N, Shivakumar SVBY, Valvi C, Kohli R, Chandrasekaran P, Mave V, Pandey A, Gupta A. Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India. RePORT International...

Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens

Post Date:

2017-07-26

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Bhattacharya D , Gupta A, Tierney C, Huang S, Peters M, Chipato T, Martinson F, Dula D, George K, Chaktoura N, Klingman K, Gnanashanmugam D, Currier J, Fowler MG. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens. IAS 2017. International AIDS Society. Paris, France...

Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens in PROMISE P1077

Post Date:

2017-05-31

Amita Gupta. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens in PROMISE P1077. 2017 IMPAACT Annual Meeting. Washington, DC. 2017

IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection

Post Date:

2017-05-30

Jyoti Mathad. IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

CTRIUMPh Pediatric Biomarker Substudy

Post Date:

2017-05-30

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Tornheim J . Paradkar M. CTRIUMPh Pediatric Biomarker Substudy. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

A5300B/IMPAACT 2003B – PHOENix MDR TB: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant TB Patients

Post Date:

2017-05-30

Gupta, A. A5300B/IMPAACT 2003B – PHOENix MDR TB: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant TB Patients. 2017 IMPAACT Annual Meeting. Washington, DC.

A5300/I2003/PHOENIx Trial Update

Post Date:

2017-05-30

Gupta, A. A5300/I2003/PHOENIx Trial Update. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

A5300/I2003/PHOENIx Preparatory Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial

Post Date:

2017-05-29

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Gupta, A. A5300/I2003/PHOENIx Preparatory Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

How Americans Benefit from Global Health Research

Post Date:

2017-05-25

Countries:

Bollinger, R. How Americans Benefit from Global Health Research. The Fogarty International Center: How Americans Benefit from Global Health Research Webinar, Research!America. Washington, DC.

Knowledge, Attitudes and Practices About Multidrug-Resistant Tuberculosis (MDR-TB) and Preventive Therapy Among Adult and Adolescent Household Contacts of MDR-TB Index Cases

Post Date:

2017-05-22

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Suryavanshi N, Shah S, Murrill M , Gupta A. Knowledge, Attitudes and Practices About Multidrug-Resistant Tuberculosis (MDR-TB) and Preventive Therapy Among Adult and Adolescent Household Contacts of MDR-TB Index Cases. American Thoracic Society 2017 International Conference. Washington, DC. 2017.

It Simply Won’t Work Here – Few Eligible for the Newly Recommended Short Course MDR-TB Regimen in a Mumbai Private Clinic

Post Date:

2017-05-21

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Tornheim J , DeLuca A, Ganatra S, Radhika B, Gupta A, Udwadia Z. It Simply Won’t Work Here – Few Eligible for the Newly Recommended Short Course MDR-TB Regimen in a Mumbai Private Clinic. American Thoracic Society 2017 International Conference. Washington, DC. 2017.

Communicating Whole Genome Sequencing Results for Tuberculosis: What Does It Mean and Who Needs to Know?

Post Date:

2017-04-25

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