Clinical Research

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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

Countries:

United States

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

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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...

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

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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

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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...

Establishing an Observational Cohort Database for Patient Care and Research at the Hinduja Hospital Chest Clinic

Post Date:

2016-08-30

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India has the largest burden of global tuberculosis (TB), accounting for one quarter of the total number of cases reported. Together with South Africa, India sees one-third of the total number of deaths from TB. Drug-resistant strains of the disease are also on the rise, with India having one of...

Measuring TB Drugs in Hair as a Tool to Monitor Adherence, Exposure and Response in Patients with HIV

Post Date:

2016-08-16

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Our study will examine whether hair levels of two key first line tuberculosis drugs will be useful markers to identify individuals at highest risk of treatment failure in active tuberculosis. Our study aims to provide a lowcost clinical tool using hair that can be noninvasively collected to monitor...

mHealth-enhanced Peer Navigation Intervention for PrEP Delivery among MSM at STD Clinics

Post Date:

2016-08-01

Countries:

United States

Using mixed methodology (quantitative surveys, qualitative interviews, and administrative data), this study will assess acceptability and feasibility of an mHealth-enhanced peer navigation to promote PrEP initiation, retention and adherence among men who have sex with men (MSM) in the Baltimore...

Adherence to Indian National Guidelines for Isoniazid Chemoprophylaxis among Pediatric Contacts of Pulmonary Tuberculosis Cases

Post Date:

2016-07-06

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The primary objective of the study was to assess the implementation of the Indian Revised National Tuberculosis Programme's (RNTCP) guidelines regarding isoniazid preventive treatment (IPT) for children under 6 years of age who had been in contact with adults diagnosed with sputum positive...

TB and Pregnancy Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis: Nested Study on Temporal Dynamics of Gut Microbiota in HIV Infected Pregnant Women

Post Date:

2016-07-05

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This is a nested prospective longitudinal cohort study of 35 HIV-infected and 35 HIV-noninfected pregnant women who are part of the parent study “Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis." The objectives are to: Determine the association of gestational age with...

A Randomized Therapeutic Interventional Comparative Study between Three Different Modalities of Paediatric Antitubercular Treatment

Post Date:

2016-06-13

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This study was funded by the Fogarty International Center at the U.S. National Institutes of Health. This study, conducted and concluded in 2013, evaluated three different TB treatment regimens in children attending Sassoon General Hospital in Pune, India. A convenience sample size of n=100...

Optimal Algorithmic Diagnosis of Genital TB among HIV-infected and Uninfected Infertile Women

Post Date:

2016-05-26

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This study was funded by the Fogarty International Center at the U.S. National Institutes of Health. There is a lack of a set protocol universally for diagnosis of genital TB, and for Indian hospitals, India's Revised National Tuberculosis Control Program (RNTCP) also does not give guidelines on...

Whole Genome Sequencing and Trek Sensititre Testing of Stored Isolates of Drug-resistant Tuberculosis from a Clinical Cohort at Hinduja Hospital, Mumbai

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2016-05-02

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Among HIV-positive TB patients presenting to Médecins San Frontières (MSF) clinics in Mumbai, 78% carried MDR-TB strains, with nearly half also found to have additional drug resistance. A previously published cohort of 202 patients cared for at these MSF clinics have enrolled in a cross-sectional...

Barriers to Early Treatment Initiation in Childhood Tuberculosis in High Incidence Setting

Post Date:

2016-04-21

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Funded by the Fogarty International Center and led by PI Dr. Chhaya Tukaram Valvi, the aim of this study is to evaluate the time to treatment initiation and barriers to early treatment initiation in childhood tuberculosis. TB diagnosis in children is challenging, often overlooked or missed, because...

RePORT: C-TRIUMPH: Substudy on Comparison of Available Purified-protein Derivative (PPD) Tuberculin Skin Test (TST) Antigen Solutions in Detecting Latent Tuberculosis Infection in India

Post Date:

2016-04-21

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Given the worldwide shortage of PPD TST antigen solutions, it is important to establish the sensitivity of the commercially available SPAN diagnostic TST when compared products used in international settings. This study aims to establish whether the SPAN diagnostic product is bioequivalent to PPDs...

Barriers to Implementation of Isoniazid Preventive Treatment (IPT) in Pediatric Contacts of Sputum Positive Adults with Tuberculosis

Post Date:

2016-03-24

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This study was funded by the Fogarty International Center at the U.S. National Institutes of Health. Young children infected with M.tuberculosis can rapidly progress to pulmonary and extrapulmonary disease with high rates of mortality and morbidity. Studies worldwide have demonstrated that IPT not...

People with tuberculosis falling through the cracks

Post Date:

2017-11-01

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Publication:

National Medical Journal of India

India accounts for approximately one-quarter of the estimated global burden of TB and MDR-TB. [4] Achieving the 2015 WHO End TB Strategy[5] and the latest Government of India target of TB elimination by 2025[6] will require substantial efforts and funding to continue to improve TB care in India...

Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults

Post Date:

2017-10-23

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AIDS

Background: Many HIV-infected individuals present with advanced HIV disease. These patients are at high risk of death after antiretroviral therapy (ART) initiation, but risk factors for death in these patients are unclear. Methods: We used data from a multisite randomized trial comparing empiric vs...

Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial

Post Date:

2017-10-23

Countries:

Uganda

Publication:

Trials

Abstract Background: Effective yet practical strategies are needed to increase engagement in HIV treatment and prevention services, particularly in high-HIV-prevalence hotspots. We designed a community-based intervention called "Health Scouts" to promote uptake and adherence to HIV services in a...

Of testing and treatment: Implications of implementing new regimens for multidrug-resistant tuberculosis

Post Date:

2017-10-01

Publication:

Clinical Infectious Diseases

A novel, shorter-course regimen for treating multidrug-resistant (MDR) tuberculosis was recently recommended by the World Health Organization. However, the most appropriate use of drug susceptibility testing (DST) to support this regimen is less clear. Implementing countries must therefore often...

Global, regional, and national under-5 mortality, adult mortality, age-specific mortality, and life expectancy, 1970-2016: a systematic analysis for the Global Burden of Disease Study 2016

Post Date:

2017-09-16

Publication:

The Lancet

Abstract Background: Detailed assessments of mortality patterns, particularly age-specific mortality, represent a crucial input that enables health systems to target interventions to specific populations. Understanding how all-cause mortality has changed with respect to development status can...

Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016

Post Date:

2017-09-16

Publication:

The Lancet

Abstract Background: As mortality rates decline, life expectancy increases, and populations age, non-fatal outcomes of diseases and injuries are becoming a larger component of the global burden of disease. The Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) provides a...

Measuring progress and projecting attainment on the basis of past trends of the health-related Sustainable Development Goals in 188 countries: an analysis from the Global Burden of Disease Study 2016

Post Date:

2017-09-12

Publication:

The Lancet

Abstract Background: The UN's Sustainable Development Goals (SDGs) are grounded in the global ambition of "leaving no one behind". Understanding today's gains and gaps for the health-related SDGs is essential for decision makers as they aim to improve the health of populations. As part of the...

Healthcare Access and Quality Index based on mortality from causes amenable to personal health care in 195 countries and territories, 1990-2015: a novel analysis from the Global Burden of Disease Study 2015

Post Date:

2017-07-15

Publication:

The Lancet

Abstract Background: National levels of personal health-care access and quality can be approximated by measuring mortality rates from causes that should not be fatal in the presence of effective medical care (ie, amenable mortality). Previous analyses of mortality amenable to health care only...

A qualitative study exploring factors influencing clinical decision-making for influenza-like illness in Solapur city, Maharashtra, India

Post Date:

2017-07-03

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Anthropology and Medicine

Abstract The co-existence of different types of medical systems (medical pluralism) is a typical feature of India's healthcare system. For conditions such as influenza-like illness (ILI), where non-specific disease signs/symptoms exist, clinical reasoning in the context of medical pluralism becomes...

Cardiovascular risk in an HIV-infected population in India

Post Date:

2017-07-03

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Heart Asia

Findings: HIV+ Indian patients who had cardiovascular disease at a younger age appear to be at imminent risk for morbidity.

Household food insecurity is associated with low interferon-gamma levels in pregnant Indian women

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2017-07-01

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International Journal of Tuberculosis and Lung Disease

Objective: To determine the association between household food insecurity and interferon-gamma (IFN-γ) levels in pregnancy. Design: Pregnant women in India were administered the Household Food Insecurity Access Scale (HFIAS) questionnaire and underwent an IFN-γ release assay. Logistic regression...

Vitamin A and D deficiencies associated with incident tuberculosis in HIV-infected patients initiating antiretroviral therapy in multinational case-cohort study

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2017-07-01

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Journal of Acquired Immune Deficiency Syndromes

Introduction: Numerous micronutrients have immunomodulatory roles that may influence risk of tuberculosis (TB), but the association between baseline micronutrient deficiencies and incident TB after antiretroviral therapy (ART) initiation in HIV-infected individuals is not well characterized...

Maternal syphilis: An independent risk factor for mother to infant human immunodeficiency virus transmission

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2017-06-15

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Sexually Transmitted Diseases

Abstract Syphilis is associated with increased human immunodeficiency virus acquisition and sexual transmission; we examined impact on human immunodeficiency virus mother-to-child transmission among mother-infant pairs enrolled in the India Six-Week Extended-Dose Nevirapine study. Maternal syphilis...

Presence of human hepegivirus-1 in a cohort of people who inject drugs

Post Date:

2017-06-07

Publication:

Annals of Internal Medicine

Findings on the sensitivity of next-generation metagenomic sequencing for discovery of new viral infections.

Tuberculosis screening among persons with diabetes mellitus in Pune, India

Post Date:

2017-06-02

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Publication:

BMC Infectious Diseases

Background: Diabetes mellitus (DM) increases tuberculosis (TB) risk, and there is increasing concern over the public health implications of the convergence of these two epidemics. Screening for TB among people with DM is now recommended in India. Methods: People with DM seeking care at a large...

Pulmonary infections in pregnancy

Post Date:

2017-06-01

Publication:

Seminars in Respiratory and Critical Care Medicine

Clinical review from Drs. Amita Gupta & Jyoti Mathad on improving tuberculosis treatment outcomes for pregnant women.

The impact of preexposure prophylaxis among men who have sex with men: An individual-based model

Post Date:

2017-06-01

Countries:

United States

Publication:

Journal of Acquired Immune Deficiency Syndromes

Objectives Preexposure prophylaxis (PrEP) is recommended for preventing HIV infection among individuals at high risk, including men who have sex with men (MSM). Although its individual-level efficacy is proven, questions remain regarding population-level impact of PrEP implementation. Design We...

Design and implementation of a community health worker HIV treatment and prevention intervention in an HIV hot spot fishing community in Rakai, Uganda

Post Date:

2017-05-22

Countries:

Uganda

Publication:

Journal of the International Association of Providers of AIDS Care

Abstract Innovative approaches are needed to increase engagement in HIV treatment and prevention services, particularly in HIV hot spots. Here, we detail our design, training approach, and early implementation experiences of a community-based HIV intervention called "health scouts." The...

Extrapulmonary tuberculosis

Post Date:

2017-04-27

Publication:

Handbook of Tuberculosis

M. tuberculosis (MTB) can cause disease in almost any organ of the body. Extrapulmonary tuberculosis (EPTB) is defined as tuberculosis (TB) disease outside of the lung parenchyma [1]. Much like pulmonary TB, EPTB can occur as a primary infection or as reactivation of a latent focus with subsequent...

Treatment of pulmonary tuberculosis

Post Date:

2017-04-27

Publication:

Handbook of Tuberculosis

This chapter addresses the treatment of pulmonary tuberculosis highlighting drug classes, recommended regimens, adverse drug reactions, drug-drug interactions, and practical aspects of monitoring, The principles of treatment of latent tuberculosis are also addressed including whom to treat, what...

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

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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

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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

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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?

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2017-04-25

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Tornheim, J. Communicating Whole Genome Sequencing Results for Tuberculosis: What Does It Mean and Who Needs to Know? Foundation for Medical Research. Mumbai, India.

What are We Trying to Say Here? Standardizing Next Generation Sequencing Reports for Tuberculosis

Post Date:

2017-03-30

Tornheim, J. What are We Trying to Say Here? Standardizing Next Generation Sequencing Reports for Tuberculosis. 2017 Critical Path to TB Drug Regimens Annual Workshop. Washington, DC. 2017.

Validity of Reported Measures of Secondhand Smoke Exposure in Indian Households: Mishri Preparation a Potentially Overlooked Source in Low-Income Indian Communities

Post Date:

2017-03-10

Clinical Sites:

Elf JL , Kinikar AA, Khadse S, Mave V, Gupte N, Kulkarni V, Patekar S, Raichur P, Cohen J, Breysse PN, Gupta A, Golub JE. Validity of Reported Measures of Secondhand Smoke Exposure in Indian Households: Mishri Preparation a Potentially Overlooked Source in Low-Income Indian Communities. 23rd Annual...

mHealth in medicine: A Hopkins-Focused Perspective

Post Date:

2017-02-24

Chang, L. mHealth in medicine: A Hopkins-Focused Perspective. Digital Health Day. Johns Hopkins University. Baltimore, MD.

Hepatotoxicity in People with Advanced Immunosuppression taking Isoniazid Preventive Therapy and Antiretroviral Therapy

Post Date:

2017-02-14

Clinical Sites:

Ngongondo M , Miyahara S, Hughes MD, Sun X, Gupta A, Kumwenda J, Torres TS, Bisson G, Hosseinipour MC. Hepatotoxicity in People with Advanced Immunosuppression taking Isoniazid Preventive Therapy and Antiretroviral Therapy. CROI 2017. Seattle, Washington. 2017.

Factors Associated with Pulmonary Impairment in HIV-infected South African Adults

Post Date:

2017-02-14

Countries:

South Africa

Gupte A , Wong M, Msandiwa R, Barnes G, Golub J, Chaisson R, Hoffmann C, Martinson N. Factors Associated with Pulmonary Impairment in HIV-infected South African Adults. CROI 2017. Seattle, Washington. 2017.

HIV Testing Uptake Among Household Contacts of MDR-TB Index Cases in Eight Countries

Post Date:

2017-02-14

Opollo VS, Wu X, Lando R, Swindells S, Gupta A, Hesseling A, Dawson R, Hughes MD, Shah S. HIV Testing Uptake Among Household Contacts of MDR-TB Index Cases in Eight Countries. CROI 2017. Seattle, Washington. 2017.

Impact of INH Adherence on TB Incidence and Mortality by Week 96 in ACTG 5274 Trial

Post Date:

2017-02-14

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Gupta A , Sun X, Miyahara S, Matoga M, Langat D, Riviere C, Bisson C, Kumwenda J, Hosseinipour MC, for the ACTG A5274/REMEMBER Study Team. Impact of INH Adherence on TB Incidence and Mortality by Week 96 in ACTG 5274 Trial. CROI 2017. Seattle, Washington. 2017.

Inflammation Biomarkers Predict Clinical Treatment Failure in HIV-infected Adults

Post Date:

2017-02-14

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Shivakoti R , Gupte N, Pillay S, Riviere C, Cardoso SW, Balagopal A, Semba R, Campbell T, Gupta A. Inflammation Biomarkers Predict Clinical Treatment Failure in HIV-infected Adults. CROI 2017. Seattle, Washington. 2017.

Risk Factors for Death in Advanced HIV-Infected Adults in an Empiric TB Therapy Trial

Post Date:

2017-02-14

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Bisson G, Ramchandani R , Miyahara S, Sun X, Bao J, Gupta A, Hosseinipour MC, Kumwenda J. Risk Factors for Death in Advanced HIV-Infected Adults in an Empiric TB Therapy Trial. CROI 2017. Seattle, Washington. 2017.

Impact of Drug Susceptibility Testing on Drug Choice in a Tuberculosis Cohort with High Rates of Drug Resistance from the Private Sector in Mumbai

Post Date:

2017-02-03

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Clinical Sites: