Clinical Research

Led by Sarah Kiguli at the Makerere University College of Health Sciences, the goal of this effort is to improve service delivery of the Ugandan health system through strengthened health professional interdisciplinary education and research training to produce graduates with competencies to address...

Assessing the Impact of Psychosocial Involvement in Health Care Workers with and without Active Tuberculosis at the Byramjee Jeejeebhoy Government Medical College, Pune, India

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2018-09-13

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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. The overall goal is to understand the psychosocial involvement in health care workers with and without active tuberculosis. The specific aims of this study are: To understand the...

Evaluation of National Video Directly Observed Therapy Implementation

Post Date:

2018-08-05

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United States

emocha Mobile Health, Inc., and Johns Hopkins investigators have developed a user-friendly, HIPAA compliant application for asynchronous video directly observed therapy (DOT) miDOT. The miDOT platform consists of a patient-facing mobile application where patients can record videos of themselves...

RCT to Reduce HIV Acquisition and Viral Load among Migrants, Rakai, Uganda

Post Date:

2018-08-01

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The Rakai Health Sciences Program (RHSP), Uganda, proposes an implementation science community- randomized controlled trial (CRCT) of a novel intervention to newly in-migrated individuals (Welcome In-coming Neighbor [WIN]), to optimize their rapid linkage to combination HIV prevention (CHP)...

Assessment of Depression and Anxiety among HIV-infected Adolescents in Pune, India

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2018-07-22

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This study is conducted under the TREAT Asia Network and funded by amfAR. PURPOSE The purpose of this study is to estimate the prevalence of depression and anxiety among adolescents living with HIV in India and their determinants. DESIGN Cross-sectional, single time point, conveniently sampled...

Assessing Psychological Distress among Tuberculosis Patients and Their Household Members

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2018-07-17

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By assessing psychological distress, Indo-JHU researchers hope to better understand the correlation between depression and TB severity.

Evaluating the Source of Neonatal Bloodstream Infections due to Classically Hospital Acquired Pathogens in the Neonatal Intensive Care Unit in Pune, India

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2018-07-12

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Bharati Vidyapeeth Medical College

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KEM Hospital

This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. The PIs for this study are Dr. Julia Johnson of Johns Hopkins and Dr. Shilpa Naik of BJGMC. CoPIs are Dr...

Assessing the Feasibility and Acceptability of a Computer-based Avatar-delivered Alcohol Reduction Intervention

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2018-07-05

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Study is assessing whether computer-delivered alcohol screening and intervention helps overcome barriers to treatment in India.

Molecular Signatures of Tuberculosis-Diabetes Interaction: Metabolomics Study

Post Date:

2018-06-15

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This study is using stored samples from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Type 2 diabetes mellitus (DM...

Molecular Signatures of Tuberculosis-Diabetes Interaction: Transcriptomics Study

Post Date:

2018-06-15

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Gut Microbiota of HIV Infected Pregnant Women

Post Date:

2018-06-14

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Birth Outcomes in HIV Both antiretroviral-therapy (ART)-naïve and ART-experienced HIV-infected pregnant women have higher incidences of pre-term birth (PTB) compared to HIV-uninfected women. For example, the global prevalence of PTB is around 8%, while the rates in in HIV-infected populations are...

Optimal Approach for TB Screening among HIV Infected Indian Children

Post Date:

2018-06-11

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This study was terminated May 20, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Determining TB status (ie, uninfected, latent, and active TB disease) is more difficult among children, particularly HIV-infected children. Diagnosis of TB disease is...

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

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2018-06-07

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New study will characterize the pharmacokinetics of delamanid using a model-based approach, and evaluate safety and tolerability of over 24 weeks of study treatment in HIV infected and uninfected children.

Evaluation of Video-Based Directly Observed Therapy for Tuberculosis in India

Post Date:

2018-05-14

Countries:

United States

This study was designed to evaluate Directly Observed Therapy conducted through miDOT, a secure mobile health interface, with traditional in-person Directly Observed Therapy.

Multidisciplinary Research Training to Understand and Reduce HIV Incidence in Uganda

Post Date:

2018-05-09

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Dr. Larry Chang is PI for this multi-year (2018-2023) training grant sponsored by the Fogarty International Center at the National Institute of Health. Abstract While substantial progress has been made in the global HIV response, impact has been uneven. Uganda provides a prime case study. Uganda...

Implementing the Comprehensive Unit-based Safety Program to Reduce Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

Post Date:

2018-04-19

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This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. Dr. Aaron Milstone is the PI, and Dr. Amita Gupta and Yuka Manabe are Co-PIs. The Study Investigator is...

Predictors of Resistance Emergence Evaluation in Multidrug Resistant-Tuberculosis Patients on Treatment (PREEMPT Pilot Study)

Post Date:

2018-03-20

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Indo-JHU Clinical Resarch Partnership is participating with Brazilian colleagues in a 3-year effort led by Boston University to identify what contributes to TB drug resistance.

A Multicenter Phase II/II 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:

2018-01-23

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Dr. Vidya Mave is leading this clinical trial evaluating the safety and efficacy of a new recombinant BCG vaccine.

Perceptions of HCWs on Barriers and Opportunities to Airborne Infection Control Guideline Implementation

Post Date:

2017-12-07

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This study was terminated in December 2020 It was funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. Led by Dr. Nishi Suryavanshi, this qualitative, cross-sectional study is assessing healthcare worker (HCW) perceptions about barriers and facilitators...

Building on Needle Exchange to Optimize HIV Prevention/Treatment

Post Date:

2017-12-01

Countries:

United States

Biomedical interventions that have direct applicability to people who inject drugs (PWID) have flourished over the past 15 years (HIV treatment as prevention, pre-exposure prophylaxis, office-based medication-assisted treatment (MAT) with buprenorphine, and hepatitis C virus (HCV) treatment with...

HIV, Pregnancy, and Isoniazid Preventive Therapy. Reply

Post Date:

2020-03-18

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The New England Journal of Medicine

Gupta et al. (Oct. 3 issue)1 report a higher incidence of adverse pregnancy outcomes among women with human immunodeficiency virus (HIV) infection who were exposed to isoniazid preventive therapy (IPT) during the second and third trimesters than among those not exposed to IPT during pregnancy. From...

Quantifying HIV transmission flow between high-prevalence hotspots and surrounding communities: a population-based study in Rakai, Uganda

Post Date:

2020-03-17

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The Lancet HIV

BACKGROUND: International and global organisations advocate targeting interventions to areas of high HIV prevalence (ie, hotspots). To better understand the potential benefits of geo-targeted control, we assessed the extent to which HIV hotspots along Lake Victoria sustain transmission in...

Hepatotoxicity and Liver-Related Mortality in Women of Child-Bearing Potential Living With HIV and High CD4 Counts Initiating Efavirenz-Containing Regimens

Post Date:

2020-03-11

Publication:

Clinical Infectious Diseases

Background: Severe hepatotoxicity in people with HIV receiving efavirenz (EFV) has been reported. We assessed the incidence and risk factors of hepatotoxicity in women of child-bearing age initiating EFV-containing regimens. Methods: In the PROMISE trial, ART-naïve pregnant women with HIV and CD4...

Tuberculosis in children, adolescents, and women

Post Date:

2020-02-27

Publication:

Lancet Respiratory Medicine

In this Lancet Respiratory Medicine commentary, Dr. Amita Gupta and colleagues note that TB prevalence among children, adolescents, and women isn't well documented. This poses big challenges for the goal of TB elimination.

Migration, hotspots, and dispersal of HIV infection in Rakai, Uganda

Post Date:

2020-02-20

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Nature Communications

Abstract HIV prevalence varies markedly throughout Africa, and it is often presumed areas of higher HIV prevalence (i.e., hotspots) serve as sources of infection to neighboring areas of lower prevalence. However, the small-scale geography of migration networks and movement of HIV-...

Whole genome enrichment approach for rapid detection of Mycobacterium tuberculosis and drug resistance-associated mutations from direct sputum sequencing

Post Date:

2020-02-20

Publication:

Tuberculosis

Tuberculosis is the leading cause of death among infectious diseases worldwide. Detection of Mycobacterium tuberculosis (Mtb), using routine culture-based methods is time consuming resulting in delayed diagnosis and poor treatment outcomes. Currently available molecular tests provide faster...

High prevalence of late presentation of ART-naïve perinatally infected children for care in Pune, India

Post Date:

2020-02-19

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AIDS Care

AIDS Care : There is an urgent need to identify strategies that improve linkage of perinatally infected ART-naïve children to care, and earlier than what is currently observed.

Compliance of private pharmacies in Uganda with controlled prescription drugs regulations: A mixed-methods study

Post Date:

2020-02-08

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Substance Abuse Treatment, Prevention, and Policy

Background: Controlled prescription drug use disorders are a growing global health challenge in Sub-Saharan Africa. Effective supply chain regulations on dispensing and stock control are important for controlling this epidemic. Since compliance with these regulations in resource-limited countries...

Applying a risk-benefit analysis to outcomes in tuberculosis clinical trials

Post Date:

2020-02-03

Publication:

Clinical Infectious Diseases

CID: Analyzing efficacy and safety separately in clinical trials could yield misleading study conclusions if there's an increase in efficacy and a decrease in safety

Assessment of the Xpert assay among new pulmonary tuberculosis suspects with and without diabetes mellitus

Post Date:

2020-01-01

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Publication:

International Journal of Tuberculosis and Lung Disease

IJTLD: Deshmukh and colleagues: High sensitivity and specificity of Xpert underscores need for rapid scale up for early detection of TB in settings with a high dual burden of TB and DM

Addressing the global burden of hepatitis B virus while developing long-acting injectables for the prevention and treatment of HIV

Post Date:

2019-12-20

Publication:

Lancet HIV

Lancet HIV: Dr. Bob Bollinger and colleagues discuss the urgent need and opportunity to include activity against Hepatitis B in formulations of long-acting drugs for HIV prevention and treatment

Transcriptomic profiles of confirmed pediatric tuberculosis patients and household contacts identifies active tuberculosis, infection, and treatment response among Indian children

Post Date:

2019-12-04

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Publication:

Journal of Infectious Diseases

Journal of Infectious Diseases: Gene expression profiles among Indian children with confirmed TB were distinct from those of adults, highlighting the importance of including distinct populations in differential gene expression models

Evaluating the Concordance of Clinician Antiretroviral Prescribing Practices and HIV-ASSIST, an Online Clinical Decision Support Tool

Post Date:

2019-12-02

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Publication:

Journal of General Internal Medicine

Recent studies have shown that more than half of HIV care is provided by primary care practitioners.However, clinicians with experience and expertise in HIV medicine are declining.

A parsimonious host inflammatory biomarker signature predicts incident TB and mortality in advanced HIV

Post Date:

2019-11-25

Publication:

Clinical Infectious Diseases

BACKGROUND: People with advanced HIV (CD4<50) remain at high risk of TB or death despite the initiation of antiretroviral therapy. We aimed to identify immunological profiles that were most predictive of incident TB disease and death. METHODS: The REMEMBER randomized clinical trial enrolled 850...

Lipid mediators of inflammation and resolution in individuals with tuberculosis and tuberculosis-diabetes

Post Date:

2019-11-11

Publication:

Prostaglandins and Other Lipid Mediators

Individuals with concurrent tuberculosis (TB) and Type 2 diabetes (DM) have a higher risk of adverse outcomes. To better understand potential immunological differences, we utilized a comprehensive panel to characterize pro-inflammatory and pro-resolving (i.e., mediators involved in the resolution...

Incidence of tuberculosis in HIV-infected adults on first- and second-line antiretroviral therapy in India

Post Date:

2019-10-29

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BMC Infectious Diseases

In this study among people living with HIV, Akshay Gupte and colleagues found that the risk of acquiring tuberculosis was higher in those receiving first-line antiretrovial therapy versus those receiving second-line medications.

Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV

Post Date:

2019-10-20

Publication:

Cochrane Database of Systematic Reviews

Why is improving the diagnosis of tuberculosis important? Tuberculosis causes more deaths in people living with HIV than any other disease. The lateral flow urine lipoarabinomannan assay (LF-LAM, Alere Determine™ TB LAM Ag assay) is a World Health Organization-recommended rapid test to assist in detection of active tuberculosis in HIV-positive people with severe HIV disease. Rapid and early tuberculosis diagnosis may allow for prompt treatment and alleviate severe illness and death. An incorrect tuberculosis diagnosis may result in anxiety and unnecessary treatment.

Impact of combination HIV interventions on HIV incidence in hyperendemic fishing communities in Uganda: a prospective cohort study

Post Date:

2019-10-06

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Publication:

The Lancet HIV

BACKGROUND: Targeting combination HIV interventions to locations and populations with high HIV burden is a global priority, but the impact of these strategies on HIV incidence is unclear. We assessed the impact of combination HIV interventions on HIV incidence in four HIV-hyperendemic...

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

Post Date:

2019-10-03

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Publication:

New England Journal of Medicine

New England Journal of Medicine: Dr. Amita Gupta and colleagues found that the current standard of care given to HIV+ pregnant women to prevent TB should wait until 12 weeks after delivery. The study underscores the need to include pregnant women in clinical trials.

Challenges in conducting trials for pediatric tuberculosis meningitis: lessons learned in the field

Post Date:

2019-10-01

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Publication:

International Journal of Tuberculosis and Lung Disease

International Journal of Tuberculosis and Lung Disease: Researchers describe the challenges associated with conducting the first randomized clinical trial of antimicrobial agents in pediatric tuberculosis meningitis.

IL-6, TIMP-2 and TGFβ-2 Are Associated with Respiratory Impairment During and Following Successful Treatment of Pulmonary Tuberculosis

Post Date:

2019-02-04

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Gupte A , Paradkar M, Selvaraju S, Kumar P, Lokhande R, Kulkarni V, Hanna LE, Thiruvengadam K, Sekar K, Momin A, Shivakumar SVBY, Gupte N, Babu S, Salvi S, Golub J, Checkley W, Bollinger RC, Andrade B, Mave V, Chandrasekaran P, Gupta A. IL-6, TIMP-2 and TGFβ-2 are associated with respiratory...

Determination of Plasma Clofazimine Levels by Liquid Chromatography-Mass Spectrometry

Post Date:

2019-02-04

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Clinical Sites:

Chawla PK , Lokhande RV, Naik PR, Dherai AJ, Udwadia ZF, Mahashur AA, Pinto L, Soman R, Rodrigues C, Gupta A, Tornheim JA, Martinson N, Variava E, Weisner L, Joubert A, Ashavaid TF. Determination of Plasma Clofazimine Levels by Liquid Chromatography-Mass Spectrometry. 8th Annual Regional...

Determination of Serum Linezolid Levels by HPLC

Post Date:

2019-02-04

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Chawla PK , Lokhande RV, NaiF PR, Dherai AJ, Udwadia ZF, Mahashur AA, Soman R, Rodrigues C, Gupta A, Tornheim JA, Ashavaid TK. Determination of Serum Linezolid Levels by HPLC. 8th Annual Regional Prospective Observational Research for Tuberculosis (RePORT) India Joint Leadership meeting – ‘’...

Mental Health and TB: High Prevalence of Depression among Drug-resistant TB Patients not Associated with Cycloserine

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2019-02-04

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Shivakumar SVBY , Tornheim JA, Gajjar I, Porwal S, Kishore G, Karane M, Sayed S, Chawla PK, Rodrigues C, Ashavaid TK, Gupta A, Udwadia ZF. Mental Health and TB: High prevalence of depression among drug-resistant TB patients not associated with cycloserine. 8th Annual Regional Prospective...

Quality of Life Among MDR-TB Patients from the Public Sector in Mumbai

Post Date:

2019-02-04

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Gajjar IN , Udwadia ZF, Kishore G, Karane M, Sayed S, Sawant N, Chawla PK, Rodrigues C, Ashavaid TK, Shivakumar SVBY, Gupta A, Tornheim JA. Quality of Life Among MDR-TB Patients from the Public Sector in Mumbai. 8th Annual Regional Prospective Observational Research for Tuberculosis (RePORT) India...

Whole Genome Sequencing of Mycobacterium Tuberculosis Directly from Clinical Samples Accurately Identifies Drug Resistance

Post Date:

2019-02-04

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Kambli P , Tornheim JA, Soundararajan L, Priyadarshini S, Gupta R, Ramprasad VL, Gupta A, Rodrigues C. Whole Genome Sequencing of Mycobacterium Tuberculosis Directly from Clinical Samples Accurately Identifies Drug Resistance. 8th Annual Regional Prospective Observational Research for Tuberculosis...

Host Lipidomic Profile Associated with Adverse Tuberculosis Treatment Outcomes

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2019-02-04

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Shivakoti R , Chandrasekaran P, Hannah LE, Thiruvengadam K, Saravanan N, Karunaianatham R, Gupta A, Mave V, Gupte N, Kulkarni V, Pradhan N, Gupte A, Paradkar M, Shivakumar SVBY, Bharadwaj, Kagal A, Gaikwad S, Sangle S, Borkowski K, Newman J, Fiehn O. Host Lipidomic Profile Associated with Adverse...

Mobile Phone Access and Comfort: Implications for HIV and Tuberculosis Care in India and South Africa

Post Date:

2018-10-04

Countries:

South Africa

Clinical Sites:

Cox SN , Elf J, Lokhande R, Ogale YP, DiAndreth L, Dupuis E, Milovanovic M, Mpongose N, Martinson N, Mave V, Suryavanshi N, Gupta A, Golub JE, Mathad JS. Mobile Phone Access and Comfort: Implications for HIV and Tuberculosis Care in India and South Africa. I DSA. IDWeek 2018. San Francisco, CA,...

Perinatal Depression among HIV and TB Infected and Uninfected Women in an Urban Slum in India: Prevalence and Associated Birth Outcomes

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2018-10-04

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Grossman TB , Bhosale R, Alexander M, Suryavanshi N, Mave V, Jain D, Patil NU, Gupta A, Mathad JS. Perinatal depression among HIV and TB infected and uninfected women in an urban slum in India: prevalence and associated birth outcomes. IDSA. ID Week 2018. San Francisco, CA. October 3-7, 2018.

Antibiotic Use and Drug-Resistant Late-Onset Infections Among Neonates Admitted to Neonatal Intensive Care Units in Pune, India

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2018-08-28

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Agarkhedkar S, Armstrong D, Bharadwaj R, Cox SR, Dohe V, Gupta A, Gupte N, Johnson J, Kadam A, Kinikar A, Malwade S, Manabe Y, Mave V, Milstone A, Parikh T, Rajput U, Randive B, Robinson M , Smith R, Suryavanshi N, Vaidya U, Westercamp M. Antibiotic Use and Drug-Resistant Late-Onset Infections...

High Prevalence of Dengue among Pregnant Women in India

Post Date:

2018-08-27

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Alexander M, Naik S, Robinson M , Sapkal G, Deshpande P, Kulkarni V, Nimkar S, Sambarey P, Kinikar A, Mave V, Suryavanshi N, Gupte N, Bollinger R, Gupta A, Bharadwaj R, Mathad J. High Prevalence of Dengue among Pregnant Women in India. 2018 International Conference on Emerging Infectious Diseases...

Association of Maternal Viral Load and CD4 Count with Perinatal HIV-1 Transmission Risk during Breastfeeding in the PROMISE Postpartum Component

Post Date:

2018-07-26

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Clinical Sites:

Flynn P, Taha T, Cababasay M, Butler K, Fowler MG, Mofenson L, Owor M, Fiscus S, Stranix-Chibanda L, Coutsoudis A, Gnanshanmugam D, Chakhtoura N, McCarthy K, Mukuzunga C, Makanani B, Moodley D, Nematadzira T, Kusakara B, Patil S, Vhembo T, Bobat R, Mmbaga B, Masenya M, Nyati M, Theron G, Mulenga H...

Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster Randomized Trial

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2018-07-24

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Clinical Sites:

Suryavanshi N, Kadam A, Hegde A, Sivalenka S, Kumar VS, McKenzie-White J, Kanade S, Gupta A, Bollinger RC, Shankar A, Gupte N, Mave V. Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster...

Opportunities, Challenges and Implications of m-Health Oral Cancer Screening for HIV-positive Individuals in India

Post Date:

2018-07-23

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Clinical Sites:

Joshi S, Chandanwale A, Sangle S, Marbaniang I , Khaire S, Thakur R, Gupta A, Chigurupati R, Mave V. Opportunities, Challenges and Implications of m-Health Oral Cancer Screening for HIV-positive Individuals in India. AIDS 2018. Amsterdam, The Netherlands. July 23-27, 2018.

Health-related Quality of Life in the A5274 Trial of TB Therapy in Advanced HIV

Post Date:

2018-07-22

Clinical Sites:

Lando R, Sun X, Miyahara S, Hosseinpour MC, Bisson GP, Kumwenda J, Gupta A, Nyirenda M, Katendey K, Torres TS, Suryavanshi N, Beulah F, Opollo V, Shah NS on behalf of the A5274 study team. Health-related Quality of Life in the A5274 Trial of TB Therapy in Advanced HIV. TB 2018, Amsterdam, The...

Role of Maternal Viral Load and CD4 Count on Perinatal HIV-1 Transmission during Breastfeeding in the PROMISE Postpartum Component

Post Date:

2018-07-20

Clinical Sites:

Flynn P, Taha T, Cababasay M, Butler K, Fowler MG, Mofenson L, Owor M, Fiscus S, Stranix-Chibanda L, Coutsoudis A, Gnanshanmugam D, Chakhtoura N, McCarthy K, Mukuzunga C, Makanani B, Moodley D, Nematadzira T, Kusakara B, Patil S , Vhembo T, Bobat R, Mmbaga B, Masenya M, Nyati M, Theron G, Mulenga H...

Association between Dietary Intake and the Composition of the Vaginal Microbiota

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2018-06-20

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Shivakoti R , Tuddenham S, Caulfield LE, Robinson C, Rave J, Ghanem K, Brotman R. Association between dietary intake and the composition of the vaginal microbiota. Society for Epidemiologic Research 51st Annual Meeting. Baltimore, MD. June 19-22, 2018.

Association between Dietary Intake and the Composition of the Vaginal Microbiota

Post Date:

2018-06-09

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Shivakoti R , Tuddenham S, Caulfield LE, Robinson C, Rave J, Ghanem K, Brotman R. Association between Dietary Intake and the Composition of the Vaginal Microbiota. Oral presentation at Nutrition 2018 Conference. American Society for Nutrition. Boston, MA. June 9, 2018.

Bloodstream Infections among Neonates Admitted to Neonatal Intensive Care Units in Pune, India

Post Date:

2018-05-05

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Clinical Sites:

DY Patil

Johnson J , Rajput U, Valvi C, Bharadwaj R, Parikh T, Agarkhedkar S, Robinson M, Randive B, Gupte N, Smith R, Westercamp M, Mave V, Manabe Y, Milstone A, for the CDC SHEPheRD India Study Team. Bloodstream Infections among Neonates Admitted to Neonatal Intensive Care Units in Pune, India. Pediatric...

Importance of Diagnosis of TB Infection in Pregnant Women in India: Findings from a Cohort Study in Pune, India

Post Date:

2018-04-24

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