Vandana Kulkarni, MS

Pune, India
Role: 
Staff
Laboratory Manager
Vandana Kulkarni, MS

Vandana Kulkarni has a master’s degree in microbiology and has completed the Professional Development Program for Quality Assurance and Regulatory Affairs in Biopharmaceutical Industry.

Ms. Kulkarni is Laboratory Manager at Byramjee Jeejeebhoy Government Medical College Clinical Research Site (BJMC-CRS) in collaboration with Johns Hopkins University, Baltimore, USA, where she has worked since September of 2004. During the last 11 years, she has worked in the research laboratory providing lab support to NIH-funded ACTG and IMPAACT trials as well other studies.

She is responsible for the overall operations of the research laboratory and for supervision of laboratory staff comprising laboratory supervisors and technicians, and evaluates personnel competency and proficiency as well as waste management, vendor development for instrument purchase, and maintenance contracts. She also is responsible writing and revising all laboratory standard operating procedures (SOPs), for training staff in new methodologies as required, and for ensuring that laboratory and staff operate under Good Clinical Laboratory Practices. Additionally she conducts method/instrument validations, ensures that periodic EQA evaluations and methodology improvements are conducted to ensure that quality control and quality assessment programs are established and maintained, maintains the specimen repository and coordinates international shipping, lab documentations, and is responsible for annual audit to the Division of AIDS, NIAID, NIH. She is also responsible for procuring import and export permits for lab. Her prior experience includes quality control, microbiological testing, antibiotic and vitamin assays, and toxicity and sterility testing in the pharmaceutical industry. She has undergone GCLP, IATA and LDMS trainings.

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date: 
2007-02-02
   |   
Countries: 
   |   
Clinical Sites: 
Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

Mother-to-Child Transmission (MTCT) of HIV: India SWEN Study

Post Date: 
2002-06-07
   |   
Countries: 
   |   
Clinical Sites: 
This study was officially terminated August 2018. Primary and secondary analyses of the India SWEN study, an NIH-funded phase III randomized controlled trial of an extended nevirapine prophylaxis regimen among 783 HIV-infected pregnant women and their...

Pages

Diabetes and prediabetes among household contacts of tuberculosis patients in India: Is it time to screen them all?

Post Date: 
2018-06-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
International Union Against Tuberculosis and Lung Disease
SETTING: Pre-diabetes mellitus (pre-DM) and DM increase the risk of developing tuberculosis (TB). Screening contacts of TB patients for pre-DM/DM and linking them to care may mitigate the risk of developing TB and improve DM management. OBJECTIVE: To measure the prevalence of pre-DM/DM and...

Sources of household air pollution and their association with fine particulate matter in low-income urban homes in India

Post Date: 
2018-05-23
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
Journal of Exposure Science and Environmental Epidemiology
INTRODUCTION: Household air pollution (HAP) is poorly characterized in low-income urban Indian communities. MATERIALS AND METHODS: A questionnaire assessing sources of HAP and 24 h household concentrations of particulate matter less than 2.5 microns in diameter (...

Diabetes and pre-diabetes among household contacts of tuberculosis patients in India: is it time to screen them all?

Post Date: 
2018-05-22
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
The International Journal of Tuberculosis and Lung Disease
Authors find that screening contacts of TB patients for pre-DM/DM and linking them to care may mitigate the risk of developing tuberculosis and improve management of diabetes.

Vector-borne disease is a common cause of hospitalized febrile illness in India

Post Date: 
2018-03-26
   |   
Clinical Sites: 
Publication: 
American Journal of Tropical Medicine and Hygiene
Diagnostic strategies adapted for season and age may reduce diagnostic uncertainty and identify causative organisms in treatable, fatal causes of AFI.

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

Post Date: 
2018-03-24
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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.

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

Post Date: 
2018-01-10
   |   
Countries: 
Publication: 
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.

Prevalence of dysglycemia and clinical presentation of pulmonary tuberculosis in Western India

Post Date: 
2017-12-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
International Journal of Tuberculosis and Lung Disease
Objectives: To estimate the prevalence and risk factors of pre-diabetes mellitus (DM) and DM, and its associations with the clinical presentation of tuberculosis (TB). Design: Screening for DM was conducted among adults (age  18 years) with confirmed TB between December 2013 and...

Cardiovascular risk in an HIV-infected population in India

Post Date: 
2017-07-03
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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

Post Date: 
2017-07-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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...

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

Post Date: 
2017-06-15
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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...

High prevalence of cryptococcal antigenaemia amongst asymptomatic advanced HIV patients in Pune, India

Post Date: 
2017-03-21
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
Indian Journal of Medical Microbiology
Methods : A prospective study was conducted in a large public sector ART centre and the inpatient wards of Sassoon Hospital, Pune, India. All consenting patients> 18 years of age with CD4 count <100 cells/mm3 were screened for CrAg by latex agglutination assay. Those with positive CrAg...

Efficacy of six-week extended-dose nevirapine varies by infant birth weight with greatest relative efficacy in low birth weight infants

Post Date: 
2016-09-30
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
PLOS One
Low birth weight (LBW), defined by the World Health Organization (WHO) as birth weight less than 2500 g, is a significant public health issue in resource-limited settings, particularly in Sub Saharan Africa and South Asia where the estimated annual incidence is 14% and 28–31%, respectively,...

Quantitative IFN-y,IL-2 response and latent tuberculosis test discordance in HIV-infected pregnant women

Post Date: 
2016-06-15
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
American Journal of Respiratory and Critical Care Medicine
Rationale: Pregnant women with latent tuberculosis infection (LTBI) are at high risk for development of TB, especially if infected with HIV. Objectives: To assess the performance of LTBI tests in pregnant and postpartum women infected with HIV, investigate the...

Vitamin D deficiency and risk of postpartum tuberculosis among HIV-infected breastfeeding mothers in India

Post Date: 
2015-03-15
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
International Journal of Tuberculosis and Lung Disease
Some studies have associated low vitamin D levels with the risk of tuberculosis (TB), but its association in human immunodeficiency virus (HIV) infected mothers in a TB-endemic region has not been well studied. We conducted a nested 1:2 case-control study among HIV-infected mothers in western...

Impact of maternal hepatitis B virus coinfection on mother-to-child transmission of HIV

Post Date: 
2014-07-15
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
HIV Medicine
Objectives: Despite high hepatitis B virus (HBV) endemicity in various resource-limited settings (RLSs), the impact of maternal HIV/HBV coinfection on infant health outcomes has not been defined. We aimed to assess the prevalence of HBV coinfection among HIV-infected pregnant women and its...

Modifiable risk factors associated with tuberculosis disease in children in Pune, India

Post Date: 
2014-02-15
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
International Journal of Tuberculosis and Lung Disease
Setting: India accounts for the largest burden of tuberculosis (TB) worldwide, with 26% of the world's cases. Objective: To assess the association between novel modifiable risk factors and TB in Indian children. Design: Cases were children aged...

Patterns of TB drug-resistance in a tertiary care facility in Pune, India

Post Date: 
2013-07-18
   |   
Countries: 
Publication: 
Clinical Microbiology
Introduction:Globally, the emergence of multi-drug resistant tuberculosis (MDRTB) (defined as resistance to isoniazid (INH) and rifampicin (RIF) and extensively drug resistant (XDR-TB) (defined as resistance to INH, RIF, any fluoroquinolone and to at least one of the three injectable second...

Determination of a reference interval in a population

Post Date: 
2012-02-01
   |   
Countries: 
Publication: 
National Medical Journal of India
The reference interval is the most widely used medical decision-making tool that separates healthy from diseased individuals. We briefly discuss the methods used to determine reference interval and its limitations.

Maternal tuberculosis: a risk factor for mother-to-child transmission of human immunodeficiency virus

Post Date: 
2011-02-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
The Journal of Infectious Diseases
Background: Maternal human immunodeficiency virus (HIV) RNA load, CD4 cell count, breast-feeding, antiretroviral use, and malaria are well-established factors associated with mother-to-child transmission (MTCT) of HIV; the role of maternal tuberculosis (TB), however, has not been well...

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomized controlled trials

Post Date: 
2009-07-26
   |      |   
Clinical Sites: 
Publication: 
The Lancet
Background: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was...

Pages