Smita Nimkar, MSc

Pune, India

Role:

Staff

Study Coordinator & Regulatory Coordinator

Smita Nimkar is Study Coordinator for TREATAsia studies, and Regulatory Coordinator & IRB/EC Liaison for the clinical research site (CRS) at BJ Government Medical College (BJGMC) in Pune, India. The BJGMC CRS is part of the JHU Baltimore- India Clinical Trials Unit (JHUBI-CTU), which conducts clinical trials under the NIH ACTG and IMPAACT Trial Networks—along with the Johns Hopkins CRS (Baltimore, MD). She works with the India research team to ensure training on and compliance with scientific regulatory standards at all levels. She is a Director of the Training and Education Committee of JHUBI. She is serving on various ACTG committees. Smita has worked in healthcare for more than 20 years, and her experience includes HIV/AIDS, TB, and other comorbidities. She has implemented several research projects on mental health, and communicable and non-communicable diseases. Currently, she is a trainee ESI under Fogarty-IeDEA Mentorship Program (FIMP) from Asia-Pacific region.

Studies/Projects
Publications
News

Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non contrast CT among PLHIV in Pune, India

Post Date:

2022-11-25

|

Countries:

|

Clinical Sites:

Primary objective Determine the prevalence of pulmonary nodules, including lung cancer using NCCT. Determine the risk of pulmonary nodules, including lung cancer using NCCT. Evaluate the association of smoking, immune suppression, ART, and TB with the prevalence and risk of NCCT-diagnosed pulmonary...

Prevalence of Risk Factors for Lung Cancer and Facilitators and Barriers for Tobacco Cessation among People Living with HIV

Post Date:

2020-04-01

|

Countries:

|

Clinical Sites:

India has the world’s third largest HIV epidemic, with 2.1 million people currently living with HIV and an additional 90,000 new infections each year.[29] At the same time, expansion of the HIV response under India’s premier governmental agency - the National AIDS Control Organization (NACO), has...

The Sentinel Research Network of IeDEA: A Prospective Cohort among People Living with HIV

Post Date:

2020-03-12

|

Clinical Sites:

This study is nested within the TREAT Asia HIV Observational Database initiative. The global scale up of antiretroviral therapy (ART) has significantly improved the immune recovery and life expectancy of people living with HIV (PLHIV). However, PLHIV on long-term ART now face health challenges...

Markers of Lung Impairment in HIV-TB Coinfected Indian Adults

Post Date:

2019-12-11

|

Countries:

|

Clinical Sites:

Objectives/Aims We will compare the degree of lung impairment between HIV-TB co-infected adults (HIV-TB group) and TB cases without HIV co-infection (TB group) who successfully complete TB therapy. We hypothesize that the HIV-TB group will have a greater degree of lung...

Vaginal Microbiota in HIV Infected and Uninfected Pregnant Women (Stand Alone)

Post Date:

2018-10-16

|

Countries:

|

Clinical Sites:

Amita Gupta, MD, MHS, and Shilpa Naik, MD, are PIs for this study; Rupak Shivakoti, PhD, MSPH, is Co-Investigator The makeup of vaginal microbiota is dynamic and may play a role in the birth outcomes of pregnant women. While HIV and pregnancy both uniquely impact vaginal microbiota, the impact of...

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

Post Date:

2018-07-22

|

Countries:

|

Clinical Sites:

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...

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

Post Date:

2018-07-12

|

Countries:

|

Clinical Sites:

Bharati Vidyapeeth Medical College

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...

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

|

Countries:

|

Clinical Sites:

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...

Lipid Mediators of Inflammation in TB and TB-Diabetes

Post Date:

2017-10-02

|

Countries:

|

Clinical Sites:

This study was terminated August 1, 2019. It was funded and conducted under the U.S. National Institutes of Health and is nested within Impact of Diabetes on TB Treatment Outcomes. Dr. Jonathan Golub was the PI. Studies have shown that individuals with...

Targeting Mycobacterium Tuberculosis Persisters by Enhancing Stringent Response-specific Cellular Immunity

Post Date:

2017-09-11

|

Countries:

|

Clinical Sites:

C-TRIUMPH nested study begins to see if stringent response antigen is enhanced while treating drug-susceptible TB using the first-line anti-TB regimen.

Zika Surveillance among Antenatal Clinic Outpatients in BJ Government Medical College and Sassoon General Hospitals, Pune, India

Post Date:

2017-08-31

|

Countries:

|

Clinical Sites:

This study was terminated July 21, 2020. Zika virus is a vector-borne disease carried by the mosquito Aedes aegypti . Pregnant women infected with Zika may pass the virus to the fetus, which may cause microcephaly and other severe brain defects. It is also linked to...

TREAT Asia Pediatric HIV Observational Database

Post Date:

2017-02-09

|

Countries:

|

Clinical Sites:

Studies conducted under the TREAT Asia Network and funded by amfAR. 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...

TREAT Asia Observational Database

Post Date:

2017-02-09

|

Countries:

|

Clinical Sites:

Study conducted under the TREAT Asia Network and funded by amfAR. The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and...

Optimizing Treatment to Improve TBM Outcomes in Children

Post Date:

2014-05-01

|

Countries:

|

Clinical Sites:

This study, known as TBM Kids, is being conducted in India and Malawi. Primary Objectives To characterize the pharmacokinetics (PK) (plasma and cerebrospinal fluid (CSF)) of rifampicin given at model-derived optimal daily doses and...

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...

Challenges with the use of Xpert HPV as a screening tool for oral HPV among people living with HIV (PLHIV): experiences from Pune, India

Post Date:

2023-05-04

|

Countries:

|

Clinical Sites:

Publication:

BMC Infectious Diseases

Background: People living with HIV (PLHIV) are at higher risk for human papillomavirus (HPV)-related oropharyngeal cancers compared to the general population. Xpert HPV test is a polymerase chain reaction (PCR) assay capable of rapid HPV detection. Performing the assay requires minimal intervention...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV (PLWH)

Post Date:

2023-04-21

|

Countries:

|

Clinical Sites:

Publication:

Diabetes & Metabolic Syndrome

Background People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

Virological Failure among People living with HIV Receiving Second-Line Antiretroviral Therapy in Pune, India

Post Date:

2022-12-17

|

Countries:

|

Clinical Sites:

Publication:

BMC Infectious Diseases

Background The number of people receiving second-line antiretroviral therapy (ART) has increased as global access to ART has expanded. Data on the burden and factors associated with second-line ART virologic failure (VF) from India remain limited. Methods We conducted cross-sectional viral load (VL...

Randomized Clinical Trial of High Dose Rifampicin with or without Levofloxacin versus Standard of Care for Paediatric Tuberculous Meningitis: The TBM-KIDS Trial

Post Date:

2022-10-29

|

Countries:

Publication:

Clinical Infectious Diseases

Background Pediatric tuberculous meningitis (TBM) commonly causes death or disability. In adults, high-dose rifampicin may reduce mortality. The role of fluoroquinolones remains unclear. There have been no antimicrobial treatment trials for pediatric TBM. Methods TBM-KIDS was a phase 2 open-label...

Clinical and Immunological Markers of Pulmonary Impairment Among People With HIV in India

Post Date:

2022-10-06

|

Countries:

Publication:

Open Form Infectious Diseases

Dr. Akshay Gupte and team found females were 7 times more likely to have restrictive spirometry pattern and 22 times more likely to have preserved ratio impaired spirometry, compared with men.

Development of shortened HIV-related stigma scales for young people living with HIV and young people affected by HIV in India

Post Date:

2022-07-31

|

Countries:

|

Clinical Sites:

Publication:

BMC Health and Quality of Life Outcomes

Background: HIV-related stigma is associated with poor quality of life and poor healthcare-seeking behaviours in young people living with HIV (YPLHIV) and young people affected by HIV (YPAHIV). India has an estimated 120,000 YPLHIV and 4 million YPAHIV, but efforts to measure HIV-related stigma in...

Smokeless tobacco use and oral potentially malignant disorders among people living with HIV (PLHIV) in Pune, India: Implications for oral cancer screening in PLHIV

Post Date:

2022-07-13

|

Countries:

|

Clinical Sites:

Publication:

PLOS ONE

Introduction In India, smokeless tobacco (SLT) is a predominant form of tobacco used among people living with HIV (PLHIV). Despite SLT being a risk factor for oral potentially malignant disorders (OPMDs), no prior studies have quantified the association of OPMDs with SLT use among PLHIV. This...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV in Pune, Western India

Post Date:

2022-07-01

|

Countries:

|

Clinical Sites:

Publication:

Diabetes & Metabolic Syndrome: Clinical Research & Reviews

Background: People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

Clinical and Immunological Markers of Pulmonary Impairment among People with HIV(PWH) in India

Post Date:

2022-05-12

|

Countries:

Publication:

Open Forum Infectious Diseases

Background Despite anti-retroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods 210 adult PWH receiving antiretroviral...

Clinical and Immunological Markers of Pulmonary Impairment among People Living with HIV in India

Post Date:

2022-05-11

|

Countries:

|

Clinical Sites:

Publication:

Open Forum Infectious Diseases

Background Despite antiretroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods Two hundred ten adult PWH receiving...

The burden of anxiety among people living with HIV during the COVID-19 pandemic in Pune, India

Post Date:

2020-10-23

|

Countries:

Publication:

BMC Public Health

Introduction: Globally, India has the third largest population of people living with HIV (PLHIV) and the second highest number of COVID-19 cases. Anxiety is associated with antiretroviral therapy (ART) nonadherence. It is crucial to understand the burden of anxiety and its sources among Asian...

Mental health and quality of life among healthcare professionals during the COVID-19 pandemic in India

Post Date:

2020-09-11

|

Countries:

Publication:

Brain and Behavior

Background: The COVID-19 pandemic has placed healthcare professionals (HCP) in stressful circumstances with increased patient loads and a high risk of exposure. We sought to assess the mental health and quality of life (QoL) of Indian HCPs, the fourth highest-burden country for COVID-19. Method:...

Mullen Scales of Early Learning Adaptation for Assessment of Indian Children and Application to Tuberculous Meningitis

Post Date:

2020-07-04

|

Countries:

Publication:

Journal of Tropical Pediatrics

Introduction: Tuberculous meningitis (TBM) results in significant morbidity and mortality among children worldwide. Associated neurocognitive complications are common but not well characterized. The Mullen Scales of Early Learning (MSEL), a well-established measure for assessment of...

Trends and gender differences in access to HIV care with scale up of national HIV treatment guidelines in India

Post Date:

2020-06-24

|

Countries:

Publication:

Journal of the International Association of Providers of AIDS Care

Test and treat is the current global standard, yet sex differences persist in access to HIV care. We assessed the differences in presentation and antiretroviral therapy (ART) uptake by sex and ART-eligibility period among ART-naive adults registered at a public ART center in India. Four ART...

Intensified short symptom screening program for Dengue infection during pregnancy, India

Post Date:

2020-04-15

|

Countries:

|

Clinical Sites:

Publication:

Emerging Infectious Diseases

Mosquitoborne diseases (e.g., malaria, dengue, and chikungunya) are endemic to India and pose diagnostic challenges during pregnancy. We evaluated an intensified short symptom screening program in India to diagnose dengue during pregnancy. During October 2017-January 2018, we screened pregnant...

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

Post Date:

2020-02-19

|

Countries:

|

Clinical Sites:

Publication:

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.

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

Post Date:

2019-10-29

|

Countries:

|

Clinical Sites:

Publication:

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.

High prevalence of insulin resistance and occurrence prior to hyperinsulinemia threshold among people living with HIV in Pune, India

Post Date:

2019-05-21

|

Countries:

Publication:

Diabetes Metabolic Syndrome: Clinical Research & Reviews

BACKGROUND Diabetes prevalence in HIV is not well characterized for India, despite the high burden of both individual diseases. Epidemiology of insulin resistance (IR): a precursor to diabetes, and its associated risk factors are also poorly understood in Asian Indian people living with HIV (PLHIV...

Female global health leadership: Data-driven approaches to close the gender gap

Post Date:

2019-02-09

|

Countries:

|

Clinical Sites:

Publication:

The Lancet

Lancet article investigates gender-based challenges of female health trainees and professionals and identifies interventions

Loss to follow‐up and mortality among HIV‐infected adolescents receiving antiretroviral therapy in Pune, India

Post Date:

2018-06-25

|

Countries:

|

Clinical Sites:

Publication:

HIV Medicine

Over 6 years, one-third of HIV+ adolescents in this study discontinued medical treatment, indicating a critical need for retention counselling and closer clinical monitoring.

Pages

Research Update: TB Trials Conducted by JHU-India Team Will Shorten Drug-Susceptible TB Treatment for Children and Adults

Post Date:

2020-12-07

Reporting from the virtual 51st Union Conference on Lung Health, the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) announced promising findings from 2 TB trials

Pride in Pune: BJGMC TREAT Asia Team Conducts Health Camp

Post Date:

2019-06-24

TREAT Asia Team Members

Pride in Pune: The BJGMC CRS teamed up with the Udaan Trust to convene a sexual health awareness & screening camp

World AIDS Week Is Local at BJGMC in Pune, India

Post Date:

2018-12-20

The BJGMC Clinical Research Site convened community awareness activities that focused on HIV and HPV