Smita Nimkar, MSc

Pune, India
Role: 
Staff
Study Coordinator & Regulatory Coordinator

Smita Nimkar is Study Coordinator for TREATAsia, an Regulatory Coordinator and 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 Baltimore-Washington-India Clinical Trials Unit (BWI-CTU), which conducts clinical trials under the NIH ACTG and IMPAACT Trial Networks—along with the Johns Hopkins CRS (Baltimore, MD) and the Whitman Walker Health CRS (Washington, DC). She works with the India research team to ensure training on and compliance with scientific regulatory standards at all levels, assists with all submissions to IRBs including new protocols, progress reports, amendments, reviews, adverse event reports, and other assurance requirements. She is Vice Chair of the ACTG -Site Management Clinical Care Committee (SMCCC), ex member of IMPAACT Training and Education Committee, Life Member of the Forum for Ethics Review Committees in India, and member of Public Responsibility in Research (PRIM&R). Smita has worked in healthcare for more than 20 years, and her experience includes HIV/AIDS work, and clinical pathology, clinical research, contract research, and integrated research (Modern and Traditional) to develop new drugs and formulations from medicinal plants, She also has coordinated several research projects on communicable and non-communicable diseases. She is currently pursuing a PhD in health sciences.

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

Post Date: 
2018-10-16
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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
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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...

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
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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. The PIs for this study are Dr. Julia Johnson of Johns Hopkins and Dr. Shilpa Naik of BJGMC. CoPIs are Dr...

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...

Lipid Mediators of Inflammation in TB and TB-Diabetes

Post Date: 
2017-10-02
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This study is 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 is the PI. Studies have shown that individuals with Tuberculosis (TB) and diabetes (TB-DM) have a distinct immune profile compared to...

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

Post Date: 
2017-09-11
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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
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CCGHE is keeping an eye on Zika among pregnant women, which is transmitted by mosquitoes & can cause devastating birth defects.

TREAT Asia Pediatric HIV Observational Database

Post Date: 
2017-02-09
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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 enrolled and followed at selected TREAT...

TREAT Asia Observational Database

Post Date: 
2017-02-09
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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 disease progression; short- and long-term responses to ART;...

TBM Kids Substudy: Assessment of Neurocognitive Functions in Children with Tuberculosis Meningitis and Healthy Control Children Using the Mullen Scale of Early Learning Attending a Tertiary Care Public Hospital in Pune, India

Post Date: 
2014-09-01
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Objectives: The aim of the present study is to examine the neurological deficit in TBM kids and for that we need to assess, feasibility of the MSEL in our set up an Indian population of healthy children and children with meningitis in particular TB meningitis(TBM). The primary objective of the...

Optimizing Treatment to Improve TBM Outcomes in Children

Post Date: 
2014-05-01
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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 levofloxacin in children ages 6 months to 12 years of age with TBM...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date: 
2007-02-02
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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...

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

Post Date: 
2019-05-21
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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
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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
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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.

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.

Tuberculosis screening among persons with diabetes mellitus in Pune, India

Post Date: 
2017-06-02
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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...

Isoniazid hair concentrations in children with tuberculosis: a proof of concept study

Post Date: 
2016-06-01
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Publication: 
International Journal of Tuberculosis and Lung Disease
Assessing treatment adherence and quantifying exposure to anti-tuberculosis drugs among children is challenging. We undertook a 'proof of concept' study to assess the drug concentrations of isoniazid (INH) in hair as a therapeutic drug monitoring tool. Children aged <12 years initiated on...

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...

Attrition among HIV-infected Adolescent Girls and Young Women in Pune, India

Post Date: 
2016-12-06
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Nimkar S , Kadam D, Marbaniang I, Suman R, Gupte N, Salvi S, Suryavanshi N, Gupta A, Mave V. Attrition among HIV-infected Adolescent Girls and Young Women in Pune, India. Center for AIDS Research. Women and HIV: Inter-CFAR Joint Symposium on HIV Research in Women. Birmingham, AL.

Characteristics of HIV-infected Transgender Women Registered under Programmatic Conditions in Pune, India

Post Date: 
2016-12-06
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Marbaniang I , Kadam D, Gupte N, Suman R, Salvi S, Nimkar S, Suryavanshi N, Gupta A, Mave V. Characteristics of HIV-infected Transgender Women Registered under Programmatic Conditions in Pune, India. Center for AIDS Research. Women and HIV: Inter-CFAR Joint Symposium on HIV Research in Women...

Spousal Serostatus Affects Retention in Care among Married HIV Infected Women in Pune, India

Post Date: 
2016-12-06
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Nimkar S , Kadam D, Marbaniang I< Suman R, Gupte N, Salvi S, Suryavanshi N, Gupta A, Mave V. Spousal Serostatus Affects Retention in Care among Married HIV Infected Women in Pune, India. Center for AIDS Research. Women and HIV: Inter-CFAR Joint Symposium on HIV Research in Women. Birmingham, AL.

High Risk for Loss to Follow-Up among Adolescents Living with HIV in Pune, India

Post Date: 
2016-07-19
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Nimkar S , Valvi C, Khadse S, Kadam D, Kinikar A, Marbaniang I, Rewari BB, Chandanwale A, Suryavanshi N, Patil S, Nevrekar N, Raichur P, Gupta A, Mave V. High Risk for Loss to Follow-Up among Adolescents Living with HIV in Pune, India. 21st International AIDS Conference. International AIDS Society...

Isoniazid Hair Concentrations in Children with TB

Post Date: 
2015-12-05
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Mave V, Kinikar AA, Gupte N, Nimkar S, Kagal A, Horng H, Ramachandran G, Dooley K, Gupta A. Isoniazid Hair Concentrations in Children with TB. 46th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease. Cape Town, South Africa.

World AIDS Week Is Local at BJGMC in Pune, India

Post Date: 
2018-12-20
Performers conduct a play to raise awareness about HIV and HPV
The BJGMC Clinical Research Site convened community awareness activities that focused on HIV and HPV