Le Thi Thu Hien, Pharm, MIPH – Pharmacist – Study Coordinator

Le Thi Thu Hien, Pharm, MIPH – Pharmacist – Study Coordinator

Pharm. Le has a background in pharmacy, economics and public health with over 20 years working with different roles of national regulatory affair, pharmacist, study coordinator and manager with various donors, international and national investigators, partners and beneficial people in projects on TB, TB-HIV, PPM, HIV/AIDS, PMTCT, COVID-19 and antibiotic resistance at all the levels in Vietnam, and the US. She specializes in infectious disease surveillance system, managing projects from developing concepts, strategies, protocols, SOPs, work-plan to implementation, monitoring, evaluation, training and technical support, data management and analysis, preparing reports and publishing papers and widely sharing experience and results. She presented many oral and poster presentations at national and international conferences such as annual conferences of the Union World Conference on Lung Health and published many articles on international and national journals, and fliers/ booklets. Importantly, she becomes confident in working with ethics committees and regulatory authorities to submit applications and supporting documents to obtain approval for project implementation in Vietnam. Her B.A. Economics at National University of Foreign Trade in Vietnam provided her with basic accounting and financing knowledge and skills for developing project budgets and managing expenses in the healthcare projects since 2004. She is familiar with frequent online working with international investigators and partners from different countries via email or online meetings via online applications such as Zoom, MS. Teams and Google meet. She speaks fluent Vietnamese and English.

Education

B.Sc. Pharmacy – Hanoi School of Pharmacy, Vietnam – 1997

B.A. Economics – National University of Foreign Trade, Vietnam – 2002

M.I.P.H. – School of Public Health, University of Sydney, Australia – 2004

Research Interest

Infectious diseases

Tuberculosis

HIV/AIDS

COVID

Antibiotic resistance

Selected Research Projects and working experiences

Rapid Research for Diagnostics Development in TB Network (R2D2 TB Network) (2022-2025). Sponsor: NIH. Role: Study coordinator                                                                          

 

DRAMATIC Phase 2 Duration Randomized MDR-TB Treatment Trial (2022-2025). Sponsor:  NIAID – NIH. Role: Trial pharmacist

Combating the emergence and spread of antimicrobial resistant infectious diseases in Vietnam: The V-RESIST study (2018 – 2022). Sponsor: Australian Department of Foreign Affairs and Trade. Employer: Woolcock Institute of Medical Research, University of Sydney. Role: Senior Study Officer/ Study Manager

 

The V-RESIST study aims to develop, implement and evaluate the effectiveness of AMS interventions to reduce inappropriate antimicrobial use in the local community and within district health facilities in Vietnam.

Sub-study: Geospatial mapping of pharmacies. Great experiences on hiring and coordinating a large number of service providers and team members to conduct geospatial mapping of pharmacies in four provinces.

Sub-study: Standardized Patient Surveys on pharmacy dispensing practices. Great experiences on hiring and coordinating a large number of local people to act as standardized patients and observers with standardized scenarios for common viral and TB infections to observe real practices of pharmacy staff in the four study provinces.

Sub-study: Identify belief, attitude, practice and behavior of stakeholders participating in the process of antibiotic supply and use. A qualitative study with in-depth interviews with healthcare workers, pharmacists and community people attitudes towards antimicrobial use to understand drivers of antibiotic use in Vietnam was conducted.

Sub-study: Analyses of the relationship between antimicrobial use and health system factors with desk reviews of current policies and regulatory and qualitative research interviews of healthcare policy makers and healthcare workers was conducted.

Sub-study: Pilot interventions in community. A community antibiotic knowledge campaign for 400 community people with participation of representatives from WHO, MoH, partners and local authorities was successfully organized.

Sub-study: Delivery of a comprehensive package of interventions aims to reduce inappropriate antibiotic use at district hospitals and pharmacies.

Understanding community transmission of COVID-19 in Vietnam (2020 – 2021). Sponsor: Australian Department of Foreign Affairs and Trade. Employer: Woolcock Institute of Medical Research, University of Sydney. Role: Study Manager

Sub-study: Serological evaluation of the community spread of SARS-COV-2

Primary objectives: To ascertain unbiased estimates of the key parameters informing predictive models for COVID-19 and, hence, (1) to enable evidence-based policy decisions on testing, isolation, quarantine and social distancing interventions, (2) to predict the subsequent course of the epidemic, and (3) to understand the extent of transmission within high-risk populations.

Coordinating such new projects let her work with many new partners in new working environments with different knowledge and experiences. She learned how to coordinate with authorities from national to commune levels and community people to successfully organize large sero-prevalence surveys on site for community members, healthcare workers and migrant workers in communities highly impacted by COVID in five provinces. Those five provinces were the centers of the first three COVID waves in Vietnam in 2020-2021. The surveys were conducted with computer-based interviews, blood and nasal swab specimen collection, transportation, testing and storage procedures. These surveys provided timely evidence to the authorities of effectiveness of public health measures in COVID-19 prevention and control.

Sub-study: The Impact of the COVID-19 Pandemic on the care of Tuberculosis

The study aims to quantify the effect the COVID-19 outbreak may have in the provision and outcomes of TB care in Vietnam, and to provide recommendations on strategies to mitigate and support patients who are being treated for TB during this pandemic and in the future.

Sub-study: Radiological and clinical characteristics of patients hospitalized with laboratory-confirmed COVID-19 in Vietnam

The study aims to characterize chest x-ray abnormalities among hospitalized patients with confirmed SARS-CoV2 infection and compare their clinical and laboratory characteristics.

Health Care Improvement Project (2009-2011). Sponsor: The United States Agency for International Development (USAID). Role: TB-HIV Technical Manager

The project aims to improve TB-HIV integration between NTP healthcare facilities and HIV out-patient clinics and PPM interventions to strengthen the collaboration, case detection and referral among non-TB public and private healthcare facilities and NTP facilities.

Go the extra mile: She supported the pilot deployment of the NTP web-based TB case management and surveillance database (called Vitimes), which has been used nation-wide.

TB CARE II Project (2011-2018). Sponsor: The United States Agency for International Development (USAID). Role: TB-HIV Technical Manager

The project conducted FAST strategy, focusing on shortening time to TB diagnosis and treatment initiation at TB and lung hospitals, resulted in an issuance of the National Guideline for Implementation of FAST. FAST acronym comes from Find cases Actively, Separate safely, and Treat effectively. This FAST strategy has widely been applied by the NTP. For such outstanding contribution to the NTP, she and her organization – URC were awarded Certificates of Recognition from the Vietnam NTP manager in 2016 and from Vietnam Minister of Health in 2017.

Go the extra mile: At the beginning, a simple MS Access database was designed to record, track, and report visiting patients and FAST indicators. The functionality of the FAST database resulted in developing a single, integrated hospital data management system which allowed all departments to access patient records using unique patient identifiers. This improved patient management and enabled the hospital to detect missed opportunities for earlier diagnosis and effective treatment.

Enhanced hepatitis C surveillance in Great Houston areas (2005 to 2006). Employer: Bureau of Epidemiology, Houston Department of Health and Human Services (HDHHS), Texas, USA. Role: Surveillance Investigator

Go the extra mile: Solely designed databases included Enhanced Houston Hepatitis C Surveillance, Street Solicitation Survey and Houston Enhanced Hepatitis B and C Surveillance; Jointly designed database was Contact Evaluation and Treatment for Tuberculosis Control; Contributed to development of the provider package for enhanced hepatitis C surveillance project.

Enhanced Perinatal HIV surveillance (EPS) in Great Houston areas (2006 to 2009). Employer: Bureau of Epidemiology, Houston Department of Health and Human Services (HDHHS), Texas, USA. Role: Surveillance Investigator

Identified HIV-infected mothers and their HIV-exposed or infected infants through routine pediatric surveillance, birth registry match with eHARS and facility-based identification; Conducted facility based record review of maternal and pediatric medical records using data abstraction form, birth and death records at the health department.

Innovative data management: Wrote SAS programs to integrate the EPS database with special projects of 2007-2008 birth registry matching and pregnant women tracking, and link with eHARS – a HIV/AIDS Reporting System to create an automatically and weekly updated All-in-One database. The All-in-One database improved efficiency of data management, search, and investigation progress reports for investigators and supervisors.

Go the extra mile: Developed internal training materials named “Pediatric Case Writing Hints” and “Completing EPS form – Hints” in 2007 to standardize the case investigation and improve efficiency of case report; Wrote a SAS program to refine and share a CDC’s SAS programs, which were able to run with real surveillance data collected in the field, to generate monthly datasets for CDC.

Healthcare for the Central Highlands project. Employer: Project Management Unit (PMU) at Vietnamese Ministry of Health (2004-2005). Sponsor: Asia Development Bank (ADB) and Swedish International Development Agency (SIDA). Role: Senior project officer

This US$30 million project  aims to improve service quality and heighten abilities of using and paying for health services, especially for poor people and ethnic minorities in five Central Highlands provinces. She participated in development and appraisal phases of the master plan with inter-ministry review meetings with officials from the Government Cabinet and Ministries of Health, Planning and Investment, Foreign Affairs and Finances, ADB and the Swedish embassy. She supported to start up the project, provided training and technical support to staff at five provincial health departments and monitored implementation of master and specific work plans.

Regulatory Affairs to facilitate the process of visa registration, renewal, quotas, tender and importation for GSK drugs marketed in Vietnam (1997 to 2001). Employer: GlaxoSmithKline (GSK). Role: National Regulatory Affairs Assistant

The role is to establish and maintain effective communication with Vietnamese Ministry of Health (MoH) officials and communicate Vietnamese policies, strategies and regulatory issues with GSK Vietnam representative offices, headquarters, oversea manufacturing plants, and importation and supply partners to accomplish the company’s drug visa registration, renewal, marketing, tender and importation plans.