Phan Thi Thu Ha MD, DrPH – Director

Dr. Phan has been working in the field of infectious disease epidemiology, HIV/AIDS research for a decade. In the last 6 years, she has been focusing on tuberculosis (TB) clinical research.  She has conducted quality assurance evaluation of a Rifapentine–containing regimen for intensive phase treatment of pulmonary tuberculosis, including all study site visits to monitor and provide quality control. This is part of CDC funded Multi-Center Clinical Trial on Tuberculosis treatment (Tuberculosis Trial Consortium) in Vietnam. She has also been working in partnership with the University of California at San-Francisco since October 2011. Her key responsibilities are to manage and coordinate a series of TBTC clinical trials and research and also all other TB related UCSF studies conducted in Hanoi in collaboration with the Vietnam National TB Program. She is working very closely with the National Reference Laboratory at the National Lung Hospital and other Microbiology laboratories for TB in Hanoi.

 

Dr Phan has considerable experience conducting program evaluation studies in Vietnam. She  was Co-PI on a USAID funded Vietnam Save the Children evaluation study of street youth HIV prevention in Hai Phong and Ho Chi Minh City.  She also conducted a program evaluation (qualitative approach) of PEPFAR and PACT partners in response to sexual reproductive health needs of people living with HIV.

 

Education

MD – Hanoi Medical University – 1992

MPH – University of Washington, Seattle – USA – 2003

DrPH – University of Texas at Houston Health Science Center – 2009

 

Research Interest

Infectious disease

Tuberculosis

HIV/AIDS and Reproductive Health

Nutrition

 

Selected Research Projects

 

Effects of Air Pollution on Childhood Tuberculosis in Viet Nam (2016-2020).  Sponsor: NIH/UCSF.  Role: Study Advisor

This study aims to 1) develop and validate a questionnaire and air pollution models that accurately predict air pollution exposures in children at risk for TB living in Ha Noi, Viet Nam; 2) evaluate the clinical effects of air pollution exposures on TB infection, active TB, respiratory tract infection, and lung function; and 3) evaluate the immunologic effects of air pollution exposures on T-cell responses to Mycobacterium tuberculosis.

 

TBTC Study 31. A5349: Rifapentine-containing treatment shortening regimens            

for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial (2015-2019). Sponsor: University of California, San Francisco (UCSF). Role: Protocol team member/Senior Study Coordinator

This phase 3 clinical trial aims to evaluate the efficacy of a Rifapentine-containing regimens to determine whether the single substitution of rifapentine for rifampin or in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase would be able to shorten treatment duration of drug susceptible pulmonary tuberculosis to 17 weeks.

 

Sub-Study: Population Pharmacokinetic and Pharmacodynamic Study of Efficacy and Safety of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis in the Study 31 Treatment Trial: Intensive PK Sampling (2016-2020). Sponsor: CDC/UCSF. Role: Study Coordinator

This sub-study is nested with Study 31.A5349 to 1) Characterize the population pharmacokinetics of rifapentine and 25-desacetyl rifapentine, using sparse PK data from Study 31 and intensive PK data from Study 31 PK/PD; and 2) Examine the relationship between rifapentine PK parameters of interest and treatment efficacy.

 

Sub-Study: M. tuberculosis RNA transcriptomic expression profiling in sputum of patients with active pulmonary TB enrolled in Study 31 / A5349  (STEPS-EXPRESS 31) (2016 – 2019). Sponsor: NIH/UCSF. Role: Study coordinator 

This sub-study of S31/A5349 aims to evaluate and describe drug impact on Mtb transcriptional profiles across regimens, diverse lineages of Mtb and diverse patient populations at 2 ACTG and 2 TBTC sites located in Sub-Saharan Africa, South East Asia, and South America.

                                                                          

An Observational Study of Individuals Treated for Pulmonary Tuberculosis (TB) (2015-2020). Sponsor: CDC/UCSF. Role: Protocol team member/Study Coordinator

This observational study is a plaform study aims to 1) Determine the optimal methods for identification and quantification of M. tuberculosis (MTB) in sputum over the course of TB treatment; 2) Assess outcomes of TB treatment (treatment failure, cure, relapse and death) in a rigorous and standardized manner; 3) Assess sputum parameters as surrogate markers for outcomes of TB treatment TB Trial Consortium Study 29 extension

 

Evaluation of Rifapentine – containing regimen for intensive phase treatment of pulmonary tuberculosis (Study 29x: taking drugs with food) (2011-2019). Sponsor: CDC/UCSF. Role: Study Coordinator  

This phase 2 study aims to evaluate the antimicrobial activity and safety of an experimental intensive phase (8 first week of treatment) tuberculosis treatment regimen in which Rifapentine is substantial for rifampin

 

Automated smear-positive tuberculosis diagnosis (2014-2016).  Sponsor: /USAID and Nina Ireland Foundation. Role: Study Manager

This study aims to complete the design and initial field testing of a novel, mobile phone-based digital fluorescence imaging platform to diagnose smear-positive tuberculosis in an automated fashion

 

Evaluation of Hain GenoType® MTBDRplus assay performance for detection of MTB     

and drug resistance as part of screening and enrollment procedures for TBTC Study 29x in Hanoi, Vietnam (2012-2013). Role: Study coordinator

This study aims to evaluate Hain GenoType® MTBDRplus assay performance for detection of MTB and drug resistance by comparing the detection of MTB in sputum using Hain GenoType® MTBDRplus test to solid and liquid Mycobacteria Growth Indicator Tube (MGIT) culture method, and comparing detection of isoniazid and rifampin resistance using GenoType® MTBDRplus to drug susceptibility testing (DTS) on solid medium

 

Evaluating the Accuracy of the Quantiferon Test Boosted with Immunomodulators in Active Tuberculosis (2011 – 2012). Sponsor in Active Tuberculosis. Role: study Coordinator

This diagnostic study aims to determine the accuracy of the Quantiferon Gold In Tube (QFT-IT) with the addition of immunomodulators (pathogen associated molecular patterns i.e. PAMPs), thought to “boost” the test effect as compared to the standard QFT-IT for detection of active pulmonary tuberculosis

 

The use of novel technologies to increase the accessibility and accuracy of           

Tuberculosis diagnostic services in Hanoi Province, Vietnam (2010-2012). Sponsor: WHO/Stop TB Partnership. Role: Study Coordinator

The aim of this intervention study is to increase TB case detection in Vietnam by using novel technologies (mobile‐phone based microscopy technology called CellScope and GeneXpert) to provide highly decentralized TB diagnostic services.

 

TB Trial Consortium Study 29: Evaluation of Rifapentine – containing regimen for intensive phase treatment of pulmonary tuberculosis (Study 29: taking drugs without food) (2010-2011). Sponsor: NIH. Role: Clinical Research Associate

This phase 2 study aims to evaluate the antimicrobial activity and safety of an experimental intensive phase (8 first week of treatment) tuberculosis treatment regimen in which rifapentine is substantial for rifampin

 

Evaluation of   “Positive Prevention (PP) interventions in 4 PEPFAR provinces of Vietnam” (2011-2012). Sponsor: USAID/HPI. Role: Principle Investigator

This study aims to assess the effectiveness and factors influence these effectiveness on changing behavior of People Living with HIV/AIDS and Most at risk populations

 

Facilitators and Barriers to people living with HIV enrolling and being retained in HIV care and treatment services in Vietnam (2011). Sponsor: USAID/FHI. Role: Co-Principle Investigator

This study aims to gain an understanding of why PLHIV Injecting Drug Users (IDUs) do not access pre-ART care and ART services as well as to understand why patients default from these services once they enroll in Hai Phong and Can Tho provinices

 

Second round of Behavior Survey on sexual and injecting behavior and use of HIV services among Female sex workers, including sex workers who are injecting drugs in 7 PEPFAR funded provinces (2011). Sponsor: PSI. Role: Investigator

This aims to assess the levels and trends of behavioral indicators and behavioral determinants, evaluate the output of programs, and finally review and inform project plans in terms of objective setting.

 

Qualitative Assessment of Infant and Young Child Feeding in the Context of HIV in Vietnam for FANTA-2 (2009 – 2011). Sponsor: USAID/AED. Role: Co-investigator  

This study aims to determine whether HIV-positive women in Vietnam can safely follow Ministry of Health guidelines to provide replacement feeding (i.e., no breast milk whatsoever) for their infants.

 

Condom use, VCT use, BTC TRaC Study among Male Injecting Drug Users in the 7 provinces (2009 – 2010). Sponsor: PSI. Role: Co-investigator

This study aims to assess the attitudes and behaviors of male Injecting Drug Users (IDU) on their sexual and drug use risk behaviors as well as their use of VCT services and HIV prevention interventions.

 

Evaluation of Street Youth HIV Prevention Project in Hai Phong and Ho Chi Minh City       

using participatory research approach (2011). Sponsor: USAID/Save the Children. Role: Principle Investigator

This study aims to evaluate the impacts of the HIV prevention project on behavior change for street youth in Hai Phong and Ho Chi Minh city.

 

Review of “Experiences of PEPFAR and Pact Partners in Responding to the SRH Needs of PLHIV” (2009). Sponsor: PACT. Role: Co-Principle Investigator

This study reviews all PEPFAR and PACT partners’ activities in responding to the needs of PLHIV and most at risk populations (MARP) with respect to sexual and reproductive health to help PACT understanding of the achievements, opportunities and challenges of providing SRH services to PLHIV and to MARPs.

 

Infections of hepatitis C and HIV among injecting drug users in drug treatment centers in northern Vietnam (2008-2009). Dissertation. Role: Principle Investigator  

This study aims to estimate the prevalence of HIV, HCV and co-infection of HIV/HCV among IDU in drug treatment centers in northern Vietnam.

 

Gathering input from youth MSM and other young men (2007-2008). Sponsor: Save the Children USA. Role: Principle Investigator.

The study seeks to understand MSM risk behaviors and their determinants as well as their functional linkages and operation within communities in Hanoi and Ho Chi Minh City, Vietnam.