Phan Thi Thu Ha MD PhD – Director

Phan Thi Thu Ha MD, DrPH – Director

Dr. Phan has been working in the field of infectious disease epidemiology, HIV/AIDS research for over a decade, with a focus on tuberculosis (TB) clinical research for the last 12 years. As part of a CDC funded Multi-Center Clinical Trial on Tuberculosis treatment (Tuberculosis Trial Consortium) in Vietnam, 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. Since October 2011, she has also been working in partnership with the University of California at San-Francisco, managing and coordinating a series of TBTC clinical trials and research, EndTBQ – Phase 3 clinical trial for Pulmonary TB with Rif resistant and Fluoroquinolone resistant, DRAMATIC – Phase 2 clinical trial for Pulmonary TB with Rif resistance and Fluoroquinolone susceptible. She also manages 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, using a 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

Rapid Research for Diagnostics Development in TB Network (R2D2 TB Network) (2020-2025). Sponsor: NIH. Role: Site study Manager

This study aims to conduct pilot studies to assess the diagnostic accuracy and usability of early and late prototypes of novel TB tests in the intended settings, with the goal of informing

their further development. Additionally, the study aims to conduct large-scale validation studies to assess the diagnostic accuracy and usability of design-locked novel TB tests, with the aim of informing policy development.

DRAMATIC Phase 2 Duration Randomized MDR-TB Treatment Trial (2020-2025). Sponsor: NIAID- NIH. Role: Site Study Manager

This phase two trial aims to determine the optimal duration of the experimental regimen that can be deemed non-inferior to the new standard of care. The objectives include a) analyzing the correlation between the duration of the experimental regimen and the percentage of participants who achieve sustained cure at 76 weeks after randomization, without any treatment failure or relapse; b) examining the relationship between baseline prognostic risk strata and sustained cure at 76 weeks after randomization without treatment failure or relapse, and c) assessing the link between novel biologic markers and sustained cure at 76 weeks after randomization without treatment failure or relapse.

EndTBQ (Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB with Fluoroquinolone Resistance (Q) – One trial of Expand New Drug markets for TB (END-TB) Extension and Expansion Project (2020-2024).

Sponsor: Unitaid and PIH. Role: Country coordinator

This is a Phase III randomized, controlled, open-label, multi-country trial aimed at evaluating the effectiveness of a new combination regimen and treatment strategy for fluoroquinolone-resistant MDR-TB. The trial will determine whether the efficacy of experimental arm at Week 73 is non-inferiority to that of the control.

Improving the efficiency of clinic-based active tuberculosis case finding: evaluation of point-of-care C-reactive protein-based triage testing in Vietnam. (2021-2024).

Sponsor: NIH. Role: Study Manager.

This study aims to enroll 1200 outpatients who present with at least one symptom suggestive of TB to pursue the following objectives: 1) To determine the diagnostic accuracy of point-of-care C-reactive protein (POC CRP) for culture-confirmed pulmonary TB; 2) To compare the diagnostic yield and efficiency of symptom-based screening strategies (including any TB symptom, any cough, or prolonged cough) with and without POC CRP-based triage testing to identify the optimal TB screening algorithm.

Effects of Air Pollution on Childhood Tuberculosis in Viet Nam (2016-2020). Sponsor: NIH. 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: 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: NIH. 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.

An Observational Study of Individuals Treated for Pulmonary Tuberculosis (TB) (2016-2020). Sponsor: NIH. Role: Study Coordinator

This observational study is a platform 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: NIH. 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

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

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: Principal 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-Principal 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: Principal 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: Principal 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.