HIV Research Training Program

HRTP Fellow working at the International Pharmacology Lab at UB.

The UB-UZ HIV Research Training Program (HRTP) is supported by the NIH Fogarty International Center and is a postgraduate fellowship training initiative with an emphasis on HIV/AIDS clinical pharmacology between the University at Buffalo (UB) and the University of Zimbabwe (UZ). Program faculty at both institutions contribute mentored training to UZ students and scholars who, in turn, will contribute clinical pharmacology expertise to multidisciplinary teams to achieve the HIV/AIDS research goals for Zimbabwe.

The UB-UZ HIV Research Training Program (HRTP) is supported by the NIH Fogarty International Center and is a postgraduate fellowship training initiative

On this page:

About the Program

The program is designed for HRTP fellows to benefit from mentored interactions with faculty and health professionals with established clinical/translational and laboratory research environments. The HRTP infrastructure is broadened to include formalized collaboration with NIAID-funded international, multidisciplinary research networks in Zimbabwe, coordinated through the UZ Clinical Trials Site, as well as other U.S.-supported and Zimbabwe-based research programs. This approach provides opportunities for HRTP fellows to develop their research career during the program and then continue in a collaborative, mentored environment after the training period. The UB-UZ HRTP includes a focused didactic curriculum for postgraduate fellows and an integrated research project experience that includes on-site training at UB and UZ.

The program focuses on a group of highly trained individuals who will then pursue their research programs within the multidisciplinary environment that is present at UZ with continued mentoring and career development. Strong institutional support for the UB-UZ HRTP is evident through participation of faculty and administrative leaders at UZ in recognition of the need to support the development of future researchers to address the HIV/AIDS epidemic in Zimbabwe.

Center for International Pharmacotherapy Education and Research Initiatives

IPERI Introduction

The Center for International Pharmacotherapy Education and Research Initiatives (IPERI) provides a mechanism for collaborations between the University at Buffalo New York State Center of Excellence in Bioinformatics and Life Science and the School of Pharmacy and Pharmaceutical Sciences to be developed with universities and investigators around the world. The goals of this collaborative center are to:

  • Promote technology transfer in support of evidence-based clinical pharmacology and therapeutics and medication management strategies that have been successfully implemented in developed countries to resource limited settings through education and research initiatives. 

This is accomplished by:

  • Promotion of sustainable access to essential drugs in developing countries
  • Conducting and applying pharmacotherapy research to advance topics such as medication adherence, health information technology, pharmacogenomics, therapeutic drug monitoring, bioanalysis, clinical pharmacokinetics, pharmacodynamics, adverse drug reactions/pharmacovigilance, drug interactions, nanotechnology and pharmacoeconomics
  • Provide support and guidance to develop research capacity and infrastructure through collaborative programs such as our HIV Training and Research Program (HRTP) with the University of Zimbabwe (UZ). This UB/UZ partnership supports the capacity building for clinical and translational researchers as well as the clinical and laboratory infrastructure to conduct research on practical and affordable pharmacotherapy interventions in the management of HIV/AIDS and chronic diseases in local populations.
  • The HRTP also promotes clinical pharmacology training for traditional healers in Zimbabwe and fosters a bridge between ARV therapy and indigenous medicine use. The photo below illustrates the first fraduation of Zimbabwe traditional healers attending a certificate program graduation.

UB-UZ HRTP

About Us

The UB-UZ HRTP is a postgraduate fellowship training initiative with an emphasis on HIV/AIDS clinical pharmacology between the University at Buffalo (UB) and the University of Zimbabwe (UZ). Program faculty at both institutions contribute mentored training to UZ students and scholars who, in turn, will contribute clinical pharmacology expertise to multidisciplinary teams to achieve the HIV/AIDS research goals for Zimbabwe.

The program is designed for HRTP fellows to benefit from mentored interactions with faculty and health professionals with established clinical/translational and laboratory research environments. The HRTP infrastructure is broadened to include formalized collaboration with NIAID-funded international, multidisciplinary research networks in Zimbabwe, coordinated through the UZ Clinical Trials Site, as well as other U.S.-supported and Zimbabwe-based research programs. This approach provides opportunities for HRTP fellows to develop their research career during the program and then continue in a collaborative, mentored environment after the training period. The UB-UZ HRTP includes a focused didactic curriculum for postgraduate fellows and an integrated research project experience that includes on-site training at UB and UZ.

The program focuses on a group of highly trained individuals who will then pursue their research programs within the multidisciplinary environment that is present at UZ with continued mentoring and career development. Strong institutional support for the UB-UZ HRTP is evident through participation of faculty and administrative leaders at UZ in recognition of the need to support the development of future researchers to address the HIV/AIDS epidemic in Zimbabwe.

Program Goals

Main Goals:

  1. Train researchers to contribute to the mission of antiretroviral access and optimizing treatment in Zimbabwe through the UZ International Center for HIV/AIDS Pharmacotherapy Research and Training (ICHAPRT) Center in Harare.
  2. Implement and support a long-term plan to provide ongoing research training to UZ faculty of the Pharmacy and Medical School.
  3. Implement and support a long-term plan to provide ongoing research training to UZ pre-doctoral, doctoral and post-doctoral students.
  4. Establish web-based training programs to complement mentored training programs for Zimbabwe and southern African countries to facilitate technology transfer from the UB HIV Pharmacology program.

The UB-UZ HRTP has established a postgraduate fellowship training initiative to conduct HIV/AIDS clinical and translational pharmacology research in Zimbabwe. The University at Buffalo (UB) and University of Zimbabwe (UZ) faculty provide mentored training with a focus on current and investigational drug treatment for HIV/AIDS and tuberculosis and the clinical pharmacology expertise to integrate with multidisciplinary teams to achieve the HIV/AIDS research goals for Zimbabwe and other southern African countries and build research capacity.

Key programmatic themes include pharmacokinetics, pharmacodynamics, pharmacogenomics, pharmacoinformatics and pharmacoeconomics with targeted research training in medication adherence, drug interactions, traditional medicines, bioequivalence testing, integrating therapeutic drug monitoring and viral load/resistance tests and biochemical and clinical adverse effect monitoring. The program utilizes clinical research sites and bioanalytical laboratories to design mentored interactions with faculty and health professionals for HRTP fellows to benefit from established clinical and translational research environments.

The HRTP infrastructure includes collaboration with the UZ International Clinical, Operational, and Health Services Research and Training Award (ICOHRTA), NIH/Division of AIDS (DAIDS)-funded HIV research networks, the UZ Clinical Trials Site, as well as other US-supported and Zimbabwe-based research programs. The approach provides opportunities for HRTP fellows to develop their research career during the HRTP period and then continue in a collaborative, mentored environment after the training period. The HRTP includes a focused didactic curriculum for postgraduate trainees and an integrated research project experience that includes on-site training at UB and UZ.

The HRTP will focus on a group of highly trained individuals who will then pursue their research programs within the multidisciplinary environment that is present at UZ with continued mentoring and career development. Strong institutional support for the proposed HRTP is evident through participation of faculty and administrative leaders at UZ in recognition of the need to support the development of future researchers to address the HIV/AIDS epidemic in Zimbabwe and surrounding regions.

Specific Aims

  1. Conduct HIV/AIDS clinical and translational pharmacology research and mentoring in Zimbabwe and southern African countries with a focus on current and investigational drug treatment for HIV/AIDS and tuberculosis.
  2. Conduct HIV/AIDS clinical and translational pharmacology research and mentoring in key programmatic themes including pharmacokinetics, pharmacodynamics, pharmacogenomics, pharmacoinformatics and pharmacoeconomics with targeted training in medication adherence, drug interactions, traditional medicines, bioequivalence testing, integrating therapeutic drug monitoring and viral load/resistance tests and biochemical and clinical adverse effect monitoring.
  3. Provide a mentored research training environment to establish independent clinical and translational pharmacology investigators and enhance the research capacity of Zimbabwe and surrounding regions.

Program Summary

This HIV Research and Training Program (HRTP) between the University at Buffalo (UB) and the University of Zimbabwe (UZ) is a program with proven results. The HRTP will build on a recently completed AIDS International HIV Research and Training Program that was focused on re-initiating postgraduate training at the Master’s level in HIV clinical pharmacology research at UZ. Scientific breakthroughs in HIV prevention and treatment research have produced evidence suggesting that interventions involving early access to antiretroviral therapy (ART) are highly effective in preventing HIV sexual transmission and vertical transmission during pregnancy, childbearing and delivery. Government and academic leaders in Zimbabwe have identified HIV Clinical Pharmacology Research as a key component of national planning for ARV access and HIV therapeutics to implement these scientific breakthroughs.

The UB-UZ HRTP will focus on novel aspects that integrate clinical pharmacology research with:

  1. ARV adherence,
  2. clinically important pharmacokinetic drug interactions (e.g. anti-tuberculosis drugs, anti-malarials, hormonal contraceptives and traditional medicines),
  3. ARV disposition during pregnancy (secondary to WHO Option B+ implementation) and in infants, and to determine in utero ARV exposure, and
  4. bioequivalency testing for generic ARV products prior to widespread implementation. These research areas integrate well with other NIH funded projects and regional capacity building.

The HRTP will broaden the training focus to include masters, doctoral and post-doctoral trainees and emphasize a curriculum that provides an HIV Clinical Pharmacology Research Skills Toolbox for HRTP trainees to gain the skillset that will be required to be an independent researcher. HRTP trainees will gain focused clinical pharmacology research training at UB in an internationally recognized HIV Clinical Pharmacology Laboratory that complements the UZ Clinical Pharmacology Laboratory program. The UB-UZ HRTP has strong support from the UZ College of Health Sciences and the Ministry of Health. The HRTP will benefit from an expert Training Advisory Committee and a complement of highly motivated faculty that will provide the curriculum, structured research training and program evaluation that will assure a highly productive, efficient HIV research training initiative.

Program Development

The UB-UZ antiretroviral pharmacology training initiative was initiated in 2002 in collaboration with the NIAID AIDS Clinical Trials Group (ACTG) and resulted in a Memorandum of Understanding between UB and UZ and the initial implementation of a collaborative research program. Through a two-year supplement to the UC Berkeley HRTP (A. Reingold-PI) in 2005, a more formalized training program was established between UB and UZ and provided the opportunity to train two new UZ postgraduate students. This effort has resulted in our current growth into a multidisciplinary HRTP between UB and the UZ College of Health Sciences.

The UB Pharmacotherapy Research Center (PRC), including the PRC Core Analytical Laboratory (PRC CAL), was the primary focus for initial training programs. The PRC CAL began HIV research when the ACTG was developed in 1987 as a NIAID-supported, ACTG Pharmacology Specialty Laboratory (PSL). The PRC-CAL has subsequently received funding from multiple NIH sources including NIDA, NIMH and the Fogarty International Center. Many of the past experiences of the UB PSL also formed the foundation for recently established UZ-UB International Center for HIV Pharmacology Research Training (ICHAPRT) in Zimbabwe. The ICHAPRT, directed by Dr. Charles Chiedza Maponga, Co-PI and Collaborator on this UB-UZ HRTP, leads an effort to increase antiretroviral access while implementing clinical and translational pharmacology research programs to evaluate HIV/AIDS medicines in a multidisciplinary environment.

The UB-UZ HRTP postgraduate fellowship training initiative provides a sound approach to addressing the needs in Zimbabwe and lead to a greater clinical research capacity comprised of well-trained investigators who will contribute to multidisciplinary research teams. The well recognized antiretroviral pharmacology research programs that have been established at UB will provide an excellent training environment for integrating antiretroviral therapeutics and medication management, patient education and adherence counseling and applied clinical pharmacology research with multidisciplinary research teams. The UB PRC CAL provides an opportunity for the HRTP fellows to be mentored by established investigators in bioanalytical methods and pharmacogenomics research. These skills are essential to conduct bioequivalency studies in a region where counterfeit drugs and generic formulations contribute to the overall challenge of implementing and sustaining effective antiretroviral therapy. In addition, UB and UZ faculty mentors have a variety of NIH funded research projects that will supplement the clinical pharmacology opportunities.

The UB-UZ HRTP has developed a training strategy that allows future Zimbabwe researchers to gain valuable experience at UB and return to UZ to complete their studies. The program has a system for following-up the developing researchers, providing them with guidance in preparing publications and presentations for scientific conferences, as well as offering them opportunities for repeat visits to UB for further mentoring in advanced scientific techniques. While our program has an emphasis in clinical pharmacology, we recognize the importance of exposing the fellows to a multidisciplinary environment to ensure a well-balanced research training experience. This will be accomplished through the efforts of UB and UZ faculty and clinicians.

Motivation for Program

HIV/AIDS in Africa- Higher HIV infection within low to middle income countries (LMIC)

HIV infection rates are disproportionately higher in sub-Saharan countries than those found in developed countries. It has been estimated that there are 24.7 million HIV-positive adults and children in this region. While it consists of ~10% of the world’s population, this region counts for ~ 60% of all people living with HIV. In the same region an estimated 2.8 million people acquired new infection and 2.1 million adults and children died from AIDS in 2006. Despite a high prevalence of HIV/AIDS in sub-Saharan Africa, national health programs in these poorly-resourced, developing countries can hardly afford the essential medicines, especially antiretrovirals (ARVs), given their current high prices. The net effect is that while developed countries are now focusing on improving the effectiveness of already established HAART regimes, LMIC are still struggling to increase the accessibility to HIV/AIDS medicines.

According to UNAID/WHO, at the end of June 2006, ARV therapy coverage for sub-Saharan Africa was 23% while the overall coverage for LMIC was 24%. Faced with the overwhelming HIV/AIDS epidemic, sub-Saharan countries with limited resources are managing the emergency using epidemiological approaches as opposed to individualized therapy for patients. Programs are more interested in regimens that can be used effectively and safely in the majority of patients as opposed to regimens that focus on catering to patient differences. This approach has led to the increased need to understand ARV pharmacology from both an individual and a population-based approach, and has been the primary motivation for setting up the UB-UZ HRTP program.

Since the need for training in HIV/AIDS Clinical Pharmacology has expanded in scope, this is a focus area for the UB-UZ HRTP. The program provides a mechanism for multi-disciplinary training to conduct HIV/AIDS treatment research and achieve the goals that Zimbabwe has established for optimizing ARV therapy and expanding its pool of clinician scientists. This will significantly contribute to the fight against HIV/AIDS in the sub-Saharan Africa region.

Application and Selection Process

Recruitment

The UB-UZ HRTP focuses on the development of a group of highly trained individuals who will then pursue their research programs within the multidisciplinary environment at UZ with continued mentoring and career development. In this post-graduate research fellowship training program, trainees will benefit from mentored interactions with faculty and health professionals with established clinical/translational and laboratory research environments. The UB-UZ HRTP is currently seeking trainees in the following areas:

  • Health Information Technology
  • Clinical Research Ethics
  • HIV Clinical Pharmacology

The UZ College of Health Sciences assumes the primary role in recruiting individuals with an interest in applying to the UB-UZ HRTP. HRTP faculty mentors identify qualified applicants through a variety of mechanisms with an emphasis on recruiting from the UZ College of Health Sciences. These recruiting efforts are part of an ongoing recruitment and retention plan that includes programmatic announcements, faculty presentations and individual recruiting efforts at biomedical research conferences.

If you are interested in this challenging fellowship training opportunity, please review the application requirements below. To access the application, click on the Student Activity link from the main menu.

Application Process

Individuals will be encouraged to complete the application materials, which include the following:

  1. application form
  2. current resume or curriculum vitae
  3. official transcript
  4. one-page letter of intent
  5. letters from two supporting references
  6. research proposal, as approved by the UZ Higher Degrees Committee

Applicants must be registered as postgraduate students by the Higher Degrees Committee of the University of Zimbabwe College of Health Sciences since courses offered through the UB-UZ HRTP will be aimed at building capacity to carry out pharmacology research within the college. Application materials are submitted online with the assistance of the UZ HRTP Administrative Staff.

Application Review Process

Application materials are reviewed by the HRTP ESC and each applicant is designated with a ranking. Applicant materials and the ranking will be forwarded to the HRTP Training Advisory Group (TAG) for additional review of the proposed candidate outcomes (accept/denied). The review criteria utilized for ranking applicants include the following:

  1. Highly motivated applicant with considerable interest in advancing HIV clinical pharmacology and therapeutics research in Zimbabwe.
  2.  Applicant with an interest in an academic career with a research component.
  3. Prior training with strong didactic coursework and experience in an established research environment.
  4. Demonstrated interest in working in a collaborative HIV research environment.

Tips for Constructing your Letter of Intent

Your letter of intent should be addressed to the UB-UZ HRTP Executive Steering Committee, and should include a brief description of your project proposal (as approved by the UZ Higher Degrees Committee). You should include a statement on the role your project has with relation to the goals of the UB-UZ HRTP program, and Zimbabwe’s healthcare priorities. Your letter should demonstrate that you:

  1. Are a highly motivated applicant with considerable interest in advancing HIV clinical pharmacology and therapeutics research in Zimbabwe.
  2. Are an applicant with an interest in an academic career with a research component.
  3. Have prior training with strong didactic coursework and experience in an established research environment.
  4. Have demonstrated interest in working in a collaborative HIV research environment.

Program Curriculum

All of our HRTP trainees complete a core curriculum that provides general skills that will be needed to embark on a career in clinical and translational pharmacology. Depending on the applicant and their prior training, supplemental coursework may be needed as prerequisites to these required core courses. On the other hand, individuals who have completed courses of similar content and intensity will be encouraged to identify supplemental courses that will complement their overall HRTP training program.

All trainees will be required to complete the online training programs offered through the Collaborative Institutional Training Initiative (CITI) for The Protection of Human Research Subjects and Responsible Conduct of Research (Biomedical Research Investigator focus). Trainees are encouraged to discuss this online training with their mentors. All trainees will receive instruction in the following areas:

  • Conflict of interest -- personal, professional, and financial
  • Policies regarding human subjects, live vertebrate animal subjects in research
  • Safe laboratory practices
  • Mentor and mentee responsibilities and relationships
  • Collaborative research including collaborations with industry
  • Peer review
  • Data acquisition and laboratory tools; management, sharing and ownership
  • Research misconduct and policies for handling misconduct
  • Responsible authorship and publication, including specific discussions regarding scientific writing practices, collaborative writing, publication practices, responsible authorship, the peer review process, conflicts of interest
  • The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
  • Compliance with regulatory requirements for clinical and translational research

Courses:

Course 1: International HIV Pharmacotherapy; Introductory
- Module 1: HIV/AIDS Pharmacotherapy HIV Certificate (Web based)
- Module 2: Introduction to Clinical Pharmacokinetics
- Module 3: Drug Interactions
- Module 4: Adverse Drug Reactions

Course 2: Pharmacology Laboratory Skills (Web based)
- Module 1: Introduction to Laboratory Quality Assurance and Quality Control

Course 3: Clinical Research
- Module 1: Human Subjects Protection (web based)
- Module 2: Ethics in HIV/AIDS Clinical Research
- Module 3: HIPAA
- Module 4: Biostatistics and Epidemiology
- Module 5: Clinical Research Methods

Course 4: Pharmacology Research Protocol
- Module 1: Research project Design and submission
- Module 2: Distribution

Course 5: PK/PD and Pharmacogenomics
- Module 1: ACTG Clinical Pharmacology Module
- Module 2: WINNONLIN Pharmacokinetics Primer
- Module 3: Pharmacogenomics Primer (One week)

Course 6: Scientific Writing
- Module 1: Literature search techniques
- Module 2: Proposal development and IRB submission completion
- Module 3: Abstracts, publication, and grants

 



Optional Modules
Applied Clinical Pharmacokinetics
Intermediate Pharmacokinetics
Advanced Pharmacokinetics

 



MODULE SUMMARIES

Course 1: International HIV Pharmacotherapy; Introductory

Module 1: HIV/AIDS Pharmacotherapy HIV Certificate (Web based)

Module 2: Introduction to Clinical Pharmacokinetics

Module 3: Drug Interactions

Module 4: Adverse Drug Reactions

Course 2:
Pharmacology Laboratory Skills (Web based)

Module 1: Introduction to Laboratory Quality Assurance and Quality Control

Course 3: Clinical Research

Module 1: Human Subjects Protection (web based)

Module 2: Ethics in HIV/AIDS Clinical Research
The module aims to provide a comprehensive introduction to the field of ethics of scientific research and satisfy all Federal requirements for education and exposure of graduate and post-doctoral students. The module explores the relationship between science and society with particular emphasis on the bioethical implications of contemporary genomic biological knowledge.

Module 3: HIPAA
UB HIPAA Training Tutorial and NIH Human Subjects Protection Tutorial
These tutorials are required for all AITRP trainees participating in clinical research projects. HIPAA tutorials outline changes and workplace effects trainees can expect because of HIPAA regulations.

Module 4: Biostatistics and Epidemiology
Introductory and advanced modules in HIV/AIDS statistics and epidemiological applications in HIV/AIDS research.

Module 5: Clinical Research Methods
This module prepares AITRP trainees for the process of clinical research in industry or academia. It provides a background of information on the clinical research process including: protocol development and implementation into study unit; ethics: informed consent and institutional review boards; clinical data acquisition and management; laboratory analysis of clinical specimens (with an emphasis on Good Laboratory Practices).

Course 4: Pharmacology Research Protocol

Module 1: Research project Design and submission

Module 2: Distribution

Course 5: PK/PD and Pharmacogenomics

Module 1: ACTG Clinical Pharmacology Module

Module 2: WINNONLIN Pharmacokinetics Primer

Module 3: Pharmacogenomics Primer (one week)
The module consists of lectures and in class exercises designed to introduce the principles and concepts in pharmacogenomics and pharmaceutical genetics. The module goal is to give students an understanding of the principles of human genetics and genomics such that they can then apply these skills to problems in therapy optimization and patient care.

Course 6: Scientific Writing

Module 1: Literature search techniques

Module 2: Proposal development and IRB submission completion

Module 3: Abstracts, publication, and grants

 



Optional Modules

Applied Clinical Pharmacokinetics:
The general goal of the module is to provide trainees with an introduction to the application of pharmacokinetic principles in pharmacy practice. The module involves trainees in the process of clinical pharmacokinetic and pharmacodynamic monitoring of drug therapy. The application of pharmacokinetics and pharmacodynamics to individualized drug dosage regimens in the clinical context, including such hepatic and renal functional impairment, other effects of disease, immaturity of drug metabolizing enzymes, and drug interactions are emphasized.

Intermediate Pharmacokinetics:
This module covers the theoretical development of the major methods, models and equations used in pharmacokinetics with their physicochemical and physiological assumptions and limitations. It employs the current graphical and computer methods of applying pharmacokinetics to analysis of experimental and clinical data; and it evaluates literature and approaches of design of studies and recovery of essential drug parameters.

Advanced Pharmacokinetics:
Rigorous theoretical development and application of kinetics and related mathematical and computer techniques to the study of drug absorption, distribution, metabolism, excretion presented at an advanced level.

Supportive Collaborations

HIV Research Collaborations at UB and UZ: The HRTP is well positioned to collaborate with other NIH supported programs in Zimbabwe and foster new interactions that improve HIV research training with the following:

  • UZ Center of Excellence in HIV Clinical Pharmacology: The UZ academic leadership have designated the development of the UZ Center of Excellence in HIV Clinical Pharmacology as a high priority initiative. The HRTP will train clinical pharmacology investigators and laboratory scientists to expand the capacity of the Center of Excellence and increase the competitiveness of the grant applications submitted. The UZ clinical pharmacology laboratory was implemented in 2011 with funding from NIAID with the goal of establishing an academic research laboratory that would provide a core resource for UZ clinical researchers. The laboratory is focused on innovative drug assay development, clinical pharmacology training and becoming a source of UZ investigators for NIAID HIV research network protocols. The laboratory has made great progress, and in December 2014 received designation as an ACTG International Pharmacology Specialty Laboratory. The UB-UZ HRTP has used the laboratory for training UZ graduate students to become independent investigators with a long-term goal of establishing a leading center in HIV Clinical Pharmacology.

Key points in the laboratory development include:

  •  Transitioning the laboratory from its initial site in the UZ College of Health Sciences to a new facility in the Zimbabwe Medicines Control Authority (MCAZ) with a ten–year lease agreement.
  • An excellent component of the UZ Pharmacology Specialty Laboratory is in collaboration with the African Institute of Biomedical Science and Technology (AiBST). AiBST provides another highly qualified HRTP mentor, Prof. Collen Masimirembwa (DPhil, PhD), the President and Chief Scientific Officer. In addition, current trainees have access to additional mass spectrometry instrumentation to conduct the proposed HRTP clinical pharmacology research projects.
  • The New Partnership for Africa’s Development which is the planning and coordinating technical body of the African Union recently designated the MCAZ as a Regional Center of Regulatory Excellence in drug laboratory analysis. The regional center is receiving support from the European and Developing Countries Clinical Trials Partnership. UZ International Pharmacology Specialty Laboratory - NIAID ACTG Laboratory Center Network: In 2014, the UZ HIV Clinical Trials Unit (CTU) successfully competed to be a NIAID CTU with a 7 year award period. The CTU conducts research protocols developed by the NIH’s AIDS Clinical Trials Group (ACTG), International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT), HIV Prevention and Treatment Network (HPTN), Microbicide Trials Network (MTN) and Vaccine networks and utilizes the clinical pharmacology laboratory for bioanalysis, protocol development and pharmacokinetic analysis and modeling.
  • The UZ Pharmacology Specialty Laboratory is the only NIH specialty laboratory at the UZ CTU site. • The UZ Pharmacology Specialty Laboratory was initially funded through a competitive award by the NIAID AIDS Clinical Trials Group in 2012 as a “developmental” laboratory. The funds were used to establish the laboratory and begin to train laboratory staff.
  • In December 2014, the UZ pharmacology laboratory was elevated in status by NIAID to a fully implemented International Pharmacology Specialty Laboratory (annual direct cost budget of $100,000). This designation now provides funding to support full-time laboratory technicians, and a supply budget. *NIAID HIV Clinical Pharmacology Laboratory Proficiency Testing Program: In 2010, NIAID added the UZ Clinical Pharmacology Laboratory to the network of labs that are eligible to participate in semi-annual proficiency testing through the NIAID Clinical Pharmacology Quality Assurance (CPQA) Program.

Inclusion in the proficiency testing program is accompanied by technical guidance from the CPQA and is a valuable resource for the UZ Center of Excellence in HIV Clinical Pharmacology as it expands the number of drug assays as well as the inclusion of new cells/tissue samples for bioanalysis.

UZ College of Health Sciences: The HRTP is well positioned to benefit from the institutional progress that has been made through the UZ MEPI. Dr. Morse, the D43 principal investigator, was invited to be the chair of the UZ MEPI Training Advisory Committee in 2012. Dr. Morse attended the MEPI retreat and participated in extensive presentations and discussions with the MEPI faculty and investigators. This participation has solidified the UB-UZ HRTP collaboration creating a synergistic environment that facilitates research mentoring within both programs and has led to new multidisciplinary research projects. This approach creates a vision of how these two programs can identify research areas that are of mutual interest and this will lead to joint grant applications and efficient program development within the UZ College of Health Sciences. The MEPI PI, Professor James Hakim, is a member of the HRTP Training Advisory Committee. Dr. Morse has also led workshops at UZ that were targeted at writing scientific publications and peer reviewed grant applications. These types of collaborations will continue during the new HRTP award period. Biomedical Research and Training Institute (BRTI), International Clinical Operational and Health Systems Research Training Award (ICOHRTA) was recently refunded to support the African Program for Research Training in HIV and TB, a joint program of BRTI and Stanford within Zimbabwe. This program is different in that it does not provide mentored research training as the HRTP does but does benefit the UB-UZ HRTP by providing auxiliary research support resources. Access to both programs has helped our prior fellows and facilitated the leveraging of projects to obtain additional support from ICOHRTA.

University of California (UC) Berkeley HRTP: UC Berkeley offers training for international scholars in AIDS-related research through support from their HRTP with an emphasis in epidemiology and public health. An example of an individual who benefited from this collaboration is Mr. Samuel Gavi, a UB-UZ AITRP fellow who also completed a Master’s degree at Berkeley. As a result of this complementary training Samuel is now a junior UZ faculty member and a resource for the UB-UZ HRTP trainees in the area of study design and data analysis. Through conversations with Dr. Reingold (PI: UC Berkeley HRTP), we have developed plans for an integrated approach for UB-UZ HRTP trainees to receive joint mentoring during visits and teleconferencing while in the US, or through collaborative workshops offered in Zimbabwe.) Kings College London maintains a behavioral health focus of many initiatives through its collaboration with the UZ CHS at Parirenyatwa Hospital. Within the Parirenyatwa Opportunistic Infection Clinic, Kings College London has created an opportunity to foster collaboration among externally funded research training programs. As one example, a multidisciplinary research team has been formed to investigate behavioral aspects of patient retention and medication adherence. (UZ-University of California San Francisco (UCSF) NIAID AIDS Clinical Trials Site (CTS) conducts protocols for the NIH HIV Research Networks (ACTG, IMPAACT, HPTN, MTN and VTN) and offers opportunities for HRTP faculty and fellows to collaborate and benefit from CTS mentors. The HRTP is also integral to the ACTG-supported International Pharmacology Specialty Laboratory at UZ, its partnership with the UZ CTS, and the training received by young scientists, laboratory technologists and data managers who contribute to UZ research.

University of Rochester (UR) Center for AIDS Research (CFAR): is a NIAID CFAR, and Dr. Morse (D43 PI), is a senior investigator in the UR CFAR. The UR CFAR recently facilitated an international supplement application for one of the UB-UZ AITRP fellows, who successfully competed and is conducting a study of maternal and neonatal hair tenofovir concentrations to quantitate maternal and neonatal pharmacokinetics during pregnancy, respectively. The UR CFAR director and co-director are members of the UB-UZ HRTP Scientific Advisory Board.

About Zimbabwe

Zimbabwe is a country located in the southern part of Africa with a population of 11.6 million. The country is a part of the so-called “AIDS Belt” Southern African countries and has among the highest HIV prevalence rates in the world with an estimated 1.8 million people and about 18% of all adults infected. The estimated total of children orphaned by AIDS is 1.2 million, and by 2010, more than 30% of children are expected to be AIDS orphans unless steps are taken to ensure the survival of their HIV-infected parents. Zimbabwe’s national response to the HIV/AIDS epidemic has been significant over the past decade. In 2002 the government declared a national “state of emergency” regarding HIV/AIDS and subsequently sourced funding from the Global Fund for AIDS, TB and Malaria.

Zimbabwe Facts:

Population: 14,229,541

Total Median Age: 20.35 years

Male Median Age: 20.4 years

Female Median Age: 20.7

Physician Density: .08 physicians / 1,000 population (2011)

HIV/AIDS adult prevalence rate: 16.74% (2014 est)

HIV/AIDS - People living wiht HIV/AIDS: 1,550,300 (2014 est)

HIV/AIDS deaths per year: 38,600 (2014 est)

Facts provided by CIA.gov

People & Personnel

PI & Co-PI

PI: Gene D. Morse, PharmD

Dr. Gene D. Morse has been conducting antiretroviral pharmacology research since the beginning of the HIV epidemic. In 1986, Dr. Morse developed the Laboratory for Antiretroviral Research at the University at Buffalo in the School of Pharmacy and Pharmaceutical Sciences. The laboratory has been a training site for numerous post-doctoral fellows and residents as well as pre-doctoral students. The laboratory is approved by New York State to conduct protease inhibitor assays in support of therapeutic drug monitoring research for antiretrovirals.

Dr. Morse has developed HIV pharmacology clerkship training for clinical evaluation of antiretroviral therapy in acute care and ambulatory settings, established an HIV Certificate program, a post-doctoral pharmacy residency program and a post-doctoral fellowship program in HIV/AIDS pharmacology. Dr. Morse has mentored international fellows from Cairo and Harare and collaborated with Dr. Maponga on the development of the International Center for HIV/AIDS Pharmacotherapy Research and Training (ICHAPRT). Dr. Morse has served as a grant reviewer for the National Institutes of Health, The Ontario HIV Research Council and the Netherlands HIV/AIDS Research Council. Dr. Morse established the HIV ePharmacotherapy Network an international website to foster education, research and technology transfer in HIV/AIDS pharmacotherapy.

Co-PI: Chiedza C. Maponga, PharmD

Dr. Maponga is a Senior Lecturer and Director of the School of Pharmacy in the University of Zimbabwe’s College of Health Sciences. He also holds a visiting faculty position at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences. This position requires him to rotate 3 to 4 times annually between the USA and Zimbabwe while coordinating the activities of a collaborative program called the International Pharmacotherapy Education and Research Initiative (IPERI). In April 2009, this program was awarded the Fogarty AIDS International Training and Research Program (AITRP) grant (grant no. 1D43TW007991-01A2) to implement a postgraduate training initiative with an emphasis on HIV/AIDS clinical pharmacology between the University at Buffalo (UB) and the University of Zimbabwe (UZ).

Fellows

Mqondisi Tshabalala M.Phil, BPharm, PhD candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mr. Mqondisi Tshabalala applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP, and began training in the UB-UZ HRTP in May 2011. Currently, Mr. Tshabalala is a lecturer in the Immunology Department at the University of Zimbabwe and is working on his research project proposal, “Investigation of the role of HLA gene polymorphism, co-receptor usage and primary drug resistant mutations on HIV-1 disease progression among antiretroviral therapy naïve individuals with CD4+ T lymphocytes above 350 cells/μL.” Mr. Tshabalala is also a DPhil Fellow under the International, Clinical Operational and Health Services Research Training Award (ICOHRTA).

 

Nathan Madanhi BPharm, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mr. Nathan Madanhi applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP, and began training in the UB-UZ HRTP in May 2011. Currently, Mr. Madanhi is a Pharmacist at United Bulawayo Hospitals in Zimbabwe and an MPhil candidate at UZ. At UZ, Mr. Madanhi was recently appointed as a graduate teaching assistant, Lecturer and junior faculty member under the University of Zimbabwe's Staff Development program. Mr. Madanhi’s research project proposal, “An investigation of the pharmacokinetic properties of stavudine, lamivudine and nevirapine in a dispersible fixed dose tablet versus individual innovator paediatric formulations among HIV-1 infected Zimbabwean paediatric patients,” has been approved by the University of Zimbabwe Higher Degrees Committee, Parirenyatwa Group of Hospitals Joint Research and Ethics Committee and Medical Research Council of Zimbabwe.

 

Nyashadzashe Bepe BPharm, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mr. Nyashadzashe Gideon Bepe applied and was accepted as a postgraduate fellow in the UB-UZ AITRP in the fall of 2010. Mr. Bepe is an MPhil candidate at UZ and recently received an appointment there as a Lecturer and junior faculty member under the University of Zimbabwe’s Staff Development program. Mr. Bepe’s research project proposal, “Investigation of Adverse Drug Reaction Profiles of Fixed-Dose Combination Antiretroviral Drug Preparations,” has been submitted to the UZ Higher Degrees Committee, and will then be submitted to the Medical Research Council of Zimbabwe and the Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics Committee for approval. During his initial training visit at UB, Mr. Bepe received training and mentoring in key areas that included: Human Subjects Research Protections and Ethics;  Pharmacokinetic and Pharmacodynamic data analysis; Translational Pharmacogenomics, Health Information Technology; Scientific Writing; and Adherence Pharmacology. Mr. Bepe’s abstract "Patient Perceptions, Knowledge, and Practices of the Role of Nutrition in HIV/AIDS Management in a Resource Limited Setting" was accepted to the IAS2010 conference in Rome.

 

Takudzwa Joylyn Mtisi MSc, BPharm, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mrs. Takudzwa Joylyn Mtisi applied and was accepted as a postgraduate fellow in the UB-UZ AITRP in 2009. She recently completed her MSc in Microbiology at UZ. Mrs. Mtisi completed her initial training visit at the University at Buffalo in 2009, and a second visit in 2011. She returned to Zimbabwe to complete her academic requirements for her project, part of a national drug resistance monitoring network under the Ministry of Health and Child Welfare in Zimbabwe.  Following her engagement as an HRTP trainee and her return to Zimbabwe, Mrs. Mtisi has spearheaded the development of the drug resistance monitoring laboratory had has been analyzing samples country wide. In December 2010 she received a promotion to a Medical Laboratory Scientist position under the Global Fund’s Early Infant Diagnosis Programme. In her new role, she has performed HIV DNA PCR for pediatric cases.  Ms. Mtisi is currently working with the newly designated ACTG Pharmacology Specialty Laboratory to develop a Quality Management System for the laboratory.

 

Samuel Gavi MS Epidemiology, BPharm, PhD candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mr. Samuel Gavi applied and was accepted as a postgraduate fellow in the UB-UZ AITRP in 2010. During his visits to UB, Mr. Gavi received mentored training in basic research areas with focus on the use of electronic health information technologies in the management of HIV and Tuberculosis (TB) co-infected patients in Harare, Zimbabwe.  With this guidance, Mr. Gavi established strong fundamental knowledge in the skills required to organize, analyze, interpret, monitor, and report on medication management and effects of ARV drugs in an effort to improve clinical decision making and patient care.  In addition, Mr. Gavi developed methods to evaluate existing information database silos and developed a plan to connect these systems into an integrated network.  During his visit, Mr. Gavi began theoretical training on possible pharmacokinetic and pharmacodynamic statistical applications to data analyses, and applied statistical software tools.

Mr. Gavi presented a poster titled “Establishing a Health Information Technology Network for HIV and TB Medication Management Research” at the University of Rochester Center for AIDS Research (CFAR) 2nd Annual World AIDS Days Scientific Symposium.  As part of an HRTP supplement, Mr. Gavi helped finalize a Health Information Technology online training module designed specifically for HIV research and management.  The education module incorporates pre-test and post-test sections to determine the effectiveness of the module. 

Mr. Gavi is currently developing a working group in Zimbabwe with key personnel to discuss the current state of systems and process for integration in addition to developing data analysis tools to monitor treatment outcomes.

 

Tinashe Mudzviti MPhil, BPharm, DPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

As the first UB-UZ HRTP fellow, Mr. Tinashe Mudzviti applied and was accepted as a postgraduate fellow in 2009. Mr. Mudzviti has completed two mentored training periods at UB, and has returned to Zimbabwe, where he completed his research project for his Master of Philosophy degree from UZ. The UB-UZ HRTP fellowship program has afforded him an opportunity to combine his ICOHRTA fellowship to make significant scientific development. He has published a number of abstracts that were also presented at scientific conferences locally and internationally. Mr. Mudzviti is responsible for running the Parirenyatwa Opportunistic Infections Clinic’s adherence and pharmacovigilance program. He has supervised at least six undergraduate students whom he coordinates with the Pari Support Group, a community-organized patient recruitment and retention project. With these undergraduate students he has been able to publish a manuscript and several other abstracts that have been presented at various conferences.

In November 2010 Mr. Mudzviti was thrust into the chairmanship of the Newlands Clinic Research Unit, where he is working on increasing the research agenda. He is taking up further work in pharmacovigilance and therapeutic drug monitoring. During the year 2012, Tinashe fulfilled his training requirements with the UB-UZ HRTP, which included two visits to UB and two years of mentored follow-up as specified in the original training plan. Tinashe’s main aims were to develop grant writing skills, to complete his MPhil project (Determining the Rate, Nature and Predictors of Adverse Drug Reactions Associated with the Use of HAART in a Resource-Limited Setting). These activities lead to the conceptualization of a DPhil research proposal that would be registered with the College of Health Sciences’ Higher Degrees Committee. Following his AITRP training, he was awarded a Southern Africa Consortium for Research Excellence small grant to run a research protocol. Through this award he was able to register the protocol titled, Prevalence and risk factors of pre-cancerous cervical lesions in HIV infected women, with the Medical Research Council of Zimbabwe. This protocol is currently in the data collection phase. During the year Tinashe drafted a review article titled, Implementation science research in the concomitant use of traditional herbal medicines in patients on antiretroviral therapy, for submission to the journal Evidence-Based Complementary and Alternative Medicine. As part of a team, Tinashe contributed to a workshop proposal for the 17 Congress of Basic and Clinical Pharmacology, as well as an abstract submitted to IAS2013. Tinashe also completed and fulfilled all of the requirements of the Master of Philosophy degree which he was consequently awarded mid-2012. Tinashe’s goal for 2013 is to ensure that the DPhil proposal that he submitted in 2012 is approved by higher degrees committee to ensure that he builds on what he has achieved in previous years as an HRTP fellow.

 

Tsitsi Grace Monera MPhil, DPhil candidate, University of Zimbabwe                                                          

Fellowship Program: UB-UZ HRTP

Ms. Tsitsi Grace Monera applied and was accepted as a pre-doctoral fellow in the UB-UZ AITRP in 2011. The goal of Tsitsi’s research is to evaluate the effect of Moringa oleifera on the pharmacokinetics of efavirenz and nevirapine in-vivo. Ms. Monera is also working on the validation of the assay methods that she will use to assay the rat and human plasma samples. Ms. Monera plans to return to UB for six weeks and travel to the University of Cape Town, where she will spend an additional six weeks to receive additional training finalize her data analysis plans. Recently, she attended the 7th International Microbicides Conference (M2012) Sydney, Australia, 15 to 18 April 2012 and The International Pharmaceutical Federation Centennial Congress (FIP2012) Amsterdam, Netherlands, 3 to 8 October 2012, where she presented three abstracts:

Monera TG, Thebe M. Knowledge, attitudes and perceptions of pharmacists in Zimbabwe on their role in the prevention and management of non-communicable diseases. FIP 2013: Accepted for poster presentation.

Monera TG, Tapfumanei P. Lifestyle Interventions for Cancer Health Promotion: Assessing Attitudes, Perceptions and Awareness among Community Pharmacist in Harare. FIP 2013: Accepted for poster presentation.

Monera TG, Gwekwe N. Herbal medicine use in dysmenorrhea: determining extent of use and the commonly used herbs. FIP 2013: Accepted for poster presentation.

 

Tsitsi Hamandawana BPharm, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Ms. Tsitsi Hamandawana applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP in 2012. The goal of Tsitsi’s research is to evaluate the effect of nutrition status on the adverse drug reaction profiles of antiretroviral and anti-tuberculosis drugs in HIV-1 infected paediatric patients. She had her first UB visit between August and November 2012 where she developed her research proposal with the assistance of the UB team. When she came back to UZ, she finalized the requirements and submitted her application to gain approval from the Joint Research and Ethics Committee (JREC). In 2013, following approval of her project from the UB IRB, Tsitsi will begin reviewing medical records to collect a complete dataset for analysis. She plans to return to UB for mentoring in data analysis and development of her HRTP project. She will return to Zimbabwe to continue courses and research toward her MPhil.

 

Dexter Chagwena BSc Nutrition, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mr. Dexter Chagwena applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP in 2011. Dexter’s research goal is to compare the response to cART among malnourished and well-nourished paediatric patients. Dexter completed his initial training period at UB in May 2012 and has used the knowledge for his daily research and teaching at UZ. Some of his accomplishments during this year include receiving an in-country scholarship from the German Exchange Service programme (DAAD). This is an in-country research training grant for one year that supports postgraduate students from developing countries.

Mr. Dexter Chagwena, a pre-doctoral fellow, returned to Buffalo for his second training visit during summer 2013. Dexter has been working on his research project aimed at evaluating the influence of nutritional status on outcomes of cART among pediatric HIV and TB infected patients receiving ARVs. His primary goals for the second visit include developing analysis tools for dietary evaluation of HIV pediatric patients on cART through the assistance of Dr. Peter Horvath's nutrition team. Dexter is also developing an in-depth nutritional pharmacology research agenda that include both laboratory nutrition biomarkers assay development that can be used to predict HIV adverse outcomes and nutrition clinical outcomes assessed to improve efficacy of ART among pediatric patients. Dexter has been involved in mentoring other UB and UZ students with interest in nutrition pharmacology mainly focusing on traditional herbal remedies and how they impact ARV drug metabolism among malnourished and well-nourished patients.

 

Marvelous Sibanda BPharm, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Mr. Marvelous Sibanda applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP in 2011. The goals of his research are to study factors influencing AST/ALT levels and nevirapine plasma concentrations in HIV-infected children on cART in a resource limited setting, to study the effects of age, nutritional status, herbal medicines, HBV and/or HCV on AST/ALT levels and nevirapine plasma concentrations, and evaluate any significant relationship between AST/ ALT plasma levels with plasma nevirapine concentrations in HIV-infected children stable on cART.

 

Dr. Admire Dube PhD, Monash University

Fellowship Program: UB-UZ HRTP

Dr. Admire Dube applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP in 2012. Dr. Dube research project is titled, Multimodal nanoparticle systems for tuberculosis chemotherapy. During his UB visits, Dr Dube formulated Chitosan (CS) shell, poly(lactide)co-glycolide (PLGA) core nanospheres functionalized with 1,3-β-glucan (Glu-CS-PLGA) to provide enhanced intracellular rifampicin concentrations with concurrent immunomodulation through stimulation of ROS/RNS and pro-inflammatory cytokine release in human alveolar like macrophages (ALM).

 

Tariro Sithole BPharm, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

Ms. Tariro Sithole applied and was accepted as a pre-doctoral fellow in the UB-UZ HRTP in 2012. Tariro completed her UB training visit in October 2012, which was shortened to six weeks due to academic and employment obligations. Her objectives were to learn different methods of making nanoparticles, nanoparticle characterization methods and HPLC assay development and validation. In May 2012, she submitted an MPhil proposal for registration with the University of Zimbabwe and her research was titled “Nanoparticle delivery systems for the enhanced bioavailability of the antimalarial compound Artemether”. As a result of her initial training visit at UB, she changed her topic to, “Super-paramagnetic nanoparticles for the enhanced intracellular concentrations of drugs used in HIV/AIDS and TB.”  Since her return to UZ from UB, she has drafted a new proposal for submission to the University of Zimbabwe for registration. The proposal is currently being reviewed by her supervisor. She also hopes to travel to UB in the second half of the year to carry out her laboratory experiments and receive mentoring on formulation and characterization of the nanoparticles, investigation of intracellular uptake by macrophages and CD4 cells, pharmacokinetics of the drugs in the cells, in vitro drug release at different pHs and HPLC assay method development and validation. She also hopes to begin statistical analysis of her results.

 

Faithful Chingombe BSc Applied Biology & Chemistry, MPhil candidate, University of Zimbabwe

Fellowship Program: UB-UZ HRTP

The UB Translational Pharmacology Research Core (TRPC) is pleased to welcome Ms. Faithful Chingombe.  Ms. Chingombe is a MPhil candidate at the University of Zimbabwe (UZ) and a Fellow in the UB-UZ AIDS International Training & Research Program (UB-UZ AITRP). She is currently receiving mentored research training at the TPRC for her research project, “Development of a Nanoformulated Antiretroviral Triple Combination and Investigation of In-vitro Uptake by Macrophages.”

 

Dr. Fatai Fehintola

Fellowship Program: UB-NU HRTP

Dr. Fatai Fehintola completed a customized HIV Clinical Pharmacology module in 2009 as part of a collaborative program between the UB AITRP, the Northwestern University AITRP and the University of Ibadan, Nigeria. This training module was developed to meet the needs of an investigator with a focus on HIV-malaria treatment research, and has led to an entire new program of collaboration. During 2010, the UB AITRP continued to collaborate with Dr. Fehintola to produce a manuscript, which has now been accepted for publication in the peer-reviewed journal Current Drug Metabolism, and to submit a grant application to the NIH. Dr. Fehintola has also written a protocol to evaluate drug interactions between HIV medications and malaria medications. The project has IRB approval, is fully enrolled and the samples assayed.

 

Dr. Onyeadumarakwe Reginald Obiako

Fellowship Program: UB-NU HRTP

Dr. Reginald Obiako is a physician/neurologist at the Ahmadu Bello University Teaching Hospital (ABUTH) in Zaria, Nigeria. He also has a MS in pharmacology and is a Fellow in the West African College of Physicians for both internal medicine and clinical pharmacology. He is an active clinician at the ABUTH HIV clinic, with which NU provides clinical support through the Harvard PEPFAR program, is head of clinic's toxicology and ARV switch committees, and is actively involved with the hospital's pharmacovigilance efforts. His current research interest include the evaluation of drug interactions between ARVs and carbamazepine in HIV-infected patients with new-onset seizure disorders. Dr Obiako joins us at the UB TPRC for additional training in clinical pharmacology to support his efforts to establish a clinical pharmacology facility in his own university. 

The UB-NU AITRP collaboration provides a mentored training experience for clinical pharmacologists from Nigeria here at UB and at NU. This collaborative initiative is funded by a recent NIH grant from the Fogarty International Center for an AIDS International Training and Research Program (AITRP). The AITRP collaboration will also contribute to the development of a new clinical pharmacology laboratory at Ibadan University in Nigeria.

Currently Dr. Obiako is a fellow at the Nigerian National Postgraduate Medical College, Head of Neurology Unit and acting head of Clinical Pharmacology Unit of ABUTH Zaria.

 

Mr. Martin Zende

Fellowship Program: UB-UZ HRTP

Mr. Martin Zende received his Bachelor of Science in Agriculture and his Master of Science in Tropical Resource Ecology from the University of Zimbabwe. Mr. Zende was working with an HIV patient support group called PARI SG in Harare, Zimbabwe where he directed members in completing various agricultural projects. The agricultural projects were aimed at increasing food security, thereby improving patient retention in care, treatment and medication adherence. Mr. Zende began working with the PARI SG in Zimbabwe in May 2011. In this program, he provided training and education PARI SG members on organic vegetable production. Together, they produced vegetables such as covo (a green leaf vegetable), rape (an oilseed plant of the mustard family), onions, potatoes and tomatoes. Mr. Zende was also providing training & education to PARI SG members on chicken production, most recently on producing broiler chickens. All these programs were a way of retaining patients in the PARI SG, which improves patient care and treatment, medication adherence, and improves members’ personal economic state since any surplus products can be sold. Mr. Zende’s goals during his Buffalo visit included training in methods of patient retention, scientific writing, grant writing, and research protocol development.

 

 

Dr. Titilayo Fakeye

Fellowship Program: IPERI

Dr. Titilayo Fakeye completed a short-term training experience at the UB TPRC under the UB International Pharmacotherapy Education & Research Initiative (IPERI) in 2011, and is currently teaches Bachelor of Pharmacy students in topics including documentation of patient’s care activities, patient review process, clinical pharmacokinetics lectures such as pharmacokinetics of drugs in liver and renal impairment; pharmacotherapeutics of selected tropical diseases, and pharmacy laws & ethics. At the postgraduate MSc (Clinical Pharmacy) level, she teaches selected clinical pharmacokinetic topics, documentation and methodology of research activities.

Her research focus includes surveys into drug use among different populations, attitude of patients to use of herbal agents, and tendency to co administer conventional and herbal medicines. The need to evaluate and note herb use when a patient’s drug medication history is being taken, and proper counseling of patients on herb use when drugs are being dispensed has been unearthed. Her team is also trying to relate some of the adverse drug reactions to the use of non-prescribed medicines and herb use. Ongoing studies involve evaluating the mechanism of these interactions with emphasis on those suspected to be due to activity of cytochrome P450 isozymes.

Recent publications include:

Fakeye TO, Adisa R, Olatunji A. (2010) Self medication among hospitalized patients in selected secondary health facilities in south western Nigeria. Pharmacy Practice   Oct-Dec;8(4):233-237

Adisa R, Fakeye TO, Fasanmade O. Medication adherence among ambulatory patients with type 2 diabetes in a tertiary healthcare setting in southwestern Nigeria. Pharmacy Practice (In press)

 

Dr. Sarah Nanzigu

Fellowship Program: IPERI

Dr. Sarah Nanzigu completed a short-term training experience at the UB TPRC under the UB International Pharmacotherapy Education & Research Initiative (IPERI) in 2010, and is currently an Assistant Lecturer in the Pharmacology Department of the Makerere University College of Health Sciences in Uganda.  There she does health service training and provision as well as clinical research.  Her interests include HIV and other diseases endemic in her area.  The two journal articles she has published in 2011 are: CD4-T-Lymphocyte reference ranges in Uganda and its influencing factors. Journal of Lab Medicine 2011 and HIV/AIDS patients display lower efavirenz relative bioavailability compared to healthy volunteers.  Journal of Clinical Pharmacokinetics in press 2011.

 

Mr. Jackson Mukonzo

Fellowship Program: IPERI

Jackson K Mukonzo is a pharmacist in Uganda, a Lecturer at Makerere University, Kampala- Uganda and a PhD candidate at Karolinska Institute, Stockholm- Sweden. Jackson’s research project proposal is titled, “The role of pharmacogenetics in treatment of infectious diseases, with emphasis on Ugandan population.” During his training visit at UB, Jackson will receive training and mentoring in principles and practical aspects of Pharmacokinetic / Pharmacodynamic modeling. Jackson has about ten years work experience as a clinical pharmacist in the field of infectious diseases, has participated on a number studies including the cellulose sulphate Microbicide trial and the on-going WHO TB-HAART study. Jackson has also worked as consultant pharmacist to the Department of HIV and Sexually Transmitted Disease, Ministry of Health Botswana, where he participated in the development of the National strategy for HIV prevention and treatment for the government of Botswana, and The Global Fund where he executed a consultancy on how to mitigate loss and mismanagement of the Global Fund Health Products in Uganda. Jackson also participated as founder member of Mbarara- Mulago Joint AIDS program (M-JAP), which initiated integrated HIV treatment in public hospitals in Uganda and currently provides care to about 12 000 HIV patients.

Scientific Advisory Board

The HRTP Scientific Advisory Board (SAB) includes a number of internationally recognized leaders in their field. The purpose of the board is to bring together members of academia and industry with various scientific experiences and knowledge to inform the projects of the fellows and the specific aims of the HRTP. 

The SAB is chaired by Robert T. Schooley, MD, UCSD

SAB Members include: 

Training Advisory Committee

Training Advisory Committee (TAC): The TAC is comprised of an accomplished group of senior educators and researchers with extensive capacity building experience in Zimbabwe, and other countries, that will provide excellent guidance to the HRTP. The members include:

  • Midion Chidzonga, FFDRCSI, MMedSc: Professor Chidzonga is the TAC Chair, Dean of the UZ CHS and a senior academic leader at UZ. Professor Chidzonga plays a pivotal role as a liaison between the CHS and the UZ Vice Chancellor and the Ministry of Health and Child Care.
  • James Hakim, MD: Professor Hakimis one of the foremost international HIV researchers in Africa. Prof. Hakim is the PI for the UZ MEPI and was the Zimbabwean PI of the Development of Antiretroviral Therapy Trial in Africa. He is director of the UZ Clinical Research Center and Harare PI of the Europe-Africa Research Network for Evaluation of Second-line therapy, one of the largest studies addressing second-line ART.  
  • Arthur Reingold, MD: Professor Reingold has been an HRTP PI since 1988 and has recently received a HRTP award with the University of Zimbabwe that is focused on public heath epidemiology training. Dr. Reingold brings a wealth of experience and experience in global health and infectious diseases research. 
  • Robert Schooley, MD: Professor Schooley is an international infectious diseases researcher with extensive experience in capacity building programs in Africa. He is a past Chair of the NIAID ACTG and as International Liaison to the Executive Committee. He coordinated the ACTG’s expansion from a domestically based clinical and translational therapeutic research agenda to one with multiple international sites and a global focus. He established the International Core of the University of California at San Diego CFAR in 2005 and is Co-Director.
  • Constance Benson, MD: Professor Benson is an internationally recognized HIV/AIDS researcher who has been involved in translational and clinical HIV/AIDS research for over 26 years. As the PI/Chair of the ACTG network, she has extensive experience in the scientific and organizational administration and fiscal management of a multinational clinical trials network and international laboratories.
  • Tom Campbell, MD: Professor Campbell has extensive experience in clinical and translational investigations of HIV/AIDS and the development of research capacity in Zimbabwe. He has collaborated with Professor James Hakim in the development of antiretroviral clinical trials capacity at UZ CHS (with funding from NIAID) and is the Co-PI for the Novel Education Clinical Trainees and Researchers Program to improve medical education and healthcare-related research capacity at the UZ CHS.
  • Peter Mason, PhD: Dr. Mason has been PI for the Clinical, Operational, and Health Services AIDS/TB in Zimbabwe. He has fostered collaboration with the UZ-UB HRTP and provides important support for UZ graduate students and fellows.
  • Jack DeHovitz, MD, MPH: Distinguished Professor DeHovitz has extensive experience in developing care programs and program evaluation in both the US and Eastern Europe and has served as project director of the New York State International Training and Research Program with continuous funding since 1994. Dr. DeHovitz brings extensive capacity building experience to the TAC.
  • Gary Maartens, MD: Professor Maartens is an international HIV/TB researcher and head of Clinical Pharmacology at the University of Cape Town. He has experience with post-doctoral fellowship training programs. He has mentored many junior researchers and has been a mentor in two research training grants. 
  • Chiratidzo Ndlovu, MMed Sci (Clin Epi), FRCP: Dr. Ndlovu is a Senior Lecturer in the Department of Medicine and the Deputy Dean of the UZ CHS. She chaired the Department of Medicine at UZ CHS from 2006-2010 and is focused in Internal Medicine with sub-specialties in Nephrology and HIV Medicine.

Faculty/Mentors

PROGRAM FACULTY: UB mentors for the HRTP represent both highly and newly experienced faculty in a broad variety of health sciences and other disciplines. The blend of specialties complement the core research areas of the HRTP and provide one or more experts to these areas.

UB Mentors: The UB mentoring team has had extensive experience with LMIC trainee mentoring. UZ trainees have been retained and are completing graduate degrees while also being appointed to staff fellowship position allowing them to contribute UZ faculty mentoring of undergraduate students.

  • Gene D. Morse, PharmD, is a tenured SUNY Distinguished Professor with ~30 years of experience in HIV Clinical Pharmacology research and mentoring. Dr. Morse has had continued NIH support from NIAID since 1987. Dr. Morse is the Clinical Pharmacology Core Director for the NIAID ACTG Laboratory Center Network, and directs UB’s Translational Pharmacology Research Core. He also directs the regional HIV Education Program that is located in the New York State-designated HIV Center at the Erie County Medical Center. Dr. Morse has been mentoring LMIC fellows since 1998, and has extensive experience with research mentoring programs for undergraduate, graduate, professional and post-doctoral mentees.
  • Qing Ma, PhD, is an Assistant Professor who has been a mentor for numerous LMIC fellows providing didactic and experiential training in clinical pharmacokinetics. Currently an NIMH K08 awardee, with an emphasis on neuroAIDS, Dr. Ma provides seminars and direct mentoring for fellows focused on compartmental and non-compartmental pharmacokinetic analysis, pharmacogenomics and central nervous system drug penetration studies. Dr. Ma provides mentoring for protocol development, biostatistics and pharmacokinetic analysis.
  • Charles Venuto, PharmD, is an Assistant Professor and a current K23 awardee, with a focus in pharmacokinetics and pharmacodynamics, with an emphasis in pharmacogenomics, drug-drug interactions, and disease progression modeling for optimizing drug delivery and development. Dr. Venuto coordinates the weekly research forum that has been attended by all LMIC with each presenting their research at UB or via teleconference from UZ.
  • Robin DiFrancesco, MBA, MT: Ms. DiFrancesco is a Research Assistant Professor with ~30 years of experience in managing a NIAID-supported clinical pharmacology laboratory. She has mentored numerous residents, LMIC fellows and post-doctoral fellows in the area of bioanalysis, assay development and validation and bioanalysis of clinical samples from research protocols. Ms. DiFrancesco is an internationally recognized expert in quality assurance for HIV clinical pharmacology laboratories and also mentors trainees in pharmacokinetic analysis software.
  • Richard Browne, PhD, is a tenured Associate Professor in the Department of Biotechnical and Clinical Laboratory Sciences. Dr. Browne directs the medical technology program and has extensive mentoring experience with graduate students and fellows.
  • Stanley Schwartz, MD, PhD, is a tenured Distinguished Professor and a senior academic physician-scientist at UB. He has an extensive track record of LMIC mentoring of trainees in clinical pharmacology and is a highly productive researcher in HIV immunology with prior NIAID and NIDA support for research in HIV/AIDS. Dr. Schwartz was a member of the UB team that visited UZ for training program workshops and planning sessions.
  • Peter Horvath, PhD, is an Associate Professor with a research emphasis in carbohydrate and exercise nutrition. He is actively involved in distance learning and international education at UB. As an AITRP mentor, he provided direct mentorship to three fellows for graduate research projects in the area of clinical pharmacology and nutritional factors that influence treatment outcomes in patients with HIV and tuberculosis.
  • Paul Wallace, PhD, is an Associate Professor who is an internationally recognized expert in flow cytometry with a strong background in immunology and research interests in macrophage, dendritic cell and myeloid derived suppressor cells biology. Dr. Wallace directs the Flow and Image Cytometry Core at Roswell Park Cancer Institute and UB and provides trainees with access to an excellent core resource. Dr. Wallace has mentored two LMIC with an interest in macrophage targeting for HIV and TB treatment.
  • Alexander Cartwright, PhD, is a Professor of electrical engineering and bioengineering with an international reputation for biosensors and photonics applications development. Dr. Cartwright is an outstanding mentor and will contribute to mentoring HRTP projects with point of care clinical pharmacology and diagnostics applications.
  • Venu Govindaraju, PhD, is a SUNY Distinguished Professor of Computer Science and Engineering at UB. Dr. Govindaraju is a Fellow of the Association of Computing Machinery, the Institute of Electrical and Electronics Engineers (IEEE), American Association for the Advancement of Science, and the International Association of Pattern Recognition. Dr. Govindaraju has recently completed a visit to UZ to determine the health information technology environment for HRTP projects that includes point of care diagnostics applications.
  • Melanie Abas, MBChB, MSc, MRCP, MRCPsych, MD, is a senior lecturer at the Kings College and is an investigator in the UZ Medical Education Partnership Initiative supplement Improving Mental Health Education and Research in Zimbabwe program. The aim of this program is to develop a sustainable and relevant innovative mental health education curriculum with a strong emphasis on community-based intervention research and forms a natural collaboration with the HRTP. Dr. Abas mentors graduate students conducting research at UZ.

 

UZ Mentors:

  • Chiedza Maponga, PharmD, MHPE, is a tenured Associate Professor and the Director of the UZ School of Pharmacy. Professor Maponga is the PI for a NIAID-supported Clinical Pharmacology Laboratory. He also was the Co-I for the prior Fogarty International Center AITRP. Under Professor Maponga’s leadership UZ was added to a select group of NIAID-supported pharmacology labs that receive blinded ARV and TB proficiency testing samples and receive technical guidance for assay development.  He is a member of the ACTG Clinical Pharmacology Advisory Committee and an elected member of the ACTG HIV Cure and Eradication Transforming Sciences Committee. Professor Maponga chairs the Registration Committee and is a member the Zimbabwe Medicines Control Authority’s Executive Committee. With his Master’s degree in Health Professions Education, Professor Maponga has mentored 8 AITRP fellows and has extensive experience with research mentoring.
  • Collen Masimirembwa, PhD, the President and Chief Scientific Officer at the African Institute of Biomedical Science and Technology in Harare, Zimbabwe. A former UZ graduate in clinical pharmacology, Dr. Masimirembwa is an internationally known researcher in clinical pharmacology and pharmacogenomics. He has extensive experience mentoring graduate students and is a current mentor in a clinical pharmacology CFAR supplement for one of the prior UB-UZ HRTP fellows that is investigating ARV hair pharmacology.
  • Tariro Makadzange, MD, PhD, is an infectious disease physician scientist with training in immunology and a specific interest in adolescent HIV immunology. Dr. Makadzange is co-director of the Parirenyatwa Hospital Family Care Centre and the Opportunistic Infection (OI) Clinic, which is one of the largest HIV treatment programs in Zimbabwe. Dr Makadzange manages clinical and mentoring activities under the Global Fund Project and conducts clinical and operational research.
  • Star Khoza, PhD, is a Senior Lecturer at UZ with an interest in clinical pharmacology, therapeutics and regulatory affairs. Dr. Khoza has mentored three prior HRTP fellows and is very interested in providing mentorship to UZ Masters, PhD and post-doctoral trainees during the new HRTP funding period.
  • Lynda Stranix-Chibanda, MD, is the IMPAACT Project Director for the UZ-UCSF Clinical Trials Unit. Dr. Stranix is currently a Co-I on the NIAID Promise protocol and has included hair clinical pharmacology testing at the UZ site as a sub-study in collaboration with a UB-UZ HRTP fellow and current UZ PhD candidate.

Staff

U.S Staff

Administrative & Operational

Kelly Tooley, MsEd, is the UB-UZ HRTP Project Administrator and coordinates program operations. She also provides mentoring to the trainees in study conduct, sample management and research administration.

Scientific Dissemination

Fellow Publications 2008-Present

1.     Bepe N, Madanhi N, Mudzviti T*, Gavi S, Maponga CC, Morse GD. The impact of herbal remedies on adverse effects and quality of life in HIV-infected individuals on antiretroviral therapy. J Infect Dev Ctries. 2011:5(1):48-53.PMCID: PMC3424263. 2. Fehintola FA, Akinyinka OO, Adewole IF, Maponga CC, Ma Q, Morse GD. Drug Interactions in the Treatment and Chemoprophylaxis of Malaria in HIV infected individuals in Sub Saharan Africa. Curr Drug Metab. 2011: Jan 1;12(1):51-6. PMCID: PMC3233991.

2.     Fehintola FA, Scarsi KK, Ma Q, Parikh S, Morse GD, Taiwo B, Akinola IT, Adewole IF, Lindegardh N, Phakderaj A, Ojengbede O, Murphy RL, Akinyinka OO, and Aweeka FT. Nevirapine-Based Antiretroviral Therapy Impacts Artesunate and Dihydroartemisinin Disposition in HIV-Infected Nigerian Adults. AIDS Research and Treatment 2012: ID 703604, 2012. doi:10.1155/2012/703604 PMCID: PMC3303559.

3.     Mudzviti T*, Maponga CC, Khoza S, Ma Q, and Morse GD. The Impact of Herbal Drug Use on Adverse Drug Reaction Profiles of Patients on Antiretroviral Therapy in Zimbabwe. AIDS Research Treatment 2012: Article ID 434171, 4 pages doi:10.1155/2012/434171 PMC3313558.

4.     Mudzviti T*, Sibanda M, Gavi S, Maponga CC, Morse GD. Implementing a pharmacovigilance program to evaluate cutaneous adverse drug reactions in an antiretroviral access program. J Infect Dev Ctries. 2012 Nov 26;6(11):806-8. doi: 10.3855/jidc.1908.PMC3535441.

5.     Tshabalala M, Manasa J, Zijenah LS, Rusakaniko S, Kadzirange G. Surveillance of Transmitted Antiretroviral Drug Resistance among HIV-1 Infected Women Attending Antenatal Clinics in Chitungwiza, Zimbabwe. PLoS ONE 2011: 6(6): e21241. PMCID: PMC3116901.

6.     Mushonga NGT, Chagwena D, Benhura C, Nyanga LK. An Assessment of the Nutritional Status of University of Zimbabwe Students. Pakistan J Nutrition 2013: 12 (1): 30-33.

7.     Tshabalala M, Morse GD, Zijenah L. HLA Genetic Polymorphisms: Role in HIV-1 Susceptibility, Disease Progression and Treatment Outcomes. Retrovirology: Research and Treatment. 2013:5 1–8 doi: 10.4137/RRT.S11589/Libertas Academica Ltd. 

8.     Mudzviti T*, Maponga C, Khoza S, Ma Q, Tagwireyi D. Clinical Pharmacology in the Emerging Countries: Clinical Toxicities of First-Line Antiretroviral Therapy in a Resource limited Setting. Basic and Clinical Pharmacology Toxicology 2010: 107 (Suppl. 1), p475. 

9.     Dube A, Reynolds JL, Law WC, Prasad PN, Morse GD. Multimodal nanoparticles that provide immunomodulation and intracellular drug delivery for infectious diseases. Nanomedicine 2013: Dec 10. pii: S1549-9634(13)00677-1. doi: 10.1016/j.nano.2013.11.012. [Epub ahead of print]. PMID: 24333593.

10.  Scarsi KK, Fehintola FA, Ma Q, Aweeka FT, Darin KM, Morse GD, Akinola IT, Adedeji WA, Lindegardh N, Tarning J, Ojengbede O, Adewole IF, Taiwo B, Murphy RL, Akinyinka OO, Parikh S. Disposition of amodiaquine and desethylamodiaquine in HIV-infected Nigerian subjects on nevirapine-containing antiretroviral therapy. J Antimicrob Chemother. 2014 May;69(5):1370-6. PMCID: PMC3977609

11.   Mushonga NGT, Kujinga P, Chagwena DT, Chituwu R and Nyabanga G. Retrospective Study of the Nutritional Status of Primary School Children in Harare. African Journal of Food, Agriculture, Nutrition and Development. 2014 May; 14(3): 8837-47.

12.   Chopera P, Chagwena DT, Mushonga NGT. Food label reading and understanding in parts of rural and urban Zimbabwe. African Health Sciences. 2014 Sep;14(3):576-84. PMCID: PMC4209636

13.   Mudzviti, T*., Mudzongo, N.T., Gavi, S., Chimbetete, C., Maponga, C.C. and Morse, G.D. (2015) A Time to Event Analysis of Adverse Drug Reactions Due to Tenofovir, Zidovudine and Stavudine in a Cohort of Patients Receiving  Antiretroviral Treatment at an Outpatient Clinic in Zimbabwe. Pharmacology & Pharmacy, 6, 201-206.http://dx.doi.org/10.4236/pp.2015.

14.   Mudzengi J, Monera TG*, Nhachi CHB. Microbial and heavy metal quality of selected herbal medicines commonly used by HIV patients in Zimbabwe. Journal of Applied Science in Southern Africa. 2013. Vol 19i: 28-42.

15.   Bhunu CP, Mushayabasa S,  Monera TG*. Assessing the Impact of Vaccination on Controlling the Spread of Human Scabies.  ISRN Computational Biology, vol. 2013, Article ID 362973, 7 pages, 2013. doi:10.1155/2013/362973.

16.   Tapfumaneyi P, Monera TG*. Lifestyle Interventions for Cancer Health Promotion: Assessing Attitudes, Perceptions and Awareness Among Community Pharmacist in Harare. Pharmaceutical Journal of Zimbabwe Vol.5, Issue 1 ,February 2013

17.   Mureyi DD, Monera TG*, Maponga CC. Prevalence and patterns of prenatal use of traditional medicine among women at selected Harare clinics: a cross-sectional study. BMC Complement Altern Med 12 (1): 164 (2012) PMID 23016608

18.   Monera TG*, Maponga CC.  Prevalence and patterns of Moringa oleifera use among HIV positive patients in Zimbabwe: a cross-sectional survey.  Journal of Public Health in Africa Vol3, No 1 2012-10-24

19.   Monera TG*.  The Pharmacist’s Role in Clinical Trials. Pharmaceutical Journal of Zimbabwe Vol.2, Issue 2, September 2009

20.   Monera TG*, Wolfe AR, Maponga CC, Benet LZ, Guglielmo J.  Moringa oleifera leaf extract inhibit 6beta-hydroxylation of testosterone by CYP3A4.  J Infect Dev Ctries 2(5): 379 – 83 (2008) PMID 19745507.

Related Links and Resources

Online Tutorials

UB Sponsored Programs

The University at Buffalo (UB) School of Pharmacy and Pharmaceutical Sciences Department of Pharmacy Practice Office of Postgraduate Professional Education designed several distinct postgraduate training programs offering HIV health care providers the opportunity to select the specific educational program which is best suited for their practice setting.

HIV pharmacotherapy is unsurpassed in its complexity when compared with other chronic illnesses, making pharmaceutical care in this area particularly challenging. However, caring for patients infected with HIV is becoming more common as patients with the disease are living longer and are presenting to a diversity of practice settings. Many pharmacists find themselves uncomfortable with their level of knowledge in the area of HIV either because they did not receive any HIV training in their formal education or simply because of the rapid and on-going advancements in this therapeutic area.

The UB continuing education programs provide varied levels of training for pharmacists seeking the knowledge and skills necessary to assess, counsel and manage the medications of patients living with HIV infection and other common co-morbidities. The basic pathophysiology of HIV and pharmacology of antiretrovirals will be covered in the programs as well as contemporary issues in patient management such as adherence, adverse drug reactions, drug interactions, and antiretroviral resistance.

Link: https://tdm.pharm.buffalo.edu/hiv_cert_main/

 

Clinical Pharmacology Tutorial (PK Tutorial), sponsored by the Clinical Pharmacology Quality Assurance Program (CPQA)

The Clinical Pharmacology Quality Assurance and Quality Control Program (CPQA) sponsors the Clinical Pharmacology Tutorial (PK Tutorial) which is hosted on the Frontier Science and Technology Research Foundation (FSTRF) Portal.  ACTG and IMPAACT networks require that at least one individual at the clinical research site (CRS) complete and retain this certificate in order to conduct trials that involve pharmacology testing.

Staff who complete the online tutorial will:

  • Learn what study conduct practices cause some of the most common and serious problems seen in PK-PD analysis.
  • Learn about specific factors that affect the specimens staff collect for PK-PD studies and how these factors impact analysis of PK-PD data.
  • Learn about types of pharmacology studies other than intensive that are typically used in clinical trials.
  • Learn the basic terminology and concepts behind pharmacology studies.

Four complete sections guide staff step-by-step providing the knowledge and tools needed to successfully conduct pharmacology protocols. The tutorial features clear, easy-to-read graphics throughout to illustrate specific problems often seen in pharmacology protocols. Each section is followed by a quiz. The PK Tutorial takes approximately one hour to complete. A certificate is issued upon completion, and is valid for two years.

Link: http://www.fstrf.org/cpqa-training   

Contact CPQASupport@fstrf.org for access information.

Resources for Admitted Fellows

Organizations and their Interactions with fellows:

  • University of Zimbabwe – College of Health Sciences: Training of Junior Pharmacy and Pharmacology Faculty in HIV Pharmacotherapy
  • Medicines Control Authority of Zimbabwe (Ministry of Health): Development of Bioequivalence Surveillance System for Generic Drugs
  • Chitungwiza UTANO – Community Partnership in Health:  Antiretroviral Adherence Support system for Chitungwiza Patients
  • USA Center for Disease Control and Prevention – Zimbabwe office: Technical Support to funded project on Pharmacy and Pharmacology issues
  • Ministry of Health – Zimbabwe: Technical support to the National Emergency Task Force on Antiretrovirals
  • International AIDS Clinical Trials Group: Study Pharmacology Committees
  • AIDS Healthcare Foundation: The development of HIV/AID clinics in developing countries will foster a partnership between AHF and the UB ATRP as new programs are implemented and health professionals receive training on the integration of clinical care and research.

VISA Preparations

HRTP fellows come to the U.S on a J-1 scholar VISA. To apply for a visa, fellows need a DS-2019. To receive a DS-2019, fellows need to complete the DS-2019 application packet. The UB-UZ AITRP program staff will assist you in the submission of your DS-2019 application packet. Fellows will need the following to complete the DS-2019 packet:

Curriculum vitae (CV)/ resume

1.     A letter from University of Zimbabwe confirming that you are in good academic standing and that this research training will fulfill the educational objectives for your current degree program

2.     Copy of your passport biographic data

3.     Signed Medical Insurance Attestation

4.     Signed Letter of Commitment from the Fellowship Acceptance Contract Letter

5.     Completed DS-2019 application form

You may also be asked to provide additional documentation as applicable. The DS2019 form will be mailed to your Zimbabwe address. Additional information can be found at the UB International Student and Scholar Services website http://wings.buffalo.edu/intlservices/j1_scholars.html.

Requirements change. We recommend that you also check with the U.S Consulate in Zimbabwe for recent J-1 VISA application requirements prior to making any VISA appointments.

Fees and Accommodation

The UB-UZ AITRP program will provide fees directly related to your expenses to come to Buffalo. These include:

  • VISA fees (reimbursed after arrival at UB)
  • SEVIS fees
  • Round trip ticket between Harare, Zimbabwe and Buffalo, NY (UB will book this for you; do not book yourself!)
  • Stipend (for housing, meals, living and incidental expenses)
  • Fellow Health Insurance during UB visit

For any assistance do not hesitate to contact the Program Staff

Additional Resources

Transportation Services
The University provides free bus services between UB North Campus and UB South Campus and shuttle services to the UB Center of Excellence in Bioinformatics & Life Sciences. The buses also take students for grocery shopping and to the Boulevard Shopping Mall on select days. UB bus and shuttle schedules can be found at http://www.ub-parking.buffalo.edu/. Public buses (Niagara Frontier Transportation Authority) are also available for a fee opposite UB South Campus library. A train station is located at the same place for transportation between UB South Campus and Downtown Buffalo where you can also get access to long distance buses.

Food Services at UB
The University at Buffalo has various dining services locations, ‘fast food’ areas and convenience stores. The campus card and cash can be used at most of these locations. Fellows will be advised on the usage limits of the cards that will be provided through the program at these outlets. For a list and location of outlets including menus please visit http://www.myubcard.com/dining/. Depending on the place you will be allocated to live, you might also have access to a kitchenette should you want to prepare your own meals.

Phone Services
Dial tone services are provided in UB residence halls except in Flickinger Court. However, you will need to get your own receiver (which cost $5 or more). You can call local numbers (#s beginning with 716) and toll free numbers (#s beginning with 1-800,1-866 etc) for free using the residence hall phones. You can alternatively obtain a cell phone prepaid or contract line. Contract lines will be dependent on your duration of stay and the company. There are some cell phone providers within walking distance from South Campus whose services you can generally inquire. Zimbabwe and U.S. cell phone services are quite different thus it is advisable to talk to someone before getting a phone. Public telephone booths (call boxes) are also available around campus.

International calls can be conveniently and more cheaply made using international calling cards. Phone cards are available at various off campus convenience stores and are usually tailor-made for calls to specific areas. Since most phone cards have toll free access numbers, you can use your residence hall phones to make international calls using phone cards.

Laundry, Television and Other Services
All UB residence halls have laundry washers and driers which you can use to do your laundry. Laundry service fees are paid as part of your accommodation fees so you do not need to worry about these. Television services are also available in each room although you need to purchase your personal television. However, a communal television is usually available for shared use at any time.

UB South Campus is conveniently located near a shopping plaza should you need basic commodities. Shops for various services and a movie theater are also located at the Plaza. For banking, shopping, restaurant guides and other suggestions please visit the International Student and Scholar Services website.

International Students’ and Scholars’ Activities
The University at Buffalo International Students and Scholar Services (ISSS) provides various activities and workshops for international scholars and students. Some events include visiting places such as Niagara Falls, Darien Lake Amusement Park and Zoar Valley. While the UB-UZ AITRP program will sponsor a few events, fellows interested in spending time and meeting other international students are encouraged to attend these trips. Available activities and details (costs, etc) can be found on the ISSS website.