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.