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Z Mike Chirenje MD FRCOG [email protected]. Year 8 into Year 9 (April 2014- April 2015) Major...
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Transcript of Z Mike Chirenje MD FRCOG [email protected]. Year 8 into Year 9 (April 2014- April 2015) Major...
UZ –UCSF Collaborative ResearchProgramme
Annual Research Day 2015Z Mike Chirenje MD FRCOG
Year 8 into Year 9 (April 2014- April 2015)Major Changes Are:New Funding Structure Core Directly From NIH through UCSF
Subcontract Network PF Directly to each CRS Impact is monthly income for CTU now
dependant on participants seen on daily basis.Spilhaus CRS Expansion into HPTN Protocol
specific Site that will conduct HPTN 076
INTRODUCTION
HPTN 076 Phase II Safety and Acceptability of an
Investigational Injectable Agent, TMC278 LA, for Pre-Exposure Prophylaxis
Expected timeline Screening started April 2015, and have
screened 7 potential ppts and expect to finish enrolment by Sept 2015 (48 ppts)
Major Changes
Expansion of Pari CRS NIH provided more Core funding of new CRS Harare Family Care with Dr Mutsa Bwakura as Site
Leader became operational 13 March 2015Capacity development Seke South approved for development as a Protocol
Specific Site for HVTN in April 2014 Awarded $513,739 for preparatory activities:
◦ Clinic renovations (lab and pharmacy)◦ Stakeholder engagement◦ Training This is the site that will execute HVTN 107 Protocol (Dr Portia Hunidzarira)
Major Changes
Seke South clinic renovations
Original space available for research activities
Extension
Formation of Institutional Biosafety Committee Invited scientists from the College of Health
Sciences and Chitungwiza municipal staff to serve on the IBC, now registered with the NIH Office of Biotechnology Activities◦ Collective experience and expertise in
recombinant or synthetic nucleic acid molecule technology, the capability to assess the safety of research and the ability to identify any potential risk to public health or the environment.
Training for regulators Dr Jim Kublin, P5 overview, Oct14 Regional regulators’ forum, Oct14 Regional regulators’ forum, Oct15 HVTN scientific meeting, Oct15
Total of 21 Protocols 2 393 participants 1033 Mother/infant pairs Very high retention rate at 95.7% 052 Closure – Last participant will exit 0n
30th April 2015 Aspire Closure – Last aprticipant will exit
25th July 2015
Scientific Achievements
Scientific AchievementsAbstracts Presented-3Articles Published - 8
Name Network Abstract Presentation Conference
P Ndadziyira MTN The Impact of Participant Mobility on Missed Visits Among Women Taking Part in the VOICE (MTN-003) Study in Zimbabwe
Poster HIV R4P Conference, Cape Town October 2014
N Mgodi MTN Uptake of HBV Vaccination and Incident HBV Infection in Women of Reproductive Age and at Risk of HIV-1 Infection in the VOICE (MTN 003) Study
Poster HIV R4P Conference, Cape Town October 2014
P Musara MTN The Effect of Presentation of Pharmacokinetic (PK) Drug Results on Self-reported Study Product Adherence among VOICE Participants in Zimbabwe.
Oral HIV R4P Conference, Cape Town October 2014
Scientific Achievements: Scientific Publications
Name Network Article Journal published Month/Year
ZM Chirenje, N Mgodi
MTN Oral and Topical Tenofovir –Based Pre-exposure Prophylaxis for HIV Infection among African Women.
New England Journal of Medicine
Feb/2015
P Gomani, A Matubu
N/A Hematological and Biochemical Laboratory Reference Intervals for Zimbabwean Adolescents
Clinical Laboratory Feb/2015
ZM Chirenje, N Mgodi
MTN Factors associated with bone mineral density in healthy African women.
New England Journal of Medicine
Feb/2015
ZM Chirenje, N Mgodi
MTN Bacterial Vaginosis and the Risk of Trichomonas vaginalis Acquisition Among HIV-1 Negative Women
Sexually Transmitted Diseases
Feb/2014
ZM Chirenje, N Mgodi
MTN HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women.
Sexually Transmitted Diseases
May/2014
M Borok, I Gudza
ACTG Relationship of vitamin D insufficiency to AIDS-associated Kaposi's sarcoma outcomes: retrospective analysis of a prospective clinical trial in Zimbabwe.
International Society for Infectious Diseases
May/2014
W Samaneka ACTG Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir or nevirapine.
AIDS May/2014
J G Hakim, W Samaneka
ACTG Psychosocial Predictors of Non-Adherence and Treatment Failure in a Large Scale Multi-National Trial of Antiretroviral Therapy for HIV: Data from the ACTGA5175/PEARLS Trial
PLoS One Aug/2014
SBF Assisted Education
11 Enrolled (4 Diplomas, 5 First Degrees and 2 Masters)
Completed Masters Programmes- 3 (Scientists 1 Non- Scientist 2)
2014 Academic Achievements
Recognition of CTU Owing to the excellent systems in place CTU
has gained a reputation of efficiency and transparency
This has attracted partnerships with I-TECH, Word Bank and ICAP
2014 Achievements
Human ResourcesTotal staff Complement: 302New Engagement: 27Terminations : 17Managed to achieve high staff retention
2014 Achievements
Suellen Miller has been an EC member until retirement in 2014
Thanks to the UCSF team led by Jennifer McElroy for all the assistance rendered.
Thank you Amy who has done the Writer’s Algorithm which was well attended and will be conducting upcoming Grant Writer’s Lecture
UCSF Contribution
All our research participants. University of Zimbabwe Leadership: Big thank you
to Prof Dyanda Dean - CHS Chairpersons of Dpts: Obs&Gynae, Medicine,
Paediatrics, Histopathology Ministry Of Health and Child Care City of Chitungwiza Dept of Health City of Harare Dept of Health Regulatory Bodies: RCZ, MRCZ, MCZA, JREC, NBAZ Our Funders: NIH UCSF Team
Acknowledgements