Transcript Slide 1

Z Mike Chirenje MD FRCOG
[email protected]
Year 8 into Year 9 (April 2014- April 2015)
Major Changes Are:
New Funding Structure
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Core Directly From NIH through UCSF
Subcontract
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Network PF Directly to each CRS
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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
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)
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 2015
Capacity 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)
Extension
Original space available for research activities
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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.
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Dr Jim Kublin, P5 overview, Oct14
Regional regulators’ forum, Oct14
Regional regulators’ forum, Oct15
HVTN scientific meeting, Oct15
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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
Abstracts PresentedArticles Published -
3
8
Name
Network
Abstract
Presentation
P Ndadziyira
MTN
Poster
The Impact of Participant
Mobility on Missed Visits
Among Women Taking Part in
the VOICE (MTN-003) Study in
Zimbabwe
HIV R4P Conference,
Cape Town October
2014
N Mgodi
MTN
Uptake of HBV Vaccination and Poster
Incident HBV Infection in
Women of Reproductive Age
and at Risk of HIV-1 Infection
in the VOICE (MTN 003) Study
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
Conference
HIV R4P Conference,
Cape Town October
2014
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
ZM Chirenje, N
Mgodi
ZM Chirenje, N
Mgodi
N/A
Hematological and Biochemical Laboratory Reference
Intervals for Zimbabwean Adolescents
Factors associated with bone mineral density in
healthy African women.
Bacterial Vaginosis and the Risk of Trichomonas
vaginalis Acquisition Among HIV-1 Negative Women
Clinical Laboratory
Feb/2015
New England Journal of
Medicine
Sexually
Transmitted Diseases
Feb/2015
ZM Chirenje, N
Mgodi
MTN
Sexually
Transmitted Diseases
May/2014
M Borok, I
Gudza
ACTG
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.
Relationship of vitamin D insufficiency to AIDSassociated Kaposi's sarcoma outcomes: retrospective
analysis of a prospective clinical trial in Zimbabwe.
International Society for
Infectious Diseases
May/2014
W Samaneka
ACTG
MTN
MTN
ACTG
J G Hakim, W
Samaneka
Renal events among women treated with
AIDS
tenofovir/emtricitabine in combination with either
lopinavir or nevirapine.
Psychosocial Predictors of Non-Adherence and
PLoS One
Treatment Failure in a Large Scale Multi-National Trial
of Antiretroviral Therapy for HIV: Data from the
ACTGA5175/PEARLS Trial
Feb/2014
May/2014
Aug/2014
SBF Assisted Education
11 Enrolled
(4 Diplomas, 5 First Degrees and 2 Masters)
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Completed Masters Programmes- 3
(Scientists 1 Non- Scientist 2)
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
Human Resources
Total staff Complement: 302
New Engagement:
27
Terminations :
17
Managed to achieve high staff retention
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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
 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