UZ –UCSF Collaborative ResearchProgramme

Annual Research Day 2015Z Mike Chirenje MD FRCOG

chirenje@uz-ucsf.co.zw

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