HARP Project

Role

WITS-WRHI has an impressive track record in the conduct of international clinical trials of HIV/STI prevention interventions. WITS-WRHI has its own clinical research teams and access to dedicated facilities and runs the largest PEPFAR funded HIV treatment centre in South Africa. WITS-WRHI is one of the study sites and will be responsible for organising patient recruitment at HIV clinics and VCT centres, follow-up, and management (including management of cervical disease); collecting, processing, and shipment of specimens to the NHLS laboratory for further testing. In addition, WRHI will coordinate shipping of samples to UM-1 for HPV testing and QC.

WHC has extensive experience in managing grants on behalf of the university’s research units. In order to effectively manage the volume of these complex projects, WHC has created a Shared Service Centre which provides amongst others human resources and payroll, financial, administrative and contract support services to the Wits research units. WHC will, in accordance with the rules for participation by a foundation/spin-off company established by a beneficiary, act as the project administrator on behalf of WITS-WRHI and will be responsible for the financial and administrative tasks.

NHLS-Centre for HIV & STIs provides access to world class laboratories for STI and HIV molecular and other testing. NHLS provides a complete range of laboratory and support services, including laboratory set up, GCLP training and lab accreditation with full documentation development, project start-up and ongoing project support (testing, storage and shipping of samples) and performance monitoring. NHLS has published widely over several decades in international peer-reviewed journals. NHLS will coordinate STI/HIV testing (plasma HIV-1 RNA, CD4 count, and STI tests), cytology and histology evaluations (cytology reading, histology for HSIL cases) taking place within the NHLS network of laboratories. NHLS will also take responsibility for laboratory QC procedures.

Key personnel

Dr Sinead Delany-Moretlwe MD PhD, Site PI & Co-Investigator: oversees the overall coordination of the study site; organise the clinical activities; coordinate with the laboratory, data management and a team of clinicians; and contributes to study design, SOP review and other scientific inputs. She is also the WP leader for WP2 and WP6.

Prof Helen Rees MD OBE, Co-Investigator and Executive Director (WITS-WRHI): will provide advice to the overall coordination of the study site and contribute to study design, and other scientific inputs.

Dr Admire Chikandiwa, Local Project Manager: oversees the daily operations, including performing SOP & CRFs design and basic administrative functions of the study.

Linh Diep, Data Manager: responsible for the data gathered and ensure the completeness, accuracy and consistency of the data for the study site.

Senior Clinician: Performing specialised medical procedures (colposcopy) pertaining to HARP, results interpretation and positive result management.

Ms Daphne van der Wind, Site Project Administrator: she is the WRHI Grant Manager, who will oversee the finance and administration of the study, with the support of the Project Administrator.