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Stellenbosch 肆客足球 Faculty of Medicine and Health Sciences (FMHS)

Stellenbosch 肆客足球 (SU) was established 101 years ago and its Faculty of Medicine and Health Sciences (FMHS) is 63 years old. FMHS is situated on SU's Tygerberg Campus, Parow, Cape Town, next to the Tygerberg Academic Hospital. SU has established itself as a leader in clinical training and research in South Africa and Africa, recognized nationally and internationally especially for its work on HIV/AIDS and Tuberculosis (TB). To address Africa's major health challenges, the FMHS has formulated a 7-item strategic research agenda: Infectious Diseases (ID), especially TB; HIV/AIDS and viral genomics; Non-Communicable Diseases, especially diabetes, cancer and cardiovascular disease; Public Health, especially health systems and evidence-based health care; and Genetics. World-class faculty members in many departments, divisions, centres and units are engaged in or developing research programs in these areas. The FMHS research themes are aligned with the strategic plan of the South African National Department of Health to develop a health system capable of producing improved health outcomes through its medium-term strategic framework "A long and healthy life for all South Africans."

Tygerberg Academic Hospital

Tygerberg Academic Hospital, SU's main facility for clinical teaching and research, is a public tertiary healthcare facility with approximately 1,340 active beds, situated in the northern suburbs of Cape Town, South Africa. The hospital was officially opened in 1976 and is the largest hospital in the Western Cape Province and the second largest hospital in South Africa. It includes the 331-bed Tygerberg Children's hospital, a day-surgery unit, and a private patient unit. The hospital admits more than 107,000 inpatients and 492,000 outpatients annually. It has more than 4 400 staff, including over 1 900 nurses, 570 physicians, and 200 health science staff. The hospital provides a full range of general specialist and sub-specialist services and trains a large number of both local and international medical students, residents, fellows, as well as other types of clinical staff.

The Family Centre for Research with Ubuntu (FAMCRU)

FAMCRU is located inside the Tygerberg Academic Hospital complex adjacent to the Family Clinic for HIV.  Its director Prof Shaun Barnabas (MD, PhD), in response to the coinciding HIV and TB pandemics, established the Centre in 2002 as the Children's Infectious Diseases Clinical Research Unit (KID-CRU), to conduct prospective studies and clinical trials focusing on children. 

In 2002 KID-CRU received its initial NIH funding as a trial centre for the Paediatric AIDS Clinical Trials Group, renamed the International Maternal Paediatric Adolescent AIDS Clinical trial (IMPAACT) group in 2007. Also, in 2002 SU in collaboration with the Universities of Cape Town (UCT) and the Witwatersrand (Wits) to develop local clinical trial expertise relevant to resource-constrained settings, participated in the seminal NIAID-funded Comprehensive International Program for Research in AIDS (CIPRA). Through these mechanisms, KID-CRU contributed to studies that have fundamentally changed HIV and TB management in women and children. 

The unit changed its name to the Family Clinical Research Unit (FAMCRU) in 2013 after successful affiliation with the AIDS Clinical Trial Group (ACTG) and the subsequent involvement in adult clinical trials. The name was again changed in March 2019 to the Family Centre for Research with Ubuntu to comply with SU's policy of supporting centres rather than units, but the acronym FAMCRU was retained. ('Ubuntu' in IsiXhosa means 'I am because you are'. It's philosophy is 'the belief in a universal bond of sharing that connects humanity'). Prof Cotton retired in 2022 and was replaced by Prof Shaun Barnabas (MD, PhD) 

The primary FAMCRU site occupies 810m² (8719ft?) on the 8th floor of Tygerberg Academic Hospital. In addition, there are three satellite facilities. Prof Shaun Barnabas has a 27m² (292ft?) office with an iMac with full Microsoft Office software (2016 version), high-speed intra- and internet connections, a Macbook Pro and Macbook Air. 

Approximately 84 full-time research staff work at the primary FAMCRU site. These include: 9 medical officers, 9 counsellors, 8 registered nurses, 8 staff nurses, 6 data captures, 5 drivers, 6 recruiters, 4 pharmacists, 4 neurology testers, 4 project managers, 2 study coordinators, 3 administrative officers, 1 data managers, 1 clinical trial investigator and coordinator, 2 paediatricians (Drs. Sam Fry and Els Dobbels, MD), 2 laboratory technicians, 2 janitorial staff, 1 neurodevelopmental pediatrician (Prof Barbara Laughton MD), 1 educational psychologist (Dr Sharon Kruger PhD), 1 infectious diseases pediatrician (Dr Shaun Barnabas MD, PhD),1 quality assurance manager, 1 financial manager, 1 social worker, 1 general assistant  and three large community advisory boards – one adult and the other adolescent. Prof Barnabas is a member of the ACTG cure committee, has recently completed a mucosal immunology PhD and is site PI on the HVRRICANE (RV543) study that will examine therapeutic vaccines in HIV+ adolescents. 

The FAMCRU's primary site facilities include 11 administration offices, 10 consulting rooms, 8 counselling rooms, 6 filing rooms, 4 medical procedure rooms, 3 neurocognitive testing rooms, 2 data collection rooms, a large research pharmacy, a board room, storeroom, freezer room, social worker's office, staff kitchen and a comfortable waiting room. The large reception area is manned by a receptionist, who controls access and accepts or dispatches deliveries. An air-conditioned waiting room provides a comfortable setting complete with snacks and age-appropriate entertainment. The clinical areas are child-friendly, with age-appropriate toys, games and pictures. FAMCRU has a fleet of 5 vehicles and 5 dedicated drivers, who provide transport for study participants and their caregivers.

Specimen processing unit

There is a dedicated, on-site specimen processing room for coordinating handling, documentation and shipping of samples. Both lab technologists are IATA certified and oversee shipping to other laboratories.

Pharmacy

The FAMCRU Pharmacy, owned by SU, is located within FAMCRU. It is a 50m² (538ft?) unit with controlled access, an after-hours alarm system, protocol-specific shelves and cupboards for drug storage. The pharmacy was registered with the South African Pharmacy Council in 2004 and has been a DAIDS approved Pharmacy since 2007.

Data Management

The data team is in 2 offices over 35m² (377ft?) in size and is equipped with 9 computers. The data team have excellent knowledge of the following data management systems and databases: eData, Medidata Rave, Advantage, CACTUS, Clindex RDE, Inform, OpenClinica, Oracle Clinical and Research Electronic Data Capture (REDCap). 

Case Report Forms (CRFs) are used to record all clinical and laboratory data collected for each participant. A separate study file is maintained for each participant, which contains all forms, lab results and other pertinent study information. All data collection forms are completed and data entered according to the Data Management SOP and according to the FAMCRU QA/QC plan. All forms are reviewed prior to data entry for accuracy, consistency, and completeness by designated study staff. A participant's name and contact information is only recorded in clinical notes and kept separately from CRF files. Participants are not identified by name on any study documents but only by a unique study identification number. All data collection forms are stored in locked file cabinets in a secure area. Access to study records and data files is limited to study personnel, including field staff and independent staff conducting quality control. 

Input of data is secure, and web based. Electronic data capturing software with logical checks and verification capabilities are used to enter data into the study database. REDCap is a secure web application for building and managing online surveys and databases and is one of the software packages that is currently being used at FAMCRU. Its software is available at no cost for REDCap Consortium Partners, such as SU. REDCap is fully personalized to meet the sites security policies and user needs and is compatible with the Reservoir database established in 2014 in OpenClinica. All new databases, including for the current application will be entered into REDCap. The REDCap server is based at the 肆客足球 of Cape Town, who have agreed to host it until SU acquires its own server. The UCT server is backed up weekly. 

Computerized data files are password protected. The QA Manager does quality assurance reviews every 2 months. Reviews occur on the first 20 patients and then 10% of all newly enrolled patients and 10% of previously enrolled patients. 

FAMCRU has secure network storage space that is password protected and only accessible to the necessary members of the team. All information on this network space is backed up by the Stellenbosch IT department weekly. All study databases are also backed up daily by the unit data manager on an external device which is kept in a safe place. 

All local participant tracking databases are stored on the FAMCRU network and are password protected. Only the data team know the passwords. Maintenance on tracking databases is also done once a week by capturing staff. Personnel are responsible for saving their valuable documents on the network drive. Hard-copy files are kept in locked fire-resistant cabinets. All offices that contain research data are locked at the end of each working day and weekends. 

The filing rooms are access controlled. CRFs are stored in stainless steel (fire resistant), shelved, lockable cupboards in locked, access-controlled rooms, as per DAIDS standards. In the event of power failure, the CRS has uninterrupted power supply through access to the Tygerberg Hospital Emergency Generator system.

Neuropsychology developmental team

The team for performing neurodevelopmental and cognitive assessments has three dedicated offices in FAMCRU [23m² (248ft?) in total] and is headed by developmental paediatrician Dr Barbara Laughton (MD). One office is for administrative use and two child-friendly rooms are in a quiet area for assessments. Other team members comprise of Dr Sharon Kruger (PhD Educational Psychologist), Ms Kaylee van Wyhe (PHD candidate neuropsychology), Mrs Thandiwe Hamana (Administrative Assistant), Busi Fanga (Research Assistant) and Filicity Landani (Research Assistant with Psychology honors degree). All are trained and experienced testers in a range of the proposed neurocognitive and behavioral assessments battery and have contributed to the translation of the tests into the local languages isiXhosa and Afrikaans (translated under research licenses from the copyright holders): Pearson for the KABC-II and PPVT-IV, ASEBA for the CBCL, PAR including for the BRIEF. These have been piloted on 6-year-old HIV-negative children. The KABC-II, TOVA and BRIEF are currently being implemented in a new neurodevelopmental sub-study for the IMPAACT P1060 cohort. Dr Laughton is currently PI on an RO1 HD085813 which assesses and compares the outcomes of infants exposed to antiretroviral therapy from pre-conception with those exposed from 12 weeks of gestation. 

Community advisory boards

The FAMCRU team has established strong relationships with the HIV-infected and -affected families they serve, leading to strong support of our work by local communities. FAMCRU's large adult community advisory board, which consists of patients, caregivers, family members and community leaders, assisted by scientific advisors, meets monthly to review new studies and give recommendations about appropriateness of each research question, fair recruitment and culturally acceptable conduct of studies. There is also an active adolescent community advisory board which meets regularly and an adolescent support group which helps the HIV positive adolescents deal with the diagnosis and management of their condition.

?Satellite clinics

FAMCRU has 3 satellite clinics.

• The first was established in 2007 in at the Michael Mapongwana Community Clinic in Harare, Khayelitsha, a densely populated town within the Cape Town metropole. The facility occupies 83m² (893ft?) and has 3 offices and an administration centre for 2 counsellors, 1 medical officer, 1 registered nurse, 1 staff nurse, 1 recruiter and 1 janitor. There are 2 fridges, 1 -20°C (-4°F) freezer, 1 -70°C (-94°F) freezer, 1 computer, 1 printer, 1 telephone and a centrifuge.
• The second, established next to the Kraaifontein Community Clinic in 2013, has 82m² (883ft?) with 2 counsellors. The site has 4 telephones, 2 computers, 1 fridge, 1 -70°C freezer, a printer and a centrifuge.
• Finally, the newest site was established in Worcester in 2018. Worcester is 62 miles from FAMCRU, connected by the N1 highway. This site is staffed by 4 counsellors, 3 registered nurses, 2 medical officers, 1 study coordinator, 2 lab technician, 2 data capturer, 1 staff nurse, 2 driver, I administrative officer and 1 janitor. The site is equipped with 10 computers, 4 telephones, 2 fridges, 1 -80°C freezer, 1 centrifuge, 1 printer and a laminar flow cabinet. Dr  Hennie Geldenhuys is the site head.