SA Medical Research Council Isipingo Clinical Research Site

Experience

The MRC HIV Prevention Research Unit, led by Prof Gita Ramjee, is an internationally recognized NIH Clinical Trials Unit (CTU) for the impeccable conduct of HIV prevention and treatment clinical trials ranging from Phase I through to Phase III licensure trials. Six satellite Clinical research sites (CRSs) currently contribute to the research objectives of the Unit. Together with Professor Ramjee, the CRSs are supported by three principal investigators viz. Dr Vaneshree Govender, Ms. Jothi Moodley and Ms. Arendevi Pather are individual site investigators. Over 10 studies have been conducted at the CRS since its establishment in 2004. These include Phase IIB and Phase III microbicides and PrEP trials, observational studies and behavioural research.

Research interests

National Institutes of Health (NIH), Division of AIDS (DAIDS - NIH), South African National, Provincial and Local Department of Health, South African Department of Science and Technology, Microbicides Trials Network (MTN), HIV Vaccine Trials Network.

Disease areas

• HIV
• Maternal Health
• Newborn Health
• Sexually Transmitted Diseases (STDs)

Other information

Isipingo is an urban area south of Durban with access to semi urban and rural populations in a 38 mile radius. The CRS is a tenant in a local commercial building and is approximately 19 miles south of Westville. According to the 2011 South African census, the population of Isipingo is over 400,000; 57% are male and 43% female; 69% are 15- 49 years old. The self-identified ethnic background of the local population is 92.1% Black African, 7% Asian or Indian, 0.7 % mixed-race, and 0.1 % White. The predominant language is isiZulu (83.4%), followed by English (8.6%) and Xhosa (4.5%). Over 40% of the local population resides in informal dwellings. In addition, 30.5% are formally employed and only 25.7 % have secondary education. The CRS management includes the CRS Leader (CRSL) and the Study Coordinator (SC). They work closely with the CTU PI, CTU Coordinator, Network Coordinators, and PI/IoRs (CTU Management); they take overall responsibility for oversight and implementation of all studies at their CRS, ensuring that staff is well trained, and that data quality and integrity is maintained. Several management systems are in place to ensure that all trials are completed within protocol-specified timelines, on budget, and with excellent data quality. Research Clinicians, Pharmacists, Medical Technologists, laboratory QA/QC Research Assistants, the Community Team, and QA/QC Officers) are co-managed by their Division Managers. Training and mentoring is routinely provided to all staff. The CRS has an established Memorandum of Understanding with local hospitals and clinics to facilitate care and referral of research participants.