SA Medical Research Council

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. The Tongaat CRS has been involved in HIV Prevention clinical trial research since 2004 at the site. The CRS has extensive experience with feasibility studies, Phase III clinical trials focusing on 1st and 2nd generation microbicides, behavioural studies and PrEP trials. The site is well equipped in terms of infrastructure, equipment and highly skilled staff to conduct these trials.

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).

Disease areas

• HIV
• Sexually Transmitted Diseases (STDs)

Other information

Tongaat is a semi urban area north of Durban. The CRS is located immediately adjacent to a local NGO, Tongaat Woman and Child Welfare, and is approximately 30 miles north of Westville. According to the 2011 South African census, the population of Tongaat is 77,000; 49.1% are male and 50.9% female. The self-identified ethnic background of the local population is 84.5% Black African, 13.3% Asian or Indian, 0.8 % mixed-race, and 0.6 % White. The predominant language is isiZulu (68.7%), followed by English (18.4%) and Xhosa (7.6%). Over 26.7% of the local population resides in informal dwellings. In addition, 60% are formally employed and only 78.1% 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.