SA Medical Research Council Botha’s Hill Clinical Research Site

Experience

The South African Medical Research Council (MRC) HIV Prevention Research Unit, led by Prof Gita Ramjee, is an internationally recognized NIH Clinical Trial 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. The Botha’s Hill CRS within HPRU was established in 2003 and has conducted 4 trials and studies. 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 site's success in conducting large scale trials can be attributed to our strong partnership with various communities, sustained through regular dialogue and updates on research activities. The site was established in 2003 for the MIRA study. VOICE phase 2B trial, MTN001 and MTN009 study were also completed at the site. SPARTAC treatment trial also implemented at the Botha's Hill CRS. The CRS is currently completing MTN020, MTN015 and MTN016 studies.

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

Other information

Botha's Hill is a semi-rural area approximately 19 miles west of Durban, located in close proximity to an urban area. The CRS is located on the grounds of an NGO, Valley Trust. According to the 2011 South African census, the population of Botha's Hill is 27,782; 48.9% are male and 51% female; 52% are 15- 44 years old. The self-identified ethnic background of the local population is 87.8% Black African, 9.6 % White, 1.9% Asian or Indian, and 0.4 % mixed-race. The predominant language is isiZulu (77.9%), followed by English (13.7%) and Xhosa (3.5%). Over 27% of the local population resides in informal dwellings. In addition, 25.2 % are formally employed and only 18.6 % have secondary education.The CRS management includes the CRS Leader (CRSL) and the Study Coordinator (SC). They work closely with Unit Management; they take overall responsibility for oversight and implementation of all studies at their CRS, ensuring that staff 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.