SA Medical Research Council Chatsworth Clinical Research Site

Experience

The MRC HIV Prevention Research Unit, led by Prof Gita Ramjee, is an internationally recognized NIH Clinical Trials Unit (CTU) with a track record 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 Chatsworth 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.The Chatsworth CRS is complimented by a highly skilled interdisciplinary clinical research team. The staff categories include clinical staff, a pharmacist, counselors, research administrative staff, a QA / QC team as well as community staff. The site is spacious, well equipped and efficiently set up for optimal study conduct. This dynamic mix of staff and well defined infrastructure has resulted in the conduct of trials exhibiting high retention, impeccable participant safety and high quality data. The Chatsworth CRS has participated in clinical trials that tested first and second generation microbicides, and has recently participated in trials testing ARV-based products that test pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in women. Over the past decade and within the context of conducting clinical trials, the site has served the community by offering free voluntary counseling and testing for HIV, diagnosis and treatment of STIs and other infections, and provision of referral to various health care providers for follow up and care of HIV infection. In doing so, thousands of women have benefited from these services, and the education provided has strengthened awareness in the community about HIV/AIDS and other issues. The site continues to conduct clinical trials for HIV prevention, and is committed to excellence in research and strengthening our relationship with the surrounding community.

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

Chatsworth is an urban area approximately 17 miles south of Durban. The CRS is located on the property of the RK Khan Hospital. According to the 2011 South African census, the population of Chatsworth is 750,000; 48.5% are male and 51.5% female; 46.2% are 15- 39 years old. The self-identified ethnic background of the local population is 52.7% Black African, 46% Asian or Indian, 4.9 % White and 2.8 % mixed-race. The predominant language is English (53.8%), followed by isiZulu (36%), and Xhosa (2.7%). There are over 20 informal settlements. In addition, 55.2% are formally employed and only 29.6% 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.