St. Mary’s Clinical Research Site
St. Mary’s CRS is located on the grounds of the Chitungwiza Primary Care Clinic, in Chitungwiza, a satellite city approximately 30km south of the UZ-CTRC’s administrative offices in Harare. The CRS is easily accessible by foot for those living in the immediate area and by public transport to those further afield., with a combined average of 10,000 patients being treated annually for acute and chronic illnesses, maternity care, family planning, and well-baby services The clinic refers in-and out-patient cases for specialty care in emergency medicine, obstetrics and gynecology, internal medicine, surgery, and pediatrics to the Chitungwiza Central Hospital, located 6km away.
St. Mary’s CRS involvement with NIH-funded research began in 1998, with the recruitment of a cohort of HIV-infected pregnant women to participate in a pilot PMTCT trial in Zimbabwe. Since 2002, over 1,000 participants have been enrolled across four large clinical trials. The CRS has capacity to manage up to 750 participants at a time, across multiple protocols.
The CRS has well developed expertise and infrastructure to conduct high quality research in the following priority areas:
- Strategies to address HIV and HIV-associated infections in pediatric and maternal populations
On-Site Testing and Specimen Preparation
The CRS has excellent support from a DAIDS-certified satellite laboratory that is temperature controlled by an air-conditioner with continuous monitoring by a data logger, and a connection to the back-up power supply when necessary. It is equipped with a double sink, an eye wash station, 9 cubic foot refrigerator, clean and dirty workbenches, shelves, sharps boxes, and fire extinguisher. There is also a centrifuge, incubator, maximum/minimum thermometers, insulated cooler bags, micropipettes, and timers. Biohazardous waste is placed in marked puncture-proof containers for incineration by the municipality. The laboratory performs on-site testing, including HIV rapid tests, wet mount, urine pregnancy tests, and dipstick urinalysis. The laboratory processes and prepares specimens for transfer to the Central Laboratory and participates in external quality control on all tests performed. Specimens from up to 25 participants can be processed each day. Each is staffed by a laboratory scientist. For more information on our centralized testing capacity, please see our Central Laboratory page.
The CRS has an on-site DAIDS and Medicines Control Authority of Zimbabwe (MCAZ) approved pharmacy that is temperature controlled and continuously monitored by a data logger and Sensaphone®. The pharmacy has an incubator as a back-up for relevant study products, which can be adjusted in the range of 2⁰C-40⁰C. It is equipped with a networked computer, label printer, cellular telephone, satellite telephone, filing cabinet, shelves, double sink, refrigerator, storage cupboards for study products and primary care drugs, and a double locking door with dispensing hatch. An off-site study drug storage facility is maintained in the labor ward of the adjacent municipal clinic to house the labor kits of study drugs for ongoing studies. Up to 25 participants can be served each day. St. Mary’s CRS on-site lab performs the following: HIV rapid tests, wet mount, urine pregnancy tests, dipstick urinalysis, urine microscopy, and trichomonas tests. Additional, more complex protocol testing such as chemistry, hematology, serology, and immunology, are conducted at the CTU Central Laboratory, with back-up external labs available as needed. For more information on our centralized pharmacy please see our Central Pharmacy page.
For inquiries related to St. Mary’s CRS and the research it conducts, please contact Site Leader, Tsungai Chipato, MBChB, FRCOG.