Seke South Clinical Research
Seke South CRS is located in Chitungwiza, a satellite city that is the second largest in Zimbabwe. The city is approximately 30km south of UZ-CTRC’s core administrative offices in Harare. The CRS is situated within the grounds of Seke South Municipal Primary Care Clinic, approximately 3km away from Chitungwiza Central Hospital. Strategically located, the CRS is easily accessible to diverse populations living in the immediate suburb and surrounding peri-urban areas boosting the site’s ability to recruit key populations. The municipal clinic is itself one of the largest primary care clinics in Chitungwiza, providing treatment of acute and chronic illnesses, including HIV, sexually transmitted infections (STI), and TB, in addition to family planning, maternity care, and well-baby services to an average of 262 adults and 88 children each day.
The CRS has a reception and waiting area with seating capacity for 35 participants. There are 8 examination rooms, 2 procedure rooms equipped with resuscitation areas, 3 counselling rooms, 2 Interviewer’s room, 2 meetings/training rooms, 1 data management room, an onsite Laboratory, and a DAIDS-certified Pharmacy with an ISO 7 cleanroom.
Seke South CRS has capacity to screen, enroll, and retain up to 450 participants per year across multiple protocols. The CRS has a demonstrated capacity to sensitize, recruit, follow-up, and retain study participants in HIV prevention trials, as evidenced by a 95% retention rate since 2006.
The CRS has well developed expertise and infrastructure to conduct high quality research in the following priority areas:
- Female-controlled HIV/STI prevention strategies, including microbicides and cervical barriers
- HIV preventative Vaccines and monoclonal antibodies
- Integrated strategies to prevent HIV infection
- Vaccines for COVID-19
Facilities and Equipment.
Seke South CRS has developed sophisticated infrastructure to accommodate the increasingly complex HIV prevention biomedical and vaccine clinical trials.
The CRS Laboratory is a Biosafety Level (BSL) 1 Laboratory, that is accredited by DAIDS and is registered under, Health Professions Authority (HPA) of Zimbabwe. It is comprised of a testing section and an office for records keeping and is equipped to process biological specimens including blood, urine, mucosal samples (such as soft cups, vaginal swabs, rectal swabs and nasal swabs/ wash) requiring temperature control, from Phase I-III trials. The laboratory is temperature-controlled by an air-conditioner with a continuous 24-hour monitoring system by a Sensaphone to detect any anomalous temperature excursions, and a connection to the backup power supply when necessary. It is equipped with a double sink, an eyewash station, safety shower, two upright refrigerators (one for reagents and controls, and the other for temporary sample storage and ice packs), clean and dirty workbenches, shelves, sharps boxes, and a carbon dioxide fire extinguisher. There is also a light microscope, centrifuge, maximum/minimum thermometers, insulated cooler bags, micropipettes, timers, two Clinitek machines and two 4 Module GeneXpert analysers. The laboratory performs on-site testing, including HIV rapid tests, wet mount microscopic examination, urine pregnancy tests, OSOM® Trichomonas Rapid Test, Chlamydia trachomatis & Neisseria gonorrhoeae (CT/NG) simplified PCR screening test and dipstick . The site is an accredited COVID-19 sample collection and testing centre. The laboratory processes and prepares specimens for transfer to the Central Laboratory, and participates in College of American Pathologist (CAP) external quality assurance/ control assessment on all tests performed. The on-site laboratory is manned by a trained and qualified Medical Laboratory Scientist under the supervision of a Site Laboratories Supervisor. 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 with the capacity to prepare recombinant vaccines, monoclonal antibodies, and nanoparticle suspensions using aseptic technique. One section of the pharmacy is designated for office work and the other room for Investigational Product (IP) storage and preparation. The IP Preparation Room houses 2 biosafety cabinets (BSC), Classes IIb and III designed to handle study product preparations with a high biohazard protection to investigational products, personnel and the environment. The Preparation Room is temperature and humidity-controlled using industrial-grade air conditioners, coupled with temperature monitoring through data loggers and remote temperature monitoring through a Sensaphone®. Airflow is controlled and filtered by a HEPA filter air supply unit. In addition to this and the local requirements prescribed by MCAZ for a dispensing pharmacy, the pharmacy is further equipped with scientific grade refrigerators and freezers, a cellular telephone, satellite telephone, a dispensing hatch and a double locking door inclusive of an access control unit. Up to 40 participants can be served each day. The pharmacy is staffed by a Pharmacist of Record (PoR), Associate Pharmacist and a back-up pharmacist when there is need. For more information on our centralized pharmacy please see our Central Pharmacy page.
Additionally, the clinic has an autoclaving room and a dedicated infusion room with 2 infusion pumps. This increased capacity and infrastructure positions the CRS to continue participation in HIV vaccine and other biomedical prevention studies. The CRS data room has reliable Internet access ensuring timely data transmission, via data-fax and electronically (using Medidata Rave). The data room has efficient high-volume Zippel filing cabinets with storage capacity of 1200 files. The CRS also has a 100 KVA generator and a renewable solar energy system to provide backup electricity ensuring equipment and clinical operations are uninterrupted.
For inquiries related to Seke South CRS and the research it conducts, please contact Site Leader, Portia Hunidzarira, MBChB, MPH.