Introduction & summary
Right to Care Research Esizayo is a subsidiary of the Right to Care (RTC) Group. RTC is a Johannesburg-based South African organisation set up in 2001 as a non-profit organisation. The 14-member RTC board, chaired by Dr Ali Bacher, includes five executive directors led by RTC’s chief executive – Professor Ian Sanne – a prominent researcher, clinician, and infectious diseases specialist. Over the past 20 years, RTC has demonstrated its commitment to supporting and improving the quality of health services and care for patients with HIV, TB, and HIV-related illnesses in South Africa and on the African continent.
RTC provided direct service delivery (DSD) to Sierra Leone in 2015 in the management of the Ebola epidemic. Similarly, we supported Zambia in the control of the Cholera outbreak in 2017. Since early 2020, RTC has supported the South African government with its COVID-19 response.
To date, RTC has tested over 10 million people for HIV, circumcised over 1,2 million men as a measure to minimise HIV transmission and started over 800 000 people living with HIV on antiretroviral treatment. The organisation has also introduced several innovations within the health sector such as ATM pharmacies and Collect & Go smart lockers which enable quick, safe, and convenient access to chronic medication for patients.
Over the past three years, RTC has developed a Primary Health Care (PHC) programme which included the opening of a clinic in Cosmo City in Region C of the City of Johannesburg. The initiative is in direct response to the National Department of Health’s intention to roll out national health insurance (NHI) in South Africa. Right Clinic Esizayo is situated on a site comprising two adjacent properties approximately 700m from Cosmo City Mall and between Lascaris Road, Tennessee Avenue and Malibongwe Drive. Right to Care Research Esizayo is on the same premises
Right Clinic Esizayo provides Primary Healthcare (PHC) services to the community living in and around Cosmo City, situated in the northwest of Johannesburg. In 2020, the site’s capacity was expanded to include the launch of a clinical research site (CRS), Right to Care Research Esizayo. The site initially supported the Wits Health Consortium’s Clinical HIV Research Unit (CHRU) with recruiting and enrolling participants for a major COVID-19 vaccine trial but has subsequently progressed to conducting clinical trials independent of CHRU. The clinic and the research unit have the necessary research and healthcare personnel and infrastructure to conduct high quality, ethical, relevant, and GCP-standard compliant clinical trials; in addition to developing and training new research study staff members.
The CRS has a participant handling facility situated within about 150 metres of the clinic and its administration buildings. The site uses the Medical Research Council’s biometric co-enrolment prevention system which is administered in accordance with the ethics guidelines. Both the clinic and screening and enrolment buildings have a combined capacity to handle 20-30 participants at a time with sufficient seating for waiting, COVID-19 screening and group consenting. The site has access to the PHC facility. It has a pharmacy with an extensive research infrastructure and a fireproof archive room. The pharmacy is equipped with an Omniflex temperature monitoring system to detect excursions from ideal temperature remotely.
Key Personnel
About the site
Right to Care Research Esizayo (the research unit) is situated within the vibrant community of Cosmo City next to Kya Sands, Randburg. Cosmo City is a relatively new multiclass township with a population of about 70,000 people (2011 Census estimate). The population is comprised of approximately 97% black Africans. It is 23km from the Johannesburg city centre and 40km from Pretoria. The site is situated at the corner of Malibongwe Drive and Tennessee Avenue and is easily accessible from the N14 and N1 South Freeways. Right to Care Research Esizayo (the research unit) is situated within the same grounds as the Right Clinic Esizayo (the clinic) which offers primary healthcare services. The clinic also serves as the site resource for any required procedures that must be done in a formal healthcare setting.
Right to Care Research Esizayo (the research unit) is situated within the vibrant community of Cosmo City next to Kya Sands, Randburg. Cosmo City is a relatively new multiclass township with a population of about 70,000 people (2011 Census estimate). The population is comprised of approximately 97% black Africans. It is 23km from the Johannesburg city centre and 40km from Pretoria. The site is situated at the corner of Malibongwe Drive and Tennessee Avenue and is easily accessible from the N14 and N1 South Freeways. Right to Care Research Esizayo (the research unit) is situated within the same grounds as the Right Clinic Esizayo (the clinic) which offers primary healthcare services. The clinic also serves as the site resource for any required procedures that must be done in a formal healthcare setting.
Participants taking part in the research unit’s clinical trials are recruited from the adjoining areas of Cosmo City, Zandspruit, Diepsloot, Kya Sands and the surrounding City of Johannesburg Region C metropolitan areas. Our Community Engagement teams have successful community relationships that enable reach within Region C and beyond. The Community teams have established relationships within the community as most members of the team also reside within these areas. This is a big plus for the site during outreach programs, when looking to recruit participants. Other key links to the community include our Community Liaison Officer and an established Community Advisory Board.
Clinic and trial facilities
The research unit has a participant handling facility situated within 150 metres of the clinic and 20 metres from administration buildings. This facility has been in operation since October 2020 for a COVID-19 vaccine study for screening and enrolment, which is subsequently continuing with retention activities. The facility is now a site for a COVID-19 treatment trial. The facility uses the Medical Research Council’s Biometric Co-Enrolment Prevention System, which is administered in accordance with ethics guidelines. This is a national, digital, fingerprint-based participant identification method to prevent co-enrolment at multiple clinical trial sites and studies.
Both the clinic and screening and enrolment buildings have a combined capacity to handle 20 to 30 participants at a time with seating space for waiting, COVID-19 screening and group consenting areas. The reception areas also provide facilities for participant’s registration, re-imbursements, and bookings.
The pharmacy
Facilities include
The site also has space for specialised procedures as per protocol requirements, including ECG monitoring facilities and a room with capacity for sample processing and shipping.
All relevant site Standard Operating Procedures (SOPs) are available and in place e.g., handling of medical emergencies, informed consent, Investigational Medicinal Product handling and accountability, participant re-imbursement, adverse event handling and reporting, the clinical quality management plan, filing and archiving of study documents, staff training, participant recruitment and retention, etc.
Emergency facilities
The clinic has a dedicated well-equipped emergency room with an emergency trolley. The second emergency trolley is housed in the participant handling facility. The two trolleys are checked by research nurses every week to replenish any medications and consumables that are approaching expiration date. The unit’s two emergency trolleys are stocked as per SAHPRA guidelines. There is also a defibrillator, first aid kits and fire extinguishers in each of the two buildings, as well as easily accessible fire exits.
An evacuation plan has been developed in case of emergencies and evacuation drills are conducted regularly. The unit is compliant with all health and safety regulations. In case of emergencies that the site cannot handle, the site falls under the Johannesburg North emergency medical services so transports patients to Helen Joseph Hospital for further advanced care. There are also other private hospitals such as Netcare Olivedale, Life Wilgeheuwel, Sunninghill Hospital and Life Fourways facilities, if needed.
COVID-19 screening is performed at the first point of participant entry with the necessary triage policies. All staff are screened daily and use PPE appropriately. The unit has full comprehensive screening, referral, and testing; safe return to work SOPs; and COVID-19 workplace readiness plans are in place for all staff.