Clinical Trials

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

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Prof Ian Matthias Sanne

Principal Investigator
Tel: 27 10 493 6950

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Dr Karla Mellet

Principal Investigator
Tel: 27 10 493 6950

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Dr Pauline JB Howell

Sub-Investigator
Tel: 27 10 493 6950

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Wendy Ovens

MD Right to Care Health Services

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Prof. Pedro Pisa

Chief Strategic Information Officer and Principal Investigator

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Prof. Charles Chasela

Chief Scientific Officer and Principal Investigator

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Rebecca Kane-Berman

Programme/Project Manager

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Kedishi P Ngoepe

Study Coordinator/Program Manager
Tel: 27 10 493 6950

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Mpato Mokobori

Pharmacist of Record
Tel: 27 10 493 6950

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

Extensive research infrastructure with fridges

A minus 20-degree Celsius freezer

A biological safety cabinet

A web based real-time temperature monitoring system (CTMD) with an alert system for power outages and temperature excursions (Omniflex)

Electronic dispensing and drug accountability system

Panic button system linked to armed response

Ample storage space for other medications and study supplies

UPS system connected to a generator

Digital min-max thermometers

Security cameras

Electronic access control

Facilities include

A fireproof archive room with 3 lockable mobile steel shelves

6 offices and 16 workstations to accommodate management and staff in the administration, regulatory, data and finance departments

Access to the primary healthcare facility and emergency resuscitation room

Group counselling stations as well as 4 individual consenting stations

5 consulting rooms for research nurses and doctors wherein phlebotomy, vital signs, basic procedures (e.g. nasopharyngeal swabs) and physical examinations are conducted

Individual counselling is also performed in the consultation rooms if necessary

1 room for laboratory preparations for sample shipping

1 vaccination room and 1 post vaccination room/post observation room

A minus 20-degree Celsius freezer

A centrifuge

Security cameras

A generator and UPS connected to all buildings to provide uninterrupted power supply during electricity outages

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.

Volunteer-base from which trial participants are recruited

Recruitment activities in the surrounding areas are led by the community engagement team which, over the years, has built established community networks. These links were originally formed during the time when the team were involved in health systems prevention programmes including, for example, voluntary medical male circumcision (VMMC), HIV testing and community ART services and COVID-19 door-to-door screening programmes. These programmes were conducted in partnership with the Department of Health (DOH). The team uses the established networks to educate communities about current clinical trials and interested individuals are then invited to the site for further education and possible participation. The team works with community leaders, churches, business forums and other community structures to reach the intended populations via meetings, social functions, events, community outreach activities and visiting popular gathering places which include malls, community multipurpose centres and schools.
In addition, through patient consent, the research unit has access to the clinic’s database enabling it to conduct research in various therapeutic areas. The site also uses popular media which includes local radio stations, publications, and social media to reach potential participants.
As per GCP/ICH guidelines, all of the above methods of participant recruitment are first approved by IRB/IEC (Wits HREC/Pharma Ethics) before being implemented and are all POPIA compliant.

Details of capacity building

It is RTC’s policy to ensure transformation takes place effectively by providing an environment that is attractive and welcoming to designated persons, while maintaining the high morale, productivity, and confidence of all employees. RTC seeks to promote equal opportunities in the workplace and prohibit unfair discrimination through all RTC policies and procedures. Where necessary capacity building is employed, and appropriate steps are taken to retain and develop persons from designated groups, subject to available resources.
Capacity building includes various forms of learning, such as ongoing coaching and mentoring, job-related training, and attendance of conferences, conventions, and workshops that may take place at various sites, academic institutions or online. Line managers are responsible for facilitating and actively supporting the transfer of skills in the workplace, as well as identifying the skills development needs of employees. Such needs are identified with employees during performance reviews, through a skills audit and/or through training needs analyses.
The research unit and clinic provide ongoing training and support to all staff to increase clinical trial work capacity locally and nationally.
All staff members have received training in ICH-GCP and Human Subject’s Protection (through an online course provided by US National Institute of Health).
RTC endeavours to employ local community members and boasts a diverse staffing compliment.

Right to Care Research Esizayo

Cnr. Malibongwe Drive and Tennessee Avenue,
Kya Sands, Randburg, 2087, South Africa
Telephone: +27 63 097 7207 / +27 10 493 7887 or
Fetsi: +27 81 818 9023

Email: ian.sanne@righttocare.org
Email: fetsi.ngoepe@righttocare.org
Web address: www.righttocare.org / www.esizayoclinic.com

Community outreach and participant recruitment

Previously, RTC has been involved in various initiatives to promote health in disadvantaged communities. This has been replicated in how the research unit conducts clinical trials within the surrounding communities. We are directly accessing populations who have previously not been approached to participate in clinical trials. This has directly empowered these communities to be involved in their health and the health of future generations.

The site has an active community advisory board (CAB) consisting of stakeholders from the local community. The CAB members are from previously disadvantaged backgrounds. Members of the CAB receive ongoing training on issues relevant to the research being conducted. Regular meetings are held with the CAB members to share experiences and offer site support.

The site has active links with national and international collaborators as well as local community leaders and public health authorities, forming a strong basis for rapid knowledge dissemination and implementation.

    Treating health seriously, caring, making treatment available in South Africa and abroad.

    Contact Us

    Email : info@righttocare.org
    Phone : +27 (0) 11 276-8850

    For official information on the COVID-19 situation, click here:

    COVID-19 Corona Virus South African Resource Portal