The Setshaba Research Centre (SRC) was founded in 2004 as a medical research centre with the objective of creating value and contributing to the greater good of society. The centre was developed with a core focus of conducting HIV prevention studies, specifically aimed at reducing the risk of HIV infection for women in particular, who are often a vulnerable population for a number of reasons.
Since its foundation in 2004, the centre has grown extensively and has developed the capacity to conduct large scale biomedical and social scientific research studies. Although our primary focus still remains on HIV prevention in women, we have also conducted other research trials including TB diagnostic studies and other clinical and social studies.
The centre is optimally situated in a residential area in Block H, Soshanguve Township (next to the “Transfer” area), as an independent site. The unit is easily accessible by minivan taxis – the common mode of transport of most South Africans and the local residents.
Since 2008, the SRC has been registered as a section 21 non-governmental organisation and functions as an independent entity.
Soshanguve Research Centre’s vision is to establish a vibrant, sustainable and professional research centre that is relevant and beneficial to the community.
SRC’s mission is to conduct relevant, ethical, cost beneficial research studies in collaboration with academic institutions and according to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Dispensing Practice (GDP) and Good Participatory Practice (GPP).
SRC’s values include:
- Maintain confidentiality of the research study product;
- Maintain confidentiality of the study trial participants;
- To be polite and sensitive to the study trial participants;
- To conduct research in accordance with the study protocol;
- To report accurate and correct results;
- To commit to ongoing staff development;
- To be accountable to sponsors / donors for funds utilised.
The SRC has gained extensive experience in conducting large-scale efficacy and safety studies in HIV Prevention through the Carraguard microbicide trial with the Population Council and the FEM-PrEP clinical trial with FHI 360.
In collaboration with CONRAD, SRC is currently involved in a pivotal study assessing the safety and effectiveness of 1 percent Tenofovir vaginal microbicide gel as an HIV prevention option for women (FACTS 001). In addition to the above HIV prevention studies, the centre also conduct studies with private pharmaceutical companies.
The SRC, with its experienced and dedicated staff, is committed to continue to strive to be a centre of excellence and to conduct clinical trials and actively contribute to the field of research.
The size of the site is 800.62m2 and this includes 196.80m2 of the clinical area, 152.30m2 of the laboratory, 425.20m2 of offices and 26.32m2 of the pharmacy.
SRC facilities include: 12 administrative offices, 12 clinical rooms, 6 counseling rooms, 5 interviewing rooms, 3 receptions, 1 board room, an on-Site lab, a Pharmacy, 3 filing rooms, DM room, Facilities for child care and Ablution facilities.
The SRC has the infrastructure and staff capacity to conduct clinical trials on a medium to large scale basis. The Centre is staffed from Monday to Saturday and as determined by participants’ needs, the center may be staffed on Sundays and / or public holidays.
The infrastructure allows various trials to be conducted in various buildings. The center is stroller and wheelchair accessible. The center has fully equipped clinical rooms and counseling / interviewing rooms which are manned by registered, research nurse-Counsellors, lay-counsellors and Social Science interviewers who are all under supervision of Site investigators. The SRC has a fully equipped pharmacy (including a private counselling room) with three registered pharmacists.
The SRC has grown and developed over the last ten years, both in terms of space and staffing. Currently SRC has a capacity of approximately 62 staff members.
The SRC, under the leadership of Dr Khatija Ahmed (executive director) and Dr Mookho Malahleha (deputy director), is critically poised to execute HIV prevention trials, TB trials and other pharmaceutical trials. For the past ten years, Dr Ahmed and her dedicated team have been working in this research environment and have effectively and efficiently managed large scale Phase three efficacy trials in Microbicides (e.g. Carraguard Trial) and oral Pre-exposure Prophylaxis (PrEP), e.g. FEM PrEP.
Since the centre’s inception in 2004, Dr Ahmed has promoted an interest in both biomedical and social science research in relation to HIV prevention options, in particular identifying different prevention strategies for those most at risk of HIV.
Dr Ahmed has extensive experience in conducting large-scale efficacy and safety studies in the field of HIV prevention. She was the national principal investigator (PI) and site investigator for the safety and effectiveness trial of the potential microbicide “Carraguard” with the Population Council. She also worked in collaboration with FHI 360, in the FEM PrEP clinical trial. She is currently the site PI for the FACTS 001 1 percent Tenofovir microbicide study.
The centre has over the past ten years, developed a great depth of capacity to manage clinical trials. There are nine line managers who report directly to the Deputy Director who in turn is reporting to the executive director. The operations manager assists the executive director and deputy director with coordination of resources, including both financial and human resources. The project administrator / regulatory officer also assists the executive director and deputy director with the administrative and regulatory issues of the site. Each manager is responsible and accountable for the functioning of a section(s) within the site. The site has an organogram that clearly distinguishes roles and responsibilities. Sectional staff are managed by well-trained and experienced supervisors, who in turn are overseen by the various line managers.
The site has a wealth of experience and under Dr Ahmed’s guidance, the SRC has also conducted a trial to assess the reporting of adherence and sexual activity in a simulated microbicide trial using an audio computer assisted self-reporting interviews (ACASI) compared to face-to-face interviews to determine reporting patterns of gel and condom use. Reported behaviors were validated through biomarkers that detect product use and unprotected sex. This study showed that for most behaviour ACASI generated significantly higher reporting with social desirability potentially impacting upon the information obtained in interviewer-based methods of acquiring sensitive sexual and behavioral information. Dr Ahmed also led an interventional, placebo controlled, efficacy trial on a single day high dose treatment of famciclovir for recurrent genital herpes. The trial showed no difference in outcomes between the two arms. She was also involved in PrEP and risk compensation and wound study. Currently, Dr Ahmed is also involved in a HPV vaccine trial, TB diagnostic studies and FACTS-001 study.
The Setshaba Research Centre recognises community engagement as an important and integral part of all clinical trials, from the period before trial inception until the data is available and disseminated to the lay public. Engaging all relevant stakeholders as active and informed partners in decision-making about the proposed research and its implementation enhances both the scientific validity and ethical integrity of clinical trials.
The SRC has implemented a community engagement plan which comprises of ongoing and planned activities involving different stakeholders in the community. The SRC uses the Good Participatory Practice (GPP) guidelines for the Community Liaison Officers (CLO) and recruiting officers to educate and recruit the community. In addition, all staff are GPP trained and can assist with information on SRC and studies in the community. The goal of all community activities is to increase research literacy and to get community involvement, engagement and support in all relevant fields of research. To meet the objectives of the overall planned trial and the specific aims of this site while achieving effective community engagement, the following activities are ongoing:
Community Advisory Board (CAB):
The SRC has a functional, active CAB that represents the various sectors of the population within our catchment areas. CAB members are volunteers who serve in an advisory capacity to the SRC and provide input on important aspects of the trials conducted. CAB also serves to educate the community on research and the SRC’s position within the area.CAB members are trained in research literacy, ethics in research, basic aspects of HIV transmission, prevention, treatment and management, and on specific protocols.
Community Education (CE):
Successful CE efforts make recruitment easier and provide the community with knowledge and thus gain their acceptance of the trials. The SRC has worked to raise awareness of and to build support for research within the community at large before the more specific recruitment-focused education can be effective. Before trial inception, during the trial, and also after the trial results are released, the CLO provides education to the various organizations, stakeholders and general population on an on-going basis.
Mapping of the clinics:
SRC previously has used the mechanism of mapping catchment areas and this proved to be a success in different trials. The importance of mapping activities is to get the buy in of the community and to find out more about the recruitment areas and strategies to be used during the trial. Mapping activities were performed extensively across all recruitment sites both during and after working hours. Clinics in the catchment area will be mapped to get numbers of women who deliver, perform termination of pregnancy and who come for contraception.
Retention of Participants:
SRC has systems in place to prevent loss to follow up, with dedicated Retention Officers (ROs) to ensure that retention efforts are maximised and are documented. ROs provide ongoing retention messages in the participants’ waiting areas; reminder calls and missed visit calls are prioritised; and a bulk SMS system has been implemented to remind participants in advance of their scheduled visits. This has also been used as a source of forwarding complimentary messages, for example: thanking participants for attending a scheduled visit, or congratulating participants on good attendance for their scheduled visits over a certain period. ROs make additional efforts with home visits during weekdays and over weekends if need be.
The retention team at SRC has ensured that they improve retention of FACTS001 participants from 77 percent to 87 percent within a month and concerted efforts are ongoing to improve on this further. Participants who are dedicated to their scheduled visits are requested to motivate other participants to honor appointments. Peer motivation is done through sharing the benefits and experiences of being in the trial. The SRC also provides the participants with a platform to express their suggestions, comments, dissatisfaction, and appreciation in writing using an appropriately placed suggestion box. The suggestion box has been the source of many improvement plans implemented at SRC to optimise the quality of their work.
The SRC’s on-site laboratory is a wing of Global Clinical Viral Laboratory (GCVL) and is fully South African National Accreditation System (SANAS) accredited. The laboratory is capable of conducting all rapid diagnostics tests such as pregnancy tests, HIV tests, Hepatitis B surface antigen (HBsAg) tests; as well as safety chemistry and haematological tests with a rapid turnaround time. All additional tests are sent to GCVL and results are obtained in real time.
SRC laboratory is able to store samples at -200 C and -70 0C. The fridges and freezers at the site laboratory are monitored by a Continuous Temperature Monitoring System (CTM) that alerts both the laboratory and site managers when deviations in temperature occur. The backup generator ensures temperature maintenance during an interruption in the electrical power supply. In the event of total power failure, SRC has an arrangement with the Medunsa Clinical Research Unit (MeCRU) and University of Pretoria both within 30km from SRC, to store laboratory specimens and pharmacy products.
The laboratory is also equipped with centrifuges, including a -90 C to 400 C centrifuge, microscopes and a 370 C incubator. Further to this the SRC has used other laboratories as recommended by the sponsor. They have worked with the Bio-Analytical Research Corporation (BARC), and also with Contract Laboratory Services.
Setshaba Pharmacy is located within Setshaba Research Centre’s main building at ground level. The pharmacy’s main entrance is eight meters from the participants’ waiting area and opposite the motivational interviewers’ rooms. The pharmacy has a separate entrance for the participants leading into the participants’ counselling room. The pharmacy is operational Monday to Saturday between 8h00 and 17h00. Pharmacists work beyond the times when and as the need arise to accommodate all participants. The pharmacy has relevant equipment available that is functional. The pharmacy equipment is calibrated annually and when necessary.
Compliance and Regulatory Requirements:
Research done at SRC is subject to review by an Ethics Research Committee and the site uses the University of the Witwatersrand Human Research Ethics Committee. The University of the Witwatersrand holds a Federal Wide Assurance from the Office of Human Research Protection (OHRP): FWA00000715 and the IRB is registered with OHRP: IRB00001223. The site also uses Pharma-Ethics or any Ethics committee that the sponsor chooses. All these Ethics committees hold FWA from OHRP.
Regulatory requirements for protocols involving investigational drugs or devices will also be mandated by South African Medicines Control Council (SA MCC). As mandated by the South African Department of Health protocols will also be reviewed and approved by the National Health Research Ethics Council (NHREC). The site operates in accordance with the International Conference on Harmonisation (ICH), GCP and Office of Human Research Protection Guidelines (OHRP).
All Clinical trial personnel are certified on the protection of human research participants and GCP guidelines. The study coordinators maintain site regulatory files and ensures that all team members have valid certification.
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