KwaZulu-Natal Clinical Trials Unit

Summary – KZN-CTU
The KwaZulu-Natal Clinical Trials Unit (KZN-CTU), strategically located in the epicentre of one of the
world’s most severe HIV and tuberculosis epidemics, seamlessly combines the Clinical Research Sites (CRSs)
of existing, high-performing CTUs at CAPRISA and the South African Medical Research Council (SAMRC). In
the current funding cycle, the combined CTUs enrolled 4,713 participants in 28 protocols, with an overall
retention rate of 93%. Further, several KZN-CTU scientists participated at the highest levels in the Clinical Trial
Networks (CTNs), making influential new scientific contributions, including as network Protocol Chairs, that
have impacted global policy/practice, including tenofovir-containing PrEP for HIV prevention, co-treatment
strategies to reduce HIV-tuberculosis deaths and nevirapine prophylaxis to reduce breastfeeding transmission.
This renewal application’s goal is to make even greater contributions to the scientific priorities of all 4
CTNs through novel research concepts, innovative prevention technologies (eg. CAPRISA 256 antibody) and
high-quality clinical trials in high priority populations by experienced research teams at well-equipped CRSs.
The KZN-CTU, led by Quarraisha Abdool Karim of CAPRISA, comprises 4 components: i) Leadership and
governance, ii) Coordination and monitoring, and iii) 8 CRSs, supported by iv) 8 research support cores.
The Leadership and governance component will ensure effective CTU decision-making and governance,
active engagement with each CTN and oversee the efficient functioning of the CTU. The Coordination and
monitoring component is responsible for coordination of clinical trial implementation at high quality. The 8
CRSs, with HIV incidence rates ranging from 4.6 to 8.2 per 100 person-years in recent trials, are in the highest
burden districts of South Africa with diverse populations suited to HIV prevention, vaccine and treatment trials
as well as trials in children, adolescents and pregnant women. The Support Cores work with all the CRSs
providing assistance in the conduct of clinical trials, with administration and financial resource management,
communication, evaluation, training and quality assurance, community engagement, pharmacy, laboratory,
data management and IT, and regulatory compliance. The CTU’s organizational structures (Leadership Group,
Executive Committee and Community Advisory Boards) and communication tools (regular meetings, video
conferences, monthly newsletters and an informative website) enable effective communication, coordination
and governance in the unit. The KZN-CTU has groundswell support from KwaZulu-Natal community groups
and high-level political backing of the National and Provincial Departments of Health.
Overall, the KZN-CTU has well-characterized high-risk populations, well-established clinical facilities,
accredited laboratories, pharmacies, and data management systems, strong community linkages, and
extensive experience in conducting clinical trials, together with a track record of scientific innovation available
to support all 4 CTNs in developing new approaches to HIV and tuberculosis prevention and treatment.

Grant Number: 5UM1AI069469-19
NIH Institute/Center: NIH
Principal Investigator: QUARRAISHA ABDOOL KARIM