? 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.
In the global HIV epidemic, Africa accounts for about 70% of the 38 million people living with HIV (PLHIV) and the 1.7 million new infections. In South Africa, which has a fifth of all the PLHIV in the world, the province of KwaZulu-Natal bears a disproportionate burden, with 2 million PLHIV. In this province, community-based adult HIV prevalence exceeds 30% and incidence rates exceed 4 per 100 person-years. KwaZulu-Natal also has a substantial tuberculosis burden, with 50,822 new cases of tuberculosis (incidence of 494 per 100,000) in 2018, of which about 60% are co-infected with HIV. The KwaZulu-Natal Clinical Trials Unit?s overall goal is to contribute to the scientific priorities of the four Clinical Trial Networks through novel research concepts, innovative prevention technologies and high-quality clinical trials in target populations by highly experienced research teams at well-equipped Clinical Research Sites.
|Bekker, Linda-Gail; Moodie, Zoe; Grunenberg, Nicole et al. (2018) Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV 5:e366-e378|
|Flynn, Patricia M; Taha, Taha E; Cababasay, Mae et al. (2018) Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomi J Acquir Immune Defic Syndr 77:383-392|
|Montgomery, Elizabeth T; Stadler, Jonathan; Naidoo, Sarita et al. (2018) Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS 32:1517-1525|
|Riddler, Sharon A; Husnik, Marla; Ramjee, Gita et al. (2017) HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One 12:e0178594|
|Naidoo, Kogieleum; Hassan-Moosa, Razia; Yende-Zuma, Nonhlanhla et al. (2017) High mortality rates in men initiated on anti-retroviral treatment in KwaZulu-Natal, South Africa. PLoS One 12:e0184124|
|Bisson, Gregory P; Ramchandani, Ritesh; Miyahara, Sachiko et al. (2017) Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults. AIDS 31:2217-2225|
|Chirenje, Zvavahera Mike; Gundacker, Holly M; Richardson, Barbra et al. (2017) Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Transm Dis 44:135-140|
|Livant, Edward; Heaps, Amy; Kelly, Cliff et al. (2017) The fourth generation AlereTM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples. J Clin Virol 94:15-21|
|Balkus, Jennifer E; Brown, Elizabeth R; Hillier, Sharon L et al. (2016) Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial. Contraception 93:25-31|
|Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko et al. (2016) Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet 387:1198-209|
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