The University of KwaZulu-Natal - Centre for the AIDS Programme of Research in South Africa (CAPRISA) HIV/AIDS Clinical Trials Unit (CTU) brings together three senior investigators from the leadership of the HPTN, MTN and IMPAACT to lead a uniquely South African CTU, comprising a consortium of five partner institutions conducting research in five research priority areas. To achieve this, the CTU includes six well-established clinical trials sites which have a track record for being able to recruit and retain large cohorts for prevention and treatment trials. The rural community based CAPRISA Vulindlela Site, with HIV prevalence of 42.7% and incidence of 8.5 per 100 person-years in cohorts of adolescent and young women (annual retention rate: 95.0%) will conduct vaccine, microbicide and prevention trials. The Aurum - CAPRISA Site, which serves gold miners and their communities, has HIV prevalence of 32.1% and HIV incidence of 4.1 per 100 person-years in gold miners (annual retention rate: 95.1%) will conduct vaccine and clinical management optimization trials. The CAPRISA - Thekwini Site at one the country's largest TB clinics, which treated 8580 new TB patients last year with HIV prevalence of 64.6% and ART adherence of 95.2%, will conduct optimization of clinical management trials. The Umbilo Site at the Doris Duke Medical Research Institute in Durban, which is well suited to conduct clinically intensive phase I trials, also has a sex worker cohort with 57.9% HIV prevalence and an incidence rate of 9.8 per 100 women-years (annual retention rate: 98%) for vaccine and microbicide trials. The Umlazi Site at a 1,200 bed Durban hospital manages about 12,000 deliveries annually with HIV prevalence of 50.7% and MTCT rate of 20% at 9 months and the Cato Manor Site at a Durban primary health clinic, manages 1320 pregnancies annually with HIV prevalence of 48.1% and MTCT rate of 18% at 9 months will both conduct pMTCT trials. The CTU administrative component has eleven cores of expertise (pharmacy, data management, statistics, laboratory, behavioral, health economics, bioethics, community involvement, quality assurance, regulatory and training) which will support site level activities and centralize certain functions, where appropriate. An experienced full-time Operations Director will coordinate support provided by the cores to each site and will ensure effective systems for monitoring the quality of trial implementation at each site. Effective communication between sites and the CTU administrative component and collective monitoring of CTU performance occurs through the monthly meetings of the CTU Executive Committee comprising the PI, co-PIs, Operations Director, Administrative Manager and the Site Leaders. Further, each site has a community advisory committee with representatives on the CTU Community Advisory Board. This CTU encompasses a track record of scientific leadership in HIVNET, HPTN, HVTN, and CIPRA, ready access to large cohorts at high HIV risk, established clinical trial infrastructure with experienced personnel in the cores and sites, a training programme integrated with Fogarty AIDS training, and potential scientific contributions well aligned with the scientific agendas of five Networks. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZAI1-BLG-A (M1))
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Pouliot, Eileen M
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University of Kwazulu-Natal
South Africa
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Murphy, Michael E; Phillips, Patrick P J; Mendel, Carl M et al. (2017) Spot sputum samples are at least as good as early morning samples for identifying Mycobacterium tuberculosis. BMC Med 15:192
Charalambous, Salome; Grant, Alison D; Churchyard, Gavin J et al. (2016) Clinic-level factors influencing patient outcomes on antiretroviral therapy in primary health clinics in South Africa. AIDS 30:1099-109
Smith, Chanelle; Gengiah, Tanuja N; Yende-Zuma, Nonhlanhla et al. (2016) Assessing Adherence to Antiretroviral Therapy in a Rural Paediatric Cohort in KwaZulu-Natal, South Africa. AIDS Behav 20:2729-2738
Leitman, Ellen M; Hurst, Jacob; Mori, Masahiko et al. (2016) Lower Viral Loads and Slower CD4+ T-Cell Count Decline in MRKAd5 HIV-1 Vaccinees Expressing Disease-Susceptible HLA-B*58:02. J Infect Dis 214:379-89
Kashuba, Angela D M; Gengiah, Tanuja N; Werner, Lise et al. (2015) Genital Tenofovir Concentrations Correlate With Protection Against HIV Infection in the CAPRISA 004 Trial: Importance of Adherence for Microbicide Effectiveness. J Acquir Immune Defic Syndr 69:264-9
Shiboski, C H; Chen, H; Ghannoum, M A et al. (2014) Role of oral candidiasis in TB and HIV co-infection: AIDS Clinical Trial Group Protocol A5253. Int J Tuberc Lung Dis 18:682-8
Hopkins, Kathryn L; Laher, Fatima; Otwombe, Kennedy et al. (2014) Predictors of HVTN 503 MRK-AD5 HIV-1 gag/pol/nef vaccine induced immune responses. PLoS One 9:e103446
Nandlal, Vikesh; Moodley, Dhayendre; Grobler, Anneke et al. (2014) Anaemia in pregnancy is associated with advanced HIV disease. PLoS One 9:e106103
Gillespie, Stephen H; Crook, Angela M; McHugh, Timothy D et al. (2014) Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med 371:1577-87
Volk, Jonathan E; Hessol, Nancy A; Gray, Glenda E et al. (2014) The HVTN503/Phambili HIV vaccine trial: a comparison of younger and older participants. Int J STD AIDS 25:332-40

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