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 with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-BLG-A (M1))
Program Officer
Pouliot, Eileen M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Kwazulu-Natal
South Africa
Zip Code
Fowler, Mary Glenn; Coovadia, Hoosen; Herron, Casey M et al. (2014) Efficacy and safety of an extended nevirapine regimen in infants of breastfeeding mothers with HIV-1 infection for prevention of HIV-1 transmission (HPTN 046): 18-month results of a randomized, double-blind, placebo-controlled trial. J Acquir Immune Defic Syndr 65:366-74
Gray, Glenda E; Moodie, Zoe; Metch, Barbara et al. (2014) Recombinant adenovirus type 5 HIV gag/pol/nef vaccine in South Africa: unblinded, long-term follow-up of the phase 2b HVTN 503/Phambili study. Lancet Infect Dis 14:388-96
Guffey, M Bradford; Richardson, Barbra; Husnik, Marla et al. (2014) HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women. Sex Transm Infect 90:363-9
Balkus, Jennifer E; Richardson, Barbra A; Rabe, Lorna K et al. (2014) Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women. Sex Transm Dis 41:123-8
Naranbhai, Vivek; Moodley, Dhayendre; Chipato, Tsungai et al. (2014) The association between the ratio of monocytes: lymphocytes and risk of tuberculosis among HIV-infected postpartum women. J Acquir Immune Defic Syndr 67:573-5
Nandlal, Vikesh; Moodley, Dhayendre; Grobler, Anneke et al. (2014) Anaemia in pregnancy is associated with advanced HIV disease. PLoS One 9:e106103
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