The Wits HIV Research Group Clinical Trials Unit (WHRG CTU) under the joint PI Leadership of Ian Sanne and Helen Rees, includes four experienced pleuripotent Clinical Research Sites (CRSs), namely the Wits Helen Joseph Hospital CRS (Dr Sharlaa Badal-Faesen), The Wits RHI Shandukani Maternal and Child CRS (Dr Lee Fairlie), Wits RHI Hillbrow Health Precinct Ward 21 CRS (Prof. Sinead Delaney-Moretlwe) and the Wits RHI Research Centre (Dr Thesla Palanee-Phillips). These four CRSs have capacity to conduct clinical trials across all four NIH Networks, the ACTG, IMPAACT, HPTN and VTN. The CTU?s research agenda includes HIV treatment, HIV-associated infections and HIV-related cancers; HIV prevention; TB treatment and prevention (including MDR-TB) and Hepatitis. The CTU conducts research across all key populations, including adolescent girls and young women, men who have sex with men, transgender populations and female sex workers; as well as vulnerable populations such as neonates, infants, older children, pregnant and breastfeeding women. The CTU has capacity to conduct Investigational New Drug (IND) level trials including phase I/II/II trials, blinded and unblinded randomized trials, across a wide range of products including oral products for treatment and prevention; vaccines for infants, children, adolescents, pregnant women and adults; injectable long acting antiretrovirals for treatment and prevention; monoclonal antibody infusions and microbicides. The expertise, facilities and specialized equipment at each CRS results in the sites conducting these studies at a high level of quality and efficiency. The CTU has in-house laboratory capacity and contracts external laboratories to perform testing to the required Network standards. The four sites are situated in Johannesburg, South Africa?s bustling urban centre and populations included in the CTU research are recruited within Johannesburg, using a targeted approach appropriate for each, and ensuring that hard-to-engage people who may be at highest risk are not excluded. This requires facility- and community-based recruitment and the CTU has a formalized approach, for community engagement across all relevant populations based on good participatory practice principles. The CTU has substantial experience and expertise within all components including but Pharmacy, Regulatory Processes, Data Management, Quality Management, Training and Mentoring and although the four CRSs are distinct, the CTU optimizes efficiencies and collaboration across all CRSs. Experience related to specific populations is shared within the CTU, but also externally locally in South Africa, Regionally and Internationally. The CTU has had over 10 successful IND audits and inspections FDA, EMEA and SAHPRA; and numerous successful PPD and sponsor inspections.
The Wits HIV Research Group Clinical Trials Unit (WHRG CTU) consists of four pleuripotent Clinical Research Sites-The Wits Helen Joseph Hospital CRS, The Wits RHI Shandukani Maternal and Child CRS, Wits RHI Hillbrow Health Precinct Ward 21 CRS and the Wits RHI Research Centre. The WHRG CTU research agenda includes HIV treatment, HIV-associated infections and HIV-related cancers; HIV prevention; TB treatment and prevention (including MDR-TB) and Hepatitis. The CTU conducts research across key populations, including adolescent girls and young women, men who have sex with men, transgender populations and female sex workers; as well as vulnerable populations such as neonates, infants, older children, pregnant and breastfeeding women to a high standard of quality, which has been recognized locally and internationally.
|Cespedes, Michelle S; Kang, Minhee; Kojic, Erna Milunka et al. (2018) Anogenital human papillomavirus virus DNA and sustained response to the quadrivalent HPV vaccine in women living with HIV-1. Papillomavirus Res 6:15-21|
|Swindells, S; Gupta, A; Kim, S et al. (2018) Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003). Int J Tuberc Lung Dis 22:1016-1022|
|Palanee-Phillips, Thesla; Roberts, Sarah T; Reddy, Krishnaveni et al. (2018) Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial. J Acquir Immune Defic Syndr 79:580-589|
|Hosseinipour, Mina C; Kang, Minhee; Krown, Susan E et al. (2018) As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial. Clin Infect Dis 67:251-260|
|Ruiseñor-Escudero, Horacio; Familiar, Itziar; Nyakato, Mary et al. (2018) Building capacity in neurodevelopment assessment of children in sub-Saharan Africa: A quality assurance model to implement standardized neurodevelopment testing. Child Neuropsychol :1-16|
|Robertson, K; Oladeji, B; Jiang, H et al. (2018) HIV-1 and TB Co-infection in Multinational Resource Limited Settings: Increased neurological dysfunction. Clin Infect Dis :|
|Laborde, Nicole D; Pleasants, Elizabeth; Reddy, Krishnaveni et al. (2018) Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex. AIDS Behav 22:437-446|
|Balkus, Jennifer E; Brown, Elizabeth R; Palanee-Phillips, Thesla et al. (2018) Performance of a Validated Risk Score to Predict HIV-1 Acquisition Among African Women Participating in a Trial of the Dapivirine Vaginal Ring. J Acquir Immune Defic Syndr 77:e8-e10|
|Shivakoti, Rupak; Gupte, Nikhil; Tripathy, Srikanth et al. (2018) Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study. BMC Med 16:161|
|Tracy, LaRee A; Struble, Kimberly; Firnhaber, Cynthia et al. (2018) Age Differences by Sex in Antiretroviral-Naïve Participants: Pooled Analysis from Randomized Clinical Trials. J Assoc Nurses AIDS Care 29:371-382|
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