CAPRISA CASCADE Clinical Trials Network Clinical Research Site

总结 南非艾滋病研究项目中心（CAPRISA）CASCADE临床试验网络 临床研究中心，旨在为开展临床试验提供基础设施和运营领导 通过CASCADE临床试验网络进行临床试验。拟定的临床试验中心为 位于夸祖鲁-纳塔尔省的战略位置，该省是人类免疫缺陷病毒的中心 (HIV)南非的疫情。由于这种情况下艾滋病毒的高流行率，KZN省 仍然是一个宫颈癌疾病负担很高的区域，尽管扩大和改善了获得 抗逆转录病毒治疗（ART）。 CAPRISA一直在进行具有全球相关性和地方响应性的高影响力研究， 将近二十年Ethekwini临床研究中心（ECRS）是四个临床研究中心之一， 总部位于Ethekwini的中央商务区。这是一个完善的研究网站，有超过15个 多年的高质量临床试验经验。我们建立了研究基础设施， 支持CAPRISA领导的研究以及美国国立卫生研究院（NIH）网络的开展- 附属试验，主要招募年轻女性参与我们的试验。到目前为止，我们的核心重点是 尽管我们在涉及艾滋病毒的研究方面同样经验丰富， 妇女艾滋病毒感染者（WLHIV）的发病机制和临床管理。与以前的人类 乳头瘤病毒（HPV）的流行病学研究，我们的团队进行，我们已经开始了初步工作， 在一项正在进行的CAPRISA试验中进行宫颈癌筛查，我们正在评估HPV即时检测 在WLHIV。 通过CASCADE网络，我们的目标是支持和促进宫颈癌预防， 参与临床试验。通过我们的相关临床试验经验和科学专业知识，我们 能够为网络提出的四个科学重点领域做出贡献：增加筛查的使用， 改善筛查阳性的管理，促进癌前治疗的获得和优化癌前 宫颈癌的治疗方法有哪些我们已经召集了一个强大的调查小组， 支持该项目，包括一名主要研究者（PI）和一名曾领导多项HIV研究的合作研究者 和COVID-19临床试验，并作为国家PI领导几项NIH资助的方案， 礼宾共同主席。该团队能够为方案制定做出贡献，并提供实验室数据， 为通过网络进行的试验提供管理和统计支助。此外，我们能够 与网络建议的各自研究基地和协调中心合作。 考虑到CAPRISA在艾滋病毒研究方面的专业知识和在HPV流行病学方面开展的初步工作， 和HPV诊断，我们有能力成为CASCADE网络中强大的合作伙伴。

Summary The Center for the AIDS Program of Research in South Africa (CAPRISA) CASCADE Clinical Trials Network Clinical Research Site, aims to provide clinical trial infrastructure and operational leadership for the conduct of pragmatic clinical trials through the CASCADE Clinical Trials Network. The proposed clinical trial site is strategically located in KwaZulu-Natal (KZN) province, the epicentre of the Human Immunodeficiency Virus (HIV) epidemic in South Africa. Due to the high background HIV prevalence in this setting, KZN province remains a region with a high burden of cervical cancer disease, despite expansion and improved access to antiretroviral treatment (ART). CAPRISA has been undertaking high-impact globally relevant and locally responsive research for nearly two decades. The Ethekwini Clinical Research Site (ECRS) is one of four clinical research sites and is based in the central business district in Ethekwini. This is a well-established research site, with over 15 years’ experience conducting high-quality clinical trials. We have established research infrastructure which supports the conduct of both CAPRISA-led research as well as National Institutes of Health (NIH) network- affiliated trials, primarily recruiting young women for participation in our trials. To date, our core focus of research has been HIV prevention, although we are equally experienced in research involving HIV pathogenesis and clinical management of women living with HIV (WLHIV). Together with previous Human Papilloma Virus (HPV) epidemiological studies undertaken by our team, we have begun preliminary work in cervical cancer screening in an ongoing CAPRISA trial, where we are evaluating HPV point-of-care testing in WLHIV. Through the CASCADE network we aim to support and advance cervical cancer prevention, through participation in clinical trials. Through our relevant clinical trial experience and scientific expertise, we are able to contribute to the four scientific focus areas proposed by the network: increasing screening uptake, improving management of screen positives, facilitating precancer treatment access and optimising precancer treatment for cervical cancer prevention in WLHIV. We have assembled a strong team of investigators to support this program, including a Principal Investigator (PI) and Co-Investigators who have led multiple HIV and COVID-19 clinical trials at a site level and are leading several NIH-funded protocols as national PIs or protocol co-Chairs. The team are able to contribute to protocol development and to provide laboratory, data management and statistical support for trials undertaken through the network. Furthermore, we are able to collaborate with the respective research bases and coordinating centers proposed by the network. Considering CAPRISA’s expertise in HIV research and preliminary work undertaken in HPV epidemiology and HPV diagnostics, we are well-placed to be a strong partner in the CASCADE network.