CAPRISA CASCADE Clinical Trials Network Clinical Research Site

摘要 南非艾滋病研究中心(CAPRISA)级联临床试验网络 临床研究网站，旨在为开展临床试验提供基础设施和运营领导 通过级联临床试验网络进行的实用临床试验。建议的临床试验地点为 位于夸祖鲁-纳塔尔省(KZN)的战略位置，是人类免疫缺陷病毒的中心 (艾滋病)在南非流行。由于在这个背景下艾滋病毒感染率很高，KZN省 仍然是一个宫颈癌疾病负担很重的地区，尽管扩大和改善了获得治疗的机会 抗逆转录病毒治疗(ART)。 CAPRISA一直在进行具有全球相关性和当地响应性的高影响力研究 将近20年了。Ethekwini临床研究网站(ECRS)是四个临床研究网站之一， 总部设在Ethekwini的中央商务区。这是一个久负盛名的研究网站，有超过15个 多年进行高质量临床试验的经验。我们已经建立了研究基础设施， 支持CAPRISA领导的研究以及国家卫生研究院(NIH)网络的开展- 附属试验，主要招募年轻女性参加我们的试验。到目前为止，我们的核心重点是 研究一直是艾滋病毒预防，尽管我们在涉及艾滋病毒的研究方面同样有经验 女性HIV感染者(WLHIV)的发病机制及临床处理与以前的人类一起 由我们的团队进行的乳头状瘤病毒(HPV)流行病学研究，我们已经开始了初步工作 正在进行的CAPRISA试验中的宫颈癌筛查，我们正在评估HPV护理点检测 在WLHIV。 通过CASCADE网络，我们旨在支持和推进宫颈癌预防，通过 参与临床试验。通过我们相关的临床试验经验和科学专业知识，我们 能够为该网络提出的四个科学重点领域作出贡献：增加筛查吸收， 改善筛查阳性者的管理，便利癌前治疗途径，优化癌前病变 WLHIV中宫颈癌预防的治疗。我们已经组建了一支强大的调查团队来 支持这一方案，包括一名首席调查员(PI)和联合调查员，他们曾领导多个艾滋病毒 和新冠肺炎临床试验，并正在领导几个由国家卫生研究院资助的国家PI或 礼宾联席主席。该团队能够为方案开发做出贡献，并提供实验室、数据 对通过该网络进行的审判进行管理和统计支持。此外，我们能够 与网络提出的各个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，我们处于有利地位，可以成为级联网络中的强大合作伙伴。

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.