CAPRISA CASCADE Clinical Trials Network Clinical Research Site

CAPRISA CASCADE 临床试验网络临床研究网站

基本信息

批准号：
10754981
负责人：
Nivashnee Naicker
金额：
$ 21.6万
依托单位：
CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-05 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10754981
关键词：
AIDS prevention Acceleration Acquired Immunodeficiency Syndrome African Aftercare Age Area Businesses CD4 Lymphocyte Count COVID-19 Cancer Etiology Cervical Cervical Cancer Screening Cervical Smears Cervix Uteri Clinical Clinical Management Clinical Research Clinical Trials Clinical Trials Network Collaborations Colposcopy Communities Cytology Data Diagnostic Disease Educational Status Epidemic Epidemiology Evaluation Feasibility Studies Female Funding Goals HIV HIV Infections HIV Vaccine Trials Network HIV vaccine HPV-High Risk Health Services Accessibility Healthcare Systems High Prevalence Household Human Papilloma Virus Vaccination Human Papillomavirus Human papilloma virus infection Improve Access Incidence Infection Infrastructure International Intervention Laboratories Leadership Lesion Malignant Neoplasms Malignant neoplasm of cervix uteri Oncogenic Outcome Participant Pathogenesis Population Pragmatic clinical trial Pregnant Women Prevalence Prevention program Prevention strategy Principal Investigator Protocols documentation Province Public Sector Recommendation Recurrence Reporting Research Research Infrastructure Research Personnel Risk Schools Secondary Prevention Services Sexually Transmitted Diseases Site South Africa Surveys Testing United States National Institutes of Health Woman Work World Health Organization ablative procedure aged antenatal antiretroviral therapy base cancer diagnosis cervical cancer prevention clinical research site clinically relevant clinically significant co-infection cohort data management epidemic virus epidemiology study experience follow-up improved insight mortality novel point of care testing premalignant programs protocol development recruit screening sex treatment optimization treatment program uptake young woman

项目摘要

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.

概括南非研究中心（CAPRISA）级联临床试验网络临床研究网站，旨在为行为提供临床试验基础设施和运营领导通过级联临床试验网络进行务实的临床试验。拟议的临床试验现场是人类免疫缺陷病毒的震中夸祖鲁 - 纳塔尔省（KZN）省（HIV）南非流行病。由于这种情况下的艾滋病毒率高，KZN省仍然是一个宫颈癌疾病，目的地膨胀并改善进入的地区抗逆转录病毒治疗（ART）。卡普里萨（Caprisa 将近二十年。埃塞克维尼临床研究地点（ECRS）是四个临床研究地点之一，位于埃塞克维尼的中央商务区。这是一个完善的研究网站，有15多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领导的研究以及国立卫生研究院（NIH）网络的进行 - 附属试验，主要招募年轻妇女参加我们的试验。迄今为止，我们的核心重点研究一直是预防艾滋病毒的，尽管我们在涉及艾滋病毒的研究方面同样经验丰富艾滋病毒（WLHIV）妇女的发病机理和临床管理。与以前的人一起我们团队进行的乳头状瘤病毒（HPV）流行病学研究，我们已经开始进行初步工作在正在进行的CAPRISA试验中进行宫颈癌筛查，我们正在评估HPV测试在wlhiv。通过级联网络，我们旨在通过参与临床试验。通过我们相关的临床试验经验和科学专业知识，我们是有可能为网络提出的四个科学重点领域做出贡献：增加筛选吸收，改善屏幕阳性的管理，支持预科治疗访问并优化卓越者 WLHIV预防宫颈癌的治疗。我们已经组建了一个强大的调查人员团队支持该计划，包括领导多发艾滋病毒的首席研究员（PI）和共同投资者和COVID-19在现场级别进行的临床试验，并领导着几项由NIH资助的方案作为国家PI或协议联合主席。团队能够为协议制定做出贡献，并提供实验室，数据通过网络进行试验的管理和统计支持。此外，我们能够与网络提出的相对研究基础和协调中心合作。考虑Caprisa在HPV流行病学上从事HIV研究和初步工作方面的专业知识和HPV诊断，我们的位置很好，可以成为级联网络的强大合作伙伴。