UNC CASCADE Network Research Base

UNC CASCADE网络研究基地

• 批准号: 10696082
• 负责人: Lameck Chinula
• 金额: $ 61.52万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-02 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10696082
• 关键词: Acquired Immunodeficiency Syndrome; Adherence; Adjuvant; Advisory Committees; Area; Award; Cancer Control; Cervical; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Skills; Clinical Trials; Clinical effectiveness; Cluster randomized trial; Collaborations; Communicable Diseases; Comprehensive Cancer Center; Cost Effectiveness Analysis; Coupled; Data; Disparate; Dissemination and Implementation; Educational workshop; Ensure; Epidemiologist; Evidence based intervention; Funding; Gills; Goals; HIV; Health Services Accessibility; Human Papillomavirus; Information Dissemination; Institution; International; Intervention; Intravaginal Administration; Leadership; Lesion; Malawi; Malignant neoplasm of cervix uteri; Mentorship; Methodology; North Carolina; Outcome; Pathology; Patient advocacy; Performance; Postdoctoral Fellow; Prevention; Procedures; Process; Protocols documentation; Public Health; Randomized; Recurrence; Regulatory Affairs; Research; Research Activity; Research Design; Research Personnel; Research Training; Schools; Self Administration; Statistical Data Interpretation; Structure; Testing; Training; Training Programs; Translational Research; Triage; United States; Universities; Woman; World Health Organization; automated visual evaluation; base; cancer health disparity; career; cervical cancer prevention; clinical research site; clinical training; cost effective; cost effectiveness; design; effective therapy; effectiveness evaluation; effectiveness research; effectiveness/implementation trial; evidence base; experience; global health; high risk; hybrid type 1 trial; implementation outcomes; implementation science; improved; innovation; low and middle-income countries; multidisciplinary; novel; premalignant; prevent; screening; screening guidelines; skills; skills training; standard of care; training opportunity; treatment guidelines; treatment strategy; trial comparing; uptake

ABSTRACT The Director-General of the World Health Organization has called for invasive cervical cancer (ICC) elimination by 2030. Women living with HIV (WLWH) have a ~10-fold higher risk of ICC. There is an urgent need for high quality evidence on optimal strategies for ICC prevention directly applicable to WLWH who face a disparate burden of cervical precancer and ICC. We will establish a CASCADE Network UG1 Research Base (RB) at the University of North Carolina-Chapel Hill (UNC) to prevent ICC among WLWH. The overarching goal of this UNC RB proposal is to develop, test, and implement effective, scalable, and cost-effective screening and treatment strategies to reduce ICC among WLWH. We will develop, implement, and analyze innovative hybrid effectiveness-implementation trials in the CASCADE Network focus areas of “Improving the Management of Screen Positives” and “Optimizing Precancer Treatment”. The UNC RB will be composed of clinicians, epidemiologists, biostatisticians, and training experts with decades of research experience on ICC prevention and HIV in both LMIC and the US. Our multi-disciplinary team has expertise in implementation science, screening with automated visual evaluation (AVE), pathology, and cost-effectiveness analyses. In Aim 1, we will Develop CASCADE Network trials of evidence-based interventions to optimize the screening for and management of cervical precancer among WLWH by 1) providing scientific, clinical and statistical expertise to develop innovative concepts and protocols for novel, yet pragmatic, hybrid effectiveness- implementation trials, and 2) creating organized processes to efficiently develop concepts and protocols by leveraging diverse input from the UNC RB Scientific, Statistical, Clinical Sites Advisory, Patient Advocacy Advisory, and Scientific Advisory Committees. As an illustrative example of a potential clinical trial for “Improving Management of Screen-Positives”, we propose Protocol 1, a stepped wedge cluster randomized trial to Evaluate AVE triage versus HPV-and-treat among HPV-positive WLWH for CIN2+ prevention. For “Optimizing Precancer Treatment”, we propose Protocol 2, a Hybrid Type 1 trial to evaluate the effectiveness of adjuvant, self- administered intravaginal topical therapy following primary 2/3 treatment to prevent CIN2+ recurrence among WLWH. Outcomes for both trials will include clinical effectiveness for precancer, implementation outcomes, and cost effectiveness analyses. In Aim 2, we will ensure successful Implementation and Analysis of CASCADE Network trials by providing scientific, clinical and statistical expertise, operational support, and regulatory oversight. In Aim 3, we will provide Rigorous Foundational Clinical and Research Training for UG1 Clinical Sites and Early-Stage Investigators to design and implement clinical effectiveness research. If successful, CASCADE Trial findings will advance clinical screening and treatment guidelines for WLWH in LMIC and United States.

抽象的 世界卫生组织总干事呼吁进行入侵性宫颈癌（ICC）进化 到2030年，艾滋病毒（WLWH）妇女的ICC风险高约10倍。迫切需要高 ICC预防最佳策略的质量证据直接适用于面对不同的WLWH 宫颈预科和ICC的负担。 我们将在北卡罗来纳大学 - 教堂山建立级联网络UG1研究基地（RB） （UNC）防止ICC在WLWH中。该UNC RB建议的总体目标是开发，测试和 实施有效，可扩展和具有成本效益的筛查和治疗策略，以减少ICC wlwh。我们将在 “改善屏幕积极管理的管理”和“优化预科师）的级联网络重点领域 治疗”。UNC RB将由临床医生，流行病学家，生物统计学家和培训专家组成 LMIC和美国的ICC预防和HIV的数十年研究经验。我们的多学科 团队在实施科学方面拥有专业知识，并通过自动视觉评估（AVE），病理学，病理学， 和成本效益分析。 在AIM 1中，我们将开发基于证据的干预措施的级联网络试验，以优化筛查 WLWH中的宫颈预科剂的管理和管理1）提供科学，临床和统计 为新颖但务实的混合有效性开发创新概念和协议的专业知识 - 实施试验，以及2）创建有条理的过程，以有效地开发概念和协议 利用UNC RB科学，统计，临床站点咨询，患者倡导的多种输入 咨询和科学咨询委员会。作为潜在临床试验的说明性示例 屏幕授权的管理”，我们提出了协议1，一个阶梯楔形集群随机试验来评估 用于CIN2+预防的HPV阳性WLWH中的AVE分类与HPV和治疗。为了“优化预科剂 处理”，我们提出了协议2，这是一项混合1型试验，以评估调整，自我的有效性 初级2/3治疗后，管理经阴道局部疗法，以防止CIN2+复发 wlwh。这两个试验的结果都将包括针对预科师，实施成果的临床有效性和 成本效益分析。在AIM 2中，我们将确保成功实施和分析级联 通过提供科学，临床和统计专业知识，运营支持和监管的网络试验 监督。在AIM 3中，我们将为UG1临床提供严格的基础临床和研究培训 站点和早期研究人员设计和实施临床有效性研究。如果成功， 级联试验结果将推进LMIC和United中WLWH的临床筛查和治疗指南 国家。