UNC CASCADE Network Research Base

UNC CASCADE网络研究基地

基本信息

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
项目类别：
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

项目摘要

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消除浸润性宫颈癌（ICC）到 2030 年，感染 HIV 的女性 (WLWH) 罹患 ICC 的风险将增加约 10 倍，因此迫切需要高水平的治疗。关于 ICC 预防最佳策略的高质量证据直接适用于面临不同问题的 WLWH 宫颈前体和ICC的负担。我们将在北卡罗来纳大学教堂山分校建立CASCADE Network UG1研究基地（RB） (UNC) 防止 WLWH 中发生 ICC 此 UNC RB 提案的总体目标是开发、测试和实施。实施有效、可扩展且具有成本效益的筛查和治疗策略，以减少 ICC WLWH。我们将开发、实施和分析创新的混合有效性实施试验。 CASCADE 网络的重点领域是“改善筛查阳性的管理”和“优化癌前病变” 北卡罗来纳大学 RB 将由殖民者、流行病学家、生物统计学家和培训专家组成。在中低收入国家和美国拥有数十年的 ICC 预防和艾滋病毒研究经验。团队拥有实施科学、自动视觉评估 (AVE) 筛查、病理学等方面的专业知识，和成本效益分析。在目标 1 中，我们将开发基于证据的干预措施的 CASCADE 网络试验，以优化筛查通过 1) 提供科学、临床和统计数据来诊断和管理 WLWH 中的宫颈癌前病变开发创新概念和协议的专业知识，以实现新颖但务实的混合有效性- 实施试验，以及 2) 创建有组织的流程，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、患者倡导的不同意见作为“改善”的潜在临床试验的说明性例子。筛查阳性的管理”，我们提出方案 1，一项阶梯式楔形聚类随机试验来评估 AVE 分类与 HPV 阳性 WLWH 中的 HPV 联合治疗用于 CIN2+ 预防。治疗”，我们提出了方案 2，这是一项混合 1 型试验，旨在评估辅助、自我治疗的有效性。在初次 2/3 治疗后进行阴道内局部治疗，以预防 CIN2+ 复发 WLWH 两项试验的结果将包括前兆的临床有效性、实施结果和在目标 2 中，我们将确保 CASCADE 的成功实施和分析。通过提供科学、临床和统计专业知识、运营支持和监管来进行网络试验在目标 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， CASCADE 试验结果将推动中低收入国家和美国 WLWH 的临床筛查和治疗指南国家。