KEMRI-PHRD UG1 CASCADE NETWORK UNIT: CERVICAL CANCER PREVENTION FOR WOMEN LIVING WITH HIV RESEARCH

KEMRI-PHRD UG1 级联网络单元：艾滋病毒感染女性的宫颈癌预防研究

• 批准号: 10763054
• 负责人: Nelly Rwamba Mugo
• 金额: $ 21.6万
• 依托单位: KENYA MEDICAL RESEARCH INSTITUTE (KEMRI)
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10763054
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Africa; Area; Behavioral; Behavioral Research; Behavioral Sciences; CCR; Cancer Control; Cancer Etiology; Cancer Prevention Intervention; Caring; Cervical Cancer Screening; Cessation of life; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Communities; County; Dose; Eastern Africa; Eligibility Determination; Enrollment; Feasibility Studies; Foundations; Funding; Goals; Gynecologist; HIV; HIV Infections; HIV/TB; Health; Health Personnel; Health Services Accessibility; Health care facility; Hospitals; Human Papillomavirus; Inequity; Infrastructure; International; Joints; Kenya; Knowledge; Laboratories; Leadership; Malignant neoplasm of cervix uteri; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Cancer Institute; Newly Diagnosed; Nongovernmental Organizations; Observational Study; Operations Research; Participant; Persons; Policy Maker; Positioning Attribute; Prevention Guidelines; Prevention Research; Protocols documentation; Provider; Public Health; Public Hospitals; Reporting; Reproductive Health; Research; Research Design; Research Personnel; Research Priority; Resources; Rural; Scientist; Site; Southern Africa; Standardization; System; Techniques; Testing; Thermal Ablation Therapy; Training; Universities; Visit; Vulnerable Populations; Washington; Woman; Work; base; burden of illness; care providers; cervical cancer prevention; clinical care; clinically significant; data standards; experience; implementation evaluation; implementation research; implementation science; improved; insight; member; mortality; pre-exposure prophylaxis; premalignant; programs; protocol development; randomized, clinical trials; recruit; reproductive; research study; response; screening; screening services; service programs; social; treatment optimization; treatment program; treatment services; uptake; urban setting; working group

KEMRI-PHRD CLINICAL TRIAL SITE FOR CASCADE NETWORK ‘CERVICAL CANCER PREVENTION FOR WOMEN LIVING WITH HIV Project Summary/Abstract: Cervical cancer is the leading cause of cancer-related deaths in women in eastern and southern Africa, the regions with the highest burden of HIV infection globally. (1) In East Africa, 2020 estimates reported that a quarter of new cervical cancer cases could be attributed to HIV infection. (2) Cervical cancer morbidity and mortality reflects global inequity with the most vulnerable populations carrying the greatest disease burden. The KEMRI-CCR-PHRD research clinic in partnership with LVCT Health Dhibiti HIV/TB PEPFAR/CDC program (supporting 31,800 PLHIV in central region of Kenya) have organized a consortium of HIV and cervical cancer clinical, research and program experts and through this application propose to join the UG1 as a Network clinical trial site and implement HIV/cervical cancer prevention studies. We propose to implement the UG1 Network studies at three selected HIV care clinics based in rural urban public hospitals in Kiambu county (Thika level 5, Ruiru level 4, Igegania level 4 hospitals). The three selected hospitals are part of ten reproductive health (RH) clinics implementing the ‘TIBA’ study (5R01CA258590-02 Mugo), an implementation science study evaluating the implementation of Screen and Treat (SAT) + Single Visit Approach (SVA) with Thermal Ablation (TA). We have capacity and resources to participate in all four proposed focal UG1 research areas; increase screening uptake, improve management of screen positives, facilitate precancer treatment access and optimize precancer treatments for cervical cancer prevention for WLWH. Through partnership with LVCT Health Dhibiti HIV/TB CDC/PEPFAR funded care program and leveraging on- going implementation science studies conducted in the selected public health facilities, we propose in Aim 1, to provide infrastructure to recruit, enroll and retain WLWH to the UG1 network studies. The three selected facilities have an estimate of 4,000 WLWH enrolled in the HIV/TB care clinics, with the option to expand to 10,000 by incorporating the ten TIBA study clinics. In Aim 2, we propose to interface with the UG1 Research Bases and U24 Network Coordinating Center during concept and protocol development to provide insights and input on issues pertaining to clinical significance, study feasibility, implementation and contribute towards raising up relevant priority research questions. KEMRI-CCR-PHRD co-PIs have participated in multiple multisite clinical trials and have been protocol chairs on network studies. In Aim 3, we propose to provide on-site operational leadership for the successful conduct of the network clinical trials. The KEMRI-CCR-PHRD research unit has 16 years’ experience conducting clinical research and has well tested standardized systems and materials for implementation of research in accordance with international regulatory requirements.

Kemri-Phrd级别宫颈癌的临床试验地点 预防艾滋病毒的妇女 项目摘要/摘要： 宫颈癌是东部和南部非洲妇女与癌症相关死亡的主要原因，这些地区 全球艾滋病毒感染的最高燃烧。 （1）在东非，2020年估计报告了四分之一 新的宫颈癌病例可能归因于HIV感染。 （2）宫颈癌的发病率和死亡率 反映出全球不平等的人口最脆弱的人群携带最大的疾病伯恩。 Kemri-CCR-PHRD研究诊所与LVCT Health dhealti hiv/tb pepfar/cdc合作 计划（肯尼亚中部地区支持31,800个PLHIV）已经组织了一个艾滋病毒和宫颈联盟 癌症临床，研究和计划专家，并通过该申请提案以加入UG1作为网络 临床试验地点并实施HIV/宫颈癌预防研究。我们建议实施UG1 位于Kiambu县农村城市公立医院（THICA）的三个选定的HIV护理诊所的网络研究 5级，Ruiru 4级，Igania级4级医院）。这三家选定的医院是十个复制健康的一部分 （RH）实施“ TIBA”研究的诊所（5R01CA258590-02 MUGO），一项实施科学研究 评估屏幕和治疗（SAT） +单次访问方法（SVA）的实现（SVA） （ta）。我们有能力和资源参与所有四个拟议的焦点UG1研究领域；增加 筛选吸收，改善屏幕积极的管理，促进预科治疗访问并进行优化 WLWH的宫颈癌预防的预科治疗。 通过与LVCT Health Dhibiti HIV/TB CDC/PEPFAR资助的护理计划的合作，并利用 我们在选定的公共卫生设施中进行的实施科学研究，我们在AIM 1中提出 提供基础架构，以招募，注册和保留WLWH到UG1网络研究中。三个 选定的设施估计在HIV/TB护理诊所注册了4,000 wlwh，可以选择 通过纳入十个TIBA研究诊所扩展到10,000。在AIM 2中，我们建议与UG1接口 研究基地和U24网络协调中心在概念和协议开发过程中提供 有关临床意义，研究可行性，实施的问题的见解和意见 并有助于提出相关的优先研究问题。 kemri-ccr-phrd co-pis 已经参加了多个多站点临床试验，并且是网络研究的协议椅子。目标 3，我们建议为网络临床试验的成功进行现场运营领导。 Kemri-CCR-PHRD研究部门具有16年的进行临床研究的经验，并且经过了经过良好测试 根据国际监管的标准化系统和材料进行研究 要求。