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

KEMRI-PHRD CASCADE NETWORK宫颈癌临床试验网站 预防感染艾滋病毒的妇女 项目概要/摘要： 宫颈癌是东非和南部非洲妇女与癌症有关的死亡的主要原因， 全球艾滋病毒感染负担最高的国家。(1)在东非，2020年的估计报告称， 新的宫颈癌病例可归因于艾滋病毒感染。(2)宫颈癌发病率和死亡率 这反映了全球的不平等，最脆弱的人群承受着最大的疾病负担。 KEMRI-CCR-PHRD研究诊所与LVCT Health Dhibiti艾滋病毒/结核病防治紧急救援计划/疾病预防控制中心合作 在肯尼亚中部地区，一个艾滋病毒和宫颈癌联合方案（支助31 800名艾滋病毒感染者）组织了一个艾滋病毒和宫颈癌联合会， 癌症临床，研究和项目专家，并通过此应用程序建议加入UG 1作为一个网络 开展艾滋病毒/宫颈癌预防研究。我们建议实施UG 1 在基安布县（蒂卡）农村城市公立医院的三个选定艾滋病毒护理诊所进行的网络研究 5级、Ruiru 4级、Igegania 4级医院）。这三家被选中的医院是十家生殖健康医院的一部分。 (RH)实施“TIBA”研究（5 R 01 CA 258590 -02 Mugo）的诊所，一项实施科学研究 评价筛查和治疗（SAT）+单次访视方法（SVA）与热消融的实施 （TA）。我们有能力和资源参与所有四个拟议的重点UG 1研究领域;增加 筛查吸收，改善筛查阳性的管理，促进癌前治疗的获得，并优化 WLWH预防宫颈癌的癌前治疗。 通过与LVCT Health Dhibiti建立伙伴关系，疾病预防控制中心/总统艾滋病紧急救援计划资助的护理方案，并利用- 在选定的公共卫生设施进行的实施科学研究中，我们在目标1中建议， 提供基础设施，以招募，注册和保留WLWH到UG 1网络研究。三 选定的设施估计有4,000名WLWH在艾滋病毒/结核病护理诊所登记， 通过合并十个TIBA研究诊所，将其扩大到10，000个。在目标2中，我们建议与UG 1接口 研究基地和U24网络协调中心在概念和协议开发期间提供 关于临床意义、研究可行性、实施等问题的见解和意见 并有助于提出相关的优先研究问题。KEMRI-CCR-PHRD联合PI 参与了多个多中心临床试验，并担任网络研究的方案主席。在Aim中 3、我们建议为网络临床试验的成功进行提供现场运营领导。 KEMRI-CCR-PHRD研究单位拥有16年的临床研究经验， 根据国际法规，实施研究的标准化系统和材料 要求.

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.