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级联网络宫颈癌临床试验站点 预防感染艾滋病毒的妇女 项目摘要/摘要： 宫颈癌是东部和南部非洲地区妇女癌症相关死亡的主要原因 是全球艾滋病毒感染负担最高的国家。(1)在东非，2020年的估计报告显示，四分之一的 新的宫颈癌病例可能归因于艾滋病毒感染。(2)宫颈癌发病率和死亡率 反映了全球的不平等，最脆弱的人群承担着最大的疾病负担。 KEMRI-CCR-PHRD研究诊所与LVCT Health Dhibiti HIV/TB PEPFAR/CDC合作 该方案(在肯尼亚中部地区支持31800名艾滋病毒感染者)组织了一个艾滋病毒和宫颈疾病联盟 癌症临床、研究和计划专家并通过这项申请建议作为网络加入UG1 临床试验地点，并实施艾滋病毒/宫颈癌预防研究。我们建议实施UG1 基安布县(Thika)三家选定的农村城市公立医院艾滋病毒护理诊所的网络研究 5级、瑞鲁4级、伊格加尼亚4级医院)。这三家入选的医院是十家生殖健康医院的一部分 (Rh)实施“TIBA”研究的诊所(5R01CA258590-02 MUGO)，一项实施科学研究 热消融筛选治疗(SAT)+一次探查(SVA)的实施效果评价 (TA)。我们有能力和资源参与所有四个拟议的UG1重点研究领域；增加 筛查吸收，改善筛查阳性的管理，促进癌前治疗途径和优化 WLWH预防宫颈癌的癌前治疗。 通过与LVCT Health Dhibiti HIV/TB CDC/PEPFAR资助的关怀计划合作，并利用- 为了在选定的公共卫生设施中进行实施科学研究，我们在目标1中建议 提供基础设施，以招募、招收和保留WLWH到UG1网络研究。三位一体 选定的设施估计有4,000名WLWH登记在艾滋病毒/结核病护理诊所，并可选择 通过整合十个TIBA研究诊所扩展到10,000个。在目标2中，我们建议与UG1对接 研究基地和U24网络协调中心在概念和协议开发期间提供 对临床意义、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PIS 参与了多个多点临床试验，并担任网络研究的礼宾主席。在AIM 3、我们建议为网络临床试验的成功进行提供现场操作领导。 KEMRI-CCR-PHRD研究单位拥有16年进行临床研究的经验，并已进行了良好的测试 根据国际法规实施研究的标准化系统和材料 要求。