Implementing HIV/Cervical Cancer Prevention CASCADE Clinical Trials in Uganda (CASCADE UGANDA)

在乌干达实施艾滋病毒/宫颈癌预防 CASCADE 临床试验 (CASCADE UGANDA)

基本信息

批准号：
10700084
负责人：
Betty Mwesigwa
金额：
$ 21.44万
依托单位：
MAKERERE UNIVERSITY WALTER REED PROJECT
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：
2022-09-08 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10700084
关键词：
AIDS prevention Ablation Accreditation Acetic Acids Acquired Immunodeficiency Syndrome Address African Age Area Awareness Cancer Burden Cancer Intervention Cancer Prevention Intervention Caring Clinic Clinic Visits Clinical Clinical Research Clinical Trials Clinical Trials Network Cohort Studies Cold Therapy Collaborations Communities Community Networks Competence Conduct Clinical Trials Country DNA Development Diagnostic Procedure Diagnostic Reagent Kits Education Effectiveness Emergency Situation Ensure Environment Ethics Excision Feasibility Studies Funding Goals Good Clinical Practice Guidelines HIV Health Health Personnel Health care facility Human Papilloma Virus Vaccination Human Papillomavirus Imaging Techniques Incidence Infrastructure International Intervention Laboratories Leadership Lesion Malignant Neoplasms Malignant neoplasm of cervix uteri Military Personnel Molecular Participant Perception Phase Policies Pragmatic clinical trial Prevention strategy Procedures Prospective Studies Protocols documentation Ramp Regulation Research Research Infrastructure Research Personnel Resource-limited setting Resources Sampling Scientist Screening for cancer Site Standardization Supervision Techniques Testing Thermal Ablation Therapy Training Translating Uganda Universities Visual Woman Women&apos s Group aged base cancer prevention carcinogenesis cervical cancer prevention clinical research site clinical trial protocol clinically significant community engagement community organizations comorbidity experience human subject protection insight interest low and middle-income countries molecular marker novel participant retention point of care pragmatic trial premalignant programs protocol development recruit retention rate rural setting scale up screening skills social stigma uptake urban setting

AIDS prevention Ablation Accreditation Acetic Acids Acquired Immunodeficiency Syndrome Address African Age Area Awareness Cancer Burden Cancer Intervention Cancer Prevention Intervention Caring Clinic Clinic Visits Clinical Clinical Research Clinical Trials Clinical Trials Network Cohort Studies Cold Therapy Collaborations Communities Community Networks Competence Conduct Clinical Trials Country DNA Development Diagnostic Procedure Diagnostic Reagent Kits Education Effectiveness Emergency Situation Ensure Environment Ethics Excision Feasibility Studies Funding Goals Good Clinical Practice Guidelines HIV Health Health Personnel Health care facility Human Papilloma Virus Vaccination Human Papillomavirus Imaging Techniques Incidence Infrastructure International Intervention Laboratories Leadership Lesion Malignant Neoplasms Malignant neoplasm of cervix uteri Military Personnel Molecular Participant Perception Phase Policies Pragmatic clinical trial Prevention strategy Procedures Prospective Studies Protocols documentation Ramp Regulation Research Research Infrastructure Research Personnel Resource-limited setting Resources Sampling Scientist Screening for cancer Site Standardization Supervision Techniques Testing Thermal Ablation Therapy Training Translating Uganda Universities Visual Woman Women&apos s Group aged base cancer prevention carcinogenesis cervical cancer prevention clinical research site clinical trial protocol clinically significant community engagement community organizations comorbidity experience human subject protection insight interest low and middle-income countries molecular marker novel participant retention point of care pragmatic trial premalignant programs protocol development recruit retention rate rural setting scale up screening skills social stigma uptake urban setting

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项目摘要

PROJECT SUMMARY/ABSTRACT Uganda is one of 8 countries with the highest burden of cervical cancer (CXCA) among women living with HIV (WLWH) with an HIV-attributable age-standardized incidence rate of 10–20 per 100,000. Strategies for Cervical Cancer (CXCA) prevention include targeted Human Papillomavirus (HPV) vaccination, screening of women aged 25-49 years by visual inspection with acetic acid (VIA) or HPV DNA testing, and precancer treatment by cryotherapy or ablation. However, there is limited and sparse availability of and access to CXCA interventions which is compounded by low-uptake of ‘screen and treat’ strategies. Scalable, affordable, point-of-care, clinically proven novel interventions (including HPV self-sampling techniques, HPV molecular biomarker tests, precancer diagnostics and imaging techniques, and ablative and excisional treatments) are imperative. Further, the effectiveness of these novel clinically proven interventions remains unknown which limits implementation in intended-use settings in the US and low- and middle-income countries (LMICs). To support on-going efforts to roll-out novel screen and treat strategies, the Makerere University Walter Reed Project (MUWRP) in partnership with the U.S. Military HIV Research Program (MHRP) propose to participate in the HIV/Cervical Cancer Prevention ‘CASCADE’ Clinical Trials Network as a UG1 Clinical Research Site (UG1 CRS) to implement pragmatic clinical trials in Uganda. We will: 1) leverage MUWRP’s expertise and experience in clinical trials and CXCA prevention among WLWH to provide valuable insight and input on study feasibility, clinical significance and local context during concept and protocol development; 2) accrue CASCADE targets in a timely manner and retain ≥ 95% of study participants leveraging MUWRP’s pluripotent experience, clinical research infrastructure and resources; and 3) provide competent leadership to ensure procedural fidelity to protocols and all applicable regulations and guidelines. MUWRP will also support UG1 Research Bases and U24 Coordination Center to obtain ethical and regulatory approvals for CASCADE trials, and implement clinical trial protocols with fidelity. MUWRP is an ideal and rational choice for a UG1 CRS as MUWRP has: 1) access to over 37,000 WLWH in urban, semi-urban, and rural settings at 114 health facilities supported by MUWRP’s Comprehensive HIV/AIDS Prevention, Care and Treatment in Central Uganda (CARE) program funded by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR); 2) extensive experience conducting HIV clinical research and CXCA screening and precancer treatment in the African Cohort Study, and CARE supported CXCA program; and 3) internationally renowned scientists with experience and expertise in conducting clinical trials involving WLWH in Uganda and other LMICs. MUWRP’s expertise and capacity will support all four research focus areas of the CASCADE Network. MUWRP and MHRP will generate evidence that ultimately informs CXCA policy and screen and treat strategies for WLWH.

项目摘要/摘要在艾滋病毒的妇女中，乌干达是宫颈癌（CXCA）最高的8个国家之一（WLWH）具有可抗HIV的年龄标准化事件率为10-20每10万人。宫颈策略癌症（CXCA）预防包括靶向人乳头瘤病毒（HPV）疫苗接种，筛查年龄的妇女 25 - 49年通过乙酸（通过）或HPV DNA测试进行视觉检查，以及通过冷冻疗法或消融。但是，有限且稀疏的可用性和访问CXCA干预措施这是由“屏幕和治疗”策略低摄入量加重的。可扩展，负担得起的护理点，临床证明新颖的干预措施（包括HPV自抽样技术，HPV分子生物标志物测试，预科剂诊断和成像技术，以及消融和散布治疗）是必须的。此外，这些新型临床证明的干预措施的有效性仍然未知，哪些限制了在美国和低收入国家（LMIC）的预期使用环境。支持持续的努力推出新颖的屏幕和治疗策略，Makerere大学Walter Reed项目（MUWRP）合作通过美国军事艾滋病毒研究计划（MHRP）的提案，参加艾滋病毒/宫颈癌预防“级联”临床试验网络作为UG1临床研究站点（UG1 CRS）实施乌干达的务实临床试验。我们将：1）利用MUWRP在临床试验方面的专业知识和经验 WLWH中的CXCA预防可提供有关研究可行性的宝贵见解和投入概念和协议开发期间的本地环境； 2）及时累积级联目标保留≥95％的研究参与者利用MUWRP的多能经验，临床研究基础设施和资源； 3）提供有能力的领导才能确保程序保真对协议和所有适用法规和准则。 MUWRP还将支持UG1研究基础和U24协调中心获得级联试验的道德和监管部门批准，并以忠诚实施临床试验方案。 MUWRP是UG1 CRS的理想选择，因为MUWRP具有：1）访问37,000 wlwh MUWRP综合艾滋病毒/艾滋病支持的114个医疗机构的城市，半城市和粗糙环境美国总统紧急情况资助的乌干达中部（CARE）计划的预防，护理和治疗艾滋病救济计划（PEPFAR）； 2）进行HIV临床研究和CXCA筛查的丰富经验和非洲队列研究中的预科治疗，并且CARE支持CXCA计划； 3）国际拥有经验和专业知识的著名科学家在进行涉及WLWH的临床试验方面的经验和专业知识其他LMIC。 MUWRP的专业知识和能力将支持级联的所有四个研究重点领域网络。 MUWRP和MHRP将产生证据，最终告知CXCA政策和屏幕和治疗 WLWH的策略。