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

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.

项目概要/摘要乌干达是艾滋病毒感染者宫颈癌 (CXCA) 负担最高的 8 个国家之一 (WLWH)，HIV 归因年龄标准化发病率为每 100,000 人 10-20 例。癌症 (CXCA) 预防包括有针对性的人乳头瘤病毒 (HPV) 疫苗接种、老年妇女筛查 25-49 岁，通过目视检查，使用醋酸 (VIA) 或 HPV DNA 检测，并通过以下方法进行癌前治疗然而，CXCA 干预措施的可用性和获取机会有限且稀少。可扩展的、负担得起的、临床护理点的“筛查和治疗”策略的采用率较低，这使得情况变得更加复杂。经证实的新颖干预措施（包括 HPV 自我采样技术、HPV 分子生物标志物测试、癌前病变诊断和成像技术以及消融和切除治疗）也是必要的。这些经过临床验证的新型干预措施的有效性仍然未知，这限制了其实施美国和低收入和中等收入国家 (LMIC) 的预期用途环境支持正在进行的努力。与马凯雷雷大学沃尔特里德项目 (MUWRP) 合作推出新颖的筛查和治疗策略与美国军方艾滋病毒研究计划 (MHRP) 合作提议参与艾滋病毒/宫颈癌研究预防‘CASCADE’临床试验网络作为 UG1 临床研究中心 (UG1 CRS) 实施我们将：1）利用 MUWRP 在临床试验方面的专业知识和经验。 WLWH 中的 CXCA 预防可为研究可行性、临床意义提供宝贵的见解和投入 2) 及时制定 CASCADE 目标；利用 MUWRP 的多能经验、临床研究基础设施保留 ≥ 95% 的研究参与者和资源；以及 3) 提供称职的领导，以确保程序忠实于协议和所有适用的内容 MUWRP 还将支持 UG1 研究基地和 U24 协调中心获得 CASCADE 试验的伦理和监管批准，并忠实地实施临床试验方案。 MUWRP 是 UG1 CRS 的理想且合理的选择，因为 MUWRP 具有：1) 可以访问超过 37,000 个 WLWH 由 MUWRP 综合艾滋病毒/艾滋病项目支持的 114 个卫生设施覆盖城市、城乡结合部和农村地区由美国总统紧急情况资助的乌干达中部预防、护理和治疗 (CARE) 计划艾滋病救济计划 (PEPFAR)；2) 开展 HIV 临床研究和 CXCA 筛查的丰富经验和非洲队列研究中的癌前治疗，以及 CARE 支持的 CXCA 计划；以及 3) 国际范围内的治疗；著名科学家，在乌干达进行 WLWH 临床试验方面拥有丰富的经验和专业知识其他中低收入国家 MUWRP 的专业知识和能力将支持 CASCADE 的所有四个研究重点领域。 MUWRP 和 MHRP 将生成最终为 CXCA 政策以及筛查和治疗提供信息的证据。 WLWH 策略。