Rwanda CASCADE Clinical Trials Site for cervical cancer prevention

卢旺达 CASCADE 宫颈癌预防临床试验基地

基本信息

批准号：
10757692
负责人：
Kathryn M. Anastos
金额：
$ 22.63万
依托单位：
RESEARCH FOR DEVELOPMENT
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-22 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10757692
关键词：
12 year old 15 year old Address Adenocarcinoma In Situ Adherence Africa Africa South of the Sahara African Age Cancer Burden Cancer Etiology Central Africa Cervical Cervical Cancer Screening Cervical Intraepithelial Neoplasia Cervix Uteri Cessation of life Clinic Clinical Clinical Trials Clinical Trials Network Clinical Trials Unit Communities Consultations Country Cytology Data Disease Eastern Africa Enrollment Exposure to Genotype Government HIV HIV Seronegativity HPV-High Risk Health Healthcare Human Papilloma Virus Vaccination Human Papilloma Virus Vaccine Human Papillomavirus Human papilloma virus infection Immunization Programs Immunocompetence Incidence Infection Knowledge Laboratories Learning Lesion Location Malignant Neoplasms Malignant neoplasm of anus Malignant neoplasm of cervix uteri Methods Modality Molecular Pathology Performance Persons Population Prevention program Productivity Protocols documentation Research Research Personnel Risk Rwanda Services Site Standardization Testing Thermal Ablation Therapy Time Vaccinated Vaccination Viral Load result Visual Western Africa Woman Women&apos s Health Work World Health Organization acceptability and feasibility antiretroviral therapy arm attributable mortality cancer invasiveness cervical cancer prevention chronic infection clinical trial protocol clinically significant contextual factors experience girls health care delivery implementation evaluation implementation science implementation strategy innovation low and middle-income countries low income country mortality performance tests premalignant prevent programs protocol development screening screening program treatment program uptake vaccine effectiveness virtual virus related cancer

项目摘要

ABSTRACT Cervical cancer is a highly preventable malignancy caused by high-risk human papillomavirus (hrHPV) but is not fully prevented, especially in low- and middle-income countries (LMIC). Women living with HIV (WWH) have higher rates of hrHPV infection and 6-fold higher rates of invasive cervical cancer. Sub-Saharan Africa carries the highest burden of cervical cancer globally, as well as the highest global burden of HIV. The Einstein/Rwanda Research and Capacity Building Program (ER-RCBP) has been conducting research in cervical cancer prevention for Rwandan WWH since 2005, conducting community- and clinic-based research in screening uptake, screening modalities, assessing HPV vaccine effectiveness, evaluating how to implement innovative screening approaches, and developing pathology and molecular laboratory capacity. We have enrolled nearly 10,000 women WWH and 3,000 HIV-negative women in studies of cervical HPV infection and disease. ER-RCBP’s primary partner in this application, and in prior research in HIV services and cervical cancer prevention, is the Rwanda Biomedical Center (RBC), the implementation arm of Rwanda’s Ministry of Health for healthcare delivery and research. Rwanda has an extremely effective HIV healthcare program, an equally effective program for HPV vaccination of girls, and has recently launched a cervical cancer screening and prevention program with primary HPV testing followed by visual inspection of the cervix and immediate treatment with thermal ablation, if indicated, for screen-positive women. Rwanda is thus an ideal location for testing strategies for effective cervical cancer screening in a low-income country with a high burden of HIV, cervical cancer, and a large unscreened population. We propose here a clinical trials site in Rwanda as part of the CASCADE Clinical Trials Network for Cervical Cancer Prevention. Lessons learned in Rwanda can be generalized to many low-income countries in sub-Saharan Africa.

抽象的宫颈癌是高危人乳头瘤病毒引起的高度可预防的恶性肿瘤（HRHPV），但没有完全预防，尤其是在低收入和中等收入国家（LMIC）。艾滋病毒（WWH）的妇女的HRHPV感染率更高，高6倍侵入性宫颈癌。撒哈拉以南非洲承担着宫颈癌的最高负担在全球范围内以及全球艾滋病毒的最高负担。爱因斯坦/卢旺达研究和能力建设计划（ER-RCBP）一直在进行宫颈癌研究自2005年以来，卢旺达WWH的预防，从事社区和诊所的研究筛选吸收，筛查方式，评估HPV疫苗有效性，评估如何实施创新的筛查方法，发展病理和分子实验室能力。我们已经招募了近10,000名女性WWH和3,000名HIV阴性宫颈HPV感染和疾病研究的妇女。 ER-RCBP的主要合作伙伴卢旺达的应用以及预防HIV服务和宫颈癌的先前研究生物医学中心（RBC），卢旺达医疗保健卫生部的实施部门交付和研究。卢旺达拥有一项非常有效的艾滋病毒医疗保健计划，同样有效 HPV疫苗接种女孩的有效计划，并最近引发了宫颈癌筛选和预防计划，进行主要HPV测试，然后直观检查筛查阳性女性的热消融（如果指示）进行宫颈和立即治疗。因此，卢旺达是测试有效宫颈癌筛查策略的理想场所低收入国家，艾滋病毒，宫颈癌和大型未经人口。我们在这里建议在卢旺达一个临床试验站点，作为级联临床的一部分宫颈癌预防的试验网络。可以概括卢旺达的教训撒哈拉以南非洲的许多低收入国家。