Rwanda CASCADE Clinical Trials Site for cervical cancer prevention

摘要 宫颈癌是一种由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，特别是在低收入和中等收入国家(LMIC)。 携带艾滋病毒(WWH)的妇女hrHPV感染率更高，HPV感染率是 浸润性宫颈癌。撒哈拉以南非洲地区宫颈癌负担最重 在全球范围内，艾滋病毒是全球最大的负担。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，在卢旺达开展基于社区和诊所的研究 筛查吸收、筛查方式、评估HPV疫苗效力、评估如何 实施创新的筛查方法，发展病理学和分子生物学 实验室容量。我们招募了近10,000名女性WWH和3,000名艾滋病毒阴性者 参加宫颈HPV感染和疾病研究的妇女。呃-RCBP在这件事上的主要合作伙伴 在艾滋病毒服务和宫颈癌预防方面的先前研究中，卢旺达是 生物医学中心(RBC)，卢旺达卫生部的医疗保健实施部门 交付和研究。卢旺达有一个极其有效的艾滋病毒医疗保健计划，同样 为女孩接种HPV疫苗的有效方案，最近启动了宫颈癌 筛查和预防计划，首先进行HPV检测，然后进行目测 对于筛查阳性的妇女，如果有适应症，立即进行宫颈热消融治疗。 因此，卢旺达是测试有效宫颈癌筛查战略的理想地点 低收入国家，艾滋病毒、宫颈癌和大量未筛查的人负担很高 人口。我们在这里建议在卢旺达建立一个临床试验地点，作为级联临床试验的一部分 宫颈癌预防试验网络。在卢旺达学到的经验教训可以概括 撒哈拉以南非洲的许多低收入国家。

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.