Rwanda CASCADE Clinical Trials Site for cervical cancer prevention

摘要 宫颈癌是一种由高危型人乳头瘤病毒引起的高度可预防的恶性肿瘤 （hrHPV），但不能完全预防，特别是在低收入和中等收入国家（LMIC）。 女性艾滋病毒感染者（WWH）hrHPV感染率较高， 浸润性宫颈癌撒哈拉以南非洲的宫颈癌负担最高 全球艾滋病负担最重。爱因斯坦/卢旺达研究和 能力建设方案（ER-RCBP）一直在进行宫颈癌研究 自2005年以来，卢旺达WWH的预防工作， 筛查摄取，筛查方式，评估HPV疫苗的有效性，评估如何 实施创新的筛查方法，并开发病理学和分子生物学， 实验室能力。我们已经招募了近10，000名妇女WWH和3，000名艾滋病毒阴性 宫颈HPV感染和疾病的研究。ER-RCBP在这方面的主要合作伙伴 应用，并在艾滋病毒服务和宫颈癌预防的先前研究，是卢旺达 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。卢旺达有一个非常有效的艾滋病毒医疗保健计划， 为女孩进行HPV疫苗接种的有效方案，并于最近启动了一项宫颈癌 筛查和预防计划，主要是HPV检测，然后对 如果有指征，对筛查阳性的妇女立即进行宫颈热消融治疗。 因此，卢旺达是一个理想的地点，测试战略，有效的宫颈癌筛查， 低收入国家，艾滋病毒、宫颈癌和大量未筛查的 人口我们建议在卢旺达建立一个临床试验基地，作为CASCADE临床试验的一部分。 子宫颈癌预防试验网络。在卢旺达吸取的经验教训可以概括为 许多撒哈拉以南非洲的低收入国家。

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.