Evaluation of triage strategies and screening intervals in a human papillomavirus based cervical cancer screening program in women living with human immunodeficiency virus in Botswana

博茨瓦纳人类免疫缺陷病毒感染妇女基于人乳头瘤病毒的宫颈癌筛查计划的分诊策略和筛查间隔的评估

• 批准号: 10483598
• 负责人: Rebecca Luckett
• 金额: $ 25.86万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10483598
• 关键词: Acetic Acids; Acquired Immunodeficiency Syndrome; Africa South of the Sahara; Algorithms; Appointment; Artificial Intelligence; Benign; Biological Assay; Biopsy; Botswana; Cancer Etiology; Cervical; Cervical Cancer Screening; Cervical dysplasia; Cervix Uteri; Cessation of life; Clinical Data; Clinical Services; Clinical Trials Design; Cohort Studies; Collaborations; Colposcopy; Country; Data; Data Analytics; Disease; Effectiveness; Evaluation; Excision; Foundations; Funding; Geography; Goals; Gold; Grant; Guidelines; HIV; HPV-High Risk; Health; Health Services; High Prevalence; Histopathology; Human Papillomavirus; Improve Access; Income; Institutes; International; Israel; Logistics; Longitudinal cohort; Malignant neoplasm of cervix uteri; Medical center; Mentors; Methods; Microscope; Outcome; Participant; Pathology; Performance; Policies; Population; Positioning Attribute; Positive Test Result; Predictive Value; Prevalence; Prevention program; Reach Effectiveness Adoption Implementation and Maintenance; Research; Research Design; Research Personnel; Research Training; Resource-limited setting; Role; Services; Socioeconomic Status; Statistical Data Interpretation; Testing; Time; Training; Triage; United States National Institutes of Health; Visual; Visualization; Woman; World Health Organization; acceptability and feasibility; aged; aging population; automated visual evaluation; base; career; cervical cancer prevention; clinical research site; cohort; comparative efficacy; cost; evidence base; evidence based guidelines; experience; follow-up; high risk; high standard; implementation science; implementation strategy; implementation study; improved; innovation; low and middle-income countries; performance tests; prevention service; prospective; recruit; reproductive; screening; screening policy; screening program; screening services; skills; study population; success; uptake

ABSTRACT Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries is less clear, as is the role of primary HPV screening among women living with human immunodeficiency virus (HIV). Evaluating the performance of cervical cancer screening algorithms using primary HPV testing in high HIV prevalence settings like Botswana is essential for establishing an evidence-based strategy for cervical cancer screening in populations with a high burden of HIV living in low- and middle-income countries. The proposed study evaluates innovative HPV-based cervical cancer screening algorithms in women living with HIV (WLHIV) and builds a longitudinal cohort to evaluate long-term outcomes. With internal departmental funding, I have begun recruitment of a cohort of 3,000 women, 50% of whom are living with HIV, in South East District, Botswana. Participants in this cohort undergo baseline cervical cancer screening with high-risk HPV testing and 3 types of visual triage evaluation: 1) visual assessment with acetic acid, 2) colposcopy, and 3) automated visual evaluation. Biopsy with histopathology is collected as the gold standard in comparing the efficacy of these HPV-based screening algorithms. Excisional treatment is offered as indicated by colposcopy and biopsy results. Aim 1 of the proposed K08 will evaluate the performance of these HPV-based screening algorithms, as well as HPV testing alone in detecting cervical dysplasia in WLHIV. Additionally, in Aim 2, I will conduct interval HPV-based cervical cancer screening for the WLHIV in this cohort to evaluate safe and effective screening intervals. Specifically, I will repeat HPV testing at 2 years in WLHIV who tested positive for HPV and had benign pathology at baseline, and at 3 years in WLHIV who tested negative for HPV at baseline. Women will undergo triage testing according to the findings of the baseline screening study. Based on the data from baseline and interval screening, in Aim 3, I will develop a pilot implementation study to evaluate the incorporation of HPV-based cervical cancer screening into routine health services, in collaboration with the Ministry of Health and Wellness of Botswana. This K08 will provide protected research time and build skills in advanced clinical data analytics, clinical trial design, and implementation science to become an independent NIH-funded researcher. My career goal is to improve the health and wellness of women through evaluation and implementation of high-performance cervical cancer screening that is within reach of all women regardless of their geography and socioeconomic status. The research will be conducted with the support of the Beth Israel Deaconess Medical Center and through the Botswana Harvard AIDS Institute Partnership with which the PI has a long-standing research appointment. Furthermore, this research will be done in collaboration with the Ministry of Health and Wellness of Botswana, thus impacting national cervical cancer screening policy as well as international policy for WLHIV.

抽象的 原发性高危人乳头瘤病毒 (HPV) 检测已成为宫颈癌的一线筛查 高收入国家。这种方法在低收入和中等收入国家的可行性尚不清楚，因为 初级 HPV 筛查在感染人类免疫缺陷病毒 (HIV) 的女性中的作用。评估中 在 HIV 高流行情况下使用初级 HPV 检测的宫颈癌筛查算法的性能 像博茨瓦纳这样的国家对于建立基于证据的宫颈癌筛查策略至关重要 生活在低收入和中等收入国家的艾滋病毒高负担人群。拟议的研究 评估 HIV 感染女性 (WLHIV) 中基于 HPV 的创新宫颈癌筛查算法 建立一个纵向队列来评估长期结果。有了内部部门的资金，我已经开始 在博茨瓦纳东南区招募了 3,000 名女性，其中 50% 感染艾滋病毒。 该队列的参与者接受了基线宫颈癌筛查，包括高危 HPV 检测和 3 种类型的宫颈癌筛查。 视觉分类评估：1）醋酸视觉评估，2）阴道镜检查，3）自动视觉 评估。收集活检和组织病理学作为比较这些药物疗效的金标准 基于 HPV 的筛查算法。根据阴道镜检查和活检的指示提供切除治疗 结果。拟议 K08 的目标 1 将评估这些基于 HPV 的筛查算法的性能，如下所示 以及仅 HPV 检测可检测 WLHIV 患者的宫颈发育不良。另外，在目标 2 中，我将进行间隔 针对该队列中的 WLHIV 进行基于 HPV 的宫颈癌筛查，以评估安全有效的筛查 间隔。具体来说，我将在 HPV 检测呈阳性且患有 WLHIV 的 2 岁时重复进行 HPV 检测。 基线时为良性病理，WLHIV 患者 3 年时基线 HPV 检测呈阴性。女人会 根据基线筛查研究的结果进行分类测试。根据来自的数据 基线和间隔筛选，在目标 3 中，我将开展一项试点实施研究来评估 与以下机构合作，将基于 HPV 的宫颈癌筛查纳入常规卫生服务 博茨瓦纳卫生和保健部。 K08 将提供受保护的研究时间并培养以下方面的技能 先进的临床数据分析、临床试验设计和实施科学，成为独立的 NIH 资助的研究员。我的职业目标是通过评估和改善女性的健康和福祉 实施所有妇女都可以进行的高性能宫颈癌筛查，无论其性别如何 他们的地理位置和社会经济地位。该研究将在贝斯以色列的支持下进行 女执事医疗中心并通过博茨瓦纳哈佛艾滋病研究所合作伙伴关系，PI 有长期的研究任命。此外，这项研究将与 博茨瓦纳卫生和保健部，从而影响国家宫颈癌筛查政策 作为 WLHIV 的国际政策。