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.

摘要