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: 10655623
• 负责人: Rebecca Luckett
• 金额: $ 25.59万
• 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/10655623
• 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; Grant; Guidelines; HIV; HPV analysis; HPV-High Risk; Health; Health Services; High Prevalence; Histopathology; Human Papillomavirus; Improve Access; Income; 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; 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 初级高危人乳头瘤病毒(HPV)检测已成为#年宫颈癌的一线筛查 高收入国家。这种方法在低收入和中等收入国家的可行性不太清楚，情况也是如此。 在携带人类免疫缺陷病毒(HIV)的妇女中进行初步HPV筛查的作用。正在评估 HPV直接检测宫颈癌筛查算法在HIV高发人群中的应用 像博茨瓦纳这样的环境对于在#年建立基于证据的宫颈癌筛查战略至关重要。 艾滋病毒负担高的人口生活在低收入和中等收入国家。建议进行的研究 评估创新的基于HPV的宫颈癌筛查算法在艾滋病毒携带者(WLHIV)和 建立一个纵向队列来评估长期结果。在部门内部的资助下，我已经开始 在博茨瓦纳东南区招募了3000名妇女，其中50%携带艾滋病毒。 这一队列的参与者接受了基线宫颈癌筛查，并进行了高危HPV检测和3种类型的 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。活检和组织病理学检查是比较这些方法疗效的金标准。 基于HPV的筛查算法。阴道镜检查和活组织检查显示可提供切除治疗。 结果。建议的K08的目标1将评估这些基于HPV的筛查算法的性能，如 以及单独检测HPV检测WLHIV宫颈异型增生。此外，在目标2中，我将进行间歇 该队列中基于HPV的WLHIV宫颈癌筛查以评估安全和有效的筛查 间隔时间。具体地说，我会在两年后对HPV检测呈阳性的WLHIV患者进行HPV检测 基线时为良性病理，基线时HPV检测为阴性的WLHIV患者为3年后。女人会的 根据基线筛查研究的结果进行分类测试。基于来自 基线和间隔筛选，在目标3中，我将制定一项试点实施研究，以评估 将基于人乳头瘤病毒的宫颈癌筛查纳入常规医疗服务，与 博茨瓦纳卫生和福利部。此K08将提供受保护的研究时间和构建技能 高级临床数据分析、临床试验设计和实施科学成为独立的 美国国立卫生研究院资助的研究人员。我的职业目标是通过评估和改善妇女的健康和健康 实施所有妇女都能负担得起的高性能宫颈癌筛查 他们的地理位置和社会经济地位。这项研究将在贝丝以色列的支持下进行 女执事医疗中心和博茨瓦纳哈佛艾滋病研究所的合作伙伴关系 有一个长期的研究约会。此外，这项研究将与 博茨瓦纳卫生和福利部，因此也影响了国家宫颈癌筛查政策 作为世界艾滋病病毒的国际政策。

项目成果

Feasibility and acceptability of an HPV self-testing strategy: lessons from a research context to assess for ability to implement into primary care at a national level in Botswana.

• DOI: 10.3389/fgwh.2023.1300788
• 发表时间: 2023
• 期刊: FRONTIERS IN GLOBAL WOMENS HEALTH
• 作者: Luckett, Rebecca;Ramogola-Masire, Doreen;Harris, Devon A.;Gompers, Annika;Gaborone, Kelebogile;Mochoba, Lorato;Ntshese, Lapelo;Mathoma, Anikie;Kula, Maduke;Shapiro, Roger;Larson, Elysia
• 通讯作者: Larson, Elysia

COVID-19 as a catalyst for reimagining cervical cancer prevention.

• DOI: 10.7554/elife.86266
• 发表时间: 2023-04-18
• 期刊: eLife
• 影响因子: 7.7
• 作者: Luckett R;Feldman S;Woo YL;Moscicki AB;Giuliano AR;de Sanjosé S;Kaufmann AM;Leung SOA;Garcia F;Chan K;Bhatla N;Stanley M;Brotherton J;Palefsky J;Garland S;International Papillomavirus Society (IPVS) Policy Committee
• 通讯作者: International Papillomavirus Society (IPVS) Policy Committee