Full Project 2: Determining Optimal Anal Cancer Prevention Strategies for HIV-Infected Individuals Living in Puerto Rico

完整项目 2：为居住在波多黎各的艾滋病毒感染者确定最佳的肛门癌预防策略

• 批准号: 10249300
• 负责人: Ashish A. Deshmukh
• 金额: $ 11.58万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-16 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249300
• 关键词: 17 year old; Adherence; Adoption; Age; Anal Intraepithelial Neoplasia; Anal carcinoma; Anus; Area; Behavior Therapy; Biopsy; Caring; Clinical Research; Cohort Studies; Costs and Benefits; Cross-Sectional Studies; Data; Data Analyses; Databases; Detection; Development; Diagnostic; Disease; Epidemic; Epidemiology; Evaluation; Expert Opinion; Focus Groups; Frequencies; Future; General Population; Geographic state; Goals; Guidelines; HIV; Health Promotion; Hispanics; Human Papilloma Virus Vaccination; Human Papillomavirus; Incidence; Individual; Interview; Link; Malignant Neoplasms; Malignant neoplasm of anus; Measures; Methods; Modeling; Patient Recruitments; Patients; Persons; Prevalence; Prevention; Prevention strategy; Prospective cohort study; Puerto Rico; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Regimen; Reporting; Risk; Screening for cancer; Secondary Prevention; Series; Squamous cell carcinoma; Squamous intraepithelial lesion; Stage at Diagnosis; Surveys; Treatment outcome; Uncertainty; University of Texas M D Anderson Cancer Center; Woman; Youth; aged; anticancer research; arm; base; cancer prevention; cancer therapy; cost; cost effective; cost effectiveness; epidemiology study; evidence base; health related quality of life; improved; life time cost; mathematical model; men; mortality; neoplasm registry; patient oriented; public health priorities; racial and ethnic; screening; screening guidelines; tool; unethical

FULL PROJECT 2: DETERMINING OPTIMAL ANAL CANCER PREVENTION STRATEGIES FOR HIV-INFECTED INDIVIDUALS LIVING IN PUERTO RICO PROJECT SUMMARY/ABSTRACT Squamous cell carcinoma of the anus (SCCA) is an epidemic among persons living with HIV (PLWH). Studies in the US and Puerto Rico (PR) have reported >80-fold risk of SCCA among PLWH when compared with the general population. Guidelines based on expert opinion recommend anal cancer screening for PLWH. To inform evidence-based use of screening, studies are currently underway; however, findings from those studies will not be generalizable to PLWH in PR. This is because racial and ethnic composition, disease prevalence, anal cancer treatment outcomes including cost and quality of life (QOL) substantially differ for PLWH in PR. This increases the importance of anal cancer screening evaluation specifically and separately for PLWH in PR majority of which are of Hispanic origin. Furthermore, no ongoing or future randomized controlled trials (RCTs) will evaluate mortality benefits of screening as it unethical to evaluate a “no screening” arm. As such, a mathematical model (incorporating epidemiological, cost, and quality of life data specific to PLWH in PR) could be utilized as a unique tool to evaluate survival and QOL benefits and cost-effectiveness of screening with the goal to promote health and value-based care. Our overarching goal is to optimize anal cancer prevention for PLWH in PR. We will study the epidemiology of SCCA, and evaluate the cost of and QOL after SCCA treatment to inform a mathematical model that will determine the best screening regimen for PLWH in PR. We also seek to study critical barriers and facilitators necessary to decrease potential uncertainty in screening adoption and adherence to screening recommendations. Our Specific Aims are: (1) Determine epidemiological, cost, and QOL measures of anal precancer and cancer among PLWH living in PR. (2) Identify barriers to and facilitators of screening for anal cancer, and adherence to anal cancer screening and high-grade squamous intraepithelial lesions (HSIL) treatment. (3) Construct and execute a mathematical model to determine effective and cost-effective screening strategies for the detection of anal precancer among PLWH in PR. (4) Use value of information (VOI) analysis to determine high priority future clinical studies to improve screening accuracy and adherence to screening recommendations. In Aims 1 and 2, we will perform secondary data analyses of existing databases, and conduct focus groups and three epidemiologic studies (two cross-sectional studies and one cohort study) that involve patient recruitment. Parameters identified through these activities will inform the development of the SCCA screening model and the execution of the VOI analysis (Aims 3 and 4). The end result of this study will be utilized to inform an optimal anal cancer screening regimen specific to PLWH in PR.

完整项目 2：确定最佳的肛门癌预防策略 对于居住在波多黎各的艾滋病毒感染者 项目概要/摘要 肛门鳞状细胞癌 (SCCA) 是艾滋病毒感染者 (PLWH) 中的一种流行病。研究 美国和波多黎各 (PR) 报告称，与普通人群相比，PLWH 中 SCCA 的风险高出 80 倍以上 一般人群。基于专家意见的指南建议对感染者进行肛门癌筛查。到 为筛查的循证使用提供信息，目前正在进行研究；然而，这些研究的结果 不能推广到 PR 中的 PLWH。这是因为种族和民族构成、疾病流行率、 PRWH 中的肛门癌治疗结果（包括费用和生活质量 (QOL)）存在显着差异。 这增加了针对 PRWH 中的肛门癌筛查评估的重要性 其中大多数是西班牙裔。此外，没有正在进行或未来的随机对照试验（RCT） 将评估筛查的死亡率益处，因为评估“无筛查”组是不道德的。因此，一个 数学模型（结合 PRWH 中特定的流行病学、成本和生活质量数据）可以 可用作评估生存和生活质量益处以及筛查成本效益的独特工具 促进健康和基于价值的护理的目标。我们的首要目标是优化肛门癌的预防 公共关系中的感染者。我们将研究SCCA的流行病学，并评估SCCA后的成本和生活质量 治疗为数学模型提供信息，该模型将确定 PRWH 中 PLWH 的最佳筛查方案。我们 还寻求研究减少筛查中潜在不确定性所需的关键障碍和促进因素 采用并遵守筛查建议。我们的具体目标是： (1) 确定流行病学、 生活在 PR 的 PLWH 中肛门癌前病变和癌症的成本和 QOL 指标。 (2) 识别障碍并 肛门癌筛查的促进者，以及坚持肛门癌筛查和高级别鳞状细胞癌 上皮内病变（HSIL）治疗。 (3) 构建并执行数学模型以确定有效的 以及用于在 PR 中的 PLWH 中检测肛门癌前病变的具有成本效益的筛查策略。 (4)使用价值 信息 (VOI) 分析，以确定未来的高优先级临床研究，以提高筛查准确性 并遵守筛查建议。在目标 1 和 2 中，我们将进行二次数据分析 现有数据库，并进行焦点小组和三项流行病学研究（两项横断面研究 和一项队列研究），涉及患者招募。通过这些活动确定的参数将告知 SCCA 筛选模型的开发和 VOI 分析的执行（目标 3 和 4）。结束 这项研究的结果将用于为 PR 中 PLWH 的最佳肛门癌筛查方案提供信息。