Patient- and Practice-Centered Assessment of Self-Collection

以患者和实践为中心的自取评估

• 批准号: 8729296
• 负责人: Andrew Louis Sussman
• 金额: $ 29.77万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8729296
• 关键词: Address; American Indians; Appalachian Region; Caring; Cervical; Cervical Cancer Screening; Clinic; Clinical; Clinical Sensitivity; Collection; Communities; Community Practice; Complex; Continuity of Patient Care; Counseling; Country; Cytology; DNA; Decision Making; Development; Disease; Documentation; Effectiveness; Evaluation; Failure; Hispanics; Home environment; Human Papillomavirus; Income; Intervention; Intervention Trial; Interview; Life; Link; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methods; Mexico; Mississippi; New Mexico; Outcome; Outcome Measure; Patient Care; Patients; Performance; Phase; Population; Poverty; Prevention program; Primary Health Care; Process; Provider; Resources; Sample Size; Sampling; Self Assessment; Specimen; Test Result; Testing; Translational Research; Underserved Population; Woman; Work; aged; base; cancer care; cervical cancer prevention; cervicovaginal; design; experience; innovation; medically underserved; novel strategies; patient population; primary care setting; programs; screening; translational study; willingness

Failures to screen women for cervical cancer are well documented. The current U.S. screening program fails to reach small pockets of populations living mainly in low-resource, medically underserved regions as part of a complex of diseases linked to poverty and/or racial disparities. These populations have cen/ical cancer rates that are similar to middle-income countries and contribute approximately 60% of the cervical cancer cases that occur annually in the U.S. it is reasonable to suggest that the current cervical cancer prevention program has reached its limits and innovative strategies are needed to overcome these barriers and further reduce the burden in underserved populations. HPV DNA testing offers a promising strategy to enhance cervical screening coverage and address both patient and primary care provider challenges along the care process. HPV DNA testing is highly sensitive (90-95%) for identifying women with cervical precancer and cancer when using a clinician-collected specimen, and 20-50% more sensitive than routine cytology programs. Thus, self-collection combined with HPV DNA testing can potentially be used to extend access to women who are not reached by current Pap-based programs. However, there are only limited, small studies of self-collection in the U.S. and more work is needed to determine whether self-collection is acceptable to diverse patient populations as well as potential barriers toward integration of this approach into primary care settings. This mixed method study is designed to: 1. fully describe the current cervical cancer screening and treatment care continuum, and to assess the translational potential of a promising new approach - self-collection - by conducting a three-phase sequential mixed-method translational study (Phase la): 2. involve American Indian and Hispanic women in the co-development of a culturally-appropriate approach to self-collection (Phase lb): 3. integrate practice assessment and patient findings (Aims 1 and 2) in an intervention to assess the feasibility and comparability of self-collection methods for HPV testing and routine cervical cytology with HPV co-testing in four purposefully selected primary care clinical settings: (Phase 2)

有充分的文件证明，妇女未能进行宫颈癌筛查。美国目前的筛查计划 无法接触到主要生活在资源匮乏、医疗服务不足地区的小部分人口， 这是与贫困和/或种族不平等有关的一系列疾病的一部分。这些人群有中心/ical 癌症发病率与中等收入国家相似，约占宫颈癌发病率的60%。 美国每年发生的宫颈癌病例中，有理由认为目前的宫颈癌 预防计划已经达到了极限，需要创新的战略来克服这些问题 消除障碍，进一步减轻服务不足人群的负担。HPV DNA检测提供了一个有希望的 加强子宫颈普查复盖率及针对病人和基层医护人员策略 沿着护理过程的挑战。HPV DNA检测对于识别女性具有高度敏感性（90-95%） 当使用临床医生收集的标本时， 比常规的细胞学项目更重要因此，自我采集与HPV DNA检测相结合， 用于扩大目前基于Pap的方案无法覆盖的妇女的机会。但 在美国，只有有限的、小规模的自我收集研究，需要更多的工作来确定是否 自我采集对于不同的患者人群是可以接受的，也是整合的潜在障碍 将这种方法推广到初级保健机构。本混合方法研究旨在： 1.全面描述目前的宫颈癌筛查和治疗护理连续体，并评估 翻译潜力的一个有前途的新方法-自我收集-通过进行三个阶段 序贯混合方法转化研究（阶段la）： 2.让美国印第安人和西班牙裔妇女参与共同发展一种文化上适当的 自我收集方法（第1b阶段）： 3.在干预措施中整合实践评估和患者发现（目标1和2）， HPV检测和常规宫颈细胞学检查的自我收集方法的可行性和可比性， 在四个有目的选择的初级保健临床环境中进行HPV联合检测：（第2阶段）