Translating Molecular Diagnostics for Cervical Cancer Prevention into Practice

将宫颈癌预防的分子诊断转化为实践

基本信息

批准号：
9330126
负责人：
PATTI E GRAVITT
金额：
$ 53.26万
依托单位：
GEORGE WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-08-10 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9330126
关键词：
Acetic Acids Adoption Biological Assay Biopsy Cancer Etiology Censuses Cervical Cervical Cancer Screening Characteristics Clinical Cold Therapy Colposcopy Communities Community Health Consent Country Cytology DNA Data Data Collection Decision Modeling Detection Development Diagnosis Disease Early Diagnosis Early treatment Effectiveness Eligibility Determination Ensure Evaluation Focus Groups Future Geographic Information Systems Goals HPV-High Risk Health Healthcare Human Papilloma Virus Vaccination Human Papillomavirus Incidence Income Individual Interruption Intervention Interview Laboratories Malignant Neoplasms Malignant neoplasm of cervix uteri Measurable Methods Molecular Monitor Nucleic Acids Oncoproteins Outcome Pap smear Peru Peruvian Phase Policy Maker Population Prevention program Process Program Appropriateness Program Sustainability Proteins Protocols documentation Public Health Practice Publications Qualitative Evaluations Quantitative Evaluations Registries Research Research Infrastructure Sampling Secondary Prevention Series Surveys System Technology Time Translating Triage Visit Visual Woman Work World Health Organization base burden of illness cervical cancer prevention community based participatory research comparative effectiveness cost-effectiveness evaluation design evidence base experience implementation research implementation science improved incremental cost-effectiveness informant instrument member mobile application molecular diagnostics point of care programs prototype public health relevance remote communities research study screening standard of care translational approach working group

项目摘要

DESCRIPTION (provided by applicant): Cervical cancer remains one of the leading causes of cancer among women, yet it is an entirely preventable disease. While HPV vaccination holds the greatest promise for reducing the global burden of cervical cancer, measurable reductions will not be realized for at least another 20 years. The only option for reducing cervical cancer incidence in the near term is increased accessibility of effective screening programs in regions with the highest burden of disease. The overarching goal of the Iquitos Screen-and-Treat Implementation Study (ISaTIS) is to move a strong evidence base for the use of screen-and-treat screening strategies into sustainable cervical cancer prevention programs appropriate for the health care context in the Loreto region of Peru and other middle income countries. Pilot participatory action research with key community stakeholders identified two acceptable alternative screening strategies for implementation evaluation: (1) single visit VIA- based screen-and-treat approach and (2) HPV DNA-based screening using self- or clinician-collected samples and HPV E6 oncoprotein triage-to-treatment. We will use a Participatory Action Research (PAR) approach, applying mixed methods, in an interrupted time series (ITS) design to develop, monitor, evaluate, and compare the two implementation strategies against current VIA-based standard of care screening. In Aim 1 we will conduct a community census in three communities in the Loreto region of Peru to establish cervical cancer screening registries and identify key members for working groups to facilitate our PAR approach. In Aim 2, we will use a series of focus group discussions, key informant interviews, and surveys to develop screening intervention monitoring and evaluation (M&E) criteria, objectives, methods, and instruments to be used in ongoing M&E of the implementation of each screening program using PAR processes. Our implementation strategies will be guided by the five domains outlined in the consolidated framework for implementation research (CFIR). In Aim 3 we will use the ITS design in a RE-AIM and CFIR-guided outcomes framework to evaluate the comparative effectiveness of each strategy. Qualitative and quantitative M&E methods iteratively executed in both pre- and post-implementation phases will be embedded into the overall ITS design, allowing real-time adaptation of the programs for broader sustainability. In Aim 4, we will synthesize our experience in a formal cost-effectiveness evaluation to allow policy makers to make comprehensive comparisons of each program relative to current standard of care and provide key data for future adoption in similar middle income countries. Publication of the outcomes of each process phase of our implementation research study will ensure maximal adoption of feasible and acceptable cervical cancer screening programs across a broad range of settings.

描述（由申请人提供）：宫颈癌仍然是女性癌症的主要原因之一，但它是一种完全可以预防的疾病。虽然 HPV 疫苗接种有望减少全球宫颈癌负担，但无法实现可测量的减少。至少再过 20 年，短期内降低宫颈癌发病率的唯一选择是在疾病负担最高的地区提高有效筛查计划的可及性。实施研究 (ISaTIS) 旨在将筛查与治疗筛查策略的使用纳入适合秘鲁洛雷托地区和其他中等收入国家医疗保健背景的可持续宫颈癌预防计划中。与主要社区利益相关者的研究确定了两种可接受的替代筛查策略用于实施评估：(1) 单次就诊基于 VIA 的筛查和治疗方法；(2) 使用自我或临床医生收集的样本和 HPV E6 癌蛋白进行基于 HPV DNA 的筛查我们将采用参与式行动研究 (PAR) 方法，应用混合方法，在中断时间序列 (ITS) 设计中根据当前基于 VIA 的标准来开发、监测、评估和比较两种实施策略。在目标 1 中，我们将在秘鲁洛雷托地区的三个社区进行社区普查，以建立宫颈癌筛查登记处并确定工作组的主要成员，以促进我们的 PAR 方法。焦点小组的讨论、关键知情人访谈和调查，以制定筛查干预监测和评估 (M&E) 标准、目标、方法和工具，用于使用 PAR 流程实施每个筛查计划的持续监测和评估。在目标 3 中，我们将使用 RE-AIM 和 CFIR 指导的结果框架中概述的五个领域来评估每个策略的定性和定量 M&E 方法的比较有效性。在实施前和实施后阶段迭代执行的项目将嵌入到整体 ITS 设计中，从而能够实时调整项目以实现更广泛的可持续性。在目标 4 中，我们将综合我们在正式成本效益评估中的经验，以实现更广泛的可持续性。政策制定者将每个相关计划与当前的护理标准进行全面比较，并为未来在类似的中等收入国家采用提供关键数据，公布我们实施研究的每个过程阶段的结果将确保最大限度地采用可行和可接受的宫颈治疗。广泛的癌症筛查计划设置范围。