Mixed-Methods approach to evaluate a mHealth intervention to increase adherence to triage of HPV+ women who have performed self-collection

采用混合方法评估移动医疗干预措施，以提高对自行采集 HPV 的女性进行分诊的依从性

• 批准号: 9365804
• 负责人: Silvina Arrossi
• 金额: $ 40.72万
• 依托单位: CENTER FOR THE STUDY OF STATE / SOCIETY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9365804
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Argentina; Cancer Control; Cancer Etiology; Categories; Cervical; Cervical Intraepithelial Neoplasia; Cessation of life; Cluster randomized trial; Collection; Colon Carcinoma; Colposcopy; Communication; Communities; Community Health; Community Health Aides; Counseling; Country; Cytology; DNA; Data Analyses; Data Collection; Detection; Developing Countries; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Effectiveness; Electronic Mail; Evaluation; Factor Analysis; Family; Fright; Gender; Health; Health Promotion; Health system; Healthcare; Home visitation; Household; Human Papillomavirus; Human Resources; Hybrids; Incidence; Inequality; Intervention; Latin America; Lesion; Link; Localized Malignant Neoplasm; Maintenance; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methodology; Methods; Modeling; Pap smear; Patients; Premalignant; Prevention; Procedures; Process; Public Health; Regional Cancer; Reporting; Research Design; Risk; Sampling; Screening for cancer; Structure; System; Techniques; Test Result; Testing; Transportation; Triage; Trust; Visit; Woman; Work; Workload; base; follow-up; implementation research; implementation science; improved; innovation; innovative technologies; mHealth; malignant breast neoplasm; member; mortality; new technology; novel; population health; programs; research study; scale up; screening; social; treatment as usual

7. Project summary/abstract PROJECT: Mixed-Methods approach to evaluate a mHealth intervention to increase adherence to triage of HPV+ women who have performed self-collection Cervical cancer is a serious public health problem reflecting social and gender inequalities in health. It is the third cause of cancer death among women in the world, with more than 85% of cases occurring in developing countries. Currently, the development of new technologies based on HPV DNA detection allows HPV self- collection, increasing screening coverage. In a self-collection based strategy, triage becomes a key step in the prevention process, as it is the first method to identify HPV+ women who will need diagnostic and treatment procedures. However, high adherence to triage is difficult to obtain, which is not surprising given that adherence to follow-up and treatment is a generalized problem in cervical cancer programs. Specific aims of the study are: 1. To evaluate the effectiveness of an innovative multi-component mHealth intervention to increase adherence to triage among women with HPV+ self-collected tests compared to usual care. 2. To evaluate the implementation strategy and identify barriers and facilitators to implementation of the multi-component mHealth intervention. The research study design will follow the structure of an effectiveness-implementation hybrid type I trial, and will use mix-method approach. A cluster randomized trial including 200 CHWs (clusters) and 4000 women will be used to evaluate the effectiveness of the multi-component mHealth intervention to increase adherence to cytology triage at 120 days after positive HPV testing. The mHealth intervention will include SMS messages sent to HPV+ women to inform them when results are available, and subsequent SMS messages as reminders. In addition, for those HPV+ women who did not had a triage cytology result within 60 days of the HPV test result, CHWs will receive an e-mail and SMS message so they can contact these women during home visits for specific counseling and support. For the implementation evaluation, the Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection and analysis of factors that influence implementation. RE-AIM will be used to assess the Reach, Effectiveness, Adoption, Implementation and Maintenance of the Intervention. Results of this project will provide evidence on the effectiveness of the multi-component mHealth intervention to increase triage of HPV+ women, but it could be adapted to increase compliance of diagnoses/ treatment of cervical cancer and other health problems. Findings from the implementation evaluation will be highly applicable to programs that use or are planning to incorporate HPV self-collection in different settings and countries. In addition, the use of CFIR and RE-AIM in this innovative study will serve as a model of work, constituting an important advance in the use of Implementation Science in the Region.

7.项目概要/摘要 项目：混合方法的方法来评估移动健康干预措施，以增加遵守分诊的 进行过自我采集的HPV阳性女性 宫颈癌是一个严重的公共卫生问题，反映了健康方面的社会和性别不平等。是 癌症是世界上妇女死亡的第三大原因，85%以上的病例发生在发展中国家。 国家目前，基于HPV DNA检测的新技术的发展使得HPV自我检测成为可能。 收集，提高筛查覆盖率。在基于自我收集的策略中，分类成为 预防过程，因为它是识别需要诊断和治疗的HPV+妇女的第一种方法 程序.然而，很难获得高度遵守分诊，这并不奇怪，因为 坚持随访和治疗是宫颈癌项目中普遍存在的问题。 本研究的具体目的是：1.评估创新的多组件移动健康的有效性 干预措施，以增加与常规相比，HPV+自我收集检测的女性对分诊的依从性 在乎2.评估实施战略，并确定实施战略的障碍和促进因素， 多要素移动健康干预。 研究设计将遵循有效性-实施混合I型试验的结构， 将采用混合方法。一项包括200名CHW（集群）和4000名妇女的集群随机试验将 用于评估多组分移动健康干预措施的有效性，以提高对 HPV检测阳性后120天进行细胞学分诊。移动健康干预措施将包括短信 发送给HPV+妇女，通知他们何时有结果，以及随后的短信， 提醒.此外，对于那些HPV+的妇女谁没有在60天内的分流细胞学结果， HPV检测结果，CHW将收到一封电子邮件和短信，以便他们可以在 进行家访，以获得具体的咨询和支持。关于执行情况评价， 实施研究框架将用于指导定性数据收集和分析 影响实施的因素。RE-AIM将用于评估覆盖范围、有效性、采用率， 干预措施的实施和维护。 该项目的结果将提供证据证明多组件移动健康干预措施的有效性 增加HPV+女性的分流，但它可以适应于增加诊断/治疗的依从性， 宫颈癌和其他健康问题。执行情况评价的结果将高度 适用于在不同环境中使用或计划纳入HPV自我采集的计划， 国家此外，在这项创新研究中使用CFIR和RE-AIM将作为一种工作模式， 这是该地区应用实施科学的一个重要进步。