mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in western Kenya

mSaada：改善肯尼亚西部宫颈癌筛查的移动健康工具

基本信息

批准号：
10688110
负责人：
Megan J. Huchko
金额：
$ 16.07万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-22 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10688110
关键词：
Address Adopted Africa South of the Sahara Cancer Burden Cancer Control Case Management Cellular Phone Cervical Cancer Screening Clinic Clinical Cluster randomized trial Collaborations Communities Community Health Computerized Medical Record Counseling Country Data Data Collection Decision Making Development Education and Outreach Effectiveness Electronics Eligibility Determination Ensure Focus Groups Future Guidelines Health Health care facility Health system Healthcare Human Papilloma Virus Vaccination Human Papilloma Virus-Related Malignant Neoplasm Human Papillomavirus Human Resources Individual Information Management Infrastructure International Intervention Interview Kenya Knowledge Laboratories Malignant Neoplasms Malignant neoplasm of cervix uteri Measures Modeling Morbidity - disease rate Patient Education Patients Performance Phase Pilot Projects Play Prevention Prevention program Prevention strategy Process Program Effectiveness Program Evaluation Protocols documentation Provider Recommendation Research Research Design Resource-limited setting Role Sampling Services Specimen Surveys System Technology Test Result Testing Time and Motion Studies Training Underserved Population United States Vaccination Woman Work World Health Organization acceptability and feasibility age group aged arm cancer risk cervical cancer prevention cost design digital digital health digital platform effectiveness clinical trial effectiveness evaluation effectiveness trial effectiveness/implementation design effectiveness/implementation study evidence base experience falls follow-up implementation determinants implementation facilitators implementation strategy improved innovation low and middle-income countries mHealth mobile application mortality open source prevent prevention service programs prototype randomized, clinical trials recruit reproductive risk perception scale up screening screening program tool uptake usability volunteer

项目摘要

Abstract Cervical cancer is the most common cancer among women in many low- and middle-income countries, including Kenya. This is mainly due to the lack of screening, which remains the cornerstone of prevention for the over one hundred million reproductive-aged women who fall outside the target age group or live in countries where the human papillomavirus (HPV) vaccination is not available. While HPV-based screening has the potential to be incorporated into simplified protocols, the laboratory testing component requires programs to have capacity to track specimens, results and patient follow-up, which can be a challenge in settings with limited healthcare infrastructure and no electronic medical records. Further, low baseline knowledge of HPV and cervical cancer risk in the community is associated with low rates of screening and follow-up, making effective outreach and education a key component of screening programs. This work is often done by community health volunteers (CHVs) with limited content-specific training. We propose to fill these gaps through an integrated digital platform that includes a mobile app (mSaada) that supports CHVs with patient and specimen tracking and follow-up, and counseling and protocol support. In the R21 phase of this project, we will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot study to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness and implementation factors. We will carry out a six-month pilot in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a cluster-randomized clinical trial (c-RCT) to determine effectiveness of mSaada. In the R33 phase of the project, we will use a hybrid implementation effectiveness design to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. We anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.

抽象的宫颈癌是许多低收入和中等收入国家中女性中最常见的癌症，包括肯尼亚。这主要是由于缺乏筛查，这仍然是预防的基石属于目标年龄段或居住在目标年龄段之外的一亿多百万生殖妇女没有人乳头瘤病毒（HPV）疫苗接种的国家。而基于HPV的筛选具有将其合并到简化协议中的潜力，实验室测试组件需要程序才能具有跟踪标本，结果和患者随访的能力，这可能是与有限的医疗基础设施，没有电子病历。此外，HPV的基线知识低社区中的宫颈癌风险与筛查和随访率低有关，使得有效的外展和教育是筛查计划的关键组成部分。这项工作通常是由社区卫生志愿者（CHVS）进行了有限的特定内容培训。我们建议填补这些空白通过一个包括移动应用程序（MSAADA）的集成数字平台，该应用程序支持患者的CHV和标本跟踪和随访以及咨询和协议支持。在该项目的R21阶段，我们将：（1）与主要利益相关者以及本地和国际开发商合作，最终确定MSAADA平台，建造在现有的原型上添加患者和标本跟踪功能；（2）进行试点研究确定设计试验以评估MSAADA所需的患者，提供者和卫生系统因素有效性和实施因素。我们将在两个提供的医疗机构中进行六个月的飞行员基于HPV的筛选，并使用性能指标，包括系统使用率，工作流观测和定性数据指导群集随机临床试验（C-RCT）的计划以确定有效性 MSAADA。在项目的R33阶段，我们将使用混合实施有效性设计：（1）在12个医疗机构中进行18个月的C-RCT，以确定MSAADA对宫颈癌的影响筛选社区女性的摄取，治疗获取和宫颈癌知识水平；（2）衡量MSAADA有效性，可持续性和扩大规模的必要实施因素。严格的研究设计将使我们能够确定MSAADA的临床影响，确保本地和区域基础设施具有可持续性必要的能力，并制定了广泛的策略实施和扩展。与肯尼亚卫生部的主要利益相关者合作将随着该国朝着基于HPV的宫颈的发展，促进长期可持续性计划的制定癌症筛查。我们预计MSAADA平台将在促进引入基于HPV的筛查计划，可以在医疗保健基础设施有限的环境中吸引妇女。