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

摘要 在许多中低收入国家，宫颈癌是女性最常见的癌症， 包括肯尼亚。这主要是由于缺乏筛查，这仍然是预防疟疾的基石。 目标年龄组以外或居住在目标年龄组的1亿以上育龄妇女 没有人乳头瘤病毒(HPV)疫苗接种的国家。而基于HPV的筛查已经 为了将其整合到简化协议中，实验室测试组件需要程序来 能够跟踪样本、结果和患者随访，这在以下环境中可能是一个挑战 有限的医疗基础设施，没有电子病历。此外，对HPV的基线知识较低 社区患宫颈癌的风险与筛查和随访率低有关， 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(CHV)接受有限的特定内容培训。我们建议填补这些空白 通过包含移动应用程序(MSaada)的集成数字平台，该移动应用程序支持患者和 标本跟踪和跟踪，以及咨询和方案支持。在该项目的R21阶段，我们将： (1)与主要利益攸关方以及当地和国际开发商合作，敲定mSaada平台，建设 在现有原型上添加患者和样本跟踪功能；以及(2)进行试验性研究，以 确定设计试验以评估mSaada所需的患者、提供者和医疗系统因素 有效性和实施因素。我们将在两个卫生设施开展为期6个月的试点，提供 基于HPV的筛查，并使用包括系统使用率、工作流观察和 指导整群随机临床试验(c-RCT)计划的定性数据，以确定 萨达先生。在项目的R33阶段，我们将使用混合实施有效性设计来：(1) 对12家医疗机构进行为期18个月的c-rct，以确定msaada对宫颈癌的影响。 社区妇女的筛查吸收、治疗获得和宫颈癌知识水平； 以及(2)衡量MSAADA有效性、可持续性和扩大的必要实施因素。 严格的研究设计将使我们能够确定mSaada的临床影响，确保局部和 区域基础设施具有可持续发展所需的能力，并制定广泛的 实施和扩容。与肯尼亚卫生部的主要利益攸关方合作将 促进制定长期可持续发展计划，因为国家正在向基于HPV的宫颈转移 癌症筛查。我们预计，mSaada平台将在促进推出 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接触到妇女。

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.