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

摘要 宫颈癌是许多低收入和中等收入国家妇女中最常见的癌症， 包括肯尼亚。这主要是由于缺乏筛查，而筛查仍然是预防艾滋病毒/艾滋病的基石。 超过一亿的育龄妇女不属于目标年龄组或生活在 没有人乳头瘤病毒（HPV）疫苗的国家。虽然HPV筛查 实验室测试部分有可能被纳入简化的协议，需要程序， 有能力跟踪标本、结果和患者随访，这在 有限的医疗基础设施和没有电子病历。此外，HPV的基线知识较低 社区中的宫颈癌风险与筛查和随访率低有关， 有效的推广和教育是筛查方案的关键组成部分。这项工作往往由 社区卫生志愿者（CHV），内容特定的培训有限。我们建议填补这些空白 通过一个集成的数字平台，包括一个移动的应用程序（mSaada），支持患者和 标本追踪和随访，以及咨询和方案支持。在本项目的R21阶段，我们将： (1)与主要利益相关者以及本地和国际开发人员合作，最终确定mSaada平台， 在现有原型上增加病人和样本追踪功能;及（2）进行试验研究， 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 有效性和执行因素。我们将在两个卫生设施进行为期六个月的试点， 基于HPV的筛查，并使用性能指标，包括系统使用率，工作流程观察和 定性数据，用于指导整群随机临床试验（c-RCT）的计划，以确定 萨达。在项目的R33阶段，我们将使用混合实施有效性设计：（1） 在12个卫生机构开展为期18个月的c-RCT，以确定mSaada对宫颈癌的影响 社区妇女接受筛查、获得治疗和宫颈癌知识水平; 以及（2）衡量mSaada有效性、可持续性和规模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，确保当地和 区域基础设施具有可持续性所需的能力，并制定广泛的战略， 执行和扩大规模。与肯尼亚卫生部的主要利益攸关方合作， 促进制定长期可持续性计划，因为该国正在向基于HPV的宫颈癌转变。 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，可以在卫生保健基础设施有限的情况下接触到妇女。

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.