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

• 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
• 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

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女性最常见的癌症， 包括肯尼亚。这主要是由于缺乏筛查，而筛查仍然是预防的基石。 超过一亿不属于目标年龄组或生活在 不提供人乳头瘤病毒 (HPV) 疫苗接种的国家。虽然基于 HPV 的筛查已 由于有可能被纳入简化的方案中，实验室测试部分需要程序 有能力跟踪标本、结果和患者随访，这在有条件的环境中可能是一个挑战 医疗基础设施有限，没有电子病历。此外，HPV 基础知识较低 社区中宫颈癌的风险与筛查和随访率低有关，使得 有效的宣传和教育是筛查计划的关键组成部分。这项工作通常由 接受过有限内容特定培训的社区健康志愿者 (CHV)。我们建议填补这些空白 通过一个集成的数字平台，其中包括一个移动应用程序 (mSaada)，该应用程序支持 CHV 与患者和 样本追踪和随访，以及咨询和方案支持。在该项目的R21阶段，我们将： (1) 与主要利益相关者以及本地和国际开发商合作，最终确定 mSaada 平台，构建 在现有原型上添加患者和样本跟踪功能； (2) 开展试点研究 确定设计评估 mSaada 的试验所需的患者、提供者和卫生系统因素 有效性和实施因素。我们将在两个医疗机构进行为期六个月的试点，提供 基于 HPV 的筛查和使用绩效指标，包括系统使用率、工作流程观察和 定性数据指导整群随机临床试验 (c-RCT) 的规划，以确定有效性 萨达。在项目的R33阶段，我们将使用混合实施有效性设计来：（1） 在 12 家医疗机构中进行为期 18 个月的 c-RCT，以确定 mSaada 对宫颈癌的影响 社区妇女的筛查率、治疗获得率和宫颈癌知识水平； (2) 衡量 mSaada 有效性、可持续性和扩大规模所需的实施因素。 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发展所需的能力，并制定广泛的战略 实施和扩大规模。与肯尼亚卫生部主要利益相关者的合作将 随着国家转向基于 HPV 的宫颈癌，促进长期可持续发展计划的制定 癌症筛查。我们预计 mSaada 平台将在促进引入 基于 HPV 的筛查计划可以覆盖医疗保健基础设施有限的环境中的女性。