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临床试验/NCT06921798
NCT06921798尚未招募不适用

Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program

University of Virginia0 个研究点目标入组 3,000 人开始时间: 2025年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
主要终点
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program

研究概览

简要总结

The goal of this clinical trial is to test an mHealth intervention for cervical cancer prevention in under-screened women ages 25-64 on the Caribbean Coast of Nicaragua. The mHealth intervention combines a patient-centered mobile app, a provider portal, and connectivity to the National Breast and Cervical Cancer Surveillance System (SIVIPCAN). The mHealth intervention will be combined with HPV primary screening for cervical cancer. The main questions it aims to answer are, when integrated into an HPV-based screening program:

Is the mHealth intervention acceptable? Is the mHealth intervention feasible?

Researchers will compare the intervention group (mHealth intervention) to the control group (standard care).

Participants will:

Receive HPV-based cervical screening. Intervention group: Through the patient-centered app, participants will receive "results ready" notification and navigation to the clinic for follow-up.

Control group: Participants will receive "results ready" notification and navigation to the clinic for follow-up through existing communication channels.

详细描述

Cervical cancer, a preventable cancer of disparities, is the primary cause of cancer death for women in Nicaragua. The World Health Organization (WHO) adopted an elimination strategy for cervical cancer within the next 100 years, and outlined specific targets to meet by 2030: vaccination (90% of girls before age 15); screening/early detection (70% of women get a high-quality screen by 35 and again at 45); and treatment (90% of pre-cancerous and cancerous lesions treated). As the majority of the burden of cervical cancer exists in low- and middle-income countries (LMICs), significant research into the development, implementation, and cost-effectiveness of community-based cervical cancer screening models using HPV primary screening has developed a strong evidence-base for the acceptability and feasibility of this modality. However, significant geographic variability exists in successfully improving patient health outcomes and preventing cervical cancer, particularly in rural and remote geographic areas. In Nicaragua, significant intra-country variability exists in terms of yearly participation in cervical cancer screening by eligible women, and likelihood of lifetime screening, depending on geographic region. There is a demonstrated need for culturally tailored, regionally specific innovations in evidence-based HPV primary cervical screening programs. Researchers at the University of Virginia have worked with community partner non-governmental organization Fundacion Movicancer over the past several years to develop and create an mHealth platform that combines: (1) a patient-centered mobile application (app) called "Azulado" with (2) a provider-focused portal, as well as integration of the provider-focused portal with the (3) National Cervical Cancer Surveillance System (SIVIPCAN).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Between ages of 25-64
  • •Owns smart phone with Android operating system
  • •Lives on the Caribbean Coast of Nicaragua

排除标准

  • •Pap test or cervical screen in the last year
  • •Pregnant currently

研究组 & 干预措施

Control

No Intervention

Receives cervical screening, does not receive the mHealth intervention

Intervention

Experimental

Receives cervical screening, receives the mHealth intervention

干预措施: mHealth (Other)

结局指标

主要结局

Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program

时间窗: 2-4 weeks after enrollment in the study

The Systems Usability Scale (minimum 1, maximum 5, higher scores mean more positive outcome).

次要结局

  • mHealth Intervention Impacts(2-4 weeks after enrollment in the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma McKim Mitchell

Associate Professor

University of Virginia

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