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NCT Number: NCT06921798

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

mHealth

Other

This mHealth intervention is designed to provide health education, and to notify study participants when their result is ready and it is time for them to return to the healthcare clinic for follow up.

Primary outcomes

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

    Time frame: 2-4 weeks after enrollment in the study

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

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

    Time frame: 2-4 weeks after enrollment in the study

    (2) the uMobile App Rating Scale (minimum 1, maximum 4, higher scores mean more positive outcome).

Secondary outcomes

  1. mHealth Intervention Impacts

    Time frame: 2-4 weeks after enrollment in the study

    • Lost to follow-up (total number in control and intervention group)
    • Time from initial screen through follow up treatment (measured in days)

Study contacts

Contact information is provided by the study sponsor or research team.

Emma M Mitchell, PhD, RN, CPH

CONTACT

[email protected]

4342433962

Souad Benloukil, MD, CCRC

CONTACT

[email protected]

434-466-6314

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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