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

April 3, 2025 updated by: Emma McKim Mitchell, University of Virginia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Receives cervical screening, does not receive the mHealth intervention
Experimental: Intervention
Receives cervical screening, receives the mHealth intervention
Other: mHealth
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2-4 weeks after enrollment in the study
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).
2-4 weeks after enrollment in the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mHealth Intervention Impacts
Time Frame: 2-4 weeks after enrollment in the study
  1. Lost to follow-up (total number in control and intervention group)
  2. Time from initial screen through follow up treatment (measured in days)
2-4 weeks after enrollment in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Emma M Mitchell, PhD, RN, University of Virginia School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR231558

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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