Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-64
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between ages of 25-64
Owns smart phone with Android operating system
Lives on the Caribbean Coast of Nicaragua
Disqualifiers
Pap test or cervical screen in the last year
Pregnant currently
Trial design
Design model
Parallel
Treatments tested in this trial
mHealth
Other interventionThis 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.
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program
The Systems Usability Scale (minimum 1, maximum 5, higher scores mean more positive outcome).
Time frame
2-4 weeks after enrollment in the study2
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program
(2) the uMobile App Rating Scale (minimum 1, maximum 4, higher scores mean more positive outcome).
Time frame
2-4 weeks after enrollment in the studySecondary outcomes
1
mHealth Intervention Impacts
1. Lost to follow-up (total number in control and intervention group) 2. Time from initial screen through follow up treatment (measured in days)
Time frame
2-4 weeks after enrollment in the studyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: