mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
NCT ID: NCT04421131
Last Updated: 2022-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2021-01-08
2021-06-30
Brief Summary
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Detailed Description
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1. The digital imaging device is either a mobile phone camera or the pocket colposcope plugged into a mobile phone.
2. The telemedicine platform is mobile phone-based, with an interface for midwives in the mobile units to enter patient information and acquire and upload cervical images, and an interface for the colposcopists based remotely to review the cervical images and patient information and return feedback.
The specific aim is to pilot test mIVAA in a community-based setting in Peru.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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mIVAA
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera
The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA
A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
Interventions
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Pocket colposcope/Mobile phone camera
The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA
A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
Eligibility Criteria
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Inclusion Criteria
* Patients coming to the mobile unit for cervical cancer screening
* Willing to allow use of mIVAA during screening with VIA.
* Agree to be audio recorded
Exclusion Criteria
* History of hysterectomy
* Does not understand the study purpose and details
* Is not willing to sign an informed consent
18 Years
ALL
Yes
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Lavanya Vasudevan, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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La Liga Contra el Cancer-Peru
Lima, , Peru
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00100618
Identifier Type: -
Identifier Source: org_study_id
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