mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)

Cervical Cancer Clinical Trial

Official title:

mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421131
• Other study ID #: Pro00100618
• Secondary ID: R21TW011223-02
• Status: Completed
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The central hypothesis is that use of mIVAA (mobile Inspección Visual con Ácido Acético - Spanish for Visual Inspection with Acetic Acid (VIA)) will increase the proportion of VIA positive women who complete follow-up clinical evaluation compared to VIA positive women in situations in which mIVAA was not used, thus potentially improving cervical cancer treatment and survival rates. The study will collect qualitative and quantitative data to examine the feasibility and preliminary impact of mIVAA on reducing attrition for follow-up clinical evaluations.

Description:

The study will be conducted in Lima, Peru in the context of mobile units operated by La Liga for promoting cancer screening. mIVAA comprises two components: a digital imaging device and a telemedicine platform.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• 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:

• Currently pregnant

• History of hysterectomy

• Does not understand the study purpose and details

• Is not willing to sign an informed consent

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Device:
• Pocket colposcope/Mobile phone camera
The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix

Other:
• mIVAA
A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist

Locations

Country	Name	City	State
Peru	La Liga Contra el Cancer-Peru	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment		up to 142 days
Secondary	Percentage of Women Approached Who Consented to Participate in Study		up to 142 days
Secondary	Percentage of Women Approached Who Refused to Participate in Study		up to 142 days
Secondary	Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+	Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.	up to 142 days
Secondary	Average Number of Days From Screening to When a Follow up Appointment is Scheduled		up to 142 days
Secondary	Median Number of Days From Screening to When a Follow up Appointment is Scheduled		up to 142 days
Secondary	Percentage of Women Who Were Screened Using mIVAA		up to 142 days
Secondary	Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA		up to 142 days
Secondary	Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date		up to 7 days
Secondary	Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife		up to 142 days
Secondary	Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist		up to 142 days
Secondary	Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife		up to 142 days
Secondary	Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert		up to 142 days
Secondary	Number of Instances of Network Failure		up to 142 days