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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Device: Pocket colposcope/Mobile phone camera; Other: mIVAA

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru
    • La Liga Contra el Cancer-Peru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mIVAA; Screened for cervical cancer with mIVAA in mobile units	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment	up to 142 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Women Approached Who Consented to Participate in Study		up to 142 days
Percentage of Women Approached Who Refused to Participate in Study		up to 142 days
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
Average Number of Days From Screening to When a Follow up Appointment is Scheduled		up to 142 days
Median Number of Days From Screening to When a Follow up Appointment is Scheduled		up to 142 days
Percentage of Women Who Were Screened Using mIVAA		up to 142 days
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA		up to 142 days
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date		up to 7 days
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife		up to 142 days
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist		up to 142 days
Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife		up to 142 days
Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert		up to 142 days
Number of Instances of Network Failure		up to 142 days

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Fogarty International Center of the National Institute of Health

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: digital health; colposcopy; cervical cancer screening
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: Pro00100618; R21TW011223-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes