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

Study Overview
=================
Brief 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.

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. The digital imaging device is either a mobile phone camera or the pocket colposcope plugged into a mobile phone. 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.

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

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Device: Pocket colposcope/Mobile phone camera
* Other: mIVAA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mIVAA<br>Screened for cervical cancer with mIVAA in mobile units | Device: Pocket colposcope/Mobile phone camera<br>* The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix<br>Other: mIVAA<br>* A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer screening, colposcopy, digital health