Clinical trial NCT04421131: mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
Official title: mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer screening
colposcopy
digital health
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2020-06-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

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

Primary outcomes:
measure: Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment
timeFrame: up to 142 days
Secondary outcomes:
measure: Percentage of Women Approached Who Consented to Participate in Study
timeFrame: up to 142 days
measure: Percentage of Women Approached Who Refused to Participate in Study
timeFrame: up to 142 days
measure: Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+
timeFrame: up to 142 days
measure: Average Number of Days From Screening to When a Follow up Appointment is Scheduled
timeFrame: up to 142 days
measure: Median Number of Days From Screening to When a Follow up Appointment is Scheduled
timeFrame: up to 142 days
measure: Percentage of Women Who Were Screened Using mIVAA
timeFrame: up to 142 days
measure: Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
timeFrame: up to 142 days
measure: Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
timeFrame: up to 7 days
measure: Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
timeFrame: up to 142 days
measure: Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
timeFrame: up to 142 days
measure: Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
timeFrame: up to 142 days
measure: Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
timeFrame: up to 142 days
measure: Number of Instances of Network Failure
timeFrame: up to 142 days
Other outcomes:
Locations:
city: Lima
country: Peru
facility: La Liga Contra el Cancer-Peru
Study officials:
affiliation: Duke University
name: Lavanya Vasudevan, PhD
role: PRINCIPAL_INVESTIGATOR
References: