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

Duke University

Status: Completed

Conditions: Cervical Cancer

Treatments: Other: mIVAA; Device: Pocket colposcope/Mobile phone camera

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04421131

Pro00100618

R21TW011223-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

mIVAA

Experimental group

Description:

Screened for cervical cancer with mIVAA in mobile units

Treatment:

Other: mIVAA

Device: Pocket colposcope/Mobile phone camera