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

NCT04421131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2022-10-17

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Lavanya Vasudevan, PhD · Duke University

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

Countries

  • Peru

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421131 on ClinicalTrials.gov