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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Pocket colposcope/Mobile phone camera
mIVAA
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring cervical cancer screening, colposcopy, digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • La Liga Contra el Cancer-Peru

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mIVAA

Arm Description

Screened for cervical cancer with mIVAA in mobile units

Outcomes

Primary Outcome Measures

Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2020
Last Updated
September 20, 2022
Sponsor
Duke University
Collaborators
Fogarty International Center of the National Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04421131
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Fogarty International Center of the National Institute of Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer screening, colposcopy, digital health

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mIVAA
Arm Type
Experimental
Arm Description
Screened for cervical cancer with mIVAA in mobile units
Intervention Type
Device
Intervention Name(s)
Pocket colposcope/Mobile phone camera
Intervention Description
The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
Intervention Type
Other
Intervention Name(s)
mIVAA
Intervention Description
A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
Primary Outcome Measure Information:
Title
Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment
Time Frame
up to 142 days
Secondary Outcome Measure Information:
Title
Percentage of Women Approached Who Consented to Participate in Study
Time Frame
up to 142 days
Title
Percentage of Women Approached Who Refused to Participate in Study
Time Frame
up to 142 days
Title
Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+
Description
Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.
Time Frame
up to 142 days
Title
Average Number of Days From Screening to When a Follow up Appointment is Scheduled
Time Frame
up to 142 days
Title
Median Number of Days From Screening to When a Follow up Appointment is Scheduled
Time Frame
up to 142 days
Title
Percentage of Women Who Were Screened Using mIVAA
Time Frame
up to 142 days
Title
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
Time Frame
up to 142 days
Title
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
Time Frame
up to 7 days
Title
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
Time Frame
up to 142 days
Title
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
Time Frame
up to 142 days
Title
Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
Time Frame
up to 142 days
Title
Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
Time Frame
up to 142 days
Title
Number of Instances of Network Failure
Time Frame
up to 142 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavanya Vasudevan, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Liga Contra el Cancer-Peru
City
Lima
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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