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Completed

NCT Number: NCT04421131

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Liga Contra el Cancer-Peru

Lima, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pocket colposcope/Mobile phone camera

Device

The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix

mIVAA

Other

A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist

Primary outcomes

  1. 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 outcomes

  1. Percentage of Women Approached Who Consented to Participate in Study

    Time frame: up to 142 days

  2. Percentage of Women Approached Who Refused to Participate in Study

    Time frame: up to 142 days

  3. Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+

    Time frame: up to 142 days

    Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.

  4. Average Number of Days From Screening to When a Follow up Appointment is Scheduled

    Time frame: up to 142 days

  5. Median Number of Days From Screening to When a Follow up Appointment is Scheduled

    Time frame: up to 142 days

  6. Percentage of Women Who Were Screened Using mIVAA

    Time frame: up to 142 days

  7. Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA

    Time frame: up to 142 days

  8. Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date

    Time frame: up to 7 days

  9. Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife

    Time frame: up to 142 days

  10. Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist

    Time frame: up to 142 days

  11. Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife

    Time frame: up to 142 days

  12. Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert

    Time frame: up to 142 days

  13. Number of Instances of Network Failure

    Time frame: up to 142 days

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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