NCT04421131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

January 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 17, 2022

Completed
Last Updated

October 17, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

June 4, 2020

Results QC Date

June 29, 2022

Last Update Submit

September 20, 2022

Conditions

Cervical Cancer

Keywords

cervical cancer screeningcolposcopydigital health

Outcome Measures

Primary Outcomes (1)

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

    up to 142 days

Secondary Outcomes (13)

  • Percentage of Women Approached Who Consented to Participate in Study

    up to 142 days

  • Percentage of Women Approached Who Refused to Participate in Study

    up to 142 days

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

    up to 142 days

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

    up to 142 days

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

    up to 142 days

  • +8 more secondary outcomes

Study Arms (1)

mIVAA

EXPERIMENTAL

Screened for cervical cancer with mIVAA in mobile units

Device: Pocket colposcope/Mobile phone cameraOther: mIVAA

Interventions

Pocket colposcope/Mobile phone cameraDEVICE

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

mIVAA
mIVAAOTHER

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

mIVAA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently pregnant
  • History of hysterectomy
  • Does not understand the study purpose and details
  • Is not willing to sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Liga Contra el Cancer-Peru

Lima, Peru

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

In March of 2021, NIH agreed to reduce the scope of the study. Therefore, the investigators did not conduct any Aim 2 study activities indicated in the Study Protocol.

Results Point of Contact

Title
Lavanya Vasudevan, Ph.D.
Organization
Duke University
lavanya.vasudevan@duke.edu
919-613-1423

Study Officials

  • Lavanya Vasudevan, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

January 8, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 17, 2022

Results First Posted

October 17, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

PE(1)