Trial Outcomes & Findings for mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA) (NCT NCT04421131)
NCT ID: NCT04421131
Last Updated: 2022-10-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
up to 142 days
Results posted on
2022-10-17
Participant Flow
Informed consent was obtained prior to establishing eligibility. One consented participant was deemed ineligible and one was ineligible due to not completing screening.
Participant milestones
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
Referred to a Follow up Screening
|
17
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
App crashed
|
5
|
Baseline Characteristics
mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
Baseline characteristics by cohort
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 142 daysPopulation: Participants who were referred.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=17 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment
|
82.4 percentage of women
|
SECONDARY outcome
Timeframe: up to 142 daysPopulation: Women who were approached to participate in the study.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=112 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Percentage of Women Approached Who Consented to Participate in Study
|
100 percentage of women
|
SECONDARY outcome
Timeframe: up to 142 daysPopulation: Women who were approached to participate in the study.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=112 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Percentage of Women Approached Who Refused to Participate in Study
|
0 percentage of women
|
SECONDARY outcome
Timeframe: up to 142 daysPopulation: Participants who completed the study.
Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 142 daysPopulation: Participants who completed the study.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Average Number of Days From Screening to When a Follow up Appointment is Scheduled
|
26.6 days
Standard Deviation 41.1
|
SECONDARY outcome
Timeframe: up to 142 daysPopulation: Participants who completed the study.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Median Number of Days From Screening to When a Follow up Appointment is Scheduled
|
6 days
Interval 3.0 to 116.0
|
SECONDARY outcome
Timeframe: up to 142 daysOutcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Percentage of Women Who Were Screened Using mIVAA
|
100 percentage of women
|
SECONDARY outcome
Timeframe: up to 142 daysPopulation: Participants who completed the study.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
|
2.0 hours
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: up to 7 daysPopulation: Participants who completed the study.
Outcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
|
100 percentage of women
|
SECONDARY outcome
Timeframe: up to 142 daysOutcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 142 daysOutcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
|
17 Participants
|
SECONDARY outcome
Timeframe: up to 142 daysOutcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
|
3.35 attempts
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: up to 142 daysOutcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
|
84.3 percentage of women
|
SECONDARY outcome
Timeframe: up to 142 daysOutcome measures
| Measure |
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
n=102 Participants
Screened for cervical cancer with mIVAA in mobile units
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
|
|---|---|
|
Number of Instances of Network Failure
|
1 network failures
|
Adverse Events
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place