Cervical Cancer
Conditions
Keywords
cervical cancer screening, colposcopy, digital health
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. 1. The digital imaging device is either a mobile phone camera or the pocket colposcope plugged into a mobile phone. 2. 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.
Interventions
DEVICEPocket colposcope/Mobile phone camera
The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
OTHERmIVAA
A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
Sponsors
Fogarty International Center of the National Institute of Health
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment | up to 142 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Women Who Were Screened Using mIVAA | up to 142 days | — |
| 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 | 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 | up to 142 days | — |
| Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA | up to 142 days | — |
| Median Number of Days From Screening to When a Follow up Appointment is Scheduled | up to 142 days | — |
| Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife | up to 142 days | — |
| Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist | up to 142 days | — |
| Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife | up to 142 days | — |
| Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert | up to 142 days | — |
| Number of Instances of Network Failure | up to 142 days | — |
| Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date | up to 7 days | — |
Countries
Peru
Participant flow
Pre-assignment details
Informed consent was obtained prior to establishing eligibility. One consented participant was deemed ineligible and one was ineligible due to not completing screening.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | App crashed | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) |
|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 102 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 78 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment Peru | 102 Participants |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
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
Population: Participants who were referred.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | 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
Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
Time frame: up to 142 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife | 3.35 attempts | Standard Deviation 0.7 |
Secondary
Average Number of Days From Screening to When a Follow up Appointment is Scheduled
Time frame: up to 142 days
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Average Number of Days From Screening to When a Follow up Appointment is Scheduled | 26.6 days | Standard Deviation 41.1 |
Secondary
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
Time frame: up to 142 days
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA | 2.0 hours | Standard Deviation 5.89 |
Secondary
Median Number of Days From Screening to When a Follow up Appointment is Scheduled
Time frame: up to 142 days
Population: Participants who completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Median Number of Days From Screening to When a Follow up Appointment is Scheduled | 6 days |
Secondary
Number of Instances of Network Failure
Time frame: up to 142 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Number of Instances of Network Failure | 1 network failures |
Secondary
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.
Time frame: up to 142 days
Population: Participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+ | 6 Participants |
Secondary
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
Time frame: up to 142 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist | 17 Participants |
Secondary
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
Time frame: up to 142 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife | 6 Participants |
Secondary
Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
Time frame: up to 142 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert | 84.3 percentage of women |
Secondary
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
Time frame: up to 7 days
Population: Participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date | 100 percentage of women |
Secondary
Percentage of Women Approached Who Consented to Participate in Study
Time frame: up to 142 days
Population: Women who were approached to participate in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Percentage of Women Approached Who Consented to Participate in Study | 100 percentage of women |
Secondary
Percentage of Women Approached Who Refused to Participate in Study
Time frame: up to 142 days
Population: Women who were approached to participate in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Percentage of Women Approached Who Refused to Participate in Study | 0 percentage of women |
Secondary
Percentage of Women Who Were Screened Using mIVAA
Time frame: up to 142 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid) | Percentage of Women Who Were Screened Using mIVAA | 100 percentage of women |