Cervical CancerNCT04421131
mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
A study testing Pocket colposcope/Mobile phone camera and mIVAA in people with Cervical Cancer, run by Duke University at 1 site in Peru.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Pocket colposcope/Mobile phone camera and mIVAA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePeru
- Study dates
- 8 Jan 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant
- History of hysterectomy
- Does not understand the study purpose and details
- Is not willing to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Pocket colposcope/Mobile phone camera, mIVAA
- Keywords
- cervical cancer screening, colposcopy, digital health
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket colposcope/Mobile phone cameraDevice
The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
mIVAAOther
A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
| Study group | Role | What they receive |
|---|---|---|
| mIVAA | Experimental | Screened for cervical cancer with mIVAA in mobile units Receives: Device: Pocket colposcope/Mobile phone camera; Other: mIVAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment
Measured: up to 142 days
Secondary outcomes (13)
Percentage of Women Approached Who Consented to Participate in Study
Measured: up to 142 days
Percentage of Women Approached Who Refused to Participate in Study
Measured: up to 142 days
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.
Measured: up to 142 days
Average Number of Days From Screening to When a Follow up Appointment is Scheduled
Measured: up to 142 days
Median Number of Days From Screening to When a Follow up Appointment is Scheduled
Measured: up to 142 days
Percentage of Women Who Were Screened Using mIVAA
Measured: up to 142 days
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
Measured: up to 142 days
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
Measured: up to 7 days
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
Measured: up to 142 days
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
Measured: up to 142 days
Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
Measured: up to 142 days
Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
Measured: up to 142 days
Number of Instances of Network Failure
Measured: up to 142 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Lavanya Vasudevan, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421131
- Sponsor's protocol ID
- Pro00100618
- Other IDs
- R21TW011223-02
- Status last verified
- Sep 2022
- First submitted
- 4 Jun 2020
- Last updated
- 17 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
- ClinicalTrials.gov ID
- NCT04421131
- Acronym / sponsor ID
- Pro00100618
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer screening, colposcopy, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 17 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mIVAA | Experimental | Device: Pocket colposcope/Mobile phone camera, Other: mIVAAScreened for cervical cancer with mIVAA in mobile units |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Currently pregnant
- History of hysterectomy
- Does not understand the study purpose and details
- Is not willing to sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket colposcope/Mobile phone cameraThe Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix | Device | mIVAA |
| mIVAAA mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist | Other | mIVAA |
Primary outcome
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
13 secondary outcomes
Percentage of Women Approached Who Consented to Participate in Study
Time frame: up to 142 days
Percentage of Women Approached Who Refused to Participate in Study
Time frame: up to 142 days
Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+
Time frame: up to 142 days
Average Number of Days From Screening to When a Follow up Appointment is Scheduled
Time frame: up to 142 days
Median Number of Days From Screening to When a Follow up Appointment is Scheduled
Time frame: up to 142 days
Percentage of Women Who Were Screened Using mIVAA
Time frame: up to 142 days
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
Time frame: up to 142 days
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
Time frame: up to 7 days
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
Time frame: up to 142 days
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
Time frame: up to 142 days
Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
Time frame: up to 142 days
Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
Time frame: up to 142 days
Number of Instances of Network Failure
Time frame: up to 142 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavanya Vasudevan, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pocket colposcope/Mobile phone camera and mIVAA in people with Cervical Cancer, run by Duke University at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.