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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW011223-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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 specific aim is to pilot test mIVAA in a community-based setting in Peru.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mIVAA | Experimental | Screened for cervical cancer with mIVAA in mobile units |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pocket colposcope/Mobile phone camera | Device | The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lavanya Vasudevan, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Liga Contra el Cancer-Peru | Lima | Peru |
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Informed consent was obtained prior to establishing eligibility. One consented participant was deemed ineligible and one was ineligible due to not completing screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment | Participants who were referred. | Posted | Number | percentage of women | up to 142 days |
|
|
Up to 142 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lavanya Vasudevan, Ph.D. | Duke University | 919-613-1423 | lavanya.vasudevan@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2021 | Jun 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| mIVAA | Other | 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+ |
Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer. |
| 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 |
| Percentage of Women Who Were Screened Using mIVAA | up to 142 days |
| Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA | up to 142 days |
| Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date | up to 7 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Percentage of Women Approached Who Consented to Participate in Study | Women who were approached to participate in the study. | Posted | Number | percentage of women | up to 142 days |
|
|
|
| Secondary | Percentage of Women Approached Who Refused to Participate in Study | Women who were approached to participate in the study. | Posted | Number | percentage of women | up to 142 days |
|
|
|
| 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. | Participants who completed the study. | Posted | Count of Participants | Participants | up to 142 days |
|
|
|
| Secondary | Average Number of Days From Screening to When a Follow up Appointment is Scheduled | Participants who completed the study. | Posted | Mean | Standard Deviation | days | up to 142 days |
|
|
|
| Secondary | Median Number of Days From Screening to When a Follow up Appointment is Scheduled | Participants who completed the study. | Posted | Median | Full Range | days | up to 142 days |
|
|
|
| Secondary | Percentage of Women Who Were Screened Using mIVAA | Posted | Number | percentage of women | up to 142 days |
|
|
|
| Secondary | Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA | Participants who completed the study. | Posted | Mean | Standard Deviation | hours | up to 142 days |
|
|
|
| Secondary | Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date | Participants who completed the study. | Posted | Number | percentage of women | up to 7 days |
|
|
|
| Secondary | Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife | Posted | Count of Participants | Participants | up to 142 days |
|
|
|
| Secondary | Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist | Posted | Count of Participants | Participants | up to 142 days |
|
|
|
| Secondary | Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife | Posted | Mean | Standard Deviation | attempts | up to 142 days |
|
|
|
| Secondary | Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert | Posted | Number | percentage of women | up to 142 days |
|
|
|
| Secondary | Number of Instances of Network Failure | Posted | Number | network failures | up to 142 days |
|
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |