Trial Outcomes & Findings for 1:1 Comparison of the Pocket Colposcope in Kenya (NCT NCT04998318)
NCT ID: NCT04998318
Last Updated: 2025-06-24
Results Overview
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
434 participants
Primary outcome timeframe
Baseline
Results posted on
2025-06-24
Participant Flow
Participant milestones
| Measure |
Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
196
|
208
|
11
|
19
|
|
Overall Study
COMPLETED
|
196
|
197
|
11
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
11
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1:1 Comparison of the Pocket Colposcope in Kenya
Baseline characteristics by cohort
| Measure |
Pocket Colposcope
n=196 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=208 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
n=11 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
n=19 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Total
n=434 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
25-34 years old
|
49 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
110 Participants
n=31 Participants
|
|
Age, Customized
35-44 years old
|
87 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
176 Participants
n=31 Participants
|
|
Age, Customized
45-54 years old
|
45 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
104 Participants
n=31 Participants
|
|
Age, Customized
55-65 years old
|
15 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
434 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
404 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
196 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
434 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Kenya
|
196 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
434 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants who completed the study
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Outcome measures
| Measure |
Pocket Colposcope
n=196 Exams
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Exams
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
n=11 Exams
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
n=19 Exams
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Percent of Exams With Lesions Identified
|
14.3 percent of exams
Interval 9.7 to 20.0
|
17.3 percent of exams
Interval 12.4 to 23.1
|
0 percent of exams
Interval 0.0 to 0.0
|
21.1 percent of exams
Interval 2.3 to 39.8
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants with biopsy results
Sensitivity of Pocket vs VIA
Outcome measures
| Measure |
Pocket Colposcope
n=196 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Sensitivity
|
26.3 percent
|
25.0 percent
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants with biopsy results
Specificity of Pocket vs VIA
Outcome measures
| Measure |
Pocket Colposcope
n=196 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Specificity
|
88.9 percent
|
84.0 percent
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants with biopsy results
Negative predictive value (NPV) of Pocket vs VIA
Outcome measures
| Measure |
Pocket Colposcope
n=196 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Negative Predictive Value (NPV)
|
82.9 percentage
|
87.1 percentage
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants with biopsy results
Positive predictive value (PPV) of Pocket vs VIA
Outcome measures
| Measure |
Pocket Colposcope
n=196 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Positive Predictive Value (PPV)
|
37.5 percentage
|
20.6 percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report.
Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit.
Outcome measures
| Measure |
Pocket Colposcope
n=190 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire
Pre-exam
|
21.6 percent of participants
|
21.8 percent of participants
|
—
|
—
|
|
Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire
Post-exam
|
0.5 percent of participants
|
0.5 percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Provider surveys for participants who completed the study. Provider survey data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report.
Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'.
Outcome measures
| Measure |
Pocket Colposcope
n=191 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Percent of Providers Who Reported Experiencing no Challenges During the Exam
|
96.3 percent
|
97.0 percent
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report.
Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?"
Outcome measures
| Measure |
Pocket Colposcope
n=190 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Percent of Participants Who Reported Experiencing Pain During Their Exam
None
|
21.6 percent of participants
|
21.8 percent of participants
|
—
|
—
|
|
Percent of Participants Who Reported Experiencing Pain During Their Exam
A little
|
73.2 percent of participants
|
74.1 percent of participants
|
—
|
—
|
|
Percent of Participants Who Reported Experiencing Pain During Their Exam
Somewhat
|
5.3 percent of participants
|
3.0 percent of participants
|
—
|
—
|
|
Percent of Participants Who Reported Experiencing Pain During Their Exam
Very much
|
0 percent of participants
|
1.0 percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report.
Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?"
Outcome measures
| Measure |
Pocket Colposcope
n=190 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
None
|
0.0 percent of participants
|
0.0 percent of participants
|
—
|
—
|
|
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
A little
|
3.2 percent of participants
|
2.5 percent of participants
|
—
|
—
|
|
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
Somewhat
|
28.4 percent of participants
|
28.4 percent of participants
|
—
|
—
|
|
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
Very much
|
68.4 percent of participants
|
69.0 percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report.
Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?"
Outcome measures
| Measure |
Pocket Colposcope
n=190 Participants
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Standard of Care (VIA)
n=197 Participants
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
Mis-weighted Randomization to Pocket Colposcope
Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
|
Mis-weighted Randomization to Standard of Care (VIA)
Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
|
|---|---|---|---|---|
|
Percent of Participants Who Would Recommend the Exam to a Friend
Not likely at all
|
0.0 percent of participants
|
0.5 percent of participants
|
—
|
—
|
|
Percent of Participants Who Would Recommend the Exam to a Friend
Not likely
|
1.1 percent of participants
|
0.0 percent of participants
|
—
|
—
|
|
Percent of Participants Who Would Recommend the Exam to a Friend
Likely
|
22.6 percent of participants
|
18.8 percent of participants
|
—
|
—
|
|
Percent of Participants Who Would Recommend the Exam to a Friend
Very likely
|
76.3 percent of participants
|
80.7 percent of participants
|
—
|
—
|
Adverse Events
Pocket Colposcope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care (VIA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mis-weighted Randomization to Pocket Colposcope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mis-weighted Randomization to Standard of Care (VIA)
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