18 and older, any sex, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the AppointmentPrimary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
82.4
Percentage of Women Approached Who Consented to Participate in StudySecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
100
Percentage of Women Approached Who Refused to Participate in StudySecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
0
Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+Secondary· up to 142 days
Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
6
Average Number of Days From Screening to When a Follow up Appointment is ScheduledSecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
26.6
± 41.1
Median Number of Days From Screening to When a Follow up Appointment is ScheduledSecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
6
3 – 116
Percentage of Women Who Were Screened Using mIVAASecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
100
Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAASecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
2.0
± 5.89
Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening DateSecondary· up to 7 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
100
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by MidwifeSecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
6
Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert ColposcopistSecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
17
Average Number of Attempts Per Woman Before a Readable Image is Obtained by MidwifeSecondary· up to 142 days
Group
Value
95% CI
mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)
3.35
± 0.7
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 17 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04421131.