N/A
Completed N=110
mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
Source: ClinicalTrials.gov NCT04421131 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment — 82.4 percentage of women
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment |
82.4 | — |
| SECONDARY Percentage of Women Approached Who Consented to Participate in Study |
100 | — |
| SECONDARY Percentage of Women Approached Who Refused to Participate in Study |
— | — |
| SECONDARY Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+ |
6 | — |
| SECONDARY Average Number of Days From Screening to When a Follow up Appointment is Scheduled |
26.6 | — |
| SECONDARY Median Number of Days From Screening to When a Follow up Appointment is Scheduled |
6 | — |
| SECONDARY Percentage of Women Who Were Screened Using mIVAA |
100 | — |
| SECONDARY Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA |
2.0 | — |
| SECONDARY Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date |
100 | — |
| SECONDARY Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife |
6 | — |
| SECONDARY Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist |
17 | — |
| SECONDARY Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife |
3.35 | — |
| SECONDARY Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert |
84.3 | — |
| SECONDARY Number of Instances of Network Failure |
1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04421131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.