Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether smartphone photos may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with conventional VIA, for human papillomavirus (HPV) positive women.

Detailed Description
-----------------
Background: Cervical cancer is the leading cause of cancer death in females in Madagascar. In this country, a large-scale screening of precancerous lesions with cytology is hardly possible, because of the lack of specialists and infrastructures. Visual inspection of the cervix with application of 5% acetic acid (VIA) is an inexpensive alternative but very subjective since it depends on the examiner's experience. Mobile telemedicine is a very promising tool in order to assist non-expert health-care workers in rural area for cervical cancer screening. Objective: To assess if Smartphone may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA) compared with conventional VIA, for women testing positive for human papillomavirus (HPV). Material and method: On-site health care workers will be trained in VIA. Prescreened HPV-positive women will be referred to VIA evaluation, during which digital images with a smartphone (D-VIA) will be taken for later evaluation by a VIA specialist in Geneva linked by telemedicine. Women with positive VIA results will be treated with cold coagulation if eligible. Histological results will be considered as gold standard. The results will be analyzed with Cohen's kappa coefficient, Mcnemar's test and Bonferroni's adjustment for multiple comparisons to assess the performance of D-VIA. Expected results: Based on the results of this project, the investigators will develop an educational training and quality assurance program for health providers for VIA and so contribute to a scaling-up of cervical cancer control. An appropriate triage by VIA will reduce not only an excessive referral rate but also an excessive treatment delay, giving the possibility of a screen (HPV), see (VIA/D-VIA), and treat program in a single or two visits.

Official Title
-----------------
Cervical Cancer Screening in Madagascar: Usability of Mobile Telemedicine for Detection of Precancerous Lesions From Smartphone Photos

Conditions
-----------------
Cervical Precancer

Intervention / Treatment
-----------------
* Device: D-VIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30-49 years HPV-positive Attending the cervical cancer screening program conducted by the Saint-Damien Health-Care Centre Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF) Exclusion Criteria: Previous Hysterectomy Conditions that can interfere with visualization of the cervix Pregnancy > 20 weeks Not able to comply with protocol study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-VIA<br>HPV high risk-positive (16, 18, 45, 31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 68) women had a cervical examination using acetic acid (VIA) application and visual inspection. | Device: D-VIA<br>* D-VIA images were captured during the cervical examination with a smartphone. Biopsies and cytological samples were taken on all patients and analyzed for gold standard results. Images were shown to off site experts. D-VIA and VIA diagnoses were then compared. Women who were diagnosed on-site as pathological underwent appropriate treatment at the same consultation. Women who were diagnosed as pathological later by histopathological analyses were asked to return to the clinic for treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer | Sensitivity and specificity will be calculated using histological results as gold-standard. All lesion Cin2 and worse will be considered as pathological. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA. |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer, HPV, VIA, screening, smartphone, telemedicine