Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine

Prof. Patrick Petignat

Status: Completed

Conditions: Cervical Precancer

Treatments: Device: D-VIA

Study type: Interventional

Funder types: Other

Identifiers

NCT02693379

14-071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,041 patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,041 participants in 1 patient group

D-VIA

Experimental group

Description:

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.

Treatment:

Device: D-VIA