Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine
Condition: Cervical Precancer
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional

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.
    

Intervention name(s): D-VIA
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cervical cancer; HPV; VIA; screening; smartphone; telemedicine