Cervical Precancer Clinical Trial
Official title:
Cervical Cancer Screening in Madagascar: Usability of Mobile Telemedicine for Detection of Precancerous Lesions From Smartphone Photos
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.
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 Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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