Introduction HPV vaginal self-sampling is more acceptable by women than health-provider cervical cancer screening methods. However, only a minority of HPV positive women will need treatment for pre-cancerous lesions, which requires an effective triage test. Visual inspection with acetic acid (VIA) is recommended as a triage, but the sensitivity and specificity are questioned. The aim of this randomised controlled study is to compare the accuracy of VIA with and without Lugol’s Iodine (VILI).
Methods All women from an urban Ethiopian cohort with a cervix are eligible. Participants each collect two vaginal self-samples for HPV DNA analysis at Addis Ababa University laboratory. HPV positive women are stratified according to age and pregnancy status, and then randomized to either VIA or VIA with VILI (RedCap software). They are then examined at a clinic according to the allocated triage test. All women, except those pregnant, have a biopsy taken from the lesion or at 12 and 6 o’clock. If a lesion is visualized, they are immediately treated, unless pregnant. All biopsies are evaluated by a senior pathologist.
Current Trial Status 940 participants have been screened with an HPV vaginal self-sample (Date 16/7/2023). 131 were hrHPV positive and have visited the VIA clinic. 175 HPV positive women are needed to be examined at the clinic to get enough statistical power for the analyses we hope to reach in September 2023. Final results will be presented at IGCS.
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