Evaluation of Direct Visual Inspection of the Cervix in Detecting Cytology Diagnosed Squamous Intraepithelial Lesion in Women of known HIV Status. A Randomized Trial (CANHIV Study).

A two-arm, open label, randomized study, evaluated the test characteristics of visual inspection of cervix with Acetic acid(VIA) and Lugol‟s Iodine(VILI) in detecting cytology diagnosed squamous intraepithelial lesion(SIL) in 1160 women of known HIV status in southwestern Nigerian. Using SIL as reference standard and the HIV status masked, VIA and VILI had similar test characteristics except for the positive predictive value in which VIA value of 91.5% was significantly higher than 77.7% for VILI ( p=0.01). Among HIV positive women, VILI performed poorly across all the 4 test characteristics compared to VIA. Among severely immuno-compromised HIV positive participants VILI performance was consistently below 80% across all test characteristics (sensitivity-70.0%; specificity-66.9%; positive predictive value-46.7%; negative predictive value(NPV)-50.0%) compared to VIA (Senstivity-71.3%; specificity-88.2%; positive predictive value-83.3%; negative predictive value -88.2). Our study shows that VILI is insufficiently sensitive and specific in the presence of HIV infection especially in those with severe immunosuppression. Based on VIA‟s acceptable sensitivity and NPV in all situations, it is recommended for cervical cancer screening in HIV positive women and in settings of high HIV burden.