A Randomized Trial Comparing the Diagnostic Accuracy of Visual Inspection with Acetic Acid to Visual Inspection with Lugol’s Iodine for Cervical Cancer Screening in HIV-Infected Women

Abstract

Visual inspection with Acetic Acid (VIA) and Visual Inspection with Lugol’s Iodine (VILI) are increasingly recommended in various cervical cancer screening protocols in low-resource settings. Although VIA is more widely used, VILI has been advocated as an easier and more specific screening test. VILI has not been well-validated as a stand-alone screening test, compared to VIA or validated for use in HIV-infected women. We carried out a randomized clinical trial to compare the diagnostic accuracy of VIA and VILI among HIV-infected women. Women attending the Family AIDS Care and Education Services (FACES) clinic in western Kenya were enrolled and randomized to undergo either VIA or VILI with colposcopy. Lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Between October 2011 and June 2012, 654 were randomized to undergo VIA or VILI. The test positivity rates were 26.2% for VIA and 30.6% for VILI (p = 0.22). The rate of detection of CIN2+ was 7.7% in the VIA arm and 11.5% in the VILI arm (p = 0.10). There was no significant difference in the diagnostic performance of VIA and VILI for the detection of CIN2+. Sensitivity and specificity were 84.0% and 78.6%, respectively, for VIA and 84.2% and 76.4% for VILI. The positive and negative predictive values were 24.7% and 98.3% for VIA, and 31.7% and 97.4% for VILI. Among women with CD4+ count < 350, VILI had a significantly decreased specificity (66.2%) compared to VIA in the same group (83.9%, p = 0.02) and compared to VILI performed among women with CD4+ count ≥ 350 (79.7%, p = 0.02). VIA and VILI had similar diagnostic accuracy and rates of CIN2+ detection among HIV-infected women.Trial RegistrationClinicalTrials.gov NCT02237326

Portable Pocket colposcopy performs comparably to standard‐of‐care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru

“…Previous studies comparing the performance of VIA to visual inspection with Lugol’s iodine (VILI) found similar diagnostic accuracy and rates of CIN2+ detection (30, 31); however, no studies have been conducted that assess the additive diagnostic accuracy of VIA + VILI.…”

“…We found that the addition of Lugol's iodine as a secondary contrast agent improved the agreement between the two colposcopes for all pathological categories by 8.9% and the accuracy of physician interpretation compared with pathology by 5.6 and 9.2% for the Pocket and standard-ofcare colposcopes, respectively. Previous studies comparing the performance of VIA with visual inspection with Lugol's iodine (VILI) found similar diagnostic accuracy and rates of CIN2+ detection; 30,31 however, no studies have been conducted that assess the additive diagnostic accuracy of VIA + VILI.…”

Reliability of Visual Inspection After Acetic Acid Staining in Screening for Cervical Pre-malignant Lesion Among Female Subjects in a Rural Tertiary Hospital in Nigeria

“…[29] Similarly studies done in some other Africa countries like Egypt and Kenya revealed higher level of sensitivity of VIA. [23,30] Though, histology was not done in our study, but this is significantly high enough to validate VIA in a criterion validity. A specificity of 91.2% in a criterion validity study shows that there is an appreciable agreement between the study screening test (VIA) and the gold standard (Pap smear) in addition to the fact that VIA was able to pick 100% of HGSIL detected with Papanicolaou smear.…”

Prevention of human papillomavirus (HPV)-related tumors in people living with human immunodeficiency virus (HIV)

“…The most commonly used screening methods include conventional cervical cytology (Pap smears), hrHPV testing, and visual inspection with acetic acid (VIA). Several studies have evaluated the performance of these methods in WLWH [114][115][116][117][118][119][120][121][122][123][124][125]. Generally, hrHPV DNA testing is the most sensitive method for detecting CIN2+ lesions (range 89-95%), followed by conventional cytology (53-93%) and VIA (48-84%).…”