title: 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.
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America.
authors: Megan J
authors: MJ
authors: Huchko
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America.
authors: Jennifer
authors: J
authors: Sneden
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America.
authors: Jennifer M
authors: JM
authors: Zakaras
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America.
authors: Karen
authors: K
authors: Smith-McCune
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, United States of America.
authors: George
authors: G
authors: Sawaya
authors: Family AIDS Care and Education Services, Kenya Medical Research Institute, Kisumu, Kenya.
authors: May
authors: M
authors: Maloba
authors: Family AIDS Care and Education Services, Kenya Medical Research Institute, Kisumu, Kenya; Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya; Department of Obstetrics and Gynecology, University of Nairobi, Nairobi, Kenya.
authors: Elizabeth Ann
authors: EA
authors: Bukusi
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America.
authors: Craig R
authors: CR
authors: Cohen
mesh_terms: D019342:Acetic Acid / Q000378:metabolism*; D000328:Adult; D004396:Coloring Agents / Q000378:metabolism; D003127:Colposcopy / Q000379:methods; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006678:HIV / Q000472:pathogenicity; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007454:Iodides; D008403:Mass Screening / Q000379:methods; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears / Q000379:methods
chemical_list: D004396:Coloring Agents; D007454:Iodides; D019342:Acetic Acid; C010389:Lugol's solution