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.

Craig R. Cohen,Jennifer Sneden,Jennifer M. Zakaras,Elizabeth Ann Bukusi,Megan J. Huchko,Karen Smith-McCune,May Maloba,George Sawaya

doi:10.1371/journal.pone.0118568

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

Highlights

Cervical cancer is the fourth most common cancer in women, with an estimated 527,624 cases diagnosed globally in 2012.[1]
While studies in low-resource settings have shown that human papillomavirus (HPV) testing is most effective in reducing cervical intraepithelial neoplasia grade 2 or worse lesions, including cervical cancer,[8] at present, costs can be prohibitive and the reality remains that most countries do not have the resources to implement widespread HPV testing
Sensitivity and specificity were similar to that seen in general populations for both cytology and Visual inspection with Acetic Acid (VIA), somewhat lower in this study for Visual Inspection with Lugol’s Iodine (VILI).[12,17,27]

Summary

Introduction

Cervical cancer is the fourth most common cancer in women, with an estimated 527,624 cases diagnosed globally in 2012.[1] Nearly 85% of cases and 87% of deaths occur in less developed regions, in sub-Saharan Africa where several factors conspire to make cervical cancer a leading cause of cancer and cancer-related mortality.[2] Inadequate health care and public health infrastructure, competing health priorities, and persistent poverty prevent large-scale cervical cancer prevention programs from gaining traction; today, only an estimated 5% of women in Sub-Saharan Africa have ever been screened.[3] High rates of HIV infection in the region further escalate cervical cancer incidence through an increased risk for human papillomavirus (HPV) infection—the primary cause of cervical cancers and precancerous cervical lesions—and an accelerated incidence and progression of cervical neoplasia.[4] Growing antiretroviral use in recent years is extending lifespans for HIV-infected women, without a clear benefit for cervical cancer outcomes This increases the number of women living longer with excess cervical cancer risk,[5] making the implementation of effective screening programs an urgent public health priority these low-resource settings. While studies in low-resource settings have shown that HPV testing is most effective in reducing cervical intraepithelial neoplasia grade 2 or worse lesions, including cervical cancer,[8] at present, costs can be prohibitive and the reality remains that most countries do not have the resources to implement widespread HPV testing

Methods

Results

Conclusion