Cervical cancer screening in sub-Saharan Africa: a randomized trial of VIA versus cytology for triage of HPV-positive women.

Developing countries are interested in using human papillomavirus (HPV) testing as a primary screening test for cervical cancer prevention programs. The low specificity of the HPV assay requires triage testing of HPV-positive women. The aim of the study is to compare visual inspection with acetic acid (VIA) and cytology as triage testing methods in HPV-positive women to detect cervical intraepithelial neoplasia or Grade 2 or higher (CIN2+). The study was conducted in two Cameroonian towns (Yaoundé and Edea) and included 846 eligible women aged 25 to 65 years. All participants performed self-HPV testing. HPV-positive women (n = 259) were randomly assigned to be tested either by VIA (VIA group) or cytology (cytology group). HPV-positive women had both cervical biopsy and endocervical curettage to detect biopsy-confirmed CIN2+. All statistical tests were two-sided. The prevalence of HPV was 38.5%, and the mean age of HPV-positive women was 41.5 ± 10.1 years. One hundred ninety-eight women (97 in the VIA group and 99 in the cytology) were randomly assigned to one of the two testing arms. The sensitivity of VIA was 25.0% (95% CI, 7.1-59.1%), and the sensitivity of cytology was 90.0% (59.6-98.2%). The specificity was 74.2% (95% CI, 64.2-82.1%) for VIA and 85.2% (76.3-91.2%) for cytology. ROC area for cytology was 0.910 against the 0.496 area for VIA. In this trial, VIA was inferior to cytology as a triage test among HPV-positive women. Further investigations are needed to determine the optimal triage method for HPV-positive women.

RCT Entities:   Population Interventions Outcomes