A Randomized Clinical Trial Comparing Visual Inspection with Acetic Acid (VIA) to Pocket Colposcopy for the Triage of HPV+ women living with HIV in Kisumu, Kenya

ObjectiveThe World Health Organization recommends a "screen, triage, treat" approach for cervical cancer screening for Women Living with HIV (WLWH) in resource-limited settings, with Human Papillomavirus (HPV) testing preferred for screening. We assessed the use of the Pocket colposcope as an adjunct tool to Visual Assessment with Acetic Acid (VIA) for the triage of HPV+ WLWH. MethodsWe carried out a randomized clinical trial across six clinics in Kisumu, Kenya between November 2022 and April 2023 (NCT04998318). WLWH who screened positive with self-collected HPV were randomized to either the VIA or Pocket arm. Exam positivity was determined by presence or absence of aceto-white epithelium (AWE). Directed biopsies were performed on AWE; if negative, two random biopsies were taken. Pathology was used to determine diagnostic accuracy. Providers and participants took brief surveys after each exam. FindingsThe rate of a positive exams was 17.3% for VIA compared to 14.3% for the Pocket. The overall rate of CIN2/3 was 15.4%, with 12.2% in the VIA Arm and is 18.8% in the Pocket Arm. Pocket and VIA performed comparably on all sensitivity, specificity and negative predictive value (NPV). For Pocket compared to VIA, Sensitivity was 26.3% vs 25.0%; specificity was 88.9% vs 84.0%; and NPV was 82.9% vs 87.1%. However, the positive predictive value (PPV) of the Pocket colposcope arm was almost a factor of two higher than that of the VIA arm (Pocket arm PPV was 375 is and that of the VIA arm was 20.6%). The Pocket Colposcope was acceptable to providers and patients for clinic-based triage of HPV positivity. ConclusionProvider assessment with the Pocket colposcope detected significantly more treatable disease, thereby reducing the need for overtreatment. This study indicates that the Pocket colposcope is a feasible, lower cost colposcopic device, which could facilitate biopsy-confirmation of disease, increase provider training, patient education and facilitate remote diagnosis.