Objective The 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.

Methods We 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.

Findings The 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.

Conclusion Provider 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.

Dr. Nimmi Ramanujam is an advisor and Mary E Dotson is an employee of the Calla Health Foundation which have commercialized the Pocket Colposcope for distribution globally.

NCT04998318

This RCT was supported by USAID-Development Innovation Ventures (DIV) under award #7200AA19FA00001

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocols, consent forms, and provider and patient questionnaires were reviewed by the institutional review boards of both the Kenya Medical Research Institute (KEMRI) and Duke University prior to study initiation.

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Disclaimers: The research conducted and described in this article are the original work of the authors.

Financial Disclosure: This RCT (NCT04998318) was supported by USAID-Development Innovation Ventures (DIV) under award #7200AA19FA00001

Clinical Trails Number: NCT04998318

Competing Interests Statement: Dr. Nimmi Ramanujam is an advisor and Mary E Dotson is an employee of the Calla Health Foundation which have commercialized the Pocket Colposcope for distribution globally.

Creative Commons License: All authors agree to publish this article under the creative Commons Attribution 3.0 IGO license.

All data is available within Duke’s research data repository.