Abstract
Background: Local evidence is needed to assess dual-stain cytology against visual inspection with acetic acid (VIA) and to understand its place in HPV-based screening. Objective: To describe a proposed paired diagnostic accuracy study of p16INK4a/Ki-67 dual stain and VIA for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) among women with and without HIV at a Kisumu referral hospital. Methods: The 2023 proposal specifies consecutive enrolment of 800 women aged 25-65 years, index testing, histopathological verification where indicated, masked interpretation and HIV-stratified analysis. Sensitivity, specificity and predictive values with 95% confidence intervals are planned; partial verification requires a prespecified remedy. Operational measures include specimen adequacy, turnaround and referral completion. The indicative budget is USD 255,085. Status: The proposal supplies a design and planning estimates, not participant outcomes. The reference-standard and sample-size provisions must be finalized before recruitment. Conclusions about comparative accuracy or implementation await completed data.
Publication details
Article URL: https://www.nijamss.org/articles/nijamss-v1s2-aug2026-032/
Full-text PDF: https://www.nijamss.org/articles/nijamss-v1s2-aug2026-032/full-text.pdf
References
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Citation
Dr. Daniel A. Otwori. Comparing Dual Stain Cytology and Visual Inspection for Cervical Precancer in Kisumu, Kenya: A Diagnostic Accuracy Protocol. Nexus International Journal of Applied Science, Medicine and Social Sciences, Vol. 1, Issue 2, August 2026.
