NIJAMSS peer-reviewed article

Comparing Dual Stain Cytology and Visual Inspection for Cervical Precancer in Kisumu, Kenya: A Diagnostic Accuracy Protocol

Daniel A. Otwori

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.

Keywords: Cervical cancer screening; Diagnostic accuracy; Dual stain; HIV; Kisumu; Protocol

Journal

Nexus International Journal of Applied Science, Medicine and Social Sciences

e-ISSN

3144-2196

Publication date

August 2026

Volume / Issue

Vol. 1, Issue 2

Paper number

032

Article type

Study Protocol

Published paper ID

NIJAMSS-V1S2-AUG2026-032

Publisher

Nexus Academic Press

Access

Open Access

Full text PDF: https://www.nijamss.org/archives-download/nijamss-vol-1-series-2-august-2026-paper-032.pdf