Clinical Trial

Digital Telecytology for Triage of HPV-Positive Women in Cameroon

Recruiting
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Summary
This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings
Trial Details
NCT Number NCT07550010
Lead Sponsor University Hospital, Geneva
Collaborators: Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech
Conditions Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Cancer Screening Methods
Enrollment 1,800 participants
Start Date 2025-09-08
Primary Completion 2026-09-08 (estimated)
Study Completion 2027-09-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-24