Study of Same-Day Cervical Cancer Screening Using HPV Self-Sampling and Digital Telecytology for HPV-Positive Women in Cameroon

What this Trial Is About

Researchers are evaluating a same-day cervical cancer screening strategy in Cameroon that uses HPV self-sampling followed by digital telecytology triage for women who test positive for HPV. The study focuses on women aged 30 to 49 years, or 25 to 49 years if HIV-positive, aiming to assess the accuracy and practicality of this approach in detecting cervical intraepithelial neoplasia grade 2 or worse CIN2. The study also explores AI-assisted telecytology and visual inspection with acetic acid VIA as secondary tools, and assesses the acceptability of these screening and treatment methods among women and healthcare providers. Participants will collect vaginal samples for primary HPV testing using the GeneXpert system, which provides rapid detection and detailed genotyping. Women positive for HPV16 will be offered immediate thermal ablation treatment. Those positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo same-day triage with digital telecytology, and if cytology shows abnormalities, thermal ablation is provided. Women positive for other HPV types will be followed up after 12 months without immediate treatment unless clinically needed. All HPV-positive women will receive endocervical sampling and biopsy as part of the diagnostic process. During the study, participants will undergo visual inspection, cytology slide preparation, and biopsies with remote evaluation by cytopathologists. Women with abnormal cytology are treated on the same day, and those diagnosed with CIN2 receive appropriate treatment. Follow-up includes telephone calls 4 to 6 weeks after treatment to monitor side effects and acceptability, and a 12-month visit for repeat HPV testing and further examination when needed. The study will measure diagnostic accuracy, feasibility of the test-triage-treat method, AI tool performance, and acceptability over up to 26 months.

Digital Telecytology for Triage of HPV-Positive Women in Cameroon