Evaluating Same-Day Self-Sampling and Genotyping Screening for Cervical Cancer Prevention in Women Aged 30 to 64

What this Trial Is About

Cervical cancer remains a major health challenge, especially in low- and middle-income countries where over 90% of cases occur. Current global strategies aim to eliminate cervical cancer by 2030, but many regions may not meet these goals until much later. This trial evaluates a new rapid and affordable screening method using the AmpFireae human papillomavirus HPV test combined with artificial intelligence-based imaging triage Automated Visual Evaluation, AVE to improve early detection and treatment in Honduras. The study involves testing 4,000 women with both self- and provider-collected samples using the modified AmpFireae platform to detect cervical precancer. Women who test positive or a small random sample of negatives will undergo further examination including visual inspection with acetic acid VIA, AVE, colposcopy, and biopsy. HPV-positive women may receive immediate ablation treatment if eligible. Additionally, 1,000 women will participate in a single-visit screening approach using self-sampling with follow-up testing one year later. The study also assesses the cost-effectiveness of the new approach compared to the current VIA strategy. Participants will complete questionnaires on acceptability and experience, and healthcare providers will be surveyed on the screening process. Follow-up visits at one year will include repeat HPV testing, AVE, and colposcopy for HPV-positive women. Outcomes measured include test accuracy, feasibility of same-day screening and treatment, and economic impact. Safety and quality of pathology review are monitored throughout. The total study duration for primary outcomes is two years.

Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling