Evaluating HPV Self-sampling Strategies to Improve Cervical Cancer Screening in Women Aged 30 to 65 in France

What this Trial Is About

Researchers are evaluating three different approaches to improve cervical cancer screening participation among women aged 30 to 65 years living in two French departments. The study compares direct mailing of an HPV self-sampling kit, offering a choice between self-sampling or healthcare provider sampling, and the standard screening procedure. This randomized controlled trial aims to increase screening rates, assess feasibility, acceptability, and cost-effectiveness of these methods to inform the national screening program in France. Participants are randomly assigned to one of three groups the Outreach group receives a self-sampling kit directly by mail along with an SMS reminder if they do not participate within three months, plus assistance for follow-up cytology if HPV positive. The Choice group receives an invitation offering either to order a self-sampling kit or visit a healthcare provider, with reminders if they do not participate. The control group follows the standard invitation process with HPV self-sampling offered after a 12-month reminder if needed. Throughout the study, researchers will monitor participation rates at 18 months post-invitation, HPV positivity rates, completion of follow-up cytology, time to triage, and acceptability of self-sampling up to 24 months. Cost-effectiveness of each screening strategy will also be evaluated. Women will receive support for follow-up testing if needed, and reminders will encourage completion of screening steps. The total participation period lasts at least 24 months with ongoing data collection.

HPV Self-sampling in the General Population