NCT06749847

HPV Self-sampling in the General Population

HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.

Detailed description

In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
OTHER	Women receive invitation letter with HPV self-sampling kit	Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.
OTHER	Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider	Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.

Timeline

• Start date: 2025-06-26
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-12-27
• Last updated: 2025-07-23

Locations

2 sites across 1 country: France