HPV Self-sampling in the General Population

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06749847
• Lead Sponsor: International Agency for Research on Cancer

Brief 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4500

Inclusion Criteria

• Women aged 30 to 65 years old
• Living in the study area (Departments of Marne and Aube, France)
• At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Exclusion Criteria

• Outside the target age (less than 30 years old, or 66 years old and more)
• Already participating in the current screening round
• Total hysterectomy
• History of cervical cancer
• Current follow-up for abnormal cervical screening result or cervical lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participation rate in cervical cancer screening	18 months after invitation

Secondary Outcome Measures

Name	Time	Method
Triage cytology completion rate after positive HPV test	6 months after positive result
HPV positivity rate	12 months after invitation
Invalid result rate	18 months
Time from HPV-positive result to completion of cytological triage	18 months
Women's acceptability of HPV self-sampling	24 months	Qualitative assessment through semi-structured interviews with 40 women to assess women's acceptability of HPV self-sampling
Cost-effectiveness of screening strategies	24 months	Costs will be estimated using an ingredients approach whereby resources used for the respective interventions (' Outreach ' and ' Choice' strategies) are identified and valued. The analysis will include all costs incurred by the screening program, including invitation materials, self-sampling kits, laboratory testing, result communication, and follow-up coordination. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between each intervention arm and the control arm, divided by the mean difference in screening participation rates. Results will be expressed in euros per percentage change in screening participation.

Trial Locations

Locations (2)

Regional Cancer Screening Coordinating Centre, Marne site; 🇫🇷 Reims, Marne, France

Regional Cancer Screening Coordinating Centre, Aube site; 🇫🇷 Troyes, Aube, France