HPV Self-sampling in the General Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Women receive invitation letter with HPV self-sampling kit, Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness
Overview
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.
Interventions
- 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.
Primary outcome measures
- Participation rate in cervical cancer screening [Time frame: 18 months after invitation]
Secondary outcome measures (6)
- Triage cytology completion rate after positive HPV test [Time frame: 6 months after positive result]
- HPV positivity rate [Time frame: 12 months after invitation]
- Invalid result rate [Time frame: 18 months]
- Time from HPV-positive result to completion of cytological triage [Time frame: 18 months]
- Women's acceptability of HPV self-sampling [Time frame: 24 months]
- Cost-effectiveness of screening strategies [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 2 centers
- Regional Cancer Screening Coordinating Centre, Aube site — Troyes
- Regional Cancer Screening Coordinating Centre, Marne site — Reims
Identifiers
NCT: NCT06749847 · IEC/24-01 · 2023-215