HPV Self-sampling in the General Population (MIRABELLE)

International Agency for Research on Cancer

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Other: Women receive invitation letter with HPV self-sampling kit; Other: Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

Study type: Interventional

Funder types: Other

Identifiers

NCT06749847

IEC/24-01

2023-215 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,000 participants in 3 patient groups

Outreach

Experimental group

Description:

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.

Treatment:

Other: Women receive invitation letter with HPV self-sampling kit

Choice

Experimental group

Description:

Women receive an invitation letter offering a choice between ordering a free self-sampling kit or visiting a 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.

Treatment:

Other: Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

Control arm

No Intervention group

Description:

Standard invitation to visit healthcare provider for cervical cancer screening. Standard screening procedure. Follow standard organized screening program procedure. HPV self-sampling offered at 12-month reminder if no participation.