Clinical trial NCT06749847: HPV Self-sampling in the General Population
Official title: HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer
screening program
pilot project
randomised control trial
France
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Centre Régional de Coordination des Dépistages des Cancers de Grand Est
name: Central Hospital, Nancy, France
name: CHU de Reims
First posted: 2024-12-27
Enrollment: 4500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a three-arm study
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Participation rate in cervical cancer screening
timeFrame: 18 months after invitation
Secondary outcomes:
measure: Triage cytology completion rate after positive HPV test
timeFrame: 6 months after positive result
measure: HPV positivity rate
timeFrame: 12 months after invitation
measure: Invalid result rate
timeFrame: 18 months
measure: Time from HPV-positive result to completion of cytological triage
timeFrame: 18 months
measure: Women's acceptability of HPV self-sampling
timeFrame: 24 months
measure: Cost-effectiveness of screening strategies
timeFrame: 24 months
Other outcomes:
Locations:
city: Troyes
country: France
facility: Regional Cancer Screening Coordinating Centre, Aube site
state: Aube
city: Reims
country: France
facility: Regional Cancer Screening Coordinating Centre, Marne site
state: Marne
Study officials:
affiliation: Regional Cancer Screening Coordinating Centre, Marne site
name: Aurélie BERTRAND-BRICE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU REIMS
name: Christine CLAVEL CRAVOISIER, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Nancy
name: Hamza ACHIT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Farida SELMOUNI, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Catherine SAUVAGET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: