HPV Self-sampling in the General Population

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Participation rate in cervical cancer screening [Срок оценки: 18 months after invitation]

Вторичные конечные точки (6)

• Triage cytology completion rate after positive HPV test [Срок оценки: 6 months after positive result]
• HPV positivity rate [Срок оценки: 12 months after invitation]
• Invalid result rate [Срок оценки: 18 months]
• Time from HPV-positive result to completion of cytological triage [Срок оценки: 18 months]
• Women's acceptability of HPV self-sampling [Срок оценки: 24 months]
• Cost-effectiveness of screening strategies [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 2 центра

• Regional Cancer Screening Coordinating Centre, Aube site — Troyes
• Regional Cancer Screening Coordinating Centre, Marne site — Reims

Идентификаторы

NCT: NCT06749847 · IEC/24-01 · 2023-215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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