Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening

Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?

Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.

Objectives:

• To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
• To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.

Trial design:

1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.

Inclusion criteria

• women aged between 30 and 65 years
• living in the Departments of Mayenne, Vendée and Sarthe (Pays de la Loire, France)
• who have not carried out a screening test (cytology of smear or HPV test) following a letter sent 12 months previously (in 2020 or 2021).

Exclusion criteria

• recent cervical sampling (less than three years old)
• women younger than 30 or older than 65 years
• women who have had a hysterectomy
• women with ongoing follow-up for a cervical lesion
• women who are not members or beneficiaries of a social security system.