Acceptability of Self-sampling for Cervical Cancer Screening

Main objectives: 1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method. 1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling. Project methodology: Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random: 1. Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic. 2. No prior trainning group): Same training without practicing self-sampling collection. Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use. Acceptability will be analyzed according to two definitions: * proportion of women who returned the self-sampling device, * proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire. HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain. Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche.

Sex

Female

Minimum age

30 Years

Maximum age

65 Years

Inclusion Criteria:

Women aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago).

Exclusion Criteria:

* Women under 30 years of age.
* Women over 65 years of age.
* Pregnant women.
* Women with hysterectomy.
* Women between 30 and 65 years of age who underwent the last screening test more than four years ago.
* Women between the ages of 30 and 65 who attend for follow-up of some ongoing cervical pathology.

• BACKGROUNDSerrano B, Ibanez R, Robles C, Peremiquel-Trillas P, de Sanjose S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med. 2022 Jan;154:106900. doi: 10.1016/j.ypmed.2021.106900. Epub 2021 Nov 30. PMID 34861338
• DERIVEDIbanez R, Roura E, Acera A, Andujar M, Pavon MA, Bruni L, de Sanjose S. HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability. Prev Med. 2023 Aug;173:107571. doi: 10.1016/j.ypmed.2023.107571. Epub 2023 Jun 10. PMID 37308042